Every finding on record at Anchor Health Systems Inc

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102 Survey Dates: 4/22/2024 to 5/1/2024 Active Census: 132 QR: 5/15/24 A1

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(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 ensure each patient had an individualized emergency preparedness plan in 2 of 2 records reviewed of patients with a home visit, not receiving skilled nursing services (Patient #3, 4). The findings include: 2. An observation of care on 4/25/2024 at 8:51 AM Patient #3 was observed using a walker for ambulation. A patient-specific emergency preparedness plan failed to be observed in the patient’s home. A clinical record review of the plan of care for certification period 2/20/2024-4/19/2024 evidenced the patient’s diagnoses included, but were not limited to, epilepsy (a seizure disorder) and indicated the medications included, but were not limited to, levetiracetam (a medication used to prevent seizures). On 4/25/2024, at 8:42 AM, the patient’s caregiver indicated the patient did have a history of seizures and indicated the patient would shake and then sleep and even vomit after seizure activity. The patient’s caregiver indicated no emergency plan had been discussed or provided to the patient or caregiver. The Home Health Emergency Plan in the clinical record failed to evidence completion of the following items: friend/neighbor/family member name, phone number and address for potential evacuation location, the walker required for ambulation, and seizure precautions. A review of the nurse’s comprehensive assessment completed by Registered Nurse (RN) 5 dated 4/15/2024 evidenced an individualized emergency preparedness which failed to evidence friend/neighbor/family member name, phone number and address for potential evacuation location and seizure precautions. On 4/26/2024 at 2:42 PM, RN 5 indicated she was unsure where the patient would evacuate to in the case of an emergency. On 4/29/2024 at 12:28 PM, the Administrator indicated the individualized emergency plan should include equipment and precautions needed but did not. 1. An observation of a home visit on 4/24/2024 at 1:50 PM evidenced Patient #4 used a motorized scooter in the home, a walker for transfers, and was unable to walk. A review of the Home Health Emergency Plan in Patient #4’s home failed to evidence completion of the following items: emergency contact name and phone number, friend/neighbor/family member name, phone number and address for potential evacuation location, physician name and phone number, pharmacy name and phone number, necessary medical equipment, and documentation that the patient was non-ambulatory. A review of the nurse’s start of care assessment dated 3/24/2024 evidenced an individualized emergency preparedness which failed to evidence emergency contact name and phone number, friend/neighbor/family member name, phone number and address for potential evacuation location, physician name and phone number, pharmacy name and phone number, necessary medical equipment, and documentation that the patient was non-ambulatory. During an interview on 4/29/2024 at 2:14 PM, the Administrator indicated the individual emergency plan should be complete, both in the home and in the patient’s record, but it was not.

This visit was for a Federal Recertification and State Re-Licensure survey of a Home Health Provider in conjunction with one complaints. Survey Dates: 4/22/2024 to 5/1/2024 Complaint #: 106000 was investigated, no federal or state deficiencies were cited related to the complaint. 12-Month Unduplicated Skilled Admissions: 679 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, Anchor Home Health Care was found to be out of compliance with Conditions of Participation 484.60 Care planning, coordination of services, and quality of care. Based on the Condition-level deficiencies during the 5/1/2024 survey, your HHA was subject to an extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 4/24/2024. 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 5/1/2024 and continuing through 4/30/2026. QR: 5/14/2024

Property and person treated with respect CFR(s): 484.50(c)(1) Have his or her property and person treated with respect; This ELEMENT is not met as evidenced by: Based on record review, observation, and interview the agency failed to evidence patient care was free from verbal, mental, and physical abuse in one of five active patients with home visit observations (Patient #6). Findings include: “Standards of Professional Nursing Practice”, an agency training reference, indicates RN competencies include demonstrating caring behaviors towards people receiving care and provide holistic care that is sensitive to the needs of consumers. During a home visit observation of Patient #6 by RN 3 on 4/29/24 starting at 3:57 PM, RN stated that Patient’s wounds ‘stink’ on several occasions during the visit. When new wounds were identified to Patient’s backside, RN stated “if it was my parent, I would make sure it (the wound) was being treated.” During an interview with Patient #6 caregiver, Other #3 on 4/25/24 starting at 4:02 PM, he/she referred to RN 3 as mean and rude in her general demeanor during care to Patient. Other examples given were walking in the home without knocking multiple times, not parking where asked, and not adhering to appointment times. During an interview on 5/1/24 starting at 11:15 AM, the Administrator relayed there is a personality conflict between RN 3, Patient and caregiver, Other #3; the RN will not be returning to care for Patient. 410 IAC 17-12-3(b)(2)(A)

HHA can no longer meet the patient's needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient's welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities; This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to evidence the physician was consulted for the purpose of discharge prior discharge for 1 of 4 discharge records reviewed (Patient #11) The record for Patient #11 reviewed on 4/25/24 included a Plan of Care dated 1/27/24 – 3/26/2024 which indicated Skilled Nursing orders 1 to 2 times per week for 9 weeks. The record further indicated Patient #11 was discharged from services on 3/5/24. The record failed to evidence the attending physician was consulted in plan of the discharge. The record included an undated verbal order indicating was obtained 3/7/24 for discharge of Patient #11. During an interview on 4/25/24 beginning at 3:45 p.m., Patient #11 indicated the skilled nurse conducted the discharge over the telephone. During an interview on 5/1/24 beginning at 2:30 p.m. the Administrator indicated the nurse conducted an in person visit for discharge of Patient #11 and provided as evidence the coordinates for the nurse at the time of discharge. The record revealed two different sets of coordinates, neither was identified as Patient #11’s known address. The Administrator was unable to determine why the coordinates were not Patient’s address and further indicated the clinician is unable to open the visit unless they are within 1000 feet of patient address.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on record review and interviews, the agency failed to document the existence and resolution of a complaint in one of five active patient records with home visits (Patient #6). Findings include: On 5/1/2024, at 11:15 AM, the Administrator indicated the agency had conversations with both RN 3 and the patient's caregiver but nothing was documented related to the complaint and investigation of the personality conflict with RN 3. The Administrator indicated a complaint form should have been completed, but RN 3 had since submitted her resignation. The agency policy titled “POLICY: CC-09 PATIENT CLIENT COMPLAINTS AND CONCERNS”, revised on 1/28/03, establishes a vehicle for patients and families to communicate concerns or complaints regarding their care. The Clinical Supervisor will investigate and document the complaint and provide the Administrator with a copy for review then the Quality Assurance manager is responsible for logging all complaints in the agency Occurrence log. During an interview with Other #3, caregiver and family member for Patient #6, on 4/25/24 at 4:02 PM, he/she contacted the agency regarding inappropriate behavior and care from RN 3 on six occasions and relayed the complaints to Administrator #5 since 1/3/24. During an interview with Administrative 5 on 4/30/24 starting at 4:25 PM, she revealed the caregiver for Patient complained two times regarding the care and behavior from RN 3 during a home visit. During an interview with Administrative 1, clinical manager, on 5/1/24 starting at 11:15 PM, she stated there was one complaint made by Patient’s caregiver about the RN. When asked about the lack of complaints from Patient #6 or his family in the complaint log, no answer was given. The agency’s complaint log records failed to evidence documentation or investigation of complaint from Patient #6 and/or his/her family/caregivers. 410 IAC 17-12-3(c )(2)

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 visit within 48 hours of referral in two out of nine active patient records reviewed (Patient # 6, 7). Findings include: The agency policy titled, “POLICY CC-25 INITIAL PATIENT/CLIENT ASSESSMENT”, revised on 1/28/23, indicated a qualified professional must complete an initial assessment within 48 hours of initiation of services to determine support needs of patient. The policy titled, “POLICY: HHC-06.2 EMERGENCY AND DISASTER PREPAREDNESS PLAN- PANDEMIC INFECTIOUS DISEASE”, revised March 2023, indicated to minimize exposure the agency all staff will have access to protective equipment and staff should follow droplet precautions for patients with suspected or confirmed COVID-19. The clinical record of Patient #6 revealed a referral date of 12/22/23 with an ordered start of care date of 12/26/23. An initial assessment visit was conducted on 1/3/24. The record failed to evidence the initial assessment and care began on 12/26/23 as ordered. During an interview with Administrator 1 on 4/30/24 starting at 4:17 PM, she relayed they did not complete the initial assessment as ordered, due to Patient with COVID and there was no evidence in the clinical record that the referring physician and patient were notified of the delay. During an interview on 5/01/24, beginning at 10:45 AM, Other 3 relayed Patient did not have COVID in December of 2023 and relayed they were not able to change Patient’s dressings, as they were not physically able. 410 IAC 17-14-1(a)(1)(A) * A clinical record review for Patient #7 evidenced a document titled “Referral” which indicated the date of referral was 2/2/2024. The start of care comprehensive assessment was dated 2/14/2024, which was greater than 48 hours since time of referral. The “Interdisciplinary Communication” dated 2/9/2024 indicated the patient was ready for admission on 2/13/2024, and review failed to evidence any documentation of attempts to schedule the admission prior to 2/9/2024. On 4/26/2024, at 11:43 AM, the Administrator indicated there was no other documentation regarding attempts to schedule the admission with the patient prior to 2/9/2024. * On 4/22/2024, at 10:06 AM, the Administrator indicated the initial visit is the start of care comprehensive assessment and should be completed within 48 hours from time of referral.

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 interview, record review, observation, the comprehensive assessment failed to accurately reflect the patient’s health status in two of nine active records reviewed (Patient #6, 7). Findings include: * A clinical record review for Patient #7, evidenced a start of care comprehensive assessment for 2/14/2024, which indicated the patient had 2 open wounds to the right leg and failed to include an assessment of the depth of the wounds. The recertification comprehensive assessment on 4/12/2024 indicated the patient had an open wound to the right leg and failed to evidence the assessment of the wound size. On 4/26/2024, at 12:25 PM, the Administrator indicated the comprehensive assessment did not include the wound measurements to include depth and indicated the agency was educating nursing staff about wound documentation since the measurements should be included. The agency policy titled “POLICY: CC-59 RISK ASSESSMENT AND WOUND ASSESSMENT”, revised 1/25/24, indicates upon patient admission the wound should be assessed in order to plan and implement wound care treatment, the use of uniform descriptions is recommended to facilitate communication. The clinical record of Patient #6 evidenced a comprehensive assessment completed for the start of care on 1/3/24 and for recertification on 3/2/24 by RN 3, documentation evidenced a right foot/toe wound assessment and failed to evidence wound measurements. The comprehensive assessments failed to evidence left foot/toe wound assessment and measurements. RN visit documentation indicated left foot/toe wounds on 1/12/24, 1/15/24, 1/19/24, 1/22/24, 1/24/24, 1/26/24, 1/29/24, 1/31/24, 2/3/24, 2/5/24, 2/10/24, 2/12/24, 2/16/24, 2/20/24, 2/23/24, 2/26/24, 3/2/24, and subsequent visits. During an interview with RN 3 on 4/24/24 starting at 3:05 PM, when asked how often she measures the patient’s wounds she stated she should be measuring every first visit (of each week) but hasn’t seen a change and cannot recall when the wounds were last measured. She indicated she thought the doctor measures the wounds though she did not have the physicians’ documentation. RN relayed the patient had wounds to the right and left feet since the start of care with Patient #6 and referred to the left foot/toe wound as broken skin and excoriated (skin injury). During an interview with Administrator (admin) 1 on 4/26/24 starting at 12:42 PM, she stated wounds should be measured weekly. 410 IAC 17-14-1(a)(1)(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 agency failed to include a review of all medications to identify potential adverse effects, significant drug reactions, duplicate drug therapy, and noncompliance with drug therapy in 3 out of 9 active records (Patient #6, 7, 9). Findings include: The agency policy titled “POLICY: CC-25 INITIAL PATIENT/CLIENT ASSESSMENT”, revised on 1/28/23, indicates a qualified professional must complete an initial assessment, to determine immediate care and support needs of the patient. The clinical record of Patient #6 evidenced a major medication interactions between Nifedipine (calcium channel blocker that lowers blood pressure) and Phenytoin (anticonvulsant to treat epilepsy) stating “GENERALLY AVOID”. During an observation of a recertification home visit with Patient and RN 3 on 4/29/24 starting at 3:57 PM, the RN asked if there are any new medications, Patient answered no. The observation failed to evidence evaluation of medication interactions nor medication compliance. During an interview on 4/24/24 beginning at 3:05 PM, when asked how RN 3 knows two medications interact, she relayed it would depend on what the patient reports. When asked how a review of medication interactions was done with Patient, RN indicated the daughter helps Patient with his medications. 410 IAC 17-14-1(a)(1)(B) * A clinical record review for Patient #7, start of care 2/14/2024, evidenced a plan of care for certification period 2/14/2024-4/13/2024, which indicated the medications included, but were not limited to, bupropion (antidepressant) and tramadol (pain medication). The document titled “Medication Interaction” dated 4/25/2024 indicated a potential severe interaction between bupropion and tramadol, which could increase the risk of seizures. The start of care comprehensive assessment on 2/14/2024 failed to evidence a review of the medications to include potential drug interactions with the patient/caregiver. On 4/26/2024, at 12:19 PM, the Administrator indicated the comprehensive assessment did not include the potential drug interactions. *A clinical record review for Patient #9, start of care 1/8/2024, evidenced a plan of care for certification period 1/8/2024-3/7/2024, which indicated the patient’s medications included, but were not limited to, aspirin (a medication used to prevent blood clots) and apixaban (a medication used to treat/prevent blood clots). The document titled “Medication Interation” dated 4/26/2024 indicated a potential sever interaction between aspirin and apixaban, which could increase the risk of bleeding complications. The start of care comprehensive assessment completed by RN 6 on 1/8/2024 indicated the medications were reviewed and no issues were found. Review failed to evidence the comprehensive assessment included a review of the medications to include potential drug interactions. On 4/26/2024, at 2:42 PM, RN 6 indicated she was unaware of any potential medication interactions. *On 4/29/2024, at 12:34 PM, the Administrator indicated the nurses did not use the comprehensive assessment to review medication interactions and needed additional training on how to answer that question on the comprehensive assessment.

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 record review and interview, the comprehensive assessment failed to accurately reflect the patient’s primary caregiver’s willingness, availability nor their ability to provide care in one of five home visit patients (Patient #6). Findings include: The clinical record of Patient #6 revealed an initial comprehensive assessment dated 01/3/24, completed by RN 3, which evidenced a family member was the primary caregiver and that they managed Patient’s care. The record evidenced documentation that the caregiver provided assistance “several times during the day and night,” with willingness and ability to provide care and availability noted to be continuous. Patients' goals evidenced an inability to ambulate and decreased ability to perform activities of daily living. During an interview on 4/26/2024 beginning at 4 PM, Other #3, Patient #6's caregiver and family member indicated they cannot lift Patient (for ambulation) or lift the leg to change the wound dressing due to their back condition. During an interview at time of a home visit on 4/29/24, starting at 6:30 PM, Patient #6 indicated their caregiver, Other #3, cannot come every day. During an interview on 4/24/24 starting at 3:05 PM, RN 3 relayed that Patient #6 cannot ambulate alone. When asked if the caregiver changed Patient's wound dressings, RN 3 indicated the caregiver does not make any attempt due to their back problems.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was performed in the last 5 days of every 60-day episode in 1 of 1 active records reviewed receiving LPN (Licensed Professional Nurse) services (Patient #8). The findings include: A policy titled “Reassessment / Update of the Comprehensive Assessment” revised 1/28/2023, indicated the comprehensive assessment would be updated, at minimum, during the last 5 days of every 60-day episode of care. A clinical record review evidenced the comprehensive assessment for Patient #8, certification period 3/12/2024 to 5/10/2024, was performed on 3/5/2024 by the Administrator. During an interview on 4/29/2024 at 2:38 PM, the Administrator indicated the comprehensive assessment should be updated during the last 5 days of the certification period. When informed of the findings, the Administrator indicated they sometimes would do the comprehensive assessment early in non-OASIS patients (patients who do not require OASIS assessment, i.e. pediatric, obstetric, or personal-care only patients).

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 individualized with specific, measurable goals, and 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), patients / caregivers received necessary education and training (see tag G0610), patients / caregivers received written copies of instructions (see tag G0612), and patients / caregivers were provided a written schedule of visits (see tag G0614). 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 record review and interview, the agency failed to provide services to meet the patient's needs in 1 of 1 active patient records receiving physical therapy services only (Patient #4). The findings include: 1. A policy titled “Admission Criteria”, last reviewed 1/28/2023, indicated the agency’s criteria for admission included the expectation that the agency could adequately meet the patient’s needs. 2. A clinical record review evidenced the agency accepted a referral to provide physical therapy services for Patient #4 on 3/22/2024. The nurse completed the start of care assessment on 3/24/2024. The initial physical therapy visit was not completed until 4/5/2024. A communication note by Office Staff 5 on 4/4/2024 indicated the patient requested their physical therapy evaluation to be on 4/5/2024 because they “would not be able to work with PT (Physical Therapist) schedule”. A review of the record failed to evidence communication with the patient prior to 4/4/2024 about starting therapy. During an interview on 4/24/2024 at 2:40 PM, PT 1 indicated they did not know about a delay in initiating therapy. PT 1 indicated someone else started the case and they picked it up a few weeks ago. During an interview on 4/25/2024 at 4:17 PM, Patient #4 indicated they did not request a delay in beginning physical therapy, and they wanted to start right away. 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 ensure each patient received services written in an individualized plan of care with patient-specific, measurable goals in 5 of 12 records reviewed receiving skilled nursing services (Patient #4, 5, 7, 8, 13). The findings include: *The clinical record for Patient #13 included orders for physical therapy dated 3/22/24. Services were to be provided once a week for 4 weeks beginning 3/25/24. The record failed to evidence that physical therapy services were provided. The plan of care indicated orders for SN once per week throughout the certification period. Week 6 of the certification period the record failed to evidence the SN provided their weekly visit. The record failed to evidence the agency notified the physician of the change in the Plan of Care. *A clinical record review of Patient #7 evidenced a plan of care for certification period 2/14/2024-4/13/2024, which indicated the agency would provide skilled nursing services 1 time a week for 8 weeks. Review failed to evidence the agency provided skilled nursing services during the weeks of 3/10/2024 and 3/24/2024. A referral from Entity 5 dated 2/2/2024 indicated the patient was seen at the wound clinic weekly and was needing home care services 1 time a week. On 4/26/2024, at 12:31 PM, the Administrator indicated the no skilled nurse was provided during the week of 3/10/2024 because the patient was seen at the wound clinic and indicated no nurse was provided during the week of 3/17/2024. The Administrator indicated the patient’s previous nurse went on medical leave and another nurse had to be scheduled to take over the patient’s care. *A clinical record review for Patient #9 evidenced a plan of care for certification period 3/8/2024-5/6/2024, which indicated the agency was to provide home health aide (HHA) services up to 20 hours per week. Review failed to evidence the agency provided HHA services per the plan of care and indicated the agency provided HHA services 28 hours per week during the weeks of 3/10/2024, 3/17/2024, 3/31/2024, 4/7/2024, and 4/14/2024. On 4/29/2024, at 12:50 PM, the Administrator indicated the agency did not provide up to 20 hours per week of HHA services per the plan of care. The agency policy titled “POLICY CC-30 PATIENT/CLIENT CARE PLANNING PROCESS”, revised 1/28/23, discloses the agency is to provide services based on an individualized, goal-directed plan of care to ensure delivery of quality home care services. The patient care planning process will be demonstrated throughout the physician’s plan of treatment and orders. The agency policy titled “POLICY: CC-15.2 MISSED VISITS PROCEDURE”, reviewed 1/28/23, evidenced it is the policy to make all attempts to provide full service as determined by the physician order frequency. When a staff member does not keep a scheduled visit with a patient, an agency representative will immediately contact the patient or family to reschedule the visit. The clinical record of PATIENT #6 plan of care (POC) evidenced orders for specified wound dressings to be done three times a week. Start of care was dated 1/3/24 and initial plan of care order a skilled nurse (SN)3W9 (three times a week for nine weeks). The order was modified on 4/18/24 to 1-3W3W2 PRN (one to three times a week for three weeks plus two ‘as needed’ visits allowed for wound complications or health decline). The clinical record of SN visits the week 4/14/24 to 4/21/24 evidenced a SN visit by RN 3 on 4/15/24 and an RN cancelled visit on 4/17/24 due to a wound clinic appointment on 4/18/24. A total of two dressing changes were noted that week due to RN cancellation of visit. The record failed to evidence communication of attempts to reschedule the missed visit. The clinical record of Patient #6’s plan of care (POC) evidenced a specified wound care order as follows: wash toes to bilateral feet with soap and water, use antibacterial soap, apply collagen powder(for wound healing and tissue regeneration) to bilateral(left and right) feet excoriated area between toes, place Hydrofera blue (antibacterial wound dressing) dressing to bilateral feet between toes, place ABD (thick, absorbent dressing) over toes, wrap in coban wrap (self-adherent mild compression wrap), 4 inch ace wrap(stretchable compression wrap) from mid foot to above each ankle, Surepress (high compression bandage) wrap bilaterally from above ankle to below knee, tape in place, apply socks followed by 6 inch ace wrap from above ankle to below knee. Interventions included skilled nurse (SN) to perform irrigation. The clinical record of SN visits failed to evidence the specified ordered wound care. The clinical record evidenced verbal physician orders dated 4/23/24 for new wound care orders with a start date (backdated) to 1/3/24. During an interview with RN 3 on 4/24/24 starting at 3:05 PM, when asked who is able to do the wound dressing changes for Patient she stated the wound care or the RN during a home visit, the patient cannot change them and the caregiver does not make any attempt to do it due to back problems. She states she saw him three times a week for a long time and if the wound has more secretions, she will see him three times a week and once the drainage is decreasing, she stated she might go two times a week. 1. A review of the plan of care for certification period 3/12/2024 to 5/10/2024 evidenced the following goals for Patient #8: Patient will have optimal nutritional status without complications, patient will have appropriate response to medications, patient passes stool at a frequency that is normal for the patient, patient will maintain normal bowel habits, and patient will have needs met to maintain optimal health. The plan of care failed to evidence what the optimal nutritional status was for the Patient or how it would be measured, what “appropriate responses” to medications were, what a normal bowel habit was for the patient, what “optimal health” was for the patient and how it would be measured. During an interview on 4/29/2024 at 2:25PM, the Administrator indicated the plan of care should be individualized with measurable goals. When informed of the findings, the Administrator indicated the nurse could look back at previous assessments to determine what was normal for the patient, but the plan of care did not specify what was normal or optimal for the patient. 2. A review of the plan of care for certification period 3/24/2024 to 5/22/2024 evidenced the following 3 physical therapy interventions for Patient #4: Establish / Upgrade home exercise / walking program, therapeutic exercise – impaired strength, and assess / re-assess transfer ability. The plan of care failed to evidence specific exercises, treatments, or modalities to be used by the physical therapist. The plan of care evidenced the following 3 physical therapy goals: Patient / Caregiver able to verbalize activities allowed, limitation, and restrictions, patient / caregiver will be able to verbalize precautions related to transfers, and patient / caregiver will demonstrate compliance with using written home exercise program log. The plan of care failed to evidence measurable physical therapy goals. During an interview on 4/24/2024 at 2:30 PM, PT (Physical Therapist) 1 indicated they created the plan of care based on what the patient needed and was able to do. PT 1 indicated Patient #4’s goal was to gain strength for easier transfers. During an interview on 4/29/2024 at 3:11 PM, the Administrator indicated the plan of care should be individualized and contain measurable goals, and PT 1 could have been more specific in creating interventions and goals. 3. A review of the plan of care for certification period 3/9/2024 to 5/7/2024 evidenced the following goals for Patient #5: Urinary elimination pattern within baseline, adherence to health teaching regarding present illness, patient / caregiver demonstrates ability to cope with limitations, knowledgeable of signs / symptoms to report to nurse / doctor, and patient / caregiver verbalize understanding / demonstrate adequate fluid intake. The plan of care failed to evidence what the baseline elimination pattern was, what “health teaching” was being adhered to and how that could be measured, what signs and symptoms were to be reported, and what was adequate fluid intake for the patient. During an interview on 4/25/2024 at 3:30 PM, the Administrator indicated the plan of care should be individualized with measurable goals. When informed of the findings, the Administrator indicated the nurse could look back at previous assessments to determine what was normal for the patient, but the plan of care did not specify what was normal or optimal for the patient. 410 IAC 17-13-1(a)

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 plan of care included all required components in 7 of 9 active records reviewed (Patient #3, 4, 5, 6, 7, 8, 9). The findings include: The agency policy titled “POLICY: CC-03.1 PHYSICIAN’S PLAN OF CARE”, revised on 1/28/23, indicates the plan of care is established and periodically reviewed by the doctor to ensure appropriate care relative to patient’s condition. All clinical services are implemented only in accordance with physician’s orders including goals, nutrition requirements, medications and treatments, and safety measures. During a home visit observation with Patient #6 on 4/29/24 starting at 3:57 PM with RN 3, Patient was on oxygen at 4L (liters per minute). A plan of care (POC) present in Patient’s room for Entity 1, another home health agency caring for Patient, revealed a medication list that included one dose of lisinopril 40mg daily, Dilantin (AKA Phenytoin: a seizure medication) 530 milligrams(mg) daily. The POC indicated aide services provided to Patient #6. During an interview with Patient on 4/29/24 starting at 6:30 PM, when asked about pain control, he/she revealed pain medication at the bedside: Oxycodone (narcotic pain medication) and Ibuprofen (non-narcotic pain medication) that was prescribed by a physician. Patient verified oxygen dosage of 4L that is required around the clock, a dosage of Dilantin (seizure medication) that is 530mg daily, and one dose of Lisinopril (blood pressure medication) 40mg daily. He/she verified a diagnosis of Epilepsy (a seizure disorder). The clinical record of Patient #6 revealed a plan of care (POC) medication list that failed to include Patient’s oxygen. A dosage for Lisinopril 40mg daily was listed two times indicated two dosages and daily Dilantin dose of only 30mg daily. The POC failed to list Epilepsy as a diagnosis and seizure precautions as a safety measure. During an interview on 4/25/24 starting at 3:32 PM, Administrator 1 indicated patient with known seizures, or a seizure diagnosis should be on seizure precautions. During an interview with RN 3 on 4/24/24 starting at 3:05 PM, she stated that Patient #6 was on oxygen when she first started caring for him/her at the dose of 4L. When asked how many doses of lisinopril does the patient take per day, she stated only one. RN 3 stated patient doesn’t know why he is on Dilantin and said he has been taking it for a long time. During an interview on 4/24/24 starting at 3:30 PM, Administrator 1 indicated that a full medication reconciliation is done every recertification by the nurse. If there are changes in medication, it will be updated on the medication profile. An agency policy titled “POLICY: CC-13.1 COORDINATION OF CARE”, revised on 1/28/23, requires coordination of care for all patients, staff to act as case manager to coordinate services to implement the plan of care including other health service providers serving the patient. During an interview with Other #3, caregiver for Patient #6, on 4/26/24 starting at 16:02, he/she revealed that Patient had been receiving care from another home care agency for home aide services and from a wound care clinic. The clinical record for Patient #6 revealed a plan of care that failed to include coordination of services from Entity 1 and a wound care clinic. During an interview with RN 3 on 4/24/24 starting at 3:05 PM, she indicated knowledge of home health aid from a separate agency providing care to Patient along with care from a wound care clinic. *A clinical record review of Patient #7 evidenced a plan of care for certification period 2/14/2024-4/13/2024, which indicated the patient’s medications included, but were not limited to, warfarin (blood thinner medication used to treat/prevent blood clots). Review failed to evidence bleeding precautions in the safety measures in the plan of care. On 4/26/2024, at 12:29 PM, the Administrator indicated the bleeding precautions were not included but should be in the safety measures on the plan of care. Review of the referral documents from the wound clinic at Entity 5 indicated the patient received wound treatment from the wound clinic weekly. Documents from Entity 5 indicated the patient received wound treatment at the wound clinic on 2/15/2024, 3/21/2024, and 4/18/2024. The plan of care failed to include the wound care services and frequency of services provided by the wound clinic. On 4/26/2024, at 12:31 PM, the Administrator indicated the agency did not include wound clinics on the plan of care. *A clinical record review for Patient #9 evidenced a plan of care for certification period 3/8/2024-5/6/2024, which evidenced the patient’s medications included bisacodyl (a medication used to treat constipation) and a fleets enema (a medication used to treat constipation) as needed and failed to evidence the individual indication for use as needed. The plan of care indicated the patient’s goals included, but were not limited to, promote skin integrity and maintain usual bowel patterns and failed to evidence how the goals were to be measured. On 4/29/2024, beginning at 12:30 PM, the Administrator indicated the as needed medications were for constipation and the as needed indications for use should be included in the plan of care but were not. The Administrator indicated the goals would be measured by having no new open areas and the patient would have bowel movements during the administration of the bowel program and indicated it was not included on the plan of care. *A clinical record review for Patient #3 evidenced a plan of care for certification period 2/20/2024-4/19/2024 which evidenced the patient’s diagnoses included, but were not limited to, epilepsy (a seizure disorder) and indicated the medications included, but were not limited to, levetiracetam (a medication used to prevent seizures). The plan of care failed to evidence seizure precautions were include in the safety measures. On 4/25/2024, at 8:42 AM, the patient’s caregiver indicated the patient did have a history of seizures and indicated the patient would shake and then sleep and even vomit after seizure activity. On 4/29/2024, at 12:14 PM, the Administrator indicated seizure precautions were not included on the plan of care but should be since the patient had a diagnosis of epilepsy. 1. A review of the plan of care for certification period 3/12/2024 to 5/10/2024 indicated Patient #8 had a feeding tube that was to be changed every 3 months by the family / caregiver every 3 months and as needed. The plan of care failed to evidence if the agency caregiver was changing the feeding tube, when the tube was to be changed next, and indications for why the tube would need to be changed. During an interview on 4/29/2024 at 2:25 PM, the Administrator indicated the Patient’s family member changed the tube every 3 months, and the schedule for changing the tube was kept on a board in the patient’s home. The Administrator indicated the plan of care should have included all information about care of the feeding tube. 2. A review of the plan of care for certification period 3/24/2024 to 5/22/2024 indicated Patient #4 was taking Xarelto (a blood thinner) daily, but failed to evidence Bleeding Precautions. During an interview on 4/24/2024 at 3:35 PM, the Administrator indicated the plan of care should have included Bleeding Precautions. 3. During a home visit on 4/24/2024 at 11:18 AM, Patient #5 was observed wearing bilateral AFO’s (braces for the feet to lower legs). A review of the plan of care for certification period 3/9/2024 to 5/7/2024 evidenced Patient #5 had a diagnosis of Epilepsy. The plan of care failed to evidence seizure precautions and AFO's. During an interview on 4/25/2024 at 12:22 PM, RN (Registered Nurse) 4 indicated the Patient had been using AFO’s for as long as she knew the patient. During an interview on 4/29/2024 at 3:41 PM, the Administrator indicated AFO’s and seizure precautions should have been included in Patient #5’s plan of care.

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 implement services and treatments administered as ordered by a physician in four out of nine active records reviewed (Patient #3, 6, 7, 9). Findings include: * A clinical record review for Patient #7 failed to evidence an order for the home care services provided which began 2/14/2024 before the plan of care for certification period 2/14/2024-4/13/2024 was signed by the physician on 4/22/2024. Review failed to evidence an order for continuation of services for care that began at the start of the certification period of 4/14/2024. On 4/25/2024, at 11:54 AM, Registered Nurse (RN) 3 (nurse case manager for the patient) indicated she did not contact the physician for start of care or recertification orders for home health care because she assumed the office did that. On 4/26/2024, at 11:48 AM, the Administrator indicated the start of care order was the face sheet of the referral from Entity 5, which indicated the patient needed home care services 1 time per week. The Administrator indicated the face sheet was not from/signed by the physician, and indicated the fax included the additional documents which were signed by the physician but did not include a home care order but just the wound care order. *A clinical record review for Patient #9 failed to evidence an order for the home care services which began on 1/8/2023 before the plan of care for certification period 1/8/2024-3/7/2024 was signed by the physician on 2/5/2024. On 4/26/2024, at 2:42 PM, RN 5 (nurse case manager for the patient) indicated she did not contact the physician for a start of care order and indicated she thought the office did that. On 4/29/2024, at 12:44 PM, the Administrator indicated she could not locate a start of care order for home care services in the clinical record and would look for an order in the hospital referral information in Epic (an electronic health record for the hospital) but no additional documentation or information was provided prior to survey exit on 5/1/2024. *A clinical record review for Patient #3 failed to evidence an order for the continuation of home care services that began upon recertification on 2/20/2024 before the plan of care signed and dated by the Alternate Clinical Manager on 3/13/2024 for certification period 2/20/2024-4/19/2024 was signed by the physician on 3/18/2024. Review failed to evidence documentation of communication with the physician regarding the recertification of home health services. On 4/29/2024, at 12:06 PM, the Administrator indicated the agency did not write a recertification order because the clinician’s entry of a date on the plan of care for verbal start of care as the continuation of care order. On 4/30/2024, at 11:45 AM, the Alternate Clinical Manager indicated she did not contact the physician for a recertification order for continuation of home care services and signed the plan of care since she assisted in reviewing the plan of care. The agency policy titled “POLICY: CC-31 DOCUMENTATION OF PATIENT/CLIENT CARE”, revised on 1/28/23, indicates physician orders must be obtained for all patients receiving skilled home care services. The clinical record of Patient #6 evidenced an initial certification period of 1/3/24 (start of care) to 3/2/24 with a plan of care (POC) that was signed by his physician 1/18/24. The recertification period 3/3/24 to 5/1/24 included a recertification visit 3/2/24 and a POC signed by the physician 3/12/24. The records failed to evidence verbal orders for skilled nurse care implemented on 1/6/24, 1/8/24, 1/10/24, 1/12/24, 1/15/24, 1/17/24, 3/5/24, 3/8/24, and 3/11/24. The record review of Patient # 6 revealed a referral for patient home health care on 12/22/23 but failed to evidence a start of care (SOC) order which was completed on 1/3/24 by RN 3 for a certification period of 1/3/24 to 3/2/24. The record failed to evidence a recertification order for recertification visit completed on 3/2/24 by RN 3 for a certification period 3/3/24 to 5/1/24. During an interview with RN 3 on 4/24/24 starting at 3:05 PM, when asked how she obtained certification orders for start of care of Patient #6, she indicated she refers to the (previous) discharge orders. During an interview on 4/23/24 starting at 4:42 PM, Administrator 1 relayed the start of care order is on the cover sheet of the fax. She continued that the fax cover sheet is considered an order because the doctor attached documents to it and even though the cover sheet is not signed by the doctor. 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 physician reviewed the plan of care at least every 60 days in 1 of 7 active clinical records reviewed with more than 1 certification period. (Patient #7) The findings include: A clinical record review for Patient #7, start of care 2/14/2024, evidenced a plan of care for certification period 2/14/2024-4/13/2024, signed by the physician on 4/22/2024, which was greater than 60 days. On 4/26/2024, at 12:10 PM, the Administrator indicated there was no other documentation the physician reviewed the plan of care other than the date he signed it on 4/22/2024 and indicated the plan of care should be reviewed by the physician at least every 60 days.

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, interview, and observations the agency failed to promptly alert the physician to any changes in the patient’s condition or needs in three of nine active patient records reviewed (Patient #5, 6, 7) Findings include: A review of the plan of care for certification period 3/9/2024 to 5/7/2024 indicated the nurse was to assess Patient #5 for signs and symptoms of a UTI (urinary tract infection) and to notify the physician of significant changes. During an interview on 4/24/2024 at 11:47 AM, LPN (Licensed Practical Nurse) 1 indicated they thought the Patient might have had a UTI based on the appearance of the urine and how the patient was behaving during daily weekday visits between 3/25/2024 and 4/5/2024 LPN 2 indicated she did not notify the physician, she notified the Patient’s family member who notified the physician. 410 IAC 17-13-1(a)(2) * A clinical record review for Patient #7, start of care 2/14/2024, evidenced a plan of care for certification period 2/14/2024-4/13/2024, which indicated the medications included, but were not limited to, bupropion (antidepressant) and tramadol (pain medication). The document titled “Medication Interaction” dated 4/25/2024 indicated a potential severe interaction between bupropion and tramadol, which could increase the risk of seizures. Review failed to evidence the physician was notified of the potential severe interaction. On 4/26/2024, at 12:12 PM, the Administrator indicated the severe interaction should have been included on the plan of care to notify the physician and indicated it was not included. The Administrator indicated there was no other documentation of physician notification of the potential severe drug interaction. A skilled nurse visit note completed by Registered Nurse (RN) 3 on 4/22/2024 indicated the patient was diagnosed with a urinary tract infection and was prescribed an antibiotic effective 4/18/2024. Review failed to evidence the physician responsible for the plan of care was notified. On 4/25/2024, at 11:54 AM, RN 3 indicated the patient’s primary care physician (not the physician responsible for the plan of care) ordered the antibiotic and RN 3 did not notify the physician responsible for the plan of care of the infection and prescribed antibiotic. The agency policy titled “POLICY: CC-25.1 ASSESSMENT AND REASSESSMENT GUIDELINES”, last reviewed 1/28/23, indicates pertinent assessment and reassessment data will be communicated to team members including the patient’s physician with the use of appropriate Standards of Practice. “Standards of Professional Nursing”, an agency training reference, indicates the registered nurse collects comprehensive data assessments in an ongoing process, prioritize data collected, and collaborate with healthcare providers to implement a plan for the promotion and restoration of health. The clinical note of Patient #6 initial start of care assessment on 1/3/24 by RN 3 evidenced a right toe wound assessment and no other wounds. Starting on 1/12/24 the RN visit notes evidenced a left toe and right toe wound assessment with continued documentation of left and right toe wounds to current visits. The clinical noted failed to evidence communication with physician reporting the new wound. The clinical note of Patient #6 evidenced skilled nurse visit documents indicated Patient’s wound developed a foul odor (a sign of bacterial infection) to the left foot/toe wound on 1/12/24, 1/31/24, 2/10/24, 2/12/24, and 3/5/24. A foul odor to the right foot/toe wound was charted by the RN on 1/31/24, 2/10/24, 2/12/24, and 3/5/24. The clinical note failed to evidence communication with the physician to report changes in wound status. During an interview with RN 3 on 4/24/24 starting at 3:05 PM, when asked if she contacted the physician about the changes in wound odor she indicated she did not call the doctor. During an interview with Other #3, caregiver of Patient #6, on 4/25/24 starting at 4:02 PM, he/she indicated Patient has several wounds on his/her backside that RN 3 does not tend to. During a home visit observation with Patient #6 on 4/29/24 starting at 3:57 PM with RN 3, RN indicated that Patient has no additional wounds other than the right and left toes. Other #3, caregiver for Patient, entered and asked Patient to stand up and lesions to both sides of buttocks were evidence with redness to backside and scrotum. RN 3 indicated that she knew about the (backside) wounds two months ago. When asked if the physician is aware, RN relayed she did not report the wounds. During an interview with Patient #6 after his home visit on 4/29/24 starting at 6:30 PM, he/she indicated that RN 3 knew about the wound (on backside) two months ago and never asked to see it. The clinical note of Patient #6 failed to evidence any assessment, education, or communication with the physician regarding wounds to backside. During an interview with Administrator 1 on 4/26/24 starting at 12:42 PM, she indicated the doctor should be notified of any changes in wounds.

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 record review, interview, and observation the agency failed to provide a revised plan of care that reflects current information from the patient’s updated comprehensive assessment and contain information concerning the patient’s progress towards goals in two of five active patient records with wounds (Patient #4, 6). Findings include: XX. A review of the plan of care for certification period 3/24/2024 to 5/22/2024 indicated the physical therapist was to establish a home exercise / walking program for aerobic capacity / activity tolerance. During an interview on 4/24/2024 at 2:40 PM, PT (Physical Therapist) 1 indicated they were working on strength training for Patient #4 to ease transferring, and that Patient #4 was not on a walking program because they were unable to ambulate. PT 1 indicated they would revise the plan of care based on a patient’s needs and progress. The agency policy titled “POLICY: CC-30 PATIENT/CLIENT CARE PLANNING PROCESS”, revised 1/28/23, indicated an individualized, goal-directed plan demonstrated through the physician’s plan of treatment and orders is reviewed and revised whenever necessary based on client needs. During an observation of a home visit with Patient #6 with RN 3 on 4/29/24 starting at 3:57 PM, open wounds were observed to right and left toes during wound dressing changes and wounds were observed to Patient’s backside. Patient indicated the RN knew about the wounds and did not assess them previously. RN 3 revealed she knew about the (backside) wounds but did not assess them during prior assessments. The clinical note of Patient #6 failed to evidence a plan of care that included care for wounds to Patient’s backside or communication with the physician to report wounds. The clinical record of Patient 6’s referral for home health dated 11/16/23 evidenced the patient had a wound to the right foot with previously healed wounds including to left foot. Documentation of Patient’s start of care (SOC) was on 1/3/24 by RN 3 with a wound assessment of the right toe and no other documented wounds. RN assessment included documentation of left toe wound as reddened, with slough (dead cells accumulated from drainage), and scaly with moderate to heavy drainage on 1/12/24 throughout patient. The clinical record failed to evidence communication with the physician regarding new wounds. During an interview with RN 3 on 4/24/24 starting at 3:05 PM, when asked if the physician was aware of changes to the wounds, she said she didn’t contact the physician’s office. When asked about the left foot/toe wound, she stated it’s draining and excoriated (raw, irritated lesion).

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on observation, interviews, and record review the agency failed to ensure that the patient and his/her caregiver receive ongoing education and training as appropriate to plan of care in two of five active patient records with home visits (Patient #6, 7). Findings include: * A clinical record review for Patient #7 evidenced a skilled nurse visit note completed by Registered Nurse (RN) 3 on 4/22/2024, which indicated the patient was diagnosed with a urinary tract infection and was prescribed an antibiotic effective 4/18/2024. Review failed to evidence the RN provided education on the signs and symptoms of the urinary tract infection and the education on direction and compliance with the antibiotic therapy and potential side effects. Documents from the wound clinic at Entity 5 dated 2/15/2024, 3/21/2024, and 4/18/2024 indicated the patient was to increase the protein in the diet to promote wound healing. Review failed to evidence the agency educated the patient on the diet recommendation. On 4/25/2024, at 11:54 AM, RN 3 indicated she did not educate the patient on the antibiotic therapy because the patient got the medication information sheet from the pharmacy. RN 3 indicated she did not educate the patient on the increased protein in the diet because she was not aware of any special diet instructions. The agency policy titled “POLICY: CC-36 PATIENT/CLIENT EDUCATION”, reviewed 1/28/23, indicates the agency is to provide interdisciplinary patient education based on needs and includes communication with family to facilitate patient’s educational objectives. The agency policy titled “POLICY: CC-59 RISK ASSESSMENT AND WOUND ASSESSMENT”, revised 1/25/24, indicates the patient’s knowledge related to conditions should be assessed in order to identify and implement a teaching plan including the patient or caregivers’ ability and willingness to follow instructions in order to meet goals. This assessment should be repeated at periodic intervals and compliance with interventions should be assessed at every nursing visit. A clinical record review of Patient #6 evidenced a plan of care listing a medical history of severe weakness, falls with injuries, wounds, lung disease, diabetes, Parkinson’s disease (nervous system disease affecting movement), heart failure, neuropathy (damaged nerves), lymphedema (swelling disorder),high blood pressure, and is on medications with major interactions. Comprehensive assessments completed on 1/3/24 and 3/5/24 indicated Patient is on home oxygen. 410 IAC 17-14-1(a)(1)(G) During an observation of a home recertification visit with Patient #6 and RN 3 on 4/29/24 starting at 3:57 PM, previously undocumented wounds were noted to Patient’s backside. RN 3 failed to evidence teaching to Patient or caregiver related to Patient’s diagnoses, wounds including new wounds, or medication interactions. During the visit, RN relayed that the patient and caregiver are not open to teaching. During an interview with Patient #6 after a home visit on 4/29/24 starting at 6:30 PM, Patient verified a diagnosis of Epilepsy (a seizure disorder). During an interview with Other #3, caregiver and family member of Patient #6, on 4/25/24 starting at 4:02 PM, he/she relayed RN 3 has never provided education to Patient or family.

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD 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 in one of five active patient records with home visits (Patient #6). Findings include: During a home visit of Patient #6 with RN 3 on 4/29/24 starting at 3:57 PM, the agency folder was observed to be present failed to evidence a plan of care or care summary. During an interview with Other #3, caregiver for Patient #6, during a home visit observation, he/she stated that all the paperwork provided by the agency is present in the folder and indicated RN 3 did not provide any additional information including treatments or visit frequencies. During an interview on 4/24/24 beginning at 4:30 PM, Administrator 1 relayed all patients should be given a plan of care summary that includes visit frequency and treatments.

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 a copy of written instructions including visit schedule and frequency of visits in three of five home visit patients (Patient #4 and 6). Findings include: XX. During a home visit on 4/23/24, beginning at 7:45 a.m., the home health agency folder in Patient #1’s home failed to evidence written instructions or treatments included in the plan of care. During an interview on 4/24/24, beginning at 3:30 p.m., the Administrator verbalized that the nurse places a care plan summary in the patient folder after admission and recertification. XX. An observation of a home visit for Patient #4 on 4/24/2024 at 1:50 PM failed to evidence a written schedule of visits. A review of the agency folder in the home evidenced a blank calendar of visits. During an interview on 4/24/2024 at 2:15 PM, Patient #4 indicated they did not receive a written schedule of visits from the agency. During an interview on 4/24/2024 at 2:15 PM, PT (Physical Therapist) 1 indicated they informed the patient of the visit schedule by calling before the visit. During an observation of a home visit on 4/29/24 for Patient #6 by RN 3, the folder contents did not include a written schedule nor a plan of care. During an interview with Patient #6 on 4/29/24 starting at 6:30 PM, it was stated that the RN informs him/her of the home visit by calling the same day. No written schedule provided. During an interview with Other #6, caregiver for Patient #6, on 4/25/24 at 4:02 PM, when asked how appointments are set up, it was stated he/she will attempt to set up times but the RN comes whenever she wants. During an interview with RN 3 on 4/24/24 starting at 3:05 PM, she stated she schedules her own visits and usually tries to work around the patient’s needs. During an interview on 4/24/24 starting at 3:30 PM, when asked if a visit schedule should be placed in the patient’s home folders, Administrator 1 indicated the nurse is responsible for filling out written schedules for patients.

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 observation and interview, the agency failed to provide the patient and caregiver in writing a calendar of the visit schedule for 1 of 1 home visit conducted with the home health aide. (Patient #3). The findings include: XX. During a home visit observation for Patient #1 on 4/23/24, beginning at 7:45 a.m., the home health agency folder was reviewed and there were no visit calendars found inside the folder. There was not a calendar of planned visits by agency staff present at the home. During an interview on 4/24/24, beginning at 3:30 p.m., the Administrator verbalized that the nurse fills out the patient’s monthly visit calendar located in the patient home folder. *During an observation of care at the home of Patient #3 on 4/25/2024, at 8:30 AM, the agency documents were reviewed and there failed to evidence in writing the treatments to be provided by the agency. On 4/25/2024, at 8:42 AM, the patient’s caregiver indicated there were no other agency documents in the home and could not recall receiving anything in writing about the treatments to be provided by the agency. On 4/24/2024, at 3:30 PM, the Administrator indicated the patients should be provided a plan of care summary for their written notice of treatments to be provided by the agency. During an observation of care at the home of Patient #3 on 4/25/2024, at 8:30 AM, the agency documents were reviewed and there failed to evidence in writing the treatments to be provided by the agency. On 4/25/2024, at 8:42 AM, the patient’s caregiver indicated there were no other agency documents in the home and could not recall receiving anything in writing about the treatments to be provided by the agency. On 4/24/2024, at 3:30 PM, the Administrator indicated the patients should be provided a plan of care summary for their written notice of treatments to be provided by the agency.

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, interview, and record review the agency nursing staff failed to follow acceptable standards of practice to prevent the transmission of infection during the provision of care in two of five active patient records with home visits (Registered nurse [RN] 2 and RN 3). Findings include: The agency policy titled “POLICY: HHC-02 INFECTION CONTROL”, revised 3/15/22, implements all staff with patient contact to follow universal precautions: gloves worn if contact with blood or fluids, handling soiled items and changed after contact with blood/body fluids. Wash hands immediately after gloves are removed. Patient care surfaces and equipment should be cleaned/decontaminated after contact with potentially infectious materials using soap and water or a bleach solution. The agency policy titled “POLICY: HHC-11 BAG TECHNIQUE”, revised 1/25/24, indicates a waterproof bag with 2-3 compartments to store items should be clean, using a waterproof non permeable barrier between the bag and surface. Wash hands or use hand sanitizer each time before entering bag. During an observation of a home visit on 4/29/24 of Patient #6 with RN 3 starting at 3:57 PM, the RN’s supply bag for the visit was a plastic bag containing an ipad and scissors which she placed on a non-decontaminated surface. A barrier was not used when placing bag on a table during the home visit. RN used copious amount of hand sanitizer and dried hands with a paper towel then prepared for wound care by placing paper towels on a clean table as a barrier for dressing supplies; some items did not fit on the barrier. She donned gloves and proceeded to clean bandage scissors (from her supply bag) with hand sanitizer. RN removed the towel and washcloth from Patient’s drawer, then lifted both lower legs and the towel was placed under them on the recliner. After placing two shopping bags on the floor (for discarded dressings), RN removed soiled dressings from both legs/feet. RN discarded dressings into bags while parts of soiled dressings landed on Patient’s floor. RN 3 removed gloves and prepared a basin of water. RN used hand sanitizer then dried hands with a paper towel and donned new gloves. RN proceeded to wash slough (dead skin) and irrigate (rinse with saline) both left and right legs / wounds while verbalizing a foul smell from wounds. RN removed their right glove and then applied two new gloves to their right hand without hand hygiene. Lotion was applied to the right and left legs, then gloves were removed and new gloves were donned without hand hygiene prior to don new gloves. RN opened sterile dressing supplies on a table and used bandage scissors to cut open the alginate (absorbent dressing) while letting the cut bandage package land on the sterile supplies. Without decontaminating the scissors, she used the scissors to then cut some of the (previously) sterile alginate dressings that were placed directly on Patient’s wounds. RN placed dressings to both legs and foot wounds. Before completion of right leg/foot dressing, RN took off the gloves from their right hand. RN then used hand sanitizer to their right hand and left gloved hand then proceeded to place a new glove to their right hand. After dressings were completed, RN cleansed scissors with hand sanitizer and placed inside of a clean glove then placed them in the plastic bag. During an interview on 4/24/24 starting at 3:30 PM, the Administrator indicated hands should be sanitized before and after glove change and before staff get into their supply bag. During a home visit observation of registered nurse (RN) 2 on 4/23/24 beginning at 1:45 p.m. with Patient #2, RN 2 placed a paper barrier on a chair, placed their visit bag on barrier, and after completing hand hygiene, RN 2 assembled vital sign equipment on a different, new barrier. RN 2 then applied alcohol - based hand sanitizer to his / her gloved hands. RN 2 then applied their face mask; patient was wearing a face mask. RN 2 gloves tore and they removed the torn gloves, and donned a clean pair of gloves, without completing hand hygiene. RN 2 then reapplied alcohol based hand sanitizer to their gloved hands and then performed a dressing change to Patient #2’s Hickman catheter, without utilizing sterile gloves and was observed to reapply alcohol-based hand sanitizer to his/her gloved hands throughout procedure. During an interview on 4/24/24, beginning at 3:30 p.m., the Administrator verbalized that agency staff expectation is to apply hand sanitizer before glove change and after glove change. 410 IAC 17-12-1(m)

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, interview, and record review the agency’s skilled professionals failed to provide services that are ordered by the physician as indicated in the plan of care in one of five active patient records with home visits (Patient #6) Findings include: The clinical record of Patient #6’s plan of care (POC) evidenced a specified wound care order as follows: wash toes to bilateral feet with soap and water, use antibacterial soap, apply collagen powder(for wound healing and tissue regeneration) to bilateral(left and right) feet excoriated area between toes, place Hydrofera blue (antibacterial wound dressing) dressing to bilateral feet between toes, place ABD (thick, absorbent dressing) over toes, wrap in coban wrap (self-adherent mild compression wrap), 4 inch ace wrap(stretchable compression wrap) from mid foot to above each ankle, Surepress (high compression bandage) wrap bilaterally from above ankle to below knee, tape in place, apply socks followed by 6 inch ace wrap from above ankle to below knee. Interventions included skilled nurse (SN) to perform irrigation. During an observation of Patient #6 with RN 3 on 4/29/24 starting at 3:57 PM, wound care provided to Patient’s right and left lower leg/foot/toes was not consistent with specified wound care orders. RN failed to evidence use of antibacterial soap, collagen powder, or Hydrofera blue for wound care. The clinical record evidenced verbal physician orders dated 4/23/24 for new wound care orders with a start date (backdated) to 1/3/24. During an interview with RN 3 on 4/24/24 starting at 3:05 PM, RN denies use of Hydrofera Blue, indicating she washes the wound with baby soap and uses alginate (absorbent wound dressing) on the wounds instead.

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 agency failed to ensure skilled professionals prepared complete and accurate visit notes in 2 of 2 records reviewed of patients with a home visit, not receiving skilled nursing services (Patient #3, 4). The findings include: *A clinical record for Patient #3 evidenced a comprehensive assessment completed by RN 5 on 4/15/2024, which indicated the patient’s supplies included tracheostomy (a tube inserted into a surgically hole in the neck to assist with breathing) and urinary catheter (a tube inserted into the bladder to drain urine). During an observation of care at the patient’s home on 4/25/2024, at 8:30 AM, the patient was not observed to have a tracheostomy or urinary catheter. On 4/26/2024, at 2:42 PM, Registered Nurse (RN) 5 indicated the patient did not have a tracheostomy or urinary catheter and she made an error in her clinical note. 1. During a home visit on 4/24/2024 at 1:50 PM, Patient #4 was observed using a motorized scooter and a walker to transfer. In a physical therapy evaluation note dated 4/5/2024, PT (Physical Therapist) 1 indicated the Patient had no DME (durable medical equipment) or assistive devices. The evaluation indicated the patient had a goal to improve ability to self-care, a decreased ability to perform ADL’s (activities of daily living), and impaired functional mobility. The note failed to evidence a functional assessment related to ADL’s or aerobic capacity / activity tolerance. During an interview on 4/24/2024 at 3:11 PM, the Administrator indicated PT 1 should have documented equipment in the home that the patient used in their assessment, and that PT 1 probably did not assess the Patient’s ADL’s because they did not think it applied to their care plan. When informed it was a patient goal, the Administrator offered nothing further.

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 agency failed to assign tasks appropriately to the home health aide in 1 of 2 active clinical records reviewed with home health aide (HHA) services. (Patient #3) The findings include: During an observation of care at the home of Patient #3 on 4/25/2024, at 9:09 AM, the patient was observed ambulating with the use of a walker. The patient was not observed to use oxygen. A clinical record review of the “Multidisciplinary Care Plan” with an effective date of 3/12/2020 indicated the HHA was to assist the patient with ambulation with the use of a cane, crutches, walker, and oxygen. The HHA care plan indicated the HHA was to assist with a home exercise program and failed to evidence directions to what was included in the home exercise program. On 4/25/2024, at 9:09 AM, HHA 1 indicated the patient used a walker to ambulate and did not use oxygen. HHA 1 indicated the home exercise plan was developed by a physical therapist “a long time ago” and did not know what was included since she had not looked at it. On 4/26/2024, at 2:42 PM, Registered Nurse (RN) 5 (case manager for the patient) indicated the patient did not use oxygen and used a walker to ambulate. RN 5 indicated she was unsure why the HHA care plan included ambulation with the use of a cane, crutches, and oxygen. RN 5 indicated she was unsure if there was a written home exercise plan. 410 IAC 17-14-1(m)

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health aide (HHA) failed to provide services as directed in the plan of care in 1 of 2 active clinical records reviewed with home health aide (HHA) services. (Patient #3) The findings include: A clinical record review for Patient #3 evidenced the “Multidisciplinary Care Plan” with an effective date of 3/12/2020, which indicated the HHA was to document bowel movements. Review of HHA visit notes completed by HHA 1 on 4/1/2024 - 4/3/2024, 4/5/2024, 4/8/2024-4/10/2024 - 4/12/2024, 4/15/2024 - 4/19/2024, 4/22/2024, and 4/23/2024 indicated the HHA marked “Done” for documenting bowel movements but failed to evidenced any documentation of bowel movements. On 4/25/2024, at 9:09 AM, HHA 1 indicated the patient had a bowel movement in the mornings before she arrived for her shift, and she did not document the bowel movement other than marking “done” on the visit note. On 4/29/2024, at 12:21 PM, the Administrator indicated the HHA was to document if the patient had a bowel movement.

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, interview, and record review the agency failed to provide services in accordance with current clinical practice guidelines and accepted professional standards of practice in two of five active patient records with home visits (Patient #5, 6). Findings include: XX. During a home visit on 4/24/2024 at 11:20 AM, Patient #5 was wearing bilateral AFO’s (braces for the feet to lower legs). Observation of LPN (Licensed Practical Nurse) 1’s assessment of the Patient failed to evidence removal of the AFO’s for assessment of the patient’s skin. A review of the plan of care for certification period 3/9/2024 to 5/7/2024 evidenced Patient #5 was on skin breakdown prevention precautions. During an interview on 4/24/2024 at 11:47 AM, LPN 1 indicated she did not remove the AFO’s because the Patient did not like it. During an interview on 4/25/2024 at 12:25 PM, RN (Registered Nurse) 4 (case manager for Patient #5), indicated she saw the patient for re-certification assessments every 60 days, and had not removed the Patient’s AFO’s to assess the Patient’s skin. RN 4 indicated the Patient’s family member would tell them if there was a problem with the patient’s skin. During an interview on 4/29/2024 at 3:38 PM, the Administrator indicated the RN should have performed a full head-to-toe assessment, including removing the Patient's AFO's, at each recertification assessment. The agency policy titled “POLICY: CC-25.1 ASSESSMENT AND REASSESSMENT GUIDELINES”, last reviewed 1/28/23, indicates staff will adhere to appropriate assessment guidelines with the use of appropriate Standards of Practice. “Standards of Professional Nursing”, an agency training reference, indicates the registered nurse collects comprehensive data assessments in an ongoing process, prioritize data collected, and prioritize data collection based on immediate condition to implement a plan for the promotion and restoration of health. The agency policy titled “POLICY CC-40 PAIN MANAGEMENT”, revised 1/28/23, indicates patients experiencing pain will be assessed for appropriate interventions and management including the for the nature and intensity of pain. Clinical record of Patient #6 evidenced a comprehensive assessment completed by RN 3 on 3/5/24 which included Patient diagnoses of chronic obstructive pulmonary disease (lung disease) on home oxygen, congestive heart failure, lymphedema (swelling disorder), and neuropathy (nerve damage). During an observation of a recertification home visit with Patient #6 and RN 3 on 4/29/24 starting at 3:57 PM, RN failed to evidence a stethoscope in supplies which lead to no assessment of breath sounds, heart sounds, or bowel sounds. RN failed to evidence a thermometer which lead to no temperature measurement taken during comprehensive assessment. During wound dressing changes, RN commented on the foul odor (sign of bacterial infection) from wounds. During wound changes, Patient verbalized pain on multiple occasions. RN failed to assess Patient’s pain level during visit. RN failed to evidence assessment of pedal (foot) pulses (to assess perfusion of lower limbs). RN assessed the left radial (wrist) pulse for ten seconds. During an interview with RN 3 on 4/30/24 starting at 4:03 PM, she stated she forgot her stethoscope for the home visit. When asked how she assessed perfusion, she revealed Patient has good circulation and she checked a radial pulse. When asked how pain is assessed, she indicated that Patient would let her know when it hurts. During an interview with Patient #6 after a home visit on 4/29/24 starting at 6:30 PM, Pain assessment revealed 2-3 (out of 0-10 pain scale) pain at rest and moderate/strong pain measured at 6-7 during the dressing change.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record included all interventions and responses to those interventions in 1 of 1 active records receiving physical therapy services only (Patient #4). The findings include: A review of physical therapy visit notes for Patient #4 dated 4/11/2024, 4/15/2024, 4/17/2024, and 4/24/2024 failed to evidence how the Patient tolerated therapy. During an interview on 4/29/2024 at 3:11 PM, the Administrator indicated patient tolerance of therapy should be assessed and documented in the visit notes, but it was not.

Goals in the patient's plans of care CFR(s): 484.110(a)(3) Goals in the patient's plans of care and the patient's progress toward achieving them; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient’s clinical record included progress toward goals in 1 of 1 active records receiving physical therapy services only (Patient #4). The findings include: A review of physical therapy visit notes for Patient #4 dated 4/11/2024, 4/15/2024, 4/17/2024, and 4/24/2024 failed to evidence progress toward goals. During an interview on 4/29/2024 at 3:11 PM, the Administrator indicated patient progress toward goals should be measured and documented in the visit notes, but they were not.

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 record entries were legible, clear, complete and appropriately authenticated in 5 of 12 records reviewed receiving skilled nursing or therapy services (Patient #4, 5, 6, 7, 10). Findings include: The clinical record for Patient #6, included verbal orders obtained and entered by RN 3, noted signature on file. One of the orders was dated 4/23/24 at 4:16 PM for wound care that was back dated to start 3/03/24; this order changed the frequency of the skilled nurse visits, decreased the visits from 3 times a week to 2 for week [1, 2, 3, 4, 5, 6, 7, 8, or 9] of the certification period where there was a missed skilled nurse visit. Another verbal order was entered on 4/24/24 at 4:14 PM, for wound care that was back dated to begin on 01/03/24. During an interview with RN 3 on 4/24/24 starting at 3:05 PM, when asked how she obtained orders for wound care of Patient #6 on 4/23/24, RN relayed she didn’t contact the doctor. She recalled the last time she called the doctor to obtain an order for Patient was at the beginning of March (2024). RN stated she did not obtain these orders. During an interview with Administrator 1 on 4/24/24 starting at 12:42 PM, when asked about orders entered on 4/23 and 4/24 by RN 3 that were denied being entered by RN 3, she indicated that Administrator 2 was entering the orders for patients with wounds. The clinical record of Patient #6 evidenced a plan of care for certification period 1/3/24 to 3/2/24 that was signed by Administrative staff #4 with a title of RN on 3/17/24. Personnel records evidenced Administrative staff #4 is not an RN. During an interview on 4/29/24 with Administrative staff #4, she relayed her (RN) license is expired therefore she cannot take orders. Her part in the plans of care for patients is to verify diagnoses, interventions and goals. * Clinical record for Patient #10 with start of care date of 1/6/24 for certification period 1/6/24 – 3/5/24 failed to evidence all orders within the plan of care were obtained by a licensed clinician. This plan of care was signed by a non-clinical staff. 42 CFR 484.115 (k) defines a registered nurse as a graduate of an approved school of professional nursing who is licensed in the state they are practicing. During an interview on 5/1/24 beginning at 2:30 pm the Administer indicated that the non-clinical staff that signed the document was previously a Registered Nurse but due to issues in another state they were not licensed in Indiana. *A clinical record review for Patient #7 evidenced a plan of care for certification period 2/14/2024-4/13/2024, which was signed by Administrative Staff 4 on 2/27/2024 and failed to be signed by a clinician. On 4/29/2024, at 11:19 AM, Administrative Staff 4 indicated she did not have a current nursing license or other clinical licensure. 1. A policy titled “Contents of the Clinical Record”, revised 1/28/2023, indicated all clinical record entries were to be legible, clear, complete, and appropriately authenticated, and authentication must include signatures or “secured computer entry of POT’s [plan of treatment] obtained master”. 2. A review of a skilled nurse visit note dated 3/5/2024 by the Administrator evidenced a section titled “Patient Signature”, which stated, “Visit date and time confirmed by [Patient #8] with signature captured on 3/5/2024 12:41 CST”, followed by a signature by LPN (licensed practical nurse) 1. During an interview on 4/29/2024 at 2:38 PM the Administrator indicated the patient should sign the clinician’s electronic device to confirm the visit. If unable to sign, a family member may sign for the patient. The administrator indicated Patient #8 was cognitively unable to confirm a visit. 3. A review of an Interdisciplinary Group Meeting note for Patient #4 on 3/27/2024 evidenced a narrative note describing Person 4, a patient who was bedbound, had multiple wounds, and a leg amputation. Observation of a home visit on 4/24/2024 at 1:50 PM evidenced Patient #4 was not bedbound, had no wounds, and no amputations. During an interview on 4/29/2024 at 3:00 PM, the Administrator indicated the narrative in the note was about the wrong patient. 4. A review of the plan of care for certification period 3/9/2024 to 5/7/2024 indicated Patient #5 was homebound due to the following assessment: unable to ambulate more than a few minutes or a few feet without falling due to poor balance and extreme fatigue, very short of breath with minimal exertion and needed to stop and sit to rest every few minutes, required the assistance of another person to ambulate at all times due to unsafe gait pattern and cardiopulmonary disease. The plan of care failed to evidence a cardiopulmonary diagnosis or medications. In a comprehensive assessment dated 3/8/2024, RN (Registered Nurse) 4 indicated the Patient was paraplegic and non-ambulatory. During an interview on 4/24/2024 at 11:26 AM, LPN 2 indicated the Patient was able to transfer self with assistance but could not ambulate. During an interview on 4/25/2024 at 12:23 PM, RN 4 (case manager for Patient #5) indicated they were not aware of the Patient having cardiovascular problems. On 4/29/2024 at 3:41 PM, when informed of the findings, the Administrator indicated the homebound assessment in the plan of care did not describe Patient #5, and it was probably incorrectly transferred from another patient’s assessment.

This visit was a recertification, re-licensure, emergency preparedness, and complaint survey with 4 complaints. The survey visit took place 9/24/2021, 9/27/2021 to 10/1/2021, 10/4/2021 to 10/8/2021, and 10/12/2021. Facility ID: IN005336 At this Emergency Preparedness survey, in regards to staffing and implementation of staffing, Anchor Home Health Care was found to be in compliance with 42 CFR 484.102 Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers for Home Health Agencies.

This visit was a recertification, re-licensure, emergency preparedness, and complaint survey with 4 complaints. The survey visit took place 9/24/2021, 9/27/2021 to 10/1/2021, 10/4/2021 to 10/8/2021, and 10/12/2021. Facility ID: IN005336 Complaint: IN00339367-substantiated Complaint: IN00330235-substantiated Complaint: IN00323527-unsubstantiated Complaint: IN00319960-unsubstantiated These deficiencies reflect State Findings cited in accordance with 410 IAC 17. Refer to state form for additional state findings.

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 agency failed to ensure the identified goals on the plan of care were achieved prior to discharge in 1 of 5 closed records, in a total sample of 17 clinical records reviewed. (#16) The findings include: Review of an agency policy titled “Initial Patient/Client Assessment” revised on 10/22/2015, stated “Policy: It is the policy of ANCHOR Home Health Care (ANCHOR) to initiate discharge of a patient/ client from Home Care Services when either homecare goals are met, services are no longer medically justified, care can no longer be safely rendered in the home, the source of reimbursement has changed, the patient/ client refuses services, the patient/ client no longer meets applicable regulatory criteria, or the agency is unable to locate the patient/ client ... Purpose: 1. To provide for the appropriate discharge ... Procedure: … 3. patient/ client has been an active service, the clinical supervisor or a professional field staff member may subsequently determine that the patient/ client will be discharged for the following: 3.1 The homecare goals are met ….” Clinical record review on 10/8/2021, for patient #16, start of care 5/4/2021, primary diagnosis of osteomyelitis [bone infection] of the left foot and ankle, evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 5/4/2021 – 7/2/2021. A section of this document subtitled “Goals” stated, "SN [skilled nurse]: Complete healing of wound without complication … SN: Patient will complete IV [intravenous] antibiotic therapy without incident … “ Another area of this document stated, “Discharge: When goals are met ….” Record review evidenced an agency document titled “Discharge OASIS-D1”which was dated 5/19/2021. This document had a section subtitled “Care Plan Documentation” that stated “Problem – Antibiotic Therapy … Goal – Patient will complete IV antibiotic therapy without incident … Progress - 90% … Problem – Wound Care. Lt Foot … Goal – Complete healing of wound without complication … Progress – 90% ….” Review evidenced the goals were 90% complete. Record review evidenced an agency document titled “Discharge Summary” which was signed by administrator A on 10/1/2021. This document had an area subtitled “Status of Patient Goals/Outcomes” which stated “Goals Met …” Another area stated “Summary … Patient seen for infusion Goals were met and PICC [peripherally inserted central catheter] was pulled in MD’s office. Patient discharged from agency ….” Review failed to evidence goals were met. During an interview on 10/8/2021, at 3:53 p.m., administrator A indicated they would say the goals were met because there were no complications with the wound while Anchor was providing services.

Provide contact info other services CFR(s): 484.50(d)(5)(iii) (iii) Provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care; and This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide the patient with contact information for other agencies who may be able to provide care in 1 of 1 discharged patient records receiving home health aide services (#14). The findings include: Record review on 10/12/2021 evidenced an agency policy titled, “CLIENT RIGHTS AND RESPONSIBILITIES”, revised 5/2015, which stated, “ … You have the right to … Be admitted for care on the basis of reasonable expectation that your needs can adequately be met … Anchor Home Health Care will refer you elsewhere if they are unable to provide this level of care….” Record review evidenced an agency policy titled, “POLICY: CC-07.1 PATIENT / CLIENT DISCHARGE”, revised 10/22/2015, which stated, “ … Once the determination has been made to discharge the patient / client, the following steps must be implemented: … 4.1.3 Identify or assist with arrangement for services to meet the patient / client’s needs when indicated….” Clinical record review on 10/5/2021 for patient #14, start of care 5/31/2019, certification period 7/24/2020 to 9/21/2020, primary diagnosis of Hemiplegia following cerebral infarction affecting left side [left-sided paralysis after a stroke], evidenced a group of agency documents identified by the administrator as communication notes. A communication note dated 8/19/2020, signed by former employee F, stated, “ … Patient remains on hold at present time due to being on recruitment for CNA / HHA [certified nursing assistant / home health aide]. Pt husband is aware and will continue to recruit staffing.” A communication note dated 9/21/2020, signed by former employee G, stated, “There are no HHA’s available for this case. Discharging due to cert [certification] period ending.” Clinical record review failed to evidence the patient / caregiver was provided contact information for other agencies who may be able to provide care. During an interview on 10/4/2021, at 3:25 p.m., person H, spouse of patient #14, indicated the home health aides stopped coming to their home. Person H indicated the agency claimed to not have an available aide. Person H indicated Anchor Home Health did not provide contact information for other agencies who may be able to provide care. Person H indicated they had to find help on their own, because patient #14 still required “a lot of help”. During an interview on 10/12/2021, at 12:03 p.m., the administrator indicated patient #14 was discharged because they were no longer able to staff the case. When queried if the agency provided contact information for other agencies to provide care, the administrator stated, “He found it on his own”.

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 included the patient's current health status in 1 of 3 patient records with an active wound (#4). The findings include: Record review on 10/12/2021 evidenced an agency policy titled, “POLICY: CC-25 INITIAL PATIENT / CLIENT ASSESSMENT”, revised 11/11/2015, which stated, “POLICY: … The initial assessment visit is conducted to determine the immediate care and support needs of the patient / client The initial assessment is a comprehensive assessment … The Physician’s Plan of Care is developed and implemented based upon the problems and / or needs identified during the assessment process….” Record review evidenced an agency policy titled, “POLICY: CC-50 SAFETY MANAGEMENT”, dated 8/30/2004, which stated, “POLICY: Anchor personnel will complete an initial safety assessment … PURPOSE: To assure patient / clients are as safe in their residence as possible. PROCEDURE: 1. A safety assessment is done on admission 1.1 A safety checklist is completed. 1.2 Unsafe items identified will be addressed with the patient / client / caregiver. 2. Safety issues which occur during the course of service will be addressed with the patient / client / caregiver.” Clinical record review on 9/29/2021, for patient #4, start of care 8/23/2021, certification period 8/23/2021 to 10/21/2021, primary diagnosis of Pressure ulcer of sacral region, unstageable, evidenced an agency document titled, “SOC [start of care] OASIS [the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality]- D1”, dated 8/24/2021, signed by RN [registered nurse] F. This assessment had a subsection titled, “MAHC-10 FALL RISK ASSESSMENT TOOL”, which stated, “Required Core Elements … Age 65+ … No … Diagnosis (3 or more co-existing) … Yes, 1 pt. … Prior history of falls within 3 months … No … Incontinence … No … Visual impairment … No … Impaired functional mobility … Yes, 1 pt. … Environmental hazards … No … Poly Pharmacy (4 or more prescriptions – any type) … Yes, 1 pt. … Pain affecting level of function … No … Cognitive impairment … A score of 4 or more is considered at risk for falling … Total – 3” Clinical record review evidenced an agency document titled, “Home Health Care Certification and Plan of Care” for certification period 8/23/2021 to 10/21/2021 , which indicated the patient’s date of birth was 3/13/1956. The patient’s age at start of care was 65. During a home visit for patient #4 on 9/29/2021, at 12:00 p.m., the patient’s home was observed to be very cluttered. The patient was observed struggling to navigate their rolling walker through boxes, clothing, shoes, and other items. During an interview on 9/29/2021, at 12:04 p.m., patient #4 indicated they were unable to clean up the house, and it had gotten bad since their spouse passed away at the beginning of the year. During an interview on 10/12/2021, at 9:56 a.m., the administrator indicated the comprehensive assessment should have indicated patient #4 was a fall risk. 17-14-1(a)(1)(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 record review and interview, the agency failed to ensure a medication review was performed to identify high-risk medications for 1 of 3 patients receiving wound care treatments, from a total sample of 17 clinical records reviewed. (#7) The findings include: Review of an agency policy titled “High-Alert Medications” revised in 2014, stated “Policy … Agency staff will appropriately manage high-alert medications ... Purpose … To define high-alert medications … Procedure … 1. The following medications have been identified by the Agency as high-alert medications: Insulin … Narcotics … Antithrombotic agents (anticoagulants) … Oral hypoglycemics … TPN … 2. Agency staff will implement defined policies, procedures and processes for medication storage, ordering, transcribing, preparation, administration and monitoring for those high-alert medications ….” Review of an agency policy titled “Initial Patient/Client Assessment” revised on 11/11/2015, stated “Policy: It is the policy of ANCHOR Home Health Care (ANCHOR) that a qualified professional must complete an initial assessment within 48 hours of initiation of services. The initial assessment visit is conducted to determine the immediate care in support needs of the patient/ client, and if Medicare, determine eligibility for the home health benefit, including homebound status ... Purpose: … To collect the database information required to develop an individualized plan of care that meets the needs of each adult patient/client referred for services … Procedure: … 3. The physician’s Plan of Care is developed and implemented based upon the problems and/or needs identified during the assessment process … 8. The initial assessment includes a drug regimen review, verification of payment eligibility requirements, and the ability of Anchor to meet the patient/clients medical, nursing, therapy and social needs…. “ Clinical record review on 10/12/2021, for patient #7, start of care 8/25/2021, pertinent diagnoses include but are not limited to atrial fibrillation (is an irregular heart rhythm which can lead to blood clots in the heart), hypertension (high blood pressure), and heart failure (condition that develops when the heart doesn't pump enough blood for the body's needs), evidenced an agency document titled “SOC [Start of Care] OASIS-D1” dated 8/25/2021, and signed by RN H. This document had an area subtitled “Medications – Medication Regimen” which stated “(M2010) Patient/Caregiver High Risk Drug Education … Has the patient/caregiver received instruction on special precautions for all high-risk medications (such as hypogycemics, anticoagulants, etc.) and how and when to report problems that may occur? … NA [not applicable] – Patient not taking any high risk drugs OR patient/caregiver fully knowledgeable about special precautions associated with all high-risk medications …” An area subtitled “Narrative Notes” stated, “… [Patient #7] States [he/she] was told on Monday [he/she] is a diabetic and an Accucheck glucometer [portable machine used to check blood glucose levels] was deliver [sic] with supplies. States a nurse from [Entity J] is coming to teach [him/her] how to use the machine this week ….” Record review of an agency document titled “Home Health Care Certification and Plan of Care” evidenced an area subtitled “Medications” which indicated the patient was prescribed Eliquis (an anticoagulant; blood thinning medication),Glipizide (oral hypoglycemic medication), Pregabalin (controlled substance, used to treat nerve pain). Review evidenced the patient was prescribed 3 high-alert medications. Review evidenced the patient was a newly diagnosed diabetic. During an interview on 10/12/2021, at 10:37 a.m., when queried if this patient was taking any high alert medications, administrator A indicated some people would say Eliquis or diazepam are high-risk medications. Administrator A indicated “high-risk” would imply the medication requires lab management, chemo drugs, or a newly diagnosed patient who is not stabilized on their medications yet. Administrator A further indicated Eliquis was not a new medication for the patient.

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 ensure each patient received the treatments and services as prescribed on the individualized plan of care for 9 of 17 clinical records reviewed. (#1, #3, #6, #7, #9, #11, #12, #13, #17) The findings include: 6. Clinical record review on 9/27/2021, for patient #1, start of care 3/24/2017, certification period 8/30/2021 to 10/28/2021, primary diagnosis of Duchenne or Becker muscular dystrophy, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician on 9/27/2021. The plan of care had a subsection titled, “Orders / Treatments:”, which stated, “ … Administer care of feeding tube—Cleanse GT [gastrostomy tube-a tube placed through the abdomen into the stomach for feeding] site with sterile H2O, apply antibiotic ointment & cover w/ split 2 x 2 drain sponge daily & PRN [as needed] … Monitor ventilatory pattern, settings, connections, alarms monitor … change bedside circuit q week, backup circuit every other week, humidivent q use daily cascade q month blue pall filter q month … Perform ventilator care—Change main vent [ventilator] circuits q [every] 1-2 weeks, Change suction canister & humidity canister q month & change back up vent circuit q month….” During an interview on 9/27/2021, at 3:40 p.m., LPN J indicated the patient decided what topical medications were used for gastrostomy tube site care. LPN J stated, “Sometimes [patient #1] wants triple antibiotic ointment, sometimes [patient #1] wants Desitin”. The plan of care failed to evidence Desitin. Clinical record review evidenced a group of agency documents titled, “Skilled Nursing Visit Note”. Review of the nurse’s notes failed to evidence when bedside circuits, backup circuits, humidivent, cascade, blue pall filter, suction canister, and humidity canister were changed. During an interview on 10/8/2021, at 1:29 p.m., the administrator indicated gastrostomy tube site care should be completed as written in the plan of care. During an interview on 10/8/2021, at 1:32 p.m., the administrator indicated the tasks of changing bedside circuits, backup circuits, humidivent, cascade, blue pall filter, suction canister, and humidity canister were documented in a treatment record in the home, but were not entered into the patient’s medical record. 7. Clinical record review on 9/29/2021 for patient #3, start of care 4/6/2021, certification period 8/4/2021 to 10/2/2021, primary diagnosis of Primary pulmonary hypertension, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician on 8/28/2021. The plan of care had a subsection titled, “Orders / Treatments”, which stated, “ … Discipline Orders Physical Therapy; 2-3 wk 8 wk [2 to 3 times a week for 8 weeks … The Physician will be notified of vital signs outside the following established parameters; Adult Vital Sign Normal Ranges; BP [blood pressure] 180/100; P [pulse] 110 (resting); T [temperature] 101.0 F (orally); R [respirations] 24….” Clinical record review evidenced a group of agency documents titled, “Physical Therapy Visit Notes”. Physical therapy notes with the following dates failed to evidence a patient temperature: 8/23/2021, 8/25/2021, 8/27/2021, 8/30/2021, 9/1/2021, 9/3/2021, 9/9/2021, 9/10/2021, 9/14/2021, 9/16/2021, 9/17/2021, 9/21/2021, 9/23/2021, 9/24/2021, 9/28/2021. Physical therapy notes with the following dates failed to evidence a patient respiratory rate: 8/23/2021, 8/25/2021, 8/27/2021, 8/30/2021, 9/1/2021, 9/3/2021, 9/9/2021, 9/10/2021, 9/14/2021, 9/16/2021, 9/17/2021, 9/21/2021, 9/23/2021, 9/24/2021, 9/28/2021. Physical therapy notes with the following dates failed to evidence a patient blood pressure: 9/16/2021, 9/17/2021, 9/21/2021. During an interview on 10/12/2021 at 9:26 a.m., the administrator indicated vital signs should be done at least once by the physical therapist at each visit, and should include temperature, pulse, respiratory rate, and blood pressure. 8. Clinical record review for patient #11, start of care 1/31/2019, certification period 1/31/2019 to 3/31/2019, primary diagnosis of Diverticuli [small bulging areas] of intestine, evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, signed by the physician on 5/21/2019 ( 51 days after certification period ended). The agency failed to ensure the patient received care from a plan established by and signed by the physician. During an interview on 10/12/2021, at 10:45 a.m., the administrator indicated the agency did not have an expected timeframe for obtaining a physician’s signature on a patient’s plan of care. The administrator stated, “Ideally sooner than later”. When informed of the findings, the administrator offered no further information. 9. Clinical record review on 10/6/2021, for patient #12, start of care 5/10/2020, certification period 7/4/2021 to 9/1/2021, primary diagnosis of Crohn’s disease, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician on 9/3/2021 ( 2 days after certification period ended). The agency failed to ensure the patient received care from a plan established by and signed by the physician. During an interview on 10/8/2021 at 4:00 p.m., the administrator stated the plan of care was “not signed in time”. 10. Clinical record review on 10/4/2021, for patient #13, start of care 8/18/2021, certification period 8/18/2021 to 10/16/2021, primary diagnosis of Parkinson’s disease, evidenced an agency document titled, Home Health Care Certification and Plan of Care”. The plan of care failed to evidence a physician signature. During an interview on 10/12/2021, at 10:51 a.m., the administrator indicated the agency failed to obtain a copy of the plan of care signed by the physician. Clinical record review for patient #13, start of care 8/18/2021, certification period 8/18/2021 to 10/16/2021, primary diagnosis of Parkinson’s disease, evidenced an agency document titled, Home Health Care Certification and Plan of Care”. The plan of care had a subsection titled, “Orders / Treatments:”, which stated, “ … The Physician will be notified of vital signs outside the following established parameters:; Adult Vital Sign Normal Ranges:; BP [blood pressure] 180/100 ; P [pulse] 110 (resting) ; T [temperature] 101.0 F (orally); R [respirations] 24….” Clinical record review evidenced a group of agency documents titled, “Physical Therapy Visit Notes”. Physical therapy notes with the following dates failed to evidence a patient temperature: 8/19/2021, 8/24/2021, 8/28/2021, 8/30/2021, 9/1/2021, 9/22/2021, 9/24/2021, 9/29/2021. Physical therapy notes with the following dates failed to evidence a patient respiratory rate: 8/19/2021, 8/24/2021, 8/28/2021, 8/30/2021, 9/1/2021, 9/22/2021, 9/24/2021, 9/29/2021. During an interview on 10/12/2021, at 9:26 a.m., the administrator indicated vital signs should be done at least once by the physical therapist at each visit, and should include temperature, pulse, respiratory rate, and blood pressure. Review of a physical therapy visit note dated 9/1/2021, signed by PT L, had a subsection titled, “VITAL SIGNS”, which stated, “ … Pulse 137 beats/min … At Rest….” The visit note had a subsection titled, “NARRATIVE NOTES”, which stated, “Vitals taken multiple times, persistent LOB and increase heart rate, patient and wife advised on going to ER for check up. Patient insisted on “resting” at home for a while”. Review of the clinical record failed to evidence physician notification of the out-of-range pulse rate. During an interview on 10/12/2021, at 11:05 a.m., the administrator indicated PT L should have notified the physician of the elevated pulse rate and documented that communication in the patient’s record. When informed of the findings, the administrator indicated the visit note failed to evidence physician notification of the elevated pulse rate. Clinical record review for patient #13, start of care 8/18/2021, certification period 8/18/2021 to 10/16/2021, primary diagnosis of Parkinson’s disease, evidenced an agency document titled, Home Health Care Certification and Plan of Care”. The plan of care had a subsection titled, “Orders / Treatments:”, which stated, “ … Interventions … SN [skilled nurse]: Teach to monitor weight….” Clinical record review evidenced a group of agency documents titled, “Skilled Nursing Visit Note”. Each of these notes failed to evidence monitoring or teaching patient to monitor weight. On 10/12/2021, at 11:07 a.m., when informed of the findings, the administrator offered no further information. 11. Clinical record review on 10/7/2021 for patient #17, start of care 6/8/2021, certification period 6/8/2021 to 8/6/2021, primary diagnosis of Covid-19, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician 7/15/2021. The plan of care had a subsection titled, “Orders / Treatments:”, which stated, “ … The Physician will be notified of vital signs outside the following established parameters:; Adult Vital Sign Normal Ranges:; BP [blood pressure] 180/100 ; P [pulse] 110 (resting) ; T [temperature] 101.0 F (orally); R [respirations] 24….” Clinical record review evidenced an agency document titled, “ROC [resumption of care] OASIS [the patient-specific, standardized assessment used in Medicare home health care]- D1….”. Dated 6/16/2021, and signed by PT L. Review of the resumption of care assessment failed to evidence a patient temperature and a patient respiratory rate. Clinical record review evidenced a group of agency documents titled, “Physical Therapy Visit Notes” dated 6/23/2021, and 6/30/2021, signed by PT L. Each of the physical therapy notes failed to evidence a patient temperature. Each of the physical therapy notes failed to evidence a patient respiratory rate. During an interview on 10/12/2021, at 9:26 a.m., the administrator indicated vital signs should be done at least once by the physical therapist at each visit, and should include temperature, pulse, respiratory rate, and blood pressure. Clinical record review evidenced an agency document titled, “ROC [resumption of care] OASIS [the patient-specific, standardized assessment used in Medicare home health care]- D1….” Dated 6/16/2021, and signed by PT L. The resumption of care assessment had a subsection titled, “VITAL SIGNS”, which stated, “ … Pulse 115 bpm [beats per minute] … At Rest Vital Sign entered is outside the acceptable range for this patient (60 – 100). Action taken – Followed / Documented appropriate Care Plan Interventions….” Clinical record review failed to evidence physician notification of the elevated heart rate. During an interview on 10/12/2021, at 11:05 a.m., the administrator indicated PT L should have notified the physician of the elevated pulse rate and documented that communication in the patient’s record. When informed of the findings, the administrator indicated the visit note failed to evidence physician notification of the elevated pulse rate. 17-13-1(a) 1. Review of an agency policy titled “Physician’s Plan of Care” revised on 9/28/2015, stated “Policy: It is the policy of ANCHOR Home Health Care (ANCHOR) that home health care services are furnished under the general supervision of a doctor of medicine, osteopathy, podiatrist, dentistry, chiropractic or optometry based on a written Plan of Care that is established and periodically reviewed by the doctor to ensure the appropriateness and necessity of Home Care Services relative to the patient/ clients condition. All clinical services are implemented only in accordance with a plan of care established by a physicians written orders ... Scope: Applies to all patient/ clients receiving skilled home health care services through ANCHOR Home Health Care, and/or who require a Physician’s Plan of Care … Procedure: 1. Home Health care services are provided to patient/ clients under the general supervision of a physician and in accordance with Physician’s Orders … 4. As a result of the consult, a Plan of Care, reflecting orders for services and frequencies is developed and sent to the physician and confirmed treatment by the MD [doctor of medicine] signature ... 5. The Physician’s Plan of Care shall cover primary and secondary diagnosis and include, but is not limited to the following: ... 5.4 Types of services and equipment required ... 5.5 Frequency and duration of visits ... 5.16 Any other appropriate items … 10. In review and signature of the plan of care and or/ verbal orders, the MD is: 10.1 Diagnosing and treating medical conditions ... 10.2 Prescribing medications and therapeutic regimens ... 10.3 Developing and forward or authorizing the plan of care ….” 2. Clinical record review on 10/8/2021, for patient #9, start of care 8/17/2021, pertinent diagnosis of feeding difficulties, evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 8/17/2021 – 10/15/2021, and signed by the physician on 9/27/2021. This document had an area subtitled “Orders/Treatments:” that stated “Skilled Nursing; 2 wk 9 [twice a week, for 9 weeks] … Additional Services … The physician will be notified of vital signs outside the following established parameters … Child 3-6 years Vital Signs Normal Ranges ….” Review failed to evidence the skilled nurse frequencies were met as ordered on the plan of care. Review failed to evidence vital signs were taken as ordered on the plan of care. Record review of agency documents titled “Skilled Nursing Visit Note” evidenced a skilled nurse visit was made on 8/17/2021, which indicated to be start of care admission visit, and was signed by Administrator A on 9/27/2021. Review of this document failed to evidence vital signs were assessed, including, but not limited to blood pressure, heart rate, temperature, and respirations. Record review of agency documents titled “Skilled Nursing Visit Note” evidenced a skilled nurse visit was made on 8/26/2021, which was signed by Clinical Supervisor C on 8/30/2021. Review of this document failed to evidence vital signs were assessed, including, but not limited to blood pressure, heart rate, temperature, and respirations. Review failed to evidence a second visit was made for the week of 8/22/2021 – 8/28/2021. Review failed to evidence the physician was notified of the missed visit. During an interview on 10/8/2021, at 3:30 PM, administrator A indicated missed visit and physician notification was not documented in the clinical record for the week of 8/22/2021 – 8/28/2021. 3. Clinical record review on 10/8/2021, for patient #6, start of care 6/19/2021, diagnoses include but are not limited to Congestive Heart Failure (CHF; a chronic condition in which the heart doesn’t pump blood as well as it should ),Chronic Obstructive Pulmonary Disease (COPD; inflammatory lung disease that causes obstructed airflow from the lungs), and Type 2 Diabetes, evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 8/18/2021 – 10/16/2021, and signed by the physician on 9/14/2021. This document had an area subtitled “Supplies” which indicated Gentamycin (topical solution/cream used to control bacterial growth on wounds) and Dakins (solution used to kill germs and prevent germ growth in wounds made of tap water, baking soda, and household bleach) was supplied in the patient’s home. Another area subtitled "Orders/Treatments" which stated "... SN [skilled nurse]: Perform wound care/dressing change: 1-3x/wk [1 to 3 times per week] Bilateral LE [lower extremeties] - Cleanse with NS [normal saline] and/or Dakins, apply Gentamycin, wrap with Mepiplex ...." During an observation of a home visit on 9/29/2021, for patient #6, Registered Nurse (RN) H was observed performing wound care. At 12:39 PM, RN H changed the patient’s dressings using 2 saline flushes, gauze, and hydrofera blue (collagen dressing that is blue in color) dressing, then covered the dressing and surrounding area with an adhesive bandage. Observation failed to evidence Dakins solution used during the patient’s home visit. Observation failed to evidence Gentamycin was used during the dressing change. Review failed to evidence the dressing was changed according to the plan of care During an interview on 9/29/2021, at 12:46 PM, patient #6 indicated it had been a while since the Dakins solution was used for the dressing changes. The patient indicated they did not want to use the Dakins solution again because the smell was horrible and had to wear a mask during dressing changes. During an interview on 10/8/2021, at 3:13 PM, administrator A indicated the plan of care was not updated to show the current wound care order. 4. Clinical record review on 10/12/2021, for patient #7, start of care 8/25/2021, pertinent diagnoses include but are not limited to atrial fibrillation (is an irregular heart rhythm which can lead to blood clots in the heart), hypertension (high blood pressure), and heart failure (condition that develops when the heart doesn't pump enough blood for the body's needs), evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 8/25/2021 – 10/23/2021, and signed by the physician on 9/27/2021. An area of this document was subtitled “Orders/Treatments” which stated, “Additional Services … Vital Sign Parameters; Parameters Set By: Agency protocol. The physician will be notified if vital signs are outside of the following parameters ….” Review failed to evidence each clinician assessed vital signs at each visit. Review of agency documents titled “Physical Therapy Visit Note” failed to evidence a temperature or respirations were assessed on the following dates: 9/1/2021, 9/3/2021, 9/6/2021, 9/8/2021, 9/13/2021, 9/15/2021, and 9/22/2021. Review of an agency document titled “Physical Therapy Visit Note” failed to evidence a temperature, respirations or blood pressure was assessed on 9/20/2021. Review of an agency document titled “Skilled Nurse Visit Note” failed to evidence a temperature was assessed on 9/2/2021. 5. During an interview on 10/8/2021, at 3:19 PM, administrator A indicated a skilled nurse (SN) would assess vital signs each visit. Vital signs would include temperature, pulse, respirations, and blood pressure, although some pediatric patients do not require a blood pressure.

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 individualized plan of care included all services, safety measures, medications and treatments in 11 of 17 records reviewed (#1, #2, #3, #4, #6, #7, #8, #9, #12, #13, #15). The findings include: 7. Review of an agency policy titled “Nutritional Standards” dated 8/30/2004, stated “Policy: Anchor Personnel will complete an initial assessment of the patient/client’s nutritional status and dietary regimen … Purpose: To assure patient/clients nutritional needs are assessed … Procedure: … 1. During the initial assessment, the patient/client’s diet is established … 2. Education is available for patient/ clients with special nutritional needs…. “ 8. Clinical record review on 10/12/2021, for patient #15, start of care 1/25/2020, primary diagnosis of juvenile arthritis, evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 9/10/2021 – 11/8/2021. This document had an area subtitled “Orders/Treatments” which stated “… patient receives Remicade [intravenous medication used to decrease inflammation associated with inflammatory bowel disease and rheumatoid arthritis] infusions every 8 weeks. No infusion due this cert [certification] period. Services on hold until 9/7 [2021] for next infusion. Start Date: 7/12/2021 ….” Review failed to evidence the plan of care was individualized to show the frequency/duration for the skilled nurse to provide care. During an interview on 10/12/2021, at 11:37 AM, administrator A indicated the plan of care from 7/12/2021 rolled into the plan of care starting on 9/10/2021 and the patient was on hold until 9/7/2021 because the infusion is every 8 weeks. 9. Clinical record review on 10/12/2021, for patient #7, start of care 8/25/2021, diagnoses include but are not limited to atrial fibrillation (is an irregular heart rhythm which can lead to blood clots in the heart), hypertension (high blood pressure), and heart failure (condition that develops when the heart doesn't pump enough blood for the body's needs), evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 8/25/2021 – 10/23/2021, and signed by the physician on 9/27/2021. This document had an area subtitled “Diagnosis” which stated, “Primary Diagnosis: 08/18/2021 infect [infection] fol [following] a procedure organ and space surgical site …” An area subtitled “Safety Measures” stated “Fall precautions, Adequate lighting, Ambulation precautions, Universal precautions … “ Another area subtitled “Nutrition” stated, “Regular Diet, NCS (No Concentrated Sweets) … “ An area subtitled “Medications” evidenced the patient was taking Eliquis (an anticoagulant; a blood thinning medication used to prevent blood clots and stroke), 5mg (milligrams) twice a day ....” Review failed to evidence a cardiac/heart healthy diet individualized to include sodium and/or fluid restrictions on the plan of care, which pertained to their diagnosis. Review failed to evidence the safety measures were individualized to include anticoagulant/bleeding precautions, which pertained to the patient’s active medications. Record review of an agency document titled “SOC [Start of Care] OASIS-D1” dated 8/25/2021, and signed by RN H. Section (M1340) of this document stated, “Does this patient have a surgical wound?” in which RN H indicated no. Review failed to evidence a surgical site as indicated on the plan of care. Review failed to evidence the plan of care was individualized to show the correct primary diagnosis. During an interview on 10/12/2021, at 10:33 AM, administrator A indicated RN H’s documentation is correct and did not know why the diagnosis was “coded” that way. Additionally, administrator A was unable to locate a surgical site during clinical record review. 10. Clinical record review on 10/8/2021, for patient #6, start of care 6/19/2021, diagnoses include but are not limited to Congestive Heart Failure (CHF; a chronic condition in which the heart doesn’t pump blood as well as it should),Chronic Obstructive Pulmonary Disease (COPD; inflammatory lung disease that causes obstructed airflow from the lungs), and Type 2 Diabetes, evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 8/18/2021 – 10/16/2021, and signed by the physician on 9/14/2021. This document had an area subtitled “Safety Measures” that stated, “Skin breakdown prevention; Adequate lighting; Infection control; Clean/safe water source; Universal Precautions …” Another area subtitled “Nutrition” stated, “Regular Diet; NCS (No Concentrated Sweets) …” An area subtitled “Medications” stated, “apaxiban [a blood thinning medication used to prevent blood clots and stroke] 5 mg [milligram] oral tablet; Take 1 tab(s) [tablet(s)] orally 2 times daily ….” Review failed to evidence a diabetic diet individualized to reveal calorie and carbohydrates intake on the plan of care, which pertained to their diagnosis. Review failed to evidence a cardiac/heart healthy diet individualized to include sodium and/or fluid restrictions on the plan of care, which pertained to their diagnosis. Review failed to evidence the safety measures were individualized to include anticoagulant/bleeding precautions, which pertained to the patient’s active medications. During an interview on 10/8/2021, at 3:08 PM, administrator A indicated a patient with diabetes should follow a low concentrated sweets diet, because that was the doctor’s order. When queried about a diet that patients with a significant cardiac history should follow, Administrator A indicated the clinicians would do more education, if the doctor ordered it. 11. Clinical record review on 10/8/2021, for patient #9, start of care 8/17/2021, pertinent diagnosis of feeding difficulties, evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 8/17/2021 – 10/15/2021, and signed by the physician on 9/27/2021. This document had an area subtitled “Safety Measures” that stated, “Aseptic Technique; Needs constant supervision; Infection control; Universal Precautions …” Review failed to evidence the safety measures were individualized to include aspiration precautions, which pertained to the patient’s pertinent diagnosis. During an interview on 10/8/2021, at 3:27 PM, when asked to describe what “feeding difficulties” would mean for this patient, administrator A indicated it would imply swallowing difficulties or absorption/digestive issues. 12. Clinical record review on 10/12/2021, for patient #8, start of care 2/18/2020, primary diagnosis of Multiple Sclerosis (Progressive and potentially disabling disease of the brain and spinal cord), evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 8/11/2021 – 10/9/2021, and signed by the physician on 8/17/2021. This document indicated the patient’s activity level was up as tolerated, with a wheelchair, and functional limitations were incontinence of the bowel and bladder, ambulation, and speech. This document also indicated the patient was on a mechanical soft diet (food made easier to chew and swallow; blended, pureed, or ground). An area subtitled “Safety Measures” stated, “None …” Review failed to evidence the safety measures were individualized to include aspiration precautions, which pertained to the patient’s diet and functional limitations. Review failed to evidence the safety measures were individualized to include fall precautions, which pertained to the patient’s activity level and functional limitations. Record review evidenced an agency document titled “Prep Notes Communication” created by RN G, on 8/8/2021. An area of this document stated, “… [He/She] requires assistance to roll/reposition [him/her] self in [his/her] bed. [He/She] has a manual w/c [wheelchair] and requires someone to push [him/her] in w/c. [He/She] is dependent for all [his/her] needs. [He/She] is dysphasic [difficulty swallowing foods or liquids] and [he/she] is high risk for choking w/ [with] eating and all food needs to be cut into very small pieces, mashed or soft ….” During an observation of a home visit on 9/29/2021, with patient #7 and HHA N to observe home health aide services provided. At 10:09 AM, the patient was observed drinking milk from a bottle and attempting to feed self, but required assistance. Patient #7 had difficulty speaking and waving to greet someone. At 10:19 AM, HHA N indicated PT (physical therapy) just started coming to see the patient due to a recent fall. HHA N indicated the patient has become weaker since the Covid-19 pandemic began. At 10:33 AM, HHA N began to bathe patient #7, assisting the patient to roll from side to side, slide upwards in the bed, as well as washed and dressed completely. Observation failed to evidence the patient was up as tolerated with a wheelchair. Observation evidenced the patient to be a high fall risk. During an interview on 10/12/2021, at 9:44 AM, administrator A indicated a bedbound patient would not typically be on fall precautions. 13. Clinical record review on 10/8/2021, for patient #16, start of care 5/4/2021, diagnoses include but are not limited to osteomyelitis [bone infection] of the left foot and ankle, Type 2 Diabetes with foot ulcer, hypertension, and heart disease, evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 5/4/2021 – 7/2/2021. This document indicated the patient was on a regular diet, and no concentrated sweets ... An area subtitled “Safety Measures” stated the patient was on “Universal Precautions; Infection Control; Needle Precautions ...” An area subtitled “Medication” indicated the patient was prescribed Clopidogrel (antiplatelet which prevents blood platelets from clumping, forming, and growing; used to prevent heart attack and strokes) and Xarelto (anticoagulant used to treat and prevent blood clots). Review failed to evidence a diabetic diet individualized to reveal calorie and carbohydrates intake on the plan of care, which pertained to their diagnosis. Review failed to evidence a cardiac/heart healthy diet individualized to include sodium and/or fluid restrictions on the plan of care, which pertained to their diagnosis. Review failed to evidence the safety measures were individualized to include anticoagulant/bleeding precautions, which pertained to the patient’s active medications. Review failed to evidence a diabetic diet individualized to reveal calorie and carbohydrates intake on the plan of care, which pertained to their diagnosis. Review failed to evidence a cardiac/heart healthy diet individualized to include sodium and/or fluid restrictions on the plan of care, which pertained to their diagnosis. Review failed to evidence the safety measures were individualized to include anticoagulant/bleeding precautions, which pertained to the patient’s active medications. 410 IAC 17 13-1(a)(1)(D)(iii, viii, ix, x, xiii) 1. Record review on 10/12/2021 evidenced an agency policy titled, “POLICY: CC-03.1 PHYSICIAN’S PLAN OF CARE”, revised 09/28/15, which stated, “POLICY: It is the policy of ANCHOR Home Health Care (ANCHOR) that home health care services are furnished under the general supervision of a doctor of medicine, osteopathy, podiatric, dentistry, chiropractic or optometry based on a written Plan of Care that is established and periodically reviewed by the doctor to ensure the appropriateness and necessity of home care services relative to the patient / client’s condition. All clinical services are implemented only in accordance with a plan of care established by a physician’s written orders. SCOPE: Applies to all patient / clients receiving skilled home health care services through ANCHOR Home Health Care, and / or who require a Physician’s Plan of Care. … PROCEDURE … 5. The Physician’s Plan of Care shall cover primary and secondary diagnoses and include, but its not limited to the following: … Types of services and equipment required … Frequency and duration of visits … Goals and outcomes to be achieved … Activities permitted … Nutritional requirements … Any safety measures to protect against injury … Instructions for a timely discharge or referral as appropriate … Therapy modalities specifying length of treatment … Any other appropriate items … 6. The Physician’s Plan of Care will be reviewed by the attending Physician and home health agency personnel every 60 days, or as frequently as necessary, for all patient / clients requiring a Plan of Care. A written summary report shall be sent to the attending Physician, every 60 days. 7. The Physician’s Plan of Care must be signed and dated within a reasonable amount of time, unless otherwise specified by state or federal regulations….” 2. Record review on 10/12/2021 evidenced an agency policy titled, “POLICY: CC-44 MEDICATION ADMINISTRATION AND DOCUMENTATION”, revised 09/09/04, which stated, “POLICY: It is the policy of Anchor Home Health Care that all patients / clients, caregivers, and staff are provided with education and instruction for safe administration of medications … PROCEDURE: 1. The Nurse or Designee provides education regarding safe and effective use of medication according to the physician’s directed plan of care. 2. Medications will be documented on the Medication Profile as well as the plan of care. 3. Medication documentation and education will include: 3.1 Name 3.2 Route 3.3 Duration 3.4 Action 3.5 Storage 3.6 Contraindications 3.7 Side effects 3.8 Potential drug / food interactions – Nutritional intervention….” 3. Record review on 10/12/2021 evidenced an agency policy titled, “POLICY: CC-50 SAFETY MANAGEMENT”, dated 08/30/04, which stated, “ … PROCEDURE: 1. A safety assessment is done on admission. 1.1 A safety checklist is completed. 1.2 Unsafe items identified will be addressed with the patient / client / caregiver. 2. Safety issues which occur during the course of service will be addressed with the patient / client / caregiver.” 4. Clinical record review on 9/27/2021 for patient #1, start of care 3/24/2017, certification period 8/30/2021 to 10/28/2021, primary diagnosis of Duchenne or Becker muscular dystrophy, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician on 9/27/2021. The plan of care had a subsection titled, “Safety Measures:”, which stated, “None;”. The plan of care failed to evidence any safety precautions. During a home visit on 9/27/2021, at 3:00 p.m., patient #1 was observed to have a tracheostomy, was on a ventilator, and was receiving tube feedings. During an interview on 10/8/2021, at 1:33 p.m., the administrator indicated because the patient had a tracheostomy, was on a ventilator, and received tube feedings, they should be on respiratory and aspiration precautions. When informed of the findings, the administrator stated, “I’ll look into that”. Clinical record review on 9/27/2021, for patient #1, start of care 3/24/2017, certification period 8/30/2021 to 10/28/2021, primary diagnosis of Duchenne or Becker muscular dystrophy, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician on 9/27/2021. The plan of care had a subsection titled, “Orders / Treatments:”, which stated, “ … SHILEY trach [tracheostomy-a hole made in the windpipe to help someone breathe] clean stoma [opening] with h202 [hydrogen peroxide] / h20 [water] apply bacitracin pack stoma and cove [sic] with 4 x 4 [gauze] daily….” During an interview on 10/8/2021, at 1:45 p.m., the administrator indicated nothing should cover the stoma and the bacitracin should only be placed around the opening. When informed of the findings, the administrator stated, “That can be misunderstood” and indicated she would have the nurse review and correct the order. Clinical record review for patient #1, start of care 3/24/2017, certification period 8/30/2021 to 10/28/2021, primary diagnosis of Duchenne or Becker muscular dystrophy, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician on 9/27/2021. The plan of care had a subsection titled, “Medication:”, which stated, “ … alprazolam [a sedative] 0.25 milligrams 1 tablet via tube ; PRN [as needed] ; May be given 1-4 x a day … nystatin-triamcinolone topical [a topical anti-fungal] 10 gm(s) [grams] topical ; TID [three times a day] ; APPLY TO AFFECTED AREA 1-3 TIMES DAILY….” The plan of care failed to evidence an indication for use of the alprazolam. The plan of care failed to evidence where on the body the nystatin-triamcinolone topical was used. During an interview on 10/8/2021, at 1:36 p.m., the administrator indicated all orders for “as needed” medications should include the indication for use and orders for topical medications should include where on the body the medication is used. 5. Clinical record review on 9/27/2021, for patient #2, start of care 7/1/2021, certification period 8/30/2021 to 10/28/2021, primary diagnosis of Unspecified atherosclerosis of autologous vein bypass graft(s) of the extremities, left leg [obstructed blood flow despite bypass surgery to the leg] evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician on 9/26/2021. The plan of care had a subsection titled, “Medication:”, which stated, “BD Normal Saline Flush 0.9% injectable solution; Inject 10 milliliter(s) intravenously every 8 hours; before and after infusion … Heparin Lock Flush 100 units / mL solution; Inject 3 milliliter(s) intravenously every 8 hours; following SASH technique … meropenem [an antibiotic] 1000 mg powder for injection; Inject 1000 milligrams intravenously every 8 hours….” Clinical record review of patient #2’s electronic medical record (MatrixCare) on 9/29/2021, evidenced a patient medication profile. This medication profile included a list of 23 active patient home medications. During an interview on 9/29/2021, at 10:48 a.m., patient #2 stated, “I’m on 3 blood pressure meds and 2 blood thinners”. Patient #2 indicated he was on “a lot of meds”. During an interview on 10/8/2021, at 1:50 p.m., the administrator indicated when a clinician performs a start or resumption of care, a medication reconciliation is performed in MatrixCare. The administrator indicated that list should be in the patient’s medication profile and the plan of care. When informed of the findings, the administrator indicated all 23 of the patient medications should be in the plan of care. The administrator stated, “I need to find out why it’s like that. They automatically populate”. Clinical record review for patient #2, start of care 7/1/2021, certification period 8/30/2021 to 10/28/2021, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”. The plan of care had a subsection titled, “Diagnosis:”, which stated, “ … Long term (current) use of anticoagulants….” The plan of care had a subsection titled, “Safety Measures”, which failed to evidence anticoagulant or bleeding precautions. During an interview on 10/8/2021, at 1:58 p.m., the administrator indicated patient #2 should be on bleeding precautions. The administrator indicated bleeding precautions should be included under safety precautions in the plan of care. Clinical record review on 9/27/2021, for patient #2, certification period 8/30/2021 to 10/28/2021, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”. The plan of care had a subsection titled, “Medication:”, which stated, “BD Normal Saline Flush 0.9% injectable solution; Inject 10 milliliter(s) intravenously every 8 hours; before and after infusion … Heparin Lock Flush 100 units / mL solution; Inject 3 milliliter(s) intravenously every 8 hours; following SASH technique … meropenem [an antibiotic] 1000 mg powder for injection; Inject 1000 milligrams intravenously every 8 hours….” The plan of care failed to include a diluent and instructions for reconstituting the powdered antibiotic (meropenem). During an interview on 10/8/2021, at 1:36 p.m., the administrator indicated the plan of care should include complete orders for all medications. 6. Clinical record review on 9/29/2021, for patient #3, start of care 4/6/2021, certification period 8/4/2021 to 10/2/2021, primary diagnosis of Primary pulmonary hypertension, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician on 8/28/2021. The plan of care had a subsection titled, “Supplies:”, which stated, “Rolling walker.” The plan of care failed to evidence the patient had a shower chair. During an interview on 9/28/2021, at 3:19 p.m., patient #3 indicated they had a shower chair they used regularly. During an interview on 10/12/2021, at 9:33 a.m., the administrator indicated the plan of care should include all equipment in the home that is meant for the patient’s use. 7. Clinical record review on 9/29/2021, for patient #4, start of care 8/23/2021, certification period 8/23/2021 to 10/21/2021, primary diagnosis of Pressure ulcer of sacral region, unstageable, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician on 9/30/2021. The plan of care failed to evidence the patient went to the wound clinic. During an interview on 9/29/2021, at 12:15 p.m., RN F indicated patient #4 went to wound clinic B every 3 weeks. During an interview on 10/4/2021, at 7:00 p.m., patient #4 indicated they went to wound clinic B at least once a month. During an interview on 10/12/2021, at 9:33 a.m., the administrator indicated the plan of care should include all therapies and treatments the patient was currently receiving. On 10/12/2021 at 9:56 a.m., when informed of the findings, the administrator indicated patient #4 was currently receiving care at wound clinic B. Clinical record review for patient #4, certification period 8/23/2021 to 10/21/2021, primary diagnosis of Pressure ulcer of sacral region, unstageable, evidenced an agency document titled, Home Health Care Certification and Plan of Care”, signed by the physician on 9/30/2021. The plan of care had a subsection titled, “Supplies:” which failed to evidence a hospital bed and bedside commode. During observation of a home visit for patient #4 on 9/29/2021, at 12:00 noon, a hospital bed and bedside commode were observed in the patient’s home. During an interview on 9/29/2021, at 12:06 p.m., patient #4 indicated they lived alone. The patient indicated the hospital bed and bedside commode were for their own use. During an interview on 10/12/2021, at 9:33 a.m., the administrator indicated the plan of care should include all equipment in the home that is meant for the patient’s use. Clinical record review for patient #4, certification period 8/23/2021 to 10/21/2021, primary diagnosis of Pressure ulcer of sacral region, unstageable, evidenced an agency document titled, Home Health Care Certification and Plan of Care”, signed by the physician on 9/30/2021. The plan of care had a subsection titled, “Medication:”, which stated, “ … levothyroxine [a thyroid medication] 112 mcg [ microgram] (0.112 mg)/mL oral solution; Take 1 tab(s) orally once a day….” The plan of care failed to evidence which form of the medication the patient took (oral solution or tablet). During an interview on 10/8/2021, at 1:36 p.m., the administrator indicated the plan of care should include complete orders for all medications. When informed of the findings on 10/12/2021, at 9:54 a.m., the administrator stated, “I think she [the SN] is mistaken. I think she hit tab by accident” 8. Clinical record review on 10/6/2021, for patient #12, start of care 5/10/2020, certification period 7/4/2021 to 9/1/2021, primary diagnosis of Crohn’s disease, evidenced an agency document titled, Home Health Care Certification and Plan of Care”. The plan of care had a subsection titled, “Medication:”, which stated, “ … infliximab abda [a medication used to treat Crohn’s disease] 500 mg [milligram] intravenous powder for injection; 5 mg/kg intravenously every 8 weeks….” The plan of care failed to include a diluent and instructions on reconstituting the powdered medication. During an interview on 10/8/2021, at 1:36 p.m., the administrator indicated the plan of care should include complete orders for all medications. On 10/8/2021, at 4:00 p.m., when informed of the findings, the administrator stated, “We should add instructions in there”. 9. Clinical record review on 10/4/2021, for patient #13, start of care 8/18/2021, certification period 8/18/2021 to 10/16/2021, primary diagnosis of Parkinson’s disease, evidenced an agency document titled, Home Health Care Certification and Plan of Care”. The plan of care had a subsection titled, “Nutrition:”, which stated, “Regular Diet; Low Sodium Diet; NCS (No Concentrated Sweets); Jevity [a high-fiber liquid nutrition used for tube feedings];” The plan of care had a subsection titled, “Orders / Treatments”, which stated, “ … SN [skilled nurse]: Administer enteral [nutrition given via a feeding tube into the stomach or intestines] and / or parenteral [nutrition given intravenously] nutrition….” The plan of care failed to evidence instruction on amount, frequency, and technique (using a feeding pump or bolus feeding method) for enteral feedings. The plan of care failed to evidence route by which enteral feedings were given. The plan of care failed to evidence care/maintenance of the site used for giving enteral feedings. Clinical record review evidenced an agency document titled “SOC [start of care] OASIS [the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality]- D1”. This assessment had a subcategory titled, “(M1030 THERAPIES THE PATIENT RECEIVES AT HOME”, which stated, “ … 3 – Enteral nutrition (nasogastric, gastrostomy, jejunostomy, or any other artificial entry into the alimentary canal)....” During an interview on 10/12/2021, at 11:02 a.m., the administrator indicated the plan of care should include all therapies and treatments a patient receives. When informed of the findings, the administrator looked at the patient’s electronic medical record and stated, “I don’t see anything else”.

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 ensure all drugs and treatments were administered as ordered by the physician for 2 of 12 active records, in a total sample of 17 clinical records reviewed. (#6, #10) The findings include: 1. Review of an agency policy titled “Physician’s Plan of Care” revised on 9/28/2015, stated “Policy: It is the policy of ANCHOR Home Health Care (ANCHOR) that home health care services are furnished under the general supervision of a doctor of medicine, osteopathy, podiatrist, dentistry, chiropractic or optometry based on a written Plan of Care that is established and periodically reviewed by the doctor to ensure the appropriateness and necessity of Home Care Services relative to the patient/ clients condition. All clinical services are implemented only in accordance with a plan of care established by a physicians written orders ... Scope: Applies to all patient/ clients receiving skilled home health care services through ANCHOR Home Health Care, and/or who require a Physician’s Plan of Care … Procedure: 1. Home Health care services are provided to patient/ clients under the general supervision of a physician and in accordance with Physician’s Orders … 4. As a result of the consult, a Plan of Care, reflecting orders for services and frequencies is developed and sent to the physician and confirmed treatment by the MD [doctor of medicine] signature ... 5. The Physician’s Plan of Care shall cover primary and secondary diagnoses and include, but is not limited to the following: ... 5.4 Types of services and equipment required ... 5.12 Medications and treatments ... 5.16 Any other appropriate items … 10. In review and signature of the plan of care and or/ verbal orders, the MD is: ... 10.2 Prescribing medications and therapeutic regimens ....” 2. Clinical record review on 10/12/2021, for patient #10, start of care 4/22/2020, primary diagnosis of quadriplegia (paralysis of all 4 limbs), evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 4/22/2020 – 6/20/2020, and signed by the physician on 4/28/2020. This document had an area subtitled “Medications” that stated “Aquaphor [treatment for dry, cracked skin] Healing 1 application topical ; bid [twice daily]… lidocaine [an over the counter, local anesthetic that prevents pain by blocking signals at the nerve endings in the skin] topical 5% 1 patch topical; qd [once daily] … Valium [Diazepam; sedative used to treat anxiety] 5 milligrams 1-2 tab [tablets] By Mouth; qhs [take at bedtime] ….” Review failed to evidence a location for where to apply the Aquaphor ointment. Review failed to evidence the order for lidocaine was individualized to indicate where the patch should be applied or when it should be removed. During an interview on 10/12/2021, at 11:22 a.m., administrator A indicated the patient took the Valium every night, but the patient would decide to take 1 or 2 tablets depending how anxious they were. During an interview on 10/12/2021, at 11:24 a.m., administrator A indicated according to the medications listed on the plan of care, it was not clear how long to leave the lidocaine patch on or a site. 3. Clinical record review on 10/8/2021, for patient #6, start of care 6/19/2021, diagnoses include but are not limited to Congestive Heart Failure (CHF; a chronic condition in which the heart doesn’t pump blood as well as it should),Chronic Obstructive Pulmonary Disease (COPD; inflammatory lung disease that causes obstructed airflow from the lungs), and Type 2 Diabetes, evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 8/18/2021 – 10/16/2021, and signed by the physician on 9/14/2021. This document had an area subtitled “Safety Measures” that stated, “Skin breakdown prevention; Adequate lighting; Infection control; Clean/safe water source; Universal Precautions …” An area subtitled “Medications” stated, “apaxiban [a blood thinning medication used to prevent blood clots and stroke] 5 mg [milligram] oral tablet; Take 1 tab(s) [tablet(s)] orally 2 times daily ….” Review failed to evidence the safety measures were individualized to include anticoagulant/bleeding precautions, which pertained to the patient’s active medications.

Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the plan of care was reviewed and revised for each patient in 4 of 17 clinical records reviewed (#2, #6, #11, #15). The findings include: 4. Clinical record review on 10/7/2021, for patient #2, start of care 7/1/2021, certification period 8/30/2021 to 10/28/2021, primary diagnosis of Unspecified atherosclerosis of autologous vein bypass graft(s) of the extremities, left leg [obstructed blood flow despite bypass surgery to the leg] evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician on 9/26/2021. The plan of care had a subsection titled, “Medication:”, which stated, “BD Normal Saline Flush 0.9% injectable solution; Inject 10 milliliter(s) intravenously every 8 hours; before and after infusion … Heparin Lock Flush 100 units / mL solution; Inject 3 milliliter(s) intravenously every 8 hours; following SASH technique … meropenem [an antibiotic] 1000 mg powder for injection; Inject 1000 milligrams intravenously every 8 hours….” Review of the plan of care evidenced a subsection titled, “Orders / Treatments;”, which stated, “ … Interventions SN [skilled nurse]: Administer IV antibiotic if pt [patient] is due for dose at time of visit. SN: Assess integrity of venous access device and dressing each visit SN: Change IV injection cap q [each] week and prn [as needed] SN: Change PICC [peripherally inserted central catheter][a tube inserted into a vein for long-term use] line dressing weekly and prn via sterile technique SN: Obtain labs per orders-weekly CBC w diff [complete blood count], CMP [complete metabolic panel-a blood test that provides important information about the body's chemical balance and metabolism], ESR [erythrocyte sedimentation rate-a blood test that measures inflammation], CRP [C-reactive protein-a blood level that determines inflammation]…." Clinical record review evidenced a document titled, “Skilled Nursing Visit Note”, dated 9/20/2021, signed by RN I. The visit note had a subsection titled, “NARRATIVE NOTES”, which stated, “ … PICC line to RUE [right upper arm] was removed by pt’s [patient’s] physician at [their] follow up appointment … pt has now completed antibiotic therapy and goals are met….” Clinical record review failed to evidence revision to the plan of care when the PICC line was removed and antibiotic therapy was completed. During an interview on 10/8/2021, at 2:02 p.m., when informed of the findings, the administrator offered no further information. 5. Clinical record review on 10/5/2021, for patient #11, start of care 1/31/2019, certification period 1/31/2019 to 3/31/2019, primary diagnosis of Diverticuli [small bulging areas] of intestine, evidenced an agency document titled, “Nursing Visit Assessment”, dated 2/19/2019, signed by former employee I. The visit note had a subsection titled, “Narrative”, which stated, “Narrative: Patient was ordered per doctor for drain placement on 2/13. Drain placed 2/15 Patient arrived home 2/19. Patient has a drain on (L) [left] side of abdomen. Drain intact and patent….” Clinical record review evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”. Review of the plan of care failed to evidence a drain to the patient’s abdomen. During an interview on 10/12/2021, at 10:48 a.m., the administrator indicated the plan of care should contain drain care for patients with drains. The administrator indicated the nurse failed to update the plan of care when the patient had the drain placed after the start of care. 1. Review of an agency policy titled “Physician’s Plan of Care” revised on 9/28/2015, stated “Policy: It is the policy of ANCHOR Home Health Care (ANCHOR) that home health care services are furnished under the general supervision of a doctor of medicine, osteopathy, podiatrist, dentistry, chiropractic or optometry based on a written Plan of Care that is established and periodically reviewed by the doctor to ensure the appropriateness and necessity of Home Care Services relative to the patient/ clients condition. All clinical services are implemented only in accordance with a plan of care established by a physicians written orders ... Scope: Applies to all patient/ clients receiving skilled home health care services through ANCHOR Home Health Care, and/or who require a Physician’s Plan of Care … Purpose: 1. To ensure the provision of appropriate and medically necessary home health care services ... Procedure: 1. Home Health care services are provided to patient/ clients under the general supervision of a physician and in accordance with Physician’s Orders … 4. As a result of the consult, a Plan of Care, reflecting orders for services and frequencies is developed and sent to the physician and confirmed treatment by the MD [doctor of medicine] signature ... 5. The Physician’s Plan of Care shall cover primary and secondary diagnoses and include, but is not limited to the following: ... 5.4 Types of services and equipment required ... 5.5 Frequency and duration of visits ... 5.8 Goals and outcomes to be achieved ... 5.11 Nutritional requirements ... 5.12 Medications and treatments ... 5.13 Any safety measures to protect against injury ... 5.16 Any other appropriate items … 6. The Physician’s Plan of Care reviewed by the attending Physician and home health agency personnel every 60 days, or as frequently as necessary, for all patients/ clients requiring a Plan of Care … 9. Implementation of physicians orders reflects the following: 9.1 Development, review and revision of the Plan of Care based upon initial and ongoing patient/ client assessments and supervision of services, which identifies patient/ client problems and forward or needs ... 10. In review and signature of the plan of care and or/ verbal orders, the MD is: 10.1 Diagnosing and treating medical conditions ... 10.2 Prescribing medications and therapeutic regimens ... 10.3 Developing and forward authorizing the plan of care ... 10.4 Approving additions or modifications to the original plan recommended by professional home care staff ... 10.5 Performing periodic review for necessary revisions and changes ….” 2. Clinical record review on 10/12/2021, for patient #15, start of care 1/25/2020, primary diagnosis of juvenile arthritis, evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 9/10/2021 – 11/8/2021. This document had an area subtitled “Orders/Treatments” which stated “… patient receives Remicade [intravenous medication used to decrease inflammation associated with inflammatory bowel disease and rheumatoid arthritis] infusions every 8 weeks. No infusion due this cert [certification] period. Services on hold until 9/7 [2021] for next infusion. Start Date: 7/12/2021 ….” Record review evidenced an agency document titled ”Skilled Nursing Visit Note” from 9/13/2021 and signed by Clinical Supervisor C. The document stated “Description: RN [Registered Nurse] IV [intravenous] VISIT.” Another area subtitled “Care Plan Documentation” stated “Problem: Infusion Therapy … Intervention: Administer q8w [every 8 weeks] intravenous infusion of Remicade 200mg [milligrams] in 250ml [milliliters] normal saline per flow rate tubing with inline filter over 1-2 hours. Rate 250ml/hr [hour] … Note: Completed ….” Review evidenced the patient received an infusion during the certification period 9/10/2021 – 11/8/2021. Review failed to evidence the plan of care was revised to show current treatments. During an interview on 10/12/2021, at 11:37 AM, administrator A indicated the plan of care from 7/12/2021, rolled into the plan of care starting on 9/10/2021, and the patient was on hold until 9/7/2021, because the infusion is every 8 weeks. 3. Clinical record review on 10/8/2021, for patient #6, start of care 6/19/2021, diagnoses include but are not limited to Congestive Heart Failure (CHF; a chronic condition in which the heart doesn’t pump blood as well as it should ),Chronic Obstructive Pulmonary Disease (COPD; inflammatory lung disease that causes obstructed airflow from the lungs), and Type 2 Diabetes, evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 8/18/2021 – 10/16/2021, and signed by the physician on 9/14/2021. This document had an area subtitled “Supplies” which indicated Dakins [solution used to kill germs and prevent germ growth in wounds made of tap water, baking soda, and household bleach] was supplied in the patient’s home. During an observation of a home visit on 9/29/2021, for patient #6, Registered Nurse (RN) H was observed performing wound care. At 12:39 PM, RN H changed the patient’s dressings using 2 saline flushes, gauze, and hydrofera blue (collagen dressing that is blue in color) dressing, then covered the dressing and surrounding area with an adhesive bandage. Observation failed to evidence Dakins solution used during the patient’s home visit. Review failed to evidence the plan of care had been updated to show a current list of supplies. During an interview on 9/29/2021, at 12:46 PM, patient #6 indicated it had been a while since the Dakins solution was used for the dressing changes. The patient indicated they did not want to use the Dakins solution again because the smell was horrible and had to wear a mask during dressing changes. During an interview on 10/8/2021, at 3:13 PM, administrator A indicated the plan of care was not updated to show the current wound care order.

Revisions communicated to patient and MDs CFR(s): 484.60(c)(3)(i) (i) Any revision to the plan of care due to a change in patient health status must be communicated to the patient, representative (if any), caregiver, and all physicians or allowed practitioner's issuing orders for the HHA plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure changes to the plan of care were communicated to the physician in 2 of 3 records of patients with a feeding tube or foley catheter [a tube placed to drain the bladder] (#13, #17). The findings include: 1. Record review on 10/12/2021, evidenced an agency document titled, “POLICY: CC-03.1 PHYSICIAN’S PLAN OF CARE”, revised 9/28/2015, which stated, “POLICY: It is the policy of ANCHOR Home Health Care (ANCHOR) that home health care services are furnished under the general supervision of a doctor of medicine … based on a written Plan of Care that is established and periodically reviewed by the doctor to ensure the appropriateness and necessity of home care services relative to the patient / client’s condition. All clinical services are implemented only in accordance with a plan of care established by a physician’s written orders….” 2. Record review evidenced an agency document titled, “POLICY: CC-30 PATIENT / CLIENT CARE PLANNING PROCESS”, revised 9/25/2006, which stated, “ … The Patient / client Care Plan is reviewed and revised whenever necessary, but no less than every certification period or according to state regulations … The Clinical Supervisor or Designee will assure that: … Actions taken or services provided are consistent with the Physician’s Plan of Care….” 3. Clinical record review on 10/4/2021, for patient #13, start of care 8/18/2021, certification period 8/18/2021 to 10/16/2021, primary diagnosis of Parkinson’s disease, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”. The plan of care had a subsection titled, “Orders / Treatments:”, which stated, “ … Skilled Nursing; 1-2 wk 8 wk [1-2 times a week for 8 weeks]; Beginning during week of 8/23/2021 - Ending on 10/16/2021….” Review of the patient’s electronic medical record (MatrixCare) on 10/4/2021, failed to evidence any skilled nursing visits after 9/17/2021. Clinical record review failed to evidence an order to discontinue skilled nursing services and any communication with physician regarding discontinuation of skilled nursing. When informed of the findings on 10/12/2021, at 10:52 a.m., the administrator looked in the computer and stated, “It looks like they didn’t have nursing continue”. The administrator indicated the patient didn’t want nursing services. When queried, the administrator indicated the clinical record failed to evidence physician notification or physician order to discontinue skilled nursing services. 4. Clinical record review on 10/7/2021, for patient #17, start of care 6/8/2021, certification period 6/8/2021 to 8/6/2021, primary diagnosis of Covid-19, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician 7/15/2021. The plan of care had a subsection titled, “Orders / Treatments:”, which stated, “Discipline Orders … Skilled Nursing; 1-2 wk 9 wk [1 to 2 times per week for 9 weeks] Beginning during week of 6/8/2021 – Ending on 8/6/2021….” Clinical record review evidenced an agency document titled, “SOC [start of care] OASIS [the patient-specific, standardized assessment used in Medicare home health care] -D1….”, dated 6/8/2021 and signed by RN H. This assessment had a subsection titled, “NARRATIVE NOTES”, which stated, “SOC. [patient #17] states no SN [skilled nurse] needed at this time. PT [physical therapy] to evaluate and treat”. Clinical record review failed to evidence any communication with the physician that the patient refused nursing services. During an interview on 10/12/2021, at 12:31 p.m., the administrator indicated patient #17 refused nursing services, looked in the computer and stated, “That’s all I can find.” The administrator indicated the clinical record failed to evidence physician notification of nursing services. 17-14-1(a)(1)(G)

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 record review and interview, the agency failed to ensure the physician involved with the plan of care was notified of point of care lab testing for each patient in 1 of 2 pediatric patients, from a total sample of 17 records reviewed. (#5) The findings include: Review of an agency policy titled “Coordination of Care” revised on 3/1/2004, stated “Policy: It is the policy of ANCHOR Home Health Care to provide coordination of care for all patients/ client... Purpose: 1. The Clinical Coordinator, Clinical Supervisor or Designated Primary RN [Registered Nurse] or Therapist acts as the case manager to coordinate services to implement the Physician’s Plan of Care throughout the treatment plan ... 2. Communication of information among interdisciplinary team members is documented in the clinical record ... 3. Anchor shall coordinate its services with other health or social service providers serving the patient/ client ... 4. Communication can be verbal or written …4.1.1 Case conferences may be conducted via telephone, in person or in writing ... 4.1.2 Topics discussed in case conferences will focus on patient/ client progress in identifying further needs.... ” Review of an agency policy titled “Nursing Care Services” revised on 9/1/2006, stated “Policy: It is the policy of ANCHOR Home Health Care (ANCHOR) to provide quality nursing care to its patient/ clients ... Purpose: To provide quality nursing care ... Procedure: 1. Nursing care services are under the direct supervision of the Clinical Supervisor who is a Registered Professional Nurse and licensed in the state of Indiana ... 2. Nursing care services are provided in accordance with the Physician’s Plan of Care … 3. The clinical Supervisor or staff RN will … collaborate in the implementation and coordination of the total health care regimen and execute the medical regime under the direction of a licensed physician, initiate appropriate preventative and rehabilitative nursing procedures, and referrals to other services as needed ….” Clinical record review on 10/12/2021, for patient #5, start of care 12/10/2019, diagnoses include, but are not limited to congenital tricuspid stenosis (rare disorder where blood flow is obstructed from the right atrium to the right ventricle in the heart) and thrombophilia (blood clots can form easily in the body), evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 2/8/2020 - 4/7/2020, and signed by the physician on 2/27/2020. This document had an area subtitled “21. Orders for Discipline and Treatment” that stated “… Vital Sign Parameters … Parameters Set By: Agency protocol … Cardiovascular Plan of Care … Assess cardiovascular system via objective clinical assessment and signs and symptoms of proper and improper functioning. Perform finger stick method or venipuncture for PT/INR [prothrombin time/ international normalized ratio] laboratory diagnostic test to evaluate pathway of coagulation] and coordinate findings with physician and instruct patient on new blood thinner medication dosage as directed QOD [every other day] ... Assess vitals and mitigate as able for vital signs out of parameters and/or signs and symptoms of cardiovascular dysfunction ….” Review failed to evidence documentation of communication with the physician involved with the plan of care regarding PT/INR readings. Record review of agency documents titled “Nursing Visit Assessment” evidenced the patient’s oxygen was below pediatric normal range (94%-100%) on: 3/18/2020 (82%), 3/19/2020 (84%), 3/20/2020 (84%), and 3/23/2020 (84%). Review failed to evidence the patient's physician involved in the plan of care was notified of the abnormal objective findings. During an interview on 10/12/2021, at 11:44 a.m., administrator A was queried where documentation of communication with patient's physician for PT/INR results and responded, "Anchor [clinicians] does the reading. Then the doctor is called by [person E] in front of the nurses." During an interview on 10/12/2021, at 11:46 a.m., administrator A was queried what the oxygen parameters were for patient #5 and responded "Oxygen would not be a standard vital sign." 410 IAC 17-14-1(a)(1)(F)

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 home health agency failed to coordinate care with other entities providing services to the patient in 3 of 7 clinical records reviewed with a home visit conducted (#2, #4, #7). The findings include: 5. Clinical record review on 10/12/2021, for patient #7, start of care 8/25/2021, pertinent diagnoses include but are not limited to atrial fibrillation (is an irregular heart rhythm which can lead to blood clots in the heart), hypertension (high blood pressure), and heart failure (condition that develops when the heart doesn't pump enough blood for the body's needs), evidenced an agency document titled "SOC [Start of Care] OASIS-D1" dated 8/25/2021, and signed by RN H. This document had sections where patients mobility was assessed. Section "(GG0170) Mobility J... " stated, "Walk 50 feet with two turns ..." The section "Mobility - M. 1 step (curb)" stated "The ability to go up and down a curb and/or up and down one step ..." The Section "Mobility P. Picking Up an Object" stated "The ability to bend/stoop from a standing position to pick up a small object, such as a spoon, from the floor ..." The response to sections Mobility J, M, and P stated "Not attempted due to medical conditions or safety concerns." Record review of an agency document titled "Physical Therapy Visit Note" which evidenced to be the Physical therapy (PT) evaluation performed on 9/1/2021, by PT L. This document had an area subtitled "Functional Assessment" indicated the patient had exhaustion with minimal exertion/activity. Another area subtitled "Equipment/Supplies - DME [durable medical equipment]/Prosthetics/Orthotics" which indicated the patient used assistive ambulation devices including but not limited to a 2 wheeled walker and cane. The patient also had bathroom equipment including but not limited to a shower bench. Review evidenced the patient had difficulty with ambulation. Review evidenced the patient was exhausted from minimal activity. During an observation of a home visit, on 9/29/2021, at 1:55 PM, patient #7 was observed with Occupational Therapist (OT) K. The patient lived alone, had no caregiver or support system, and there was no assistance available. The patient indicated a strained relationship with living family members and their child was recently deceased. The patient indicated it was hard to get around the small home and would like to sit outside, but was unable to wipe off a chair. The patient also indicated that if they were able to get up and down the 3 steps leading to the entrance of the home, they could take a taxi to appointments which would save the patient money. Record review failed to evidence referral to a medical social worker and/or for a Home Health Aide/Homemaker was made for this patient. 1. Record review on 10/12/2021, evidenced an agency policy titled, “POLICY: CC-13.1 COORDINATION OF CARE”, revised 3/1/2004, which stated, “POLICY: It is the policy of ANCHOR Home Health Care to provide coordination of care for all patient / clients … PROCEDURE: 1. The Clinical Coordinator, Clinical Supervisor or designated Primary RN or Therapist acts as the case manager to coordinate services to implement the Physician’s Plan of Care throughout the treatment plan. 2. Communication of information among interdisciplinary team members is documented in the clinical record. 3. Anchor shall coordinate its services with other health or social service providers servicing the patient / client. 3.1.1 On initiation, a Care Coordination Form is completed and shared with the other entity to establish a means of communication. 3.1.2 Information is updated every 60 days and documented on the clinical record….” 2. Record review on 10/12/2021, evidenced an undated agency policy titled, “SUBJECT: COORDINATION OF CARE DEPARTMENT: INFUSION THERAPY SERVICES REFERENCE #2104….”, which stated, “POLICY: Infusion Therapy Services will coordinate care with other organizations and individuals who are providing care to the client….” 3. Clinical record review on 9/27/2021, for patient #2, start of care 7/1/2021, certification period 8/30/2021 to 10/28/2021, primary diagnosis of Unspecified atherosclerosis of autologous vein bypass graft(s) of the extremities, left leg [obstructed blood flow despite bypass surgery to the leg] evidenced antibiotic infusion orders from entity D. Clinical record review evidenced a group of documents titled, “Skilled Nursing Visit Note”, dated 8/30/2021, 9/7/2021, 9/13/2021, and 9/20/2021. Each of the notes failed to evidence coordination of care with entity D. Review of patient #2’s electronic medical record (MatrixCare) on 10/7/2021 failed to evidence coordination of care with entity D. During an interview on 10/8/2021, at 2:35 p.m., the administrator indicated the nurse should coordinate care with entity D, and document the communication either in the nurse’s visit note or a separate communication note. When informed of the findings, the administrator looked in her computer and offered no additional documentation or information. 4. During an interview on 9/29/2021, at 12:15 p.m., RN F indicated patient #4, start of care 8/23/2021, went to wound clinic B every 3 weeks. During an interview on 10/4/2021, at 7:00 p.m., patient #4 indicated they went to wound clinic B at least once a month. During an interview on 10/12/2021, at 9:56 a.m., the administrator indicated patient #4 was currently receiving care at wound clinic B. Clinical record review for patient #4, start of care 8/23/2021, certification period 8/23/2021 to 10/21/2021, primary diagnosis of Pressure ulcer of sacral region, unstageable, evidenced a group of documents titled, “Skilled Nursing Visit Note”, dated 8/25/2021, 8/27/2021, 8/30/2021, 9/1/2021, 9/3/2021, 9/6/2021, 9/8/2021, 9/10/2021, 9/13/2021, 9/16/2021, 9/18/2021, 9/20/2021, 9/22/2021, 9/25/2021, 9/27/2021, and 9/29/201. Each of the notes failed to evidence coordination of care with wound clinic B. Review of patient #4’s electronic medical record (MatrixCare) on 10/4/2021, failed to evidence coordination of care with wound clinic B. During an interview on 10/12/2021, at 9:56 a.m., the administrator indicated the nurse should coordinate care with wound clinic B. The administrator indicated there were faxed notes from the wound clinic in MatrixCare. The surveyor requested the notes to be printed. No notes from clinic B were received.

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 ensure patients were provided a written schedule of visits in 6 of 7 home visits conducted (#1, #2, #3, #4, #7, #8). The findings include: 7. During an observation of a home visit on 9/29/2021, at 2:25 PM, for patient #7, start of care 8/25/2021, the patient’s agency home folder was reviewed. The agency’s home folder failed to evidence a visit schedule, to include frequency of visits provided by the agency. 8. During an observation of a home visit on 9/29/2021, at 11:02 AM, for patient #8, start of care 2/18/2020, the patient’s agency home folder was reviewed. The agency’s home folder failed to evidence a visit schedule, to include frequency of visits provided by the agency. 1. Record review on 10/12/2021 evidenced an agency policy titled, “POLICY: CC-02 HOME CARE BILL OF RIGHTS”, revised 10/22/2015, which stated, “POLICY: It is the policy of ANCHOR Home Health Care that home care patient / clients will receive a written notice of patient rights in advance of receiving care … PROCEDURE: 1. The Home Care Bill of Rights will be reviewed and explained by an agency representative to the patient / client….” 2. Record review evidenced an agency document titled, “CLIENT RIGHTS AND RESPONSIBILITIES”, which stated, “ … YOU HAVE THE RIGHT TO … 13. Be advised in advance of the disciplines that will furnish care, and be aware of the frequency of services being performed, and any changes in your schedule….” 3. Observation of a home visit for patient #1 on 9/27/2021, at 3:00 p.m. failed to evidence a written schedule of visits from the agency. 4. Observation of a home visit for patient #2 on 9/29/2021, at 10:00 a.m. failed to evidence a written schedule of visits from the agency. 5. Observation of a home visit for patient #3 on 9/28/2021, at 3:15 p.m. failed to evidence a written schedule of visits from the agency. 6. Observation of a home visit for patient #4 on 9/29/2021, at 12:00 p.m. failed to evidence a written schedule of visits from the agency. During an interview on 10/8/2021, at 1:45 p.m., the administrator indicated the clinicians should write out a calendar of patient visits at the start of care and leave it in 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, record review and interview, the agency failed to ensure patients were provided a current written patient medication list in 6 of 7 home visits performed (#1, #2, #3, #4, #7, #8). The findings include: 6. During an observation of a home visit on 9/29/2021, at 2:25 PM, for patient #7, start of care 8/25/2021, the patient’s agency home folder was reviewed. The agency’s home folder failed to evidence the patient’s medication list to include medication name, dosage and frequency and which medications will be administered by Anchor Home Health. 7. During an observation of a home visit on 9/29/2021, at 11:02 AM, for patient #8, start of care 2/18/2020, the patient’s agency home folder was reviewed. The agency’s home folder failed to evidence the patient’s medication list to include medication name, dosage and frequency and which medications will be administered by Anchor Home Health 1. Record review on 10/12/2021, evidenced an agency policy titled “Medication Reconciliation”, revised 2014, which stated, “POLICY The Agency will reconcile patient’s medications at time of admission and on an ongoing basis … PROCEDURE 1. At time of admission, the admitting RN [registered nurse], PT [physical therapist], or SLP [speech-language pathologist] will create and document a complete list of medications that patient is taking at home, including dose, route, and frequency….” 2. During observation of a home visit for patient #1 on 9/27/2021, at 3:45 p.m., LPN J identified a large binder in the patient’s closet as the patient’s home folder from the agency. The LPN indicated the medication list was in the folder. The binder evidenced only one medication list, from 2019. Observation of the home visit failed to evidence a current patient medication list from the home health agency. 3. During observation of a home visit for patient #2 on 9/29/2021, at 10:10 a.m., review of the patient’s home folder failed to evidence a current medication list. During an interview on 9/29/2021, at 10:30, patient #2 and RN I indicated there was no current medication list in the home. 4. Observation of a home visit for patient #3 on 9/28/2021, at 3:15 p.m., failed to evidence a patient home folder from the agency and a list of current home medications. During an interview on 9/28/2021, at 4:03 p.m., PT [physical therapist] L indicated he did the medication review electronically and did not leave any papers in the home. PT L indicated he performed the most recent comprehensive assessment. 5. Observation of a home visit for patient #4 on 9/29/2021, at 12:00 p.m. failed to evidence a written list of the patient’s current medications. During an interview on 10/8/2021, at 1:49 p.m., the administrator indicated at start of care, the clinician should complete the written medication list from the admission packet. The administrator indicated the form should be left in the patient’s home folder, reviewed, and signed at each comprehensive assessment.

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 ensure Standard Precautions were followed by every employee during 3 of 7 home visits. (employee H, L, N) The findings include: 6. Observation of a home visit was conducted for patient #3 on 9/28/2021, at 3:15 p.m. At 3:15 p.m., PT [physical therapist]L entered patient #3’s home, placed his bag on a barrier on the couch, and washed his hands with soap and water. At 3:19 p.m., PT L removed a blood pressure cuff and stethoscope, and wiped them with a disposable wipe. At 3:20 p.m., PT L took the patient’s blood pressure on their left arm. At 3:23 p.m., PT L removed the blood pressure cuff from the patient’s arm, wiped the cuff and stethoscope with a disposable wipe, returned the equipment to the bag, and removed a tablet from the bag. PT L failed to perform hand hygiene before entering the bag. At 3:25 p.m., PT L stated, “I’m going to check your pulse”, placed his fingers on the patient’s left wrist, and watched a timer on his phone. At 3:26 p.m., PT L stated, “78”, and began typing on his tablet. At 3:27 p.m., PT L removed a disposable wipe from a plastic bag and wiped down hand weights he removed from his bag. PT L failed to perform hand hygiene before entering the bag. When queried, PT L indicated the wipes were Clorox disinfecting wipes. PT L handed the weights to the patient, who then started doing arm exercises. At 3:43 p.m., PT L was observed looking in bag, moving items around in the bag, then removing a disposable wipe from the plastic bag, and used it to wipe his hands. PT L was observed to keep the wipe in his left hand after using it to clean his hands. At 3:45 p.m., PT L was observed taking the weights from the patient, wiping them with the used wipe from his left hand, and returning the weights to his bag. PT L failed to properly clean equipment prior to returning it to his bag. During an interview on 10/12/2021, at 9:20 a.m., the administrator indicated bag technique meant that everything in the bag is clean, only clean hands enter the bag, and equipment should be cleaned after use and returned to the bag. The administrator indicated hand hygiene should be performed when entering a home, in between procedures, and upon leaving. When queried, the administrator indicated a Clorox wipe was an appropriate hand hygiene product. When informed of the findings, the administrator indicated a Clorox wipe used on the hands should be disposed, and was not an appropriate tool for disinfecting equipment. 17-12-1(m) 1. Review of an agency policy titled “Standard Precautions” revised in 2014, stated “Policy … Blood and body fluid precautions will be followed for all patients … Purpose … To prevent transmission of communicable diseases … Procedure … 1. 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, tissue, and moist areas, e.g., mucous membranes … 2. 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: All health care workers will routinely use appropriate barrier precautions to prevent skin and mucous membrane exposure when contact with blood or other body fluids of any patient is anticipated ... Gloves will be worn before touching blood and body fluids, mucous membranes for non-intact skin of all patients; for handling items or surfaces soiled with blood or body fluids … gloves will be changed and hands washed after contact with each patient ... 3. Hands and other skin surfaces will be washed immediately and thoroughly if contaminated with blood or other body fluids ... 8. Standard precautions, applicable policies and standards of practice will be implemented for: Immunocompromised patients ... Infusion therapy ... Urinary tract care … Wound care ... Respiratory tract care ....” 2. Review of an agency policy titled “Hand Hygiene Policy and Compliance Program” revised in 2014, stated “Policy … Hand hygiene will be done by all employees to reduce the transfer of microbes to patients and to prevent the growth of microorganisms on the nails, hands and forearms … Purpose … To prevent transfer of germs and transmission of infections to patients and caregivers and to implement a hand hygiene compliance program ... Procedure 1. Indications for staff performing hand hygiene are: Before and after direct patient care … Before and after each procedure ... When hands are soiled ... After any contact with contaminated materials ... 2. All employees are responsible for implementing hand hygiene procedures in an ongoing attempt to prevent and/or contain infectious processes and communicable diseases ....“ 3. Record review evidenced an undated agency policy titled, “PROCEDURE: NURSING BAG – CARE AND MAINTENANCE”, which stated, “PURPOSE: To provide a clean environment for clients … To prevent the spread of microorganisms … GUIDELINES: 1. The inside of the bag and its contents are considered clean. Therefore: a. Hand washing must occur before entering the bag for any reason … d. Instruments and equipment which have been used in the care of a client must be cleaned or disinfected before being returned to the bag….” 4. During an observation of a home visit on 9/29/2021, for patient #6, start of care 6/19/2021, Registered Nurse (RN) H was observed performing wound care. At 12:35 PM, RN H washed her hands with soap and water at the patient’s kitchen sink, dried hands with paper towels, and donned new gloves. At 12:39 PM, patient #6 adjusted the height and recline on their motorized wheelchair to elevate their legs in preparation for dressing changes to their bilateral lower extremities (BLE). RN H placed a barrier under the patient’s legs and cut the old gauze dressing off from the BLE. At 12:41 PM, RN H removed her gloves, retrieved 2 saline flushes, and donned new gloves without sanitizing first. RN H sprayed a saline flush onto a clean gauze and patted the patient’s 2 wounds on the right leg. RN H repeated the process on the other leg; sprayed a saline flush onto a clean gauze and patted the patient’s wound on the left leg. At 12:46 PM, without changing gloves in between dirty/clean tasks, RN H obtained a clean hydrofera blue (collagen dressing that is blue in color) dressing, placed on top of the 2 wounds on the right leg, then covered the dressing and surrounding area with an adhesive bandage. RN H repeated the process on the other leg; obtained a clean hydrofera blue dressing, placed on top of the wound to the left leg, then covered the dressing and surrounding area with an adhesive bandage. At 12:48 PM, RN H placed all soiled items from dressing change into a plastic garbage bag, removed gloves, and washed hands with soap and water. Observation failed to evidence the skilled nurse (SN) performed hand hygiene according to agency policy. Observation failed to evidence the SN performed hand hygiene before and after each procedure, in between glove changes, and after contact with contaminated materials. 5. During an observation of a home visit on 9/29/2021, for patient #8, start of care 2/18/2020, Home Health Aide (HHA) N was observed providing ADL (activities of daily living) care. At 10:38 AM, HHA N washed her hands with soap and water at the bathroom sink and donned new gloves. HHA N prepared 2 pink basins with warm water to provide a sponge bath. At 10:41 AM, HHA N opened a new bar of soap and placed it into one of the pink basins to make to water soapy. With a clean, damp washcloth, HHA N wiped the patient’s face, placed in the soapy basin, then the clinician’s glove ripped. HHA N removed her gloves, placed in the garbage, washed her hands with soap and water, and donned new gloves. At 10:44 AM, HHA N obtained a clean washcloth, soaked it in the soapy basin, wiped the patient’s neck, chest, and underarms, then placed back in the soapy basin. HHA N rinsed the washcloth in the non-soapy basin and wiped the patient’s neck, chest, and underarms again, then dried the patient off with a clean bath towel. At 10:46 AM, HHA N retrieved a washcloth previously left in the soapy basin; She wiped the patient’s right arm, then left arm, rinsed washcloth in non-soapy basin, and wiped the right and left arms again. While still wearing gloves, HHA N opened a cabinet door and retrieved deodorant, then applied it to the patient’s underarms. HHA N returned the deodorant and obtained a blue bottle of lotion from the same cabinet. HHA N applied the lotion to the patients face, arms, and hands. At 10:50 AM, still wearing the same gloves, HHA N opened the closet door, retrieved a diaper, then rolled the patient on their right side, facing the wall. HHA N obtained a washcloth from the soapy basin, wiped the patients back, rinsed in non-soapy basin, and wiped patient back again. HHA N dried the patient’s back with a bath towel, then applied lotion from the blue bottle. At 10:54 AM, HHA N adjusted the patient’s head of bed to lay flat, then adjusted the knee of the bed to the most upright position. HHA N applied the patient’s shoes, assisted the patient to bend knees, then from the head of bed, assisted to pull the patient up. At 10:56 AM, HHA N removed gloves, then washed hands with soap and water. Observation failed to evidence the HHA performed hand hygiene according to agency policy. Observation failed to evidence the HHA performed hand hygiene before and after each procedure, and after contact with contaminated materials. Observation failed to evidence the HHA removed potentially contaminated gloves prior to applying lotion to the patient’s face, neck, arms, and back. Observation failed to evidence the HHA removed potentially contaminated gloves prior to entering cabinets and closets around the patient’s living space.

Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the skilled professional performed complete assessments in 2 of 4 records reviewed receiving IV therapy (#2, #11). The findings include: 1. Record review on 10/12/2021, evidenced an agency policy titled, “POLICY: CC-61 PROFESSIONAL STANDARDS OF PRACTICE”, dated 4/22/2015, which stated, “POLICY: It is the policy of Anchor Home Health Care and staff comply with acceptable standards of practice and plan of care … PURPOSE: To assure appropriate provision of care … PROCEDURE: 1. ANCHOR and staff will comply with acceptable standards and principles that apply to the professionals who are furnishing care….” 2. Record review evidenced an agency policy titled, “POLICY: HR-17 NURSING CARE SERVICES”, revised 9/1/2006, which stated, “POLICY: It is the policy of ANCHOR Home Health Care (ANCHOR) to provide quality nursing care to its patients / clients. … PROCEDURE … 3. The Clinical Supervisor or staff RN will complete the nursing initial and ongoing comprehensive assessments….” 3. Record review evidenced an agency policy titled, “POLICY: CC-31 DOCUMENTATION OF PATIENT / CLIENT CARE”, revised 9/28/2015, which stated, “POLICY: It is the policy of ANCHOR Home Health Care (ANCHOR) to develop and maintain a clinical file for every patient / client admitted to home health care services … PURPOSE: 1. To document the care / service that is being rendered to the patient / client. 2. To evaluate the care and the patient / client’s response to the care being given in the home. 3. To comply with all local, state, and federal regulations regarding documentation of care … 4. Documentation must be clear, concise, detailed, accurate, and reflective of the care or services provided, including any deviation from established parameters….” 4. Clinical record review on 9/27/2021, for patient #2, start of care 7/1/2021, certification period 8/30/2021 to 10/28/2021, primary diagnosis of Unspecified atherosclerosis of autologous vein bypass graft(s) of the extremities, left leg [obstructed blood flow despite bypass surgery to the leg] evidenced an agency document titled, “Recert [recertification] OASIS [the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality]- D1….”, dated 8/26/2021, signed by RN [registered nurse] I. This assessment had a subsection titled, “REVIEW OF SYSTEMS – INTERVENTIONS PROVIDED THIS VISIT”, which stated, “ … VENOUS ACCESS DEVICE / INFUSION THERAPY Please refer to intervention documentation….”. The assessment had a section titled, “CARE PLAN DOCUMENTATION”, which stated, “ … Intervention- Assess integrity of venous access device and dressing each visit … Venous Access Device / Infusion Therapy Device Type PICC [peripherally inserted central catheter-a catheter inserted into a vein for long-term IV therapy]….” Assessment of the PICC line failed to evidence length of the catheter. Clinical record review evidenced a group of agency documents titled, “Skilled Nursing Visit Note”, signed by RN I. Notes dated 8/30/2021, 9/7/2021, 9/13/2021, and 9/20/2021, each evidenced a PICC line assessment which failed to include the length of the catheter. During an interview on 10/8/2021, at 2:42 p.m., the administrator indicated the skilled nurse should assess the PICC line at each visit and document the catheter length at least once a week. 5. Clinical record review for patient #11, start of care 1/31/2019, certification period 1/31/2019 to 3/31/2019, primary diagnosis of Diverticuli [small bulging areas] of intestine, evidenced a group of agency documents titled, “Nursing Visit Assessment”, signed by former employee I. Notes dated 2/5/2019. 2/12/2019, 2/19/2019, 2/26/2019, 3/5/2019, 3/12/2019, and 3/19/2019 evidenced a PICC line assessment which failed to include location of the PICC line. During an interview on 10/8/2021, at 2:42 p.m., the administrator indicated the skilled nurse should assess the PICC line at each visit. The administrator indicated the location of the PICC line should be included in the assessment. Clinical record review evidenced a group of agency documents dated, “Nursing Visit Assessment”, signed by former employee I as follows: Review of a nurse’s note dated 2/19/2019, had a subsection titled, “Narrative”, which stated, “Narrative: Patient was ordered per doctor for drain placement on 2/13. Drain placed 2/15 Patient arrived home 2/19. Patient has a drain on (L) [left] side of abdomen. Drain intact and patent….”. The nurse’s note had a section titled, “Surgical or Other Drains”, which stated, “Where are they located and for what purpose? (L) [left] side of abdoamen [sic] for drainage of abscess placed on 2/15 Any signs of dysfunction or infection? No. Narrative: Patient was ordered patient to go to the hospital [sic] and have drain placed for abscess. Drainage bag noted with yellowish colored residual.” The nurse’s note failed to evidence assessment of the drain insertion site, type of drain, if a dressing was present, and amount of drainage present. The nurse’s note failed to evidence drain care. Review of a nurse’s note dated 2/26/2019, evidenced a subsection titled, “Skilled Care Provided: Direct Care:” which failed to evidence drain care. Review of the nurse’s note evidenced a subsection titled, “Narrative”, which stated, “Patient alert and oriented. Patient has a drain to (L) side of abdomen clean dry and intact….” The nurse’s note failed to evidence assessment of the drain insertion site, drain type, if a dressing was present, and if drainage was present. Review of a nurse’s note dated 3/5/2019, evidenced a subsection titled, “Skilled Care Provided: Direct Care:” which failed to evidence drain care. Review of the nurse’s note evidenced a subsection titled, “Narrative”, which stated, “ … Tube to (L) side intact and patent.” The nurse’s note failed to evidence assessment of the drain insertion site, type of drain, if a dressing was present, and if drainage was present. Review of a nurse’s note dated 3/12/2019, evidenced a subsection titled, “Skilled Care Provided: Direct Care:” which failed to evidence drain care. Review of the nurse’s note evidenced a subsection titled, “Narrative”, which stated, “JP [Jackson -Pratt—a drain placed to empty excess fluid from the body] drain remains. PICC intact.” The nurse’s note failed to evidence assessment of the drain insertion site, if a dressing was present, and if drainage was present. Review of a nurse’s note dated 3/19/2019, evidenced a subsection titled, “Skilled Care Provided: Direct Care:” which failed to evidence drain care. Review of the nurse’s note evidenced a subsection titled, “Narrative”, which stated, “PICC line intact. Drain intact and patent Labs obtained.” The nurse’s note failed to evidence assessment of the drain insertion site, type of drain, if a dressing was present, and if drainage was present. During an interview on 10/12/2021, at 10:48 a.m., the administrator indicated the nurse should assess a patient’s drain at each visit. The administrator indicated the assessment should include where the drain was, what type of drain, if dressing was present, if drainage was present, appearance of site if visible, and site care, if done. When informed of the findings, the administrator offered no further information.

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 record review and interview, the registered nurse failed to provide complete patient care instructions for the home health aide in 1 of 2 records reviewed receiving home health aide services (#14). The findings include: Record review on 10/12/2021, evidenced an agency policy titled, “POLICY: CC-05 HOME HEALTH AIDE ASSIGNMENT”, revised 9/17/2012, which stated, “POLICY: It is the policy of ANCHOR Home Health Care to provide Home Health Aide services based on an individualized, written patient / client care instruction … PROCEDURE: 1. The Home Health Aide Assignment will be developed prior to initiation of Home Health Aide services. 2. A Registered Nurse or Therapist … must develop the Home Health Aide Assignment. 3. The Home Health Aide Assignment must be individualized to meet patient / client needs 3.1 Patient / client name 3.2 Patient / client address … 3.8 Personal care … 3.11 Parameters for reporting changes in patient / client condition and needs 3.12 Safety instructions ….” Clinical record review on 10/5/2021, for patient #14, start of care 5/31/2019, certification period 7/24/2020 to 9/21/2020, primary diagnosis of Hemiplegia following cerebral infarction affecting left side [left-sided paralysis after a stroke], evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician on 7/23/2020. The plan of care had a subsection titled, “Safety Measures”, which stated, “Safe transfers; Fall precautions; 24 Hour supervision; Skin breakdown prevention; Bleeding precautions; Home emergency plan;” (end of document). Clinical record review evidenced an agency document titled, “Aide Care Plan”, dated 5/25/2020. Review of the aide care plan failed to evidence bleeding precautions. During an interview on 10/12/2021, at 12:06 p.m., the administrator indicated safety should be addressed at each visit by all clinicians. The administrator indicated if a patient was on bleeding precautions, the home health aide should be aware to watch for bleeding and bruising. The administrator indicated the aide care plan failed to include all safety precautions for patient #14. 17-13-2(a)

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health aide failed to provide services included in the plan of care in 1 of 2 records receiving home health aide services (#14). The findings include: Record review on 10/12/2021, evidenced an agency policy titled, “POLICY: CC-31 DOCUMENTATION OF PATIENT / CLIENT CARE”, revised 9/28/2015, which stated, “POLICY: It is the policy of ANCHOR Home Health Care (ANCHOR) to develop and maintain a clinical file for every patient / client admitted to home health care services … PURPOSE: 1. To document the care / service that is being rendered to the patient / client. 2. To evaluate the care and the patient / client’s response to the care being given in the home. 3. To comply with all local, state, and federal regulations regarding documentation of care … 4. Documentation must be clear, concise, detailed, accurate, and reflective of the care or services provided, including any deviation from established parameters….” Record review evidenced an agency policy titled, “POLICY: CC-06.1 SUPERVISION OF PATIENT / CLIENT CARE: HOME HEALTH AIDE”, revised 7/1/2004, which stated, “ … PURPOSE: … To assess that plan of care by Home Health Aide is being followed … Elements of supervision should include: … An assessment that plan of care by Home Health Aide is being followed….” Clinical record review on 10/5/2021, for patient #14, start of care 5/31/2019, certification period 7/24/2020 to 9/21/2020, primary diagnosis of Hemiplegia following cerebral infarction affecting left side [left-sided paralysis after a stroke], evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician on 7/23/2020. The plan of care had a subsection titled, “Orders / Treatments:”, which stated, “ … Interventions … Aide: Diet: Record intake and output each visit … Aide: Elimination: Document each bowel movement….” Clinical record review evidenced an agency document titled, “Aide Care Plan”, dated 5/25/2020, had a subsection titled, “INTERVENTIONS”, which stated, “ … 7. Diet – Record intake and output each visit … 9. Elimination – Document bowel movements; report to RN if no BM in 3 days; give SSE [soap suds enema] as directed by RN….” Clinical record review evidenced a group of documents titled, “Aide Visit Note”, dated 7/27/2021, 7/28/2021, 7/29/2021, 7/30/2021, 7/31/2021, 8/3/2021, 8/4/2021, 8/5/2021, and 8/6/2021. Each of the aide visit notes failed to evidence recording of intake and output and documentation of bowel movements. During an interview on 10/12/2021, at 12:09 p.m., the administrator indicated the aide probably documented the patient’s intake and output and bowel movements on a document in the patient’s home. The administrator indicated the agency failed to ensure that document was entered into the patient’s clinical record.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient's clinical record evidenced all interventions and responses to those interventions in 4 of 5 patient records receiving physical therapy (#3, #8, #13, #17). The findings include: 6. Clinical record review on 10/12/2021, for patient #8, start of care 2/18/2020, primary diagnosis of Multiple Sclerosis (Progressive and potentially disabling disease of the brain and spinal cord), evidenced an agency document titled “Physical Therapy Visit Note” from 8/20/2021, and signed by PT M. This document had an area subtitled “Skilled Interventions” that stated, “Impaired Strength Interventions … Therapeutic Exercise” and indicated active -assisted range of motion (AAROM) was performed for the patient’s hip, knee, and ankle/foot. The area stated “AAROM: Patient Tolerance to Treatment … Please refer to intervention documentation …” A section subtitled “Care Plan Documentation” stated “AAROM: Patient Tolerance to Treatment … Vital signs taken prior to completion of therapeutic exercise ….” Review failed to evidence the patient’s response to the AAROM treatment once completed. Record review evidenced agency documents titled “Physical Therapy Visit Note” from 8/23/2021 and 8/26/2021, and were signed by PT M. These documents had an area subtitled “Skilled Interventions” that stated, “Impaired Strength Interventions … Therapeutic Exercise” and indicated AAROM was performed for the patient’s shoulder, elbow, hip, knee, and ankle/foot. The area stated “AAROM: Patient Tolerance to Treatment … Please refer to intervention documentation …” A section subtitled “Care Plan Documentation” stated “AAROM: Patient Tolerance to Treatment … Vital signs taken prior to completion of therapeutic exercise ….” Review failed to evidence the patient’s response to the AAROM treatments once completed. Record Review evidenced an agency document titled “Physical Therapy Visit Note” from 8/30/2021, and signed by PT M. This document had an area subtitled “Skilled Interventions” that stated, “Impaired Strength Interventions … Therapeutic Exercise” and indicated active -assisted range of motion (AAROM) was performed for the patient’s hip and knee. The area stated “AAROM: Patient Tolerance to Treatment … Please refer to intervention documentation …” An section subtitled “Care Plan Documentation” stated “AAROM: Patient Tolerance to Treatment … Vital signs taken prior to completion of therapeutic exercise ….” Review failed to evidence the patient’s response to the AAROM treatment. 1. Record review on 10/12/2021, evidenced an agency policy titled, “POLICY: CC-31 DOCUMENTATION OF PATIENT / CLIENT CARE”, revised 9/28/2015, which stated, “POLICY: It is the policy of ANCHOR Home Health Care (ANCHOR) to develop and maintain a clinical file for every patient / client admitted to home health care services … PURPOSE: 1. To document the care / service that is being rendered to the patient / client. 2. To evaluate the care and the patient / client’s response to the care being given in the home. 3. To comply with all local, state, and federal regulations regarding documentation of care … 5. Documentation must describe pertinent medical history, physical and psychosocial signs and symptoms; treatment rendered; care given; medication administered; patient / client response to treatment and care; ongoing status of problems identified in the care plan and patient / client teaching; date and time of deviation from established parameters, pertinent information regarding changes, progress toward goals documented in appropriate measurable terms, and notification of Supervisor / Clinical Nursing Manager or Designee as needed….” 2. Record review on 10/12/2021, evidenced an agency policy titled, “POLICY: CR-02.1 CONTENTS OF THE CLINICAL RECORD”, revised 4/20/2002, which stated, “ … The Director of Clinical Services or Designee will assure that clinical notes are dated and signed and include but are not limited to: 2.1 Physical and psychosocial signs and symptoms, 2.2 Treatment, care or service provided, 2.3 Patient / client response to treatment….” 3. Clinical record review on 9/29/2021, for patient #3, start of care 4/6/2021, certification period 8/4/2021 to 10/2/2021, primary diagnosis of Primary pulmonary hypertension, evidenced a group of agency documents titled, “Physical Therapy Visit Note”. Each of the visit notes stated, “ … Patient Tolerance to Treatment Vital signs taken prior to completion of therapeutic exercise….” Each of the visit notes failed to evidence an assessment of how the patient tolerated therapy. Clinical record review of the physical therapy notes and patient’s electronic medical record (MatrixCare) evidenced the patient’s pulse and blood pressure were checked once per visit. Each visit note failed to evidence the patient’s respiratory rate was assessed. During an interview on 10/12/2021, at 9:27 a.m., the administrator indicated a physical therapist should observe a patient during and after exercise to determine how the patient is tolerating therapy. The administrator indicated the therapist should look at the patient’s skin, their breathing, and re-assess their vital signs. When informed of the findings, the administrator indicated checking the patient’s blood pressure and pulse once per visit was not an assessment of how a patient tolerated therapy. The administrator indicated patient’s clinical record failed to evidence an assessment of how the patient tolerated therapy. 4. Clinical record review on 10/4/2021, for patient #13, start of care 8/18/2021, certification period 8/18/2021 to 10/16/2021, primary diagnosis of Parkinson’s disease, evidenced a group of agency documents titled, “Physical Therapy Visit Note”. Each of the visit notes stated, “ … Patient Tolerance to Treatment Vital signs taken prior to completion of therapeutic exercise….” Each of the visit notes failed to evidence an assessment of how the patient tolerated therapy. Clinical record review of the physical therapy notes and patient’s electronic medical record (MatrixCare) evidenced the patient’s pulse and blood pressure were checked once per visit. Each visit note failed to evidence the patient’s respiratory rate was assessed. During an interview on 10/12/2021, at 9:27 a.m., the administrator indicated a physical therapist should observe a patient during and after exercise to determine how the patient is tolerating therapy. The administrator indicated the therapist should look at the patient’s skin, their breathing, and re-assess their vital signs. When informed of the findings, the administrator indicated checking the patient’s blood pressure and pulse once per visit was not an assessment of how a patient tolerated therapy. The administrator indicated patient’s clinical record failed to evidence an assessment of how the patient tolerated therapy. 5. Clinical record review on 10/7/2021, for patient #17, start of care 6/8/2021, certification period 6/8/2021 to 8/6/2021, primary diagnosis of Covid-19, evidenced a group of agency documents titled, “Physical Therapy Visit Note”. Visit notes dated 6/23/3021 and 6/30/2021 stated, “ … Patient Tolerance to Treatment Vital signs taken prior to completion of therapeutic exercise….” Each of the visit notes failed to evidence an assessment of how the patient tolerated therapy. Clinical record review of the physical therapy notes and patient’s electronic medical record (MatrixCare) evidenced the patient’s pulse and blood pressure were checked once per visit. Each visit note failed to evidence the patient’s respiratory rate was assessed. During an interview on 10/12/2021, at 9:27 a.m., the administrator indicated a physical therapist should observe a patient during and after exercise to determine how the patient is tolerating therapy. The administrator indicated the therapist should look at the patient’s skin, their breathing, and re-assess their vital signs. When informed of the findings, the administrator indicated checking the patient’s blood pressure and pulse once per visit was not an assessment of how a patient tolerated therapy. The administrator indicated patient’s clinical record failed to evidence an assessment of how the patient tolerated therapy.

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 a complete discharge summary was sent to the physician within 5 business days after discharge, and a complete transfer summary was sent to the physician within 2 business days of transfer for 3 of 7 records reviewed of patients who were discharged or transferred (#13, #16, #17). The findings include: 3. Clinical record review on 10/4/2021, for patient #13, start of care 8/18/2021, certification period 8/18/2021 to 10/16/2021, primary diagnosis of Parkinson’s disease, evidenced an agency document titled, “Occupational Therapy Visit Note”, dated 9/3/2021, signed by OT K, which stated, “This patients son cancels appointment and reports that patient is hospitalized….” Clinical record review evidenced an agency document titled, “Transfer OASIS [ Outcome and Assessment Information Set] [the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality]….”, dated 9/7/2021, signed by the clinical supervisor. The transfer assessment indicated the patient was transferred to the hospital. Review of the transfer assessment failed to indicate why the patient went to the hospital. Review of all communication notes, nurse’s notes, occupational therapy notes, and physical therapy notes failed to evidence why the patient went to the hospital. Review of the patient’s electronic medical record (MatrixCare), failed to evidence why the patient went to the hospital. Clinical record review evidenced the agency failed to notify the physician of patient transfer to the hospital until 4 days after they were informed by the patient’s family. During an interview on 10/12/2021, at 10:52 a.m., the administrator indicated the case manager should send a transfer summary, which included the reason for transfer, when informed a patient was hospitalized. When informed of the findings, the administrator offered no further information. 4. Clinical record review on 10/7/2021, for patient #17, start of care 6/8/2021, certification period 6/8/2021 to 8/6/2021, primary diagnosis of Covid-19, evidenced an agency document titled, “Physical Therapy Visit Note”, dated 7/7/202, signed by PT L, which stated, “ … An attempted visit was made today, no response to multiple phone calls nor at the door. To continue to follow….” Clinical record review evidenced a physical therapy visit note dated 7/21/2021, signed by PT M, which stated, “ … Therapist attempted to set up and make visit called patient several times but unable to get a hold of patient….” Clinical record review evidenced a physical therapy visit note dated 7/26/2021, signed by PT M, which stated, “ … Therapist called patient left message on voicemail to return call or call Anchor….” Clinical record review evidenced an agency document titled, “Transfer OASIS [ Outcome and Assessment Information Set] [the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality]….”, dated 7/30/2021, signed by RN P. The transfer assessment indicated the patient was transferred to the hospital. Review of the transfer assessment failed to indicate why the patient went to the hospital. Clinical record review evidenced the agency failed to notify the physician of patient transfer to the hospital until 28 days after the last patient visit. During an interview on 10/12/2021, at 10:52 a.m., the administrator indicated the case manager should send a transfer summary, which included the reason for transfer, when informed a patient was hospitalized. When informed of the findings, the administrator offered no further information. 17-15-1(a)(6)1. Review of an agency policy titled “Discharge Policy - Infusion” dated 6/1/2006, stated “Policy: It is the policy of ANCHOR Home Health Care to initiate discharge of a patient/ client from Home Care Services when either homecare goals are met, services are no longer medically justified, care can no longer be safely rendered in the home, the source of reimbursement has changed, the patient/ client refuses services, the patient/ client no longer meets applicable regulatory criteria, or the agency is unable to locate the patient/ client ... Procedure 1. a notice of discharge will be given to the patient/ client, the patient/ clients legal representative, or other individual responsible for the patient/ clients care at least five calendar days before the services are stopped unless otherwise stated by contract or physician’s orders … 5. Prepare a discharge summary report … 6. The Discharge Summary must be a part of the permanent clinical record of the patient/client….” 2. Clinical record review on 10/8/2021, for patient #16, start of care 5/4/2021, diagnoses include but are not limited to osteomyelitis [bone infection] of the left foot and ankle, Type 2 Diabetes with foot ulcer, hypertension, and heart disease, evidenced an agency document titled “Home Health Care Certification and Plan of Care” for certification period 5/4/2021 – 7/2/2021. This document had an area subtitled “Orders/Treatments” which stated “Skilled Nursing [SN], 1-2 wk [once to two times per week] 9 wk [for 9 weeks] … SN for line care and labs weekly ….” Record review evidenced an agency document titled “Discharge OASIS-D1” from 5/19/2021, by RN H. This document had an area subtitled “Discharge Reasons/MD [doctor of medicine] and Patient Agreement” which stated “… MD agreement MD contacted … Contact Date – 5/18/2021 …” Another area subtitled “Discharge/Transfer/Death Date- Enter the date of the discharge, transfer, or death (at home) of the patient … 5/19/2021 …” Another section titled “Narrative Notes” stated, “PICC [peripherally inserted central catheter] pulled at infectious disease [doctor’s office] on 5/18/21 ….” Record review evidenced an agency document titled “Discharge Summary” from 5/18/2021, which stated “Agency Discharge To: Home … Discharge Effective Date: 5/19/2021 ….” This document was signed by administrator A on 10/1/2021. Review failed to evidence the discharge summary completed and sent to the physician within 5 business days from the discharge date.

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 home health agency failed to ensure all entries in the clinical record were complete and appropriately authenticated in 5 of 17 clinical records reviewed (#1, #3, #4, #11, #17). The findings include: 1. Record review on 10/12/2021, evidenced an agency policy titled, “POLICY: CC-31 DOCUMENTATION OF PATIENT / CLIENT CARE”, revised 9/28/2015, which stated, “POLICY: It is the policy of ANCHOR Home Health Care (ANCHOR) to develop and maintain a clinical file for every patient / client admitted to home health care services … PURPOSE: 1. To document the care / service that is being rendered to the patient / client. 2. To evaluate the care and the patient / client’s response to the care being given in the home. 3. To comply with all local, state, and federal regulations regarding documentation of care 4. Documentation must be clear, concise, detailed, accurate, and reflective of the care or services provided, including any deviation from established parameters of patient / clients and notification of Clinical Nursing Manager / Supervisor or Designee. 5. Documentation must describe pertinent medical history, physical and psychosocial signs and symptoms; treatment rendered; care given; medication administered; patient / client response to treatment and care; ongoing status of problems identified in the care plan and patient / client teaching; date and time of deviation from established parameters, pertinent information regarding changes, progress toward goals documented in appropriate measurable terms, and notification of Supervisor / Clinical Nursing Manager or Designee as needed. 6. The Date, Time, Signature, and Title of the person completing the documentation must appear clear and legible whether in written format or in secure electronic format….” 2. Record review on 10/12/2021, evidenced an agency policy titled, “POLICY:CR-02.1 CONTENTS OF THE CLINICAL RECORD”, revised 4/20/2002, which stated, “POLICY: It is the policy of ANCHOR Home Health Care to maintain patient / client clinical records in accordance with accepted professional standards and / or contract requirements … All notes and reports in the patient / client’s record must be legible, clear, complete and appropriately authenticated and dated….” 3. Clinical record review on 9/27/2021, for patient #1, start of care 3/24/2017, certification period 8/30/2021 to 10/28/2021, primary diagnosis of Duchenne or Becker muscular dystrophy, evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician on 9/27/2021. The plan of care had a subsection titled, “Orders / Treatments:”, which stated, “ … SHILEY trach [tracheostomy-a hole made in the windpipe to help someone breathe] clean stoma [opening] with h202 [hydrogen peroxide] / h20 [water] apply bacitracin pack stoma and cove [sic] with 4 x 4 [gauze] daily….” During an interview on 10/8/2021, at 1:45 p.m., the administrator indicated nothing should cover the stoma and the bacitracin should only be placed around the opening. When informed of the findings, the administrator stated, “That can be misunderstood” and indicated she would have the nurse review and correct the order. 4. Clinical record review on 9/29/2021, for patient #3, start of care 4/6/2021, certification period 8/4/2021 to 10/2/2021, primary diagnosis of Primary pulmonary hypertension, evidenced an agency document titled, “Physical Therapy Visit Note”, dated 9/28/2021, signed by PT [physical therapist] L, which stated, “ … Medication Profile reviewed for new or changed medications and identification of possible issues with both prescription and non-prescription medications….” Observation of a home visit by PT L for patient #3 on 9/28/2021, at 3:15 p.m., failed to evidence medication review. During an interview on 10/12/2021, at 9:38 a.m., the administrator indicated if a clinician documented, , “ … Medication Profile reviewed for new or changed medications and identification of possible issues with both prescription and non-prescription medications….”, that indicated the clinician reviewed the patient’s medications with the patient and that the patient expressed no complications with medications. When informed of the findings, the administrator offered no further information. 5. Clinical record review on 10/5/2021, for patient #4, start of care 8/23/2021, certification period 8/23/2021 to 10/21/2021, primary diagnosis of Pressure ulcer of sacral region, unstageable, evidenced an agency document titled, “Skilled Nursing Visit Note”, visit date 9/29/2021, signed by RN F. The visit note had a subsection titled, “VITAL SIGNS”, which stated, “ … Pulse 76 beats / min … Apical [a pulse assessed by listening with a stethoscope on the chest]….”. Review of the nurse’s visit note evidenced a subsection titled, “REVIEW OF SYSTEMS – CARDIOVASCULAR”, which stated, “ … Heart Sounds [listening to the heart by using a stethoscope on the chest] WNL [within normal limits]….” Review of the nurse’s visit note evidenced a subsection titled, “REVIEW OF SYSTEMS – RESPIRATORY”, which stated, “Breath Sounds [listening to the lungs by using a stethoscope on the chest and/or back] WNL….” Review of the nurse’s visit note evidenced a subsection titled, “REVIEW OF SYSTEMS – GASTROINTESTINAL”, which stated, “ … Bowel Sounds [listening to the movement of the intestines by using a stethoscope on the abdomen] WNL / Present All Quads [quadrants]….” A home visit for patient #4 was conducted on 9/29/2021, at 12:00 p.m. The visit was observed in its entirety by the surveyor. Observation of the home visit failed to evidence RN F assessing an apical pulse, heart sounds, breath sounds, and bowel sounds. Observation of the home visit failed to evidence RN F had a stethoscope. When informed of the findings on 10/12/2021, at 10:04 a.m., the administrator stated, “She didn’t pull out a stethoscope?” and offered no further information. 6. Clinical record review for patient #11, start of care 1/31/2019, certification period 1/31/2019 to 3/31/2019, primary diagnosis of Diverticuli [small bulging areas] of intestine, evidenced an agency document titled, “HOME HEALTH CERTIFICATION AND PLAN OF CARE”, signed by the physician on 5/21/2019. The plan of care had a subsection titled, “Medications: Dose / Frequency / route (N)ew (C)hanged”, which stated, “Lasix [a diuretic] 40 mg [milligram] 80 mg in AM 40 mg in afternoon BID [twice a day] PO [by mouth]….” Clinical record review evidenced an agency document titled, “Initial Nursing Assessment”, dated 1/31/2019. The assessment had a subsection titled, “Medications”, which stated, “ … Lasix 40mg BID PO….” Clinical record review failed to evidence any order for a change in the Lasix dose. During an interview on 10/12/2021, at 10:45 a.m., the administrator indicated the medication orders from the plan of care and the medication list should match, and she did not know why they didn’t. 7. Clinical record review on 10/7/2021, for patient #17, start of care 6/8/2021, certification period 6/8/2021 to 8/6/2021, primary diagnosis of Covid-19, evidenced an agency document titled, “ROC [resumption of care] OASIS [the patient-specific, standardized assessment used in Medicare home health care]- D1….”. Dated 6/16/2021, and signed by PT L. The assessment had a subsection titled, “PAIN MANAGEMENT”, which stated, “Relief Measures Narcotic analgesics”. Clinical record review evidenced an agency document titled, “Home Health Care Certification and Plan of Care”, signed by the physician 7/15/2021. The plan of care had a subsection titled, “Medications”, which failed to evidence any narcotic analgesics [pain medications]. During an interview on 10/12/2021, at 12:34 p.m. the administrator indicated the plan of care should contain all the patient’s medications. When informed of the findings, the administrator indicated the clinical record did not clearly indicate if the patient was taking any narcotic analgesics. 17-15-1(a)(7)