Every finding on record at In Homecare Network North LLC

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: March 5, 6, 10, 12, 13, 14, and 17, 2025 Active Census: 398 At this Emergency Preparedness survey, Angels of Mercy Homecare was found in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102. Abbreviations: EP Emergency Preparedness

This visit was for a Federal Recertification and State Re-Licensure survey of a Home Health Provider. Survey Dates: March 5, 6, 10, 12, 13, 14, and 17, 2025 12-Month Unduplicated Skilled Admissions: 1158 The survey was partially extended on 03/12/2025 at 9:40 AM. The survey was extended on 03/13/2025 at 4:20 PM. During this Federal Recertification Survey, Angels of Mercy Homecare was found to be out of compliance with Condition of Participation 484.60 Care planning, coordination of services, and quality of care. Based on the Condition-level deficiencies during the 03/17/2025 survey, your HHA was subject to an extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 03/13/2025. 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 03/17/2025 and continuing through 03/16/2027. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Abbreviations: SN Skilled Nurse RN Registered Nurse PT Physical Therapist PTA Physical Therapist Assistant OT Occupational Therapist COTA Certified Occupational Therapy Assistant ADLs Activities of Daily Living SOC Start of Care LPN Licensed Practical Nurse HHA Home Health Aide CM Clinical Manager

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure all therapy evaluations were conducted within five calendar days after the SOC for 4 of 8 active records reviewed of patients with physical therapy and/or occupational therapy services ordered (Patients #1, 5, 9, 12). Findings include: 1. The agency policy “Patient Assessment, Initial and Reassessment,” revised 9/01/24, indicated the PT and OT would make initial evaluations to determine the need for specific therapies. The evaluations were to be conducted within five days of the SOC or ordered date. 2. The review of Patient #1’s clinical record indicated Patient was referred to the agency for physical therapy and occupational therapy services. Patient’s SOC date was 2/17/25. A PT comprehensive assessment visit, documented on 2/17/25 by PT 2, indicated Patient requested SN and occupational therapy services during the admission visit. A POC for the initial certification period of 2/17/25 – 4/17/25 included orders for an OT evaluation, effective 3/02/25. The record failed to evidence Patient was notified and in agreement with the delayed OT evaluation. The record included an order, dated 2/19/25, for SN evaluation to be completed the week of 2/23/25 – 3/01/25. The record failed to evidence Patient was notified and in agreement with the delayed SN evaluation. A SN evaluation was documented on 2/26/25 by RN 4, which was nine days after Patient had requested services and seven days after an order was obtained. During an interview on 3/13/25 beginning at 2:51 PM, RN 4 reported she was unsure the reason Patient’s nursing evaluation was completed nine days after SOC. An OT evaluation was documented on 3/04/25 by OT 1, which was 15 days after Patient had requested services and the POC was initiated. During an interview on 3/13/25 beginning at 1:20 PM, OT 1 reported an OT evaluation was to be completed within 24-48 hours of being ordered. OT 1 was unsure the reason Patient’s OT evaluation was conducted 15 days after SOC, but reported she was the only OT assigned to the branch, and had limited availability. During an interview on 3/17/25 beginning at 10:42 AM, Patient Care Manager 3 reported the agency had 5 – 7 days to conduct evaluation visits after the SOC. The nurse reported after Patient requested SN and occupational therapies at SOC, Patient Care Manager 3 had written the order for SN to start the following week, since the order was obtained on a Wednesday. Patient Care Manager 3 reported the OT evaluation was ordered for the week of 3/02/25 due to staffing availability. The nurse reported the delay in evaluations should have been discussed with Patient during the SOC visit. During an interview on 3/17/25 beginning at 12:15 PM, PT 2 reported during the SOC visit, he did not discuss the timeframe Patient’s SN and occupational therapy services were to begin, as he was unsure when orders would be obtained and when the staff would be available. 3. The review of Patient #5’s clinical record indicated Patient was referred to the agency for physical therapy and occupational therapy services. Patient’s SOC date was 2/10/25. A POC for the initial certification period of 2/10/25 – 4/10/25 included orders for an OT evaluation, effective 2/16/25. The record failed to evidence Patient was notified and in agreement with the delayed OT evaluation. An OT evaluation was documented on 2/17/25 by OT 3, which was seven days after the SOC. During an interview on 3/14/25 beginning at 2:15 PM, Patient Care Manager 5 reported a therapy evaluation was to be completed within five days of the SOC. The nurse reported Patient’s record failed to evidence the reason Patient’s OT evaluation was delayed. 4. The review of Patient #9’s clinical record indicated Patient was referred to the agency for skilled nursing, physical therapy, and home health aide services. Patient’s SOC date was 1/31/25. A POC for the initial certification period of 1/31/25 – 3/31/25 indicated a PT evaluation was to be completed, effective 2/02/25 and an OT evaluation was to be completed, effective 02/09/25. The record failed to evidence Patient was notified and in agreement with the delayed PT and OT evaluations. A PT evaluation was documented on 2/07/25 by PT 2, which was seven days after Patient’s SOC. The record included orders to reschedule Patient’s OT evaluation on 2/11/25 and 3/04/25 by Patient Care Manager 3. The record failed to evidence the reason for the rescheduled visits and failed to evidence Patient was aware and in agreement with the rescheduled visits. The review of the record on 3/12/25 failed to evidence an OT evaluation had been completed. During an interview on 3/13/25 beginning at 12:56 PM, Patient reported he/she had needed assistance with ADLs after being discharged from the hospital, but he/she did not have any assistance, so Patient “learned to do it myself.” Patient reported they had an OT evaluation that morning, which was the first time he/she had heard from the agency regarding the OT evaluation. During an interview on 3/17/25 beginning at 8:32 AM, COTA 2 reported she had provided home health aide services to Patient. The OT assistant reported Patient did have a need for OT services, as Patient had decreased range of motion and needed assistance with ADLs. COTA 2 stated she thought OT 1 was going to conduct an OT evaluation visit, but was unsure of the reason the evaluation had not been done. During an interview on 3/13/25 beginning at 1:20 PM, OT 1 reported she had not been assigned an OT evaluation for Patient. During an interview on 3/13/25 beginning at 3:32 PM, Alternate Clinical Manager reported during Patient’s SOC visit, the nurse had explained the agency only had one OT working limited hours, so the OT service start could be delayed. The nurse was unable to provide documentation of patient notification and agreement for the delay in OT services. During an interview on 3/17/25 beginning at 10:51 AM, Alternate CM reported the agency had conducted the PT evaluation seven days after the SOC due to Patient request. Alternate CM was unable to provide documentation of this request. During an interview on 3/13/25 beginning at 3:56 PM, Patient Care Manager 3 reported Patient had requested to reschedule the OT evaluation on 2/11/25 and 3/04/25. Patient Care Manager 3 was unable to provide documentation of these requests. 5. The review of Patient #12’s clinical record indicated Patient was referred to the agency on 1/23/25 for SN, physical therapy, and occupational therapy services. Patient’s SOC date was 1/29/25. A POC for the initial certification period of 1/29/25 – 3/29/25 included orders for a PT evaluation and OT evaluation, effective 2/02/25. The record failed to evidence Patient was notified and in agreement with the delayed PT and OT evaluation. A PT evaluation was documented on 2/06/25 by PT 2, which was eight days after the SOC. During an interview on 3/17/25 beginning at 12:18 PM, PT 2 reported he was unsure the reason Patient’s PT evaluation was conducted eight days after the SOC. The record included orders to reschedule Patient’s OT evaluation on 2/04/25 and 2/11/25 by Patient Care Manager 3. The record failed to evidence the reason for the rescheduled visits and failed to evidence Patient was aware and in agreement with the rescheduled visits. The review of the record on 3/13/25 failed to evidence an OT evaluation had been completed. During an interview on 3/17/25 beginning at 10:51 AM, Alternate CM reported she was unsure the reason Patient’s PT evaluation was conducted eight days after the SOC. Alternate CM reported Patient’s OT evaluation had been rescheduled due to staff availability. The nurse reported she had attempted to discuss the rescheduling with Patient via phone, but Patient did not answer the agency’s calls. Alternate CM was unable to provide documentation of these attempts.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure a discharge summary was sent to the patient’s physician for 1 of 5 discharge patient records reviewed (Patient #14). Findings include: 1. The Patient Discharge/ Transfer Process policy, revised 10/01/2023, indicated “…A discharge summary… is sent to the physician or other healthcare professional responsible for care after discharge from the agency within 5 business days of patient’s discharge…” 2. Review of Patient #14’s record failed to include a discharge summary was sent to the patient’s physician. 3. During an interview on 03/17/2025 at 1:24 PM, the Administrator indicated documentation the discharge summary was sent to the physician should be in the communication notes. The Administrator further indicated she would attempt to locate documentation that a discharge summary for Patient #14 was sent to the physician. 4. During an interview on 03/17/2025 at 2:40 PM, the Administrator indicated she couldn’t find that a discharge summary was sent to Patient #14’s physician. 410 IAC 17-14-1(a)(1)(B)

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 POC included an accurate medication list (see Tag G574), failed to ensure wound care was performed according to the current physician order (see G580), failed to notify the physician of changes in the patient’s arm circumference measurement and failed to notify the physician of an increase in wound measurements (see G590). Based on observation, record review, and interview, the home health agency failed to meet the rehabilitative needs of the patient for 4 of 10 records reviewed of patients with ordered physical and/or occupational therapy services ordered (Patients #3, 9, 11, 13). The cumulative effect of these systemic issues evidenced the agency failed to meet all patients' needs, which resulted in Angels of Mercy Homecare being found out of compliance with 42 CFR Condition for Participation 484.60 Care planning, coordination of care, and quality of care. 4. Review of Patient #11’s clinical record indicated Patient was referred to the agency on 01/06/24 for SN, PT, and OT due to “weakness, balance, and gait training.” Patient #11 had a discharge date of 01/21/25 from a skilled nursing facility and a SOC date of 01/22/2025 with the home health agency. Patient #11 was noted to have left shoulder during the initial PT assessment on 01/24/25 with dressing upper extremities, reaching for items above Patient’s head, and ADLs being activities with which the pain interfered. The record included a verbal order entered by OT 3 on 01/23/2025 which included orders to move the OT evaluation to the following week (01/26/2025 to 02/01/2025) due to Patient #11’s request. The record included an OT note for the initial OT evaluation conducted on 02/04/2025. The agency failed to conduct an OT evaluation during the period requested by the patient and ordered by the provider. The agency’s complaint log included a Complaint Report documented by the Administrator on 02/06/2025. The report indicated Person 1 called the agency on 01/30/2025 and requested an update on when Patient #11’s OT evaluation would be conducted. Person 1 reported they were “disappointed” with the delay in the OT evaluation. The log indicated Person 1 called the agency again on 02/03/2025 to follow-up on the complaint “solutions.” During an interview on 03/17/2025, OT 3 indicated she normally assesses patients within five days of SOC, but if the patient requests the assessment be moved, she will honor the patient’s request. OT 3 further indicated she was the only OT for both the parent and branch locations of the agency at the time of Patient #11’s SOC. OT 3 also indicated she had been on leave from work for a week at the end of January due to illness. During an interview on 03/17/2025 at 1:47 PM, RN 3 indicated she was Patient #11’s RN case manager and indicated therapy evaluations should be conducted within 24 hours of an RN SOC. RN 3 also indicated the only reason she could think of for Patient #11 having a SOC of 01/22/2025 and receiving the initial OT evaluation on 02/04/2025 was the availability of OT 3. During an interview on 03/17/2025 at 1:28 PM, Person 1, caregiver for Patient #11, indicated Patient was home for 11 days with no shower because the OT evaluator was on leave. Person 1 indicated someone came out to assist Patient #11 with showers after they called regarding the delay. Person 1 further indicated the agency did not communicate with them about the OT evaluation delay until they called to ask about it. Findings include: 1. The review of agency policy “Acceptance of Patients/Admission Process,” last revised 1/01/25, indicated admission criteria included the agency “must be able to meet the patient’s needs including staffing of available services adequate to meet the immediate and ongoing patient care needs in appropriate timeframes ….” 2. The review of Patient #3’s clinical record indicated Patient was referred to the agency on 11/26/24 for physical therapy due to “frequent falls, generalized weakness, very sedentary.” The referral order indicated Patient’s primary caregiver was “struggling to help” Patient with his/her care, “primarily bathing,” and was “interested in home help available.” The referring provider noted Patient had diffuse left arm pain, which was Patient’s dominant side. Patient began receiving home physical therapy services on 12/03/24. A PT visit note, documented by PTA 4 on 1/07/25, evidenced Patient reported they could not raise their left arm. Patient felt their shoulder was getting weaker, and he/she reported being unable to comb their hair due to shoulder weakness. An order was obtained on 1/07/25 by Patient Care Manager 3 for an OT evaluation due to left shoulder pain. An OT evaluation note, documented on 1/18/25 by OT 1, evidenced Patient reported “significant” pain to the left neck and shoulder, “affecting safety with ADL [activities of daily living] completion.” Patient required maximum assistance with all ADLs. OT 1 documented Patient would benefit from occupational therapy services to “increase strength and endurance as well as reduce pain in left shoulder to allow Patient to regain greater functional ADL independence.” An order for OT services was obtained, with OT visits occurring once per week for one week, twice per week for one week, then once per week for one week. An OT visit note, documented on 1/29/25 by COTA 2, evidenced Patient reported pain to the left shoulder, which worsened with movement. Patient required maximum assistance with ADLs including oral care and donning socks. COTA 2 documented Patient’s therapy plan was to “continue occupational therapy to address pain, strengthening and endurance.” A COTA case conference between OT 1 and COTA 2, documented on 1/31/25, evidenced COTA 2 was to continue with Patient’s treatment plan. A POC for the recertification period of 2/01/25 – 4/01/25 indicated Patient was to receive an OT re-evaluation, effective 2/09/25. The record included orders to reschedule Patient’s OT re-evaluation, obtained on 2/06/25, 2/10/25 and 3/06/25 by Patient Care Manager 3 and Alternate Clinical Manager. The record failed to evidence the reason for the rescheduled visits and failed to evidence Patient was aware and in agreement with the rescheduled visits. The review of the record on 3/06/25 failed to evidence an OT re-evaluation had been completed. During a home visit observation with Patient #3 on 3/06/25 beginning at 2:38 PM, Patient reported pain to the left shoulder and was unable to lift his/her left arm past his/her chest. Patient also reported difficulty with writing. Patient asked PT 2 if occupational therapy was going to provide any further services, to which PT 2 responded he had put a request in for an OT evaluation. During an interview on 3/06/25 beginning at 3:28 PM, Patient #3 reported they had previously received OT services, and was told by agency staff the services were to continue, however no OT had attempted to schedule a visit in over one month. Patient reported they had not spoken with anyone at the agency about a change in OT services. During an interview on 3/13/25 beginning at 1:20 PM, OT 1 reported when a patient’s ordered OT services were to expire, she would determine if a patient needed a re-evaluation or services were to end based on the case conference with COTA 2. If COTA 2 reported a patient had not yet met their goals, the OT would obtain an order to re-evaluate the patient. When asked the reason Patient’s OT services did not continue after 1/29/25, OT 1 reported Patient’s certification period had ended on 2/01/25, and she thought COTA 2 had reported Patient was progressing towards their goals. When asked the reason Patient’s re-evaluation had been rescheduled three times, OT 1 reported this was done by the agency office staff due to the OT’s limited availability. The OT reported she did not communicate with Patient regarding rescheduling the evaluation. During an interview on 3/17/25 beginning at 8:28 AM, COTA 2 reported the plan for Patient at the time of recertification was to continue OT services. COTA 2 reported there was a “gap” in services due to staffing availability. During an interview on 3/13/25 beginning at 3:32 PM, Alternate Clinical Manager reported the agency had to reschedule Patient’s OT re-evaluation for the weeks beginning 2/10/25 and 3/06/25 due to staff availability. Alternate Clinical Manager reported she did not document her communication with Patient regarding the schedule changes. During an interview on 3/13/25 beginning at 3:46 PM, Patient Care Manager 3 reported the agency had to reschedule Patient’s OT re-evaluation for the week beginning 2/06/25 due to staff availability. Patient Care Manager reported she did not document her communication with Patient regarding the schedule changes. 3. The review of Patient #9’s clinical record indicated Patient was referred to the agency on 1/23/25 for SN, HHA, and physical therapy services. Patient’s primary diagnosis was fracture of the left forearm. Referral documents included an inpatient OT evaluation, which evidenced Patient had deficits with ADLs and IADLs, including “bathing/showering, Toileting/hygiene, Dressing, Functional mobility … Home establishment/management, Meal prep/clean up.” Patient’s SOC was 1/31/25, and the POC for the initial certification period of 1/31/25 – 3/31/25 indicated an OT evaluation was to be completed, effective 02/09/25. The record included orders to reschedule Patient’s OT evaluation on 2/11/25 and 3/04/25 by Patient Care Manager 3. The record failed to evidence the reason for the rescheduled visits and failed to evidence Patient was aware and in agreement with the rescheduled visits. The review of the record on 3/12/25 failed to evidence an OT evaluation had been completed. During an interview on 3/13/25 beginning at 12:56 PM, Patient reported he/she had needed assistance with ADLs after being discharged from the hospital, but he/she did not have any assistance available, so Patient “learned to do it myself.” Patient reported they had an OT evaluation the morning of 3/13/25, which was the first time he/she had heard from the agency regarding the OT evaluation. During an interview on 3/17/25 beginning at 8:32 AM, COTA 2 reported she had provided home health aide services to Patient. The OT assistant reported Patient did have a need for OT services, as Patient had decreased range of motion and needed assistance with ADLs. COTA 2 stated she thought OT 1 was going to conduct an OT evaluation visit, but was unsure of the reason the evaluation had not been done.During an interview on 3/13/25 beginning at 1:20 PM, OT 1 reported she had not been assigned an OT evaluation for Patient. During an interview on 3/13/25 beginning at 3:32 PM, Alternate Clinical Manager reported during Patient’s SOC visit, the nurse had explained the agency only had one OT working with limited availability, so the OT service start could be delayed. The nurse was unable to provide documentation of patient notification and agreement with the delay in OT services. During an interview on 3/13/25 beginning at 3:56 PM, Patient Care Manager 3 reported Patient had requested to reschedule the OT evaluation on 2/11/25 and 3/04/25. Patient Care Manager 3 was unable to provide documentation of these requests. 5. The review of Patient #13’s clinical record indicated a SOC date of 8/27/24 and included an order for physical therapy services, effective 11/03/24, with visits once a week for 8 weeks. A PT re-evaluation note, documented 12/06/25 by PT 2, indicated Patient was to continue PT services to improve “strength and mobility … balance and safety.” A PT visit note, documented 12/12/24 by PTA 4, indicated Patient would “continue to benefit from physical therapy to focus on balance activities, endurance training, transfer gait training.” The record failed to evidence further PT visits were provided nor was a PT re-evaluation completed. The record included a POC for the recertification period of 12/25/24 – 2/22/25, which indicated the only ordered service was skilled nursing. During an interview on 3/17/25 beginning at 12:18 PM, PT 2 reported he would “always” do a re-evaluation visit after a new certification period to determine if a patient’s PT services should continue or if the patient could be discharged. The therapist could not recall the reason Patient’s PT services did not continue nor the reason a PT re-evaluation was not done after Patient’s recertification. 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 home health agency failed to ensure the POC included an accurate medication list for 2 of 7 home visit observations (Patient #1, 2). Findings include: 1. The agency policy “Monitoring Medications,” last revised 7/01/24, indicated “all clinicians participating in the patient’s care are responsible to assist with the maintenance of accurate patient medication information throughout the episode of care.” 2. During the Entrance Conference on 3/05/25 beginning at 8:40 AM, Administrator reported all staff were to reconcile the patient’s medications at each visit. The reconciliation was to be performed by comparing the medication bottles in the home against the agency’s medication list. 3. During a home visit observation with Patient #1 on 3/06/25 beginning at 9:04 AM, PTA 1 reconciled Patient’s medication bottles against the agency’s medication list. The agency’s POC indicated Patient’s active medications included Sertraline (a medication used to treat a variety of mental health disorders), however Patient kept the Sertraline separate from his/her active medication bottles, and Patient reported he/she was not taking this medication. During an interview on 3/06/25 beginning at 9:56 AM, Patient reported he/she had stopped taking Sertraline prior to being admitted to the home health agency. Patient reported the agency staff had reviewed Patient’s medication bottles “maybe twice” since the SOC. 4. During a home visit observation with Patient #2 on 3/06/25 beginning at 10:49 AM, LPN 1 reconciled Patient’s medication bottles against the agency’s medication list and a list provided by Patient’s physician. Patient’s medication bottles included Tamsulosin (a medication used to treat an enlarged prostate) with a fill date of 11/11/24. The physician medication list also indicated Patient’s active medications included Tamsulosin. The POC failed to evidence Tamsulosin was an active medication. During an interview on 3/06/25 beginning at 11:49 AM, Patient reported he/she had been taking Tamsulosin prior to being admitted to the home health agency. 410 IAC 17-13(1)(a)(1)(D)(ix)

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure wound care was performed according to the current physician order for 1 of 3 home visit observations of a SN visit where wound care was performed (Patient #7). Findings include: 1. The agency policy “Wound Assessment, Documentation, and Photography,” last revised 9/01/24, indicated wound care was to be performed according to physician order. 2. The agency policy “Physician Orders,” last revised 10/01/23, indicated services were to be provided “according to the most recent orders updating the patient’s Plan of Care.” 3. The review of Patient #7’s clinical record indicated a start of care date of 9/15/24. A POC for the recertification period of 1/13/25 – 3/13/25 indicated Patient was to receive skilled nursing services, with interventions to include performing wound care. Patient had two open diabetic ulcers to the left foot, including one diabetic ulcer to the left lateral foot. Patient’s wounds were being managed by Entity B, a wound clinic. The record included Entity B’s clinic notes dated 2/14/25 and received by the agency on 2/14/25. The visit note indicated wound care to Patient’s left lateral wound included applying an Aquacel Ag Advantage dressing (a fiber wound dressing with ionic silver imbedded) and covering with a bordered gauze dressing, to be done three times a week. The record included Entity B’s clinic notes dated 2/21/25 and received by the agency on 2/21/25. The visit note included a new order for wound care to Patient’s left lateral wound included applying an IoPlex dressing (a wound dressing which slowly releases iodine) and covering with a bordered gauze dressing, to be done three times a week. A SN visit note, documented on 2/26/25 by RN 2, indicated the nurse performed wound care to Patient’s left lateral wound dressing, including applying an Aquacel Ag Advantage dressing, covering with an ABD (abdominal) gauze pad, and wrapping with Kerlix (a gauze wrap). The record failed to evidence the nurse had reviewed Entity B’s clinic note from 2/21/25 and failed to evidence the nurse performed wound care according to the current order. A SN visit note, documented on 3/03/25 by RN 2, indicated the nurse performed wound care to Patient’s left lateral wound dressing, including applying an Aquacel Ag Advantage dressing, covering with an ABD pad, and wrapping with Kerlix. The record failed to evidence the nurse had reviewed Entity B’s clinic note from 2/21/25 and failed to evidence the nurse performed wound care according to the current order. The record indicated RN 2 entered an order on 3/05/25 to apply an IoPlex dressing to Patient’s left lateral wound. RN 2 documented a verbal order for this wound care was received on 2/28/25. During a home visit observation on 3/10/25 beginning at 3:18 PM, RN 2 was observed performing wound care to the left lateral wound. The nurse reported she had ordered a supply of IoPlex dressings on 3/05/25, however the agency had not yet received it. The nurse stated she had contacted Entity B earlier that day to verify alternative dressings which could be used, and received an order to use PolyMem (a foam dressing) until the IoPlex supply was received. During an interview on 3/17/25 beginning at 10:12 AM, RN 2 reported she called Entity B two to three times per week to verify Patient’s wound care orders and reviewed the wound clinic’s notes at each SN visit. RN 2 reported she received the order to change the left lateral wound’s primary dressing from Aquacel to IoPlex through Entity B’s 2/21/25 clinic note. RN 2 could not recall when she reviewed Entity B’s clinic notes and obtained the updated order. 410 IAC 17-13-1(a)

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to notify the physician of changes in the patient’s arm circumference measurement for 1 of 1 record reviewed of a patient with a PICC line (Patient #2) and failed to notify the physician of an increase in wound measurements for 2 of 3 home visit observations of a SN visit with wound assessment (Patient #6, 7). Findings include: 1. The agency policy “Coordination of Care, From Admit Through Discharge,” last revised 9/01/24, indicated coordination of services was to be promoted through “routine communication with the patient’s physician”, including “when changes occur in the patient’s condition or response to treatment.” 2. The agency policy “Dressing Change Procedure for Central Venous, Midline, and Peripherally Inserted Central Catheters [PICC, a long IV placed into a large vein for medication infusions and/or blood draws],” last revised 10/01/16, indicated assessment during a PICC dressing change included measuring the upper arm circumference and comparing to the baseline measurement. The physician should be notified of “any significant findings in measurement as this may be indicative of a thrombus [blood clot].” 3. The review of Patient #2’s clinical record indicated Patient was to receive SN services with interventions to include observing and assessing Patient’s right upper arm PICC. Patient received four antibiotic infusions every day and had blood drawn weekly thru the PICC line. A RN start of care note, documented on 1/29/25 by Patient Care Manager 3, indicated Patient’s right arm circumference (measurement taken above the PICC line to monitor for potential complications from the PICC) was 28.0 centimeters (cm). A SN visit note, documented on 2/21/25 by Patient Care Manager 3, indicated Patient’s right arm circumference was 30.0 cm, an increase by 2 cm. The visit note failed to evidence Patient Care Manager 3 notified Patient’s physician of the increase in PICC arm circumference. During an interview on 3/13/25 beginning at 3:49 PM, Patient Care Manager 3 reported she would report “any increase” in arm circumference when a patient had a PICC line. The nurse stated she had communicated the increase in arm circumference to Patient’s physician, however she was unable to provide documentation of this communication. 4. The review of Patient #6’s clinical record indicated Patient was to receive SN services with interventions to include assessing Patient’s wounds. Patient had open ulceration wounds to both lower legs. Patient’s POC indicated potential wound complications included “increase in wound size,” and Patient’s goals included “improved wound status as evidenced by decrease in size ….” A SN visit note, documented on 2/19/25 by LPN 2, indicated Patient’s left lower leg wound measured 5 cm in length by 27 cm in width by 0.2 cm in width (5 cm x 27 cm x 0.2 cm). A RN recertification note, documented on 3/03/25 by RN 3, indicated Patient’s right lower leg wound measured 4 cm x 8 cm x 0.4 cm and the left lower leg wound measured 5 cm x 7 cm x 0.2 cm. During a home visit observation with Patient #6 on 3/10/25 beginning at 12:56 PM, LPN 2 was observed measuring Patient’s leg wounds. Patient had large wounds to both legs, covering both the anterior and posterior leg, with “islands” of skin scattered throughout. LPN 2 noted Patient’s right lower leg wound measured 6 cm x 10 cm x 0.1 cm, an increase of 2 cm in length and 2 cm in width from the previous measurement. The left lower leg wound measured 5 cm x 36 cm x 0.1 cm, an increase in 29 cm in width from the previous measurement. The record failed to evidence LPN 2 notified Patient’s physician of the increase in wound measurements. During an interview on 3/14/25 beginning at 3:36 PM, LPN 2 reported no changes in Patient’s wounds were noted during the 3/10/25 visit, so the nurse had not reported any changes to Patient’s physician. LPN 2 stated she would report any change in wound measurements to Patient’s physician. When asked if LPN 2 had noted the increase in her wound measurements when compared with the previous measurements, the nurse stated no and thought the wounds had been measured incorrectly by RN 3. 5. The review of Patient #7’s clinical record indicated Patient was to receive SN services with interventions to include assessing Patient’s wounds. Patient had two open diabetic ulcers to the left foot, including one to the posterior foot and one to the lateral (side) foot. Patient’s POC indicated potential wound complications included “increase in wound size,” and Patient’s goals included “improved wound status as evidenced by decrease in size ….” A SN visit note, documented on 1/27/25 by LPN 3, indicated Patient’s left lateral wound was new and measured 5.5 cm x 2.8 cm x 0.1 cm. A SN visit note, documented on 1/30/25 by RN 2, indicated Patient’s left lateral wound measured 7 cm x 5 cm by 0.2 cm, an increase of 1.5 cm in length and 2.2 cm in width. The record failed to evidence RN 2 notified Patient’s physician of the increase in wound measurements. During an interview on 3/17/25 beginning at 10:12 AM, RN 2 stated she would report an increase in wound measurements to the physician. The nurse thought she had left a message with Patient’s wound clinic regarding the increase in size after the 1/30/25, however she was unable to provide documentation of this communication. 410 IAC 17-13-1(a)(2)

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, policy review, and interview, the home health agency failed to ensure all staff followed standard precautions and infection control policies and procedures for 6 of 7 home visit observations (Patient #1, 2, 3, 4, 5, 6). Findings include: 1. The agency policy “Hand Hygiene,” last revised 5/01/19, indicated staff were to perform hand hygiene “after contact with … non-intact skin, wound dressings … if moving from a contaminated body site to a clean body site during patient care, after contact with inanimate objects … in the immediate vicing of the patient, before and after removal of personal protective equipment (PPE) ….” 2. The agency policy “Dressing Change Procedure for Central Venous, Midline, and Peripherally Inserted Central Catheter [PICC],” last revised 10/01/16, indicated during a PICC line dressing change, staff should don clean gloves, remove the old PICC dressing, remove gloves and perform hand hygiene, then don sterile gloves. After inspecting the catheter site, staff should cleanse the site with chlorohexidine in “a back and forth motion.” When povidone-iodine is used, staff should apply the disinfectant in “a circular motion, moving from the catheter insertion site outward in concentric circles.” 3. An untitled agency procedure indicated when flushing a PICC line, staff should scrub the needleless connector “using a vigorous mechanical scrubbing for a minimum of 5 seconds with an appropriate disinfecting agent” prior to attaching a flush syringe. Staff should repeat the procedure prior to connecting a heparin lock syringe. 4. The agency policy “Cleaning of Re-Usable Equipment,” last revised 6/01/22, indicated “non-critical items,” such as stethoscopes, blood pressure cuffs, and pulse oximeters, would be cleaned with a disinfectant “after each patient use and before returning to staff bags.” 5. The manufacturer’s instructions for CaviWipes, obtained from www.metrex.com, indicated the dry time for the disinfectant wipes was 3 minutes. 6. During a home visit observation with Patient #1 on 3/06/25 beginning at 9:04 AM, PTA 1 was observed obtaining Patient’s vital signs and measuring Patient’s ankles. PTA then failed to perform hand hygiene prior to donning gloves. During an interview on 3/06/25 beginning at 9:52 AM, PTA 1 reported she should perform hand hygiene after contact with a patient and prior to donning gloves. 7. During a home visit observation with Patient #2 on 3/06/25 beginning at 10:49 AM, LPN 1 was observed performing a PICC line dressing change. After removing the old dressing, the nurse failed to change her gloves, perform hand hygiene, and don new sterile gloves prior to cleaning the PICC. When cleansing the site, LPN 1 failed to apply the disinfectant to the PICC insertion point. After completing the PICC dressing change, LPN 1 scrubbed the needless connector with an alcohol swab for 2 seconds prior to connecting the initial line flush and prior to connecting the heparin lock flush. During an interview on 3/06/25 beginning at 11:43 AM, LPN 1 reported during a PICC line dressing change, she should change her gloves and perform hand hygiene between removing the old dressing and cleaning the site. The nurse reported she cleaned Patient’s PICC line with alcohol then betadine (a povidone iodine solution). LPN 1 stated she did not realize she had failed to clean the PICC insertion site with disinfectant. LPN 1 reported the needless connector should be scrubbed with alcohol for “30 seconds” prior to connecting a flush or lock syringe. When asked if the nurse had done this during the visit, LPN 1 reported she had sung the “happy birthday” song in her head as a method of counting, but had done it “quickly.” 8. During a home visit observation with Patient #3 on 3/06/25 beginning at 2:38 PM, PT 2 was observed wiping reusable equipment including a stethoscope, manual blood pressure cuff, thermometer, and pulse oximeter with CaviWipes disinfectant wipes. After wiping the equipment, PT 1 placed them immediately into his supply bag, failing to allow the disinfectant to dry. During an interview on 3/06/25 beginning at 3:20 PM, PT 2 reported the dry time for CaviWipes disinfectant wipes was “around 60 seconds.” 9. During a home visit observation with Patient #4 on 3/10/25 beginning at 9:03 AM, RN 1 was observed performing wound care to an open wound. After cleansing the wound, the nurse failed to change gloves and perform hand hygiene prior to applying a new, clean dressing. During an interview on 3/10/25 beginning at 9:56 AM, RN 1 reported during wound care, she should change her gloves and performed hand hygiene at the start of the procedure, after removing the old dressing, and after completing the procedure. 10. During a home visit observation with Patient #5 on 3/10/25 beginning at 11:00 AM, OT 3 was observed conducting an OT re-evaluation visit. The therapist failed to perform hand hygiene after removing gloves on two occasions. During an interview on 3/10/25 beginning at 11:54 AM, OT 3 reported she should perform hand hygiene after removing gloves if her hands had been soiled while wearing gloves. 11. During a home visit observation with Patient #6 on 3/10/25 beginning at 12:56 PM, LPN 2 was observed conducting a SN visit. Patient was noted to have an active shingles rash to the left lateral (side) chest and back. The nurse failed to perform hand hygiene after removing gloves on two occasions, including after assessing Patient’s shingles rash. During an interview on 3/10/25 beginning at 2:03 PM, LPN 2 reported she should perform hand hygiene after removing gloves. The nurse stated Patient’s shingles rash began draining on 3/07/25, and the nurse noted Patient’s T-shirt had drainage from the rash on it. 12. During an interview with CM, Alternate CM, and Patient Care Manager 3 on 3/12/24 beginning at 9:20 AM, the administrative staff reported staff should perform hand hygiene before and after changing gloves, with “every point of [patient] contact,” and when hands were soiled. When changing a PICC line dressing, staff should change gloves and perform hand hygiene after removing the old dressing, clean directly at the PICC insertion site, and scrub the needless connector with an alcohol wipe for five seconds prior to connecting syringes. The administrative staff reported staff should allow equipment wiped with disinfectant to dry prior to returning it to their supply bag, and the nurse should change gloves and perform hand hygiene between cleaning an open wound and applying a new dressing. 410 IAC 17-12-1(m)

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on observation, record review, policy review, and interview, the skilled professional failed to use an appropriate sized blood pressure (BP) cuff to assess a patient’s BP for 2 of 7 home visit observations (Patient #1, 7), failed to perform a complete assessment of a patient’s lung, heart, and bowel sounds for 3 of 7 home visit observations (Patient #2, 3, 5), failed to conduct a complete assessment of a patient’s wound and cough for 1 of 3 home visit observations of a SN visit with wound care (Patient #4), and failed to perform a complete medication reconciliation for 1 of 1 home visit observations of an OT re-evaluation visit (Patient #5). Findings include: 1. The agency policy “Monitoring Medications,” last revised 7/01/24, indicated “all clinicians participating in the patient’s care are responsible to assist with the maintenance of accurate patient medication information throughout the episode of care.” Staff were to “compare medications [the] patient is currently taking with medications ordered for the patient in order to identify and resolve discrepancies.” 2. The agency policy “Wound Assessment, Documentation, and Photography,” last revised 9/01/24, indicated the wound assessment should include a measurement of the wound’s depth, taken at “the deepest area using [a] cotton tipped applicator ….” 3. An untitled agency procedure on BP measurement indicated the BP cuff’s bladder (inflatable tube inside the cuff which expands to measure BP) “should be proportionate to the limb circumference,” and “an improperly sized cuff produces an inaccurate BP measurement.” 4. American Heart Association guidance titled “Measuring Blood Pressure Accurately,” obtained from www.heart.org, indicated the length of the BP cuff’s bladder should be “75 – 100%” of the Patient’s measured arm circumference. 5. During a home visit observation with Patient #1 on 3/06/25 beginning at 9:04 AM, PTA 1 was observed obtaining Patient’s BP. The therapy assistant used a standard-sized BP cuff on Patient’s upper arm. The cuff’s bladder length was less than 75-80% of Patient’s arm circumference, indicating the cuff was too small. PTA 1 reported Patient's BP was "96/58." Review of Patient's clinical record evidenced three of Patient's previous blood pressure readings were: a. 112/62 on 3/04/25 b. 118/68 on 2/26/25 c. 142/79 on 2/17/25 During an interview on 3/06/25 beginning at 9:52 AM, PTA 1 reported she only had a standard sized BP available. The PT assistant stated she would take a patient’s BP in their lower arm if the cuff was too small. 6. During a home visit observation with Patient #2 on 3/06/25 beginning at 10:49 AM, LPN 1 was observed performing a SN visit. The nurse failed to listen for lung sounds in all lung lobes and for bowel sounds in all abdominal quadrants. During an interview on 3/17/25 beginning at 8:38 AM, LPN 1 reported a SN assessment included listening for lung sounds in all lung lobes, both anteriorly and posteriorly, and listening for bowel sounds in all abdominal quadrants. 7. During a home visit observation with Patient #3 on 3/06/25 beginning at 2:38 PM, PT 2 was observed conducting a PT re-evaluation visit. The therapist failed to assess Patient’s lung sounds, heart tones, and bowel sounds during the visit. During an interview on 3/17/25 beginning at 12:11 PM, PT 2 reported during a PT re-assessment visit, the assessment would include listening to lung sounds, heart tones, and bowel sounds. PT 2 reported he did not assess these for Patient during the 3/06/25 visit due to Patient reporting during the previous visit on 1/30/25 that Patient “didn’t like” the stethoscope on his/her chest and back. The review of PT 2’s visit note from 1/30/25 evidenced PT 1 had assessed Patient’s lung sounds and bowel sounds during the visit. The record failed to evidence Patient had declined the assessment or had requested no further lung, heart, or bowel sound assessments. 8. During a home visit observation with Patient #4 on 3/10/25 beginning at 9:03 AM, Patient reported a productive cough to RN 1. The nurse failed to conduct a further assessment of the cough, including the sputum color, consistency, and amount. RN 1 performed a wound assessment to Patient’s right forearm open wound. RN 1 failed to measure the depth of the wound as part of the wound assessment. During an interview on 3/10/25 beginning at 9:56 AM, RN 1 reported Patient had a history of COPD (Chronic Obstructive Pulmonary Disease, a progressively worsening lung disease). The nurse reported she did not assess the color or consistency of Patient’s sputum. She reported Patient had previously reported the sputum was “creamy” in color and consistency. During an interview on 3/10/25 beginning at 10:03 AM, Patient reported their sputum was clear to brown in color and had a thin consistency. 9. During a home visit observation with Patient #5 on 3/10/25 beginning at 11:00 AM, OT 3 was observed conducting an OT re-evaluation visit. The therapist reconciled Patient’s medication bottles against the agency’s medication list. OT 3 failed to review the medication bottles or verify if Patient was still taking Melatonin (a supplement used to treat insomnia), Mirtazepine (a medication used to treat depression), Metamucil (a medication used to treat constipation), and Repatha (an injected medication used to treat high cholesterol). The therapist also failed to listen for lung sounds in all lung lobes and for bowel sounds in all abdominal quadrants. During an interview on 3/10/25 beginning at 11:54 AM, OT 3 reported she reconciled Patient’s medications by comparing Patient’s medication bottles against the agency’s medication list. The therapist reported she did not observe a bottle or verify Patient was taking Melatonin, Mirtazepine, Metamucil, or Repatha. OT 3 also reported she assessed Patient’s lung sounds by listening to the left upper lobe only and assessed Patient’s bowel sounds by listening to the midline upper abdomen only. 10. During a home visit observation with Patient #1 on 3/10/25 beginning at 3:18 PM, RN 2 was observed obtaining Patient’s BP. The nurse used a standard-sized BP cuff on Patient’s upper arm. The cuff’s bladder length was less than 75-80% of Patient’s arm circumference, indicating the cuff was too small. RN 2 reported Patient's BP was "104/60." Review of Patient's clinical record indicated Patient's three previous blood pressure readings were as follows- a. 140/82 on 3/05/25 b. 128/64 on 3/03/25 c. 128/68 on 2/26/25 During an interview on 3/17/25 beginning at 10:12 AM, RN 2 reported she used a standard sized BP cuff on all patients unless the cuff would not go all the way around a patient’s arm and the Velcro would not stick securely. 11. During an interview with CM, Alternate CM, and Patient Care Manager 3 on 3/12/24 beginning at 9:20 AM, the administrative staff reported if a BP cuff was too small, staff should use a larger cuff or take the BP reading on an alternative site. CM reported staff should reconcile the patient’s medications at each visit by comparing the medication bottles in the home against the agency’s medication list. If a medication was included on the agency’s list but not observed in the home, staff should investigate if Patient was still taking the medication. The administrative staff reported the nurse should assess a wound’s depth when measuring an open wound, the nurse should assess a patient’s cough “quality,” including sputum color and consistency, when a patient reported a productive cough, and the therapist should “check all systems” at every visit, including listening to all lung lobes, heart tones, and all bowel quadrants. 410 IAC 17-14-1(a)(1)(b), 17-14-1(a)(2)(A), 17-14-1(c)(3)

An unannounced Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.22. Survey Dates: March 10, 11, 14, 15, 16, 17, 18, 21, 22; 2022 Facility Number: 003890 Provider Number: 157544 Census: 501 Angels of Mercy was found in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.22.

This was an unannounced Federal recertification and State re-licensure survey of a home health agency, completed on March 22, 2022. The survey was fully extended on 3/16/22 at 3:45pm. Survey Dates: March 10, 11, 14, 15, 16, 17, 18, 21, 22; 2022 Provider ID: 157554 Facility ID: 003890 Unduplicated admissions for past 12 months: 2507 Active Patient Census: 501 These deficiencies reflect State findings cited in accordance with 410 IAC 17.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the comprehensive assessment included a complete and thorough assessment of all patient conditions and diseases for 4 of 12 active records reviewed (Patients # 1, 10, 11, and 12). 1. An agency policy #2.1.002 titled “Patient Assessment, Initial and Reassessment,” last revised 10/1/18, included, but not limited to, “upon admission and reassessments, the qualified clinician performs the following assessment activities and collects the following data … current health status … additional assessment needs are determined by patient acuity....” 2. The clinical record of Patient #1 was reviewed on 3/15/22, with start of care of 01/22/2022. The plan of care for the certification period 01/22/22 to 3/22/22 included patient diagnoses, but not limited to, heart disease, high blood pressure, heart failure, Type 2 Diabetes with polyneuropathy (decreased sensation in more than one peripheral nerve), Atrial Fibrillation (an irregular heart rhythm), and depression and included physician orders for physical therapy. The record evidenced an initial comprehensive assessment was completed on 01/22/22 by Physical Therapist (PT) #1. The assessment included a ranking system of the patient’s current diagnoses and identified the diagnoses which included heart disease with high blood pressure and heart failure and PT#1 rated as “4 - poorly controlled, history of rehospitalizations,” the diagnoses of atrial fibrillation was rated as “3 - poorly controlled, patient needs frequent adjustments in treatment and dose monitoring,” and the diagnosis of depression was rated as “2 - symptoms controlled with difficulty, affecting daily functioning; patient needs ongoing monitoring.” The comprehensive assessment failed to evidence a thorough and complete assessment including the presence or absence of symptoms for the patient’s poorly or difficultly controlled diagnoses, including heart failure and atrial fibrillation. The assessment included a PHQ-2 (screening tool used to assess for two major symptoms of depression) but failed to evidence further assessment for other symptoms of depression. The comprehensive assessment included a section titled “Integumentary [system of organs which make up the outer layer of the body, including skin, hair, and nerves] Assessment.” The documentation failed to evidence an assessment of the patient’s integumentary system, including an assessment for the presence or absence of wounds. The comprehensive assessment included a “Summary of Therapy Assessment and Need” with documentation that stated, “Patient saw [primary physician] in late December for a follow up after labs and X-rays for a cough … Patient’s cough slightly improved ….” The assessment failed to evidence a thorough and complete assessment of the patient’s cough (productive or non-productive, worse at night, etc.). The comprehensive assessment included a medication list which indicated the patient was actively prescribed midodrine (medication given to treat dizziness caused by changing positions) and Flomax (medication given to treat benign prostate hyperplasia, an enlargement of the prostate gland). The assessment failed to evidence diagnoses related to the use of these medications and an assessment of the status and presence or absence of the medication-related conditions. 3. The clinical record of Patient #10 was reviewed on 3/20/22 and indicated a start of care date of 2/23/22. The record included a plan of care for the certification period 02/23/22 to 4/23/22 which indicated patient diagnoses included but was not limited to hypertension (high blood pressure), chronic respiratory failure, and venous insufficiency (condition where the blood in veins does not flow properly). The record included an initial comprehensive assessment completed on 02/23/22 by PT #1. The assessment included a ranking of the status of the patient diagnoses which indicated the diagnoses of hypertension, chronic respiratory failure, and venous insufficiency were rated “3 – Symptoms poorly controlled, patient needs frequent adjustments in treatment and dose monitoring.” The comprehensive assessment failed to evidence a thorough and complete assessment, including the presence or absence of symptoms, for the patient’s poorly or difficultly controlled diagnoses, including hypertension, chronic respiratory failure, and venous insufficiency. The assessment indicated the patient had a tracheostomy (trach, tube placed into the windpipe to assist with oxygenation) and wore oxygen continuously via tracheostomy mask. The assessment failed to evidence a complete and thorough assessment of the patient’s tracheostomy status and requirements (size of trach tube, appearance of trach site, frequency of changing, etc.). The assessment included a medication list, which indicated the patient was actively prescribed famotidine (medication given to treat Gastro Esophageal Reflux Disease, GERD) and Alka-Seltzer (medication given to treat the symptoms of heartburn, upset stomach, and indigestion). The assessment failed to evidence a diagnosis, status, and thorough and complete assessment of the patient’s condition which required the above medications. 4. The clinical record of Patient #11 was reviewed on 3/20/22. The plan of care for the certification period 02/07/2022 to 4/07/2022, start of care 6/17/2020, included patient diagnoses that included, but not limited to, COVID-19, dysphagia (difficulty swallowing), hemiplegia (paralysis to one side of the body) post stroke, and history of brain cancer. The recertification comprehensive assessment was completed on 2/4/22 by RN #6 and included a ranking system of the patient’s current diagnoses which indicated the patient’s diagnoses of dysphagia and hemiplegia post stroke were “3 – Symptoms poorly controlled, patient needs frequent adjustments in treatment and dose monitoring.” The assessment failed to evidence a thorough and complete assessment, including presence or absence of symptoms, for the diagnoses of dysphagia and hemiplegia post stroke. With the assessment was a “Narrative” which documented the patient had a PEG tube (percutaneous endoscopic gastrostomy, tube placed through the abdomen into the stomach) to be used for nutrition. The comprehensive assessment failed to evidence a complete and thorough assessment of the status of the patient’s PEG tube (appearance of site, size of tube, etc.) and tube feeding (type and frequency of tube feeding, any signs, or symptoms of intolerance, etc.). The plan of care included a medication list which indicated the patient was currently prescribed three medications, levetiracetam, topiramate, and Vimpat for “seizure management.” The comprehensive assessment failed to evidence a diagnosis and status assessment of the patient’s condition which required the above medications. 5. The clinical record of Patient #12 was reviewed on 3/20/22 and indicated a start of care date of 3/3/22. The record included a plan of care for the certification period 3/3/22 – 5/1/22 and indicated patient diagnoses included but were not limited to Type 2 Diabetes Mellitus, amputation of left leg below the knee, removal of right first and second toe, and pressure ulcers (wound caused by prolonged pressure on one area of the body) to the right heel and tailbone. The record included a comprehensive assessment completed on 3/3/22 by RN #5. The assessment included a medication list which indicated the patient was actively prescribed miconazole cream to be applied for “redness” to the patient’s abdominal folds. The assessment failed to evidence the presence or absence of redness in the patient’s abdominal folds. An interview was conducted on 3/16/22 at 3:20 PM with Administrator / Clinical Manager and Branch Director #1. During the interview the Administrator / Clinical Manager relayed that the comprehensive assessment included an assessment of all active patient conditions and diseases would depend on then number of diagnoses and which diagnoses the agency decided were necessary for them to educate, assess, and observe. He / She also relayed that the diagnoses with focus were at the RN (or other skilled professional)’s discretion. The Branch Director #1 relayed the skilled professional assessment of the diagnoses status was a ranking of 1-4, “1” being well controlled and “4” being unstable. 410 IAC 17-14-1(a)(1)(B)

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 home health agency failed to ensure the patients received all services and interventions as ordered in the plan of care for 1 of 12 active records reviewed (Patient #6). 1. An agency policy 2.1.007 titled “Plan of Care (POC),” with last revision date of 01/01/20, included, but not limited to, “…purpose: … to ensure that physician’s orders are followed…interventions are provided by qualified agency staff as ordered by the physician….” 2. Clinical record of Patient #6 was reviewed on 3/17/22. The plan of care for the certification period 02/09/2022 to 4/09/3033, start of care date 10/12/2021, included the diagnoses, but not limited to, hemiplegia following brain bleed, ischemic cardiomyopathy (condition where the heart is enlarged and not able to work efficiently), anxiety, and pressure ulcer to the sacrum (end of the spinal column below the hip bones). The plan of care included physician orders of skilled nursing visits, once a week for 8 weeks, and included skilled nurse interventions were to include measuring the patient’s calves at each visit and to notify the physician of an increase of 2 centimeters or more. The record included skilled nursing visits that were documented on 02/15/22, 02/24/22, 3/01/22, 3/08/22, and 3/15/22. The nurse visit documentation failed to evidence the calf measurements were obtained during the nurse visits. 3. An interview was conducted on 3/22/22 at 1:07 PM with Administrator / Clinical Manager who confirmed staff should perform all tasks and interventions as ordered in the plan of care.” 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 was patient specific, and included all pertinent diagnoses, durable medical equipment (DME), medications and treatments, safety measures appropriate to the patient, patient - specific discharge planning, and patient-specific interventions and measurable goals for 12 of 12 active records reviewed (Patients #1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12). 1. An agency policy #2.1.007 titled “Plan of Care (POC)”, last reviewed 01/01/20, indicated but was not limited to "...the POC includes: …medications and treatments...safety measures to protect against injury...pertinent diagnosis(es)…measurable outcomes and goals...required equipment and supplies ….” 2. Clinical record of patient #1 was reviewed on 3/15/22. The plan of care [POC] for the certification period 01/22/2022 to 3/22/2022, with start of care [SOC] date of 01/22/2022 included, but not limited to, the diagnoses, heart disease with high blood pressure and heart failure, Type 2 Diabetes with polyneuropathy (decreased sensation in more than one peripheral nerve), Atrial Fibrillation (an irregular heart rhythm), and depression. The POC included a medication list which included, but not limited to, atorvastatin (given to treat high cholesterol), midodrine (given to treat dizziness due to change in position), Flomax (given to treat benign prostatic hyperplasia, a condition of enlarged prostate gland), and Eliquis (given to thin the blood and prevent blood clots). The plan of care failed to evidence diagnoses related to the use of the atorvastatin, midodrine, and Flomax, failed to evidence safety precautions related to the use of Eliquis, and failed to evidence patient-specific and measurable goals. The plan of care with the discharge plan(s) “discharge to care of family / caregiver under supervision of physician, when all goals met.” The POC failed to evidence a patient specific discharge plan. During a home visit observation, on 3/11/2022 at 10:17 AM, with patient #1 (start of care 1/22/22) and Physical Therapist (PT) #1, a cane and lift chair were noted in the patient’s home. The patient also reported the result of their morning blood sugar reading. The POC failed to evidence the cane, lift chair, and diabetic testing supplies. 3. The clinical record of patient #2 was reviewed on 3/15/22. The POC for the certification period 02/15/2022 to 4/15/2022, with SOC of 12/17/21, with diagnoses that included, not limited to, malignant neoplasm of esophagus, Type 2 diabetes mellitus, hypertension, and constipation. The POC included, but not limited to, the goals “…will verbalize / demonstrate understanding of home safety and fall prevention … will verbalize / demonstrate adequate knowledge of integumentary status … will understand and demonstrate compliance with treatment regimen for cancer….” The POC failed to evidence patient-specific and measurable goals. The POC included, but not limited to, discharge plans “…DC [discharge] Plans: Discharge to care of family / caregiver under supervision of physician when all goals met....” The discharge plan failed patient specific. 4. The clinical record of patient #3 was reviewed on 3/18/22. The POC for the certification period 01/13/2022 to 03/14/2022, with SOC date of 01/13/22, included, but not limited to, the diagnoses intestinal obstruction, emphysema, heart failure, heart failure, chronic kidney disease, and Parkinson’s disease. The POC included physician orders for skilled nursing and occupational therapy and included a medication list, which included, not limited to, Breo Ellipta (medication given to treat Chronic Obstructive Pulmonary Disease [COPD], Spiriva (medication given to treat various respiratory disorders, including asthma and COPD, omeprazole (medication given to treat Gastro Esophageal Reflux Disease [GERD]), Tums (medication given to treat heartburn), and Senna (medication given to treat constipation). The plan of care failed to evidence diagnoses for these medications and failed to evidence patient specific and measurable goals. The POC indicated patient’s discharge plans included “discharge to care of family / caregiver under supervision of physician when all goals met.” The POC failed to evidence a patient specific discharge plan. During a home observation on 3/11/22 at 11:35 AM with patient #3 and Occupational Therapist (OT) #1, it was observed that home oxygen was set up, which included oxygen tanks and tubing, and a nebulizer. The POC failed to evidence these items. 5. The clinical record of patient #4 was reviewed on 3/15/22. The POC for the certification period 3/08/2022 to 5/06/2022, with SOC of 3/13/2021, and included the diagnoses, but not limited to, complications of amputation, Type 2 Diabetes, osteomyelitis, and cellulitis. POC failed to evidence diabetic precautions and patient specific measurable goals. The plan of care indicated the patient’s discharge plans included “discharge to care of family / caregiver under supervision of physician when all goals met.” The POC failed to evidence a patient specific discharge plan. 6. The clinical record of patient #5 was reviewed on 3/15/22. The POC for the certification period 01/27/2022 to 3/27/2022, with SOC of 01/27/22, included the diagnoses, but not limited to, lymphedema, hypertensive chronic kidney disease, morbid obesity, and history of falling. During a home visit observation, on 3/14/22 at 10:31 AM with patient #5 and RN #2, a rollator walker was observed in the patient’s home. The POC failed to include use of a rollator walker. The POC included the goals, but not limited to, “…will verbalize / demonstrate knowledge in preserving skin integrity … will verbalize / demonstrate understanding of home safety and fall prevention … will be knowledgeable on utilizing the healthcare journal to document health information … will exhibit optimum level of personal hygiene during illness … will have safe and effective personal hygiene this episode ….” The POC failed to evidence patient-specific and measurable goals. The POC included the discharge plans, “…DC [discharge] Plans: Discharge to care of family / caregiver under supervision of physician when all goals met ….” The discharge plan failed to be detailed and patient specific. 7. The clinical record of patient #6 was reviewed on 3/17/22. The POC for the certification period 02/09/2022 to 4/09/2022, with SOC of 10/12/2021, included the diagnoses, but not limited to, hemiplegia following brain bleed, ischemic cardiomyopathy (condition where the heart is enlarged and not able to work efficiently), anxiety, and pressure ulcer to the sacrum (end of the spinal column below the hip bones). The plan of care indicated the patient’s discharge plans included “discharge to care of family / caregiver under supervision of physician when all goals met.” The POC failed to evidence a patient specific discharge plan. The POC indicated goals which included, but not limited to, “… Patient will exhibit optimum level of personal hygiene during illness. Patient will have safe and effective personal hygiene this episode. Patient / caregiver will demonstrate proper use and administration of prescribed medications … Patient / caregiver will verbalize / demonstrate ability to care for myocardial infarction [heart attack] … Patient / caregiver will verbalize / demonstrate adequate knowledge of pneumonia … Patient / caregiver will demonstrate compliance with treatment regimen prescribed for coronary artery disease … Patient’s body measurement will remain within physician guidelines ….” The POC failed to evidence patient-specific and measurable goals. 8. The clinical record of patient #7 was reviewed on 3/15/22. The POC for the certification period 3/08/2022 to 5/06/2022, with SOC of 01/07/22, and included, the diagnoses, but not limited to, Type 2 diabetes mellitus with chronic kidney disease, COPD, hypertensive chronic kidney disease, and a history of falling. The POC medication list indicated levothyroxine (a medication used to replace thyroid hormone.) The POC failed to include a diagnosis related to this medication and failed to evidence patient - specific and measurable goals. The POC indicated “… DC [discharge] Plans: Discharge to care of family / caregiver under supervision of physician when all goals met ....” The discharge plan failed to be detailed and patient specific. 9. The clinical record of patient #8 was reviewed on 3/21/22. The POC for the certification period 02/09/2022 to 4/09/2022, with SOC of 8/13/21, included the diagnoses, but not limited to, chronic venous hypertension with ulcer and inflammation of right lower extremity, non-pressure chronic ulcer right lower limb, cellulitis right lower limb, lymphedema, asthma, morbid obesity, and a history of falling. The POC included the goals of, but not limited to, “…will understand and demonstrate compliance with treatment regimen for hypertension…will verbalize / demonstrate understanding of home safety and fall prevention ….” The POC failed to evidence patient specific and measurable goals. The POC indicated “…DC [discharge] Plans: Discharge to care of family / caregiver under supervision of physician when all goals met ….” The discharge plan failed patient specific. 10. The clinical record of patient #9 was reviewed on 3/20/22. The POC for the certification period 02/01/2022 to 4/01/2022, with SOC 02/06/2022, included the diagnoses, but not limited to, abscess of the back, chronic ulcer of the back, osteomyelitis, heart failure, and COPD. The POC included the goals, but not limited to, “Patient / caregiver will verbalize understanding of pharmacologic and nonpharmacologic pan control measures as evidenced by improvement in pain levels … Patient / caregiver will demonstrate proper use and administration of prescribed medications … Patient / caregiver will understand and demonstrate compliance with treatment regimen for heart failure … Patient / caregiver will understand and demonstrate compliance with treatment regimen for Chronic Obstructive Pulmonary Disease ….” The POC included the discharge plans, “discharge to care of family / caregiver under supervision of physician when all goals met.” The POC failed to evidence a patient specific discharge plan. 11. The clinical record of patient #10 was reviewed on 3/20/22. The POC for the certification period 02/23/2022 to 4/23/2022, with SOC of 02/23/22, included the diagnoses, but not limited to, hypertension (high blood pressure), chronic respiratory failure, and venous insufficiency (condition where the blood in veins does not flow properly). The POC included a medication list which indicated patient medications included, but were not limited to, albuterol sulfate HFA (medication given as inhaler to treat shortness of breath caused by a multitude of conditions) to be taken every 4 hours as needed for “breathing support,” famotidine (medication given for GERD), Alka-Seltzer Heartburn + Gas (medication given to treat the symptoms of heartburn, upset stomach, and indigestion) to be given as needed for “antacid,” melatonin (medication given to treat insomnia), and oxygen at 5.5 liters per minute through a nasal cannula (tube placed in the nostrils to deliver oxygen). The record included an initial comprehensive assessment completed on 02/23/22 by PT #1. The assessment evidenced the patient had a tracheostomy (trach, tube placed into the windpipe to assist with getting oxygen in) and the patient received the oxygen through a trach mask. The POC failed to evidence diagnoses for the use of famotidine, Alka-Seltzer, and melatonin and clear directions for administration for the as needed medications albuterol and Alka-Seltzer and failed to evidence the correct route of administration for the patient’s oxygen. The POC indicated the patient’s discharge plans included “discharge to care of family / caregiver under supervision of physician when all goals met.” The POC failed to evidence a patient specific discharge plan. 12. The clinical record of patient #11 was reviewed on 3/20/22. The POC for the certification period 02/07/2022 to 4/07/2022, with SOC of 6/17/2020, and included the diagnoses, but not limited to, COVID-19, dysphagia (difficulty swallowing), hemiplegia (paralysis to one side of the body) post stroke, and history of brain cancer. The POC included a medication list which indicated the patient was actively prescribed the medications levetiracetam, topiramate, and Vimpat. The POC failed to evidence a diagnosis related to these medications. The POC indicated the discharge plans “discharge to care of family / caregiver under supervision of physician when all goals met.” The POC failed to evidence patient specific discharge plan. The POC included the orders and interventions, but not limited to, “… Skilled Nurse to provide instructions related to the administration of Peptamen 1.5 (type of tube feeding) 1000 [milliliters, mL] over 16 [hours] … Nutritional Requirements: Peptamen 1.5 … 120 [mL] intermittent … Medications: … Peptamen 1.5 … 125 [milliliters per hour over] 16 hours ….” The POC failed to evidence patient specific orders for tube feeding, nursing interventions to assess for tube feeding residual (process where the amount of tube feeding remaining in the stomach is measured), and tube feeding residual call parameters. The plan of care indicated goals included but were not limited to “Patient / caregiver will verbalize understanding of pharmacologic and nonpharmacologic pain control measures as evidenced by improvement in pain levels from _ to _ … Patient / caregiver will verbalize / demonstrate adequate knowledge of gastrostomy feedings and gastrostomy site care … Patient / caregiver will verbalized understanding of care required secondary to bowel incontinence [inability to control release of stool] … Patient verbalizes tolerance of NG tube [nasogastric tube, placed into the nose and down to the stomach] … Patient/caregiver will demonstrate proper use and administration of prescribed medications ….” The POC failed to evidence patient-specific and measurable goals. 13. The clinical record of patient #12 was reviewed on 3/20/22. The POC for the certification period 3/03/2022 to 5/01/2022, with SOC of 3/3/22, included the diagnoses, but not limited to, Type 2 Diabetes Mellitus, amputation of left leg below the knee, removal of right first and second toe, and pressure ulcers (wound caused by prolonged pressure on one area of the body) to the right heel and tailbone. The POC included the intervention “skilled nurse to instruct caregiver on dementia to include definition, signs and symptoms of different stages, care of the patient.” The POC included the medication memantine (medication given to treat dementia). The POC failed to evidence a diagnosis of dementia. The POC with the discharge plans that included “discharge to care of family / caregiver under supervision of physician when all goals met.” The POC failed to evidence a patient specific discharge plan. The POC indicated goals included but were not limited to “…. Patient / caregiver will understand and demonstrate compliance with treatment regimen for diabetes … Patient / caregiver will demonstrate compliance with Diabetic ADA diet … Patient / caregiver will understand and demonstrate knowledge compliance with treatment regimen for hypertension [high blood pressure] … Patient / caregiver will demonstrate compliance with treatment regimen prescribed for coronary artery disease … Patient / caregiver will understand and demonstrate compliance with treatment regimen for heart failure … Caregiver will demonstrate ability to manage dementia in the home setting … Patient will tolerate lab draw from vascular access device … Patient will exhibit optimum level of personal hygiene during illness. Patient will have safe and effective personal hygiene this episode … Patient / caregiver will demonstrate proper use of and administration of prescribed medications ….” The POC failed to evidence patient specific and measurable goals. An interview was conducted on 3/22/22 at 1:07 PM with Administrator / Clinical Manager and Branch Director #1. During the interview, Administrator / Clinical Manager confirmed the POC should include all pertinent diagnoses, all DME / supplies required by the patient, all applicable safety precautions, all medications the patient was taking, clear indications for administration of the PRN (as needed) medications, patient specific discharge planning, measurable and patient-specific goals, and call orders for tube feeding residual only if ordered by the physician. 410 IAC 17-13-1(a)(1)(C) 410 IAC 17 17-13-1(a)(1)(D)(ii) 410 IAC 17-13-1(a)(1)(D)(ix) 410 IAC 17-13-1(a)(1)(D)(x) 410 IAC 17-13-1(a)(1)(D)(xiii)

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the physician was notified of a change in patient condition for 5 of 12 active records reviewed (Patients #4, 6, 10, 11, and 12). 1. An agency policy 2.1.017 titled “Coordination of Care, from Admit through Discharge,” last revision date of 8/1/19, indicated, but not limited to, “…coordination of services is promoted through routine communication with the patient’s physician … when changes occur in the patient’s condition or response to treatment … when a missed visit occurs altering the Plan of Care ... when there is a need to change the patient’s plan of care ….” 2. Agency policy 2.1.020, titled “Vital Signs” and most recent revision date of 03/01/21, indicated, but not limited to, “...the clinician shall collaborate with the other clinicians and / or Patient Care Manager / Case Manager and notify physician for deviations per physician orders ....” 3. Agency policy 2.1.011 titled “Pain Assessment,” last revised 01/01/2020, indicated, but not limited to, “… Policy: The clinician will select one of the following pain assessment tools to assess pain at the present time in the patient and to initiate pain relief measures in the Plan of Care (POC) during each skilled visit. A score of 7 or greater on any of the pain assessment tools below is indicative of severe pain, which will require physician notification and patient appropriate interventions … Procedure: 1. Clinicians assess pain at each comprehensive and subsequent skilled visit … 5. Appropriate documentation is to include the quality, location, response to pain, mitigating factors that relieve or increase pain, and severity ….” 4. The clinical record of Patient #4, with start of care [SOC] of 3/13/2021, was reviewed on 3/15/22. The plan of care [POC] for the certification period 3/8/22 – 5/6/22 included the patient diagnoses, complications of amputation, Type 2 Diabetes, osteomyelitis and cellulitis. The POC included physician orders for skilled nursing visits and interventions to include dressing changes to the patient’s left foot amputation wound. The documentation included a skilled nursing visit note, dated 02/05/22, indicated the patient’s wound measured 2 centimeters [cm] in length by 5 cm in width and 0 cm in depth, an increase of 0.8 cm in length and 2.7 cm in width from the previous measurement completed on 02/01/22. The documentation also indicated an increase in slough (dead tissue which needs to be removed for wound healing) and necrotic (tissue that has lost blood flow and is now non-viable) tissue observed from the 020/1/22 visit. The clinical record failed to evidence the patient’s physician was notified of the increase in wound size and abnormal wound tissue. 5. The clinical record of Patient #6, with SOC of 10/21/2021, was reviewed on 3/17/22. The POC for the certification period 02/09/22 – 4/09/22 included the patient diagnoses of hemiplegia following a brain bleed, ischemic cardiomyopathy (condition where the heart is enlarged and not able to work efficiently), anxiety, and pressure ulcer to the sacrum (end of the spinal column below the hip bones). The POC included physician orders for skilled nursing visits once a week for 8 weeks and skilled nurse interventions included to perform and instruct on wound dressing care of the patient’s pressure ulcer, on his sacrum, at each visit. The record included a recertification assessment, completed on 02/08/22, by registered nurse [RN] #2, which indicated the patient had recently fallen (unclear if any injuries sustained from fall), his pulse was weak and thready (difficult to feel), rhonchi (gurgling-like sound which typically indicate fluid or secretion movement in the airways) were heard while listening to lung sounds, the patient was short of breath at rest, and was anxious and irritable. The clinical record failed to evidence the patient’s physician was notified of the change in patient status. The record included a skilled nursing visit note, dated 3/8/22, authored by RN #8 which indicated the patient’s sacral wound “healed.” The record failed to evidence the patient’s physician was notified of the healed wound and failed to evidence orders were obtained to discontinue the order for wound dressing changes. The POC included physician orders for physical therapy [PT]. The record included a PT visit note, authored by PT #2 and dated 3/02/22. The documentation revealed the PT noted Patient #6’s blood pressure was 95/52, that the patient reported cough and lethargy, and that the PT advised the patient to contact his physician if his symptoms worsened but failed to evidence the therapist notified the physician of a change in patient status. (Documented within skilled visit note, dated 03/01/2022 was a blood pressure of 120/80.) 6. The clinical record of Patient #10, with SOC date of 02/23/2022, was reviewed on 3/20/22. The POC for the certification period 02/23/22 – 4/23/22 which included diagnoses of, but not limited to, hypertension (high blood pressure), malformation of the heart, chronic respiratory failure, and venous insufficiency (condition where the blood in veins does not flow properly). A skilled nurse visit note, dated 3/18/22 by Registered Nurse (RN) #5, noted the patient had thick yellow mucus coming from their tracheostomy (hole surgically made in the windpipe to assist with oxygenation), wheezing sounds were noted when listening to the patient’s lung sounds, and the patient had started an as needed prescription of levofloxacin for “respiratory infection.” The note revealed RN #5 noted increased swelling and tightness in patient’s lower legs, the right leg more swollen than the left, and that the patient’s weight was increased by 3 pounds since admission. The clinical record failed to evidence RN #5 notified the patient’s physician of the change in condition. 7. The clinical record of Patient #11, with SOC date of 6/17/2020, was reviewed on 3/20/22. The POC for the certification period 02/07/22 – 4/07/22 included, but not limited to, the diagnoses of COVID-19, dysphagia (difficulty swallowing), hemiplegia (paralysis to one side of the body) post stroke, and history of brain cancer. The record evidenced a skilled nurse visit was completed on 3/04/22 by Licensed Practical Nurse #3. The nurse included an assessment of patient’s blood pressure to be “92/58” (blood pressures on the two previous visits were 120/80 and 142/68), and the patient exhibited congestion, [location was not documented), shortness of breath with exertion, and lethargy. The record failed to evidence the patient’s physician was notified of a change in patient condition. 8.The clinical record of Patient #12, with SOC of 3/03/2022, was reviewed on 3/20/22. The POC for the certification period 3/3/22 – 5/1/22 included, but not limited to, the diagnoses, Type 2 Diabetes Mellitus, amputation of left leg below the knee, removal of right first and second toe, and pressure ulcers (wound caused by prolonged pressure on one area of the body) to the right heel and tailbone. The POC with physician orders / interventions for a licensed professional to report a pain level greater than “6” (no specific pain scale documented). The comprehensive assessment, completed on 3/3/22 by RN #5, indicated Patient rated their pain as an “8” on a 0 – 10 numeric pain scale (0 is no pain, 10 is the worst pain), described the pain as “aching, shooting, stabbing,” and that the pain was interfering with the patient’s activities and “not relieved at an acceptable level.” The record evidenced that Patient’s Case Manager #1 flagged the elevated pain rating and commented on the assessment on 3/7/22 “please fax to doctor.” The record failed to evidence the physician was notified of the patient’s pain level. 9.During an interview on 3/22/22 at 1:07 PM, the Administrator / Clinical Manager confirmed the physician should be notified for a change in a patient condition.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the physician who ordered and signed the home care orders, was notified of a medication change when ordered by another physician, for 1 of 1 home visit observation of patient receiving physical therapy services only (Patient #1). Findings include: Agency policy 2.1.017 titled “Coordination of Care, from Admit through Discharge,” last revised 8/1/19, indicated, but not limited to, “… coordination of services is promoted through routine communication with the patient’s physician … when changes occur in the patient’s condition or response to treatment … when there is a need to change the patient’s plan of care….” During a home visit observation, on 3/11/2022 at 10:17 AM, with Patient #1 (start of care 1/22/22) and Physical Therapist (PT) #1, Patient #1’s family member relayed that the patient’s nephrologist recently increased the patient’s dose of Flomax (medication given to treat benign prostatic hyperplasia, a condition where the prostate is enlarged), the dose was increased from one pill to two pills every day. The clinical record of Patient #1 was reviewed on 3/15/22. The plan of care for the certification period 01/22/22 – 3/22/22, revealed the patient’s primary care physician was the provider that signed the patient’s home care orders. The record failed to evidence the patient’s primary care physician was notified of the change in Flomax dose by the nephrologist. During an interview on 3/22/22 at 1:07 PM, the Administrator / Clinical Manager relayed that the physician who provided the home care orders should be notified when there is a medication order changed by another physician. 410 IAC 17-14-1(a)(1)(G)

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure their policies and procedures included the specific additional precautions in place for the prevention of COVID-19 transmission, for the agency's unvaccinated staff with an approved temporary, religious, or medical exemption to the COVID-19 vaccination for 1 of 1 agency and failed to ensure 1 of 1 approved medical exemption reviewed [employee H] met the federal requirements, with the potential to affect all agency patients and staff. 1. An agency policy 9.1.021 titled “COVID-19 Vaccination Policy,” last revised 03/01/22, indicated but was not limited to “…requires all employees, students, volunteers, and contract workers who are subject to a mandatory vaccination rule, policy, regulation, or law…to be fully vaccinated against COVID-19 unless granted a legally-recognized exemption…staff in a ‘Covered Position’…are required to comply with the CMS Vaccination Rule…’Covered Positions’ include all employees (including administrative support staff), volunteers, students, and contract workers that work in…Home Health…before, March 15, 2022, all Covered Staff Members…must either (i) provide proof that they are ‘Fully Vaccinated’; (ii) provide proof of a need for a temporary delay due to clinical precautions and considerations as recommended by the CDC; or (iii) have been granted an exemption due to a medical contraindication or disability, or a sincerely held religious belief or religious practice…Covered Staff Members who are not in compliance…may not provide care, treatment, or other services for the company or its patients…Employees who are not in compliance will be placed on unpaid leave of absence for up to 30 days…Individuals who have been granted a medical or religious exemption must comply with all COVID-19 precautions required by the LHC Group COVID-19 Task Force, company policy, state law, or the individual’s work location, including without limitation COVID-19 testing (if applicable), social distancing, and PPE requirements.” 2. CDC (12/21/21). Summary Document of Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized or Approved in the United States. Retrieved 3/18/22 from www.cdc.gov. The document indicated the CDC recognized contraindications to the COVID-19 vaccine was “severe allergic reaction … after a previous dose or to component of the COVID-19 vaccine.” The CDC document also indicated “Antibody testing not recommended for vaccine decision-making ….” 3. A log of active employee COVID-19 vaccination status was reviewed on 3/18/22. The log indicated Employee H had a medical exemption for the COVID-19 vaccination. 4. The COVID-19 vaccination medical exemption request for Employee H, dated 11/2021, was reviewed on 3/21/22. The request indicated the reason for medical exemption for the vaccine was the employee "...currently has the antibodies, so there is no need for the COVID vaccine at this time..." The request was approved by the Angels of Mercy corporate office. 5. An interview was conducted on 3/21/22 at 3:52 pm with Administrator/Clinical Manager. During the interview Administrator/Clinical Manager confirmed no additional precautions were put into place for staff with medical or religious exemptions to the COVID-19 vaccine. The Administrator/Clinical Manager also confirmed the request and decision making of religious or medical exemption to the COVID-19 vaccine was conducted by the corporate office. 6. A follow up interview was conducted on 3/22/22 at 10:05 AM was conducted with the Administrator/Clinical Manager. During the interview, the Administrator/Clinical Manager confirmed Employee H’s medical exemption was input into the vaccine tracking log incorrectly as it was meant to be a temporary exemption for the vaccine. The Administrator/Clinical Manager also confirmed Employee H was not currently vaccinated.

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 observation, record review, and interview, the home health agency failed to ensure the home health aide (HHA) performed tasks only as ordered on the aide care plan for 1 of 1 home health aide visit observed (Patient #6). 1. An agency job description titled “Aide Home Health” indicated but was not limited to “...the Home Health Aide is responsible for providing patients with in-home personal care...while following the written plan of care...follows current written aide assignment sheet to provide personal care and assistance with activities of daily living (ADLs) ... provides care according to the aide plan of care/assignment sheet ....” 2. A home visit observation was conducted on 3/14/22 at 12:00 PM with Patient #6 (start of care 10/12/21) and HHA #1. During the visit, the aide was observed assisting the patient with a full bed bath. During the bath, the aide noted redness to the patient’s bilateral inner buttocks and asked the patient if he would like Boudreaux’s Butt Paste (medicated ointment applied to treat and prevent diaper rash or skin breakdown) applied to the area. The patient agreed and the cream was applied by the aide. The clinical record of Patient #6 was reviewed on 3/14/22 and 3/17/22. The record included an Aide Care Plan Report entered and approved by the Administrator / Clinical Manager on 2/9/22. The aide care plan failed to evidence an aide task to apply the medicated ointment to the patient’s inner buttocks. 3. An interview was conducted on 3/14/22 at 3:00 PM with Administrator/Clinical Manager and Branch Director #2. During the interview, the Administrator/Clinical Manager confirmed the home health aide should perform tasks only as ordered on aide care plan.