Every finding on record at Community Home Care Services Inc

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: 6/5/2024 to 6/11/2024 Active Census: 30 At this Emergency Preparedness survey, Community Home Care Services, Inc, was found in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102. QR: A1 6/21/2024

This visit was for a Federal Recertification and State Re-Licensure survey of a Home Health Provider. Survey Dates: 6/5/2024 to 6/7/2024 and 6/10/2024 to 6/11/2024 12-Month Unduplicated Skilled Admissions: 86 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. During this Federal Recertification Survey, Community Home Care Services, Inc. was found to be out of compliance with Conditions of Participation 484.60 Care planning, coordination of services, and quality of care and 484.105 Organization and administration of services. Based on the Condition-level deficiencies during the 6/11/2024 survey, your home health agency was subject to an extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 6/7/2024. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating a home health aide training, skills competency and/or competency evaluation programs for a period of two years beginning 6/11/2024 and continuing through 6/10/2026. QR: A1 6/21/2024

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to provide the name and contact information of the administrator in 1 of 2 home visits with a registered nurse. (Patient #3) The findings include: At an observation of care at the patient’s home for Patient #3 on 6/6/2024 between 11:54 AM and 12:58 PM, the agency’s folder was reviewed with the name of Person 8 as the agency administrator. On 6/6/2024, beginning at 12:18 PM, the patient indicated they were unsure who the agency administrator was. On 6/7/2024, at 2:30 PM, the Administrator indicated Person 8 was the previous administrator that left the agency in 2023 and indicated the agency folder in the patient’s home should be updated with the current administrator’s name and contact information.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient was informed about and consented to the type and frequency of care provided in advance of and during treatment in 5 of 7 records reviewed (Patient #1, 3, 4, 5, 6). The findings include: 4. A clinical record review for Patient #3 evidenced a plan of care for certification period 7/18/2023-9/15/2023, which indicated the agency was to provide physical therapy services 1 time a week for 8 weeks and skilled nursing services 1 time a week for 9 weeks. The “Admission Consent” signed and dated by the patient on 7/18/2023, failed to evidence the frequency of the physical therapy and skilled nursing services to be provided. The consent indicated the agency would provide occupational therapy (OT) services, and review failed to evidence the agency provided OT services. No additional consents were noted and no documentation the patient was notified of the visit frequency or the change in OT services to be provided. On 6/7/2024, beginning at 1:40 PM, the Administrator indicated the agency documented the patient was notified in advance and with any changes in care on the consent form and indicated the visit frequency was not completed on the form. The Administrator indicated the agency did not provide OT services and there was no other consent form. 5. A clinical record review for Patient #4 evidenced a plan of care for certification period 6/8/2024-8/6/2024 which indicated the agency would provide skilled nursing services 2 times a week. The “Admission Consent” signed and dated by the patient on 4/9/2024, failed to evidence the patient was informed prior to the change in frequency. On 6/10/2024, at 1:57 PM, the Administrator indicated there was no documentation that the patient was informed of the change in skilled nurse visit frequency to 2 times per week. On 6/11/2024, at 10:45 AM, the Administrator-in-Training indicated the correct skilled nurse visit frequency for the certification period beginning 6/8/2024 was 2 times per week. 410 IAC 17-12-3(b)(2)(D)(i)(AA) 1. A review of the admission consent for Patient #1, signed 5/15/2024, indicated the Patient was to receive skilled nursing visits once a week for 9 weeks, and a physical therapy evaluation. The plan of care for certification period 5/15/2024 to 7/13/2024 indicated the Patient was receiving skilled nursing once a week for four weeks, then one visit every other week, and physical therapy twice a week for four weeks, then once a week for 4 weeks. A clinical record review failed to evidence the patient was informed about and consented to the change in nursing visit frequency and schedule of physical therapy visits. During an interview on 6/10/2024 at 11:44 AM, the Administrator indicated the clinician should have ensured the patient consented to the change in frequency from what was on the consent, and had the Patient fill out a “change form” to acknowledge their consent, but she did not find this in the Patient’s record. 2. A review of the plan of care for certification period 6/5/2024 to 8/3/2024 indicated Patient #5 was to receive skilled nursing visits once a week for 9 weeks. A clinical record review evidenced skilled nurse visits were scheduled once every other week but failed to evidence the patient was informed about and consented to the change in nursing visit frequency. During an interview on 6/11/2024 at 11:44 AM, Administrative Staff 2 indicated the clinician should have ensured the patient consented to the change in frequency of nurse visits and documented this, but she did not find this in the Patient’s record. 3. A review of the plan of care for certification period 5/3/2024 to 7/1/2024 indicated physical therapy was to evaluate and treat Patient #6. A review of the Patient’s admission consent failed to evidence a frequency of physical therapy visits. During an interview on 6/11/2024 at 11:40 AM, PT (Physical Therapist) 2 indicated most post-knee replacement patients get 3 PT visits a week, but the Patient agreed to 2 PT visits per week because they had a previous knee replacement and knew what to expect. During an interview on 6/11/2024 at 11:00 AM, the Patient indicated they were supposed to get 3 PT visits per week, but PT 2 changed it to twice a week. The Patient indicated they did not know why, and did not want less than 3 visits per week.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to conduct an initial assessment within 48 hours of patient referral in 3 of 5 active clinical records reviewed (Patient #2, 3, 4) and 1 of 2 closed clinical records reviewed (Patient #7). Findings include: 3. A clinical record review for Patient #3 evidenced a referral order dated 7/14/2023 for home health services. The start of care comprehensive assessment dated 7/18/2023 indicated the referral date was 7/14/2023 and failed to evidence documentation to the reason for delay in the start of care. On 6/7/2024, at 1:46 PM, the Administrator indicated she was unsure why there was a delay in the initial visit after referral and indicated there was no documentation regarding the delay. 4. A clinical record review for Patient #4 evidenced a referral document from Entity 9 dated 4/3/2024, which indicated the patient was moving back to the assisted living facility (ALF) on 4/5/2024 and would need home health services. The start of care comprehensive assessment was completed 4/9/2024 and failed to evidence the reason for the delay in the initial assessment. On 6/10/2024, at 1:23 PM, the Administrator indicated there was no documentation on the reason for the delay in the initial assessment. 5. During the entrance conference on 6/5/2024, beginning at 11:25 AM, the Administrator indicated the initial visit was completed at the time of the start of care comprehensive assessment and should be completed within 48 hours of referral. The agency policy “Initial Assessments/Comprehensive Assessments,” revised April of 2023, indicated the initial assessment is completed within 48 hours of the referral. The clinical record of Patient #2 evidenced a referral for home health care dated 01/8/24. A communication document indicated Patient was contacted and accepted home health services through the agency on 1/11/24 and initial assessment and start of care both dated 1/18/24. The clinical record of Patient #7 evidenced a communication document which indicated Patient’s home health referral was 01/29/24 and Patient requested services to have started 2/2/24. The initial assessment/start of care was completed 2/8/24. During an interview on 6/10/24 beginning at 12:15, Administrator indicated there is no documentation regarding the late initial visits for Patient #2 and Patient #7. Good 410 IAC 17-14-1(a)(1)(A)

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the comprehensive assessment failed to include the complete current health status of the patient in 4 of 7 records reviewed (Patient #1, 4, 5, 6). The findings include: 4. A clinical record review for Patient #4 evidenced the start of care comprehensive assessment dated 4/9/2024 which indicated the patient’s diagnoses included, but were not limited to, venous insufficiency (improper functioning of the veins in the legs causing swelling) and heart failure. The comprehensive assessment indicated the patient had edema (swelling) to the right leg and indicated the clinician was to report to the physician an increase in edema measurements greater than 3 centimeters. The comprehensive assessment failed to evidence measurement of the edema upon admission as a baseline on when to notify the physician with changes in edema measurement. On 6/10/2024, at 1:23 PM, the Administrator indicated there was no measurement of edema during the comprehensive assessment but should have been so changes in edema could be monitored. 410 IAC 17-14-1(a)(1)(A) 1. A review of the start of care assessment dated 5/15/2024 indicated Patient #1, who had a history of heart disease and heart failure, had pitting edema (swelling) to both legs, but failed to evidence an assessment of pulses in the feet. During an interview on 6/10/2024 at 11:28 AM, the Administrator indicated the nurse should have assessed and documented pulses in the feet for the Patient, but she did not. 2. A review of the recertification assessment dated 5/31/2024 for Patient #5 evidenced the following: the Patient had a urostomy (a surgically created opening for urine to leave the body), but failed to evidence an assessment of the urostomy site; the patient had 2+ (severity rating out of 4) edema (swelling), but failed to evidence the location of the edema; the patient had a history of compromised circulation to the legs, but failed to evidence an assessment of pulses in the feet. During an interview on 6/11/2024 at 11:54 AM, Administrative Staff 2 indicated the recertification should have included an assessment of the urostomy site, the location of the edema, and an assessment of pulses in the feet, but it did not. 3. A review of the start of care assessment dated 5/3/2024 and the discharge assessment dated 5/24/2024 indicated Patient #6 had a left knee surgical wound, but failed to evidence measurements of the wound and if a dressing was used on the wound. The assessments failed to evidence assessments of pulses in the feet. During an interview on 6/11/2024 at 1:15 PM, Administrative Staff 2 indicated the nurse should have measured the surgical wound and documented if a dressing was in use as well as assessed and documented pulses in the Patient’s feet in each assessment, but she did not.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to provide a comprehensive assessment that accurately reflects the patient’s status including a review of all medications and side effects in 2 of 5 active clinical records reviewed (Patients #2, 3). Findings include: The agency policy titled “Initial Assessments/Comprehensive Assessments”, revised in April of 2023, indicated a comprehensive assessment should include a review of all medications the patient is currently taking to identify side effects, interactions, and potential adverse effects. The clinical record of Patient #2 revealed a recertification comprehensive reassessment dated on 5/14/24 for the care period 5/17/24 to 7/15/24 that included a summary note which indicated Patient has an implanted Dilaudid (an opioid analgesic used for moderated to severe pain) pump for pain control. The summary indicated Patient was falling asleep with a lit cigarette in his/her hand during the medication review and RN 1 had to wake him/her. The comprehensive assessment failed to include Dilaudid in the medication profile. During an interview on 6/7/24 beginning at 2:00 PM, RN 1 indicated Patient #2 has an implanted pain medication pump and takes Lyrica (an oral pain medication) for breakthrough pain (a sudden increase in pain). 410 IAC 17-14-1(a)(1)(B) *A clinical record review for Patient #3 evidenced a plan of care for certification period 5/13/2024-7/11/2024, which indicated the primary diagnosis was cellulitis (a deep infection of the skin). During an observation of care at the patient’s home on 6/5/2024, at 12:15 PM, swelling to both legs and feet were observed, at which time the Clinical Manager/Registered Nurse (RN) touched the patient’s ankles and indicated the patient had a little swelling to both legs and redness to the right lower leg. At this time, the patient indicated they apply a cream to the reddened area to the right leg and provided the nurse with a cream with a prescription label indicated the patient was to apply silver sulfadiazine topically twice a day. During the visit from the Clinical Manager in its entirety from 11:54 AM to 12:40 PM, the Clinical Manager was not observed to review any other patient medications. At 12:45 PM and after the Clinical Manager left the patient’s home, the following medications were observed in the cabinet of the patient’s kitchen: acyclovir twice daily, Breo Ellipta 1 puff daily, and albuterol as needed. On 6/6/2024, at 12:45 PM, the patient indicated they took acyclovir twice a day, Breo Ellipta daily, and albuterol as needed. The progress notes from the physician responsible for the plan of care dated 5/10/2024 indicated the patient’s medications included, but were not limited to, acyclovir, albuterol, Breo Ellipta, and silver sulfadizine The undated medication profile reviewed on 6/5/2024 failed to evidence acyclovir, Breo Ellipta, albuterol, and silver sulfadiazine to include the review of the medication for potential drug interactions. Review failed to evidence any medication profile was signed and dated to indicate who reviewed the medications and when. On 6/7/2024, beginning at 2:14 PM, the Administrator indicated all the medications taken by the patient should be reviewed by looking at the medication label to ensure the medications match the medication profile. The Administrator indicated any new medications should be documented on the visit note and on the medication profile. The Administrator indicated the medication list provided by the physician must not have been reviewed to catch the acyclovir, Breo Ellipta, albuterol, and silver sulfadizine but should have been and then clarified with the patient to ensure the patient was still taking them. The Administrator indicated she was only made aware today the medication profiles were not signed and dated but should be to indicate who completed the medication review and when.

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview the agency failed to provide a comprehensive assessment that accurately reflected the patient’s status to include an assessment of the patient’s primary caregiver’s willingness, ability, and availability to provide care in 3 of 5 active clinical records reviewed. (Patient #2, 4, 5) Findings include: XX. A review of the recertification assessment dated 5/31/2024 evidenced Patient #5 lived alone and required set-up assistance to perform activities of daily living but failed to evidence the availability and schedule of patient caregivers. During an interview on 6/11/2024 at 12:38 PM, Administrative Staff 2 indicated the recertification assessment evidenced the Patient’s family member was able to assist with care, but failed to evidence the availability and schedule of the family member. XX. The agency policy “Initial Assessments/Comprehensive Assessments”, revised in April of 2023, indicated the comprehensive assessment should include the patient’s ability to function in the home and the patient’s caregiver’s willingness to provide care, availability, and schedule. An observation of a home visit of Patient #2 on 6/7/24 beginning at 1:00 PM evidenced Patient #2 residing in the basement. The caregiver/mother, noted as frail and on oxygen, was on the first level in a recliner and relayed difficulty in ‘getting around.’ The clinical record of Patient #2 evidenced a comprehensive assessment completed on 5/14/24 for the care period 5/17/24 to 7/15/24 that indicated Patient #2 has a history of falls, requires a walker to ambulate, fatigues easily, and requires assistance for most to all daily activities. Support system documentation in the comprehensive assessment included Patient’s primary caregiver was his/her mother who is willing to provide wound care and daily activity assistance. The comprehensive assessment failed to evidence an assessment of the caregiver’s ability and availability. The clinical record failed to evidence Patient was offered addition assistance nor referral or resources for assistance. During an interview on 6/11/24 starting after 2:00 PM, Patient #2 indicated his/her mother is the full-time caregiver to assist Patient with daily activities and wound care. Patient relayed the mother has a hard time caring for Patient and additional assistance is needed. During an interview on 6/11/24 beginning at 11:00 AM, Administrative staff 2 indicated the comprehensive assessment should include a caregiver assessment and relayed it was not completed in Patient #2’s comprehensive assessment. A clinical record review for Patient #4 evidenced the start of care comprehensive assessment dated 4/9/2024 which indicated the patient required assistance with grooming, dressing, and toilet hygiene. The comprehensive assessment indicated the patient lived in an assisted living facility (ALF) and failed to evidence the assessment of what care the ALF provided regarding the patient’s need for assistance with grooming, dressing, and toilet hygiene. On 6/11/2024, at 11:40 AM, the patient indicated the ALF helped with meals and laundry and not personal care. On 6/11/2024, at 10:01 AM, RN 1 indicated the ALF did not assist the patient with ADLs and indicated she needed to address the needs of the patient with the ALF.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on observation, interview, and record review the agency failed to provide an updated and revised comprehensive assessment as a patient condition warranted in 1 of 1 clinical record reviewed of a home visit of a patient with a wound (Patient #2). Findings include: In an observation during a home visit on 6/7/24 starting at 1:00 PM, Patient #2 was observed with wound dressings to the left foot, right foot, and right lower leg. The clinical record for Patient #2 evidenced a skilled nurse visit note completed on 6/1/24 by RN 1 which indicted three wounds: on the left heel, on the right lower leg, and the right 2nd toe. The summary noted new wound formation to the right lower leg and right second toe. The last comprehensive assessment was completed 5/14/24. The record failed to evidence a new comprehensive assessment to reflect the new wounds. During an interview on 6/11/24 beginning at 11:00 AM, Administrative staff 2 relayed a comprehensive reassessment should be completed after any changes are noted in a patient’s condition such as a new wound or a fall. 410 IAC 17-14-1(a)(1)(B)

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the discharge planning was followed per agency policy in 1 of 1 closed record reviewed. The findings include: A review of a policy titled “Discharge Criteria and Planning” revised April 2023 indicated the patient would be informed of discharge plan in a timely manner, the physician would be notified of discharge, and the agency will provide the patients with discharge instructions and contact numbers of other agencies who could provide services to the patient. The clinical record of Patient #7 evidenced a start of care date of 2/8/24 for a care period of 2/8/24 to 4/7/24 with a discharge on 3/6/24. Discharge documentation indicated Patient requested early discharge. The record failed to evidence that Patient was referred to other agencies or that the physician was notified of Patient’s discharge. The discharge comprehensive assessment completed on 3/8/24 indicated the patient needed assistance to complete all activities of daily living and had a history of falls. During an interview on 6/11/24 beginning at 11:00 AM, Other 4, family member and emergency contact for the patient, relayed the patient did not request discharge and was told by the nurse that the agency could no longer meet the patient’s needs. Other 4 indicated the patient lived alone. During an interview on 6/10/24 beginning at 11:15AM, the Administrator relayed if the agency could not provide appropriate care the patient would be referred to another agency. During an interview on 6/11/24 beginning at 11:00, the Alternate -in- Training could not find documentation that Patient #7 was given referrals to other resources or agencies.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to provide discharge summary to the receiving health care practitioner to ensure a safe and effective transition of care in 2 of 2 closed clinical records reviewed (Patient #6, 7). Findings include: XX. The agency policy titled “Discharge Summary”, revised in February of 2021 indicates a discharge summary will be sent to the primary care practitioner within five days of discharge. The clinical record of Patient #7 failed to evidence documentation that a discharge summary was provided to Patient’s physician. During an interview on 6/10/24 beginning at 12:15PM, Administrator was unable to locate documentation that a discharge summary was sent to the physician. 410 IAC 17-13-2(a)(b)(9) XX. A review of the discharge summary dated 5/24/2024 indicated Patient #6 was discharged due to goals met. A clinical record review failed to evidence the Patient’s goals were met, and they had not been evaluated by a physical therapist since the initial evaluation on 5/6/2024. During an interview on 6/11/2024 at 11:00 AM, the Patient indicated they requested to be discharged from the agency because they were not getting the therapy they needed, and wanted to go to therapy at the hospital. During an interview on 6/11/2024 at 1:31 PM, Administrative Staff 2 indicated the Patient's goals were not met, and the discharge summary failed to evidence why the patient was discharged.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure: the plan of care was individualized to meet the patient needs (see tag G0570), the plan of care was followed by all agency staff as directed by the primary care physician (see tag G0572), the plan of care contained all required elements for their patients (see tag G0574), services and treatments were provided only as ordered by the physician (see tag G0580), the plan of care was reviewed / revised by the physician every 60 days, at minimum (see tag G0588), the home health agency staff promptly alerted the primary care physician to changes in the patient’s condition (see tag G0590), the plan of care was revised to reflect the current health status and nursing needs of the patient (see tag G0592), care was coordinated by all disciplines (see tag G0606), patients / caregivers received written copies of instructions (see tag G0612), patients / caregivers were provided a written schedule of visits (see tag G0614), patients / caregivers were provided written medication schedule / instructions (see tag G0616), patients / caregivers were provided written information about treatments provided (see tag G0618), and patients were provided with the name and contact information of the agency’s clinical manager (see tag G0622). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.60 Care Planning, Coordination, Quality of Care. A deficient practice citation was also evidenced at this standard as follows: Based on observation, record review, and interview, the agency failed to provide services to meet the patient's needs in 5 of 7 records reviewed (Patient #1, 3, 4, 5, 6). The findings include: 1. During a home visit on 6/6/2024 at 9:20 AM, Patient #1 was observed to have tremors, generalized weakness, shortness of breath with exertion and poor balance. While attempting to put on their shoes, the Patient needed to take breaks to sit up and take deep breaths in order to complete the task. A review of the start of care assessment dated 5/15/2024 evidenced the Patient had Parkinson’s, required assistance with grooming and dressing, was weak, had tremors, and a history of falls. The assessment indicated the Patient did not refuse home health aide services. A review of an X-ray report from Hospital 1 on 5/10/2024 evidenced the Patient had chest trauma and an acute rib fracture after a fall at home. During an interview on 6/6/2024 at 10:05 AM, Person 2 (family member of Patient #1) indicated the Patient had fallen 5 or 6 times in the past 3 months, and they had to call an ambulance for assistance each time. Person 2 indicated the Patient had their own physical problems that made it difficult to help the Patient, but they did the best they could. Person 2 indicated the Patient had difficulty trying to bathe, and Person 2 had difficulty trying to help them. Person 2 indicated when he asked for getting help for the Patient with bathing and dressing, the agency referred them to Agency 3, which they would have to pay for out of pocket and could not afford. During an interview on 6/10/2024 at 12:15 PM, the Administrator indicated the agency did not offer Home Health Aide services, and if a patient required them, they would either have a nurse provide the care needed or refer the patient to another agency for the services. When informed of the findings, the Administrator indicated they did not know the patient would have to pay out of pocket for services from Agency 3. The Administrator indicated they needed to talk to the clinician about the situation because the patient’s needs should be met. 2. A review of the plan of care for certification period 6/5/2024 to 8/3/2024 indicated Patient #5 was to receive skilled nursing visits once a week for 9 weeks. A clinical record review evidenced skilled nurse visits were scheduled once every other week but failed to evidence the patient was informed about and consented to the change in nursing visit frequency. During an interview on 6/11/2024 at 11:44 AM, Administrative Staff 2 indicated the clinician should have ensured the patient consented to the change in frequency of nurse visits and documented this, but she did not find this in the Patient’s record. 3. A clinical record review indicated physical therapy was to evaluate and treat Patient #6 for post-knee replacement care. The nurse performed the start of care visit on 5/3/2024, and the PT (Physical Therapy) evaluation was done on 5/6/2024. The Patient was scheduled for 2 PT visits per week. A clinical record review evidenced one PT visit was performed on the week of 5/12/2024 to 5/18/2024 and failed to evidence any PT visits were performed the following week. The skilled nurse discharged the Patient on 5/24/2024. A review of the referral information from Hospital 7 evidenced orders for the Patient to receive home health for skilled nursing, physical therapy, and occupational therapy. A clinical record review evidenced the Patient received no occupational therapy and no routine skilled nursing visits. During an interview on 6/11/2024 at 11:40 AM, PT (Physical Therapist) 2 indicated most post-knee replacement patients get 3 PT visits a week, but the Patient agreed to 2 PT visits per week because they had a previous knee replacement and knew what to expect. PT 2 indicated they should see the patient for the initial evaluation within 24 to 48 hours of the start of care or receipt of the therapy order and they did not know why there was a delay in starting therapy for the Patient. During an interview on 6/11/2024 at 11:00 AM, the Patient indicated PT 3 was supposed to do the initial PT evaluation on 5/4/2024, but he never showed up. The Patient indicated they were supposed to get 3 PT visits per week, but PT 2 changed it to twice a week. The Patient indicated they did not know why and did not want less than 3 visits per week. The Patient indicated they requested to be discharged from the agency because they were not getting the therapy they needed and wanted to go to therapy at the hospital. During an interview on 6/11/2024 at 1:21 PM, Administrative Staff 2 indicated the initial PT evaluation should have been done within 48 hours of the admission, or there should be documentation explaining the delay, but the Patient’s record failed to evidence such documentation. When informed of the findings, Administrative Staff 2 indicated the agency failed to meet the Patient’s needs. XX. The agency policy titled “Patient Admission Criteria”, revised 2/2021, indicated if the agency is not able to provide the needed care, the agency will assist and notify the referral source. The clinical record of Patient #7 evidenced a start of care date of 2/8/24 for a care period of 2/8/24 to 4/7/24 with a discharge on 3/6/24. Discharge documentation indicated a comment that Patient requested early discharge. The record failed to evidence that Patient was referred to other agencies or that the physician was notified of Patient’s discharge. The clinical record of Patient #7 evidenced the comprehensive assessment completed on 2/8/24 which indicated Patient needs assistance to complete all activities of daily living and has a history of falls. During an interview on 6/11/24 beginning at 11:00 AM, Other 4, the son/daughter and emergency contact for Patient #7, relayed Patient did not request discharge and was told by the nurse that the agency could no longer meet Patient’s needs. Other indicated Patient #7 lived alone. During an interview on 6/10/24 beginning at 11:15AM, Administrator relayed if the agency could not provide appropriate care the patient would be referred to another agency. During an interview on 6/11/24 beginning at 11:00, Administrative staff 2 could not find documentation that Patient #7 was given referrals to other resources or agencies. 410 IAC 17-13-1(a) 1. During a home visit on 6/6/2024 at 9:20 AM, Patient #1 was observed to have tremors, generalized weakness, shortness of breath with exertion and poor balance. While attempting to put on their shoes, the Patient needed to take breaks to sit up and take deep breaths in order to complete the task. A review of the start of care assessment dated 5/15/2024 evidenced the Patient had Parkinson’s, required assistance with grooming and dressing, was weak, had tremors, and a history of falls. The assessment indicated the Patient did not refuse home health aide services. A review of an X-ray report from Hospital 1 on 5/10/2024 evidenced the Patient had chest trauma and an acute rib fracture after a fall at home. During an interview on 6/6/2024 at 10:05 AM, Person 2 (family member of Patient #1) indicated the Patient had fallen 5 or 6 times in the past 3 months, and they had to call an ambulance for assistance each time. Person 2 indicated the Patient had their own physical problems that made it difficult to help the Patient, but they did the best they could. Person 2 indicated the Patient had difficulty trying to bathe, and Person 2 had difficulty trying to help them. Person 2 indicated when he asked for getting help for the Patient with bathing and dressing, the agency referred them to Agency 3, which they would have to pay for out of pocket and could not afford. During an interview on 6/10/2024 at 12:15 PM, the Administrator indicated the agency did not offer Home Health Aide services, and if a patient required them, they would either have a nurse provide the care needed or refer the patient to another agency for the services. When informed of the findings, the Administrator indicated they did not know the patient would have to pay out of pocket for services from Agency 3. The Administrator indicated they needed to talk to the clinician about the situation because the patient’s needs should be met. 2. A review of the plan of care for certification period 6/5/2024 to 8/3/2024 indicated Patient #5 was to receive skilled nursing visits once a week for 9 weeks. A clinical record review evidenced skilled nurse visits were scheduled once every other week but failed to evidence the patient was informed about and consented to the change in nursing visit frequency. During an interview on 6/11/2024 at 11:44 AM, Administrative Staff 2 indicated the clinician should have ensured the patient consented to the change in frequency of nurse visits and documented this, but she did not find this in the Patient’s record. 3. A clinical record review indicated physical therapy was to evaluate and treat Patient #6 for post-knee replacement care. The nurse performed the start of care visit on 5/3/2024, and the PT (Physical Therapy) evaluation was done on 5/6/2024. The Patient was scheduled for 2 PT visits per week. A clinical record review evidenced one PT visit was performed on the week of 5/12/2024 to 5/18/2024 and failed to evidence any PT visits were performed the following week. The skilled nurse discharged the Patient on 5/24/2024. A review of the referral information from Hospital 7 evidenced orders for the Patient to receive home health for skilled nursing, physical therapy, and occupational therapy. A clinical record review evidenced the Patient received no occupational therapy and no routine skilled nursing visits. During an interview on 6/11/2024 at 11:40 AM, PT (Physical Therapist) 2 indicated most post-knee replacement patients get 3 PT visits a week, but the Patient agreed to 2 PT visits per week because they had a previous knee replacement and knew what to expect. PT 2 indicated they should see the patient for the initial evaluation within 24 to 48 hours of the start of care or receipt of the therapy order and they did not know why there was a delay in starting therapy for the Patient. During an interview on 6/11/2024 at 11:00 AM, the Patient indicated PT 3 was supposed to do the initial PT evaluation on 5/4/2024, but he never showed up. The Patient indicated they were supposed to get 3 PT visits per week, but PT 2 changed it to twice a week. The Patient indicated they did not know why and did not want less than 3 visits per week. The Patient indicated they requested to be discharged from the agency because they were not getting the therapy they needed and wanted to go to therapy at the hospital. During an interview on 6/11/2024 at 1:21 PM, Administrative Staff 2 indicated the initial PT evaluation should have been done within 48 hours of the admission, or there should be documentation explaining the delay, but the Patient’s record failed to evidence such documentation. When informed of the findings, Administrative Staff 2 indicated the agency failed to meet the Patient’s needs. 4. A clinical record review for Patient #3 evidenced a comprehensive assessment dated 5/8/2024 which indicated the patient lived alone and required assistance for grooming. The comprehensive assessment indicated the patient had a non-skilled caregiver 2 days a week from Entity 3 for bathing and light housekeeping and a had a family member that visited every 2 weeks. Review indicated the patient required a walker for ambulation, was at risk for falls, and had a history of falls. On 6/6/2024, at 12:40 PM, the patient indicated he/she paid out-of-pocket for a caregiver 2 days a week to assist with bathing and housekeeping. The patient indicated the agency did not offer to provide home health aide services and indicated home health aide services through the agency could reduce the cost the patient paid out-of-pocket for a caregiver. On 6/7/2024, at 11:55 AM, Person 5 at Entity 3 indicated Entity 3 was a personal services agency and did not provide home health aide services. On 6/7/2024, beginning at 2:30 PM, the Administrator indicated she was unaware Entity 3 was a personal services agency and was not providing a home health aide. The Administrator indicated the patient had Medicare, which would cover home health aide services if needed, and was not aware the patient was paying out-of-pocket for a caregiver. The Administrator indicated the agency could not find any home health aides to hire. Requested recruitment effort documentation for home health aides and no additional information or documentation was provided prior to survey exit on 6/11/2024. 5. A clinical record review for Patient #4 evidenced a referral document from Entity 9 dated 4/3/2024, which indicated the patient needed home health services to include occupational therapy (OT) services. The start of care comprehensive assessment dated 4/9/2024 indicated the patient required assistance with grooming, dressing, and toilet hygiene. Review failed to evidence the agency provided OT services or provided the patient with contact information for agencies to provide OT services. The comprehensive assessment indicated the patient lived in an assisted living facility (ALF) and failed to evidence what services the ALF provided regarding the patient’s need for assistance with grooming, dressing, and toilet hygiene. The comprehensive assessment for the recertification on 6/4/2024, completed by Registered Nurse (RN) 1, indicated the ALF did not provide assistance with activities of daily living (ADLs) and the patient’s family lived out of state. The comprehensive assessment dated 6/4/2024 indicated the patient had redness and cellulitis (a deep infection of the skin) to the right leg and required Minerin cream (moisturizer) to be applied daily to both legs. The comprehensive assessment dated 6/42024 indicated the patient was unable to apply the cream and the ALF did not provide that type of care. The plan of care for 6/8/2024-8/6/2024 indicated Minerin cream was to be applied daily to both legs and indicated the agency would provide skilled nursing 1 time weekly. Review failed to evidence the agency provided services to meet the patient’s needs to have the cream applied daily. On 6/10/2024, at 1:26 PM, the Administrator indicated the agency could not provide OT services due to staffing and the patient was not provided contact information for other agencies to provide OT services. The Administrator indicated home health aide services were not provided to the patient to assist with ADLs, because the Administrator believed the ALF was providing ADL assistance. On 6/11/2024, at 11:40 AM, the patient indicated they could not reach their legs to apply cream and indicated the ALF helped with meals and laundry and not personal care. On 6/11/2024, at 10:01 AM, RN 1 indicated the ALF could not apply the cream and did not assist the patient with ADLs. RN 1 indicated the patient did not feel confident about being able to apply the cream to the legs, and RN 1 indicated she needed to address the needs of the patient with the ALF. On 6/11/2024, beginning at 10:45 AM, the Administrator-in-Training indicated the agency determined the frequency of the disciplines provided based on patient’s need, staff availability, and insurance coverage. The Administrator-in-Training indicated if the patient required care 7 days a week, and the insurance allowed it, the agency would have to provide services 7 days a week to meet the patient’s need. The Administrator-in-Training indicated the patient had a managed Medicare plan which required authorization for requested home health visits and indicated the agency had only requested skilled nurse visits 2 times a week. 410 IAC 17-13-1(a)

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to evidence services were provided as directed in the plan of care in 4 of 7 clinical records reviewed. (Patient #1, 4, 6, 7) The findings include: XX. The agency policy titled “Plan of Care – CMS #485 and Physician/Practitioners Orders,” revised 4/2023, indicates each plan of care should include patient specific interventions, education, measurable outcomes and goals which are individualized based on medical diagnosis, orders, comprehensive assessment and patient input. The clinical record of Patient #2 evidenced a plan of care for care period 5/17/24 to 7/15/24 that indicated Patient has nicotine dependence (cigarettes), and chronic obstructive pulmonary disease (lung disease) with the use of ongoing supplemental oxygen. The plan of care goals failed to evidence interventions and goals related to Patient’s safety related to smoking and use of oxygen. education or interventions related to smoking. During an interview on 6/11/24 beginning at 11:00 AM, Administrative staff 2 relayed there should be an interventions and goal related to smoking cessation. The clinical record for Patient #7 evidenced a start of care/initial comprehensive assessment on 2/8/24 which indicated Patient had diagnoses of Atrial fibrillation (an irregular heart rhythm), hypertensive (referring to high blood pressure) heart disease with heart failure, congestive heart failure (heart muscle doesn’t pump as well as it should, may cause swelling), and diabetes mellitus type 2 (disease with high blood sugar). The plan of care for certification period 02/8/24 to 4/7/24 included 22 goals specific to Patient. Skilled nursing notes dated 2/13/24, 2/22/24, and 2/29/24 failed to evidence any individualized goals addressed with Patient other than symptoms to report to physician. 410 IAC 17-13-1(a) A clinical record review for Patient #4 evidenced a plan of care for 4/9/2024-6/7/2024 which indicated the agency would provide physical therapy (PT) services 2 times a week for 3 weeks and then 1 time a week for 4 weeks. Review failed to evidence the agency provided any PT services during the week of 5/5/2024. On 6/10/2024, at 1:45 PM, the Administrator indicated there was a PT missed visit on 5/10/2024 and no other PT visits were provided during the week. 1. A review of the plan of care for Patient #1, certification period, 5/15/2024 to 7/13/2024 evidenced the following orders: physical therapy twice a week for four weeks, then once a week for four weeks and physician notification for pulse oximeter (oxygen level) less than 92%. A clinical record review evidenced the Patient received one physical therapy visit for the week of 5/26/2024 to 6/1/2024. A physical therapy visit note dated 5/23/2024 evidenced the Patient’s pulse oximeter reading was 90% but failed to evidence physician notification. During an interview on 6/6/2024 at 9:41 AM, PTA (Physical Therapy Assistant) 1 indicated if a patient’s vital signs were out of range, they would notify the nurse case manager and document it in the visit note. During an interview on 6/10/2024 at 12:09 PM, the Administrator indicated the PTA should have communicated the pulse oximeter reading with the nurse case manager or the supervising physical therapist who would have contacted the physician. The Administrator indicated the Patient’s record failed to evidence the physician was notified of the patient's pulse oximeter reading. 2. A review of the plan of care for certification period 5/3/2024 to 7/1/2024 evidenced the physician should be notified if Patient #6’s pulse oximeter (oxygen level) reading was less than 92% and if their pain level was greater than 7 out of 10. The plan of care evidenced PT (Physical Therapy) was to evaluate and treat the patient but failed to evidence a frequency of visits. A clinical record review failed to evidence a PT plan of care that had been signed by the physician. Clinical record review evidenced the following findings not reported to the physician as ordered in the plan of care: The PT evaluation dated 5/6/2024 evidenced the Patient had constant pain, rated 8 out of 10; a physical therapy note dated 5/10/2024 evidenced the Patient’s pulse oximeter reading was 90%. During an interview on 6/11/2024 at 1:20 PM, Administrative Staff 2 indicated the clinical record failed to evidence the physician was notified of the out of range pain level and pulse oximeter readings. During an interview on 6/11/2024 at 11:40 AM, PT 2 indicated they did not communicate with the physician about Patient #6.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included all necessary components in 7 of 7 records reviewed (Patient #1, 2, 3, 4, 5, 6, 7). The findings include: XX. The clinical record for Patient #2 evidenced a plan of care for care period 5/17/24 to 7/15/24 that included a comment by RN 1 that Patient has an implanted Dilaudid (narcotic analgesic) pump for pain control. The plan of care failed to evidence Dilaudid on the medication list. Wound care documentation from Entity 6 dated 6/5/24 included orders to wear a surgical shoe when walking, increase protein intake, elevate legs above the heart for 30 minutes 3-4 times daily, to cleanse the wound with antibacterial soap, and an order for two new medications: Doxycycline (an antibiotic) and Diflucan (an antifungal). The plan of care failed to evidence the new medications and orders from the wound care clinic. XX. During an interview on 6/11/24 beginning at 11:00 AM, Other 4, son/daughter of Patient #7, relayed that Patient #7 required home oxygen. The clinical record for Patient #7 evidenced a plan of care that included durable medical equipment of an oxygen concentrator but failed to include oxygen and dosage on Patient’s medication list. 410 IAC 17-13-1(a)(1)(D)(ix) *A clinical record review for Patient #3 evidenced a plan of care for certification period 5/13/2024-7/11/2024 which indicated the safety measures included bleeding precautions and the medical supplies included urinary ostomy (a surgically created hole in the bladder through the abdomen to drain urine from the body) supplies. Review of the plan of care failed to evidence the patient’s medications included a blood thinner which warranted bleeding precautions and indicated the patient’s medications included Nystatin-triamcinolone ointment to be applied topically twice daily and failed to evidence to where it was to be applied. The plan of care indicated the skilled nurse was to assess the patient’s blood sugar and report to the physician if outside of ordered parameters and assess the patient’s use of oxygen and spirometry (breathing test). The comprehensive assessment dated 5/8/2024 indicated the patient did not check blood sugar and was not on oxygen. During an observation of care in its entirety at the patient’s home on 6/6/2024 from 11:54 AM to 12:40 PM, the Clinical Manager failed to assess the patient’s blood sugar. No oxygen or spirometry use was observed by the patient. On 6/6/2024, beginning at 12:18 PM, the patient indicated they had not checked their blood sugar since February 2024 and applied the Nystatin-triamcinolone ointment to the abdominal folds. On 6/6/2024, at 12:18 PM, the Clinical Manager indicated the patient did not have a urinary ostomy and ostomy supplies should not be included in the plan of care. On 6/7/2024, beginning at 1:36 PM, the Administrator indicated there was no medication included in the medication list in the plan of care that warranted bleeding precautions and indicated the plan of care did not include to where the Nystatin-triamcinolone ointment was to be applied. The Administrator indicated the intervention on the plan of care for the nurse to assess the blood sugar was a standard order for a patient with diabetes (disease that affects the blood sugar) diagnosis but should not be included on the plan of care if it was not needed. The Administrator indicated the patient did not use oxygen and spirometry and was unsure if they could be removed from the plan of care. *A clinical record review for Patient #4 evidenced a plan of care for certification period 4/9/2024-6/7/2024 which indicated the functional limitations included prescribed exercises and failed to include the individual prescribed exercises. The plan of care indicated the agency would notify the physician of changes in the patient’s weight of 2 pounds difference in 1 day or 5 pounds difference in 1 week. The plan of care failed to be individualized to include what interventions the agency would implement to monitor the patient’s weight. On 6/10/2024, beginning at 1:16 PM, the Administrator indicated there were not patient-specific prescribed exercises included in the plan of care. The Administrator indicated there were no patient-specific interventions in the plan of care to monitor the patient’s weight such as keeping a weight log and reviewing it at every nurse visit. 1. During a home visit on 6/6/2024 at 9:20 AM, a review of the home folder evidenced a copy of Patient #1’s DNR (Do Not Resuscitate) order. A review of the plan of care for certification period 5/15/2024 to 7/13/2024 failed to evidence Patient #1 had an Advanced Directive or DNR order. A review of the patient’s clinical record evidenced a copy of the Patient’s DNR order. When informed of the findings on 6/11/2024 at 12:42 PM, Administrative Staff 2 indicated the plan of care should have evidenced the Patient had a DNR order, but it did not. 2. A review of the plan of care for certification period 6/5/2024 to 8/3/2024 evidenced Patient #5 had a urostomy (a surgically created opening for urine to leave the body), and the nurse was to observe and assess patient / caregiver ability to manage the urostomy, but failed to evidence what the Patient’s urostomy care was. The plan of care evidenced the patient was using Mupirocin Ointment (a topical antibiotic) and Nystatin-Triamcinolone Cream (a topical anti-fungal) but failed to evidence where on the body they were used. During an interview on 6/11/2024 at 12:03 PM, Administrative Staff 2 indicated the plan of care should have included the specific care for the urostomy, including what was to be used and how frequently it should be done. Administrative Staff 2 indicated orders for topical medications should include the location on the body where they were used, but the plan of care failed to evidence the location. 3. A review of the plan of care for certification period 5/3/2024 to 7/1/2024 evidenced the following surgical wound care orders for Patient #6: assess incision site, may cleanse with warm soapy water or saline and gauze, cover with dry gauze and tape as needed for drainage. During an interview on 6/11/2024 at 1:10 PM, Administrative Staff 2 indicated the plan of care failed to include specifically what was to be done with the surgical incision, by whom, and at what frequency.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide services only as ordered by a physician in 5 of 7 clinical records reviewed. (Patient #2, 3, 4, 6, 7) The findings include: The agency policy titled “Plan of Care – CMS #485 and Physician/Practitioner Orders”, revised 4/2023, indicated care and services provided to patient are according to physician orders which should be current and updated. XX. The clinical record for Patient #2 evidenced a start of care and initial comprehensive assessment dated on 1/18/24 for the certification period 1/18/24 to 3/7/24; the plan of care was signed by a physician on 2/15/24. The record failed to evidence a physician’s order for care prior to 2/15/24. A recertification comprehensive assessment was completed on 3/17/24 for the certification period of 3/18/24 to 5/16/24 with a physician’s signature dated 4/16/24. A 2nd recertification comprehensive assessment was completed on 5/14/24 for the certification period of 5/17/24 to 7/15/24; this plan of care failed to evidence authorization by the attending physician as of 6/11/24. During an interview on 6/11/24 beginning at 10:50 PM, RN 1 stated she has never spoken to Patient #2’s primary care physician. She indicated she has only spoken to the physician’s medical assistant and left messages therefore no physician communication was documented. XX. The clinical record for Patient #7 evidenced an initial comprehensive and start of care assessment completed on 2/8/24 for a certification period of 2/8/24 to 4/7/24. The plan of care for this care period was signed by a physician 3/4/24. The clinical record failed to evidence a physician’s order for care for nurse and physical therapy visits documents on 2/13/24, 2/22/24, and 2/29/24 nor a start of care order. During an interview on 6/11/24 beginning at 11:00 AM, Administrative staff 2 was not able to find a start of care order for Patient #7. 410 IAC 17-13-1(a) XX. A clinical record review evidenced Patient #6 received PT (Physical Therapy) services from 5/6/2024 to 5/17/2024 but failed to evidence a signed PT plan of care or PT orders. During an interview on 6/11/2024 at 1:10 PM, Administrative Staff 2 indicated the Patient’s record failed to evidence signed physician orders for PT services provided. 1. A clinical record review for Patient #3 evidenced a plan of care for certification period 5/13/2024-7/11/2024, which failed to evidence a physician signature. Review failed to evidence a verbal order or any other physician orders to continue home health services since the end of the previous certification period ending on 5/12/2024. On 6/10/2024, beginning at 1:07 PM, the Administrator indicated the plan of care for certification period 5/13/2024-7/11/2024 had not yet been sent to the physician for review/signature and indicated no physician order for continuation of home health services could be found since the previous plan of care, which ended on 5/12/2024. 2. A clinical record review for Patient #4, start of care 4/9/2024, evidenced an initial plan of care for certification period 4/9/2024-6/7/2024, which was not signed by the registered nurse (RN) until 5/10/2024 and not signed by the physician until 5/16/2024. The start of care comprehensive assessment completed by RN 2 and dated 4/9/2024 and the plan of care indicated the nurse left the physician a voicemail regarding the assessment and findings and clinical record review failed to evidence a start of care order for home health care services. On 6/11/2024, at 10:17 AM, RN 2 indicated the physician never returned her call and she did not receive start of care orders. On 6/10/2024, at 1:50 PM, the Administrator indicated she could not locate start of care orders for home health care services. 410 IAC 17-13-1(a)

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care was reviewed by the physician at least every 60 days in 2 of 3 active clinical records reviewed with more than 1 certification period. (Patient #3, 5) The findings include: XX. A review of the plan of care for certification period 6/5/2024 to 8/3/2024 indicated Patient #5 was to receive skilled nursing visits once a week for 9 weeks. A clinical record review evidenced skilled nurse visits were scheduled once every other week. During an interview on 6/11/2024 at 11:44 AM, Administrative Staff 2 indicated the frequency of skilled nurse visits was once every other week, and the plan of care had not been revised with the new frequency of visits, but it should have been. 1. A clinical record review for Patient #3 evidenced plans of care for certification period 1/14/2024-3/13/2024 signed by the physician on 1/30/2024 and for certification period 3/14/2024-5/12/2024 signed by the physician on 4/23/2024, which was greater than 60 days. On 6/7/2024, at 2:22 PM, the Administrator indicated the physician should review the plan of care at least every 30 days and was unsure why the physician did not review the plan of care timely. 410 IAC 17-13-1(a)(2)

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to promptly alert physicians to any changes in the patient’s condition that suggest outcomes are not being achieved in 4 of 7 clinical records reviewed (Patient #2, 4, 6, and 7). Findings include: XX. The agency policy “Coordination of Patient Care”, revised 2/2021 indicates the agency should provide the physician/practitioner with patient information on an ongoing basis regarding changes in condition. The clinical record of Patient #2 evidenced a recertification assessment completed on 5/17/24 for a care period 5/17/24 to 7/15/24 with a wound assessment to Patient’s left heel. On 6/1/24, a skilled nurse visit note with RN 1 evidenced an assessment of three wounds: one to the left heel, one to the right lower leg, and to the right second toe. The comments indicated two new wound formations with plans to notify Patient’s physician on Monday, 6/3/24. The record failed to evidence physician notification of new wounds. XX. The clinical record of Patient #7 evidenced a start of care assessment completed on 2/8/24 with weekly visits from both an RN and physical therapy. Patient was discharged prior to goals being met per Patient request on 3/6/24. The record failed to evidence notification of Patient’s physician of early discharge and the cessation of services. 410 IAC 17-13-1(a)(2) XX. A physical therapy visit note dated 5/10/2025 evidenced Patient #6 had constant pain rated 8 out of 10, and that the Patient would tell the surgeon about their pain next week. A review of the Patient’s record evidenced a PT (Physical Therapy) visit was missed on 5/15/2024, and no PT visits were made on the week of 5/19/2024 to 5/25/2024, although they had been scheduled twice a week. Clinical record review failed to evidence physician notification of the Patient’s pain and the missed visits. During an interview on 6/11/2024 at 1:16 PM, Administrative Staff 2 indicated the clinical record failed to evidence physician notification of the missed visits, and the clinician should have notified the physician of the Patient’s pain. * A clinical record review for Patient #4 evidenced a referral document from Entity 9 dated 4/3/2024, which indicated the patient needed home health services to include occupational therapy (OT) services. The start of care comprehensive assessment dated 4/9/2024 indicated the patient required assistance with grooming, dressing, and toilet hygiene. Review failed to evidence the agency provided OT services and failed to evidence the agency notified the physician that OT services could not be provided. On 6/10/2024, at 1:31 PM, the Administrator indicated the agency could not provide OT services due to staffing and there was no documentation the physician was notified the agency could not provide OT services. The plan of care for certification period 4/9/2024-6/7/2024 which indicated the patient’s diagnoses included, but were not limited to, venous insufficiency (improper functioning of the veins in the legs causing swelling), and heart failure. A skilled nurse visit note dated 5/15/2024, completed by Registered Nurse (RN) 2, indicated the patient’s right leg was seeping and indicated the RN applied aquafor (skin protectant/moisturizer), covered with an ABD (a padded wound dressing to absorb wound drainage and gauze and instructed the patient to change the dressing daily. Review failed to evidence the agency notified the physician of the seeping and wound treatment. On 6/11/2024, at 9:59 AM, RN 2 indicated she left a message at the physician’s office regarding the right leg seeping and the wound treatment applied but she did not receive a return call and was unsure if the physician received the message.

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the plan of care was revised to include relevant changes in 2 of 5 active clinical records reviewed. (Patient #3, 4) The findings include: 1. A clinical record review for Patient #3 evidenced a plan of care for certification period 5/13/2024-7/11/2024, which indicated the primary diagnosis was cellulitis (a deep infection of the skin). During an observation of care at the home of Patient #3 on 6/5/2024, at 12:15 PM, swelling to both legs and feet were observed, at which time the Clinical Manager/Registered Nurse touched the patient’s ankles and indicated the patient had a little swelling to both legs and redness to the right lower leg. At this time, the patient indicated they applied a cream to the reddened area to the right leg and provided the nurse with a cream with a prescription label indicating the patient was to apply silver sulfadiazine topically twice a day. A clinical record review evidenced a skilled nurse visit note completed by the Clinical Manager and dated 6/6/2024 which indicated the nurse advised the patient to continue taking the silver sulfadiazine cream. Review of the plan of care for certification period 5/13/2024-7/11/2024 failed to evidence it was revised to include the silver sulfadiazine cream prior to survey exit on 6/11/2024. On 6/7/2024, at 2:21 PM, the Administrator indicated the plan of care should have been revised to reflect the new medication used by the patient but it was not. 2. A clinical record review for Patient #4 evidenced a skilled nurse visit note dated 5/15/2024 which indicated the patient’s right leg was seeping and indicated the nurse applied aquafor (skin protectant/moisturizer), covered with an ABD (a padded wound dressing to absorb wound drainage and gauze, and instructed the patient to change the dressing daily. Review failed to evidence the agency revised the plan of care for certification period 4/9/2024-6/7/2024 to include the wound treatment daily as instructed to the patient by the nurse. On 6/10/2024, at 1:47 PM, the Administrator indicated the plan of care should have been revised with the daily treatment to the right leg but it was not. The physical therapy (PT) plan of care dated 5/20/2024 indicated the patient’s PT goals included, but were not limited to, ambulating greater than 200 feet with a rolling walker, decrease pain to 1 out of 10 on a scale of 0-10 (with 10 being the worst), increase upper and lower extremity strength to 5/5, and perform safe transfers from bedroom to bathroom. The medical plan of care for certification period 4/9/2024-6/7/2024 failed to evidence the plan of care was revised to include the PT goals. On 6/10/2024, at 1:53 PM, the Administrator indicated the agency tries to revise the medical plan of care with the therapy interventions and goals if they can before it is sent to the physician, but this plan of care was not revised with the PT goals.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to integrate all services provided directly or under arrangement to assure coordination of care provided by all disciplines in 4 of 5 active clinical records reviewed. (Patient #1, 3, 4, 5) Findings include: XX. The agency policy titled “Coordination of Patient Care”, revised 2/2021 indicates the agency must integrate all services to assure identification of patient needs and treat effectiveness. During an interview on 6/7/24 starting at 2:00 PM, Patient #2 indicated he/she visited a physician for pain every month and a wound care physician once a week and was receiving treatment from both physicians. The clinical record of Patient #2 evidenced a plan of care (POC) for care period 5/17/24 to 7/15/24 with a comment that Patient goes to a wound care clinic. The POC failed to include Entity 6 wound care clinic, the wound care physician, and Patient’s pain physician as part of the care team. The clinical record of Patient #2 evidenced wound care orders from Entity 6 on 5/31/24 and 6/7/24 with orders to wear surgical shoe when walking, increase protein intake, elevate legs above the heart for 30 minutes 3-4 times daily, and to cleanse the wound with antibacterial soap. The POC failed to include orders from the wound care physician. 410 IAC 17-12-2 (h) XX. A review of the plan of care for certification period 5/15/2024 to 7/13/2024 evidenced Patient #1 was receiving skilled nursing visits once a week for four weeks, then once every other week as well as physical therapy twice a week for four weeks, then once a week for four weeks. A review of the clinical record failed to evidence coordination of care between the nurse and physical therapist. During an interview on 6/10/2024 at 12:16 PM, the Administrator indicated the nurse and physical therapist should coordinate patient care, and document this communication in the record, but Patient #1’s record failed to evidence this care coordination. XX. A skilled nurse visit note dated 5/16/2024 evidenced Patient #5 received services at a wound clinic 3 times a week. A review of the Patient’s clinical record for certification period 4/6/2024 to 6/4/2024 failed to evidence coordination of care with the wound clinic. During an interview on 6/11/2024 at 12:10 PM, Administrative Staff 2 indicated the Patient’s clinical record failed to evidence communication with the wound clinic. *A clinical record review for Patient #3 evidenced a comprehensive assessment dated 5/8/2024 which indicated the patient lived alone and required assistance for grooming. The comprehensive assessment indicated the patient had a non-skilled caregiver 2 days a week from Entity 3 for bathing and light housekeeping. Review failed to evidence care coordination with Entity 3. At the entrance conference on 6/5/2024, at 11:25 AM, the Administrator indicated the agency would document care coordination by communicating via fax or phone with other agencies providing services to the patient and documenting the coordination in the clinical record. The Administrator indicated care coordination should take place at the start of care and at time of recertification. On 6/10/2024, at 1:13 PM, the Administrator indicated there was no care coordination with Entity 3. * A clinical record review for Patient #4 evidenced a comprehensive assessment dated 6/4/2024, completed by Registered Nurse (RN) 1, which indicated the patient lived at an assisted living facility (ALF) and had redness and cellulitis (a deep infection of the skin) to the right leg and required Minerin cream (moisturizer) to be applied daily to both legs. The comprehensive assessment indicated the patient informed the nurse they were unable to apply the cream and the ALF did not provide that type of care. Review failed to evidence the agency coordinated care with the ALF regarding the patient’s need for assistance with the application of the cream to the legs. On 6/10/2024, at 1:55 PM, the Administrator indicated the clinicians should coordinate care with the ALF after every visit and would check for any documentation of care coordination regarding the patient’s need for assistance with the cream daily. No additional documentation/information was provided before survey exit on 6/11/2024. On 6/11/2024, at 10:01 AM, RN 1 indicated she needed to check with the ALF on what they could do to help the patient apply the cream to the legs daily and had not yet done so.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation and interview, the agency failed to provide the patient and caregiver with a copy of written instructions outlining the visit schedule in 3 of 3 clinical records reviewed with home visits. (Patient #1, 2, 3) Findings include: XX. During observation of a home visit for Patient #1 on 6/6/2024 at 9:20 a.m., review of the patient’s home folder evidenced a blank calendar of visits form. During an interview on 6/6/2024 at 9:53 AM, PTA (Physical Therapy Assistant) 1 indicated they had not filled out the calendar of visits, but would call the Patient 2 to 3 days before to remind the Patient of the upcoming visit. XX. The agency policy titled “Coordination of Patient Care”, revised 2/2021, indicated the agency will coordinate care with the patient by providing a copy of written instructions that include the visit schedule. In an observation of a home visit on 6/7/24 with Patient #2 and RN 1 beginning at 1:00 PM, the agency folder at Patient’s home failed to include a visit schedule. During an interview on 6/7/24 after the home visit, Patient #2 relayed that no other paperwork was been provided by the agency including a visit schedule. *At an observation of care at the patient’s home for Patient #3 on 6/6/2024 between 11:54 AM and 12:58 PM, the agency’s folder was observed and failed to evidence a written visit schedule since March 2024. On 6/6/2024, at 12:18 PM, the patient indicated all documents provided by the agency were kept in the agency folder and did not have any other written visit schedule. On 6/7/2024, at 2:30 PM, the Administrator indicated the visit schedule should be provided in writing to the patient by mailing it to the patient’s home.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation and interview, the agency failed to provide the patient and caregiver with a copy of a writing instructions outlining the patient medication list and instructions in 3 of 3 clinical records reviewed with home visits. (Patient #1, 2, 3) Findings include: XX. During observation of a home visit for Patient #1 on 6/6/2024 at 9:20 a.m., review of the patient’s home folder failed to evidence a current medication list. During an interview on 6/6/2024 at 10:15, Patient #1 indicated the agency did not provide them with a list of their current medications. In an interview on 6/10/2024 at 11:25 AM, the Administrator indicated the agency should mail each patient a copy of their plan of care, which includes a medication list, and document the mailing in the clinical record. The Administrator indicated Patient #1’s clinical record failed to evidence the plan of care was mailed to the Patient. The agency policy titled “Coordination of Patient Care”, revised 2/2021, indicated the agency will coordinate care with the patient by providing a copy of written instructions that include the patient’s medication list and with instructions. In an observation of a home visit on 6/7/24 with Patient #2 and RN 1 beginning at 1:00 PM, the agency folder at Patient’s home failed to include a medication list. During an interview on 6/7/24 after the home visit, Patient #2 relayed that no other paperwork was been provided by the agency including a medication list. *At an observation of care at the patient’s home for Patient #3 on 6/6/2024 between 11:54 AM and 12:58 PM, the agency’s folder was observed and failed to evidence a written medication list since the plan of care for the certification period ending on 5/12/2024. At 12:45 PM the following medications were observed in the cabinet of the patient’s kitchen: acyclovir twice daily, Breo Ellipta 1 puff daily, and albuterol as needed. The plan of care in the patient’s home failed to include acyclovir, Breo Ellipta, and albuterol. On 6/6/2024, beginning at 12:18 PM, the patient indicated all documents provided by the agency were kept in the agency folder and indicated they took acyclovir twice a day, Breo Ellipta daily, and albuterol as needed. On 6/7/2024, at 2:30 PM, the Administrator indicated the agency should provide the medication profile as the written medication instructions and schedule and indicated the list of medications on the plan of care did not include medication instruction.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide the patient with written information about services and treatments to be provided in 1 of 1 home visits with physical therapy observed (Patient #1) and 1 of 1 home visit observation with skilled nurse services Patient #2). The findings include: During observation of a home visit for Patient #1 on 6/6/2024 at 9:20 a.m., review of the patient’s home folder failed to evidence a current plan of care or treatment plan. During an interview on 6/6/2024 at 10:15 AM, Patient #1 indicated they had not received a written plan of care or treatment plan from the agency. In an interview on 6/10/2024 at 11:25 AM, the Administrator indicated the agency should mail each patient a copy of their plan of care and document the mailing in the clinical record. The Administrator indicated Patient #1’s clinical record failed to evidence the plan of care was mailed to the Patient. XX. An agency policy titled “Plan of care – CMS #485 and Physician/Practitioners Orders”, revised 4/2023, indicated each patient must receive an individualized plan of care. In an observation of a home visit on 6/7/24 with Patient #2 and RN 1 beginning at 1:00 PM, the agency folder at Patient’s home failed to include a plan of care. During an interview on 6/7/24 after the home visit, Patient #2 relayed that no other paperwork was been provided by the agency including a plan of care.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the agency provided in writing to the patient the name and contact information of the case manager in 1 of 2 home visits with a registered nurse. (Patient #3) The findings include: At an observation of care at the patient’s home for Patient #3 on 6/6/2024 between 11:54 AM and 12:58 PM, the agency’s folder was reviewed and failed to evidence the name and contact information of the case manager. On 6/6/2024, beginning at 12:18 PM, the patient indicated they were unsure who their case manager was. On 6/7/2024, at 2:30 PM, the Administrator indicated the agency folder in the patient’s home should include the case manager’s name and contact information and this was how the agency provided the case manager’s contact information in writing to the patient.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Governing Body approved the frequency and detail of the data collection of the quality assurance performance improvement (QAPI) program. The findings include: The agency’s QAPI binder, Governing Body minutes from 2023 to current, and the contract with Entity 11 were reviewed and failed to evidence documentation of the frequency and detail of the data collection approved by the Governing Body. On 6/10/2024, at 3:22 PM, the Administrator indicated there was no documentation in the QAPI binder regarding the Governing Body approval of the frequency and detail of the data collection and indicated maybe it was in the contract with Entity 11. 410 IAC 17-12-2(a)

Program activities CFR(s): 484.65(c) (1) The HHA's performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the quality assurance performance improvement (QAPI) program’s performance improvement activities focused on high risk and problem-prone areas. The findings include: 1. An undated document titled “Hospitalizations” reviewed on 6/11/2024 indicated 10 patient hospitalizations in December 2023 and January 2024. No additional hospitalizations were provided prior to December 2023 or after January 2024. The hospitalization log failed to evidence tracking information to include the dates of and admitting diagnosis for the hospitalization. A clinical record review for Patient #1 evidenced the patient was hospitalized in May 2024 following a fall and a urinary tract infection. The hospitalization for Patient #1 failed to be included in the hospitalization log. The agency’s QAPI binder failed to evidence performance improvement activities for the patient hospitalizations. On 6/10/2024, at 3:22 PM, the Administrator indicated no patient hospitalizations were tracked by the agency prior to December 2023 and since January 2024 due to the Intake Coordinator being out of the office. The Administrator indicated she thought the Office Manager was tracking the hospitalizations in the absence of the Intake Coordinator but maybe not. 2. The Incident Report Summary from 9/5/2023-6/10/2024 indicated there were 5 patient falls with an average patient census of 40 equaling 13% of the patient population with a fall in Quarter 4 of 2023 and 9 patient falls with an average patient census of 37 equaling 24% of the patient population with a fall in Quarter 1 of 2024. Quarter 2 of 2024 indicated 8 additional patient falls. The agency’s QAPI binder failed to evidence performance improvement activities for the patient falls. On 6/10/2024, at 3:22 PM, the Administrator indicated she did not track every fall and indicated there were no performance improvement activities for falls. 3. The patient satisfaction survey reports for February 2023-February 2024 indicated 21% of the responses were unfavorable for the agency keeping the patients informed about the clinicians’ arrival at the patient’s home, 19% of the responses were unfavorable for the response time of the agency to provide answers or advice as needed, 22% of the responses were unfavorable for the agency talking to the patient about setting up the home for safety, 29% of the responses were unfavorable for if the agency providers talked with the patients regarding when to take medications, and 43% of the responses were unfavorable regarding the agency providers talking to the patients regarding medication side effects. On 6/10/2024, at 3:22 PM, the Administrator indicated there were no performance improvement actions for the patient satisfaction survey unfavorable responses.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review, and interview the agency failed to follow accepted standards of practice to prevent the transmission of infections in 2 of 2 clinical records reviewed with home visits with a registered nurse (RN). (Patient# 2, 3) Findings include: At an observation of care at the home for Patient #3 on 6/6/2024, at 11:54 AM, the Clinical Manager was not observed performing hand hygiene prior to entering the main compartment of the visit bag before removing a stethoscope, blood pressure machine/cuff, and thermometer. At 12:11 PM, the Clinical Manager was observed applying the blood pressure cuff to the pateint’s left arm and at 12:26 PM was observed placing the stethoscope on the patient’s back, chest, and abdomen. At 12:40 PM, the Clinical Manager was observed leaving the patient’s home without cleaning the stethoscope and blood pressure cuff and performing hand hygiene. On 6/7/2024, at 2:34 PM, the Administrator indicated the clinician should wash hands or apply hand sanitizer prior to entering the visit bag and before leaving the patient’s home. XX. The agency policy titled “Hand Hygiene Policy and Compliance Program”, revised 7/2021, indicates hand hygiene is recommended before and after contact with blood, body fluids, and wound dressings. The agency policy titled “Standard Precautions”, revised 4/2023, indicates manufacturers’ instructions will be followed for proper use of disinfecting products. In an observation of a home visit with Patient #2 on 6/7/24 beginning at 1:00 PM, while gloved RN 1 was providing wound care, she used gauze and saline (a mixture of salt and water) to clean dried blood from Patient’s foot. Without sanitizing hands or donning clean gloves, RN proceeded to open Puracol (a collagen dressing) and place the previously sterile dressing up against the wound and cut with scissors to fit inside wound. The cut Puracol was then placed in the wound bed of Patient’s foot. The bandage scissors used to cut the dressing were not sanitized prior to use. Throughout the wound treatment, RN did deglove and use hand sanitizer and don new gloves two times, however the hand sanitizer bottle was placed in the field touching the removed, soiled wound dressing. Once the treatment was completed, RN put the hand sanitizer into her bag without cleansing the bottle. RN then used antibacterial wipes to cleanse bandage scissors, stethoscope, blood pressure cuff, and thermometer and cleansed items were each placed directly into her bag with a dry time of less than 10 seconds each. In an interview with RN 1 during the home visit with Patient #2 on 6/7/24 starting at 1:00 PM, when asked what kind of antibacterial wipes she uses to clean her supplies, she indicated it was the purple topped wipes provided by the office staff of the agency. When asked what the dry time is of the wipes, she didn’t know. During an interview on 6/10/24 starting at 10:00 AM, Administrative staff 2 relayed the antibacterial wipes provided to staff for cleaning supplies is called Sani-wipes and offered the container. The directions for use to decontaminate indicated a 2 minute dry time for cleaning. 410 IAC 17-12-1(m) ed on observation, record review, and interview the agency failed to follow accepted standards of practice to prevent the transmission of infections in two of three clinical records reviewed with home visits (Patient# 2, 3). Findings include:

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the registered nurse, physical therapy assistant, and physical therapist failed to provide the services as directed in the plan of care in 5 of 7 clinical records reviewed. (Patient #2, 3, 4, 6, 7) The findings include: XX. The agency policy titled “Professional Standards of Practice”, revised 10/2017, indicates agency staff will comply with professional standards and provide care according to the plan of care. The clinical record of Patient #2 evidenced a recertification assessment completed on 5/17/24 for a care period 5/17/24 to 7/15/24 with a wound assessment to Patient’s left heel. On 6/1/24, a skilled nurse visit note with RN 1 evidenced an assessment of three wounds: one to the left heel, one to the right lower leg, and to the right second toe. The comments indicated two new wound formations with plans to notify Patient’s physician on Monday, 6/3/24. The record failed to evidence physician notification of new wounds. The clinical record for Patient #2 evidenced a start of care comprehensive assessment on 1/18/24 with a recertification comprehensive assessment completed on 3/17/24 and 5/14/24 by RN 1. The record failed to evidence orders for recertification nor the review of medications and plan for Patient care. During an interview on 6/11/24 beginning at 10:50 PM, RN 1 stated she has never spoken to Patient #2’s primary care physician. She indicated she has only spoken to the physician’s medical assistant and left messages. XX. The clinical record for Patient #7 evidenced a start of care/initial comprehensive assessment on 2/8/24 which indicated Patient had diagnoses of Atrial fibrillation (an irregular heart rhythm), hypertensive (referring to high blood pressure) heart disease with heart failure, congestive heart failure (heart muscle doesn’t pump as well as it should, may cause swelling), and diabetes mellitus type 2 (disease with high blood sugar). The plan of care was signed by a physician on 3/4/24 with no verbal orders or physician communication from 2/8/24 to 3/4/24. Skilled nursing visit note on date 2/13/24 failed to include a temperature reading with vital signs and both skilled nurse visit notes on 2/13/24 and 2/22/24 were missing Patient’s weight. The plan of care for care period 2/8/24 to 4/7/24 indicated parameters of temperature reading and an order for weight assessment every visit. During an interview on on 6/10/24 starting at 12:15 PM, Administrator indicated vital signs should be done every visit including blood pressure, heart rate, temperature, respiratory rate, and oxygen saturation. 410 IAC 17-14-1(a)(1)(H) XX. A review of the plan of care for certification period 5/3/2024 to 7/1/2024 indicated the clinician should assess Patient #6’s surgical wound at each visit. A review of the PT (Physical Therapy) evaluation dated 5/6/2024 failed to evidence an assessment of the Patient’s surgical wound. During an interview on 6/11/2024 at 11:40 AM, PT 2 indicated they should have documented what the Patient’s surgical wound looked like. 1. A clinical record review for Patient #3 evidenced a plan of care for certification period 5/13/2024-7/11/2024, which indicated the primary diagnosis was cellulitis (a deep infection of the skin) and included additional diagnoses of lymphedema (tissue swelling most commonly affecting the arms and legs) and diabetes (disease affecting the body’s ability to regulate blood sugar). The patient’s medications in the plan of care included glipizide (medication used to lower blood sugar) and metformin (medication used to lower blood sugar). The plan of care indicated the skilled nurse was to provide services 1 time per week to include measure for edema (swelling) and report to the physician increases in swelling by 3 centimeters (cm) and instruct on appropriate actions to take for high/low blood sugar levels. During an observation of care at the patient’s home on 6/5/2024, at 12:15 PM, swelling to both legs and feet were observed, at which time the Clinical Manager/Registered Nurse (RN) touched the patient’s ankles and indicated the patient had a little swelling and redness. During the visit from the Clinical Manager in its entirety from 11:54 AM to 12:40 PM, the Clinical Manager was not observed to measure for edema. The comprehensive assessment completed by RN 1 dated 5/8/2024 indicated the patient had cellulitis to the right leg and had 2+ pitting edema (the grading system used to determine the severity of swelling from 0 to 4+ with 0 being no swelling and 4+ being severe) to both legs. Review failed to evidence the RN measured the edema. Skilled nurse visit notes completed by the Clinical Manager dated 5/2/2024, 5/16/2024, 5/23/2024, and 5/30/2024 indicated the patient had edema to both legs and failed to evidence the RN measured the edema. The visit notes failed to evidence the skilled nurse educated on the oral medications used to lower blood sugar levels as the box next to oral hypoglycemics (medications used to lower blood sugar levels) was left blank on the visit notes. On 6/7/2024, beginning at 2:08 PM, the Administrator indicated the nurse should follow the plan of care and indicated the measurement of the edema was not completed as ordered. The Administrator indicated the skilled nurse should have completed the visit note to include the acknowledgement of the hypoglycemic medication and teaching the appropriate actions to take for high/low blood sugar levels as directed by the plan of care. 2. A clinical record review for Patient #4 evidenced a plan of care for certification period 4/9/2024-6/7/2024 which indicated the patient’s diagnoses included, but were not limited to, pain in the right hip, lumbar spondylosis (changes in the bones and discs of the spine in the lower back), venous insufficiency (improper functioning of the veins in the legs causing swelling), and heart failure. The plan of care indicated the agency would notify the physician of pain greater than 7 on a scale of 0-10 (10 being the worst pain greater than) and the skilled nurse would assess the patient’s pain at every visit; educate the patient on non-medical pain relief measures such as applying heat/cold, repositioning, and relaxation techniques; educate the patient on pressure ulcer (wounds from prolonged pressure on the skin) prevention; notify the physician of increases in edema measurements greater than 3 cm; assess the peripheral pulse rate and strength; and notify the physician of changes in weight of 2 pounds difference in a day or 5 pounds difference in 1 week. A physical therapy note dated 4/16/2024 and completed by the physical therapy assistant (PTA) indicated the patient’s pain was 10/10 to the lower back. Review failed to evidence the PTA reported the patient’s pain to the physician. A skilled nurse visit note dated 4/17/2024 and completed by the registered nurse (RN) indicated the patient’s pain was 10/10 to the back and failed to evidence the RN notified the physician of the pain and educated the patient on non-medical pain relief measures as directed in the plan of care. The visit note indicated the patient’s skin was thin and fragile and failed to evidence the RN educated the patient on pressure ulcer prevention as directed in the plan of care. A skilled nurse visit note dated 4/24/2024 and completed by the RN failed to evidence the RN assessed the patient’s pain and indicated the patient’s skin was thin and fragile. The visit note failed to evidence the RN educated the patient on non-medical pain relief measures and pressure ulcer development as directed in the plan of care. A skilled nurse visit note dated 4/29/2024 and completed by the RN indicated the patient’s skin was thin and fragile and failed to evidence the RN educated the patient on pressure ulcer development as directed in the plan of care. The skilled nurse visit notes for certification period 4/9/2024-6/7/22042 failed to evidence the skilled nurse assessed the patient’s weight and measured the edema to be able to notify the physician of weight and edema measurement changes as ordered in the plan of care. The visit notes failed to evidence the skilled nurse assessed the peripheral pulse rate and strength as ordered in the plan of care. On 6/10/2024, beginning at 1:38 PM, the Administrator indicated there was no documentation the PTA and RN communicated the 10/10 pain to the physician and did not see the skilled nurse educated the patient on non-medical pain relief. The Administrator indicated she did not see the nurse assessed the peripheral pulses and indicated the pain assessment was blank on note dated 4/24/2024. The Administrator indicated the nurse should have educated the patient on pressure ulcer prevention but did not see that it was done. 410 IAC 17-14-1(a)(1)(H)

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the skilled nurse failed to prepare clinical notes accurately and/or timely in 1 of 2 home visits with a registered nurse (RN) (Patient #3) and in 1 of 2 active clinical records reviewed with physical therapy (PT) services (Patient #4). The findings include: 1. A clinical record review for Patient #3 evidenced a plan of care for certification period 5/13/2024-7/11/2024, which indicated the primary diagnosis was cellulitis (a deep infection of the skin). During an observation of care at the patient’s home on 6/5/2024, at 12:15 PM, swelling to both legs and feet were observed, at which time the Clinical Manager/Registered Nurse (RN) touched the patient’s ankles and indicated the patient had a little swelling to both legs and redness to the right lower leg. At this time, the patient indicated they apply a cream to the reddened area to the right leg and provided the nurse with a cream with a prescription label indicated the patient was to apply silver sulfadiazine (antibiotic cream) topically twice a day. During the visit from the Clinical Manager in its entirety from 11:54 AM to 12:40 PM, the Clinical Manager was not observed to review any other patient medications nor was the Clinical Manager observed asking the patient if there were any additional medications that were not listed. At 12:45 PM and after the Clinical Manager left the patient’s home, the following medications were observed in the cabinet of the patient’s kitchen: acyclovir (medication used to treat viral infections) twice daily, Breo Ellipta 1 puff daily (medication to relax the airway to assist breathing), and albuterol (medication used to treat shortness of breath) as needed. On 6/6/2024, at 12:45 PM, the patient indicated they took acyclovir twice a day, Breo Ellipta daily, and albuterol as needed. The undated medication profile reviewed on 6/5/2024 failed to evidence acyclovir, Breo Ellipta, albuterol, and silver sulfadiazine. On 6/10/2024, the medication profile failed to be revised to include the acyclovir, Breo Ellipta, and albuterol. The skilled nurse visit note completed by the Clinical Manager for visit date 6/6/2024 indicated the nurse reviewed and updated the medication list and indicated the medications were unchanged. The nurse failed to prepare the clinical note accurately regarding the failure to review the medication list to ensure all the medications taken by the patient were reviewed and the medication list updated. On 6/11/2024, at 10:45 AM, the Administrator-in-Training indicated the nurse should not have marked the medication list was reviewed if the nurse did not go over each medication to ensure the patient was still taking them and asking about any additional medications. 2. A clinical record review for Patient #4 indicated PT was scheduled on 5/15/2024 for a reassessment but failed to evidence the documentation of the reassessment. On 6/11/2024, at 11:30 AM, the Administrator-in-Training indicated PT 2 completed the reassessment on 5/15/2024 but was having tablet issues and had not yet submitted the documentation of the reassessment. 410 IAC 17-14-1(a)(1)(E) 410 IAC 17-14-1(c)(5)

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview, the administrator failed to: ensure the organizational structure was readily identifiable and included the lines of authority and services provided; appoint in writing a qualified administrator in conjunction with the Governing Body in the administrator’s absence; ensure the accuracy of public information; notify the regulatory entities of administrative staff changes; and ensure the Clinical Manager was coordinating the assignment of personnel and patients and referrals. The findings include: XX. During an interview on 6/7/24 beginning at 2:00 PM, RN 1 indicated that Administrator is her current administrator and clinical director and Administrative staff 2 is her Director of Nursing (DON). 1. Review of a policy titled “Administrator: Defined” revised February 2022 indicated the Administrator’s responsibilities included, but were not limited to, ensuring the accuracy of public information and appointing a similarly qualified alternate to be available in the administrator’s absence and authorized in writing by the Governing Body. 2. Review of a policy titled “Supervision of Staff” revised March 2018 indicated the Clinical Manager’s responsibilities included, but were not limited to, developing personnel assignments. 3. Review of the administrative information in iQIES and on file with the Indiana Department of Health indicated Person 8 was the agency administrator. The Governing Body Meeting Minutes dated 12/11/2023 indicated the Administrator was the interim administrator effective 12/1/2023. During an interview at the entrance conference on 6/5/2024, beginning at 11:25 AM, the Administrator indicated the agency provided services by a physical therapy assistant and did not provide medical social worker, speech therapy, and home health aide services. The Administrator indicated Person 8 terminated employment with the agency 4-5 months ago and indicated she was unaware she needed to notify the Indiana Department of Health that she was the interim administrator until the Administrator-in-Training was trained. 4. Review of the agency brochure found inside the patient admission packet indicated the agency provided services to Lake, Porter, Newton, and Jasper counties. Review of the survey document “Geographic Area Served” dated 6/5/2024 failed to evidence the agency provided services to Lake, Porter, Newton, and Jasper counties. On 6/11/2024, at 1:48 PM, the Administrator-in-Training indicated the agency did not provide services in Lake, Porter, Newton, and Jasper counties but the counties were included on the brochure, because the other two agencies in Indiana managed by Entity 10 covered those counties. Review of the agency’s website www.visitingnurse.com indicated the agency provided home health aide services. 5. Review of the undated organizational chart on 6/5/2024 failed to evidence the services provided by and the lines of authority for the physical therapy assistant. The organizational chart included services provided by speech therapy, home health aide, and medical social worker. The organizational chart evidenced the Administrator was the interim administrator. On 6/5/2024, beginning at 2:09 PM, the Administrator indicated the website should be updated to remove home health aide services and indicated the organizational chart should include the services provided by the physical therapy assistant and the discipline would report to the physical therapist. The Administrator indicated the agency did not provide home health aide and medical social work services as indicated by the organizational chart. On 6/11/2024, at 9:59 AM, Registered Nurse (RN) 2 indicated the Administrator-in-Training was the Clinical Manager. 6. On 6/6/2024, at 3:10 PM, and on 6/11/2024, at 11:55 AM, a request was made to the Administrator for the written authorization for the Alternate Administrator by the Governing Body and Administrator in the administrator’s absence. On 6/11/2024, at 1:48 PM, the Administrator-in-Training indicated there was no documentation provided by the Administrator for the written authorization by the Governing Body and Administrator for the alternate administrator. 7. On 6/11/2024, at 12:07 PM, the Clinical Manager indicated he did not provide oversight of the assignment of patients to clinicians and indicated the Office Manager assigned the patients to staff. The Clinical Manager indicated he was in the office 1 day every 2 weeks and was not involved in the patient referrals. The cumulative effect of these systemic problems has resulted in the home health agency's inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.105 Organization and Administration of Services. 410 IAC 17-12-1(d) 410 IAC 17-12-1(a)(1) 410 IAC 17-12-1(b)(1) 410 IAC 17-12-1(c)(4) 410 IAC 17-14-1(a)(1)(K)

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were provided in accordance with current clinical practice guidelines and professional standards of practice in 2 of 7 records reviewed (Patient #1, 5). The findings include: 1. A review of the American Physical Therapy Association (APTA) website, https://www.apta.org/, physical therapists should take vital signs (heart rate, blood pressure, respiratory rate, temperature, and pulse oximetry) of patients because they provide important information about a patient's cardiovascular and pulmonary systems, as well as their baseline wellness and response to physical activity, environmental conditions, and emotional stressors. 2. A review of the physical therapy evaluation dated 5/18/2024 for Patient #1, who had an acute rib fracture, heart failure, and frequent shortness of breath, failed to evidence a respiratory rate or pulse oximetry reading. During an interview on 6/10/2024 at 12:09 PM, the Administrator indicated the physical therapist should have assessed and documented the Patient’s respiratory rate and pulse oximetry in their evaluation, but they did not. 3. A review of a skilled nurse visit note dated 6/6/2024 indicated Patient #5, who had a history of compromised circulation to the legs, had 1+ (severity rating out of 4) edema (swelling) to both legs but failed to evidence an assessment of pulses in the feet. During an interview on 6/11/2024 at 11:54 AM, Administrative Staff 2 indicated the nurse should have assessed and documented the pulses in the Patient’s feet at each visit, but they did not.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure each patient record included all physician orders in 3 of 7 records reviewed (Patient #1, 2, 6). The findings include: XX. The agency policy titled “Plan of Care – CMS #485 and Physician/Practitioner Orders”, revised 4/2023, indicated care and services provided to patient are according to physician orders which should be current and updated. The clinical record of Patient #2 evidenced wound care orders from Entity 6 on 5/31/24 and 6/5/24 with orders to wear surgical shoe when walking, increase protein intake, elevate legs above the heart for 30 minutes 3-4 times daily, and to cleanse the wound with antibacterial soap. The wound care order from 6/5/24 included an order for two new medications: Doxycycline (an antibiotic) and Diflucan (an antifungal). The clinical record failed to include any orders from the wound care physician. During an interview with on 6/7/24 beginning at 2:00 PM, RN 1 relayed she has not reviewed the wound care orders and had planned on going to the agency to request a copy of them. 1. A review of the plan of care for certification period 5/15/2024 to 7/13/2024 evidenced Patient #1 was taking Ciprofloxacin (an antibiotic) every 12 hours. During observation of a home visit for Patient #1 on 6/6/2024 at 9:20 a.m., a review of the patient’s home medications failed to evidence Ciprofloxacin. During an interview on 6/6/2024 at 10:15 AM, the Patient indicated they were no longer taking Ciprofloxacin. During an interview on 6/10/2024 at 11:25 AM, the Administrator indicated the nurse should have documented an order to discontinue the Ciprofloxacin, but she did not find one in the Patient’s record. 2. A clinical record review indicated physical therapy was to evaluate and treat Patient #6 for post-knee replacement care. The nurse performed the start of care visit on 5/3/2024, and the PT (Physical Therapy) evaluation was done on 5/6/2024. The Patient was scheduled for 2 PT visits per week. A clinical record review evidenced one PT visit was performed on the week of 5/12/2024 to 5/18/2024 and failed to evidence any PT visits were performed the following week. The clinical record failed to evidence why the start of physical therapy was delayed and why no PT visits were completed from 5/17/2024 until the skilled nurse discharged the Patient on 5/24/2024. During an interview on 6/11/2024 at 11:40 AM, PT (Physical Therapist) 2 indicated they did not know why there was a delay in starting therapy for the Patient. During an interview on 6/11/2024 at 1:21 PM, Administrative Staff 2 indicated the initial PT evaluation should have been done within 48 hours of the admission, or there should be documentation explaining the delay, but the Patient’s record failed to evidence such documentation. Administrative Staff 2 indicated the record should have included communication notes to explain the missed visits, but it did not.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on observation, interview, and record review the agency failed to protect clinical records from loss or unauthorized use in one of one agency. Findings include: An agency policy titled “Information Confidentiality, Security, and Data Integrity”, revised March of 2018, indicated the agency will observe the patient’s right to confidentiality of information and will implement processes that assure confidentiality, security, and data integrity. An observation on 6/5/24 at 3:45 PM through 6/6/24 evidenced 8 cardboard boxes stacked in the corner of the agency office next to a locked back door. The boxes were marked discharge or DC charts with dates ranging from 2020 to 2023. The lids of the boxes were unsecure, easily opened, and contents were filled with files of patient data. The front door of the agency remained unlocked during working hours and multiple field staff and a plumber were noted in the area of the boxes. During an interview on 6/5/24 at 4:00 PM, Administrator relayed old charts are sent to a secure warehouse owned by the company and the boxes are scheduled to be picked up as soon as possible. An observation on 6/7/24 evidenced the boxes were no longer present in the office. During an interview on 6/11/24 beginning at 2:00 PM, Administrative staff 2 relayed the boxes were picked up and sent to the storage warehouse. 410 IAC 17-12-3(b)(3)

Names and Contact Information CFR(s): 484.102(c)(1) [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years (annually for LTC).] The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness communication plan which included names and contact information for all staff. The findings include: Review of an agency policy, revised January 2020, and obtained 12/8/2021, titled “Communication Plan and Policy for Emergency Operations Plan (EOP)” stated, “… The Agency has developed and maintains an emergency preparedness communication plan that complies with federal, state and local laws. The communication plan is reviewed and updated at least every two years … The communication plan includes the following: Names and contact information for the following: Staff ….” Review of the agency’s emergency preparedness plan on 12/6/2021 evidenced a document the administrator indicated was the call tree as part of the communication plan. The document failed to evidence the name and contact information for the alternate administrator. During an interview at the entrance conference on 12/2/2021 at 10:45 AM, the alternate clinical manager indicated employee D was the alternate administrator. During an interview on 12/6/2021 at 9:42 AM, the administrator indicated the alternate administrator’s name and contact information should be included on the call tree of the communication plan.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the OASIS data was complete, accurate, and reflected the patient’s current status in 1 of 6 clinical records reviewed. (#5) The findings include: Review of agency policy, revised March 2019 and obtained 12/8/2021, titled “Reporting of OASIS (The Home Health Outcome and Assessment Information Set) Information” stated, “… Agency staff will ensure that the accuracy of OASIS data reflects the patient’s status at time of assessment and data collection … The encoded OASIS data must accurately reflect the patient’s status at the time of assessment " Clinical record review on 12/6/2021 for patient #5, start of care 11/1/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” which indicated a principal diagnosis of displaced pilon fracture left tibia (a type of break that occurs at the bottom of the shinbone and involves the weight-bearing surface of the ankle joint). This document stated under summary of skilled nurse orders, “patient to be non-weight bearing to LLE (left lower extremity), assess surgical wound site to LLE." Review of an agency document titled “Start of Care (D1)”, dated 11/1/2021 and electronically signed by RN [registered nurse] J, indicated patient had surgical diagnosis of multiple surgeries on left ankle fracture, displaced pilon fracture left tibia. This document indicated patient was to be non-weight bearing to left lower extremity and stated there was a surgical incision and boot to left lower extremity. Review of an agency document titled “Discharge from Agency (D1)”, dated 11/23/2021 and electronically signed by RN J, indicated that patient had surgical wound to right lower extremity and dressing to right lower extremity. This document stated, “the wound to right lower extremity continued healing”. This document indicated that patient remained non-weight bearing to right lower extremity. The document failed to evidence the OASIS was accurate to include the correct location of the wound and dressing. The document failed to evidence an accurate representation of the patient’s current status in OASIS. During an interview on 12/7/2021 at 11:54 AM, the alternate clinical manager indicated the surgical wound location should have been documented as left lower extremity. Alternate clinical manager indicated that the OASIS document was not accurate, and weight bearing status should have been the left lower extremity.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on observation record review and interview, the administrator failed to ensure day-to-day operations were followed according to agency policy. (Administrator A) The findings include: Record review of an agency document titled “Home Health Care Personnel Manual” revised March 2016, had an area subtitled “Section 30: Other Policies.” This area stated “… 30.3 Dress Code: … For visiting staff: Either scrubs or a lab coat over street clothes is required. Closed toe, hard soled shoes are required and may not be removed in the patient’s home … Name tags are a required component of the dress code. Employees clothing must be tasteful and professional in style so as to neither offend nor endanger a client … For both office staff and visiting staff: jeans, jogging suits, T-shirts with writing on them, and athletic wear are not acceptable on-the-job. Examples of appropriate clothing will be given at orientation ….” An observation of a home visit was conducted on 12/6/2021, at 2:45 PM, for patient #2, start of care 3/31/2021. Licensed practical nurse [LPN] F was met outside the patient's home where she indicated her ID [identification] badge would not hook on to her shirt, but evidenced it was in her coat pocket. Inside the patient's home at 2:52 PM, LPN F was observed wearing jeans, hot pink long sleeved t-shirt, and gray, knee-high boots. Observation failed to evidence LPN F had followed the agency's dress code policy. Review evidenced the administrator failed to ensure day-to-day operations and policies were followed. During an interview on 12/8/2021, at 10:29 AM, alternate clinical supervisor B indicated field staff clinicians are instructed to wear scrubs and tennis shoes during work hours.

An Emergency Preparedness survey was conducted by the Indiana State Department of Health in accordance with 42 CFR 484.102. Survey Dates: 8/9/2021 - 8/18/2021 Facility ID: 157078 At this Emergency Preparedness survey, Community Home Care Services, Inc. was found to not be in compliance with 42 CFR 484.102, Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. *[For LTC facilities at §483.73(a)(1):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a)(1):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a)(2):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness plan was based on and included a documented facility-based and community-based risk assessment utilizing an all-hazards approach. The findings include: Review of an agency policy, revised March 2019 and obtained 8/9/2021, titled “Emergency Operations Plan and Policies” stated, “… The emergency preparedness program includes but is not limited to, the following elements: … The plan: Is based on and includes a documented, facility-based (Agency) and community-based risk assessment, utilizing an all-hazards approach….” Review of an agency policy, revised March 2019 and obtained 8/9/2021, titled “Agency Facility-Based and Community-Based Risk Assessment Policy” stated, “… The Agency will develop strategies to address emergent events identified by the risk assessments. … Weather related events (Agency will develop strategies based on emergent weather events for service area, e.g., tornado, severe thunderstorm, hurricane, ice storm, snow, flooding, etc.).” Review of an agency binder titled “Emergency Preparedness” on 8/9/2021 failed to evidence a documented facility-based and community-based risk assessment. Review failed to evidence the plan considered hazards most likely to occur specific to the location of the agency. During an interview on 8/9/2021 at 1:54 PM, the alternate clinical manager indicated the risk assessment should be included in the emergency preparedness plan but she could not locate it. The alternate clinical manager indicated the plan should include strategies for extreme winter weather and blizzard and indicated there was not any included in the agency specific emergency preparedness plan.

Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years (annually for LTC facilities). The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility's needs in the event of an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure an emergency preparedness plan included a process for cooperation and collaboration with local, regional, State and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency. The findings include: Review of an agency policy, revised March 2019 and obtained 8/9/2021, titled “Emergency Operations Plan and Policies” stated, “… The Agency will refer to and utilize the “Healthcare COOP & [and] Recovery Planning” resource document from the Assistant Secretary for Preparedness and Response (ASPR) to develop strategies to ensure continuity of operations. ... While the responsibility for ensuring a coordinated disaster preparedness response lies upon the state and local emergency planning authorities, the Agency will document its efforts to contact these officials to engage in collaborative planning for an integrated emergency response. Agency will participate in a healthcare coalition as it may provide assistance in planning and addressing broader community needs that may also be supported by local health department and emergency management resources….” Review of an agency binder titled “Emergency Preparedness” on 8/9/2021 evidenced a document titled “Healthcare COOP & Recovery Planning”, revised June 2017, which stated, “… State Health Authority Essential Supporting Activities include: Collect situational assessment data from Local/Regional Health Departments … Local/Regional Health Department Essential Supporting Activities include: Collect situational assessment data on the impact of the disruption of public service delivery in the local and regional area. Partner with local emergency management and social services ….” Review failed to evidence documented efforts to contact local and State emergency preparedness officials per Agency’s policy. Review failed to evidence the emergency preparedness plan included a process for cooperation and collaboration with local, regional, State and Federal emergency preparedness officials to maintain an integrated response during a disaster or emergency. During an interview on 8/9/2021 at 1:54 PM, the alternate clinical manager indicated the policy indicated the agency would have a process for collaboration with emergency preparedness officials and indicated she did not see in the emergency preparedness plan the agency had any collaboration with local and state emergency preparedness officials.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years.] At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and implement individualized emergency preparedness plans for the patients which provided appropriate instructions, in the event of an emergency, in 6 of 7 clinical records reviewed. (#1, #2, #3, #4, #5, #7) The findings include: 5. Clinical record review on 8/10/2021 for patient #4, start of care 7/29/2021, evidenced an agency document titled “Individual Patient Emergency Preparedness Plan” which was signed by RN H. This document had an area subtitled “Emergency Plan” which indicated the patient’s emergency contact and phone number, stated “If necessary, patient will evacuate to : Family transported by car … Relative/Friend (Name/Phone Number): ___ … Hotel (Name/Phone Number): ___ … Shelter (Location) ___ ….” This document failed to evidence the emergency plan had been completed. Review failed to evidence which family member, neighbor, hotel and/or shelter the patient could relocate to in the event of an emergency. 6. Clinical record review on 8/10/2021 for patient #5, start of care 2/24/2021, evidenced an agency document titled “Individual Patient Emergency Preparedness Plan” which was signed by former employee K, RN. This document had an area subtitled “Relevant Healthcare Information” which stated “… Patient/caregiver Independent: …” but failed to indicate “Yes” or or “No.” Another area subtitled “Emergency Plan” which indicated the patient’s emergency contact and phone number, stated “If necessary, patient will evacuate to : Family transported by car … Hotel (Name/Phone Number): ___ … Shelter (Location) ___ ….” This document failed to evidence the emergency plan had been completed. Review failed to evidence whether the patient/caregiver was independent. Review failed to evidence which neighbor, hotel and/or shelter the patient could relocate to in the event of an emergency. 7. Clinical record review on 8/17/2021 for patient #7, start of care 6/28/2021, evidenced an agency document titled “Individual Patient Emergency Preparedness Plan” which was signed by RN H. This document had an area subtitled “Emergency Plan” which indicated the patient’s emergency contact and phone number, stated “If necessary, patient will evacuate to : Family transported by car … Relative/Friend (Name/Phone Number): ___ … Hotel (Name/Phone Number): ___ … Shelter (Location) ___ ….” This document failed to evidence the emergency plan had been completed. Review failed to evidence which family member, neighbor, hotel and/or shelter the patient could relocate to in the event of an emergency. 1. Review of an agency policy, revised March 2019 and obtained 8/9/2021, titled “Emergency Operations Plan and Policies” stated, “… Mitigation activities … will be undertaken in an effort to lessen the severity and impact of a potential emergency. Such activities include: … Developing an individual emergency preparedness plan for each patient as part of the comprehensive assessment. Individual patient preparation: prioritizing patient who might require care/service during emergency and advanced planning for extra supplies, equipment, medications, food and home evacuation….” 2. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Start of Care (D1)”, which was dated 6/18/2021 and electronically signed by registered nurse (RN) K. This document indicated the patient’s diagnoses included, but were not limited to, Stage II pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in partial thickness skin loss) of the left buttock and quadriplegia. This document indicated the patient had 3 Stage II pressure ulcers consisting of 2 to the left groin and 1 pressure ulcer to the buttocks. This document indicated the patient had a foley catheter (a thin, sterile tube inserted into the bladder to drain urine). Review evidenced an agency document titled “Individual Patient Emergency Preparedness Plan”, dated 6/18/2021 and signed by registered nurse (RN) K, which failed to evidence the document was complete and individualized to include the name of the patient’s physician and phone number, diagnosis and the wound care and foley catheter care supplies necessary for the patient. This document indicated the patient would evacuate to another location in the event of an emergency but failed to evidence to which location. The document failed to evidence the priority/acuity level of the patient. During an interview on 8/12/2021 at 12:18 PM, the alternate clinical manager indicated the emergency preparedness plan for the patient should be specific and complete. 3. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Start of Care”, dated 7/14/2021 and electronically signed by RN H, which indicated the patient’s diagnosis was Type II Diabetes (a chronic condition where the body is impaired in the way it regulates and uses sugar as fuel). Review evidenced an undated agency document titled “Individual Patient Emergency Preparedness Plan”, signed by registered nurse (RN) K, which failed to evidence the document was complete and individualized to include the diagnosis and the evacuation plan in the event of an emergency. During an interview on 8/12/2021 at 10:01 AM, the alternate clinical manager indicated the emergency preparedness plan was not complete. 4. Clinical record review on 8/12/2021 for patient #3, start of care 10/8/2020, evidenced an undated agency document titled “Individual Patient Emergency Preparedness Plan”, signed by RN H. Review failed to evidence the document was complete to include an emergency contact name and phone number. The document indicated the patient’s evacuation location was a local hotel but failed to include the name of the hotel, address and phone number. During an interview on 8/16/2021 at 10:45 AM, the alternate clinical manager indicated the individualized patient emergency preparedness plan should be complete to include the evacuation location.

Names and Contact Information CFR(s): 484.102(c)(1) [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years (annually for LTC).] The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness communication plan which included names and contact information for wound clinics providing services to 2 of 2 clinical records reviewed receiving wound clinic services. (#1, #2) The findings include: 1. Review of an agency policy, revised March 2019 and obtained 8/9/2021, titled “Communication Plan and Policy for Emergency Operations Plan (EOP)” stated, “… The Agency has developed and maintains an emergency preparedness communication plan that complies with federal, state and local laws. The communication plan is reviewed and updated at least annually. … The communication plan includes the following: Names and contact information for the following: Staff ….” 2. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced agency documents titled “Skilled Visit Note”. Document dated 6/24/2021 and electronically signed by former employee licensed practical nurse (LPN) B indicated the patient was seen at the wound clinic on 6/23/2021. Document dated 8/9/2021 and electronically signed by registered nurse (RN) L indicated the patient would continue to follow up with the wound clinic weekly. Review failed to evidence the name and contact number of the wound clinic. During an interview on 8/12/2021 at 12:53 PM, administrator in training D indicated the patient’s wound physician was physician C from wound clinic D. 3. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Skilled Visit Note”, dated 7/21/2021 and electronically signed by former employee LPN B, indicated the patient had a surgical wound to the front of the left foot. Review failed to evidence the name and contact number of the wound clinic. During an interview on 8/12/2021 at 10:33 AM the alternate clinical manager indicated the patient had a paper from the wound clinic at the patient's home that explained the wound care. Review on 8/13/202 of documents from the wound clinic at hospital I, which the alternate clinical manager identified were requested of and received on 8/13/2021 from the patient’s wound clinic, evidenced a document titled “06/28/2021 – Follow Up in SM [hospital I] Wound Ostomy Clinic”, dated 6/28/2021 and electronically signed by physician J. This document indicated the wound clinic provided wound care services for the wound on the left foot on 7/7/2021 and 7/26/2021. 4. Review on 8/9/2021 of an agency binder titled “Emergency Preparedness” failed to evidence the contact information for wound clinic D and the wound clinic at hospital I. 5. During an interview on 8/10/2021 at 1:54 PM, the alternate clinical manager indicated the contact information for other agencies providing services to agency patients should be included in the communication plan.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years (annually for LTC).] The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness communication plan which included contact information for Federal, State, tribal, regional, and local emergency preparedness staff and other sources of assistance. The findings include: Review of an agency policy, revised March 2019 and obtained 8/9/2021, titled “Communication Plan and Policy for Emergency Operations Plan (EOP)” stated, “… The Agency has developed and maintains an emergency preparedness communication plan that complies with federal, state and local laws. The communication plan is reviewed and updated at least annually. … The communication plan includes the following: … Contact information for the following: Federal, state, tribal, regional or local emergency preparedness staff. Other sources of assistance….” Review on 8/9/2021 of an agency document titled “Patient Current Information”, dated 8/9/2021, evidenced patient #1 with an address in Marshall County, Indiana. Review on 8/9/2021 of an agency binder titled “Emergency Preparedness” evidenced an agency document titled “Communication Plan: Other Sources of Assistance Contact Information”, revised October 2017, which indicated the emergency preparedness staff was the police, fire and ambulance in Demotte, Indiana. Review failed to evidence the local emergency contact information for the city in which the agency was located. Review failed to evidence the health department contact information for Marshall County, Indiana. During an interview on 8/10/2021 at 1:54 PM, the alternate clinical manager indicated the local health department for all the counties the agency services patients should be included in the communication plan. The alternate clinical manager indicated the local contact information listed in the communication plan was for agency G and was not specific to their agency.

EP Training Program CFR(s): 484.102(d)(1) *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to provide and maintain documentation of initial training and every 2 years in emergency preparedness policies and procedures to all new and existing staff and failed to demonstrate staff knowledge of emergency procedures. The findings include: Review of an agency policy, revised March 2019 and obtained 8/9/2021, titled “Emergency Operations Plan (EOP) Training Program” stated, “… The Agency will do the following: … Provide initial training in emergency preparedness policies and procedures to all new and existing staff … Provide emergency preparedness training at least annually … Maintain documentation of the training….” Review of an agency binder titled “Employee Inservices” on 8/10/2021 evidenced an agency document titled “Employee Training: Emergency Operations Plan (EOP)”, dated 11/26/2019 for registered nurse H, date of hire 12/16/2019, which failed to evidence the signature and date of the instructor. Review failed to evidence emergency preparedness training for RN H was complete as indicated by a signature of the instructor. Personnel record review on 8/16/2021 for former employee licensed practical nurse (LPN) E, date of hire 2/17/2020, failed to evidence emergency preparedness training was provided. During an interview on 8/10/2021 at 1:54 PM, the alternate clinical manager indicated emergency preparedness training would be either in the personnel file or in the inservice binder and indicated annual inservices were usually completed in January or February each year. During an interview on 8/16/2021 at 10:11 AM, the alternate clinical manager indicated the personnel file for former employee LPN E did not include emergency preparedness training.

EP Testing Requirements CFR(s): 484.102(d)(2) *[For RNCHI at §403.748, ASCs at §416.54, HHAs at §484.102, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHC at §485.920, RHC/FQHC at §491.12, ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility- based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d) (2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility- based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to conduct exercises to test the emergency plan annually. The findings include: Review of an agency policy, revised March 2018 and obtained 8/9/2021, titled “Testing Program for Emergency Operations Plan (EOP)” stated, “… The Agency will conduct exercises to test the EOP at least annually. The Agency will do the following: Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based exercise. … Conduct an additional exercise that may include, but is not limited to the following: A second full-scale exercise that is community-based or individual, facility-based. A tabletop exercise ….” Review on 8/9/2021 of an agency binder titled “Emergency Preparedness” failed to evidence an exercise to test the emergency preparedness plan. During an interview on 8/10/2021 at 1:54 PM, the alternate clinical manager indicated she could not locate an emergency preparedness exercise and indicated an exercise should be completed every year.

This survey was a Federal Re-certification, a focused Infection Control and State licensure survey in conjunction with a complaint for a home health agency. Complaint: IN00358569 - substantiated with findings Survey Dates: 8/9/2021 - 8/18/2021 Facility ID: 157078 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Community Home Care Services, Inc. is precluded from providing its own home health aide training and competency evaluation for a period of two years from 08/18/2021 - 08/18/2023, due to being found out of compliance with Conditions of Participation 484.60 Care Planning, Coordination of Care and Quality of Care, 484.65 Quality Assessment and Performance Improvement, 484.75 Skilled Professional Services and 484.105 Organization and Administration of Services.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the OASIS was completed, accurate and reflected the patient's current status in 5 of 7 clinical records reviewed. (#1, #2, #3, #5, #6) The findings include: 7. During an observation on 8/11/2021, LPN (licensed practical nurse) I was observed performed a SN (skilled nurse) visit with patient #5. The patient and two family members were observed sitting in lift recliners, with their rolling walkers propped in front of them. The patient was hard of hearing, and LPN I had to speak very loudly, or the patient’s family members would answer for the patient. Clinical record review on 8/12/2021, for patient #5, start of care 2/24/2021, primary diagnosis type 2 diabetes with chronic kidney disease, evidenced an agency document titled “Recertification (D1)” for the certification period of 6/24/2021 – 8/22/2021, which was signed by RN K. This document had an area subtitled “Medications” which stated “Follow up/Recertification … 4. Drug interactions? … No ….” An area subtitled “Sensory Status” which indicated the patient wore glasses and otherwise, the patient’s ear/nose/throat [E/N/T] were within normal limits. Another area subtitled “Endocrine” indicated the patient was able to draw up and administer insulin. The section subtitled “Diet” indicated the patient was on a regular diet. A section of this document stated, “(M1820) Current ability to Dress Lower Body Safely (with or without dressing aids) including undergarments, slacks, socks or nylons, shoes: … Able to obtain, put on and remove clothing and shoes without assistance …” Another section indicated the patient did not have functional limitations, including but not limited to hearing, endurance, and ambulation. The area subtitled “Visit Summary” stated “Nursing Diagnosis/Summary: … [patient #5] … lives at home with [his/her] two [family members] … Remains homebound d/t [due to] decreased endurance … Compression stockings in place. Patient ambulates with rolling walker….” This document failed to be an accurate representation of the patient’s current status. Record review of the recertification assessment failed to evidence drug interactions of the patient’s medications. Review evidenced the patient was independent in dressing of their lower body. Review of an agency document titled “Skilled Visit Note” from 7/20/2021, which was signed by RN L, had an assessment section subtitled “Sensory” which indicated the patient had bilateral hearing aids. Record review of an agency document titled “Drug Interactions” which was received on 8/12/2021, indicated to have a total of 6 medication interactions which were as follows: Spironolactone with Potassium Chloride (listed twice) had a level 3 severity, Spironolactone with Losartan Potassium had a level 2 severity, Losartan Potassium with Potassium Chloride (listed twice) had a level 2 severity, and Carvedilol with NovoLIN had a level 1 severity. Review evidenced drug interactions of the patient’s medications. During an interview on 8/11/2021, at 1:18 PM, the patient’s family member indicated they assist the patient with applying light compression stockings and assists the patient with bathing. During an interview on 8/16/2021, at 10:06 AM, alternate clinical manager A indicated the recertification assessment was not accurate. During an interview on 8/16/2021, at 10:13 AM, alternate clinical manager A indicated the recertification was contradictory within itself and to follow up assessments. During an interview on 8/16/2021, at 10:16 AM, alternate clinical manager A indicated a patient having bilateral hearing aids should not be documented as WNL (within normal limits). 1. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Reporting of OASIS Information” stated, “… Agency staff will ensure that the accuracy of OASIS data reflects the patient’s status at time of assessment and data collection….” 2. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Initial Assessments/Comprehensive Assessments” stated, “… Drug Regimen Review: Each patient’s comprehensive assessment includes a review of all medications the patient is currently taking (prescription, non-prescription, herbs, home remedies, etc.) as well as times of medication administration and routes. The Agency nurse must consider and document each medication that the patient is taking to identify: Significant side effects. Significant drug interactions. Noncompliance with medications. Duplicative therapy. Potential adverse effects. Medication reactions. Significant medication issues … Concerns identified by clinician during medication review must be reported to physician….” 3. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an undated agency document on 8/10/2021 titled “Patient Medications” which indicated the patient’s medication included Ketoconazole (an antifungal medication used to treat skin infections) with a start date of 4/2/2021, Simvastatin (medication used to treat high cholesterol) with a start date of 4/2/2021, Norco 5-325 mg (medication used to treat pain) with a start date of 4/23/2021 and Eliquis (a type of anticoagulant medication, a class of medications used to thin the blood to prevent blood clots) with a start date of 4/2/2021. Review of an undated agency document titled “Drug Interactions” indicated an interaction with a level 3 severity rating between Ketoconazole and Simvastatin. This document also indicated interactions with a level 2 severity rating between Norco and Ketoconazole and Eliquis and Ketoconazole. Review of an agency document titled “Start of Care (D1)”, dated 6/18/2021 and electronically signed by RN K, indicated there was no drug interaction and no issues were found during drug regimen review. This document indicated the patient was not taking any high risk medication to include anticoagulants. The document failed to evidence the OASIS was accurate to include the drug interactions and the high risk drug, Eliquis. Review failed to evidence the OASIS document was complete to include the patient’s pulse. During an interview on 8/12/2021 at 12:26 PM, the alternate clinical manager indicated the OASIS document should have included the patient’s pulse. At 12:53 PM, the alternate clinical manager indicated Eliquis was considered a high risk drug. At 12:55 PM, the alternate clinical manager indicated the drug regimen review should have included the drug interactions. 4. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 –8/ 22/2021 which was electronically signed by RN H on 7/21/2021 and the physician on 7/23/2021. The plan of care indicated the patient’s medication included, but was not limited to, Allopurinol (a medication used to treat gout, a condition which causes severe pain, redness and tenderness in the joints), Warfarin Sodium (a type of anticoagulant medication), Clopidogrel (a medication used to prevent strokes), Amiodarone (a medication used to treat irregular heartbeats), Propylthiouracil (a medication used to treat a hyperactive thyroid), Pantoprazole Sodium (a medication used to treat acid reflux), Simvastatin (a medication used to treat high cholesterol) and Carvedilol (a medication used to treat high blood pressure and heart failure). Review evidenced an undated agency document titled “Drug Interactions” indicated an interaction with a level 3 severity rating between Allopurinol and Warfarin Sodium, Warfarin Sodium and Clopidogrel, Warfarin Sodium and Amiodarone, Warfarin Sodium and Propylthiouracil, Pantoprazole and Clopidogrel and Amiodarone and Simvastatin. This document also indicated interactions with a level 2 severity rating between Warfarin Sodium and Pantoprazole, Warfarin Sodium and Simvastatin, Amiodarone and Carvedilol and Propylthiouracil and Carvedilol. The document failed to evidence the drug interactions were reviewed by the clinician. Review of an agency document titled “Start of Care (D1)”, dated 7/14/2021 and electronically signed by RN H, indicated there was no drug interaction and no issues were found during drug regimen review. This document indicated the patient was not taking any high risk medication to include anticoagulants. The document failed to evidence the OASIS was accurate to include the drug interactions and the high risk drug, Warfarin Sodium. During an interview on 8/12/2021 at 10:03 AM, the alternate clinical manager indicated the RN should review all medications for drug interactions. 5. Clinical record review on 8/12/2021 for patient #3, start of care 10/8/2020, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/5/2021 – 8/3/2021, electronically signed and dated on 7/6/2021 by RN N, which indicated the patient’s medication included, but was not limited to, Diltiazem (a medication used to treat high blood pressure and chest pain), Lovastatin (a medication used to treat high cholesterol), Dilantin (a medication used to treat seizures), Coumadin (a blood-thinning medication that is used to treat and prevent blood clots), Paxil (a medication used to treat depression and anxiety) and Escitalopram (a medication used to treat depression and anxiety). Review of an undated agency document titled “Drug Interactions” indicated an interaction with a level 3 severity rating between Diltiazem and Lovastatin and indicated a level 2 severity rating between Dilantin and Lovastatin, Dilantin and Diltiazem, Coumadin and Dilantin, Coumadin and Lovastatin, Coumadin and Paxil and between Coumadin and Escitalopram. Review of an agency document titled “Recertification”, completed on 6/2/2021 and signed by RN N, indicated there were no drug interactions. The document failed to evidence the OASIS was accurate to include the drug interactions. This document failed to evidence the OASIS was complete to include the patient’s height and weight. During an interview on 8/16/2021 at 10:50 AM, the alternate clinical manager indicated there were medication interactions and the OASIS should indicate the interactions were reviewed. The alternate clinical manager indicated the OASIS should have included the patient’s height and weight. 6. Clinical record review on 8/16/2021 for patient #6, start of care 2/18/2021, evidenced an agency document titled “Comprehensive Adult Assessment, 485 P.O.C. [Plan of Care] Worksheet and Outcome and Assessment Information Set”, dated 2/18/2021, and signed by former employee RN K, which failed to evidence the OASIS was complete to include immunization history. Review failed to evidence the OASIS was complete to include community agencies/social service screening. The OASIS document indicated the patient had a surgical wound from an amputation to the right 3rd toe, and the OASIS document failed to indicate the patient’s wound in the nutritional health screening. During an interview on 8/18/2021 at 10:48 AM, the alternate clinical manager indicated immunization history should have been completed on the OASIS. At 10:50 AM, the alternate clinical manager indicated the community agencies/social service screening should have been completed on the OASIS assessment. At 10:51 AM, the alternate clinical manager indicated the surgical wound should have been included in the nutritional health screening. Review of an agency document titled “Medication Profile”, dated 2/18/2021 and signed by former employee RN K, indicated the patient’s medication included Metformin (a type of hypoglycemic medication, a class of medication used to alter the blood sugar level). Review of an agency document titled “Comprehensive Adult Assessment, 485 P.O.C. [Plan of Care] Worksheet and Outcome and Assessment Information Set”, dated 2/18/2021 and signed by former employee RN K, indicated “not applicable” for the patient taking high risk medication to include hypoglycemics. Review failed to evidence the patient/caregiver was knowledgeable about special precautions associated with hypoglycemics. During an interview on 8/18/2021 at 10:55 AM, the alternate clinical manager indicated the RN should have reviewed the medications in the home at the start of care to look for drug interactions. At 10:56 AM, the alternate clinical manager indicated the RN should have marked the patient was taking a high risk medication or documented the knowledge the patient had of the precautions associated with Metformin.

Written notice of patient's rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient's rights and responsibilities under this rule, and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient was provided written notice of the patient’s rights and responsibilities in advance of furnishing care to the patient in 2 of 5 active clinical records reviewed. (#1, #4) The findings include: 3. Clinical record review on 8/10/2021 for patient #4, start of care 7/29/2021, failed to evidence the Consent/Release of Information form per the agency’s policy. Review failed to evidence the agency provided a written notice of the patient’s rights and responsibilities in advance of furnishing care. During an interview on 8/12/2021, at 12:17 PM, office manager E indicated the consent forms were not in the clinical record for patient #4 because RN [registered nurse] H still had them from the start of care. 1. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Consent for Treatment and Services” stated, “… The patient has the right to be informed in advance regarding the care to be furnished … The staff member performing the admission visit will explain the Consent/Release of Information form during the initial visit in addition to: Frequency of visits to be provided. Various disciplines to provide services. Fees for specific services. Explanation of Medicare, Medicaid or other third party payors. Any charges to be paid by the patient. The Consent/Release of Information form is signed by the patient or designated responsible party. The Consent/Release of Information form will be placed in the medical record.” 2. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, failed to evidence the Consent/Release of Information form per the agency’s policy. Review failed to evidence the agency provided a written notice of the patient’s rights and responsibilities in advance of furnishing care. During an interview on 8/12/2021 at 12:07 PM, office manager E indicated she could not find the consent to treat form indicating the patient was informed in writing of the notice of patient rights and responsibilities. Office manager E indicated the start of care documents may still be in the home but should have been brought into the office by the nurse and scanned into the medical record.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the patient participated in, was informed about, and consented to in advance of treatment the care to be furnished, establishing and revising the plan of care, the disciplines that would furnish the care, the frequency of visits, expected outcomes of care and any changes in care to be furnished in 2 of 3 active clinical records reviewed with wounds. (#1, #2) The findings include: 1. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Consent for Treatment and Services” stated, “… The patient has the right to be informed in advance regarding the care to be furnished and any subsequent changes in the care. … The staff member performing the admission visit will explain the Consent/Release of Information form during the initial visit in addition to: Frequency of visits to be provided. Various disciplines to provide services. Fees for specific services. Explanation of Medicare, Medicaid or other third party payors. Any charges to be paid by the patient. The Consent/Release of Information form is signed by the patient or designated responsible party. The Consent/Release of Information form will be placed in the medical record.” 2. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Patient Bill of Rights and Responsibilities” stated, “… Patients have the right: … Participate in, be informed about and consent or refuse care in advance of and during treatment, where appropriate, with respect to: Completion of all assessments. The care to be furnished based on the comprehensive assessment. Establishing and revising the plan of care. The disciplines that will furnish the care. The frequency of visits. Expected outcomes of care, including patient-identified goals and anticipated risks and benefits. Any factors that could impact treatment effectiveness. Any changes in the care to be furnished….” 3. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Start of Care (D1)”, which was dated 6/18/2021 and electronically signed by registered nurse (RN) K. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and 2 times a week for 9 weeks and receive home health aide services 2 times a week for 9 weeks. Review failed to evidence the patient was informed of and consented to the services to be provided. Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/18/2021 to 8/16/2021 signed by the alternate clinical manager on 7/15/2021 and by the physician on 8/2/2021. This document indicated the patient was to receive skilled nursing 1 time a week for 9 weeks and 2 times a week for 9 weeks and receive home health aide services 2 times a week for 9 weeks. Review indicated the patient’s expected outcome was the patient’s wound would heal. Review failed to evidence the patient was informed of and consented to the services to be provided and the expected outcomes of care. Review failed to evidence the Consent/Release of Information form per the agency’s policy. Review failed to evidence the patient was informed of and consented to the disciplines to provide services and the frequency of those services. During an interview on 8/12/2021 at 12:07 PM, office manager E indicated she could not find the consent to treat form which indicated the patient was informed of and consented to services to be provided. Office manager E indicated the start of care documents may still be in the home but should have been brought into the office by the nurse and scanned into the medical record. During an observation at the patient’s home on 8/13/2021 at 7:02 PM, the agency’s home folder was observed and failed to evidence a consent to treat form and a copy of the plan of care to include what services the patient was to provide, the disciplines to provide the services, the frequency of those services and expected outcomes. During an interview on 8/18/2021 at 12:19 PM, the alternate clinical manager indicated the agency’s folder in the patient’s home should include the plan of care. 4. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Service Agreement and Admission Consent” which evidenced the patient was informed of and consented to skilled nursing and home health aide services. Review of an agency document titled “Occupational Therapy [OT] Evaluation”, dated 8/2/2021, and electronically signed by OT M, indicated the patient was evaluated for OT services and indicated OT services would be provided 2 times a week for 3 weeks. Review failed to evidence the patient was notified of and consented to OT services in advance of OT services provided. During an interview on 8/12/2021 at 9:49 AM, the alternate clinical manager indicated a new consent form would need to be signed by the patient to reflect the consent to OT services and uploaded into the electronic medical record. The alternate clinical manager indicated OT M was new and the agency needed to ensure everyone was made aware to update the consent forms with changes. Review of an agency document titled “Occupational Therapy Evaluation”, dated 7/28/2021, and electronically signed by OT M, evidenced the patient was to receive OT services 2 times a week for 3 weeks. Review of an agency document titled “Supplemental Provider Order”, dated 7/31/2021, and electronically signed by OT M, indicated OT services were to be provided 2 times a week for 3 weeks for ADL (activities of daily living) training, bathroom mobility and a home exercise program. Review of a document titled “Therapy Visit Note”, dated 8/6/2021, and electronically signed by OT M, evidenced the patient’s problems included decreased functional mobility, safety awareness and ADLs. Review evidenced the plan for the next OT visit was to continue with safety training during tub transfers and the home exercise program. Review of a document titled “Discharge/Transfer Summary”, dated 8/9/2021, and electronically signed by OT M, evidenced a subsection titled “Goals not met [and] reasons (If applicable):” which stated, “… Bathing not met due to need of someone to position shower bench and assist with lower body as there is a dressing on the (L) [left] foot ….” Review failed to evidence the patient was notified prior to the patient’s discharge from OT services that goals were not met and patient was to be discharged from OT. During an interview on 8/18/2021 at 12:12 PM, the alternate clinical manager indicated the patient should have been provided a change of care notice form related to the discharge from OT services and should have been communicated with related to the discharge plans from OT prior to discharge. 17-12-3(b)(2)(D)(i)(AA) 17-12-3(b)(2)(D)(i)(BB) 17-12-3(b)(2)(D)(ii)(BB)

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient received all services as outlined in the plan of care for 3 of 3 active clinical records reviewed with wounds. (#1, #2, #4) The findings include: 3. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/18/2021 – 8/16/2021. The document was signed by the alternate clinical manager on 7/15/2021 and by the physician on 8/2/2021 and indicated the patient's diagnoses included, but were not limited to, Stage II pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in partial thickness skin loss) of the left buttock, hypertension (high blood pressure) and quadriplegia (paralysis of all 4 limbs). Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/18/2021 – 8/16/2021. The document was signed by the alternate clinical manager on 7/15/2021 as receipt of the verbal start of care and by the physician on 8/2/2021. The plan of care failed to be established with the physician until the verbal start of care obtained by the alternate clinical manager on 7/15/2021. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and 2 times a week for 9 weeks. Review failed to evidence skilled nursing services were provided during the week of 7/25/2021. During an interview 8/12/2021 at 12:26 PM, the alternate clinical manger indicated former employee LPN B was scheduled for a skilled nursing visit on 7/26/2021 and 7/30/2021 but indicated former employee LPN B called off on 7/26/2021 and quit without notice on 7/30/2021. The alternate clinical manager indicated no other skilled nurse was available to provide skilled nursing services. 4. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 –8/ 22/2021 which was electronically signed by RN H on 7/21/2021 and the physician on 7/23/2021. The plan of care indicated the patient’s primary diagnosis was Type II Diabetes (a chronic condition where the body is impaired in the way it regulates and uses sugar as fuel) and evidenced the agency was to provide home health aide (HHA) services 2 times a week for 9 weeks. Review failed to evidence the agency provided home health aide services during the week of 7/4/2021, 7/25/2021 and 8/1/2021 as directed in the plan of care. During an interview on 8/12/2021 at 11:24 AM, the administrator in training D indicated there was a home health aide visit for 7/5/2021 but the visit note had not been downloaded into the electronic medical record and indicated the agency overlooked downloading the notes into the electronic medical record that day. The administrator in training D indicated there was a home health aide visit scheduled on 7/30/2021 but the agency was unable to staff the visit. The administrator in training D indicated a home health aide visit was provided on 8/2/2021 but the visit note had not yet been downloaded into the electronic medical record. Requested copies of the visit notes for 7/5/2021 and 8/2/2021 and no additional documents were provided. 1. Review of an agency policy titled “Patient Bill of Rights and Responsibilities” revised March 2018, stated “Purpose The agency protects and promotes the rights of each individual in its care... Procedure 1. the agency protects and promotes the rights of each individual. In advance of furnishing care to the patient, during the initial evaluation visit before the initiation of treatment, the patient is informed both verbally and in writing of all rights... 7. Agency maintains documentation in the patients’ medical record demonstrating compliance with informing patient about rights. The patient's or legal representative signature confirming that he/ she received a copy of the rights/ responsibilities must be obtained ... 8. Patients will be informed of their rights on an ongoing basis as indicated ... 9. Agency will inform patient and/ or representative during the initial evaluation visit of responsibilities and transfer and discharge criteria per agency policy ... Patients have the right: ... Receive all services in the plan of care ... Participate in, be informed about and consent or refuse care in advance of and during treatment, where appropriate, with respect to: ... The care to be furnished based on the comprehensive assessment... The disciplines that will furnish the care ... Any changes in the care to be furnished ....” 2. Clinical record review on 8/16/2021 for patient #4, start of care 7/29/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" which was unsigned and failed to evidence a certification period. An area subtitled "21. Orders for Discipline and Treatments (Specify Amount/Frequency/Duration)" stated “Services for Occupational Therapist [OT]: … Effective on 08/08/2021: OT 2W2 [twice a week, for 2 weeks] … Summary of OT Orders: … ADL [activities of daily living] … Home Exercise Program … Summary of SN orders: … Monitor BP [blood pressure], Pulse, any increase or decrease of edema, noting decrease or increase of urine output, noting changes in level of activity, assess medication management of symptoms … Home safety interventions to include: no throw rugs, non cluttered walkways... Patient r [right] shoulder incision site and staples will remain free from s/s [signs and symptoms] of infection …" The next section subtitled "22. Goals/Rehabilitation Potential Discharge Plans" stated "OT Goals ... Patient will perform bathe with SBA [stand by assist] ... Patient will perform dress with SBA ... Patient will be able to achieve ROM [range of motion] and strength of (R) UE [upper extremity] following MD instructions to safety perform ADLs/IADLs [instrumental ADLs, including but not limited to opening doors, housekeeping, and taking medications] ... SN Goals ... Patient will demonstrate vital signs within acceptable limits, dysrhythmias absent or controlled and no symptoms of failure he left says the patient safety will be enhanced as evidenced by well-lit pathways, secure drugs, uncluttered walkways and minimal usage of stairs by end of certification periods (9 weeks) ... The patients/ caregiver will verbalize understanding of (r/t [related to] wound treatment) surgical incision and staples, signs and symptoms of infection, and all aspects of associated care within two weeks period of time ....“ Review of an agency document titled "Discharge/Transfer Summary" from 8/11/2021 which was unsigned. This document had an area subtitled "Reason for Discharge" which stated, "Care Completed ... Condition on Discharge ... Vital Signs: (optional per HHA Policy & Procedures) ..." Another area stated "Current Status ... Needs assist ... Outcomes ... Goals met ...." Review evidenced the patient still required assistance after discharge. Review failed to evidence the patient's goals were met. Review failed to evidence SN services were provided as outlined in the plan of care. Review evidenced an agency document titled "Discharge/Transfer Summary" from 8/11/2021, which was signed. This document had an area subtitled "Reason for Discharge" which stated, "Pt to continue with PT [physical therapy] services for diagnosis ..." Another area stated "Goals not met [and] reasons (if applicable): Eval [evaluation] only ...." Review failed to evidence the patient received OT therapy visits. Review failed to evidence OT services were provided as outlined in the plan of care. During an interview on 8/16/2021, at 12:45 PM, when queried if services were provided as ordered on the plan of care, the alternate clinical manager A indicated that in her opinion, the patient safety goal of having secured rugs should be a physical therapy goal and not nursing. The alternate clinical manager also indicated a physical therapist can assess the surgical incision if skilled nursing is no longer on the case.

Outcomes/goals have been achieved CFR(s): 484.50(d)(3) The transfer or discharge is appropriate because the physician or allowed practitioner, who is responsible for the home health plan of care and the HHA agree that the measurable outcomes and goals set forth in the plan of care in accordance with §484.60(a)(2)(xiv) have been achieved, and the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the patient no longer needs the HHA's services; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the primary care physician was informed of and agreed the patient had met their outcome/goals in 1 of 1 closed record reviewed with a discharge due to goals met. (#6) The findings include: Review of an agency policy, revised and obtained 8/18/2021, titled “Patient Bill of Rights and Responsibilities” stated, “… Patient will be discharged from Agency based on Agency Discharge Criteria Policy: … The discharge is appropriate because the physician who is responsible for the home health plan of care and the Agency agree that measurable outcomes and goals set forth in the plan of care have been achieved and the Agency and physician responsible for the home health plan of care agree that the patient no longer needs the Agency’s services….” Clinical record review on 8/16/2021 for patient #6, start of care 2/18/2021, evidenced an agency document titled “Plan of Care” for certification period 4/19/2021 – 6/17/2021, signed by the alternate clinical manager and signed and dated on 6/30/2021 by the physician. This document indicated the patient’s diagnoses included, but were not limited to, Type II Diabetes (a chronic condition where the body is impaired in the way it regulates and uses sugar as fuel), heart disease and hemiplegia (muscle weakness or partial paralysis on one side of the body) following a stroke. The plan of care indicated the patient was to receive skilled nursing services 1 time a week every other week for 9 weeks for a complete body assessment and fall prevention and diabetic care instruction. This document indicated the goals included, but were not limited to, no falls, patient will verbalize understanding of medications, caregiver will verbalize understanding of the use of the glucometer (a medical device used to measure sugar in the blood) and the patient will verbalize understanding of her diabetic regimen and all aspects of her care. The document indicated the patient’s goal included the patient’s blood pressure would remain within normal limits of a systolic blood pressure (the pressure of the blood against the walls of the arteries during the contraction of the heart and indicated as the top number of the blood pressure reading) range of 100-160 and a diastolic blood pressure(the pressure of the blood against the walls of the arteries while the heart is at rest and indicated as the bottom number of the blood pressure reading) range of 60-90. Review of an agency document titled “Discharge Summary”, dated 6/14/2021 and signed by former employee RN K, indicated the date of discharge was 6/14/2021. Review evidenced agency documents titled “Nursing Visit Record”, all signed by former employee, RN [registered nurse] K. The “Nursing Visit Record” dated 05/03/2021, indicated the patient had a fall and failed to evidence the patient’s goal was met of no falls. The document dated 6/3/2021, indicated the patient’s blood pressure was 109/50 and 110/48 and failed to evidence the patient’s goal was met of blood pressure within normal limits. The document dated 6/3/2021 indicated the next skilled nurse visit was 6/17/2021. Review of the documents for the certification period of 4/19/2021 – 6/17/2021 failed to indicate the patient’s progress to goals related to the patient’s verbalized understanding of the medications, the caregiver’s verbalized understanding of the use of the glucometer and the patient’s verbalized understanding of the diabetic regimen. Review failed to evidence the agency and physician agreed the patient’s goals were met and patient no longer required services prior to patient discharge. During an interview on 8/18/2021 at 11:46 AM, the alternate clinical manager indicated the patient’s goals were not met and was unsure why the patient was discharged when the goals were not met. The alternate clinical manager indicated she was unsure how the discharge was initiated because there was no documentation in the clinical record with the physician regarding discharge prior to the patient’s discharge.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient’s current health and functional status in 3 of 5 clinical records reviewed with wounds. (#1, #2, #6) The findings include: 1. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Initial Assessments/Comprehensive Assessments” stated, “… The assessment will reflect the patient’s current health status … The Initial Comprehensive Assessment also includes: Physical assessment/review of systems and pertinent physical findings….” 2. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Start of Care (D1)”, which was dated 6/18/2021, and electronically signed by registered nurse (RN) K. This document indicated the patient’s diagnoses included, but were not limited to, Stage II pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in partial thickness skin loss) of the left buttock and quadriplegia (paralysis of all 4 limbs). This document indicated the patient had 3 Stage II pressure ulcers consisting of 2 to the left groin and 1 pressure ulcer to the buttocks. This document indicated the patient had a foley catheter (a thin, sterile tube inserted into the bladder to drain urine) and was incontinent (loss of control) of bowel. The document included a risk of developing pressure ulcers assessment which indicated there was no impairment to the patient’s sensory perception, the skin was rarely moist and friction/shear was a potential problem. Review on 8/13/2021, of documents from wound clinic D, which the alternate clinical manager identified were requested of and received on 8/13/2021, from the patient’s wound clinic, evidenced a document from wound clinic D titled “Final Report”, dated 7/21/2021, and electronically signed by physician H. This document stated, “… Observing transfer, we can see that there is significant shearing that occurs. Until he is appropriately offloaded I think that his wounds will continue to worsen….” During an observation of care at the patient’s home on 8/13/2021, at 8:00 PM, the patient was observed to require assistance to turn to his side in bed and was observed to be incontinent of bowel. Patient was observed to have below-the-knee amputations to both legs and had limited use of his arms and legs. Review failed to evidence the skilled nurse accurately assessed the patient’s current health and functional status to include the actual problem of the friction/shear related to the patient’s quadriplegia and limited mobility, the degree of which the skin was exposed to moisture related to the patient’s bowel incontinence and the limited sensory perception related to the patient’s quadriplegia. During an interview on 8/16/2021, at 10:43 AM, the alternate clinical manager indicated the patient’s risk assessment for pressure ulcer development should not have been scored with no sensory impairment and the skin was rarely moist. The alternate clinical manager stated, “It seems to definitely be a problem, the shearing.” 3. Clinical record review on 8/9/2021, for patient #2, start of care 6/24/2021, evidenced of an agency document titled “Start of Care (D1)”, dated 7/14/2021, and electronically signed by RN H, which failed to indicate the patient had any wounds. Review of agency documents titled “Skilled Visit Note”, dated 6/30/2021, and electronically signed by former employee licensed practical nurse (LPN) B, indicated the patient had a surgical wound on the left foot. Document dated 8/4/2021, electronically signed by RN L, indicated the patient had a wound to the left foot with a start date of 6/15/2021. Review on 8/13/2021 of documents from the wound clinic at hospital I, which the alternate clinical manager identified were requested of and received on 8/13/2021, from the patient’s wound clinic, evidenced a document titled “06/28/2021 – Follow Up in SM [hospital I] Wound Ostomy Clinic”, dated 6/28/2021 and electronically signed by physician J. This document stated, “… Patient presents today status post partial excision [surgical removal] of bone left 1st metatarsal [a bone in the foot]. … Incision site remains closed. Sutures removed. … Dressing orders: Betadine [a medication used to clean wounds] to incision site and covered by Hydrofera Blue [a type of absorptive foam dressing for wounds]. Dressing frequency: 3 times per week….” During an interview on 8/12/2021 at 10:27 AM, the alternate clinical manager indicated the patient had the wound at the start of care on 6/24/2021 and the skilled nurse should have included in the comprehensive assessment the location, size, and description of the wound to include the wound bed and surrounding skin and any odor and drainage. 4. Clinical record review on 8/16/2021 for patient #6, start of care 2/18/2021, evidenced an agency document titled “Comprehensive Adult Assessment, 485 P.O.C. [Plan of Care] Worksheet and Outcome and Assessment Information Set”, dated 2/18/2021 and signed by former employee RN K. This document indicated the diagnoses included, but were not limited to, orthopedic (the branch of medicine dealing with muscle or bone) aftercare and cellulitis (a bacterial skin infection which can cause the skin to be painful, red, swollen and hot to the touch) of the right lower limb. Review of the assessment indicated the patient had 1 surgical wound but failed to indicate the location in the comprehensive assessment. The diagram of the body failed to indicate a location of the wound. Review failed to evidence the assessment of the cellulitis to the right lower limb. During an interview on 8/18/2021 at 10:59 AM, the alternate clinical manager indicated the location of the wound and the type of dressing in place should have been included in the assessment. 17-14-1(a)(1)(A) or (B)

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure all patient medications were reviewed by a registered nurse to identify any potential drug interactions, adverse effects and drug reactions in 5 of 7 clinical records reviewed. (#1, #2, #3, #4, #6) The findings include: 7. During an observation at the home of patient #4, on 8/11/2021 at 9:23 AM, physical therapist (PT) F was observed assessing the patient. At 9:51 AM, PT F inquired about the patients pain. Patient #4 indicated they do not take the "Norco [hydrocodone-acetaminophen]" anymore and the doctor did not recommend taking aspirin. The patient indicated just taking "Tylenol [acetaminophen - a mild pain reliever]" when needed, and alluded to the bottle of over the counter (OTC) acetaminophen on the kitchen table. Clinical record review on 8/10/2021, for patient #4, start of care 7/29/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” which was indicated to be the current plan of care received on 8/10/2021, diagnosis of age-related osteoporosis with current fracture to right humerus (upper arm), with a history of falls. This document had an area subtitled “10. Medications” which indicated the patient’s ordered medications included but was not limited to Feosol (Iron supplement), Hydrocodone-acetaminophen (opioid pain medicine combined with a mild pain reliever) as needed for moderate pain, Milk of magnesia (laxative) as needed for constipation, and Pantoprazole Sodium (antacid). Record review failed to evidence the patient was ordered another option for pain management. Review failed to evidence the patient had OTC acetaminophen ordered on the plan of care. Review of an undated agency document titled “Drug Interactions” indicated an interaction with a level 2 severity rating between Pantoprazole Sodium and Feosol. This document also indicated interactions with a level 1 severity rating between Milk of Magnesia and Feosol. The document failed to evidence the drug interactions were reviewed by a registered nurse. Review of an agency document titled “Start of Care (D1)”, dated 7/29/2021 and electronically signed by RN H, indicated there was no drug interaction and no issues were found during drug regimen review. The document failed to evidence the drug interactions were reviewed. During an interview on 8/16/2021 at 12:36 PM, alternate clinical manager A indicated RN H was responsible for reviewing and updating the medication profile. The clinical manager indicated they could not identify when a medication review had been performed in the clinical record. 17-14-1(a)(1)(B) 1. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Medication Profile” stated, “… The comprehensive assessment (OASIS) performed at time of admission includes a review of all medications that the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicative drug therapy and noncompliance with drug therapy. The admitting RN [registered nurse], PT [physical therapist] or SLP [speech language pathologist] checks all medications a patient may be taking and documents on the medication profile. … The nurse or therapist will add all new/changed medication(s) to the medication profile. … The medication profile will be reviewed every home visit and updated as changes occur. When Skilled Nursing is ordered, the RN and LPN [licensed practical nurse] review the medications with the patient on an ongoing basis to ensure the understanding of medication use. The review will include side effects, storage and administration of all medications….” 2. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Initial Assessments/Comprehensive Assessments” stated, “… Drug Regimen Review: Each patient’s comprehensive assessment includes a review of all medications the patient is currently taking (prescription, non-prescription, herbs, home remedies, etc.) as well as times of medication administration and routes. The Agency nurse must consider and document each medication that the patient is taking to identify: Significant side effects. Significant drug interactions. Noncompliance with medications. Duplicative therapy. Potential adverse effects. Medication reactions. Significant medication issues … Concerns identified by clinician during medication review must be reported to physician….” 3. During an observation at the home of patient #1 on 8/13/2021 at 8:21 PM, RN H was observed leaving the patient’s home without reviewing the patient’s medication. During an interview on 8/13/2021 at 8:23 PM, the patient indicated his medication included diazepam (a medication used to treat seizures, muscle spasms and anxiety) 10 milligrams (mg) four times a day. The patient indicated he alternates Bactrim (antibiotic) twice a day for 3 months and then Macrobid (antibiotic) twice a day for 3 months as a preventive measure for urinary tract infections. Clinical record review on 8/10/2021 evidenced an agency document titled “Patient Medications”, which failed to evidence the patient’s medication included diazepam, Bactrim and Macrobid. This document indicated the patient’s medication included Ketoconazole, start date 4/2/2021, (an antifungal medication used to treat skin infections), Simvastatin, start date 4/2/2021, (medication used to treat high cholesterol), Norco 5-325 mg, start date 4/23/2021, (medication used to treat pain) and Eliquis, start date 4/2/2021, (a blood thinning medication used to prevent blood clots). This document failed to evidence a signature of the clinician who completed the medication review and a date of when the medication review was completed. Review of an undated agency document titled “Drug Interactions” indicated an interaction with a level 3 severity rating between Ketoconazole and Simvastatin. This document also indicated interactions with a level 2 severity rating between Norco and Ketoconazole and Eliquis and Ketoconazole. The document failed to evidence the drug interactions were reviewed by a registered nurse. Review of an agency document titled “Start of Care (D1)”, dated 6/18/2021 and electronically signed by RN K, indicated there was no drug interaction and no issues were found during drug regimen review. The document failed to evidence the drug interactions were reviewed. During an interview on 8/12/2021 at 12:55 PM, the alternate clinical manager indicated the drug regimen review should have included the drug interactions and should have been reported to the physician. 4. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 –8/ 22/2021 which was electronically signed by RN H on 7/21/2021 and the physician on 7/23/2021. The plan of care indicated the patient’s medication included, but was not limited to, Allopurinol (a medication used to treat gout, a condition which causes severe pain, redness and tenderness in the joints), Warfarin Sodium (a medication used to thin the blood and prevent/treat blood clots), Clopidogrel (a medication used to prevent strokes), Amiodarone (a medication used to treat irregular heartbeats), Propylthiouracil (a medication used to treat a hyperactive thyroid), Pantoprazole Sodium (a medication used to treat acid reflux), Simvastatin (a medication used to treat high cholesterol) and Carvedilol (a medication used to treat high blood pressure and heart failure). Review evidenced an undated agency document titled “Drug Interactions” indicated an interaction with a level 3 severity rating between Allopurinol and Warfarin Sodium, Warfarin Sodium and Clopidogrel, Warfarin Sodium and Amiodarone, Warfarin Sodium and Propylthiouracil, Pantoprazole and Clopidogrel and Amiodarone and Simvastatin. This document also indicated interactions with a level 2 severity rating between Warfarin Sodium and Pantoprazole, Warfarin Sodium and Simvastatin, Amiodarone and Carvedilol and Propylthiouracil and Carvedilol. The document failed to evidence the drug interactions were reviewed by a registered nurse. Review of an agency document titled “Start of Care (D1)”, dated 7/14/2021 and electronically signed by RN H, indicated there was no drug interaction and no issues were found during drug regimen review. The document failed to evidence the drug interactions were reviewed. During an interview on 8/12/2021 at 10:03 AM, the alternate clinical manager indicated the RN should review all medications for drug interactions. 5. Clinical record review on 8/12/2021 for patient #3, start of care 10/8/2020, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/5/2021 – 8/3/2021, electronically signed and dated on 7/6/2021 by RN N, which indicated the patient’s medication included, but was not limited to, Diltiazem (a medication used to treat high blood pressure and chest pain), Lovastatin (a medication used to treat high cholesterol), Dilantin (a medication used to treat seizures), Coumadin (a blood-thinning medication that is used to treat and prevent blood clots), Paxil (a medication used to treat depression and anxiety) and Escitalopram (a medication used to treat depression and anxiety). Review of an undated agency document titled “Patient Medications” indicated the patient’s medication included Diltiazem, Lovastatin, Dilantin, Coumadin, Paxil and Escitalopram. This document failed to evidence a signature of the clinician who completed the medication review and a date of when the medication review was completed. Review of an undated agency document titled “Drug Interactions” indicated an interaction with a level 3 severity rating between Diltiazem and Lovastatin and indicated a level 2 severity rating between Dilantin and Lovastatin, Dilantin and Diltiazem, Coumadin and Dilantin, Coumadin and Lovastatin, Coumadin and Paxil and between Coumadin and Escitalopram. The document failed to evidence the interactions were reviewed by a registered nurse. Review of an agency document titled “Recertification”, completed on 6/2/2021 and signed by RN N, failed to evidence the drug interactions were reviewed. During an interview on 8/16/2021 at 10:50 AM, the alternate clinical manager indicated there were medication interactions and the nurse should have documented the interactions were reviewed. 6. Clinical record review on 8/16/2021 for patient #6, start of care 2/18/2021, evidenced an agency document titled “Plan of Care” for certification period 2/18/2021 – 4/18/2021, signed by RN A and dated and signed by the physician on 6/8/2021, which indicated the patient’s medication included aspirin (a medication used to treat inflammation and reduce the risk of heart attacks) and lisinopril (a type of ACE inhibitor drug used to treat high blood pressure and heart failure by relaxing your veins and arteries). Review of a document on 8/18/2021 titled “Lisinopril – Drug Summary” website https://www.pdr.net/drug-summary/Prinivil-lisinopril-376 indicated a moderate drug interaction between lisinopril and aspirin. Review of an agency document titled “Medication Profile”, dated 2/18/2021 and signed by former employee RN K, indicated the patient’s medication included aspirin and lisinopril. Review indicated no potential contraindications had been identified. Review failed to evidence the RN reviewed the medication and identified the contraindication between lisinopril and aspirin. Review of an agency document titled “Comprehensive Adult Assessment, 485 P.O.C. [Plan of Care] Worksheet and Outcome and Assessment Information Set”, dated 2/18/2021 and signed by former employee RN K, indicated no issues were found during drug regimen review. The document failed to evidence the drug interactions were reviewed. During an interview on 8/18/2021 at 10:55 AM, the alternate clinical manager indicated the RN should have reviewed the medications in the home at the start of care to look for drug interactions.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on observation, record review and interview, the agency failed to update the comprehensive assessment as frequently as the patient’s condition warrants due to a major decline in the patient’s health status in 3 of 4 active clinical records reviewed who received skilled services from a licensed practical nurse (LPN). (#1, #2, #5) The findings include: 4. During an observation on 8/11/2021, LPN (licensed practical nurse) I was observed during a SN (skilled nurse) visit with patient #5. The patient was observed sitting in a lift recliner, with a rolling walker propped in front of her. The patient was hard of hearing, and LPN I had to speak very loudly, or the patient’s family members would answer for the patient. The patient wore light compression socks, which the caregiver indicated to have applied for the patient. The caregiver also indicated they prepared the patient’s medications every day, which included assisting the patient with checking their blood sugar and administering insulin medications by injection. Clinical record review on 8/12/2021, for patient #5, start of care 2/24/2021, primary diagnosis type 2 diabetes with chronic kidney disease, evidenced an agency document titled “Recertification (D1)” for the certification period of 6/24/2021 – 8/22/2021, which was signed by RN K. This document had an area subtitled “Sensory Status” which indicated the patient wore glasses and otherwise, the patient’s ear/nose/throat [E/N/T] were within normal limits. Another area subtitled “Endocrine” indicated the patient was able to draw up and administer insulin. A section of this document stated, “(M1820) Current ability to Dress Lower Body Safely (with or without dressing aids) including undergarments, slacks, socks or nylons, shoes: … Able to obtain, put on and remove clothing and shoes without assistance .…” Review of this document failed to evidence the patient did not have functional limitations, including but not limited to hearing, vision, endurance, and ambulation. During an interview on 8/16/2021, at 10:10 AM, when queried if the patient was independent with medications, alternate clinical manager A indicated the OASIS reassessment indicated they were. The administrator in training D and alternate clinical manager A were informed the observations made of the patient’s E/N/T and functional limitations were inconsistent with the most recent reassessment. During an interview on 8/16/2021, at 10:16 AM, alternate clinical manager A indicated a patient’s condition can change from the comprehensive assessment. Review failed to evidence a comprehensive reassessment was performed since the recertification on 6/21/2021, which indicated the patient’s current condition. 17-14-1(a)(1)(B) 1. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Reassessments/Update of the Comprehensive Assessment” stated, “… The comprehensive assessment (including OASIS data elements) must be updated and revised as frequently as the patient’s condition warrants due to a major improvement or decline in health status….” 2. Clinical record review on 8/10/2021 and 8/18/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Start of Care (D1)”, which was dated 6/18/2021 and electronically signed by registered nurse (RN) K. This document indicated the patient’s diagnoses included, but were not limited to, Stage II pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in partial thickness skin loss) of the left buttock and quadriplegia (paralysis of all 4 limbs). This document indicated the patient had 3 Stage II pressure ulcers consisting of 2 to the left groin and 1 pressure ulcer to the buttocks. This document indicated the patient’s weight was 280 pounds. Review of a document provided by the alternate clinical manager on 8/13/2021 titled “Final Report” from wound clinic D, dated 6/23/2021 and electronically signed by physician H, indicated the patient had 2 wounds to the left groin and a wound to the right ischium. Review evidenced an agency document titled “Skilled Visit Note”, dated 7/23/2021 and electronically signed by former employee licensed practical nurse (LPN) B. This document evidenced the skilled nurse assessed a pressure area to the coccyx (the area on the lower back above the buttocks) measuring 0.5 cm in length, 0.5 cm in width and 0.1 cm in depth with a wound treatment of cleanse with normal saline and apply Optifoam (an absorbent foam dressing with an adhesive border). Review failed to evidence the comprehensive assessment, to include the OASIS data elements, was revised due to the patient’s new wound. Review of an agency document titled “Skilled Visit Note”, dated 8/2/2021 and electronically signed by registered nurse (RN) L, indicated the patient’s weight was 240 pounds and failed to evidence the physician was notified of the 40 pound weight loss since the comprehensive assessment on 6/18/2021. Review failed to evidence the comprehensive assessment, to include the OASIS data elements, was revised due to the patient’s weight loss. During an interview on 8/12/2021 at 1:26 PM, the alternate clinical manager indicated weight loss and a new wound would be considered a significant change in the patient’s health status. 3. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Start of Care”, with an assessment date of 6/24/2021, and electronically signed by RN H, which indicated the patient’s weight was 185 pounds. Review of an agency document titled “Skilled Visit Note”, dated 8/4/2021 and electronically signed by RN L, evidenced the patient’s weight was 150 pounds. Review failed to evidence the comprehensive assessment, to include the OASIS data elements, was revised due to the patient’s weight loss. During an interview on 8/12/2021 at 11:19 AM, the alternate clinical manager indicated the weight loss would be considered a significant change in condition and the comprehensive assessment was not revised.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure: the plan of care was reviewed by the physician, individualized and followed by all agency staff (See tag G0572); the plan of care included all required information / elements for the treatment of the patient (See tag G0574); services and treatment were provided as ordered by a physician (See tag G0578); all treatments provided by agency staff were ordered by a physician (See tag G0580); the physician's verbal orders were documented in the patient's clinical record to include a signature, date and time of the order and failed to ensure the verbal orders were authenticated and dated by the physician (See tag G0584); the plan of care was reviewed by the patients primary care physician at least every 60 days (See tag G0588); physicians were promptly notified of a change in the patient's condition (See tag G0590); the plan of care was revised to reflect current health status and nursing needs (See tag G0592); the patient and physician were communicated with regarding revisions to the plan of care related to the plans for the patient’s discharge (see tag G0598); coordination of care for all services provided to the patient (See tag G0606); the written visit schedule was provided to patients (See tag G0614); written instructions were provided to the patient for the patient's medication schedule and instructions (See tag G0616); and written instructions were provided to the patient for the name and contact information for the clinical manager (see tag G0622). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.60 Care Planning, Coordination of Care and Quality of Care. A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview, the home health agency failed to ensure their patient's needs were met by providing services and treatments in 4 of 7 clinical records reviewed. (#1, #2, #3, #6) The findings include: 1. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Services Furnished and Written Agreements/Contracts among Providers” stated, “… The Agency will make available part-time or intermittent skilled nursing [SN] services and at least one other therapeutic service (PT [physical therapist], OT [occupational therapist], SLP [speech language pathologist], MSW [medical social worker] or HHA [home health aide]) on a visiting basis to patient’s home. The Agency will furnish one of the qualifying services (SN, PT or SLP) directly through the Agency staff. The second qualifying and additional services may be provided under arrangement (written agreement/contract) with another agency or organization….” 2. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Assessment and Reassessment Guidelines” stated, “… Assessment data gathered by each discipline will be used to assess the patient’s needs and problems initially and on an ongoing basis….” 3. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Care Planning Process” stated, “… All initial and ongoing assessments will utilize relevant baseline data to determine patient problems, needs, interventions and goals….” 4. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Start of Care (D1)”, which was dated 6/18/2021 and electronically signed by registered nurse (RN) K. This document indicated the patient’s diagnoses included, but were not limited to, Stage II pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in partial thickness skin loss) of the left buttock and quadriplegia (paralysis of all 4 limbs). This document indicated the patient had 3 Stage II pressure ulcers consisting of 2 to the left groin and 1 pressure ulcer to the buttocks. One pressure ulcer to the left groin was assessed to be 1 centimeter (cm) in length, 1 cm in width and 0.2 cm in depth and had a wound treatment of cleanse with normal saline (a solution of salt and water used to clean wounds), apply collagen (a wound treatment used to stimulate new tissue growth), cover with an ABD pad (a thick absorbent wound dressing used to absorb fluid and keep from pooling on the wound site) and secure with tape 3 times a week. One pressure ulcer to the left groin was assessed to be 1 cm in length, 0.3 cm in width and 0.2 cm in depth and had a wound treatment of cleanse with normal saline, cover with an ABD pad and secure with tape 3 times a week. The wound to the buttocks was assessed to be 1 cm in length, 0.5 cm in width, 0.2 cm in depth and had a wound treatment of cleanse with normal saline, apply collagen, cover with an ABD pad and secure with tape 3 times a week. This document indicated the patient had an amputation of both legs and the patient’s ability to transfer to and from bed to a chair required supervision. Review indicated the patient was at risk for falls and skin breakdown. This document indicated the patient required assistance with dressing and bathing and was dependent for toileting. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and 2 times a week for 9 weeks and receive home health aide (HHA) services 2 times a week for 9 weeks. Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/18/2021 – 8/16/2021. The document was signed by the alternate clinical manager on 7/15/2021 and by the physician on 8/2/2021 and indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and 2 times a week for 9 weeks and was to receive home health aide services 2 times a week. The plan of care indicated the patient’s activities permitted were to be up as tolerated and wheelchair activity. The plan of care indicated the home health aide was to assist with bathing and personal care. The plan of care stated, “… Summary of SN [skilled nurse] Orders: … Wound care will be performed by .…” and failed to evidence what the wound care treatment was and to what wound locations. The plan of care indicated the patient’s goal was for the wound to be healed. Review failed to evidence home health aide services were provided since 7/28/2021. During an interview on 8/12/2021 at 1:36PM, the alternate clinical manager indicated the home health aide that was providing home health aide services for the patient quit and there was no other home health aide available to provide visits. During an interview on 8/13/2021 at 8:29 PM, the patient indicated he needed a home health aide and indicated the agency has not told him when he would receive a home health aide visit again. Review on 8/13/2021 of documents from wound clinic D, which the alternate clinical manager identified were requested of and received on 8/13/2021, from the patient’s wound clinic, evidenced a document titled “Final Report” from wound clinic D, dated 6/23/2021 and electronically signed by physician H. The document indicated the patient had 2 wounds to the left groin and a wound to the right ischium. Review of a document titled “Final Report”, dated 7/21/2021, and electronically signed by physician H, stated, “… He refuses to be Hoyer [a medical device used to lift and transfer a person with minimal physical effort] to in the wound care center but instead is transferring himself. Observing transfer, we can see that there is significant shearing that occurs. Until he is appropriately offloaded I think that his wounds will continue to worsen….” During an observation of care on 8/13/2021 at 7:19 PM, the patient was observed to have 2 open areas on the left groin. Each open area appeared the length of a large paperclip and as wide as the width of a pen. Both open areas appeared to have a depth of the length of a pinky fingernail. RN H stated, “One is more medial, but there are two here.” The patient was observed to have 2 open areas to the right ischium (the area of the skin on the lower buttock region that covers the rounded bone of the pelvis). The lateral open area on the right ischium appeared to be the length of a large paperclip, the width of the diameter of a pen and the depth of a tip of a pen. The medial open area of the right ischium appeared to be in the peri wound (the area surrounding the wound) of the lateral open area on the right ischium and have the size of a dime with just the top layer of skin removed and a red wound base. At 7:45 PM, RN H stated, “There’s a little excoriated [the breakdown of skin due to prolonged exposure to moisture] part here. To me, there’s really another wound here. Some may call it one.” The patient was observed to require assistance for turning in bed, was dependent for bowel incontinence care and had a below the knee amputation on both legs. Review evidenced agency documents titled “Skilled Visit Note”, electronically signed by former employee licensed practical nurse B, which failed to evidence the skilled nurse provided wound care to the wounds identified at the comprehensive assessment. The document dated 6/29/2021, indicated the skilled nurse provided wound care to a wound “L ish” and “R ish” and failed to evidence wound care to 3 wounds as identified at the comprehensive assessment. Document dated 7/2/2021 stated, “… Dressing changed per orders from wound clinic … to L dressing … R dressing … Both wounds are beefy red….” and failed to evidence the skilled nurse provided wound care to 3 wounds as identified at the comprehensive assessment. Document dated 7/5/2021 stated, “… L [left] dressing had med [medium] amount of drainage … Dressing changed per order … R [right] dressing had small amount of red/tan drainage note. Dressing changed per order …” and failed to evidence the skilled nurse provided wound care to 3 wounds as identified at the comprehensive assessment. Document dated 7/7/2021, stated, “… Dressing changed on both wounds….” and failed to evidence the skilled nurse provided wound care to 3 wounds as identified at the comprehensive assessment. Document dated 7/19/2021, indicated the skilled nurse provided wound care to wound #1 identified on the groin and wound #2 identified as “Other” location and failed to evidence the skilled nurse provided wound care to 3 wounds as identified on the comprehensive assessment. Document dated 7/23/2021, indicated the skilled nurse provided wound care to wound #1 identified as the left groin and wound #2 identified as “Other” location and failed to evidence the skilled nurse provided wound care to 3 wounds as identified on the comprehensive assessment. During an interview on 8/12/2021 at 12:59 PM, the alternate clinical manager indicated the skilled nurse should have provided wound care 2 times a week. At 1:05 PM, the alternate clinical manager indicated “L ish” and “R ish” most likely was referring to the 2 wounds to the left groin and stated, “The plan of care isn’t ready by the time of the next nurse’s visit so the next nurse may not know what the wounds are called.” Review evidenced agency documents titled “Skilled Visit Note”, electronically signed by former employee LPN B. Document dated 6/23/2021 indicated the patient was bedbound and stated, “… Pt [patient] upper body is weak from being bed bound as wounds heal. Pt is thinking about PT/OT when cleared by wound dr [doctor]….” Document dated 7/2/2021 stated, “… Pt has noticed a lose [sic] in upper body strength at this time due to being bedbound due to wounds on gluteal area….” Review failed to evidence the patient received a physical therapy evaluation to assess the loss in upper body strength. During an interview on 8/12/2021 at 1:00 PM, the alternate clinical manager indicated there were not any orders or care coordination with the wound care clinic or the wound physician. At 1:08 PM, the alternate clinical manager indicated the physician should have been contacted for a therapy evaluation related to the patient’s decrease in upper body strength. 5. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Start of Care”, with an assessment date of 6/24/2021, and electronically signed by RN H, which failed to evidence the patient had any wounds. Review indicated the patient had a left partial foot amputation and a below the knee amputation of the right leg. Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 –8/ 22/2021, which was electronically signed by RN H on 7/21/2021, and the physician on 7/23/2021. The plan of care indicated the patient’s primary diagnosis was Type II Diabetes (a chronic condition where the body is impaired in the way it regulates and uses sugar as fuel) and indicated the patient was to receive skilled nursing services 1 time a week for 4 weeks and then 1 time every other week for 5 weeks. The plan of care failed to evidence interventions or goals related to wounds. Review of agency documents titled “Skilled Visit Note”, dated 6/30/2021 and electronically signed by former employee LPN B, indicated the patient had a surgical wound on the left foot but failed to evidence wound care was provided. Document dated 7/7/2021, and electronically signed by former employee LPN B stated, “… Pt has dressing applied to L foot. He sees the dr [doctor] today ….” Review failed to evidence wound care was provided. Document dated 7/15/2021, and electronically signed by former employee LPN B indicated the patient’s incision is free from signs and symptoms of infections but fails to evidence the location of the incision, and the document fails to evidence wound care was provided. Review fails to evidence the skilled nurse provided wound care prior to 7/21/2021. Document dated 8/4/2021, electronically signed by RN L, indicated the patient had a wound to the left foot with a start date of 6/15/2021. Review on 8/13/2021 of documents from wound clinic D, which the alternate clinical manager identified were requested of and received on 8/13/2021, from the patient’s wound clinic at hospital I, evidenced a document titled “06/28/2021 – Follow Up in SM [hospital I] Wound Ostomy Clinic”, dated 6/28/2021 and electronically signed by physician J. This document stated, “… Patient presents today status post partial excision [surgical removal] of bone left 1st metatarsal [a bone in the foot]. … Incision site remains closed. Sutures removed. … Dressing orders: Betadine [a medication used to clean wounds] to incision site and covered by Hydrofera Blue [a type of absorptive foam dressing for wounds]. Dressing frequency: 3 times per week….” During an interview on 8/12/2021 at 11:28 AM, the alternate clinical manager indicated the agency had been informed by the RN and HHA that former employee LPN B was not providing wound care and former employee LPN B was no longer employed with the agency. Review of an agency document titled “Occupational Therapy Evaluation”, evaluation date 7/28/2021 and electronically signed by occupational therapist (OT) M, indicated occupational therapy services would be provided 2 times a week for 3 weeks and indicated the patient required assistance for functional tasks of activities of daily living (ADL) due to decreased range of motion and strength of the left shoulder. Review of an agency document titled “Supplemental Provider Order”, dated 7/31/2021 and electronically signed by OT M and dated 8/10/2021 and signed by the physician, indicated OT services were to be provided 2 times a week for 3 weeks for ADL training, bathroom mobility and home exercise program. Review of a document titled “Discharge/Transfer Summary”, dated 8/9/2021 and electronically signed by OT M, evidenced a subsection titled “Goals not met [and] reasons (If applicable):” which stated, “… Bathing not met due to need of someone to position shower bench and assist with lower body as there is a dressing on the [left] foot ….” Review indicated the OT provided services 1 time during week 2 and did not receive OT services during week 3. Review failed to evidence communication with the physician regarding the discharge from OT services and failed to evidence a physician’s order for the discharge of OT services. Review failed to evidence the patient received OT services 2 times a week for 3 weeks as the patient was assessed to need. During an interview on 8/18/2021 at 12:12 PM, the alternate clinical manager indicated she was unaware the OT had discharged the patient for services and the record did not have any documentation for why OT M discharged the patient from services. 6. Clinical record review on 8/12/2021 for patient #3, start of care 10/8/2020, evidenced agency documents titled “Recertification”, identified by the alternate clinical manager as comprehensive assessments, dated 6/2/2021 and 8/2/2021 and electronically signed by RN N. The document dated 6/2//2021 indicated the patient’s diagnoses included, but were not limited to, atrial fibrillation (irregular heartbeat which may cause the heart to pump less effectively which may result in swelling of hands, feet, or other body parts) and dementia (a progressive disorder causing impaired ability to remember, think and make decisions that interferes with everyday activities). Review indicated the patient had a history of falls, and the patient’s risk for falls was assessed to score at 6 on 6/2/2021 and increased to 7 on 8/2/2021. Review evidenced the patient was independent for toilet hygiene on 6/2/2021 and requiring substantial assistance on 8/2/2021. Review indicated the patient was independent with the ability to sit to stand, chair to bed transfer, toilet transfer and walking 10 feet at the assessment on 6/2/2021 and assessed on 8/2/2021 requiring substantial assistance for sit to stand, chair to bed transfer, toilet transfer and walking 10 feet. The document dated 6/2/2021 indicated the patient was independent for dressing, and the document dated 8/2/2021 indicated the patient required assistance for dressing. Review of document dated 6/2/2021 indicated the patient was independent for toileting, and the document dated 8/2/2021 indicated the patient was dependent for toileting. Review indicated the patient was able to transfer and ambulate with assistance at the assessment on 6/2/2021 to being assessed on 8/2/2021 to be unable to transfer self and chairfast. The document dated 8/2/2021 stated, “… Caregiver/spouse noted increased weakness over the past 2 weeks with her ambulation….” Review failed to evidence home health aide and therapy services were provided. During an interview on 8/16/2021 at 11:17 AM, the alternate clinical manager indicated the physician should have been contacted with a request for an order for PT to evaluate the patient and indicated the patient had a need for therapy at 11:44 AM. At 11:48 AM, the alternate clinical manager indicated she was unsure why home health aide services were not provided and indicated it was possibly because the patient’s spouse provided personal care. The alternate clinical manager indicated there was no documentation the patient was offered home health aide and therapy services. 7. Clinical record review on 8/16/2021 for patient #6, start of care 2/18/2021, evidenced an agency document titled “Comprehensive Adult Assessment, 485 P.O.C. [Plan of Care] Worksheet and Outcome and Assessment Information Set”, dated 2/18/2021 and signed by former employee RN K. The document indicated the patient’s diagnoses included, but were not limited to, orthopedic (the branch of medicine dealing with muscle or bone) aftercare, cellulitis (a bacterial skin infection which can cause the skin to be painful, red, swollen and hot to the touch) of the right lower limb and Type II Diabetes. The comprehensive assessment indicated the patient was at risk for falls and had neuropathy (a condition usually caused by diabetes causing weakness, numbness and pain usually in the hands and feet). Review of an agency document titled “Encounter Certification”, dated 3/8/2021 and signed and dated by the physician on 5/26/2021, indicated the patient had significant right sided hemiparesis (muscle weakness or partial paralysis on one side of the body) and was at risk for falls. Review of agency documents titled “Nursing Visit Record”, signed by former employee RN K, failed to evidence the skilled nurse provided fall prevention education on documents dated 2/23/2021, 2/25/2021, 3/2/2021, 3/4/2021, 3/9/2021, 3/11/2021, 3/16/2021 and 3/18/2021. Review of document dated 3/11/2021 indicated the patient had right sided paralysis due to a stroke. Review indicated the skilled nurse assessed the patient to have decreased endurance on 3/25/2021 and assessed the patient to have decreased endurance, balance and gait requiring the use of assistance with a walker on 3/30/2021. On document dated 5/3/2021, the skilled nurse documented the patient had a fall. Review failed to evidence therapy services were provided related to the patient’s assessed decreased endurance, balance and gait. During an interview on 8/18/2021 at 11:24 AM, the alternate clinical manager indicated she would have had PT evaluate this patient and the physician should have been contacted to request an order for a PT evaluation. The alternate clinical manager indicated the patient had a need for physical therapy that was not met. 17-13-1(a)

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the patients received an individualized, written plan of care which was established, reviewed and signed by a physician and failed to ensure the patient received the services as directed in the plan of care in 7 of 7 clinical records reviewed. (#1, #2, #3, #4, #5, #6, #7) The findings include: 7. Clinical record review on 8/16/2021, for patient #4, start of care 7/29/2021, diagnosis of age-related osteoporosis with current fracture to right humerus (upper arm) and a history of falls, evidenced an agency document titled “Home Health Certification and Plan of Care” which was indicated to be the current plan of care received on 8/10/2021. This document had an area subtitled “21. Orders for Discipline and Treatments (Specify Amount/Frequency/Duration)” which stated “Services for Occupational Therapist [OT]: … Effective on 08/08/2021: OT 2W2 [twice a week, for 2 weeks] … Summary of OT Orders: … ADL [activities of daily living] … Home Exercise Program … Summary of SN orders: … Monitor BP [blood pressure], Pulse, any increase or decrease of edema, noting decrease or increase of urine output, noting changes in level of activity, assess medication management of symptoms … Home safety interventions … pt [patient] r [right] shoulder incision site and staples will remain free from s/s [signs and symptoms] of infection ….“ Review failed to evidence frequencies for skilled nurse [SN] services to be provided. Review failed to evidence OT visit note documentation. Review failed to evidence the agency followed the SN and OT frequencies as ordered on the plan of care. Review failed to evidence OT performed the prescribed activities as ordered on the plan of care. 8. Clinical record review on 8/16/2021, for patient #5, start of care 2/24/2021, diagnosis of type 2 diabetes with chronic kidney disease, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 – 8/22/2021. This document had an area subtitled “21. Orders for Discipline and Treatments (Specify Amount/Frequency/Duration)” which stated “Services for Skilled Nurse: … SN [skilled nurse] 1W9 [once a week, for 9 weeks] 06/24/2021 – 08/21/2021 …” Review of agency documents titled “Skilled Visit Note” failed to evidence a SN visit was conducted the week of 7/25/2021 – 7/31/2021. Review failed to evidence the agency met the frequency of visits ordered on the plan of care. During an interview on 8/16/2021, at 10:25 AM, when queried on why the patient missed a SN visit, alternate clinical manager A indicated the primary clinician for that patient was no longer with the company and could not meet the frequency of visits. Alternate clinical manager A agreed there was not documentation of physician notification. During an interview on 8/16/2021, at 10:26 AM, when queried if the patient was notified of the missed visit, the administer in training D indicated they did not document every time a patient was called. 9. Clinical record review on 8/17/2021, for patient #7, start of care 6/28/2021, diagnosis of aftercare of surgical incision on the GU [genitourinary] system, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/28/2021 – 8/26/2021. This document had an area subtitled “21. Orders for Discipline and Treatments (Specify Amount/Frequency/Duration)” which stated “Services for Skilled Nurse: Effective 6/29/2021: SN: 1W6 [once a week, for 6 weeks] ….“ Review failed to evidence the patient received SN visits as ordered in the plan of care. Review failed to evidence a SN visit took place between the start of care on 6/29/2021, until the discharge date on 7/20/2021. Review failed to evidence documentation of missed visits and/or physician notifications. During an interview on 8/17/2021, at 2:29 PM, alternate clinical manager A indicated the patient refused SN visits and there was not documentation of the missed visits or physician notifications in the clinical record at the time of review. 17-13-1(a) 1. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Plan of Care – CMS #485 and Physician Orders” stated, “… The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s) and the measurable outcomes … Each patient must receive the home health services that are written in an individualized plan of care … which is established, periodically reviewed … and signed by a doctor of medicine … If a physician refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician is consulted to approve additions or modifications to the original plan….” 2. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Start of Care (D1)”, which was dated 6/18/2021 and electronically signed by registered nurse (RN) K. This document indicated the patient’s diagnoses included, but were not limited to, Stage II pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in partial thickness skin loss) of the left buttock, hypertension (high blood pressure) and quadriplegia (paralysis of all 4 limbs). This document indicated the patient had 3 Stage II pressure ulcers consisting of 2 to the left groin and 1 pressure ulcer to the buttocks. One pressure ulcer to the left groin was assessed to be 1 centimeter (cm) in length, 1 cm in width and 0.2 cm in depth and had a wound treatment of cleanse with normal saline (a solution of salt and water used to clean wounds), apply collagen (a wound treatment used to stimulate new tissue growth), cover with an ABD pad (a thick absorbent wound dressing used to absorb fluid and keep from pooling on the wound site) and secure with tape 3 times a week. One pressure ulcer to the left groin was assessed to be 1 cm in length, 0.3 cm in width and 0.2 cm in depth and had a wound treatment of cleanse with normal saline, cover with an ABD pad and secure with tape 3 times a week. The wound to the buttocks was assessed to be 1 cm in length, 0.5 cm in width, 0.2 cm in depth and had a wound treatment of cleanse with normal saline, apply collagen, cover with an ABD pad and secure with tape 3 times a week. This document indicated the patient was at risk for skin breakdown. Review evidenced an agency document titled “Skilled Visit Note”, dated 6/24/2021 and electronically signed by former employee licensed practical nurse (LPN) B. This document stated, “… Pt [patient] seen on 6/23/2021 in wound clinic and no new orders record [sic] in regards to wounds….” Dressing changed per orders from wound clinic….” Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/18/2021 – 8/16/2021. The document was signed by the alternate clinical manager for the verbal start of care on 7/15/2021 and by the physician on 8/2/2021. The plan of care failed to be established with the physician until the verbal start of care obtained by the alternate clinical manager on 7/15/2021. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and 2 times a week for 9 weeks. The plan of care failed to be individualized to the frequency of skilled nursing services. The document indicated the skilled nurse was to provide catheter care. The plan of care stated, “… Wound care will be performed by ….” and failed to be individualized to include the location of the patient’s wounds and wound care to be provided. Review of the plan of care failed to evidence the skilled nursing interventions included a head-to-toe assessment to include obtaining patient’s vital signs for blood pressure related to patient’s diagnosis of hypertension and a skin assessment related to patient’s assessed risk of skin breakdown. The plan of care failed to evidence it was individualized to include the care the patient received at the wound clinic to include the name of the wound clinic. Review failed to evidence the plan of care included preventative measures related to the patient’s risk of skin breakdown as assessed at the start of care. During an interview on 8/12/2021 at 12:12 PM, the alternate clinical manager indicated the plan of care was supposed to indicate skilled nursing services 2 times a week for 9 weeks and the skilled nurse 1 time a week for 9 weeks was a mistake. At 12:30 PM, the alternate clinical manager indicated the plan of care should include the individualized vital sign parameters and the skilled nursing interventions should include obtain the patient’s vital signs and head-to-toe assessment. At 1:07 PM, the alternate clinical manager indicated the wound clinic name and treatment provided should be included on the plan of care. During an interview on 8/16/2021 at 10:16AM, the alternate clinical manager indicated interventions that should have been included on the plan of care to prevent skin breakdown are education on the importance of turning and repositioning and education on the use of hoyer (a mechanical lift device used to lift a patient with minimal effort) to reduce risk of shearing. Review failed to evidence skilled nursing services were provided during the week of 7/25/2021. During an interview 8/12/2021 at 12:26 PM, the alternate clinical manager indicated former employee LPN B was scheduled for a skilled nursing visit on 7/26/2021 and 7/30/2021 but indicated former employee LPN B called off on 7/26/2021 and quit without notice on 7/30/2021. The alternate clinical manager indicated no other skilled nurse was available to provide skilled nursing services. Review of agency documents titled “Skilled Visit Note”, dated 7/5/2021, 7/7/2021 and 7/9/2021 and electronically signed by former employee LPN B, evidenced skilled nursing services were provided 3 times during the week of 7/4/2021 and failed to evidence skilled nursing services were provided as ordered in the plan of care. During an interview on 8/12/2021 at 1:35 PM, the administrator in training indicated the visit on 7/7/2021 was a “PRN” (as needed) visit. During an interview on 8/12/2021 at 1:35 PM, the alternate clinical manager indicated the PRN visit was not included in the plan of care. 3. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 –8/ 22/2021 which was electronically signed by RN H on 7/21/2021 and the physician on 7/23/2021. The plan of care failed to be established with the physician until the verbal start of care on 7/21/2021 obtained by RN H. The plan of care indicated the patient’s primary diagnosis was Type II Diabetes (a chronic condition where the body is impaired in the way it regulates and uses sugar as fuel) but failed to evidence it was individualized to include interventions and measurable outcomes related to the diabetes. The document stated, “… The patient/caregiver will verbalize understanding of (r/t [related to] cardiopulmonary [relating to the heart and lungs]/hematology [relating to the blood] diagnosis) ________ and all aspects of associated care within _______ period of time….” The document failed to evidence the plan of care was individualized to include a measurable goal. The plan of care evidenced the agency was to provide home health aide (HHA) services 2 times a week for 9 weeks. During an interview on 8/12/2021 at 9:57 AM, the alternate clinical manager indicated the interventions and goals related to diabetes that should have been included on the plan of care included educating the patient on the signs and symptoms of hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar), parameters for blood sugar results and instructing the patient on how to check blood sugar. At 9:58 PM, the clinical manager indicated the goal had blanks because it was an automated goal and should have been filled in based on the patient assessment. Review of an agency document titled “Start of Care”, with an assessment date of 6/24/2021 and electronically signed by RN H, failed to evidence the patient had any wounds. Review evidenced the patient’s pain to legs and back was assessed to be a 3 on a scale of 0-10, with 0 being no pain and 10 being the most severe, with a frequency of daily but not constantly and a pain goal of a rating less than 2 on a scale of 0-10. The plan of care failed to evidence the patient’s pain treatment and goals were included in the plan of care. During an interview on 8/12/2021 at 10:36 AM, the alternate clinical manager indicated the interventions and goal for the patient’s pain should be included in the plan of care. Review of agency documents titled “Skilled Visit Note”, dated 6/30/2021 and electronically signed by former employee LPN B, indicated the patient had a surgical wound on the left foot. Document dated 8/4/2021, electronically signed by RN L, indicated the patient had a wound to the left foot with a start date of 6/15/2021. The plan of care failed to evidence the patient’s wound and wound care interventions and goals. Review on 8/13/2021 of documents from the wound clinic at hospital I, which the alternate clinical manager identified were requested of and received on 8/13/2021 from the patient’s wound clinic, evidenced a document titled “06/28/2021 – Follow Up in SM [hospital I] Wound Ostomy Clinic”, dated 6/28/2021 and electronically signed by physician J. This document stated, “… Patient presents today status post partial excision [surgical removal] of bone left 1st metatarsal [a bone in the foot]. … Incision site remains closed. Sutures removed. … Dressing orders: Betadine [a medication used to clean wounds] to incision site and covered by Hydrofera Blue [a type of absorptive foam dressing for wounds]. Dressing frequency: 3 times per week….” During an interview on 8/12/2021 at 10:27 AM, the alternate clinical manager indicated the patient had the wound at the start of care on 6/24/2021 and the plan of care should include interventions and goals related to the patient’s wound. Review evidenced agency documents titled “Skilled Visit Note”. Document dated 7/29/2021 and electronically signed by RN H evidenced the RN assessed the patient’s pain to be 3 on a scale of 0-10. This document indicated the patient’s pain goal was a rating of 2 on a scale of 0-10. Review failed to evidence the RN assessed the patient’s pain treatment. Document dated 8/4/2021 and electronically signed by RN L, evidenced the RN assessed the patient’s pain to be 6 on a scale of 0-10. This document failed to evidence the RN assessed the location of the pain and the patient’s pain treatment and effectiveness. During an interview on 8/12/2021 at 10:36 AM, the alternate clinical manager indicated pain should be assessed at every skilled visit and the RN should have assessed for nonpharmacologic treatment such as repositioning, heat and ice. Review failed to evidence the agency provided home health aide services during the week of 7/4/2021, 7/25/2021 and 8/1/2021. During an interview on 8/12/2021 at 11:24 AM, the administrator in training D indicated there was a home health aide visit for 7/5/2021 but the visit note had not been downloaded into the electronic medical record and indicated the agency overlooked downloading the notes into the electronic medical record that day. The administrator in training D indicated there was a home health aide visit scheduled on 7/30/2021 but the agency was unable to staff the visit. The administrator in training D indicated a home health aide visit was provided on 8/2/2021 but the visit note had not yet been downloaded into the electronic medical record. Requested copies of the visit notes dated 7/5/2021 and 8/2/2021 and no additional documents provided. 4. Clinical record review on 8/12/2021 for patient #3, start of care 10/8/2020, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/5/2021 – 8/3/202, signed and dated by RN N on 7/6/2021. Review indicated the patient’s primary diagnosis was atrial fibrillation (irregular heartbeat which may cause the heart to pump less effectively which may result in swelling of hands, feet, or other body parts). Review indicated skilled nursing was to provide services 1 time a week for 9 weeks and evidenced the skilled nursing goals stated, “… The patient’s safety (r/t [related to] psychological/behavioral diagnosis) will be enhanced throughout the home care service as evidenced by _______ within ______ period of time. The patient/caregiver will verbalize understanding of (r/t fall risk) ____ and all aspects of associated care within ___ period of time. … The patient/caregiver will have ____, as evidenced by ____ within _____ period of time….” Review failed to evidence the goals were individualized related to the patient’s primary diagnosis. During an interview on 8/16/2021 at 10:47 AM, the alternate clinical manager indicated the blanks in the plan of care should have been completed and the goals were not patient specific. 5. Clinical record review on 8/16/2021 for patient #6, start of care 2/18/2021, evidenced an agency document titled “Comprehensive Adult Assessment, 485 P.O.C. [Plan of Care] Worksheet and Outcome and Assessment Information Set”, dated 2/18/2021 and signed by former employee RN K. This document indicated the diagnoses included, but were not limited to, orthopedic (the branch of medicine dealing with muscle or bone) aftercare and cellulitis (a bacterial skin infection which can cause the skin to be painful, red, swollen and hot to the touch) of the right lower limb. Review of the assessment indicated the patient had 1 surgical wound but failed to indicate the location in the comprehensive assessment. Review of an agency document titled “Medication Profile”, dated 2/18/2021 and signed by former employee RN K, indicated the patient’s medication included, but was not limited to, Doxycycline (an antibiotic used to treat infection) twice a day for 10 days for an infection. Review of an agency document titled “Nursing Visit Record”, dated 2/25/2021 and signed by former employee RN K, indicated the nurse removed a compression wrap over the dressing to the right 3rd toe, dressing assessed to be dry and intact and compression wrap reapplied. Review evidenced an agency document titled “Plan of Care” for certification period 2/18/2021 – 4/18/2021, signed by RN A and dated and signed by the physician on 6/8/2021, indicated skilled nursing services were to be provided 1 time a week for 1 week, then 2 times a week for 3 weeks and then 1 time a week for 5 weeks. Review failed to evidence the plan of care was individualized to include skilled nursing interventions related to the patient’s diagnosis of the orthopedic aftercare and cellulitis to the right lower limb. Review failed to evidence skilled nursing interventions for the surgical wound identified during the comprehensive assessment to include a compression wrap. The plan of care indicated the skilled nurse was to instruct the patient on fall preventions, instruct the patient on the use of the glucose (blood sugar) measuring device and instruct on the diabetic care to include diet, activity, stress, skin care and foot care. Review of agency documents titled “Nursing Visit Record, dated 3/30/2021, 4/6/2021 and 5/17/2021 and signed by former employee RN K, failed to evidence the skilled nurse provided patient instruction as directed in the plan of care. Review failed to evidence the skilled nurse provided patient instruction on the use of the glucose measuring device during the certification period 2/18/2021 – 4/18/2021. During an interview on 8/18/2021 at 11:12 AM, the alternate clinical manager indicated there were no orders for wound care to the surgical wound and indicated the plan of care should include skilled nursing interventions to not remove the dressing until follow-up appointment date, monitor for break-through drainage, swelling and pain. The alternate clinical manager indicated the plan of care should include interventions for the cellulitis such as monitoring the area for redness, warmth, pain and swelling. At 11:30 AM, the alternate clinical manager indicated the skilled nurse does not educate on all areas at every visit but something should be documented for patient education at every visit. 6. During an interview on 8/12/2021 at 11:20 AM, former employee LPN B indicated she conducted home visits without a plan of care, medication list, physician orders and patient diagnoses because the RN that started the case was not done with the plan of care by the time the next skilled nurse visit was due.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the written individualized plan of care included safety measures, and medications in 6 of 7 clinical records reviewed. (#1, #2, #3, #4, #5, #6) The findings include: 7. Clinical record review on 8/10/2021, for patient #4, start of care 7/29/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” which was indicated to be the current plan of care received on 8/10/2021, diagnosis of age-related osteoporosis with current fracture to right humerus (upper arm), with a history of falls. This document failed to evidence information including, but not limited to: Supplies/equipment, safety measures, nutritional requirements, functional limitations, activities permitted, services/frequencies for skilled nursing, mental status, and prognosis, as well as physician name and location, and the nurse performing the assessment, which was required to individualize a plan of care. During an interview on 8/17/2021, at 12:08 PM, alternate clinical manager A indicated the individualized patient information was on the care plan located in the electronic medical record. Alternate clinical manager A indicated the document received on 8/10/2021, titled “Home Health Certification and Plan of Care” was probably printed while the document was still in the QA [quality assurance] process. The alternate clinical manager indicated the information of the nurse completing the assessment would not be shown on the plan of care until it was sent to the physician. She also indicated the physician’s name and contact information would not be displayed until the document was signed. The alternate clinical manager indicated the clinician that entered the skilled nurse frequencies, did not complete the documentation process correctly. 8. During an observation on 8/11/2021, at 1:07 PM, patient #5 was observed in their home during a skilled nurse visit. The patient was observed to be hard of hearing. The skilled nurse had to speak very loud for the patient to understand and many times, the patient’s caregivers would answer for the patient. During the visit, patient #5 sat in a recliner chair with an assisted lift, and a walker was placed in front of the patient’s body. The patient wore light compression socks, which the caregiver indicated to have applied for the patient. The caregiver also indicated they prepared the patient’s medications every day, which included assisting the patient with checking their blood sugar and insulin medications by injection. During an interview on 8/16/2021, at 9:55 AM, alternate clinical manager A indicated glucometer, test strips, and other supplies required for checking blood sugars should be listed on the plan of care. The alternate clinical manager indicated the patient’s diagnosis of type 2 diabetes should have been taken into concern before reporting a regular diet on the plan of care. The alternate clinical manager indicated functional limitations should have mentioned the patient’s hearing and endurance as a concern, and the activities permitted should have included the patient’s walker on the plan of care. At 10:02 AM, the alternate clinical manager indicated signs and symptoms of covid-19 are monitored by checking temperatures and obtaining information about travel, exposure, and cough/respiratory symptoms. The alternate clinical manager indicated the SN orders were not complete to include parameters individualized to the patient on the plan of care. 9. During an interview on 8/16/2021, at 12:11 PM, alternate clinical manager A indicated the agency had tried to narrow down the time it takes to QA the plan of care and would work to have it completed sooner 17-13-1(a)(1)(D)(ii, vi, vii, ix, x, xiii) 1. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Plan of Care – CMS #485 and Physician Orders” stated, “… The individualized plan of care must include the following: All pertinent diagnoses … The types of services, supplies and equipment required … All medications and treatments. Safety measures to protect against injury. A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. Patient and caregiver education and training to facilitate timely discharge. … Patient-specific interventions and education, measurable outcomes and goals identified by the Agency and patient.…" 2. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Medication Orders” stated, “… Each patient’s record will reflect a diagnosis, condition or indication for use for each medication ordered … “Indications for use” must be included in PRN [as needed] medication orders or if medication is ordered for a condition not usually treated with that medication …." 3. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Start of Care (D1)”, which was dated 6/18/2021 and electronically signed by registered nurse (RN) K. This document indicated the patient’s diagnoses included, but were not limited to, Stage II pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in partial thickness skin loss) of the left buttock, quadriplegia (paralysis of all 4 limbs), hypertension (high blood pressure) and chronic embolism (an obstruction of an artery, typically by a blood clot or air bubble) and thrombosis (formation of a blood clot within a blood vessel) of left iliac vein (a vein located in the abdomen). This document indicated the patient had 3 Stage II pressure ulcers consisting of 2 to the left groin and 1 pressure ulcer to the buttocks. One pressure ulcer to the left groin was assessed to be 1 centimeter (cm) in length, 1 cm in width and 0.2 cm in depth and had a wound treatment of cleanse with normal saline (a solution of salt and water used to clean wounds), apply collagen (a wound treatment used to stimulate new tissue growth), cover with an ABD pad (a thick absorbent wound dressing used to absorb fluid and keep from pooling on the wound site) and secure with tape 3 times a week. One pressure ulcer to the left groin was assessed to be 1 cm in length, 0.3 cm in width and 0.2 cm in depth and had a wound treatment of cleanse with normal saline, cover with an ABD pad and secure with tape 3 times a week. The wound to the buttocks was assessed to be 1 cm in length, 0.5 cm in width, 0.2 cm in depth and had a wound treatment of cleanse with normal saline, apply collagen, cover with an ABD pad and secure with tape 3 times a week. This document indicated the patient had a foley catheter (a thin, sterile tube inserted into the bladder to drain urine). This document indicated the patient was at risk for skin breakdown. Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/18/2021 – 8/16/2021. The document was signed by the alternate clinical manager on 7/15/2021 and by the physician on 8/2/2021 and indicated the patient’s medication included, but was not limited to, Eliquis (a blood thinning medication used to prevent blood clots) twice a day and Ketoconazole (an antifungal medication used to treat skin infections) twice a day externally. Review failed to evidence bleeding precautions were included in the plan of care. Review failed to evidence to where Ketoconazole was to be applied externally. Review evidenced the plan of care stated, “… Summary of SN [skilled nurse] Orders: … catheter care ….” The plan of care failed to evidence the specific care the SN was to perform to provide catheter care and failed to evidence paralysis as a functional limitation. During an interview on 8/12/2021 at 12:07 PM, the alternate clinical manager indicated bleeding precautions should be included in the plan of care. At 12:09, the alternate clinical manager indicated she was not sure where the Ketoconazole was to be applied but the plan of care should specify to where the medication was to be applied. AT 12:15 PM, the alternate clinical manager indicated the plan of care should indicate what specific catheter care should be provided to include the location of the catheter and protocol for the cleaning and changing of the drainage bag. During an observation of care on 8/13/2021 at 7:19 PM at the patient’s home, RN H was observed removing the wound dressing to the patient’s left groin and 2 open areas were noted. RN H was observed moistening dry gauze by squirting clear liquid from a syringe labeled “Sodium Chloride 0.9% [normal saline]” and wiping the patient’s open areas on the left groin with the moistening gauze. At 7:30 PM, RN H was observed cutting with scissors a white material she identified as alginate (a wound absorption treatment which encourages new tissue growth) to a smaller piece which RN H was observed placing on the 2 open areas on the left groin. RN H explained she would cover the wounds with gauze since the patient did not have an ABD pad. RN H was observed placing folded gauze pads over the open areas on the left groin and secured gauze with tape. At 7:35 PM, RN H was observed rolling the patient to the left side in bed and a dressing was noted to the right buttock. RN H removed the dressing from the right buttock and 2 open areas were observed to the right ischium (the area of the skin on the lower buttock region that covers the rounded bone of the pelvis). At 7:44 PM, RN H was observed moistening gauze with clear liquid from a syringe labeled “Sodium Chloride 0.9%” and then observed wiping the open areas to the right ischium with the moistened gauze. At 7:48 PM, RN H was observed cutting with scissors a white material she identified as alginate and placed over open areas on right ischium, covered with folded gauze and secured gauze with tape. Review failed to evidence the plan of care included wound care supplies alginate, gauze and tape and failed to evidence the medication included Sodium Chloride 0.9% During an interview on 8/12/2021 at 12:17 PM, the alternate clinical manager indicated the plan of care should include the wound care supplies. During an interview on 8/13/2021 at 8:23 PM, the patient indicated his medication included diazepam (a medication used to treat seizures, muscle spasms and anxiety) 10 milligrams (mg) four times a day. The patient indicated he alternates Bactrim (antibiotic) twice a day for 3 months and then Macrobid (antibiotic) twice a day for 3 months as a preventive measure for urinary tract infections. Review failed to evidence the plan of care included the medication diazepam, Bactrim and Macrobid. During an interview on 8/18/2021 at 12;37 PM, the alternate clinical manager indicated all the medication taken by the patient should be included on the plan of care. 4. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 –8/ 22/2021 which was electronically signed by RN H on 7/21/2021 and the physician on 7/23/2021. The plan of care indicated the patient’s primary diagnosis was Type II Diabetes (a chronic condition where the body is impaired in the way it regulates and uses sugar as fuel). This document evidenced the patient’s medication included, but was not limited to, Iodosorb (a medicated gel used to treat wounds) as needed to the left foot and Warfarin Sodium (a medication used to thin the blood and prevent/treat blood clots) daily. Review failed to evidence the plan of care included the indications for when the Iodosorb was to be applied to the left foot. Review failed to evidence the safety measures included bleeding precautions. During an interview on 8/12/2021 at 9:39 AM, the alternate clinical manager indicated she was unsure why the plan of care did not include when or why the Iodosorb should be applied and indicated at 9:40 AM bleeding precautions should be included in the plan of care. Review of agency documents titled “Skilled Visit Note”, electronically signed by former employee LPN B, evidenced the patient’s blood sugar result was 123 on document dated 6/30/2021, 132 on document dated 7/15/2021 and 144 on document dated 7/21/2021. Review of the document dated 7/21/2021 evidenced the assessment included a glucometer (a medical device which helps to determine the amount of sugar in the blood) reading. Document dated 8/4/2021 and electronically signed by RN L indicated the patient’s blood sugar was 127. The plan of care failed to evidence the medical supplies needed to obtain the patient’s blood sugar such as a glucometer. During an interview on 8/12/2021 at 10:59 AM, the alternate clinical manager indicated medical supplies related to the patient’s diabetes to include a glucometer, lancets (a small blade with a sharp point used to obtain a drop of blood) and strips (used with glucometers to test the amount of sugar in the blood). The alternate clinical manager indicated the agency’s focus for the patient was more on the wounds than the diabetes. 5. Clinical record review on 8/12/2021 for patient #3, start of care 10/8/2020, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/5/2021 – 8/3/2021, signed and dated by RN N on 7/6/2021. Review indicated the patient’s primary diagnosis was atrial fibrillation (irregular heartbeat which may cause the heart to pump less effectively which may result in swelling of hands, feet, or other body parts). Review indicated skilled nursing was to provide services 1 time a week for 9 weeks and obtain a weekly INR lab test (a lab test which monitors the clotting time of blood). Review failed to evidence the plan of care included the medical supplies to obtain the INR lab test. The plan of care stated, “… Summary of SN Orders: … patient-specific parameters for notifying the physician of changes in vital signs or other clinical findings ….” but failed to indicate the individualized vital sign parameters. Review of an agency document titled “Skilled Visit Note”, dated 6/21/2021 and electronically signed by RN N, indicated the nurse set up the patient’s medications. The plan of care failed to indicate the skilled nursing interventions included medication set-up. During an interview on 8/16/2021 at 11:23 AM, the alternate clinical manager indicated the supplies needed for the INR lab test should be included in the plan of care. At 11:47 AM, the alternate clinical manager indicated the individualized vital sign parameters and the skilled nursing intervention for medication set-up should be included in the plan of care. 6. Clinical record review on 8/16/2021 for patient #6, start of care 2/18/2021, evidenced an agency document titled “Medication Profile”, dated 2/18/2021 and signed by former employee RN K, which indicated the patient’s medication included, but was not limited to, Doxycycline (an antibiotic used to treat infection) twice a day for 10 days for an infection. Review evidenced an agency document titled “Plan of Care” for certification period 2/18/2021 – 4/18/2021, signed by RN A and dated and signed by the physician on 6/8/2021, indicated the patient’s diagnoses included, but were not limited to, cellulitis (a bacterial skin infection which can cause the skin to be painful, red, swollen and hot to the touch) of the right lower limb and Type II Diabetes. Review failed to indicate the plan of care included Doxycycline in the list of patient’s medications. The plan of care indicated the skilled nurse was to instruct on the use of a glucose (blood sugar) monitoring device. The plan of care failed to indicate the medical supplies included the glucose monitoring device and testing supplies. During an interview on 8/18/2021 at 10:57 AM, the alternate clinical manager indicated Doxycycline should have been included in the plan of care. At 11:21 AM, the clinical manager indicated the plan of care should include the glucometer and testing supplies.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure conformance with physician’s orders in 1 of 2 active records reviewed with occupational therapy services. (#2) The findings include: Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Plan of Care – CMS #485 and Physician’s Orders” stated, “… Care and services provided will be provided according to physician orders….” Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Supplemental Provider Order”, dated 7/31/2021 and electronically signed by occupational therapist (OT) M and dated 8/10/2021 and signed by the physician. This document indicated OT services were to be provided 2 times a week for 3 weeks for activities of daily living (ADL) training, bathroom mobility and home exercise program. Review of a document titled “Discharge/Transfer Summary”, dated 8/9/2021 and electronically signed by OT M, evidenced a subsection titled “Goals not met [and] reasons (If applicable):” which stated, “… Bathing not met due to need of someone to position shower bench and assist with lower body as there is a dressing on the [left] foot ….” Review indicated the OT provided services 1 time during week 2 and did not provide OT services during week 3. Review failed to evidence the agency communicated with the physician regarding the discharge from OT services and failed to evidence a physician’s order for the discharge of OT services. Review failed to evidence OT provided services 2 times a week for 3 weeks as ordered by the physician. During an interview on 8/18/2021 at 12:12 PM, the alternate clinical manager indicated the physician should have been notified prior to the OT discharge related to the inability to meet patient needs and the request to discharge from OT services. The alternate clinical manager indicated there was not a verbal order obtained from the physician for the discharge of OT services.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure treatments and services were provided as ordered by a physician in 3 of 3 active clinical records reviewed with wounds. (#1, #2, #4) The findings include: 7. During an observation at the home of patient #4, on 8/11/2021 at 9:23 AM, physical therapist (PT) F was observed assessing the patient. At 9:51 AM, PT F inquired about the patient’s pain. Patient #4 indicated they do not take the "Norco [hydrocodone-acetaminophen]" anymore and the doctor did not recommend taking aspirin. The patient indicated just taking "Tylenol [acetaminophen - a mild pain reliever]" when needed, and alluded to the bottle of over the counter (OTC) acetaminophen on the kitchen table. Clinical record review on 8/10/2021, for patient #4, start of care 7/29/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” which was indicated to be the current plan of care received on 8/10/2021, diagnosis of age-related osteoporosis with current fracture to right humerus (upper arm), with a history of falls. This document had an area subtitled “10. Medications” which indicated the patient’s ordered pain medication was Hydrocodone-acetaminophen (opioid pain medicine combined with a mild pain reliever) as needed for moderate pain. Record review failed to evidence the patient was ordered another option for pain management. Record review failed to evidence an order for OTC acetaminophen from the patient's physician. Review failed to evidence the patient was taking medications as ordered by the patient’s physician. During an interview on 8/16/2021, at 12:36 PM, alternate clinical manager A indicated RN H was responsible for reviewing and updating the medication profile. The clinical manager indicated they could not identify when a medication review had been performed in the clinical record. 17-13-1(a) 1. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Plan of Care – CMS #485 and Physician Orders” stated, “… All patient care orders, including verbal orders, must be recorded in the plan of care. … Drug, services and treatments are administered by staff only as ordered by physician….” 2. Review of an undated agency policy, obtained 8/18/2021, titled “Integumentary – Application of Wound Dressing” stated, “… Procedure: … Review physician’s orders. … Dress wound with appropriate dressings following manufacturer’s guidelines and physician orders….” 3. Clinical record review on 8/10/2021 and 8/18/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Start of Care (D1)”, which was dated 6/18/2021 and electronically signed by registered nurse (RN) K. This document indicated the patient’s diagnoses included, but were not limited to, Stage II pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in partial thickness skin loss) of the left buttock and quadriplegia (paralysis of all 4 limbs). This document indicated the patient had 3 Stage II pressure ulcers consisting of 2 to the left groin and 1 pressure ulcer to the buttocks. One pressure ulcer to the left groin was assessed to be 1 centimeter (cm) in length, 1 cm in width and 0.2 cm in depth and had a wound treatment of cleanse with normal saline (a solution of salt and water used to clean wounds), apply collagen (a wound treatment used to stimulate new tissue growth), cover with an ABD pad (a thick absorbent wound dressing used to absorb fluid and keep from pooling on the wound site) and secure with tape 3 times a week. One pressure ulcer to the left groin was assessed to be 1 cm in length, 0.3 cm in width and 0.2 cm in depth and had a wound treatment of cleanse with normal saline, cover with an ABD pad and secure with tape 3 times a week. The wound to the buttocks was assessed to be 1 cm in length, 0.5 cm in width, 0.2 cm in depth and had a wound treatment of cleanse with normal saline, apply collagen, cover with an ABD pad and secure with tape 3 times a week. Review of agency documents titled “Skilled Visit Note”, electronically signed by former employee licensed practical nurse (LPN) B, indicated wound treatment was performed on 6/22/2021 to the left groin and right gluteal fold area and the document stated, “… Wound care performed as ordered by this writer….” Document dated 6/29/2021 stated, “… Wounds: L ish … Wound cleansed with NS [normal saline] and dressing applied per order. … R ish … Area cleaned with NS and dressing applied per order….” Document dated 7/2/2021 stated, “… Dressing changed per orders from wound clinic….” Document dated 7/5/2021 stated, “… L dressing had med [medium] amount of drainage … Dressing changed per order. R dressing had small amount of red/tan drainage. Dressing changed per order….” Document dated 7/7/2021 stated, “… Dressing changed on both wounds….” Document dated 7/15/2021 stated, “… Dressings changed per order….” Document dated 7/19/2021 indicated the nurse cleansed the wounds to the groin and to a site with a location stated as “Other” with normal saline and packed with alginate (absorbent wound treatment), covered with an ABD pad and secured with tape. This document stated, “… Wound dressings changed per order….” Document dated 7/23/2021 evidenced the skilled nurse cleansed the wound to the left groin with normal saline, covered with an ABD pad and secured with tape and cleansed the wound to the right ischium (the area of the skin on the lower buttock region that covers the rounded bone of the pelvis) with normal saline, packed with alginate collagen, covered with an ABD pad and secured with tape. This document indicated the skilled nurse cleansed a wound to the coccyx (the lower back above the buttocks) with normal saline and applied optifoam (a foam dressing with an adhesive border). Review failed to evidence a physician order for wound care as performed by the skilled nurse. Review of agency documents titled “Skilled Visit Note”, electronically signed by registered nurse (RN) L, indicated the RN cleansed the wounds to the left groin and right ischium with normal saline, packed with collagen, covered with an ABD pad and secured with tape on document dated 8/2/2021. Document dated 8/6/2021 indicated the RN cleansed the wound to the left groin with normal saline, packed with prism, covered with gauze and secured with tape and cleansed the wound to the right ischium with normal saline, packed with prism (an absorbent wound treatment), covered with an ABD pad and secured with tape. Document dated 8/9/2021 indicated the RN cleansed the wounds to the left groin and right ischium with normal saline, packed with prism alginate, covered with gauze and an ABD pad and secured with tape. Review failed to evidence a physician order for wound care as performed by the skilled nurse. Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/18/2021 – 8/16/2021. The document was signed by the alternate clinical manager on 7/15/2021 and by the physician on 8/2/2021 and indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and 2 times a week for 9 weeks. The plan of care stated, “… Wound care will be performed by ….” and failed to be individualized to include the location of the patient’s wounds and wound care to be provided. Review failed to evidence physician orders for wound care. During an interview on 8/12/2021 at 12:12 PM, the alternate clinical manager indicated the plan of care was supposed to indicate skilled nursing services 2 times a week for 9 weeks and the skilled nurse 1 time a week for 9 weeks was a mistake. At 1:00 PM, the alternate clinical manager indicated she did not see any wound care orders or information from the patient’s wound clinic. During an observation of care on 8/13/2021 at 7:19 PM at the patient’s home, RN H was observed removing the wound dressing to the patient’s left groin and 2 open areas were noted, each appeared the length of a large paperclip and as wide as the width of a pen. Both open areas appeared to have a depth of the length of a pinky fingernail. RN H stated, “One is more medial, but there are two here.” RN H was observed to place her gloved right thumb along the length of the lateral left groin open area and then pinch her right thumb with her left thumb and forefinger. RN H then placed her right thumb over the tag on her nurse bag and stated, “The length is from H to I.” RN H was then observed to place her gloved right thumb along the width of the lateral left groin open area and then pinch her right thumb with her left thumb and forefinger. RN H placed her right thumb over the tag on her nurse bag and stated, “The width is from H to O.” RN H was observed placing her gloved right thumb into the lateral left groin open area and was observed pinching her right thumb with her left thumb and forefinger. RN H was observed placing her gloved right thumb over the tag on her nurse bag and stated, “The depth is H.” At 7:25 PM, RN H placed a retractable tape measure against the tag on her nurse bag and stated, “The measurements are just under 1.5 inches, ¾ inch and ½ inch deep.” RN H was observed moistening dry gauze by squirting clear liquid from a syringe labeled “Sodium Chloride 0.9% [normal saline]” and wiping the patient’s open areas on the left groin with the moistening gauze. At 7:30 PM, RN H was observed cutting with scissors a white material she identified as alginate (a wound absorption treatment which encourages new tissue growth) to a smaller piece which RN H was observed placing on the 2 open areas on the left groin. RN H explained she would cover the wounds with gauze since the patient did not have an ABD pad. RN H was observed placing folded gauze pads over the open areas on the left groin and secured gauze with tape. At 7:35 PM, RN H was observed rolling the patient to the left side in bed and a dressing was noted to the right buttock. RN H removed the dressing from the right buttock and 2 open areas were observed to the right ischium (the area of the skin on the lower buttock region that covers the rounded bone of the pelvis). The lateral open area on the right ischium appeared to be the length of a large paperclip, the width of the diameter of a pen and the depth of a tip of a pen. The medial open area of the right ischium appeared to be in the peri wound (the area surrounding the wound) of the lateral open area on the right ischium and have the size of a dime with just the top layer of skin removed and a red wound base. At 7:44 PM, RN H was observed moistening gauze with clear liquid from a syringe labeled “Sodium Chloride 0.9%” and then observed wiping the open areas to the right ischium with the moistened gauze. At 7:45 PM, RN H measured the lateral open area on the right ischium with a retractable tape measure and stated, “There’s a little excoriated [the breakdown of skin due to prolonged exposure to moisture] part here. To me, there’s really another wound here. Some may call it one.” At 7:48 PM, RN H was observed cutting with scissors a white material she identified as alginate and placed over open areas on right ischium, covered with folded gauze and secured gauze with tape. During an interview on 8/13/2021 at 7:12 PM, RN H indicated she had a list of the patient’s supplies and did not have the patient’s wound care order but that it was probably at the office. During an interview on 8/18/2021 at 12:43 PM, the alternate clinical manager indicated there were not any wound care orders for the patient. 4. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced of an agency document titled “Start of Care (D1)”, dated 7/14/2021 and electronically signed by RN H, which failed to indicate the patient had any wounds. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 –8/ 22/2021 which was electronically signed by RN H on 7/21/2021 and the physician on 7/23/2021, failed to evidence wound care orders. Review of agency documents titled “Skilled Visit Note”, dated 7/21/2021 and electronically signed by former employee LPN B, indicated the patient had a surgical wound to the front of the left foot. The document indicated the skilled nurse cleansed the wound with normal saline, covered with kerlix (a type of gauze) and secured with tape. Document dated 7/29/2021 and electronically signed by RN H indicated the skilled nurse cleansed the wound to the left foot with wound wash, applied Iodosorb, covered with gauze and an ABD pad and secured with tape. Document dated 8/4/2021 and electronically signed by RN L indicated the skilled nurse cleansed the wound to the left foot with wound wash, covered with gauze and an ABD pad and secured with kerlix and tape. Review of an agency document titled Supplemental Provider Order, electronically signed by RN H and dated 8/3/2021, stated, “… wound care to lle [left lower extremity] forefoot, assess for s/s [signs and symptoms] of infection, educated patient and caregiver about wound care ….” Review failed to evidence the document indicated what was the wound care to be provided and the frequency the wound care was to perform. During an interview on 8/12/2021 at 10:18 AM, the alternate clinical manager indicated the order on 8/3/2021 was incomplete. At 10:33 AM, the alternate clinical manager indicated there was not a physician order for wound care and the patient had a paper from the wound clinic that explained the wound care the nurses followed in the home. 5. During an interview on 8/12/2021 at 11:20 AM, former employee LPN B indicated she conducted home visits without a plan of care, medication list, physician orders and patient diagnoses because the RN that started the case was not done with the plan of care by the time the next skilled nurse visit was due.

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinician receiving verbal orders documented the order, signed, dated and timed the order and failed to ensure the physician signed and dated the verbal order in 1 of 3 clinical records with anticoagulant (a class of medication used to thin the blood to treat and/or prevent blood clots) therapy. (#3) The findings include: Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Plan of Care – CMS #485 and Physician Orders” stated, “… Verbal orders are put in writing, signed, timed and dated with the date of receipt by a RN or therapist responsible for furnishing or supervising ordered services….” Clinical record review on 8/12/2021 for patient #3, start of care 10/8/2020, evidenced an agency document titled “Skilled Visit Note”, dated 6/14/2021 and electronically signed by registered nurse (RN) N, which indicated the physician was notified of the patient’s INR (a lab test which monitors the clotting time of blood) result and indicated new orders were received for a change in the dose of coumadin (a medication used to thin the blood to treat and/or prevent blood clots). Review of an agency document titled “Supplemental Provider Order”, electronically signed by RN N and dated 6/14/2021, indicated the coumadin 2.5 milligrams (mg) on Sunday, Monday, Wednesday, Thursday, and Friday was discontinued on 6/14/2021. Review failed to evidence the new dose the coumadin was changed to. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 6/5/2021 – 8/3/2021, electronically signed by RN N on 7/6/2021, indicated the patient’s medication included, but was not limited to, coumadin 3 mg every day with a start date of 6/14/2021. Review failed to evidence the RN documented the verbal order of the coumadin dose change to include order, clinician signature, time and date. During an interview on 8/16/2021 at 11:00 AM, the alternate clinical manager indicated the RN added the coumadin dose change on the plan of care since the plan of care was not signed until July and indicated the verbal order should have been documented, signed and dated and sent to the physician for signature at the time the verbal order was received. 17-13-1(a)

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician reviewed the plan of care at least every 60 days in 3 of 3 clinical records reviewed with more than 1 certification period. (#3, #5, #6) The findings include: 4. Clinical record review on 8/16/2021, for patient #5, start of care 2/24/2021, diagnosis of type 2 diabetes with chronic kidney disease, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 – 8/22/2021. Review failed to evidence a 60-day summary was sent to the physician. During an interview on 8/18/2021, at 10:30 AM, the alternate clinical manager A indicated the 60-day summary should be on the plan of care. They indicated the plan of care for certification period 6/24/2021 – 8/22/2021 was sent to the physician without a summary. 17-13-1(a)(2) 1. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Plan of Care – CMS #485 and Physician Orders” stated, “… The total Plan of Care will be reviewed and signed by the attending physician and Agency personnel involved in the patient’s care as often as the severity of the patient’s condition requires, but at least once every sixty (60) days….” 2. Clinical record review on 8/12/2021 for patient #3, start of care 10/8/2020, evidenced agency documents titled “Plan of Care” which indicated the plan of care for certification period 12/7/2020 – 2/4/2021 was signed by the physician on 1/12/2021 and indicated the plan of care for certification period 2/5/2021 – 4/5/2021 was signed by the physician on 4/21/2021. Review failed to evidence the physician reviewed the plan of care at least every 60 days. During an interview on 8/16/2021 at 11:07 AM, the alternate clinical manager indicated the physician should review the plan of care at least every 60 days. 3. Clinical record review on 8/16/2021 for patient #6, start of care 2/18/2021, evidenced agency documents titled “Plan of Care” which indicated the plan of care for certification period 2/18/2021 – 4/18/2021 was signed by the physician on 6/8/2021. Review failed to evidence the plan of care was reviewed by the physician at least every 60 days. During an interview on 8/18/2021 at 10:48 AM, the alternate clinical manager indicated she discovered there was an issue that the plan of care had not been sent to the physician so she signed it and sent it to the physician.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to promptly alert the physician to changes in the patient's condition or needs that suggested that outcomes were not being achieved and/or alert the physician the plan of care should be altered in 5 of 7 clinical records reviewed. (#1, #2, #3, #4, #6) The findings include: 6. During an observation on 8/11/2021 at 9:23 AM, PT [physical therapist] F performed a physical therapy visit in the home of patient #4, which included, but was not limited to assessing vital signs, range of motion, and assessing mobility. Observation of the patient's home evidenced to have common areas on one level, mostly carpeted, with unsecured rugs on top in the TV/ sitting rooms. During the visit, at 9:45 AM, PT F stated "OT says you're good!" to the patient, indicating the patient would be discharged from OT services, and PT would take over services. At 9:50 AM, PT F indicated SN [skilled nursing] services will be discharged as well and stated "[RN H name] said I can do the vitals." Clinical record review on 8/16/2021, for patient #4, start of care 7/29/2021, diagnosis of diagnosis of age-related osteoporosis with current fracture to right humerus (upper arm), evidenced an agency document titled “Home Health Certification and Plan of Care” which was indicated to be the current plan of care received on 8/10/2021. This document had an area subtitled “21. Orders for Discipline and Treatments (Specify Amount/Frequency/Duration)” which stated “Services for Occupational Therapist [OT]: … Effective on 08/08/2021: OT 2W2 [twice a week, for 2 weeks] … Summary of OT Orders: … ADL [activities of daily living] … Home Exercise Program … Summary of SN orders: … Monitor BP [blood pressure], Pulse, any increase or decrease of edema, noting decrease or increase of urine output, noting changes in level of activity, assess medication management of symptoms … Home safety interventions … pt [patient] r [right] shoulder incision site and staples will remain free from s/s [signs and symptoms] of infection The next section subtitled "22. Goals/Rehabilitation Potential Discharge Plans" stated "OT Goals ... Patient will perform bathe [sic] with SBA [stand by assist] ... Patient will perform dress with SBA ... Patient will be able to achieve ROM [range of motion] and strength of (R) UE [upper extremity] following MD [medical doctor] instructions to safety perform ADLs/IADLs [instrumental ADLs, including but not limited to opening doors, housekeeping, and taking medications] ... SN Goals ... Patient will demonstrate vital signs within acceptable limits, dysrhythmias absent or controlled and no symptoms of failure … The patient safety will be enhanced as evidenced by well-lit pathways, secure drugs, uncluttered walkways and minimal usage of stairs by end of certification periods (9 weeks) ... The patients/ caregiver will verbalize understanding of (r/t [related to] wound treatment) surgical incision and staples, signs and symptoms of infection, and all aspects of associated care within two weeks period of time....“ Review of an agency document titled "Discharge/Transfer Summary" dated 8/11/2021, and was evidenced to be unsigned by a SN. This document had an area subtitled "Reason for Discharge" which stated, "Care Completed ... Condition on Discharge ... Vital Signs: (optional per HHA Policy & Procedures) ..." Another area stated "Current Status ... Needs assist ... Outcomes ... Goals met ...." Review evidenced the patient required assistance after discharge. Review failed to evidence the patient's goals were met. Review failed to evidence SN services were provided as outlined in the plan of care, including but not limited to safety measures and wound care treatment. Review failed to evidence documentation of when the physician was notified that SN services were discharged. Review evidenced an agency document titled "Discharge/Transfer Summary" from 8/11/2021, which was signed by OT M. This document had an area subtitled "Reason for Discharge" which stated, "Pt to continue with PT [physical therapy] services for diagnosis ..." Another area stated "Goals not met [and] reasons (if applicable): Eval [evaluation] only ...." Review failed to evidence the patient received OT therapy visits. Review failed to evidence OT services were provided as outlined in the plan of care. Review failed to evidence documentation of when the physician was notified that OT services were discharged. 17-13-1(a)(2) 1. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Plan of Care – CMS #485 and Physician Orders” stated, “… The Agency must promptly alert the relevant physician(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered....” 2. Clinical record review on 8/10/2021 and 8/18/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Start of Care (D1)”, which was dated 6/18/2021 and electronically signed by registered nurse (RN) K. This document indicated the patient’s diagnoses included, but were not limited to, Stage II pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in partial thickness skin loss) of the left buttock, quadriplegia (paralysis of all 4 limbs), hypertension (high blood pressure) and chronic embolism (an obstruction of an artery, typically by a blood clot or air bubble) and thrombosis (formation of a blood clot within a blood vessel) of left iliac vein (a vein located in the abdomen). This document indicated the patient had 3 Stage II pressure ulcers consisting of 2 to the left groin and 1 pressure ulcer to the buttocks. One pressure ulcer to the left groin was assessed to be 1 centimeter (cm) in length, 1 cm in width and 0.2 cm in depth and had a moderate amount of serous (clear) drainage. One pressure ulcer to the left groin was assessed to be 1 cm in length, 0.3 cm in width and 0.2 cm in depth and had a moderate amount of serous drainage. The wound to the buttocks was assessed to be 1 cm in length, 0.5 cm in width, 0.2 cm in depth and had a moderate amount of serous drainage. The wounds were assessed to have no odor. This document failed to evidence the patient had a rash at the time of start of care. This document indicated the patient’s weight was 280 pounds and indicated there was no altered affect to include depression. Review of a document provided by the alternate clinical manager on 8/13/2021 titled “Final Report” from wound clinic D, dated 6/23/2021 and electronically signed by physician H, indicated the patient had 2 wounds to the left groin and a wound to the right ischium. During an observation of care on 8/13/2021 at 7:19 PM, the patient was observed to have 2 open areas on the left groin. Each open area appeared the length of a large paperclip and as wide as the width of a pen. Both open areas appeared to have a depth of the length of a pinky fingernail. RN H stated, “One is more medial, but there are two here.” The patient was observed to have 2 open areas to the right ischium (the area of the skin on the lower buttock region that covers the rounded bone of the pelvis). The lateral open area on the right ischium appeared to be the length of a large paperclip, the width of the diameter of a pen and the depth of a tip of a pen. The medial open area of the right ischium appeared to be in the peri wound (the area surrounding the wound) of the lateral open area on the right ischium and have the size of a dime with just the top layer of skin removed and a red wound base. At 7:45 PM, RN H stated, “There’s a little excoriated [the breakdown of skin due to prolonged exposure to moisture] part here. To me, there’s really another wound here. Some may call it one.” Review evidenced an agency document titled “Skilled Visit Note”, dated 6/22/2021 and electronically signed by former employee licensed practical nurse (LPN) B. This document stated, “… Rash to upper body remains with pt [patient] scratching upper chest and neck folds….” Document failed to evidence the physician was notified of the patient’s rash. During an interview on 8/12/2021 at 1:03 PM, the alternate clinical manager indicated there was no communication with the physician related to the patient’s rash. Review evidenced agency documents titled “Skilled Visit Note”, electronically signed by former employee LPN B. Document dated 6/29/2021 stated, “… Wounds: L ish. Had tan to dark drainage noted to dressing when removed….” Review failed to evidence the physician was notified of the change in wound drainage. Review of document dated 7/23/2021 indicted the skilled nurse assessed the wound to the left groin size to be 1.0 cm in length, 2.5 cm in width and 0.2 cm in depth and with a slight odor and assessed the wound to the right ischium to be 3.0 cm in length, 1.5 cm in width and 1.2 cm in depth with a slight odor. Review failed to evidence the physician was notified of the change in wound status related to the odor and the increase in wound size. The document dated 7/23/2021 evidenced the skilled nurse assessed a pressure area to the coccyx (the area on the lower back above the buttocks) measuring 0.5 cm in length, 0.5 cm in width and 0.1 cm in depth with a wound treatment of cleanse with normal saline and apply Optifoam (an absorbent foam dressing with an adhesive border). Review failed to evidence the skilled nurse notified the physician of the new open area to the coccyx. During an interview on 8/12/2021 at 1:06 PM, the alternate clinical manager indicated the physician should have been notified of the change in wound drainage and at 1:20 PM indicated the physician should have been notified of the wound odor and increase in size. At 1:23 PM, the alternate clinical manager indicated the physician was not notified of the new open area to the coccyx. Review evidenced an agency document titled “Skilled Visit Note”, dated 7/2/2021 and electronically signed by former employee licensed practical nurse (LPN) B. This document stated, “… Pt has noticed a lose [sic] in upper body strength at this time due to being bedbound due to wounds on gluteal area ….” Review failed to evidence the physician was notified of the decreased upper body strength. During an interview on 8/12/2021 at 1:08 PM, the alternate clinical manager indicated the physician was not notified of the decrease in upper body strength but should have been contacted for a therapy evaluation. Review of an agency document titled “Skilled Visit Note”, dated 7/15/2021 and electronically signed by LPN B, stated, “… Wound clinic is recommending whey protein for wound healing. Pt is attempting to get it….” Review failed to evidence the physician was notified of the recommendation by the wound clinic for whey protein. During an interview on 8/12/2021 at 1:14 PM, the alternate clinical manager indicated the physician should have been informed of the recommendation for whey protein. Review of an agency document titled “Skilled Visit Note”, dated 8/2/2021 and electronically signed by RN L, indicated the patient’s weight was 240 pounds and failed to evidence the physician was notified of the 40 pound weight loss since the comprehensive assessment on 6/18/2021. During an interview on 8/12/2021 at 1:26 PM, the alternate clinical manager indicated the RN should have investigated the weight loss and the physician should have been notified. Review of an agency document titled “Skilled Visit Note”, dated 8/6/2021 and electronically signed by RN L, indicated the patient was depressed and agitated. Review failed to evidence the physician was notified of the patient’s change in mood and affect. During an interview on 8/12/2021 at 1:28PM, the alternate clinical manager indicated the physician should have been notified of the patient’s change in mood. Review of an agency document titled “Skilled Visit Note”, dated 8/9/2021 and electronically signed by RN L, indicated the patient’s last bowel movement was on 8/4/2021. Review failed to evidence the physician was notified of no bowel movement for 5 days. During an interview on 8/12/2021 at 1:30PM, the alternate clinical manager indicated the physician should have been notified of no bowel movement in 5 days. Review of an agency document titled “Skilled Visit Note, dated 8/13/2021 and electronically signed by RN H, failed to evidence the RN notified the physician of the second open area to the right ischium as observed. During an interview on 8/18/2021 at 12:43 PM, the alternate clinical manager indicated the physician should have been notified of the new open area to the right ischium and a treatment order should have been obtained. 3. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Start of Care”, with an assessment date of 6/24/2021 and electronically signed by RN H, which indicated the patient’s pain to legs and back was assessed to be a 3 on a scale of 0-10, with 0 being no pain and 10 being the most severe, with a frequency of daily but not constantly and a pain goal of a rating less than 2 on a scale of 0-10. This document evidenced the patient’s blood pressure to be 138/68. Review evidenced the patient’s weight was 185 pounds. Review evidenced agency documents titled “Skilled Visit Note”, electronically signed by former employee LPN B, which assessed the patient’s pain on document dated 6/30/2021, to be rated 4 on a scale of 0-10 and a frequency of all of the time. Document dated 7/7/2021, evidenced the skilled nurse assessed the patient’s pain to be rated 6 on a scale of 0-10 daily but not constantly with a pain goal of 3 on a scaled of 0-10. Document dated 7/15/2021, evidenced the skilled nurse assessed the patient’s pain to be rated 5 on a scale of 0-10 with a frequency of all of the time. Document dated 7/21/2021, evidenced the skilled nurse assessed the patient’s pain to be rated 6 on a scale of 0-10 all of the time with a pain goal of 2 on a scale of 0-10. Document dated 8/4/2021, and electronically signed by RN L, evidenced the skilled nurse assessed the patient’s pain to be 6 on a scale of 0-10 all of the time. Review failed to evidence the physician was notified of the patient’s pain. During an interview on 8/12/2021 at 10:39 AM, the alternate clinical manager indicated the physician should be notified of pain when the pain is not relieved despite interventions or when the pain worsens. Review of an agency document titled “Occupational Therapy Evaluation”, dated 7/28/2021 and electronically signed by occupational therapist (OT) M, evidenced the patient’s blood pressure was 104/52. Review of an agency document titled “Skilled Visit Note”, dated 7/29/2021 and electronically signed by RN H, evidenced the patient’s blood pressure was 115/58. Review of agency documents titled “Therapy Visit Note”, electronically signed by OT M, evidenced the patient’s blood pressure was 98/54 on 8/3/2021 and 104/51 on 8/9/2021. Review failed to evidence the physician was notified of the patient’s low blood pressure assessments. During an interview on 8/12/2021 at 11:17 AM, the alternate clinical manager indicated the physician should have been notified of the change in blood pressure. Review of an agency document titled “Skilled Visit Note”, dated 8/4/2021 and electronically signed by RN L, evidenced the patient’s weight was 150 pounds. Review failed to evidence the physician was notified of the 35 pound weight loss. During an interview on 8/12/2021 at 11:19 AM, the alternate clinical manager indicated the physician should have been notified of the weight loss and to at least get the accurate weight from the doctor. Review of an agency document titled “Occupational Therapy Evaluation”, dated 7/28/2021 and electronically signed by OT M, evidenced the patient was to receive OT services 2 times a week for 3 weeks. Review of an agency document titled “Supplemental Provider Order”, dated 7/31/2021 and electronically signed by OT M, which indicated OT services were to be provided 2 times a week for 3 weeks for ADL (activities of daily living) training, bathroom mobility and a home exercise program. Review of a document titled “Therapy Visit Note”, dated 8/6/2021 and electronically signed by OT M, evidenced the patient’s problems included decreased functional mobility, safety awareness and ADLs. Review evidenced the plan for the next OT visit was to continue with safety training during tub transfers and the home exercise program. Review of a document titled “Discharge/Transfer Summary”, dated 8/9/2021 and electronically signed by OT M, evidenced a subsection titled “Goals not met [and] reasons (If applicable):” which stated, “… Bathing not met due to need of someone to position shower bench and assist with lower body as there is a dressing on the (L) [left] foot ….” Review failed to evidence the physician was notified prior to the patient’s discharge from OT services of the patient’s unmet goals and upcoming discharge from OT services. During an interview on 8/18/2021 at 12:12 PM, the alternate clinical manager indicated the physician should have been notified prior to the OT discharge related to the inability to meet patient needs and the request to discharge from OT services. The alternate clinical manager indicated there was not a verbal order obtained from the physician for the discharge of OT services. 4. Clinical record review on 8/12/2021 for patient #3, start of care 10/8/2020, evidenced an agency document titled “OASIS Follow-Up”, completion date 4/2/2021 and signed by RN N, indicated the patient began Nitrofurantoin (an antibiotic, which is a class of medication used to treat infection) on 3/31/2021 and was to take the medication twice a day for 7 days for a urinary tract infection. This document also indicated the patient had a fall on 3/31/2021. Review failed to evidence the name of the physician who prescribed the antibiotic and failed to evidence the physician responsible for the plan of care was notified of the patient’s Nitrofurantoin, urinary tract infection and fall. During an interview on 8/16/2021 at 11:21 AM, the alternate clinical manager indicated the physician should have been notified of the urinary tract infection, antibiotic and fall. Review evidenced an agency document titled “Skilled Visit Note”, dated 7/19/2020 and electronically signed by former employee LPN B, which indicated the patient had a new medication. Review failed to indicate the name, dose, frequency and route of the new medication and failed to indicate the physician was notified of the new medication. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 6/5/2021 – 8/3/2021, dated 7/6/2021 and electronically signed by RN N, failed to indicate a revision to include a new medication. During an interview on 8/16/2021 at 11:13 AM, the alternate clinical manager indicated she was unsure of what the name and dose was of the new medication. The alternate clinical manager indicated she saw a start date of 7/19/2021 for Sinemet (a medication used to treat Parkinson’s Disease; a progressive nervous system disorder that affects movement) on the medication list. Review of an undated agency document titled “Patient Medications” indicated the patient’s medication included Sinemet twice daily with a start date of 7/19/2021. The plan of care failed to evidence the patient’s medication included Sinemet for the certification period of 6/5/2021 – 8/3/2021. Review failed to evidence the ordering physician of the medication and failed to evidence the physician responsible for the plan of care was notified of the patient’s medication, Sinemet. 5. Clinical record review on 8/16/2021 for patient #6, start of care 2/18/2021, evidenced an agency document titled “Comprehensive Adult Assessment, 485 P.O.C. [Plan of Care] Worksheet and Outcome and Assessment Information Set”, dated 2/18/2021 and signed by former employee RN K, which indicated the patient weighed 151.4 pounds. The comprehensive assessment indicated the patient was at risk for falls but failed to indicate any abnormal findings related to balance, endurance and gait. Review of an agency document titled “Encounter Certification”, dated 3/8/2021 and signed and dated by the physician on 5/26/2021, indicated the patient had significant right sided hemiparesis (muscle weakness or partial paralysis on one side of the body) and was at risk for falls. Review of agency documents titled “Nursing Visit Record”, signed by former employee RN K, indicated the skilled nurse assessed the patient to have decreased endurance on 3/25/2021 and assessed the patient to have decreased endurance, balance and gait requiring the use of assistance with a walker on 3/30/2021. Review failed to evidence the physician was notified of the changes in the patient’s endurance, balance and gait. Review of an agency document titled “Adult Re-Assessment, 485 P.O.C. Recertification Worksheet and OASIS Follow-Up”, dated 4/18/2021 and signed by RN K, indicated the patient weighed 185 pounds. Review failed to evidence the nurse notified the physician of the 34 pound weight gain. During an interview on 8/18/2021 at 11:24 AM, the alternate clinical manager indicated the physician should have been notified of the weight gain but could not find any documentation related to the patient’s weight gain. At 11:35 AM, the alternate clinical manager indicated the physician should have been contacted related to the changes in the patient’s endurance, balance and gait and should have requested an order for a therapy evaluation.

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to revise the plan of care to reflect current health status, medications and nursing needs in 5 of 5 active clinical records reviewed. (#1, #2, #3, #4, #5) The findings include: 5. During an observation on 8/11/2021, at 9:23 AM, PT [physical therapist] F performed a physical therapy visit in the home of patient #4, which included, but was not limited to assessing vital signs, range of motion, and assessing mobility. During these assessments, PT F and the patient went over physician orders which were in the patient's home from the last doctor visit, which included, but was not limited to home exercises and directions for care of steri-strips [surgical tape strips used to close small wounds] over the surgical incision. Observation of the patient's home evidenced to have common areas on one level, mostly carpeted, with unsecured rugs on top in the TV and sitting rooms. During the visit, at 9:45 AM, PT F stated "OT [occupational therapy] says you're good!" to the patient, indicating the patient would be discharged from OT services. At 9:50 AM, PT F indicated SN services will be discharged as well. The patient indicated it was the first time hearing about discharge from the nursing. PT F stated "[RN H] said I can do the vitals." Observation evidenced the patient was being notified of the discharge of SN and OT services during a PT visit. Clinical record review on 8/16/2021, for patient #4, start of care 7/29/2021, diagnosis of diagnosis of age-related osteoporosis with current fracture to right humerus (upper arm), with a history of falls, evidenced an agency document titled “Home Health Certification and Plan of Care” which was indicated to be the current plan of care received on 8/10/2021. This document had an area subtitled “21. Orders for Discipline and Treatments (Specify Amount/Frequency/Duration)” which stated “Services for Occupational Therapist [OT]: … Effective on 08/08/2021: OT 2W2 [twice a week, for 2 weeks] … Summary of OT Orders: … ADL [activities of daily living] … Home Exercise Program … Summary of SN orders: … Monitor BP [blood pressure], Pulse, any increase or decrease of edema, noting decrease or increase of urine output, noting changes in level of activity, assess medication management of symptoms … Home safety interventions … pt [patient] r [right] shoulder incision site and staples will remain free from s/s [signs and symptoms] of infection ….“ Review failed to evidence updated surgical incision care to include care of steri-strips. Review evidenced an agency document titled "Discharge/Transfer Summary" from 8/11/2021, which was unsigned. This document had an area subtitled "Reason for Discharge" which stated, "Care Completed ... Condition on Discharge ... Vital Signs: (optional per HHA Policy & Procedures) ..." Another area stated "Current Status ... Needs assist ... Outcomes ... Goals met ...." Review evidenced the patient still required assistance after discharge. Review failed to evidence SN services were provided as outlined in the plan of care, including but not limited to safety measures and wound care treatment, as evidenced in the observation. During an interview on 8/16/2021, at 12:45 PM, alternate clinical manager A indicated PT F could assess surgical wounds if skilled nursing was no longer on the case. During an interview on 8/16/2021, at 1:01 PM, alternate clinical manager A confirmed the directions for use of steri-strips should be included in the clinical record. 6. Clinical record review on 8/10/2021, for patient #5, start of care 2/24/2021, diagnosis of type 2 diabetes with chronic kidney disease, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 – 8/22/2021, which had a section that stated “18. A … [none indicated] … 18.B Activities permitted: … Up as tolerated …” Review of the current plan of care failed to evidence the patient had functional limitations, including but not limited to hearing, vision, and ambulation. During an interview on 8/16/2021, at 10:17 AM, alternate clinical manager A confirmed the patient’s functional limitations had been identified on 2/24/2021 and failed to be on the current plan of care. 17-14-1(a)(1)(C) 1. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Care Planning Process” stated, “… Initial care plan will be CMS #485 Plan of Care ... Demonstrates problems (diagnoses), interventions (physician orders) and long range goals. … The Nursing Care Plan Update form may be utilized to update the care plan between certification and re-certifications to document modifications. Will reflect new problems, interventions, goals and goal evaluation/goal resolution….” 2. Clinical record review on 8/10/2021 and 8/18/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Start of Care (D1)”, which was dated 6/18/2021 and electronically signed by registered nurse (RN) K. This document indicated the patient’s diagnoses included, but were not limited to, Stage II pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in partial thickness skin loss) of the left buttock and quadriplegia (paralysis of all 4 limbs). This document indicated the patient had 3 Stage II pressure ulcers consisting of 2 to the left groin and 1 pressure ulcer to the buttocks. Review evidenced agency documents titled “Skilled Visit Note”, dated 7/23/2021 and electronically signed by former employee licensed practical nurse (LPN) B. These documents evidenced the skilled nurse assessed a pressure area to the coccyx (the area on the lower back above the buttocks) measuring 0.5 cm in length, 0.5 cm in width and 0.1 cm in depth with a wound treatment of cleanse with normal saline and apply Optifoam (an absorbent foam dressing with an adhesive border). Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/18/2021 – 8/16/2021 which was signed by the alternate clinical manager on 7/15/2021 and by the physician on 8/2/2021. The plan of care failed to evidence a revision to include the new wound to the coccyx and the wound treatment which was applied on 7/23/2021. During an interview on 8/12/2021 at 1:21PM, the alternate clinical manager indicated the plan of care was not updated with the additional coccyx wound. 3. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 –8/ 22/2021 which was electronically signed by RN H on 7/21/2021 and the physician on 7/23/2021. The plan of care indicated the patient’s primary diagnosis was Type II Diabetes (a chronic condition where the body is impaired in the way it regulates and uses sugar as fuel) and failed to evidence the patient had a wound. Review of agency documents titled “Skilled Visit Note”, dated 6/30/2021 and electronically signed by former employee LPN B, indicated the patient had a surgical wound on the left foot. Document dated 7/21/2021 and electronically signed by former employee LPN B, indicated the skilled nurse cleansed the wound to the left foot with normal saline, covered with kerlix (a type of gauze) and secured with tape. Document dated 7/29/2021 and electronically signed by RN H indicated the skilled nurse cleansed the wound to the left foot with wound wash, applied Iodosorb, covered with gauze and an ABD pad and secured with tape. Document dated 8/4/2021, electronically signed by RN L, indicated the patient had a wound to the left foot with a start date of 6/15/2021. Review of an agency document titled “Supplemental Provider Order”, dated 8/3/2021 and electronically signed by RN H, stated, “…wound care to lle [left lower extremity] forefoot, assess for s/s [signs and symptoms] of infection, educated patient and caregiver about wound care ….” Review failed to evidence the plan of care was revised prior to 8/3/2021 regarding the wound to the left foot and failed to evidence the plan of care had been revised to reflect the wound treatment provided to the left foot. During an interview on 8/12/2021 at 10:27 AM, the alternate clinical manager indicated the patient had the wound at the start of care on 6/24/2021 and the RN missed it on the plan of care. The alternate clinical manager indicated there was no revision to the plan of care until the physician order was obtained on 8/3/2021. 4. Clinical record review on 8/12/2021 for patient #3, start of care 10/8/2020, evidenced an agency document titled “OASIS Follow-Up”, completion date 4/2/2021 and signed by registered nurse (RN) N, which indicated the patient began Nitrofurantoin (an antibiotic, which is a class of medication used to treat infection) on 3/31/2021 and was to take the medication twice a day for 7 days for a urinary tract infection. Review of an agency document titled “Plan of Care” for certification period 2/4/2021 – 4/5/2021, signed by RN O, failed to evidence the plan of care was revised to include Nitrofurantoin in the list of patient’s medication. Review of an agency document titled “Plan of Care” for certification period 4/6/2021 – 6/4/2021, signed by RN B, indicated a section titled “Progress Notes” which stated, “… Goals met for the last certification period …” Review failed to evidence the summary included the patient’s goal for no falls was not met and failed to indicate the patient’s urinary tract infection and antibiotic therapy. Review evidenced an agency document titled “Skilled Visit Note”, dated 6/21/2021 and electronically signed by registered nurse (RN) N. This document indicated the patient had increased incontinence (loss of control of bowel and/or bladder) and an unsteady gait. Review indicated the patient recently finished antibiotics. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 6/5/2021 – 8/3/2021, electronically signed and dated 7/6/2021 by RN N, failed to evidence the plan of care was revised to include the antibiotic in the patient’s list of medication. Review failed to evidence the plan of care was revised to include incontinence and ambulation related to unsteady gait as functional limitations. During an interview on 8/16/2021 at 11:06 AM, the alternate clinical manager indicated she did not know what antibiotic the patient had been taking and for what infection the patient was being treated with antibiotics. The alternate clinical manager indicated the plan of care should have been revised to include Nitrofurantoin, the incontinence and unsteady gait.

Discharge plans communication CFR(s): 484.60(c)(3)(ii) (ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians or allowed practitioner's issuing orders for the HHA plan of care, and the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any). This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient and physician were communicated with regarding revisions to the plan of care related to the plans for the patient’s discharge in 2 of 2 closed clinical records reviewed. (#6, #7) The findings include: 4. Clinical record review on 8/16/2021, for patient #7, start of care 6/28/2021, diagnosis of an abscess of the genitalia, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period for certification period 6/28/2021 – 8/26/2021. This document had an area subtitled “21. Orders for Discipline and Treatments (Specify Amount/Frequency/Duration)” which stated “Services for Skilled Nurse: Effective 6/29/2021: SN: 1W6 [once a week, for 6 weeks] …“ Another area subtitled “Patient Rehab Potential and Discharge Goals” which stated “… Patient, Caregiver, and/or Representative (if any) agreed with and participated in the discharge plans … Patient to be discharged when skill care is no longer needed ….” Review evidenced an agency document titled “Discharge from Agency (D1)” from 7/20/2021 which was signed by RN H. Review failed to evidence the patient received skilled services after the start of care and prior to discharge. Review failed to evidence the physician was notified of the discharge. Review failed to evidence the patient received a discharge notice prior to the discharge assessment. Review failed to evidence efforts were made to perform skilled visits prior to discharge. During an interview on 8/17/2021, at 2:29 PM, the alternate clinical manager A confirmed the clinical record failed to evidence the physician had been notified of discharge. The alternate clinical manager indicated physician notification, patient notification, and efforts on behalf of the agency were not documented in the clinical record. 1. Review of an agency policy, revised July 2020 and obtained 8/18/2021, titled “Home Health Change of Care Notice (HHCCN) and Advance Beneficiary Notice (ABN)” stated, “… HHCCNs are issued to patients receiving the home health care benefit for notification of plan of care changes. The Agency must provide the HHCCN whenever it reduces or terminates patient’s home health services due to physician/provider orders or limitations of the Agency in providing the specific service….” 2. Review of an agency policy, revised and obtained 8/18/2021, titled “Discharge Criteria” stated, “… Patient will be discharged from services as follows: … The discharge is appropriate because the physician who is responsible for the home health plan of care and the Agency agree that measurable outcomes and goals set forth in the plan of care have been achieved and the Agency and physician responsible for the home health plan of care agree that the patient no longer needs the Agency’s services. … The patient is informed of discharge plan in a timely manner and acknowledges understanding reason. Physician and other care providers will be informed and knowledgeable of discharge. Discharge planning begins at time of admission and will be reflected in the documentation….” 3. Clinical record review on 8/16/2021 for patient #6, start of care 2/18/2021, evidenced an agency document titled “Plan of Care” for certification period “4/19/2021 – 6/17/2021, signed by the alternate clinical manager and signed and dated on 6/30/2021 by the physician. Review of an agency document titled “Nursing Visit Record”, dated 6/3/2021 and signed by former employee RN K, indicated a visit was planned for 6/17/2021. Review of an agency document titled “Discharge Summary”, dated 6/14/2021 and signed by former employee RN K, indicated the date of discharge was 6/14/2021. Review failed to evidence the agency communicated the revision to the plan of care related to discharge to the patient and physician prior to discharge. During an interview on 8/18/2021 at 11:46 AM, the alternate clinical manager indicated she was unsure of how the discharge was initiated and indicated there was no communication related to the discharge with the patient and physician prior to discharge. The alternate clinical manager indicated the agency should have provided the patient with a HHCCN form to inform the patient of discharge but indicated no HHCCN form was provided to the patient.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to communicate with all physicians involved in the plan of care in 1 of 1 home visit with a registered nurse. (#1) The findings include: Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Coordination of Patient Care” stated, “… The Agency must: Assure communication with all physicians involved in the plan of care….” Clinical record review on 8/10/2021 and 8/18/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Start of Care (D1)”, which was dated 6/18/2021 and electronically signed by registered nurse (RN) K. This document indicated the patient’s diagnoses included, but were not limited to, Stage II pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in partial thickness skin loss) of the left buttock and quadriplegia (paralysis of all 4 limbs). This document indicated the patient had 3 Stage II pressure ulcers consisting of 2 to the left groin and 1 pressure ulcer to the buttocks. Review of a document provided by the alternate clinical manager on 8/13/2021 titled “Final Report” from wound clinic D, dated 6/23/2021 and electronically signed by physician H, indicated the patient had 2 wounds to the left groin and a wound to the right ischium. During an observation of care on 8/13/2021 at 7:19 PM, the patient was observed to have 2 open areas on the left groin. Each open area appeared the length of a large paperclip and as wide as the width of a pen. Both open areas appeared to have a depth of the length of a pinky fingernail. RN H stated, “One is more medial, but there are two here.” The patient was observed to have 2 open areas to the right ischium (the area of the skin on the lower buttock region that covers the rounded bone of the pelvis). The lateral open area on the right ischium appeared to be the length of a large paperclip, the width of the diameter of a pen and the depth of a tip of a pen. The medial open area of the right ischium appeared to be in the peri wound (the area surrounding the wound) of the lateral open area on the right ischium and have the size of a dime with just the top layer of skin removed and a red wound base. At 7:45 PM, RN H stated, “There’s a little excoriated [the breakdown of skin due to prolonged exposure to moisture] part here. To me, there’s really another wound here. Some may call it one.” Review of an agency document titled “Skilled Visit Note", dated 8/13/2021, and electronically signed by RN H, failed to evidence the RN notified physician H at wound clinic D of the second open area to the right ischium as observed. During an interview on 8/12/2021 at 1:23 PM, the alternate clinical manager indicated the wound clinic physician should have been notified of the second open area to the right ischium. 17-14-1(a)(1)(G)

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to coordinate care of services provided to the patient in 4 of 5 active clinical records reviewed. (#1, #2, #3, #5) The findings include: 5. Clinical record review on 8/16/2021, for patient #5, start of care 2/24/2021, diagnosis of type 2 diabetes with chronic kidney disease, evidenced an agency document titled “Home Health Certification and Plan of Care” which was unsigned by the physician for certification period 6/24/2021 – 8/22/2021. This document failed to evidence the patient was hearing impaired. This document failed to evidence the patient had functional limitations During an observation on 8/11/2021 (input time), LPN (licensed practical nurse) I was observed performing a SN (skilled nurse) visit with patient #5. The patient and two family members were observed each sitting in lift recliners, with their rolling walkers propped in front of them. The patient was hard of hearing, and LPN I had to speak very loudly, or the patient’s family members would answer for the patient. During the visit, the patient’s family member/main caregiver indicated they assisted the patient with setting up medications, bathing and dressing. Review of agency documents titled “Skilled Visit Note” from 8/5/2021 and 8/11/2021, signed by LPN I, had a section subtitled “Sensory” which indicated the patient was hearing impaired. Review failed to evidence the LPN reported a change of condition in the patient’s sensory status to the RN. Review failed to evidence care was coordinated between all disciplines to maintain patient safety and a current plan of care. During an interview on 8/16/2021, at 10:16 AM, the alternate clinical manager A and administrator in training D were notified of the observations. The alternate clinical manager A indicated a patient’s condition can change from the comprehensive assessment. 17-12-2(g, h) 1. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Coordination of Patient Care” stated, “… The Agency must: Assure communication with all physicians involved in the plan of care. Integrate orders from all physicians involved in the plan of care to assure coordination of all services and interventions provided to the patient. Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines….” 2. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced agency documents titled “Skilled Visit Note”, electronically signed by former employee licensed practical nurse (LPN) B. Document dated 6/24/2021 stated, “… Pt [patient] seen on 6/23/2021 in wound clinic and no new orders record [sic] in regards to wounds….” Dressing changed per orders from wound clinic….” Document dated 7/2/2021 stated, “… Document dated 7/15/2021 stated, “… Pt was seen at wound care on 7/14/21. Wound care took measurements….” Document dated 8/9/2021 and electronically signed by registered nurse (RN) L stated, “… Patient will continue to follow up with wound care weekly ….” Review failed to evidence care coordination with the wound clinic providing wound care services to the patient. During an interview on 8/12/2021 at 12:53 PM, the administrator in training D indicated the patient’s wound physician was physician C from wound clinic D and stated, “I don’t have any documentation yet from their wound clinic.” During an interview on 8/12/2021 at 1:00 PM, the alternate clinical manager indicated she could not locate care coordination with the wound clinic. At 1:06 PM, the alternate clinical manager indicated there was nothing specific documented in the weekly case conference notes related to the patient’s wounds. 3. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Skilled Visit Note”, dated 7/21/2021 and electronically signed by former employee LPN B, indicated the patient had a surgical wound to the front of the left foot. The document indicated the skilled nurse cleansed the wound with normal saline, covered with kerlix (a type of gauze) and secured with tape. Review failed to evidence a physician order for the wound care provided. Review failed to evidence any services provided by a wound clinic and failed to evidence care coordination with a wound clinic. During an interview on 8/12/2021, at 10:33 AM when queried what was the physician’s order for wound care, the alternate clinical manager indicated there was not a physician order for wound care and the patient had a paper from the wound clinic that explained the wound care the nurses followed in the home. The clinical manager indicated there was no care coordination with the wound clinic. Review on 8/13/2021, of documents from the wound clinic at hospital I, which the alternate clinical manager identified were requested of and received on 8/13/2021 from the patient’s wound clinic, evidenced a document titled “06/28/2021 – Follow Up in SM [hospital I] Wound Ostomy Clinic”, dated 6/28/2021 and electronically signed by physician J. This document stated, “… Patient presents today status post partial excision [surgical removal] of bone left 1st metatarsal [a bone in the foot]. … Incision site remains closed. Sutures removed. … Dressing orders: Betadine [a medication used to clean wounds] to incision site and covered by Hydrofera Blue [a type of absorptive foam dressing for wounds]. Dressing frequency: 3 times per week….” Review of documents from the wound clinic at hospital I indicated the wound clinic provided wound care services for the wound on the left foot on 7/7/2021 and 7/26/2021. Review of an agency document titled “Start of Care”, with an assessment date of 6/24/2021 and electronically signed by RN H, evidenced the patient’s blood pressure to be 138/68. Review of an agency document titled “Occupational Therapy Evaluation”, dated 7/28/2021 and electronically signed by occupational therapist (OT) M, evidenced the patient’s blood pressure was 104/52. The document indicated the patient was to receive 2 visits a week for 3 weeks. Review of agency documents titled “Therapy Visit Note”, electronically signed by OT M, evidenced the patient’s blood pressure was 98/54 on 8/3/2021 and 104/51 on 8/9/2021. Review failed to evidence the OT notified the nurse case manager of the patient's blood pressure. During an interview on 8/12/2021 at 11:17 AM, the alternate clinical manager indicated the OT should have notified the nurse case manager of the patient’s blood pressure. Review of an agency document titled “Discharge/Transfer Summary”, dated 8/9/2021 and electronically signed by OT M, indicated the patient was discharged from OT services. The document stated, “… Goals not met … Bathing not met due to need of someone to position shower bench and assist with lower body as there is a dressing of the [left] foot … [patient] states he will get a walk in bath with grab bars and seat that will allow him to be independent once dressing on left foot is no longer necessary ….” Review of the document failed to evidence the OT coordinated the patient’s discharge from OT services with the nurse case manager and communicated the patient’s need for assistance to get into the shower and dressing. During an interview on 8/18/2021 at 12:12 PM, the alternate clinical manager indicated she was unaware OT M discharged the patient from OT services. During an interview on 8/18/2021 at 12:12 PM, administrator in training D indicated she was aware OT M discharged the patient from OT services but did not know why and indicated there was no documented care coordination with the nurse case manager in the record. 4. Clinical record review on 8/12/2021 for patient #3, start of care 10/8/2020, evidenced an agency document titled “Skilled Visit Note”, dated 7/19/2020 and electronically signed by former employee LPN B, which indicated the patient had a new medication. Review failed to indicate the name, dose, frequency and route of the new medication, failed to evidence a physician order for the new medication and failed to indicate the LPN coordinated care with the nurse case manager related to the new medication as identified by the LPN. During an interview on 8/16/2021 at 11:13 AM, the alternate clinical manager indicated the LPN should have coordinated care with the nurse case manager regarding the new medication.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to provide a written visit schedule to the patient/caregiver in 4 of 4 home visits conducted. (#1, #2, #4, #5) The findings include: 4. An observation was conducted at a home visit on 08/17/202,1 at 12:07 PM, with home health aide (HHA) J to observe the services being provided by the home health aide. During the home visit, at 2:00 PM, the patient's home folder was reviewed which failed to evidence a schedule for patient services being furnished by the agency. During an interview on 8/17/2021, at 1:20 PM, when queried about how they are informed of when staff was coming to the home, patient #2 stated “Sometimes they call the night before. Sometimes they call early in the morning of the visit. And sometimes not at all. 5. Observation of a home visit was conducted on 8/11/2021at 10:00 AM, for patient #4, start of care 7/29/2021, diagnosis of age-related osteoporosis with fracture, to observe PT [physical therapist] F provide services. At 10:10 AM, the patient's home folder was reviewed and failed to evidence a schedule for patient services being furnished by the agency. 6. During an observation on 8/11/2021 1:00 PM, of a home visit for patient #5, start of care 2/24/2021, diagnosis of type 2 diabetes with chronic kidney disease, was conducted to observe LPN [licensed practical nurse] I provide care. At 1:14 PM, the patient's home folder could not be located for review by the client or caregiver. Observation failed to evidence a schedule for patient services being furnished by the agency. 1. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Patient Bill of Rights and Responsibilities” stated, “… Patients have the right: … To be informed of: Visit schedule and frequency….” 2. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Coordination of Patient Care” stated, “… Agency will coordinate care with the patient by providing a copy of written instructions outlining: Visit schedule, including frequency of visits by Agency personnel ….” 3. During an observation of care at the home of patient #1, start of care 6/18/2021, on 8/13/2021 at 7:02 PM, the agency folder was observed with blank calendars for the months of June, July and August of 2021. The home observation failed to evidence a written visit schedule was provided to the patient. During an interview on 8/18/2021 at 12:19 PM, the alternate clinical manager indicated the agency should provide to the patient in the home folder a written visit schedule.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to provide the patient and caregiver written medication schedule and instructions in 4 of 4 home visits. (#1, #2, #4, #5) The findings include: 4. During an observation on 8/17/2021, at 12:00 PM, of a home visit for patient #2, start of care 6/24/2021, primary diagnosis of type 2 diabetes, was conducted to observe HHA J provide care. At 2:00PM, the patient's home folder was reviewed failed to evidence a current medication list was supplied by the agency. 5. During an observation on 8/11/202110:00 AM, of a home visit for patient #4, start of care 7/29/2021, diagnosis of age-related osteoporosis with fracture, was conducted to observe PT [physical therapist] F provide care. At 10:10 AM, the patient’s home folder was reviewed failed to evidence a current medication list was supplied by the agency. 6. During an observation on 8/11/2021,at 1:00 PM, of a home visit for patient #5, start of care 2/24/2021, diagnosis of type 2 diabetes with chronic kidney disease, was conducted to observe LPN [licensed practical nurse] I provide care. At 1:14 PM, the patient's home folder could not be located for review by the client or caregiver. Observation failed to evidence a current medication list was supplied by the agency. 1. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Medication Profile” stated, “… The Agency must provide the patient and caregiver with a copy of written instructions outlining patient medication schedule/instructions ….” 2. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Coordination of Patient Care” stated, “… Agency will coordinate care with the patient by providing a copy of written instructions outlining: … Patient medication schedule/instructions ….” 3. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an undated agency document titled “Patient Medications”. This document indicated, but was not limited to, Ketoconazole, start date 4/2/2021, (an antifungal medication used to treat skin infections), Simvastatin, start date 4/2/2021, (medication used to treat high cholesterol), Norco 5-325 mg, start date 4/23/2021, (medication used to treat pain) and Eliquis, start date 4/2/2021, (a blood thinning medication used to prevent blood clots). During an observation of care at the patient’s home on 8/13/2021 at 7:02 PM, the agency folder was observed and failed to evidence written medication schedule and instructions. During an interview on 8/18/2021 at 12:19 PM, the alternate clinical manager indicated the agency’s folder in the patient’s home should include the plan of care and medication list. At 12:21 PM, the alternate clinical manager indicated the agency should provide the patient medication information sheets for written medication instructions.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to provide the patient with written instructions for the name and contact information for the clinical manager in 4 of 4 home visits. (#1, #2, #4, #5) The findings include: 4. During an observation of care at the home of patient #1, start of care 6/18/2021, on 8/13/2021 at 7:02 PM, the agency folder was observed which indicated RN B was the clinical manager. Review failed to evidence the patient was informed in writing of RN A as the acting clinical manager. During an interview on 8/9/2021 at 10:40 AM, the alternate clinical manager, RN A, indicated RN B had been out of the office since the end of June due to medical leave. When queried who patients and staff were to contact in the absence of clinical manager, the alternate clinical manager indicated patients and staff were to contact the alternate clinical manager and stated, “But I bet a letter did not go out to the patients about the long term change in the clinical manager.” 1. An observation was conducted at a home visit on 08/17/2021 at 12:07 PM, with home health aide (HHA) J, to observe the services being provided by the home health aide. During the home visit at 2:00 PM the patient’s home folder was reviewed and failed to evidence the contact information of the clinical manager. 2. An observation was conducted at a home visit on 08/11/2021 at 10:00 AM, with physical therapist (PT) F, to observe the services being provided by the physical therapist. During the home visit at 10:10 AM the patient’s home folder was reviewed and failed to evidence the contact information of the clinical manager. 3. An observation was conducted at a home visit on 08/11/2021 at 1:00 PM, with licensed practical nurse (LPN) I, to observe the services being provided by the physical therapist. Observation failed to evidence the contact information of the clinical manager that was available at the time of visit.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the quality assurance and performance improvement (QAPI) program failed to show measurable improvement in indicators for which there was evidence that improvement in those indicators will improve health outcomes, patient safety and quality of care (see tag G642); failed to use quality indicator data to monitor the effectiveness and safety of services and quality of care and identify opportunities for improvement (see G644); failed to focus on high risk areas (see tag G648); failed to ensure the performance improvement activities considered incidence, prevalence and severity of problems (see tag G650); failed to ensure the performance improvement activities tracked adverse patient events, analyzed their causes and implemented preventative actions (see tag G654); failed to take actions aimed at performance improvement, and after implementing those actions, the agency must measure its success and track performance to ensure improvements are sustained (see tag G656); failed to conduct performance improvement projects (see G658) and failed to ensure an ongoing program for quality improvement and patient safety is defined, implemented and maintained and agency-wide QAPI efforts which addressed priorities for improved quality of care and patient safety and improvement actions were evaluated for effectiveness (see tag G660). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation 484: 65 Condition: Quality Assessment / Performance Improvement. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation 484: 65 Condition: Quality Assessment / Performance Improvement.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to show measurable improvement in indicators for which there was evidence that improvement in those indicators will improve health outcomes, patient safety and quality of care. The findings include: Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program” stated, “…The Agency program will be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety and quality of care. 2. The Agency must measure, analyze and track quality indicators, including adverse patient events and other aspects of performance that enable the Agency to assess processes of care, services and operations….” During an interview on 8/9/2021 at 2:33 PM, after a request was made to the alternate clinical manager for the agency’s QAPI data, the alternate clinical manager indicated there was nothing to provide for review for the agency’s QAPI data. At 3:00 PM, the alternate clinical manager provided documents identified as patient satisfaction reports and indicated there was no other QAPI data. Review failed to evidence quality indicators and measurable data. During an interview on 8/10/2021 at 2:36 PM, the alternate clinical manager indicated registered nurse (RN) B printed quarterly quality averages compared to national averages and indicated she could not locate the data. The alternate clinical manager indicated she was not aware off hand of areas needing improvement in the agency. No additional documentation was provided. 17-12-2(a)

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the Quality Assessment and Performance Improvement (QAPI) Program utilized quality indicator data to monitor the effectiveness and safety of services and quality of care and identify opportunities for improvement and failed to ensure the frequency and detail of the data collection was approved by the governing body. The findings include: Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program” stated, “… The Agency must measure, analyze and track quality indicators, including adverse patient events and other aspects of performance that enable the Agency to assess processes of care, services and operations. … The Agency will use the data to: Monitor the effectiveness and safety of services and quality of care. Identify opportunities for improvement. … The frequency and detail of the data collection must be approved by the Governing Body….” Review on 8/9/2021 of agency documents titled “Governing Body Meeting Minutes”, dated 10/7/2020, 3/23/2021 and 6/4/2021, failed to evidence the governing body approved the detail and frequency of the quality indicator data collection. During an interview on 8/9/2021 at 2:33 PM, after a request was made to the alternate clinical manager for the agency’s QAPI data, the alternate clinical manager indicated there was nothing to provide for review for the agency’s QAPI data. At 3:00 PM, the alternate clinical manager provided documents identified as patient satisfaction reports and indicated there was no other QAPI data. Review failed to evidence quality indicator data. During an interview on 8/10/2021 at 2:36 PM, the alternate clinical manager indicated the quality indicators the agency monitored were the improvement or decline in patient’s ability to provide personal care, documentation, short and long term goals being patient specific, wounds and hospitalizations. The alternate clinical manager indicated she could not find any documentation of the collected data other than the patient satisfaction surveys. The alternate clinical manager indicated she believed the frequency of the data collection was quarterly but did not know if the governing body approved the detail of the data collection. The alternate clinical manager indicated there was no documentation of the governing body approval for the frequency and detail of the quality indicator data collection. 17-12-2(a)

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the performance improvement activities focused on high risk, high volume, or problem-prone areas. The findings include: Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program” stated, “… The Agency’s performance improvement activities will: Focus on high risk, high volume and problem-prone areas….” During an interview on 8/9/2021 at 2:33 PM, after a request was made to the alternate clinical manager for the agency’s QAPI data and performance improvement activities, the alternate clinical manager indicated there was nothing to provide for review for the agency’s QAPI data and activities. At 3:00 PM, the alternate clinical manager provided documents identified as patient satisfaction reports and indicated there was no other QAPI documentation. Review failed to evidence performance improvement activities. During an interview on 8/10/2021 at 2:36 PM, the alternate clinical manager indicated there was no performance improvement activities and the last activity was in 2018.

Incidence, prevalence, severity of problems CFR(s): 484.65(c)(1)(ii) (ii) Consider incidence, prevalence, and severity of problems in those areas; and This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the performance improvement activities considered incidence, prevalence and severity of problems. The findings include: Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program” stated, “… The Agency’s performance improvement activities will: … Consider incidence, prevalence and severity of problems in those areas….” During an interview on 8/9/2021 at 2:33 PM, after a request was made to the alternate clinical manager for the agency’s QAPI data and performance improvement activities, the alternate clinical manager indicated there was nothing to provide for review for the agency’s QAPI data and activities. At 3:00 PM, the alternate clinical manager provided documents identified as patient satisfaction reports and indicated there was no other QAPI documentation. Review failed to evidence performance improvement activities. During an interview on 8/10/2021 at 2:36 PM, the alternate clinical manager indicated there was no performance improvement activities and the last activity was in 2018.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the performance improvement activities tracked adverse patient events, analyzed their causes and implemented preventative actions in 2 of 2 clinical records reviewed with falls. (#3, #6) The findings include: 1. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program” stated, “… Performance improvement activities must track adverse patient events, analyze their causes and implement preventive actions. … “Adverse patient events” are those patient events that are negative and unexpected, impact a patient’s plan of care and have the potential to cause a decline in a patient’s condition….” 2. Clinical record review on 8/12/2021 for patient #3, start of care 10/8/2020, evidenced an agency document titled “Physical Therapy Functional Reassessment”, dated 11/13/2020 and signed by physical therapist (PT) F, indicated the patient had a complaint of pain rated 4 on a scale of 0-10, with 0 being no pain and 10 being the most severe, to the left hip related to a fall on 10/25/2020. Review failed to evidence the fall was tracked and its cause analyzed. Review of an agency document titled “titled “OASIS Follow-Up”, completion date 4/2/2021 and signed by registered nurse (RN) N, indicated the patient had a fall on 3/31/2021. Review failed to evidence the fall was tracked and its cause analyzed. During an interview on 8/16/2021 at 11:36 AM, the alternate clinical manager indicated there was no incident report completed for the falls on 10/25/2020 and 3/31/2021 to track and analyze the falls. The alternate clinical manager indicated a patient fall was considered an adverse event. 3. Clinical record review on 8/16/2021 for patient #6, start of care 2/18/2021, evidenced an agency document titled “Nursing Visit Record”, dated 5/3/2021 and signed by former employee RN K, stated, “… [Patient] had a fall on Friday, hit head, laid on floor for [approximately] 1 hr [hour]….” Review failed to evidence the fall was tracked and its cause analyzed. During an interview on 8/18/2021 at 11:19 AM, the alternate clinical manager indicated an incident report had not been completed for the fall to track and analyze the fall and indicated an incident report should have been completed. 17-12-2(a)

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to take actions aimed at performance improvement, and after implementing those actions, the agency must measure its success and track performance to ensure improvements are sustained. The findings include: Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program” stated, “… Agency must take actions aimed at performance improvement and, after implementing these actions, must measure its success and track performance to ensure that improvements are sustained….” During an interview on 8/9/2021 at 2:33 PM, after a request was made to the alternate clinical manager for the agency’s QAPI data, the alternate clinical manager indicated there was nothing to provide for review for the agency’s QAPI documentation. At 3:00 PM, the alternate clinical manager provided documents identified as patient satisfaction reports and indicated there was no other QAPI documentation. Review failed to evidence the agency took actions aimed at performance improvement and measure the success and track performance to ensure improvements were sustained. During an interview on 8/10/2021 at 2:36 PM, the alternate clinical manager indicated the agency typically tracked its performance with reports of the agency’s performance averages compared to the national averages and indicated there was not a report available for review. The alternate clinical manager indicated patient falls needed improvement and was unaware of performance improvement activities aimed at improving patient falls. 17-12-2(a)

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency's governing body failed to ensure an ongoing program for quality improvement and patient safety was defined, implemented and maintained and agency-wide quality assessment and performance improvement (QAPI) efforts which addressed priorities for improved quality of care and patient safety and improvement actions were evaluated for effectiveness. The findings include: Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Governing Body” stated, “… The Governing Body is responsible for assuring: That an ongoing program for Quality Assessment/Performance Improvement and patient safety is defined, implemented and maintained. That the Agency-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated for effectiveness….” During an interview on 8/9/2021 at 2:33 PM, after a request was made to the alternate clinical manager for the agency’s QAPI data and performance improvement activities, the alternate clinical manager indicated there was nothing to provide for review for the agency’s QAPI data and activities. At 3:00 PM, the alternate clinical manager provided documents identified as patient satisfaction reports and indicated there was no other QAPI documentation. Review failed to evidence QAPI data and performance improvement activities. During an interview on 8/10/2021 at 2:36 PM, the alternate clinical manager indicated all QAPI data was reported to the governing body by the administrator quarterly at a minimum either verbally or via email. The alternate clinical manager indicated there was no documentation of QAPI data reported to the governing body.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the agency failed to follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases in 2 of 2 home visits with a skilled nurse . (#1, #5) The findings include: 4. During an observation on 8/11/2021, at 1:00 PM, LPN (licensed practical nurse) I was observed performing a SN (skilled nurse) visit with patient #5. The patient and two family members were observed sitting in lift recliners, with their wheelchairs propped in front of them. The patient was hard of hearing, and LPN I had to speak very loudly, or the patient’s family members would answer for the patient. At 13:07 PM, LPN I indicated she just started and didn’t have a barrier and placed her nurse bag on the floor. LPN I sanitized her hands with alcohol based hand rub (ABHR), opened nurse bag and retrieved a blood pressure cuff, thermometer, pulse oximeter and stethoscope. At 1:07 PM, obtained the patient’s vital signs and then placed the blood pressure cuff, pulse oximeter, and thermometer directly on the floor. LPN I sanitized using ABHR and searched through her nurse bag. At 1:23 PM, LPN I pumped ABHR into hands and rubbed it into her stethoscope. LPN I retrieved a 4 inch by 4 inch (4 x 4) gauze dressing from nursing bag and pumped ABHR onto the gauze. LPN I wiped down the blood pressure cuff, pulse oximeter, and thermometer with ABHR on 4 x 4 gauze dressings and placed the items back into the nurse bag. Observation evidenced the LPN placed the reusable medical equipment on the floor. Observation failed to evidence the LPN used a barrier between the nurse bag and patient’s floor in their home. Observation failed to evidence the nurse sanitized reusable medical equipment according to agency policy. Observation failed to evidence the LPN followed infection control procedures according to agency policy. During an interview on 8/11/2021, at 1:37 PM, LPN I indicated they did have the barrier mat or disinfectant wipes provided by the agency. During an interview on 8/18/2021, at 10:35 AM, alternate clinical manager A was informed the LPN did not use a barrier for the nurse bag or disinfectant wipes on the reusable medical equipment. Alternate clinical manager A indicated all field staff was supplied with those items and should have had them at the SN visit. 17-12-1(m) 1. Review of an agency policy, revised July 2020, titled “Standard Precautions” stated, “… The concept of body substance isolation encompasses all the principles of Standard Precautions/blood and body fluid precaution, and extends to all moist body parts/tissues/surfaces, including fluids, solids, tissues and moist areas … The principles of Standard Precautions are to be followed by all employees when contacting any such substances or areas. Standard Precautions include the following procedures: … Perform hand hygiene after removing gloves. (Note: Gloves do not replace handwashing.) ….” 2. Review of an agency policy, revised March 2018, titled “Exposure Control Plan: OSHA [Occupational Safety and Health Administration] Regulations” stated, “… Keep supplies off the floor and out of reach of children … Methods of Disinfection … Thermometers will be wiped with alcohol pad after each use … Stethoscopes and blood pressure cuffs will be cleansed with Agency approved disinfectant after each use by the employee who has possession of the equipment … Nursing Bag Technique … Upon entering the home, place the bag on a clean surface; paper towels or plastic bag may be used to create a clean area if indicated … Remove all items which will be needed for the visit … Place items on one of the paper towels. Close the bag and give the patient care … Clean any visibly soiled items which will be returned to the bag ….” 3. During an observation of care at the home of patient #1, start of care 6/18/2021, on 8/13/2021 at 7:17 PM, registered nurse (RN) H was observed removing the glove to her right hand. RN H was observed entering her nurse bag with the ungloved right hand, retrieved a tape measure and then applied a glove to the right hand. RN H was not observed to have performed hand hygiene after removing the glove to the right hand before applying another glove. At 7:19 PM, RN H removed the wound dressing to the patient’s left groin and was observed placing her right thumb up against the wounds and then against the tag on the nurse bag. RN H was observed removing the gloves on both hands and then applied a new glove to the left hand. RN H was not observed to have performed hand hygiene after removing the gloves and before applying new glove to the left hand. At 7:25 PM, RN H was observed measuring the tag on the nurse bag with the tape measure, removed the glove on her left hand and applied new gloves to both hands. RN H was not observed to have performed hand hygiene after removing the glove on the left hand and before applying new gloves. At 7:30 PM, RN H cleanses the wound to the patient’s left groin and applies a clean dressing to the wounds. RN H was observed removing both gloves and then applied new gloves to both hands. RN H was not observed to have performed hand hygiene after cleansing the open areas and before applying the new wound dressing to the open areas on the left groin and was not observed to have performed hand hygiene after removing the gloves and before new gloves. At 7:35 PM, RN H rolled the patient to his left side and wiped a brown, soft substance from the patient’s buttocks using the disposable pad underneath the patient and then removed a dressing from the patient’s right buttock. Two open areas were observed on the right ischium (the area of the skin on the lower buttock region that covers the rounded bone of the pelvis). RN H wiped a brown, soft substance from in between the buttocks with disposable wipes, removed the disposable pad from under the patient’s buttocks, removed gloves from her hands and placed them in the trash can. At 7:44 PM, RN H was observed applying new gloves and cleansed the wounds to the right ischium. At 7:48 PM, RN H was observed removing her gloves, applied new gloves and applied a clean dressing to the open areas on the left ischium. RN H was not observed to have performed hand hygiene after glove removal and before applying new gloves. During an interview on 8/18/2021 at 12:24 PM, the alternate clinical manager indicated hand hygiene should be performed after the removal of gloves and before applying new gloves and before entering the nurse bag.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to provide infection control education in 4 of 7 active personnel records reviewed providing direct patient care. (F, H, L, M) The findings include: 1. Review of an agency policy, revised March 2018, titled “Exposure Control Plan: OSHA [Occupational Safety and Health Administration] Regulations” stated, “… Employees will receive education and training during orientation and at least annually ….” 2. Personnel record review on 8/10/2021 for physical therapist (PT) F, start date 1/13/2020, evidenced an agency document titled “New Employee Inservice Log”, signed by PT F and dated 1/13/2020, which indicated PT F received inservice training for infection control. Review failed to evidence PT F received infection control education annually per agency’s policy since 1/13/2020. 3. Personnel record review on 8/10/2021 for registered nurse (RN) H, start date 12/16/2019, failed to evidence RN H received infection control education. 4. Personnel record review on 8/10/2021 for RN L, start date 6/7/2021, evidenced agency documents titled “Tuberculosis [a contagious bacterial infection usually affecting the lungs] and Infection Control” and “Bloodborne Pathogens Break the Chain of Infection”, signed by RN L. Review failed to evidence the forms were completed to include a date the training was completed, a signature of the instructor who provided the training and an assessment of the employee’s competency of the education. 5. Personnel record review on 8/10/2021 for occupational therapist (OT) M, date of hire 6/16/2021, evidenced agency documents titled “Tuberculosis [a contagious bacterial infection usually affecting the lungs] and Infection Control” and “Bloodborne Pathogens Break the Chain of Infection”. Review failed to evidence the forms were completed to include a date the training was completed, OT M’s signature indicating receipt of training, a signature of the instructor who provided the training and an assessment of the employee’s competency of the education. 6. During an interview on 8/10/2021 at 4:04 PM, the alternate clinical manager indicated the education forms should have been completed when the training was provided and indicated there was no documentation of infection control education provided to RN H. The alternate clinical manager indicated infection control training should be completed annually and typically the training was offered in January and February every year. The alternate clinical manager indicated there was no additional documentation for PT F that the agency provided infection control education.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on record review and interview, the skilled professional failed to ensure the following: failed to provide ongoing interdisciplinary involvement of all skilled professionals involved in the patient's care (See tag G0706); failed to provide the services as indicated in the plan of care (See tag G0710); failed to provide the patient and caregiver education (See tag G0714); failed to prepare clinical notes (See tag G0716) and failed to participate in agency-sponsored in-services (See tag G0722). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.75 Skilled Professional Services. The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.75 Skilled Professional Services.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the skilled nurse failed to provide an ongoing assessment of the patient in 2 of 3 active clinical records reviewed with wounds. (#1, #2) The findings include: 1. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Nursing Services” stated, “… Nursing care will be provided in accordance with the patient’s plan of care, under supervision of a registered nurse. Professional nursing service will be provided by a registered nurse (RN) and include: Initial and ongoing comprehensive assessments of the patient’s needs … The Licensed Practical Nurse or Licensed Vocational Nurse (LPN/LVN) will supplement the nursing care needs of the patient as provided by the Registered Nurse and include: Providing services in accordance with Agency policies ….” 2. Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Pain Assessment and Reassessment” stated, “… Each patient receiving skilled nursing services will have pain assessed initially and on an ongoing basis using established criteria … which may include: Location. Intensity (using pain rating scale). Duration. Frequency. Character … Current pain therapy or treatment. Effectiveness of current therapy or treatment. … Each patient receiving therapy services (PT [physical therapy], OT [occupational therapy] … will have pain assessed and reassessed as appropriate and relevant to the care provided by the therapist ….” 3. Review on 8/18/2021 of a reference document titled “Diagnosis of Constipation” website https://www.niddk.nih.gov/health-information/digestive-diseases/constipation/diagnosis stated, “… During a physical exam, a healthcare professional may … use a stethoscope to listen to sounds in your abdomen … check your abdomen for swelling, tenderness or pain ….” 4. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/18/2021 – 8/16/2021, signed by the alternate clinical manager on 7/15/2021 and by the physician on 8/2/2021. This document indicated the patient’s diagnoses included, but were not limited to, quadriplegia (paralysis of all 4 limbs). This document stated, “Summary of HHA [home health aide] Orders … No BM [bowel movement] 3 Days ….” Review of an agency document titled “Skilled Visit Note”, dated 7/12/2021 and electronically signed by former employee LPN B, which indicated the patient’s last bowel movement was 3 days prior on 7/9/2021. The document failed to evidence the LPN assessed the abdomen for the type and location of bowel sounds present and failed to assess the abdomen for tenderness and distention related to no bowel movement in 3 days. Review of an agency document titled “Skilled Visit Note”, dated 8/9/2021 and electronically signed by RN L, indicated the patient’s last bowel movement was on 8/4/2021 and indicated the patient was constipated. Review failed to evidence the RN assessed the abdomen for the type and location of bowel sounds present and failed to assess the abdomen for tenderness and distention related to no bowel movement in 5 days. During an interview on 8/12/2021 at 1:12 PM, the alternate clinical manager indicated the plan of care indicated the registered nurse was to be notified if the patient did not have a bowel movement in 3 days. The alternate clinical manager indicated the skilled nurse should assess the patient’s abdomen for distention, tenderness and bowel sounds and indicated the physician should be notified if no bowel movement in 3 days for interventions. 5. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced agency documents titled “Skilled Visit Note”. Document dated 7/29/2021 and electronically signed by RN H evidenced the RN assessed the patient’s pain to be 3 on a scale of 0-10, with 0 being no pain and 10 being the most severe. This document indicated the patient’s pain goal was a rating of 2 on a scale of 0-10. Review failed to evidence the RN assessed the patient’s pain treatment. Document dated 8/4/2021 and electronically signed by RN L, evidenced the RN assessed the patient’s pain to be 6 on a scale of 0-10. This document failed to evidence the RN assessed the location of the pain and the patient’s pain treatment and effectiveness. During an interview on 8/12/2021 at 10:36 AM, the alternate clinical manager indicated pain should be assessed at every skilled visit and the RN should have assessed for nonpharmacologic treatment such as repositioning, heat and ice. 17-12-2(g)

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the skilled professional failed to provide services as ordered by the physician in the plan of care in 3 of 3 active clinical records reviewed with wounds. (#1, #2, #4) The findings include: 5. Clinical record review on 8/16/2021, for patient #4, start of care 7/29/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” which was indicated to be the current plan of care received on 8/10/2021, diagnosis of age-related osteoporosis with current fracture to right humerus (upper arm), with a history of falls. This document had an area subtitled “21. Orders for Discipline and Treatments (Specify Amount/Frequency/Duration)” which stated “Services for Occupational Therapist [OT]: … Effective on 08/08/2021: OT 2W2 [twice a week, for 2 weeks] … Summary of OT Orders: … ADL [activities of daily living] … Home Exercise Program …." Review failed to evidence OT visit note documentation. Review failed to evidence the agency followed OT frequencies as ordered on the plan of care. Review failed to evidence OT performed the prescribed activities as ordered on the plan of care. 17-14-1(a)(1)(H) 17-14-1(a)(2)(F 1. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Skilled Professional Services” stated, “… Skilled professional services include skilled nursing services … Skilled professionals must assume responsibility for, but not be restricted to the following: … Providing services that are ordered by the physician as indicated in the plan of care….” 2. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/18/2021 – 8/16/2021. The document was signed by the alternate clinical manager on 7/15/2021 and by the physician on 8/2/2021 and indicated the skilled nurse was to assess the patient and caregivers for symptoms of Covid-19 and provide catheter (a thin, sterile tube inserted into the bladder to drain urine) care to the patient. This document indicated the patient had a foley catheter (a type of catheter). Review of an agency document titled “Skilled Visit Note”, dated 7/19/2021 and electronically signed by former employee LPN B, failed to evidence the document was complete to include the patient’s temperature. During an interview on 8/12/2021 at 1:16 PM, the alternate clinical manager indicated the skilled nurse should obtain and document the patient’s temperature at every visit and indicated the symptoms of Covid-19 included a fever. Review of agency documents titled “Skilled Visit Note”, dated 8/2/2021 and 8/6/2021 and electronically signed by RN L, failed to evidence the skilled nurse provided catheter care as directed on the plan of care. During an observation of care on 8/13/2021 at the patient’s home, RN H arrived at the patient’s home at 7:07 PM. At 7:30 PM, tubing was observed inserted into the patient’s penis and draining into a plastic drainage bag in a bucket next to the patient’s bed with yellow liquid. RN H was observed to depart from the patient’s home at 8:21 PM. RN H was not observed to have provided catheter care during the skilled nursing visit as directed on the plan of care. During an interview on 8/12/2021 at 1:09 PM, the alternate clinical manager indicated the skilled nurse should provide catheter care at every visit. 3. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 –8/ 22/2021 which was electronically signed by RN H on 7/21/2021 and the physician on 7/23/2021. The plan of care indicated the patient’s diagnoses included, but were not limited to, atrial fibrillation (irregular heartbeat which may cause the heart to pump less effectively which may result in swelling of hands, feet, or other body parts) and heart failure (a progressive heart disease resulting in damaged heart muscles which can cause swelling of hands, feet or other body parts). The plan of care indicated the skilled nurse was to monitor for an increase or decrease in edema (swelling). Review of agency documents titled “Skilled Visit Note”, dated 6/30/2021, 7/7/2021, 7/15/2021 and 7/21/2021 and electronically signed by former employee LPN B and dated 8/4/2021 and electronically signed by RN L, failed to evidence the skilled nurse assessed for edema. During an interview on 8/12/2021 at 10:53 AM, the alternate clinical manager indicated the skilled nurse should document the assessment of edema but nothing about edema was indicated. 4. During an interview on 8/12/2021 at 11:20 AM, former employee LPN B indicated she conducted home visits without a plan of care, medication list, physician orders and patient diagnoses because the RN that started the case was not done with the plan of care by the time the next skilled nurse visit was due.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on record review and interview, the registered nurse failed to provide patient and caregiver education in 2 of 3 clinical records reviewed receiving anticoagulation (a class of medication used to thin the blood to prevent/treat blood clots) therapy. (#1, #2) The findings include: 1. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “High-Alert and Hazardous Medications” stated, “… The following medications have been identified by the Agency as high-alert medications: Insulin [medication used to alter the blood sugar level] … Opiods [a class of prescription drugs used to treat severe pain], Antithrombotic agency (anticoagulants) [a class of medication used to thin the blood to prevent/treat blood clots], e.g., Warfarin … Oral hypoglycemic [a class of medication used to alter the blood sugar level], especially Metformin [a type of oral hypoglycemic medication]….” 2. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an undated agency document titled “Patient Medications”. This document indicated the patient’s medication included Eliquis, start date 4/2/2021, (a type of anticoagulant medication). Review of an agency document titled “Start of Care (D1)”, dated 6/18/2021 and electronically signed by registered nurse (RN) K, indicated the patient was not taking any high risk drugs and high risk drug education was indicated to be not applicable. During an interview on 8/12/2021 at 12:53 PM, the alternate clinical manager indicated Eliquis was an anticoagulant and indicated the RN should have provided high risk drug education for the Eliquis. 3. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 – 8/22/2021, which indicated the patient’s medication included Warfarin Sodium (a type of anticoagulant medication). Review of an agency document titled “Start of Care (D1)”, dated 6/24/2021 and electronically signed by RN H, indicated the patient was not taking any high risk drugs and high risk drug education was indicated to be not applicable. During an interview on 8/12/2021 at 9:54 AM, the alternate clinical manager indicated Warfarin Sodium was a high risk drug and indicated the RN should have provided high risk drug education. 17-14-1(a)(1)(D)

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the registered nurse failed to prepare clinical notes in 1 of 1 home visit with a registered nurse. (#1) The findings include: Review of an agency policy, revised March 2018, obtained 8/18/2021 titled “Medical Record Entries and Authentication” stated, “… All entries in patient records will be legible, clear, complete and appropriately authenticated, dated and timed. All entries in the medical records will be authenticated by staff signature and title. By authenticating entries in the patient’s record, staff is validating the correctness of the information. ….” Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Nursing Services” started, “… Professional nursing service will be provided by a registered nurse and include: … Preparing clinical and progress notes….” Review of an undated agency policy, obtained 8/18/2021, titled “Integumentary – Pressure Ulcer and Wound Assessment” stated, “… Assess the wound(s) for location … Document in patient’s record: … Findings from the assessment….” Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced agency documents titled “Skilled Visit Note”, electronically signed by former employee licensed practical nurse (LPN) B, which on document dated 6/29/2021 stated, “… Wounds: L ish … Wound cleansed with NS [normal saline] and dressing applied per order. … R ish … Area cleaned with NS and dressing applied per order….” Document dated 7/2/2021 stated, “… Dressing changed per orders from wound clinic. Slight drainage noted to L [left] dressing that was dark red. … R [right] dressing had no drainage when removed….” Document dated 7/5/2021 stated, “… L dressing had med [medium] amount of drainage … Dressing changed per order. R dressing had small amount of red/tan drainage. Dressing changed per order….” Document dated 7/7/2021 stated, “… Dressing changed on both wounds. …. R wound dressing with no foul odor. L wound dressing had small amount of tan drainage noted ….” Document dated 7/15/2021 stated, “… Dressings changed per order….” Document dated 7/19/2021 indicated the nurse cleansed the wound to a site with a location stated as “Other” with normal saline and packed with alginate, covered with an ABD pad (an absorbent wound dressing) and secured with tape. The skilled nurse failed to prepare clinical notes to indicate where the wound care was provided. During an interview on 8/12/2021 at 1:05 PM, the alternate clinical manager indicated “L ish” and “R ish” most likely was referring to the 2 wounds to the left groin and stated, “The plan of care isn’t ready by the time of the next nurse’s visit so the next nurse may not know what the wounds are called.” At 1:11 PM, the alternate clinical manager indicated the skilled nurse should document the wound care provided and to what location. During an observation of care on 8/13/2021 at the home of patient #1, start of care 8/10/2021, registered nurse (RN) H was observed to arrive at the patient’s home at 7:07 PM. At 7:19 PM, RN H removed the dressing to the patient’s left groin and 2 open areas were noted, each appeared the length of a large paperclip and as wide as the width of a pen. Both open areas appeared to have a depth of the length of a pinky fingernail. RN H stated, “One is more medial, but there are two here.” RN H was observed to cleanse the wounds to the left groin and apply a new dressing. At 7:35 PM, RN H removed a wound dressing to the patient’s right buttocks and two open areas were observed to the right ischium (the area of the skin on the lower buttock region that covers the rounded bone of the pelvis). At 7:45 PM, RN H stated, “There’s a little excoriated [the breakdown of skin due to prolonged exposure to moisture] part here. To me, there’s really another wound here. Some may call it one.” At 8:02 PM, RN H was observed obtaining the patient’s vital signs and listening to the patient’s chest and back with the stethoscope. RN H was observed to depart from the patient’s home at 8:21 PM. RN H was not observed to have listened to the patient’s abdomen, touched the patient’s abdomen, touched the patient’s extremities and looked at the patient’s pupils. The patient was observed to be alert and verbal, and RN H was not observed to assess the patient’s pain. The patient did not verbalize a pain rating to RN H. Clinical record review on 8/18/2021 evidenced an agency document titled “Skilled Visit Note”, dated 8/13/2021 and electronically signed by RN H. This document indicated the RN assessed the patient’s pupils to have an equal reaction, have present peripheral pulses, have present bowel sounds and a pain rating of 3 on a scale from 0-10, with 0 being no pain and 10 being the most severe. This document indicated 1 wound measurement to the left groin and 1 wound measurement to the right buttock and failed to evidence the measurement to the second open area on the patient’s left groin and the second open area to the patient’s right buttock. The document failed to evidence the RN prepared the clinical notes and documented the care provided as observed during the home visit. During an interview on 8/18/2021 at 1:21 PM, the alternate clinical manager indicated the RN should have documented the care as it was provided. The alternate clinical manager indicated the RN should have documented the assessment of all open areas. 17-14-1(a)(1)(E)

Participate in HHA-sponsored in-service CFR(s): 484.75(b)(9) Participation in HHA-sponsored in-service training. This ELEMENT is not met as evidenced by: Based on record review and interview, all licensed professionals providing services on behalf of the agency failed to participate in agency-sponsored in-service training in 2 of 3 active personnel records for skilled nurses providing direct patient care (Employee H, Employee L) and 2 of 2 closed personnel records reviewed. (Person B, Person E) The findings include: 1. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Nursing Services” stated, “… Professional nursing service will be provided by a registered nurse [RN] and include: … Participating in inservice programs. … The Licensed Practical Nurse or Licensed Vocational Nurse (LPN/LVN) will supplement the nursing care needs of the patient as provided by the Registered Nurse ….” 2. Personnel record review on 8/10/2021 for registered nurse (RN) H, start date 12/16/2019, failed to evidence RN H participated in in-service training. 3. Personnel record review on 8/10/2021 for RN L, start date 6/7/2021, evidenced agency documents titled “Tuberculosis [a contagious bacterial infection usually affecting the lungs] and Infection Control”, “Bloodborne Pathogens Break the Chain of Infection”, “Hazardous Materials/Waste”, “Wound Care” and “OSHA [Occupational Safety and Health Administration] Hazard Communication Program , signed by RN L. Review failed to evidence the forms were completed to include a date the training was completed, a signature of the instructor who provided the training and an assessment of the employee’s competency of the education. 4. Personnel record review on 8/16/2021 for former employee LPN B, date of hire 6/7/2021, evidenced an agency document titled "Annual Training/New Hire Orientation", dated 6/7/2021 and signed by former employee LPN B. Review failed to indicate this document was reviewed by the agency to ensure the skilled nurse answered the questions correctly and completely to determine competency. During an interview on 8/11/2021 at 11:20 AM, former employee LPN B indicated her new-hire training consisted of being handed a manual and then being told to read it and take a test. Former LPN B indicated no one reviewed her training with her. During an interview on 8/16/2021 at 10:20 AM, the alternate clinical manager indicated the training tests should be reviewed and graded to ensure the staff understood the education provided. 5. Personnel record review on 8/16/2021 for former employee LPN E, date of hire 2/17/2020, failed to evidence participation in in-service training. During an interview on 8/16/2021 at 10:11 AM, the alternate clinical manager indicated there was no in-service training documented for former employee LPN E. 6. Review of an agency binder titled “Employee Inservices” on 8/10/2021 failed to evidence RN H, RN L and former employee LPN E participated in agency-sponsored in-service training. 7. During an interview on 8/10/2021 at 4:04 PM, the alternate clinical manager indicated the education forms should have been completed when the training was provided and indicated there was no documentation of participation for RN H in agency-sponsored in-service training. The alternate clinical manager indicated annual in-service training should be completed annually and typically the training was offered in January and February every year. The alternate clinical manager indicated there was no documentation of annual inservices for RN H. 17-14-1(a)(1)(G)

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure the home health aides had complete, patient-specific written patient care instructions to be performed by the home health aides in 2 of 2 clinical records reviewed with home health aide services. (#1, #2) The findings include: 6. Clinical record review on 8/18/2021, for patient #2, start of care 6/24/2021, diagnosis of type 2 diabetes, evidenced an agency document titled “Home Health Aide Assignment Sheet” which was signed by RN H, on 6/24/2021. This document had an area subtitled “Precautions” which stated “Bleeding … Falls … Infections … Total Hip … DM [diabetes mellitus] … O2 [oxygen] …“ The RN indicated falls and infections as individualized precautions. This document had a list of individualized tasks to be completed for the patient which stated “Bath (includes peri, foot and skin care) …“ which gave the options of a complete or partial assist bathing, and shower, bed bath, sponge bath, or change of clothes. The RN indicated the patient should have a complete assisted shower. Another section subtitled “Nails” indicated the patient should have the nails on their hands and feet tended to. Another area subtitled “Elimination” which indicated the patient was incontinent but failed to evidence if the patient had elimination assistive devices, such as a urinal or disposable undergarments. An area subtitled “Impairments” indicated the patient “Tires easily” but failed to indicate other impairments including but not limited to, hearing, hearing aids, vision, or glasses. This document failed to evidence the patient had a prosthetic leg. Review failed to evidence the patient was on DM precautions. Review failed to evidence the RN reviewed the care plan to ensure it was complete and appropriate for the patient. Observation evidenced a urinal on the sink in the bathroom. Observation failed to evidence the patient had toenails. Observation of a home visit for patient #2, start of care 06/24/2021, on 08/17/2021 at 12:07 PM, was conducted to observe HHA J provide services. At 11:18 AM, the patient used their walker to stand up from a sitting position, then ambulated to a wheelchair. The patient wheeled themselves to the dining room table to remove their hearing aids and glasses, then wheeled themselves to the bathroom for assist undressing and getting in the shower. HHA J slid a shower chair in the bathroom, then into the shower where a urinal bottle was evidenced on the sink. The patient was observed to have the front half of their left foot amputated to include the toes, and the right lower extremity was amputated just below the knee, with a prosthesis. The patient stated to HHA J, “You’re going to see the whole leg comes off.” HHA J replied, “They didn’t have that in my notes.” After assisting the patient with a transfer to the shower chair, without a gait belt, the patient washed most areas of the body independently, including the perineal area [genital/groin region], chest, and shampooed their hair. The patient requested assistance with washing their back bilateral lower extremities. The patient requested privacy while drying off, then called for HHA J to assist with the prothesis and pants. The patient combed their hair, then wheeled back to the dining room table where he inserted hearing aids into both ears and put glasses back on. Observation evidenced the patient had hearing and vision impairments. Observation evidenced the patient required partial assistance in the shower. During an interview on 8/17/2021, at 12:53 PM, patient #2 explained he/she had “Zero toenails” because the right lower extremity is amputated below the knee and was also missing half of the left foot. The patient indicated he/she has a urinal to use for urgency and has disposable diapers that were purchased by family but does not use them often. The patient indicated they have multiple wheelchairs, walkers, and other assistive devices. The patient indicated they would like to get a walk-in tub, to eliminate the need for a bath aid, because he/she can do most activities of daily living on their own. 17-14-1(m) 1. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Care Planning Process” stated, “… The patient care plan for the Home Health Aide [HHA] will be: Home Health Aide assignment sheet: developed by a Registered Nurse [RN] … prior to Home Health Aide rendering care. … The assignment sheet/plan of care will include: Type of service/procedure to be provided. Frequency of visits. Diagnosis/prognosis, if relevant to care. Functional limitation. Patient’s mental status. Activities permitted. Nutritional requirements. Specific procedure to be performed including amount, frequency and duration. Safety measures including use of specific equipment....” 2. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Home Care Certification and Plan of Care” for certification period 6/18/2021 – 8/16/2021 which indicated the patient was to receive home health aide services 2 times a week for 9 weeks. Review of untitled agency documents identified by the alternate clinical manager as HHA visit notes, dated 6/28/2021, 7/1/2021, 7/5/2021, 7/8/2021, 7/12/2021, 7/15/2021, 7/22/2021 and 7/28/2021 and completed by former employee A (HHA), indicated the HHA provided personal care to the patient. Review failed to evidence written patient care instructions to be performed by the HHA. During an interview on 8/11/2021 at 10:38 AM, former employee A (HHA) indicated she did not have a HHA care plan prior to providing care to the patient. During an interview on 8/12/2021 at 12:07 PM, office manager E stated, “I couldn’t find it. It might be in the home,” when a request for a copy of the HHA care plan was made. During an observation of care at the patient’s home on 8/13/2021 at 7:02 PM, the agency folder was observed and failed to evidence a written HHA care plan. 3. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/24/2021 –8/ 22/2021 which was electronically signed by RN H on 7/21/2021 and the physician on 7/23/2021. The plan of care evidenced the patient’s ordered diet was low carbohydrate and the home health aide was to assist with dressing and apply lotion. Review of an agency document titled “Home Health Aide Assignment Sheet”, dated 6/24/2021 and signed by RN H, evidenced the patient’s diet to be a regular diet and failed to evidence the RN provided the HHA written instructions on the patient’s diet. This document failed to evidence the home health aide was assigned to assist the patient with dressing and apply lotion. This document had a section subtitled “Nails” which evidenced hands and feet were checked but failed to evidence if the HHA was to clean, file or soak the patient’s nails. During an interview on 8/12/2021 at 11:31 AM, the alternate clinical manager indicated the RN should assign the HHA directions on the HHA care plan as ordered on the plan of care. At 11:33 AM, the alternate clinical manager indicated the RN should have checked what the home health aide was to do with the patient’s nails. 4. During an interview on 8/11/2021 at 10:38 AM, former employee A (HHA) indicated she was not informed in writing of the patient care instructions to be provided by the HHA prior to providing care. 5. During an interview on 8/13/2021 at 8:58 AM, HHA G indicated she did not have a copy of the HHA care plan in the patient homes and there was not written patient care instructions for the HHA in the electronic patient record on her application on her phone.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure: the organizational structure was set forth, in writing, including lines of authority and services furnished (see tag G0940), the administrator was responsible for all day-to-day operations of the agency (see tag G0948), the administrator employed qualified personnel (see tag G0952), authorization in writing by the governing body and the administrator a qualified, pre-designated person to assume the same responsibilities and obligations as the administrator (see tag G0954), to ensure the clinical manager provided oversight of patient and personnel assignments (see tag G0960), to ensure the clinical manager provided oversight of coordination of patient care (see tag G0962), to ensure the clinical manager provided oversight of the development, implementation and update of the individualized plan of care (see tag G0968) and to ensure all services were provided in accordance with current clinical practice guidelines and accepted professional standards of practice (see tag G0984). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of organization and administration of services for the condition of participation 42CFR 484.105 Organization and administration of services. A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview, the agency failed to ensure the organizational structure was set forth, in writing, including lines of authority and services furnished. The findings include: Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Organization and Services Administration” stated, “… Organization, services furnished, administrative control and the lines of authority for the delegation of responsibility for patient care are clearly defined in writing and are readily identifiable….” Pre-survey information received on 8/3/2021 from the Indiana Department of Health indicated employee B was the administrator and employee C was the alternate administrator. Review of an undated agency document titled “Organizational Chart” indicated employee B was the administrator and employee C was the alternate administrator. This document indicated the organization included medical social worker and speech therapy services if available. Review failed to evidence physical therapists were included in the organizational structure. During an interview at time of entrance on 8/9/2021 at 8:54 AM, employee D identified as the agency administrator and indicated employee E was the agency’s alternate administrator. Employee D indicated RN A was the clinical manager and person M was the alternate clinical manager. Employee D indicated RN A was at her home office in New Buffalo, Michigan and indicated she came to the agency 1 or 2 days a week. Employee D indicated RN B was the administrator before employee D assumed the administrator role and was out due to medical reasons since sometime in June when employee D took over as administrator. Review of an agency document titled “Employee Information”, dated 8/9/2021, indicated physical therapy assistant (PTA) P was a current employee with a start date of 8/2/2021. During an interview on 8/9/2021 at 9:59 AM, RN A, alternate clinical manager, indicated she was the alternate administrator and the alternate clinical manager. The alternate clinical manager indicated the administrator and clinical manager were RN B and indicated RN B was out on medical leave. The alternate clinical manager indicated person M was considered for the alternate clinical manager role but took a role at another agency within the corporation. At 10:02 AM, the alternate clinical manager indicated employee D was the administrator in training and employee E was the office manager. At 10:25 AM, the alternate clinical manager indicated the agency did not provide medical social work and speech therapy services. At 2:23 PM, the alternate clinical manager indicated speech therapy and social work services might have been offered at one time and indicated the organizational chart had not been updated to have those services removed since not currently offered by the agency. The alternate clinical manager indicated the agency utilized physical therapy assistants and should be included on the organizational chart reporting to the physical therapist. At 2:50 PM, the alternate clinical manager indicated she was unsure why employee C was listed with the Indiana Department of Health and listed on the organizational chart as the alternate administrator. The alternate clinical manager stated, “[Employee C] swings by here periodically; he’s corporate. He doesn’t do the day-to-day like me.” 17-12-1(a)(1, 2)

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency administrator failed to be responsible for all day-to-day operations of the agency. The findings include: Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “After Hours Accessibility” stated, “… A RN [registered nurse] is available 24 hours per day, 7 days per week. Contact can be made by telephone or pager through the on-call system….” Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Administrator: Defined” stated, “… The Governing Body has appointed the Administrator to run the Agency’s day-to-day operations….” The administrator failed to ensure the day-to-day operations of the home health agency as evidenced by: The administrator failed to ensure the Emergency Preparedness Plan was maintained for the home health agency. Please see tags associated with federal regulation 42CFR 484.102. The administrator failed to ensure the accuracy of all reported Oasis assessment data. Please see tag G0374. The administrator failed to ensure the patient was provided written notice of the patient’s rights and responsibilities in advance of furnishing care to the patient. Please see tag G0412. The administrator failed to obtain the patient’s or legal representative’s signature confirming that he or she has received a copy of the notice of rights and responsibilities. Please see tag G0418. The administrator failed to ensure the patient participated in, was informed about and consented to in advance of treatment with response to the completion of all assessments, the care to be furnished, establishing and revising the plan of care, the disciplines that would furnish the care, the frequency of visits, expected outcomes of care and any changes in care to be furnished. Please see tag G0434. The administrator failed to ensure agency patients received all services ordered in the plan of care. Please see tag G0436. The administrator failed to ensure the physician responsible for the plan of care and the agency agreed the patient met goals and failed to ensure the discharge from the agency was appropriate. Please see tag G0458. The administrator failed to ensure the comprehensive assessments were individualized and reflected the patient's status. Please see tag G0528. The administrator failed to ensure the comprehensive assessment medication reconciliation was reviewed by a registered nurse. Please see tag G0536. The administrator failed to update the comprehensive assessment as frequently as the patient’s condition warrants due to a major decline in the patient’s health status. Please see tag G0544. The administrator failed to ensure the home health agency was meeting all the needs of agency patients. Please see tag G0570. The administrator failed to ensure the plan of care for agency patients was followed, individualized and established by a primary care physician. Please see tag G0572. The administrator failed to ensure the plan of care contained all required elements. Please see tag G0574. The administrator failed to ensure conformance with physician’s orders. Please see tag G0578. The administrator failed to ensure all drugs, treatments, and services were only provided as ordered by a physician or other appropriate healthcare professional. Please see tag G0580. The administrator failed to ensure the clinician receiving verbal orders documented the order, signed, dated and timed the order and failed to ensure the physician signed and dated the verbal order. Please see tag G0584. The administrator failed to ensure the plan of care was reviewed and revised by the primary care physician every 60 days. Please see tag G0588. The administrator failed to ensure the primary care physician was promptly alerted to changes in the patients condition. Please see tag G0590. The administrator failed to revise the plan of care to reflect current health status, medications and nursing needs. Please see tag G0592. The administrator failed to ensure the primary care physician was notified of a patient's discharge from home health agency services. Please see tag G0598. The administrator failed to ensure communication with all physicians involved in the patients plan of care. Please see tag G0602. The administrator failed to ensure there was coordination of care amongst all agency disciplines and with outside healthcare entities who serviced agency patients. Please see tag G0606. The administrator failed to ensure there was a written visit schedule in all patients’ homes. Please see tag G0614. The administrator failed to ensure there was a written, current medication schedule in all patients homes. Please see tag G0616. The administrator failed to provide the patient with written instructions for the name and contact information for the clinical manager. Please see tag G0622. The administrator failed to ensure there was a Quality Assessment and Performance Improvement (QAPI) maintained at the home health agency. Please see tag G0640. The administrator failed to ensure the governing body maintained an ongoing QAPI program. Please see tag G0660. The administrator failed to ensure all home health agency staff followed standard precautions to ensure the prevention and transmission of infectious and communicable diseases. Please see tag G0682. The administrator failed to ensure the home health agency had documented education on infection control provided to agency staff. Please see tag G0686. The administrator failed to ensure the skilled professionals provided an ongoing assessment of the patient. Please see tag G0706. The administrator failed to ensure skilled professionals provided services as indicated on the plan of care. Please see tag G0710. The administrator failed to ensure skilled professionals provided patient and caregiver education. Please see tag G0714. The administrator failed to ensure skilled professionals created clinical notes and/or accurate complete notes for all services provided to patients. Please see tag G0716. The administrator failed to ensure all home health aide care plans were completed by a skilled professional and included task frequencies. Please see tag G0798. The administrator failed to ensure a pre-designated person was authorized in writing by the administrator and governing body to assume the same responsibilities in the administrator’s absence. Please see tag G0954. The administrator failed to ensure the clinical manager provided oversight of patient and personnel assignments. Please see tag G0960. The administrator failed to ensure the clinical manager provided oversight of coordination of patient care. Please see tag G0962. The administrator failed to ensure the clinical manager provided oversight of the development, implementation and update of the individualized plan of care. Please see tag G0968. The administrator failed to ensure all services were provided in accordance with current clinical practice guidelines and accepted professional standards of practice. Please see tag G0984. The administrator failed to ensure all clinical records contained a discharge summary that was sent to the primary care physician. Please see tag G1022. The administrator failed to ensure all clinical notes were clear, complete and appropriately authenticated. Please see tag G1024. The administrator failed to ensure all clinical patient information was safeguarded against unauthorized use. Please see tag G1028. A call was placed to the agency, phone number 574-772-3157, on 8/12/2021 at 10:39 PM to which the answering service answered. Caller’s contact information and request for a return phone call from the nurse was made to the answering service. No return phone call was received from the agency before 8/13/2021 at 8:13 AM. The administrator failed to ensure a skilled nurse was available 24 hours a day per the agency's policy. During an interview on 8/13/2021 at 9:17 AM, the alternate clinical manager indicated she was unaware of the call made to the agency on 8/12/2021 at 10:39 PM. During an interview on 8/13/2021 at 9:17 AM, the administrator in training D indicated she was on-call the previous evening and did not receive a phone call from the answering service and had been notified of the request for a nurse’s return phone call when she arrived in the office that morning and received a fax with the message from the answering service of the phone call after hours. 17-12-1( c)(1)

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on record review and interview, the administrator failed to ensure the agency employed qualified personnel for 11 of 14 personnel records reviewed. (A, B, C, D, E, G, H, I, J, M, former employee E) The findings include: 1. Review evidenced an agency policy titled, “Personnel Records” revised October 2017, stated “Policy personnel files will be established and maintained for all staff. All information will be considered confidential and will be made available to authorized management personnel only... Purpose To maintain personnel files on current and former employees... Procedures 1. the personnel record or personal information for an employee will include, but not be limited to, the following: ... Observed competencies: initial during orientation and ongoing (minimally every 3 years) for all patient care staff ... Home Health Aide competency evaluation: initially and annually … Performed appraisal/evaluation forms … Verification of education, certification and/or licensure … Agency employee orientation … Inservice education record … Criminal history check, if required by law … Job description: reviewed and signed by employee … 2. The health record for applicable employees will include: PPD tests or chest x-ray results based on Agency’s TB risk assessment … Any other Agency required health requirements … 3. Employee health information must be maintained in files separate from personnel files and in a separate location … 8. Personnel records will be retained for minimally five years after employee leaves the Agency, or according to applicable state law ….” 2. Review evidenced an agency policy titled, “Job Description” revised October 2017, stated “Policy Each employee will be furnished with a job description upon employment … Purpose To outline the responsibilities, requirements and scope of each position … 3. The job description is reviewed by the employee at time of hire/orientation and any time the job description changes….” 3. Review evidenced an agency policy titled, “Performance Appraisals/ Evaluations” revised October 2017, stated “Policy All employees will have a performance appraisal/ evaluation based upon their job description at least every three (3) years, except home health aides who must have performance appraisal/ evaluation every twelve (12) months ... Purpose To review job performance based upon an employee’s job description; to clarify duties and responsibilities; to determine the appropriateness of the description and the need for further training ... Procedure … 2. The evaluation must be signed by the employee and supervisor ... Additional [accrediting body] Requirements … 1. Personnel evaluations are completed, shared, reviewed and signed by the designated manager/ supervisor and personnel no less frequently than every twelve (12) months ... 2. Qualified personnel observe and evaluate each direct care staff member performing their job duties at least annually as part of the performance evaluation….” 4. Review evidenced an agency policy titled, “License, Registration or Certification Requirements” revised October 2017, stated “Policy The employee will be responsible for maintaining a current license for any position requiring such... Purpose To provide a mechanism whereby the Agency assures that all personnel license(s) or certification(s) are kept current and are documented in Agency records … Procedure ... 2. When current licensure, certification and/ or registration are required by law and/ or regulation to practice a profession, the Agency verifies such credentials with the primary source at time of hire and prior to or upon expiration of credentials. Primary source verification will occur through the applicable State Board of practice for: registered nurses, licensed practical nurses, physical therapist... Occupational therapist... If required by state law ... 4. Primary source verification of current licensure, registration and/ or certification may be performed via secure electronic access or by telephone. All such verification will be documented….” 5. Review evidenced an agency policy revised October 2017, titled “Employee Orientation” which stated “Policy Each employee of the Agency will complete an orientation period … Procedure 1. Orientation for all employees will be coordinated, performed and documented by supervisory staff, peers and/or preceptors … 2. The Orientation Checklist will be used to document orientation for all staff, including contract staff ….” 6. Personnel record review on 8/10/2021, for administrator/clinical manager B, date of hire 4/29/1996, evidenced an Registered Nurse (RN) license with an expiration date of 10/31/2021. Review failed to evidence the RN license verified as indicated by the agency policy and required by State law. During an interview on 8/10/2021, at 3:54 PM, alternate clinical manager A stated “No” when queried if the administrator/clinical manager B’s RN license had been verified. The alternate clinical manager indicated there was not documentation in the personnel file, but verification of licensure was performed annually. 7. Personnel review on 8/10/2021, for alternate clinical manager A, date of hire 5/1/2017, failed to evidence documentation of an orientation to the job of clinical manager at time of review. During an interview on 8/10/2021, at 3:26 PM, alternate clinical manager A indicated their job title was alternate administrator and alternate clinical manager. When queried if there was documented evidence of an orientation to the job, alternate clinical manager A stated “No.” 8. Personnel record review on 8/10/2021, for alternate administrator C, date of hire unknown, but was identified by the alternate clinical manager as an employee since the change of ownership in January 2020, evidenced a document titled “Job Description Administrator” which was unsigned. Review failed to evidence an annual evaluation had been performed within the last 12 months, at time of review. Review evidenced an untitled agency document which stated “… Community Home Care Services … Knox, IN … Effective 01-01-2020 The Governing Body has appointed the following: … Administrator is [alternate administrator C] … Alternate administrator is [alternate clinical manager A] ….” Review evidenced an agency document titled “Organizational Chart” which stated “…Assistant Administrator-Nursing- [alternate administrator C] ….” During an interview on 8/10/2021, at 3:41 PM, alternate clinical manager A indicated alternate administrator C was a corporate employee and probably listed himself as the alternate administrator of Community Home Care Services until more official plans came through. 9. Personnel record review on 8/10/2021, for office manager E, start date 3/16/2020, evidenced a document from entity G, titled “Employee Orientation Checklist” which was dated 3/11/2020, incomplete and unsigned at time of review. Review failed to evidence a signed and completed orientation, a signed job description, and an annual evaluation in the employee’s file. During an interview on 8/10/2021, at 3:49 PM, alternate clinical manager A stated, “Here is an orientation that isn’t filled out.” The alternate clinical manager indicated they could not locate a signed job description or an annual evaluation in the office manager E’s personnel file at time of review. 10. Personnel record review on 8/10/2021, for the administrator in training D, start date 6/1/2020, failed to evidence a signed job description for the administrator role they were hired for. During an interview on 8/10/2021, at 3:33 PM, alternate clinical manager A, indicated a signed job description could not be located in the administrator in training D’s personnel file at time of review. 11. Personnel record review on 8/11/2021, for home health aide (HHA) G, first patient contact date 7/30/2021, evidenced an agency document titled “Functionalized Job Description” for the position of Certified Home Health Aide, which was unsigned by the employee. Review failed to evidence a job description for the employee’s role as data specialist. During an interview on 8/11/2021, at 3:56 PM, the alternate clinical manager indicated the job description for HHA G was not signed. 12. Personnel record review on 8/11/2021, for registered nurse (RN) H, start date of 12/16/2019, evidenced an agency document titled “Orientation Checklist” which was signed by the RN on 4/26/2019. This document had an area for a supervisor’s signature which remained blank at time of review. Review failed to evidence an orientation to the job had been completed. Review failed to evidence documentation of a performance evaluation had been performed withing the last 12 months, at time of review. During an interview on 8/11/2021, at 3:59 PM, the alternate clinical manager A stated, “Unfortunately, I am not seeing it” when queried if RN H’s annual evaluation was in the employee’s personnel file. 13. Personnel record review on 8/11/2021, for Occupational Therapist (OT) M, date of hire 6/16/2021, evidenced an agency document titled “Orientation Checklist” which was undated and signed by the OT. This document had an area for a supervisor’s signature which remained blank at time of review. Review failed to evidence an orientation to the job had been completed. 14. Personnel record review on 8/16/2021, for former employee E, licensed practical nurse (LPN), date of hire 2/17/2020, evidenced an untitled document that was verification of licensure which occurred on 5/6/2021. Review failed to evidence license verification was performed prior to first patient contact on 2/18/2020. Review failed to evidence documentation of orientation to the job. 15. Personnel record review on 8/11/2021, for HHA (home health aide) J, first patient contact date 6/14/2021, failed to evidence a signed job description in the employee file, or that a criminal history background check was performed within 3 days after first patient contact. 16. Personnel record review on 8/11/2021, for licensed practical nurse (LPN) I, first patient contact date 8/4/2021, failed to evidence a criminal history background check was performed within 3 days after first patient contact. 17. During an interview on 8/11/2021, at 3:48 PM, alternate clinical manager A indicated some of the completed background checks were sent to a different home care office by mistake, instead of Community Home Care Services in Knox, IN. 17-12-1(d)(3)

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure a pre-designated person was authorized in writing by the administrator and governing body to assume the same responsibilities as the administrator when the administrator was unavailable. The findings include: Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Administrator: Defined” stated, “… When the Administrator is not available, a qualified, pre-designated person, who is authorized in writing by the Administrator and the Governing Body, assumes the same responsibilities and obligations as the Administrator….” Pre-survey information received on 8/3/2021 from the Indiana Department of Health indicated employee B was the administrator and employee C was the alternate administrator. Review on 8/9/2021 of an undated agency document titled “Organizational Chart” indicated employee B was the administrator and employee C was the alternate administrator. Review on 8/16/2021 of an undated, untitled agency document indicated effective 1/1/2020 the governing body appointed employee C as the administrator and employee A as the alternate administrator. Review failed to evidence the governing body appointed employee B as the administrator and employee C as the alternate administrator as listed with the Indiana Department of Health and on the agency’s organizational chart. During an interview on 8/9/2021 at 9:59 AM, the alternate clinical manager, employee A, indicated she was the alternate administrator and the alternate clinical manager. The alternate clinical manager indicated the administrator and clinical manager were employee B and indicated employee B was out on medical leave. At 2:50 PM, the alternate clinical manager indicated she was unsure why employee C was listed with the Indiana Department of Health and listed on the organizational chart as the alternate administrator. The alternate clinical manager stated, “[Employee C] swings by here periodically; he’s corporate. He doesn’t do the day-to-day like me.” During an interview on 8/16/2021 at 10:41 AM, the alternate clinical manager, employee A, indicated there was no other written appointment by the governing body and administrator for the alternate administrator. 17-12-1(d)(8)

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide oversight of patient and personnel assignments. The findings include: Review of an agency job description titled “Job Description Director of Clinical Services/Clinical Manager”, revised October 2017 and obtained 8/18/2021, stated, “… Responsibilities … Makes patient and personnel assignments….” Review of an agency document on 8/9/2021 titled “Master Employee Schedule” for the week of 8/9/2021 indicated registered nurse (RN) L was to provide a skilled nursing visit to patient #1, start of care 6/18/2021, on 8/11/2021 at 7:00 PM. During an interview on 8/9/2021 3:38 PM when queried about a home visit with RN L at the home of patient #1 on 8/11/2021, administrator in training D indicated RN L was planning to conduct a visit with the patient on 8/10/2021 between 7:30 PM and 8:00 PM. During an interview on 8/10/2021 at 8:59 AM when queried on the status of the home visit with patient #1 for 8/10/2021 with RN L, administrator in training D indicated RN L provided a home visit the night before on 8/9/2021 and indicated RN L had another job and possibly had to change her scheduled visit due to her other job. At 9:50AM, administrator in training D indicated the staff knew which patients they needed to see and had flexibility to change their visits. Administrator in training D indicated staff did not report to the agency when exactly the visits would be scheduled when changes were made but indicated the agency knew the general availability of the staff. During an interview on 8/10/2021 at 11:59 AM, the alternate clinical manager indicated staff scheduled their own visits for the most part and indicated administrator in training D knew more of about the staff’s schedules. Alternate clinical manager indicated staff should call and inform the office of schedule changes. 17-14-1(a)(1)(K)

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide oversight of coordination of patient care. The findings include: Review of an agency job description titled “Job Description Director of Clinical Services/Clinical Manager”, revised October 2017 and obtained 8/18/2021, stated, “… Responsibilities … coordinates patient care ….” Review of an agency policy, revised March 2019 and obtained 8/18/2021, titled “Coordination of Patient Care” stated, “… The Director of Clinical Services provides oversight of all patient care services. … Case conferences are held on an ongoing basis … Documentation of case conferences will be maintained in the patient’s medical record….” During an interview on 8/9/2021 at 10:25 AM, the alternate clinical manager indicated there was a weekly case conference call which the alternate clinical manager and most of the staff are on to discuss any patient changes. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Occupational Therapy Evaluation”, dated 7/28/2021 and electronically signed by occupational therapist (OT) M. The document indicated the patient was to receive 2 OT visits a week for 3 weeks. Review of an agency document titled “Discharge/Transfer Summary”, dated 8/9/2021 and electronically signed by OT M, indicated the patient was discharged from OT services. Review of the document failed to evidence the OT coordinated the patient’s discharge from OT services. During an interview on 8/18/2021 at 12:12 PM, the alternate clinical manager indicated she was unaware OT M discharged the patient from OT services and indicated there were no case conference notes regarding the patient discharge from OT services.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the clinical manager failed to provide oversight of the development, implementation and update of the individualized plan of care. The findings include: Review of an agency job description titled “Job Description Director of Clinical Services/Clinical Manager”, revised October 2017 and obtained 8/18/2021, stated, “… Responsibilities … Assures that patients’ plans of care are developed, implemented and updated….” Clinical record review on 8/10/2021 and 8/18/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Start of Care (D1)”, which was dated 6/18/2021 and electronically signed by registered nurse (RN) K. This document indicated the patient’s diagnoses included, but were not limited to, Stage II pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in partial thickness skin loss) of the left buttock, quadriplegia (paralysis of all 4 limbs) and chronic embolism (an obstruction of an artery, typically by a blood clot or air bubble) and thrombosis (formation of a blood clot within a blood vessel) of left iliac vein (a vein located in the abdomen). This document indicated the patient had 3 Stage II pressure ulcers consisting of 2 to the left groin and 1 pressure ulcer to the buttocks. Review of a document provided by the alternate clinical manager on 8/13/2021 titled “Final Report” from wound clinic D, dated 6/23/2021 and electronically signed by physician H, indicated the patient had 2 wounds to the left groin and a wound to the right ischium. Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/18/2021 – 8/16/2021 which was signed by the alternate clinical manager on 7/15/2021 and by the physician on 8/2/2021. The plan of care stated, “… Wound care will be performed by ….” and failed to be developed to include the location of the patient’s wounds and wound care interventions. Review evidenced agency documents titled “Skilled Visit Note”, electronically signed by former employee LPN B and dated 7/23/2021, evidenced the skilled nurse assessed a pressure area to the coccyx (the area on the lower back above the buttocks) measuring 0.5 cm in length, 0.5 cm in width and 0.1 cm in depth with a wound treatment of cleanse with normal saline and apply Optifoam (an absorbent foam dressing with an adhesive border). Review failed to evidence the plan of care was updated to include the wound and wound treatment interventions to the coccyx. During an observation of care on 8/13/2021 at 7:19 PM, the patient was observed to have 2 open areas on the left groin. Each open area appeared the length of a large paperclip and as wide as the width of a pen. Both open areas appeared to have a depth of the length of a pinky fingernail. RN H stated, “One is more medial, but there are two here.” The patient was observed to have 2 open areas to the right ischium (the area of the skin on the lower buttock region that covers the rounded bone of the pelvis). The lateral open area on the right ischium appeared to be the length of a large paperclip, the width of the diameter of a pen and the depth of a tip of a pen. The medial open area of the right ischium appeared to be in the peri wound (the area surrounding the wound) of the lateral open area on the right ischium and have the size of a dime with just the top layer of skin removed and a red wound base. At 7:45 PM, RN H stated, “There’s a little excoriated [the breakdown of skin due to prolonged exposure to moisture] part here. To me, there’s really another wound here. Some may call it one.” Review failed to evidence the plan of care was updated to include the second wound to the right ischium and the wound care interventions as provided by the RN. During an interview on 8/18/2021 at 12:43 PM, the alternate clinical manager indicated the plan of care should have been updated to include the second wound and wound treatment interventions to the right ischium. 17-14-1(a)(1)

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure all services were provided in accordance with current clinical practice guidelines and accepted professional standards of practice in 1 of 1 home visit with a registered nurse. (#1) The findings include: Review of an undated agency policy, obtained 8/18/2021, titled “Integumentary – Pressure Ulcer and Wound Assessment” stated, “… Equipment: Disposable measuring guide … Initial Assessment: … Size: … Length and width are measured as linear distances from wound edge to wound edge. Wound length and width can also be documented by making a tracing of the wound on transparent paper with a permanent marker, tracing on an acetate guide, or photographic documentation. … To measure wound depth, gently insert a sterile, flexible, cotton-tipped applicator into the deepest part of the wound. Then measure the length of the sterile cotton-tipped applicator that was in the wound. … Reassessment: Reassess the wound weekly, according to initial assessment guidelines….” Review on 8/18/2021 of a reference document titled "Recommendations for Wound Assessment & Photo Documentation in Isolation” website https://cdn.ymaws.com/member.wocn.org/resource/resmgr/covid19/Recommendations_for_Isolatio.pdf stated, “… Wound measurements: … measure length and width using a disposable measuring tape or stick … Use measuring stick or sterile cotton tipped applicator to probe depth, measure at greatest depth perpendicular to the wound edge ….” Review on 8/18/2021 of a reference document titled “Wound and Pressure Ulcer Management” website https://www.hopkinsmedicine.org/gec/series/wound_care.html stated, “… Wound Assessment … An assessment of the wound should be done weekly and be used to drive treatment decisions. Wound assessment includes: location, class/stage, size, base tissues, exudates, odor, edge/perimeter, pain and an evaluation for infection….” Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021, evidenced an agency document titled “Start of Care (D1)”, which was dated 6/18/2021 and electronically signed by registered nurse (RN) K. This document indicated the patient’s diagnoses included, but were not limited to, Stage II pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in partial thickness skin loss) of the left buttock and quadriplegia (paralysis of all 4 limbs). This document indicated the patient had 3 Stage II pressure ulcers consisting of 2 to the left groin and 1 pressure ulcer to the buttocks. One pressure ulcer to the left groin was assessed to be 1 centimeter (cm) in length, 1 cm in width and 0.2 cm in depth. One pressure ulcer to the left groin was assessed to be 1 cm in length, 0.3 cm in width and 0.2 cm in depth. The wound to the buttocks was assessed to be 1 cm in length, 0.5 cm in width, 0.2 cm in depth. Review failed to evidence the wound size of the two pressure ulcers to the left groin and the pressure ulcer to the buttocks were assessed after the start of care assessment on 6/18/2021 until 7/21/2021. During an observation of care on 8/13/2021 at 7:19 PM at the home of patient #1, start of care 8/10/2021, registered nurse (RN) H was observed to have removed the dressing to the patient’s left groin and 2 open areas were noted, each appeared the length of a large paperclip and as wide as the width of a pen. Both open areas appeared to have a depth of the length of a pinky fingernail. RN H stated, “One is more medial, but there are two here.” RN H was observed to place her gloved right thumb along the length of the lateral left groin open area and then pinch her right thumb with her left thumb and forefinger. RN H then placed her right thumb over the tag on her nurse bag and stated, “The length is from H to I.” RN H was then observed to place her gloved right thumb along the width of the lateral left groin open area and then pinch her right thumb with her left thumb and forefinger. RN H placed her right thumb over the tag on her nurse bag and stated, “The width is from H to O.” RN H was observed placing her gloved right thumb into the lateral left groin open area and was observed pinching her right thumb with her left thumb and forefinger. RN H was observed placing her gloved right thumb over the tag on her nurse bag and stated, “The depth is H.” At 7:25 PM, RN H placed a retractable tape measure against the tag on her nurse bag and stated, “The measurements are just under 1.5 inches, ¾ inch and ½ inch deep.” The RN failed to measure the open area according to current clinical practice guidelines and per agency policy. During an interview on 8/18/2021 at 1:21 PM, the alternate clinical manager indicated the RN should have measured the patient’s wound using a disposable tape measure or utilizing the wound measurement application available to the nurses by taking a photograph of the wounds.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record included a completed discharge summary that was sent to the physician within 5 days of the patient’s discharge in 2 of 2 closed clinical records reviewed. (#6, #7) The findings include: 3. Clinical record review on 8/16/2021, for patient #7, start of care 6/28/2021, diagnosis of an abscess of the genitalia, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/28/2021 – 8/26/2021. This document had an area subtitled “21. Orders for Discipline and Treatments (Specify Amount/Frequency/Duration)” which stated “Services for Skilled Nurse: Effective 6/29/2021: SN: 1W6 [once a week, for 6 weeks] …“ Review evidenced an agency document titled “Discharge from Agency (D1)” from 7/20/2021 which was signed by RN H. Review failed to evidence the patient received skilled services after the start of care and prior to discharge. Review failed to evidence the physician was notified of the discharge. Review failed to evidence the patient received a discharge notice prior to the discharge assessment. Review failed to evidence a discharge summary was sent to the physician after discharge. During an interview on 8/17/2021, at 2:29 PM, alternate clinical manager A confirmed the clinical record failed to evidence the physician had been notified of discharge. The alternate clinical manager indicated physician notification was not documented in the clinical record. 17-15-1(a)(6) 1. Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Discharge Summary” stated, “… A Discharge Summary form will include, but is not limited to: … Patient/family post-discharge instructions … Medications at time of discharge. A Discharge Summary will be sent within 5 business days of patient discharge to the primary care practitioner ….” 2. Clinical record review on 8/16/2021 for patient #6, start of care 2/18/2021, evidenced an agency document titled “Plan of Care” for certification period 4/19/2021 – 6/17/2021, signed by the alternate clinical manager and signed and dated on 6/30/2021 by the physician. This document indicated the patient’s primary diagnosis was Type II Diabetes (a chronic condition where the body is impaired in the way it regulates and uses sugar as fuel). The plan of care indicated the patient was to receive skilled nursing services 1 time a week every other week for 9 weeks for a complete body assessment and fall prevention and diabetic care instruction. Review evidenced an agency document titled “Discharge Summary”, dated 6/14/2021 and signed by former employee RN K, which indicated the date of discharge was 6/14/2021. The document indicated the specific discharge instructions for the patient were to call the home care agency if home care services were needed in the future and failed to evidence patient specific instructions related to the diagnosis and condition were provided. Review failed to evidence the document included the patient medications per agency policy. Review failed to evidence the discharge summary was sent to the physician. During an interview on 8/18/2021 at 11:56 AM, the alternate clinical manager indicated the discharge summary should have been completed and indicated the discharge summary should have been sent to the physician via fax but there was no fax confirmation document. The alternate clinical manager indicated there was no indication the discharge summary was sent to the physician.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all clinical records were clear, legible and appropriately authenticated in 6 of 7 clinical records reviewed. (#1, #2, #3, #4, #5, #6) The findings include: 8. Clinical record review on 8/16/2021, for patient #4, start of care 7/29/2021, primary diagnosis of fracture of the right shoulder, evidenced an agency document titled "Physical Therapy Evaluation" from 8/2/2021, and was signed by PT [physical therapist] F. Review of this document failed to evidence the title of the clinician who performed the visit. Review evidenced agency documents titled “Therapy Visit Note” for 8/6/2021 and 8/11/2021, signed by PT F. Review of these documents failed to evidence the credentials of the clinician who performed the visits. Review evidenced an agency document titled "Occupational Therapy Evaluation" from 8/6/2021, and was signed by OT [occupational therapist] M. Review of these documents failed to evidence the credentials of the clinician who performed the visits. Review evidenced an agency document titled "Occupational Therapy Evaluation" from 8/6/2021, and was signed by OT [occupational therapist] M. Review of these documents failed to evidence the credentials of the clinician who performed the visits. Review evidenced an agency document titled "Discharge/Transfer Summary" from 8/11/2021, and was signed by OT M. Review of these documents failed to evidence the credentials of the clinician who performed the visits. Review of an agency document titled "Discharge/Transfer Summary" from 8/11/2021 which was unsigned by a skilled nurse. Review of this document failed to evidence it was signed and dated by the clinician who performed the visit. 9. Clinical record review on 8/16/2021, for patient #5, start of care 2/24/2021, diagnosis of type 2 diabetes with chronic kidney disease, evidenced agency documents titled “Skilled Visit Note” for 8/5/2021 and 8/11/2021, signed by LPN I. Review of these documents failed to evidence the title of the clinician who performed the visits. Review of an agency document titled “Skilled Visit Note” for 7/16/2021, signed by RN L. Review of this document failed to evidence the title of the clinician who performed the visit. 10. During an interview on 8/16/2021, at 10:28 AM, alternate clinical manager A indicated the clinician should include their credentials when signing visit note documents. 17-15-1(a)(7) 1. Review of an agency policy, revised March 2018, obtained 8/18/2021 titled “Medical Record Entries and Authentication” stated, “… All entries in patient records will be legible, clear, complete and appropriately authenticated, dated and timed. All entries in the medical records will be authenticated by staff signature and title. By authenticating entries in the patient’s record, staff is validating the correctness of the information. ….” 2. Clinical record review on 8/10/2021 for patient #1, start of care 6/18/2021 evidenced an agency document titled “Patient Medications” which failed a signature and date to evidence a signature and date of the clinician who reviewed the medications. Review of an agency document titled “Start of Care (D1)”, dated 6/18/2021 and electronically signed by RN K, failed to evidence the credentials of the clinician. Review of agency documents titled “Supplemental Provider Order”, dated 8/2/2021, 8/4/2021 and 8/6/2021 and electronically signed by RN L and dated 7/19/2021 and electronically signed by RN K, failed to evidence the credentials of the clinician. Review of an agency document titled “Individual Patient Emergency Preparedness Plan”, dated 6/18/2021 and signed by RN K, failed to evidence the credentials of the clinician. Review of untitled agency documents identified by the alternate clinical manager as home health aide (HHA) visit notes, dated 6/28/2021, 7/1/2021, 7/5/2021, 7/8/2021, 7/12/2021, 7/15/2021, 7/22/2021 and 7/28/2021 and completed by former employee A (HHA), failed to evidence the credentials of the clinician. Review of agency documents titled “Skilled Visit Note”, dated 6/22/2021, 6/24/2021,6/29/2021, 7/2/2021, 7/5/2021, 7/7/2021, 7/9/2021, 7/12/2021, 7/15/2021, 7/19/2021 and 7/23/2021 and completed by former employee licensed practical nurse (LPN) B, failed to evidence the credentials of the clinician. Review of an agency document titled “Skilled Visit Note”, dated 7/12/2021 and electronically signed by former employee LPN B, indicated the patient’s last bowel movement was 7/75/21. The review failed to evidence an accurate date of the last bowel movement. During an interview on 8/12/2021 at 1:11 PM, the alternate clinical manager indicated the date documented was a documentation error. Review of an agency document titled “Skilled Visit Note”, dated 7/19/2021 and electronically signed by former employee LPN B, failed to evidence the document was complete to include the patient’s temperature. During an interview on 8/12/2021 at 1:16 PM, the alternate clinical manager indicated the skilled nurse should obtain and document the patient’s temperature at every visit. 3. Clinical record review on 8/9/2021 for patient #2, start of care 6/24/2021, evidenced an agency document titled “Occupational Therapy [OT] Evaluation”, dated 8/2/2021 and electronically signed by OT M, which failed to evidence the credentials of the clinician. Review of agency documents titled “Supplemental Provider Order”, signed and dated by OT M on 7/31/2021 and signed and dated 8/4/2021 and 8/8/2021 by RN L, failed to evidence the credentials of the clinician. Review of an agency document titled “Skilled Visit Note”, dated 7/7/2021 and electronically signed by former employee LPN B, failed to evidence the credentials of the clinician. Review evidenced an undated agency document titled “Individual Patient Emergency Preparedness Plan”, signed by RN K, which failed to evidence the document included the date signed by the clinician. This document indicated the patient’s temperature was 79.7 degrees Fahrenheit. During an interview on 8/12/2021at 11:16 AM, the alternate clinical manager indicated the documented temperature was a mistake and it should have been documented as 97.9 degrees Fahrenheit. 4. Clinical record review on 8/12/2021 for patient #3, start of care 10/8/2020, evidenced an undated agency document titled “Individual Patient Emergency Preparedness Plan”, signed by RN H, which failed to evidence the document included the date signed by the clinician. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 6/5/2021 – 8/3/202, signed and dated by RN N on 7/6/2021, failed to evidence the credentials of the clinician. Review of an agency document titled “Recertification”, completed on 6/2/2021 and signed by RN N, failed to evidence the credentials of the clinician. Review of an undated agency document titled “Patient Medications” failed to evidence a signature of the clinician and date. Review of an agency document titled “Skilled Visit Note”, dated 6/14/2021 and electronically signed by RN N, indicated the patient’s temperature was 9.8 degrees Fahrenheit. During an interview on 8/16/2021 at 10:58 AM, the alternate clinical manager indicated the documented temperature was an error and probably should have documented as 98.0 degrees Fahrenheit. Review of agency documents titled “Supplemental Provider Order”, electronically signed by RN N and dated 6/14/2021, 7/28/2021 and 8/4/2021, failed to evidence the credentials of the clinician. Review of an agency document titled “Physician’s Telephone Order”, dated 2/2/2021 and signed by RN O, failed to evidence the credentials of the clinician. Review of agency documents titled “Plan of Care” failed to evidence a date the documents were signed by RN H for certification period 10/8/2020 – 12/6/2020 and 12/7/2020 – 2/4/2021. Review failed to evidence a date the document was signed by RN O for certification period 2/5/2021 – 4/5/2021. Review failed to evidence a date the document was signed by RN B for certification period 4/6/2021 – 6/4/2021. 5. Clinical record review on 8/16/2021 for patient #6, start of care 2/18/2021, evidenced agency documents tilted “Plan of Care”. Review of the documents for certification period 2/18/2021 – 4/18/2021 and 4/19/2021 – 6/17/2021 failed to evidence a date the documents were signed by RN A. 6. During an interview on 8/12/2021 at 10:04 AM, the alternate clinical manager indicated the clinical records should include the clinician’s credentials. 7. During an interview on 8/18/2021 at 10:47 AM, the alternate clinical manager indicated the date should be included on documents signed by clinicians.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure all clinical records and patient information were safeguarded against loss or unauthorized use. The findings include: Review of an agency policy, revised March 2018 and obtained 8/18/2021, titled “Patient Confidentiality” stated, “… All written patient information is stored in the patient’s medical record. … Home care records will not be left in unattended areas in the office ….” During an observation on 8/9/2021 at 9:47 AM, an agency folder was observed sitting on the conference table in the agency’s office. Administrator in training D identified the folder to be a new patient admission folder. Observed inside the folder were documents from hospital L and a document titled “Fax Cover Sheet”, dated 7/27/2021, stated, “… [Patient #4] New Referral D/C [discharge] Today….” Record review of the documents from hospital L inside of the folder evidenced the name, social security number, phone number, address, insurance information, and medical information to include a surgical report, physical therapy evaluation, list of patient medications and laboratory results for patient #4. During an interview on 8/9/2021 at 10:40 AM, the alternate clinical manager indicated the folder was probably left on the conference table for the nurse to pick-up to take to the patient’s home for the start of care. The alternate clinical manager indicated the patient information should not have been left inside of the folder and indicated the patient’s information was not secured. 17-15-1( c)