Every finding on record at American Home Health Services Inc

The Indiana Department of Health conducted an Emergency Preparedness survey, conducted in accordance with 42 CFR §484.102, for a Home Health Provider and Suppliers. Survey Dates: January 6, 7, 8, and 9, 2025 Census: 16 During this Emergency Preparedness survey, American Home Health Services was found to be in compliance with Conditions of Participation at 42 CFR §484.102: Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers.

This visit was for Federal Recertification and State Re-Licensure survey of a Home Health Provider. Survey Dates: January 6, 7, 8, and 9, 2025 Unduplicated Skilled Admissions for the last 12 Months: 27 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. During this Federal Recertification Survey, American Home Health Services, was found to be out of compliance with Conditions of Participation at 42 CFR 484.60 Care Planning, Coordination of Services, and Quality of Care, 484.65 Quality assessment/performance improvement, and 484.70 Infection Prevention and Control. Based on the Condition-level deficiencies during the January 09, 2025 survey, American Home Health Services, was subject to an extended survey on January 07, 2025 at 4:00 PM, pursuant to section 1891(c)(2)(D) of the Social Security Act. 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 program for a period of two years beginning 1/9/2025 and continuing through January 08, 2025. Abbreviations used in report: Home Health Aide [HHA], Clinical Manager [CM], Registered Nurse [RN], Plan of Care [POC], Start of Care [SOC], Occupational Therapist [OT], Skilled Nurse [SN], and Physical Therapist [PT]. QR by Area 2 on 01/23/2025

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record reviews and interviews, the agency failed to ensure the rights of the patients including consent in advance of and during treatment in 4 of 6 active clinical records reviewed (Patients #1, 4, 5, 8). Findings include: # The agency policy titled “Voluntary Informed Consent” indicated patients are involved in decisions about care, treatments and services and a surrogate decision maker when the patient cannot participate in the decisions. #The clinical record for Patient #1 revealed an initial comprehensive assessment, completed on 11/1/2024 that indicated Patient was alert and forgetful with confusion in new and complex situations. The comprehensive assessment indicated Patient lived alone and depended on caregivers, including the primary caregiver, a family member. The clinical record included an admission consent document signed by Patient on 11/1/2024 that consented for treatment, release of medical information, financial responsibility, notice of rights and responsibilities, and advanced directives. The record failed to evidence a consent for treatment signed by Patient’s health care representative. During an interview on 1/8/2025 at 9:50 AM, Administrator relayed Patient was alert to person and place only and primary caregiver and family member, Other D, was present on admission. Administrator revealed the consents were not signed by Other D. # The clinical record for Patient #8 revealed an initial comprehensive assessment, completed on 11/19/2024 that indicated Patient was alert to person place and time with forgetfulness and confusion with new and complex situations. The comprehensive assessment indicated Patient lives with a family member, Other A, who was also the primary caregiver for Patient. The record included an admission consent document signed by Patient on 11/19/2024 that consented for treatment, release of medical information, financial responsibility, notice of rights and responsibilities, and advanced directives. The record failed to evidence a consent for treatment signed by Patient’s health care representative. During an interview on 1/9/2025 at 10:00 AM, Administrator relayed Other A was present admission, Patient was not fully alert at all times and Other A allowed Patient to sign the consent. Administrator revealed the agency should have family sign consent if Patient was not fully alert. #During an interview on 1/8/2025 at 8:06 AM, HHA 1 relayed she was on vacation and unavailable from 12/20/2024 to 12/30/2024 and the Administrator was made aware weeks ahead. 410 IAC 17-12-3(b)(2)(D)(ii)(AA) 1. A clinical record review for Patient #4 evidenced a plan of care for the recertification period of 11/09/2024-01/07/2025 which indicated the agency was to provide PT services 2 times a week for 6 weeks and HHA services 2 times a week for 8 weeks. A document titled “Physician Telephone/Verbal Order” signed by PT 1 on 11/16/2024 indicated the PT visit frequency was changed to 1 time a week for the next 8 weeks. Review failed to evidence the patient and caregiver were notified of the change in PT visit frequency. A missed visit note dated 11/16/2024 completed by PT 1 indicated the patient requested the PT visit be held for the day. A missed visit note dated 12/25/2024 completed by HHA 1 indicated the patient requested the HHA visits be held for the week. On 1/07/2025, at 3:15 PM, the patient’s caregiver indicated he/she believed PT was supposed to be coming 2 times a week. The patient’s caregiver indicated neither the caregiver nor the patient refused PT or HHA services. On 01/09/2025, at 3:45 PM, the CM indicated PT 1 was feeling ill the day of the scheduled PT visit on 11/16/2024 and there were no attempts to reschedule the visit with another PT. 2. A clinical record review for Patient #5 evidenced a plan of care for the recertification period 09/22/2024-11/20/2024 which indicated the agency was to provide PT services 2 times a week for 8 weeks. A signed physician order dated 10/5/2024 and signed by PT 1 indicated the PT frequency was changed to 1 time a week for 8 weeks and failed to evidence the patient/caregiver were informed of the change in the PT frequency. On 01/08/2025, at 5:55 PM, the patient’s caregiver indicated he/she was unaware why the PT visit frequency was changed and indicated PT 1 just started coming 1 time a week. On 01/09/2025, at 10:30 AM, PT 1 indicated the office was supposed to have notified the patient about the change in PT frequency. On 01/09/2025, beginning at 2:36 PM, the CM indicated there was no documentation the agency notified the patient of the change in PT frequency.

Patient refuses services CFR(s): 484.50(d)(4) The patient refuses services, or elects to be transferred or discharged; This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to evidence they educated patients, who declined services and requested to discharged form home health services, on the risks and potential adverse outcomes that may result from the discontinuation of services in 1 of 1 closed clinical record reviewed with a discharge per patient request (Patient #7). Findings include: The clinical record for Patient #7 revealed an initial comprehensive assessment on 9/26/2024 and an initial POC for dates 9/26/2024 to 11/24/2024 for RN visits once a week for 9 weeks and PT to evaluate and treat. The clinical record included discharge comprehensive assessment documentation dated 11/8/2024 that indicated Patient discharge was per family/patient request and a verbal physician’s order to discharge Patient per Patient request dated 11/8/2024 and signed by the physician 11/15/2024. The clinical record failed to evidence Patient communication regarding when nor why services were being declined nor education provided to Patient regarding the risks and potential adverse outcomes related to missed visits or an early discharge from home health services. During an interview on 1/8/2025 beginning at 9:50 AM, Administrator relayed the clinical record for Patient #7 did not include education documentation for specific risks or outcomes due to an early discharge.

Advise the patient of discharge for cause CFR(s): 484.50(d)(5)(i) (i) Advise the patient, representative (if any), the physician(s) or allowed practitioner(s), issuing orders for the home health plan of care, and the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) that a discharge for cause is being considered; This ELEMENT is not met as evidenced by: Based on record review and interviews the agency failed to evidence the patient or their designated decision maker was advised that discharge was imminent in 1 of 1 closed clinical record with the Patient discharged with goals being met (Patient #6). Findings include: The clinical record for Patient #6 revealed an initial SOC comprehensive assessment dated 8/30/2023 and a POC dated 8/24/2024 to 10/22/2024 that included orders for RN visits once a week. The clinical record included a verbal order dated 10/22/2024 indicating Patient may be discharged, signed by the physician 11/15/2024. The patient was discharged on 10/22/2024. During an interview on 1/8/2024 starting at 3:47 PM, Administrator relayed the ‘Notice of Medicare Non-Coverage’ document, signed by the 10/2/2024, was a notification of discharge. Administrator revealed the clinical record did not include a 15-day notice that discharge was being considered to the physician. IAC 410 17-12-2(i)

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included a review of all medications for potential adverse effects and drug reactions in 5 of 6 active clinical records reviewed. (Patient #2, 3, 4, 5, 8) The findings include: 5. The clinical record for Patient #2 revealed an initial comprehensive assessment, completed on 10/23/2024 by RN 2, that revealed Patient’s medications included aluminum hydroxide, cholecalciferol, oxycodone, enzalutamide, and gabapentin. The review of the drug regimen in the electronic medical record failed to evidence significant drug interactions nor significant side effects. On Drugs.com, a review of interactions indicated aluminum hydroxide and cholecalciferol may potentially cause a major interaction such as aluminum toxicity that may cause bone pain, fracture, weakness, seizures, and coma. Drugs.com indicated oxycodone and enzalutamide may potentially cause the oxycodone (a narcotic pain reliever) to be less effective and the medications may cause a life-threatening heart rhythm, and oxycodone and gabapentin may potentially cause an interaction such as respiratory distress. The clinical record failed to evidence medication interactions with the medication review in the electronic medical record nor education provided to Patient regarding interactions. During an interview on 01/09/2025 at 11:00 AM, Administrator revealed the EMR has issues with medication reconciliation and the interactions were not provided. Administrator failed to provide documentation Patient was educated regarding potential interactions. 6. The clinical record for Patient #8 revealed an initial comprehensive assessment, dated 11/19/2024 revealed Patient’s medication list that included hydrocodone, aripiprazole, ondansetron, and escitalopram. The review of the drug regimen failed to evidence significant drug interactions nor significant side effects. On Drugs.com, a review of interactions indicated hydrocodone and aripiprazole may potentially cause a major interaction that included profound sedation and ondansetron and escitalopram may potentially cause a major interaction that may lead to confusion, hallucinations, seizures (convulsions), and changes to vitals signs. The EMR failed to evidence medication interactions with the medication review nor the education, provided to Patient, regarding possible interactions. During an interview on 1/9/2025 at 11:00 AM, Administrator revealed the EMT was not providing the interactions during the medication reconciliation. The administrator failed to provide documentation that Patient was educated regarding interactions. 410 IAC 17-14-1(a)(1)(B) 1. A clinical record review for Patient #4 evidenced POCs for certification period 09/10/2024-11/08/2024 and 11/09/2024-01/07/2025 which indicated the patient’s medications included: aspirin (for pain or to thin the blood), chlorthalidone (reduces the amount of water in the body), metformin (lowers blood sugar), albuterol (opens the airway), levothyroxine (treats underacting thyroid), and formoterol (relaxes air passages). A review on www.drugs.com indicated 25 drug interactions with the patient’s medications to include 15 moderate drug interactions including interactions between levothyroxine and metformin leading to decreased ability to lower blood sugar and aspirin and chlorthalidone, aspirin and albuterol, and aspirin and formoterol leading to decreased levels of potassium. A SOC comprehensive assessment dated 9/10/2024 completed by the CM failed to identify the drug interactions, and the recertification comprehensive assessment completed by RN 1 on 11/06/2024 indicated issues were identified during the drug review but failed to evidence what the issues were. On 1/7/2024, at 3:37 PM, RN 1 indicated the patient had no potential drug interactions. 2. A clinical record review for Patient #3 evidenced a POC for initial certification period 11/21/2024-01/19/2025 which indicated the patient’s medications included, but were not limited to, ibuprofen (for fever or pain) and lisinopril (for high blood pressure). A review on www.drugs.com indicated 11 drug interactions to include 1 serious interaction between ibuprofen and lisinopril which inhibited the effectiveness of lowering the blood pressure. A SOC comprehensive assessment dated 12/11/2024 completed by RN 2 indicated issues were identified during the drug review but failed to evidence what the issues were. The clinical record failed to evidence any drug interactions. On 01/09/2025, at 10:59 AM, RN 2 indicated the electronic health record (EHR) program checked the drug interactions and was not sure where the drug interactions were found in the clinical record. RN 2 indicated she was not sure what the patient’s drug interactions were. 3. A clinical record review for Patient #5 evidenced a POC for a recertification period 11/21/2024-01/19/2025 which indicated the patient’s medications included, but were not limited to, Tramadol (for pain), escitalopram (antidepressant), albuterol, and melatonin (for sleep). A review on www.drugs.com indicated 8 drug interactions to include albuterol and Tramadol and Tramadol and melatonin which increased drowsiness and between escitalopram and albuterol causing an abnormal heart rhythm. A recertification comprehensive assessment dated 11/29/2024 completed by RN 2 failed to evidence the drugs were reviewed and what the drug interactions were. The clinical record failed to evidence any drug interactions. On 01/09/2025, beginning at 2:36 PM, the CM indicated the drug review was not documented at the time of the comprehensive assessment. 4. On 1/8/2024, at 12:30 PM, the CM indicated the drug interactions were to be checked by the EHR program at time of comprehensive assessments and indicated none of the drug interactions were identified in the clinical records.

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included the assessment of the availability, ability, and willingness of the primary caregiver to provide care in 2 of 2 active clinical records reviewed assessed to be bedbound. (Patient #1 and 3) The findings include: 2. The clinical record for Patient #1 revealed an initial comprehensive assessment, completed on 11/1/2024 that indicated Patient was alert and forgetful with confusion in new and complex situations, bedfast and unable to position self, and required assistance to bathe, groom, dress, toilet, and transfer. The comprehensive assessment indicated Patient had two pressure wounds, was incontinent of bowel, used a urinary catheter to eliminate urine, lived alone and depended on caregivers, including the primary caregiver, a secondary caregiver and paid care seven days a week from 8:00 AM to 11:00 AM and 4:00 PM to 7:00 PM; the availability of assistance was noted as occasional and short term. The comprehensive assessment failed to evidence the availability, ability and willingness of primary and secondary caregivers nor services provided by paid caregivers. During an interview on 1/8/2025 at 9:50 AM, Administrator relayed the hours of the paid caregiver are documented, not the services they provide nor availability of the primary and secondary caregivers. 1.A clinical record review for Patient #3 evidenced a SOC comprehensive assessment dated 12/11/2024 completed by RN 2 which indicated the patient was bedbound and unable to reposition self, forgetful, dependent for personal care and feeding, dependent for medication administration, required thickened liquids due to difficulty swallowing, incontinent of bowel and bladder, had pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (some skin loss or damage involving the top-most skin layers) to the right and left buttocks, and lived alone with some assistance during the day and evening for personal care from Entity F. The SOC comprehensive assessment failed to evidence the assessment of the primary caregiver on the ability and willingness to provide medication management/administration, wound care in the absence of the skilled nurse, feeding, turning every 2 hours, and incontinent care in absence of the paid caregivers from Entity F. On 01/09/2025, at 12:10 PM, the CM indicated the SOC comprehensive assessment did not include the assessment of the willingness, ability, and availability of the primary caregiver to provide all patient care needs based on assessment.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on record review and interviews, the agency failed to ensure the comprehensive assessment was updated and revised as frequently as the patient’s conditions warrants due to a major decline or improvement in the patient’s health status in 1 of 2 active clinical records reviewed with wounds (Patients #1) and in 1 of 2 active clinical records reviewed with falls (Patient #5). Findings include: # The agency policy titled “Client Reassessment/Update of Comprehensive Assessment” indicated the comprehensive assessment would be updated and revised with significant changes that occur in the patient’s condition or diagnoses. # The clinical record of Patient #1 included an initial comprehensive assessment, completed on 11/1/2024 by Administrator, that indicated Patient had two stage 2 pressure ulcers (partial thickness wounds) on the left buttock. The RN documentation of a visit on 11/14/2024 indicated Patient had new blisters to the left thigh and the RN documentation of a visits on 11/19/2024 included the assessment of blisters as open, no longer fluid filled. The RN documentation of the physical assessment on 12/3/2024 revealed the wounds to the left buttock and the blisters to the left thigh were healed. The RN documentation on 12/9/2024 included an assessment of a new blister on the right thigh. The clinical record failed to evidence a comprehensive reassessment for healed wounds nor new wounds. During an interview on 1/8/2025 beginning at 9:50 AM, Administrator relayed the comprehensive assessment should be updated every 60 days and as needed, including if new wounds were found. 410 IAC 17-14-1(a)(1)(B) 1. A clinical record review for Patient #5 evidenced a communication note dated 11/16/2024 which indicated the patient fell and hit his/her head. The communication note dated 11/17/2024 indicated the patient was transferred to the emergency department (ED) for evaluation. A communication note dated 01/03/2024 indicated the patient fell and sustained a bruise to the face. The clinical record failed to evidence a revised comprehensive assessment for the change in condition related to the falls and ED transfer since the last comprehensive assessment on 11/19/2024. On 01/09/2025, at 3:07 PM, the CM indicated a change in condition was defined as a patient with falls and indicated the agency did not complete a revised comprehensive assessment because the electronic health record did not have the option to complete a revised comprehensive assessment.

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 agency failed to ensure: the needs of the patient were met (See G0570); the plan of care was reviewed by the physician, individualized and followed by all agency staff (See G0572); the plan of care included all required information / elements for the treatment of the patient (See G0574); all treatments provided by agency staff were ordered by a physician (See G0580); physicians were promptly notified of a change in the patient's condition (See G0590); the agency failed to evidence coordination of care for all services provided to the patient (See G0606). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.60 Care Planning, Coordination of Care and Quality of Care. A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview, the agency failed to provide services to meet the assessed needs of the patient in 1 of 1 active patient with wounds. (Patient #3) The findings include: A clinical record review for Patient #3 evidenced a SOC comprehensive assessment dated 12/11/2024 completed by RN 2 which indicated the patient’s primary payor source was traidional Medicare, was bedbound and unable to reposition self, had a history of falls and was at a high risk for falls, forgetful, had impaired judgment, received coumadin therapy (a medication to thin the blood to treat/prevent blood clots), was dependent for personal care, feeding, and medication administration, required thickened liquids due to difficulty swallowing, incontinent of bowel and bladder, had pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (some skin loss or damage involving the top-most skin layers) to the right and left buttocks, and lived alone. The skilled nurse visit note completed by RN 2 dated 12/20/2024 indicated the patient laid in soiled briefs all night and there was no caregiver available after the evening caregiver left. RN 2 indicated the patient’s buttocks were reddened from laying in soaked briefs all night and the patient required maximum assistance to use the urinal comfortably. The skilled nurse visit completed by RN 2 dated 12/27/2024 indicated the patient needed to have a Texas catheter (an external tube held in place with a plastic covering around the penis to drain urine from the body) or a foley catheter (an indwelling tube inserted into the bladder to drain urine from the body) to keep skin dry. On 01/09/2025, at 10:44 AM, the patient’s primary caregiver indicated Entity F provided personal care services 4 hours in the morning and in the evening 7 days a week and indicated the patient needed care 24 hours a day, 7 days a week. The primary caregiver indicated the patient was left alone after the caregiver from Entity F left in the evenings and indicated there was a camera set-up on the patient that the primary caregiver had access to in order to monitor the patient. The record failed to evidence the agency provided services to meet the patient’s needs to include a referral to medical social work (MSW) services to assist the patient in acquiring additional services to meet the patient’s needs and failed to evidence additional documentation regarding the assessed need for a catheter. The agency failed to inform the physician of the patient’s assessed needs for which care was not provided and failed to provide patient/caregiver education to the risks of being left unattended. On 01/09/2025, at 10:59 AM, RN 2 indicated the patient was not referred to MSW services and MSW services “would not hurt.” RN 2 indicated the CM was supposed to follow-up with the physician regarding the Texas or foley catheter. On 01/09/2024, at 12:20 PM, the CM indicated the agency’s services included MSW but had not referred the patient for MSW services and there was no communication with the physician regarding the assessed need for a catheter. The CM indicated the patient should be in a skilled nursing facility or in hospice care.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure each patient received the home health services that are written in the individualized plan of care that identifies patient-specific measurable outcomes and goals in 6 of 6 active clinical records reviewed (Patients #1, 2, 3, 4, 5, and 8). Findings include: # The clinical record for Patient #1 included an initial POC dated 11/1/2024 to 12/30/2024 indicating RN visits ordered once every other day for 2 visits then once a week for eight weeks and PT to evaluate and treat Patient. A separate PT plan of treatment signed by PT 1 on 11/5/2024 failed to evidence dates of care and indicated PT services were twice a week for eight weeks. The clinical record included the subsequent POC dated 12/31/2024 to 2/28/2025 that indicated services were RN visits once a week for 9 weeks and PT to evaluate and treat. The home health POC failed to evidence PT frequencies and treatments. The clinical record revealed PT missed visit documentation on 11/29/2024, 12/7/2024, and 12/24/2024, documented by PT 1 and each missed visit was documented as patient requested. The clinical record failed to evidence attempts to reschedule PT visits for each missed visit nor attempts to schedule PT 2. During an interview on 1/9/2025 at 9:50 AM, PT 1 relayed the missed visit on 12/24/2024 was due to the holiday and he couldn’t find another time in his schedule to reschedule Patient. PT revealed the missed visits on 11/29/2024 and 12/7/2024 were due to working around Patient’s caregivers and he couldn’t find another time in his schedule to reschedule Patient visits. During an interview on 1/8/2024 beginning at 9:50 AM, Administrator revealed the electronic medical record creates separate plans of care for each service. During an interview on 1/9/2024 at 3:40 PM, Administrator relayed PT 2 was not contacted in efforts to cover missed visits by PT 1. # The clinical record for Patient #2 included an initial POC dated 10/23/2024 to 12/21/2024 indicating RN visits once a week for nine weeks and two extra visits if needed and PT to evaluate and treat Patient. A separate PT plan of treatment signed by PT 1 on 10/30/2024 failed to evidence dates of care and indicated PT services were once a week for one week then twice a week for eight weeks. A second PT plan of treatment signed by PT 1 on 12/23/2024 indicated PT services twice a week for eight weeks. The home health POC failed to evidence PT frequencies and treatments. The clinical record revealed PT missed visit documentation on 11/8/2024, 11/29/2024, 12/7/2024, 12/13/2024, and 12/27/2024, documented by PT 1 and each missed visit was documented as patient requested. The clinical record failed to evidence attempts to reschedule PT visits for each missed visit nor attempts to schedule PT 2. During an interview at a home visit on 1/8/2025 beginning at 11:50 AM, Other C, a spouse and primary caregiver for Patient #2, indicated only one PT appointment was requested to be changed on 12/27/24 and it was cancelled because PT couldn’t reschedule. During an interview on 1/8/2024 beginning at 9:50 AM, Administrator revealed the electronic medical record creates separate plans of care for each service. During an interview on 1/9/2024 at 3:40 PM, Administrator relayed PT 2 was not contacted in efforts to cover missed visits by PT 1. During an interview on 1/9/2025 beginning at 9:50 AM, PT 1 revealed that he had called Patient to notify them that he felt ill and the Patient canceled therefore the missed visit was documented ‘per patient request’; PT could not recall dates he was ill. # The clinical record for Patient #8 revealed a POC dated 11/19/2024 to 1/17/2025 that included RN visits once a week for 9 weeks with 2 visits that can be done as needed, HHA services once a week for one week then twice a week for eight weeks, and PT to evaluate and treat Patient. A separate PT plan of treatment signed by PT 1 on 11/26/2025 failed to evidence dates of care and indicated PT services were once a week for eight weeks. The home health POC failed to evidence PT frequencies and treatments. The clinical record revealed a PT missed visit on 12/6/2024 per patient request, resulting in no PT services the week of 12/2/2024 and a HHA missed visit on 12/25/2024 per patient request with no other scheduled HHA visits that week, resulting in no HHA service visits the week of 12/23/2024. The clinical record failed to evidence attempts to reschedule PT visits and HHA missed visit and failed to evidence a second HHA scheduled visit the week of 12/23/2024. During an interview on 1/8/2025 at 8:06 AM, HHA 1 relayed she was on vacation and unavailable from 12/20/2024 to 12/30/2024 and the Administrator was aware weeks ahead. During an interview on 1/9/2025 at 12:10 PM, Patient #8 relayed that only one PT visit was missed on 12/6/2024 and it was because of a physician’s appointment and PT couldn’t reschedule. During an interview on 1/9/2025 at 11:55 AM, Other A, a primary caregiver and family member of Patient #8, relayed PT started the day they were supposed to and the only missed visit was for an appointment. 410 IAC 17-13-1(a) 1. An undated policy titled “Wound Care Policy” indicated wounds should be assessed weekly and include measurements of length, width, and depth and description of wound. 2. A clinical record review for Patient #3 evidenced a document titled “Physician Telephone/Verbal Order” dated 12/11/2024 and signed by RN 2 which was identified as the SOC orders from the physician indicating skilled nursing was to provide a skilled assessment and patient education and indicated the patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (some skin loss or damage involving the top-most skin layers) to the right and left buttocks. The POC for the initial certification period 12/11/2024-02/08/2025 signed by RN 2 indicated skilled nursing and PT orders to include wound care. The POC indicated the skilled nurse was to provide instruction on non-pharmacological interventions on pain management and provide an assessment of the skin. On 01/09/2024, at 10:59 AM, RN 2 indicated she wrote the SOC orders and developed the POC which were sent to the physician for review and signature, but there was no communication with the physician’s office to receive or verify verbal SOC orders or review the POC. On 01/09/2024, at 12:56 PM, the CM indicated the POC was not sent to the physician for signature until 12/13/2024. The CM indicated there was no documentation the agency contacted the physician to review the POC. The SOC comprehensive assessment dated 12/11/2024 and completed by RN 2 indicated the patient’s reported pain was 7 on a scale of 0-10 and failed to evidence RN 2 provided education on non-pharmacological pain management per the POC. On 01/09/2025, at 11:59 AM, the CM indicated there was no documentation the RN provided non-pharmacological pain management education. A skilled nurse visit note completed by RN 2 and dated 12/27/2024 indicated the patient had a deep tissue injury (a type of pressure ulcer causing damage to soft tissue) to the right great toe and failed to evidence an assessment of the wound to include measurements and appearance. On 01/09/2025, at 12:16 PM, the CM indicated there was not any assessment documented of the deep tissue injury. 3. A clinical record review for Patient #4 evidenced a plan of care for certification period 11/09/2024-1/07/2025 which indicated the agency was to notify the physician for a heart rate less than 60 beats per minute (bpm) and the agency was to provide HHA services 2 times a week for 8 weeks. The clinical record review failed to evidence the agency provided HHA services the week of 12/22/2024. HHA visit notes completed by HHA 1 indicated the heart rate was 56 bpm on 12/07/2024, 57 bpm on 12/31/2024, and 58 bpm on 12/10/2024 and 12/19/2024 and failed to evidence the physician was notified of the heart rate less than 60 bpm. A skilled nurse visit completed by RN 1 and dated 01/03/2025 indicated the heart rate was 59 bpm and failed to indicate the physician was notified. On 1/09/2025, at 3:20 PM, the CM indicated the agency did not notify the physician of the heart rate less than 60 bpm. 4. A clinical record review for Patient #5 evidenced a POC for the recertification period 09/22/2024-11/20/2024 signed by RN 2 which indicated the agency was to provide PT services 2 times a week for 8 weeks and nursing 1 times a week for 8 weeks. The record failed to evidence the agency developed the POC with the physician as the POC. On 01/09/2025, at 10:30 AM, PT 1 indicated he did not call the physician to review the plan of care interventions and goals but would send the PT re-evaluation and POC to the physician for review and signature. On 01/09/2025, at 10:59 AM, RN 2 indicated she did not speak to the physician to review the POC but rather called and left a message with someone at the physician’s office and did not receive a call back confirming the continuation of home health care orders.

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, clinical record review, and interview, the agency failed to ensure the plan of care included all services provided to the patient in 3 of 6 active clinical records reviewed. (Patient #1, 3, 4) The findings include: #The clinical record for Patient #1 revealed an initial comprehensive assessment, completed on 11/1/2024 by Administrator and an initial POC dated 11/1/2024 to 12/30/2024 that was signed by the physician on 11/21/2024. The comprehensive assessment documentation included a notation that Patient received assistance from paid caregivers seven days a week from 8:00 AM to 11:00 AM and 4:00 PM to 7:00 PM. The plans of care failed to evidence the services provided to Patient by Entity B nor the frequency and hours. During an interview on 1/9/2025 at 1:45 PM, Other E, director of Entity B, relayed Patient receives personal care from staff daily that included transferring Patient with a lift into a wheelchair, bathing, dressing, grooming, cleaning and meal preparation with set care hours. 1. During an observation of care at the home of Patient #4 on 1/07/2025, at 3:46 PM, RN 1 stuck the patient’s right index finger with a lancet (sharp needle used to draw blood to check blood sugar) and obtained a blood sample. On 01/07/2024, at 3:37 PM, RN 1 indicated the patient was not able to be weighed due to the patient’s inability to stand but the POC had to include the intervention related to the patient’s weight due to the patient’s diagnosis causing edema (swelling). A clinical record review evidenced skilled nurse visit notes completed by RN 1 dated 11/13/2024, 11/18/2024, 11/25/2024, 12/2/2024, 12/09/2024, and 12/23/2024 indicated the RN checked the patient’s blood sugar. The POC for certification period 11/09/2024-01/07/2025 failed to evidence the skilled nursing interventions included obtaining the patient’s blood sugar. The POC indicated the patient’s diagnoses included pulmonary fibrosis (scarring of the lungs which can cause fluid retention and causing swelling of the lower limbs in particular) and indicated the agency should notify the physician of a weight gain of more than 5 pounds in a week or more than 2 pounds in a day. On 01/09/2025, beginning at 3:27 PM, the CM indicated the POC did not include check blood sugar for skilled nursing interventions. The CM indicated the POC was not individualized if the patient was unable to stand to obtain weight and should have included a thigh measurement for the monitoring of edema instead. 2. A clinical record review for Patient #3 evidenced a POC for an initial certification period of 12/11/2024-02/08/2025 which indicated the skilled nurse would coordinate care with the paid help. The skilled nurse visit note completed by RN 2 dated 12/20/2024 indicated she spoke with the patient’s primary caregiver urging the primary caregiver to speak to Entity F about providing additional services. The POC failed to evidence the agency and type and frequency of services to be provided to the patient. On 01/09/2025, at 10:44 AM, the patient’s primary caregiver indicated Entity F provided personal care services 4 hours in the morning and in the evening 7 days a week for bathing, personal care, feeding, and transferring. On 01/09/2025, at 11:55 AM, the CM indicated the POC did not include the agency through which the personal care services were provided and the type and frequency of services provided.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interviews, the agency failed to ensure services and treatments were administered only as ordered by a physician in 5 of 6 active clinical records reviewed (Patients #1, 2, 3, 5, 8). Findings include: 1. A clinical record review for Patient #3 evidenced a document titled “Physician Telephone/Verbal Order” dated 12/11/2024 and signed by RN 2 which was identified as the SOC orders indicating skilled nursing was to provide a skilled assessment and patient education and indicated the patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (some skin loss or damage involving the top-most skin layers) to the right and left buttocks but failed to include wound care orders. The SOC assessment completed by RN 2 and dated 12/11/2024 indicated the RN provided wound care to include a foam dressing to the pressure ulcers on the left and right buttocks. On 01/09/2024, at 10:59 AM, RN 2 indicated she was not aware the SOC orders did not include a foam dressing for wound care. RN 2 indicated she applied a foam dressing to the buttocks per the request of the caregiver since that is what was in the patient’s home. RN 2 indicated she wrote the SOC orders which were sent to the physician for review and signature, but there was no communication with the physician’s office to receive or verify verbal SOC orders. On 01/09/2024, at 12:56 PM, the CM indicated there was no order for wound care on the SOC order but was added to the POC which was not sent to the physician for signature until 12/13/2024. The CM indicated there was no documentation the agency contacted the physician for SOC orders. The POC for the initial certification period of 12/11/2024-02/08/2025 which indicated the patient had pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (some skin loss or damage involving the top-most skin layers) to the right and left buttocks requiring a foam dressing every 3 days. A skilled nurse visit note completed by RN 2 and dated 12/27/2024 indicated the RN applied a duoderm (an occlusive wound dressing that forms a gel-like substance over the wound) to the wounds on both buttocks. The clinical record failed to evidence a physician order for the douderm. On 01/09/2025, at 10:59 PM, RN 2 indicated she did not obtain a physician order for the duoderm and thought the CM called the physician to get the order. On 01/09/2025, at 12:16 PM, the CM indicated there was not a physician order for the duoderm. 2. A clinical record review for Patient #5 evidenced a POC for the recertification period 09/22/2024-11/20/2024 signed by RN 2 and signed by the physician on 12/2/2024 which indicated the agency was to provide PT services 2 times a week for 8 weeks and nursing 1 times a week for 8 weeks. The record evidenced PT 1 and RN 2 both provided services on 11/26/2024 and failed to evidence the services were provided with a physician order by the PT and RN prior to the physician signing the POC on 12/2/2024 and signing the PT evaluation and treatment plan on 12/5/2024. On 01/09/2025, at 10:30 AM, PT 1 indicated he did not call the physician for orders but would send the PT re-evaluation and POC to the physician for review and signature. On 01/09/2025, at 10:59 AM, RN 2 indicated she did not speak to the physician to review the POC but rather called and left a message with someone at the physician’s office and did not receive a call back confirming the continuation of home health care orders. # The agency policy titled “Physician Orders” indicated all medications, treatments and services for patients would be ordered by a physician. Verbal orders may be taken in accordance State and Federal laws and be read back to the physician to verify the accuracy of the orders. # During an interview on 1/8/2025 beginning at 9:50 AM, Administrator relayed that after the initial comprehensive assessment for Patient #2, a physician verbal order was created and sent to the physician to be signed as orders for care. Administrator relayed that the physician was not consulted for the documentation on the verbal order. The clinical record for Patient #1 revealed an initial comprehensive assessment, completed on 11/1/2024 by Administrator and an initial POC dated 11/1/2024 to 12/30/2024 and signed on 11/21/2024. The record included a verbal ordered dated 11/1/2024 for a comprehensive assessment, RN visits once a week for 9 weeks plus two extra visits as needed with specified assessments, and PT to evaluate and treat patient; the verbal order dated 11/1/2025 was signed by a physician on 11/19/2024. RN visits were documented 11/1/2024, 11/4/2024, and 11/14/2024 and PT visits were documented on 11/5/2024, 11/8/2024, 11/12/2024, and 11/15/2024. The clinical record failed to evidence an appropriate order for care prior to the physician signing and acknowledging the care orders on 11/19/2024. # During an interview on 1/8/2025 beginning at 11:15 AM, RN 2 relayed that after the initial comprehensive assessment for Patient #2, a physician verbal order was created and sent to the physician to be signed as orders for care. RN 2 relayed that the physician was not consulted for the documentation on the verbal order. The clinical record for Patient #2 revealed an initial assessment completed 10/23/2024 by RN 2. A verbal order dated 10/23/2024 for a comprehensive assessment, RN services once a week for nine weeks plus two visits if needed, with specified assessments and evaluations to be provided to Patient; the verbal order included PT services to evaluate and treat. The verbal order was signed by the physician 11/8/2024. RN visits were documented on 11/1/2024 and 11/6/2024 with PT documentation on 10/30/2024 and 11/6/2024. The clinical record failed to evidence an appropriate order for care prior to the physician signing and acknowledging the care orders on 11/8/2024. # During an interview on 1/8/2025 beginning at 11:15 AM, RN 2 relayed that after the initial comprehensive assessment for Patient #8, a physician verbal order was created and sent to the physician to be signed as orders for care. RN 2 relayed that the physician was not consulted for the documentation on the verbal order. The clinical record for Patient #8 revealed an initial assessment completed 11/19/2024 by RN 2. A verbal order dated 11/19/2024 for a comprehensive assessment, RN services once a week for nine weeks plus two visits if needed, with specified assessments and evaluations to be provided to Patient, PT services to evaluate and treat, and an HHA once a week for one week then twice a week for eight weeks. The verbal order was signed by the physician 11/26/2024. An RN comprehensive assessment was documented on 11/19/2024 and HHA service documentation was completed on 11/22/2024 and 11/25/2024. The clinical record failed to evidence an appropriate order for care prior to the physician signing and acknowledging the care orders on 11/26/2024. 410 IAC 17-13-1(a) 1. A clinical record review for Patient #3 evidenced a document titled “Physician Telephone/Verbal Order” dated 12/11/2024 and signed by RN 2 which was identified as the SOC orders indicating skilled nursing was to provide a skilled assessment and patient education and indicated the patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (some skin loss or damage involving the top-most skin layers) to the right and left buttocks but failed to include wound care orders. The SOC assessment completed by RN 2 and dated 12/11/2024 indicated the RN provided wound care to include a foam dressing to the pressure ulcers on the left and right buttocks. On 01/09/2024, at 10:59 AM, RN 2 indicated she was not aware the SOC orders did not include a foam dressing for wound care. RN 2 indicated she applied a foam dressing to the buttocks per the request of the caregiver since that is what was in the patient’s home. RN 2 indicated she wrote the SOC orders which were sent to the physician for review and signature, but there was no communication with the physician’s office to receive or verify verbal SOC orders. On 01/09/2024, at 12:56 PM, the CM indicated there was no order for wound care on the SOC order; indicated it was added to the POC which was not sent to the physician, for signature, until 12/13/2024. The CM indicated there was no documentation the agency contacted the physician for SOC orders. The POC for the initial certification period of 12/11/2024-02/08/2025 which indicated the patient had pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (some skin loss or damage involving the top-most skin layers) to the right and left buttocks requiring a foam dressing every 3 days. A skilled nurse visit note completed by RN 2 and dated 12/27/2024 indicated the RN applied a duoderm (an occlusive wound dressing that forms a gel-like substance over the wound) to the wounds on both buttocks. The clinical record failed to evidence a physician order for the douderm. On 01/09/2025, at 10:59 PM, RN 2 indicated she did not obtain a physician order for the duoderm and thought the CM called the physician to get the order. On 01/09/2025, at 12:16 PM, the CM indicated there was not a physician order for the duoderm. 2. A clinical record review for Patient #5 evidenced a POC for the recertification period 09/22/2024-11/20/2024 signed by RN 2 and signed by the physician on 12/2/2024 which indicated the agency was to provide PT services 2 times a week for 8 weeks and nursing 1 times a week for 8 weeks. The record evidenced PT 1 and RN 2 both provided services on 11/26/2024 and failed to evidence the services were provided with a physician order by the PT and RN prior to the physician signing the POC on 12/2/2024 and signing the PT evaluation and treatment plan on 12/5/2024. On 01/09/2025, at 10:30 AM, PT 1 indicated he did not call the physician for orders but would send the PT re-evaluation and POC to the physician for review and signature. On 01/09/2025, at 10:59 AM, RN 2 indicated she did not speak to the physician to review the POC but rather called and left a message with someone at the physician’s office and did not receive a call back confirming the continuation of home health care orders. 3. During an interview on 1/8/2025 beginning at 9:50 AM, Administrator relayed that after the initial comprehensive assessment for Patient #2, a physician verbal order was created and sent to the physician to be signed as orders for care. Administrator relayed that the physician was not consulted for the documentation on the verbal order. 4. The clinical record for Patient #1 revealed an initial comprehensive assessment, completed on 11/1/2024 by Administrator and an initial POC dated 11/1/2024 to 12/30/2024 and signed on 11/21/2024. The record included a verbal ordered dated 11/1/2024 for a comprehensive assessment, RN visits once a week for 9 weeks plus two extra visits as needed with specified assessments, and PT to evaluate and treat patient; the verbal order dated 11/1/2025 was signed by a physician on 11/19/2024. RN visits were documented 11/1/2024, 11/4/2024, and 11/14/2024 and PT visits were documented on 11/5/2024, 11/8/2024, 11/12/2024, and 11/15/2024. The clinical record failed to evidence an appropriate order for care prior to the physician signing and acknowledging the care orders on 11/19/2024. 5. During an interview on 1/8/2025 beginning at 11:15 AM, RN 2 relayed that after the initial comprehensive assessment for Patient #2, a physician verbal order was created and sent to the physician to be signed as orders for care. RN 2 relayed that the physician was not consulted for the documentation on the verbal order. The clinical record for Patient #2 revealed an initial assessment completed 10/23/2024 by RN 2. A verbal order dated 10/23/2024 for a comprehensive assessment, RN services once a week for nine weeks plus two visits if needed, with specified assessments and evaluations to be provided to Patient; the verbal order included PT services to evaluate and treat. The verbal order was signed by the physician 11/8/2024. RN visits were documented on 11/1/2024 and 11/6/2024 with PT documentation on 10/30/2024 and 11/6/2024. The clinical record failed to evidence an appropriate order for care prior to the physician signing and acknowledging the care orders on 11/8/2024. 6. During an interview on 1/8/2025 beginning at 11:15 AM, RN 2 relayed that after the initial comprehensive assessment for Patient #8, a physician verbal order was created and sent to the physician to be signed as orders for care. RN 2 relayed that the physician was not consulted for the documentation on the verbal order. The clinical record for Patient #8 revealed an initial assessment completed 11/19/2024 by RN 2. A verbal order dated 11/19/2024 for a comprehensive assessment, RN services once a week for nine weeks plus two visits if needed, with specified assessments and evaluations to be provided to Patient, PT services to evaluate and treat, and an HHA once a week for one week then twice a week for eight weeks. The verbal order was signed by the physician 11/26/2024. An RN comprehensive assessment was documented on 11/19/2024 and HHA service documentation was completed on 11/22/2024 and 11/25/2024. The clinical record failed to evidence an appropriate order for care prior to the physician signing and acknowledging the care orders on 11/26/2024. 7. The agency policy titled “Physician Orders” indicated all medications, treatments and services for patients would be ordered by a physician. Verbal orders may be taken in accordance State and Federal laws and be read back to the physician to verify the accuracy of the orders. 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 agency failed to notify the physician of changes in the patient’s condition in 3 of 6 active clinical records reviewed. (Patient #3, 4, 5) The findings include: 1. A clinical record review for Patient #4 evidenced a POC for recertification period 11/09/2024-01/07/2025 which indicated the patient’s diagnoses included pulmonary fibrosis (scarring of the lungs which can cause fluid retention and causing swelling of the lower limbs in particular) and the agency should notify the physician of a weight gain of more than 5 pounds in a week or more than 2 pounds in a day. The plan of care indicated the agency was to provide PT services 2 times a week. The recertification assessment completed by RN 1 on 11/06/2024 and the skilled nursing visit notes completed by RN 1 on 11/13/2024 and 11/16/2024 indicated the patient had 2+ pitting edema (swelling that when the skin is pressed, leaves an indentation measured from 1+ to 4+ in severity) to the legs at 2+. The skilled nurse visit note completed by RN 1 on 11/25/2024 indicated the patient had 3+ pitting edema to the legs and failed to evidence a weight was obtained and the physician was notified of the change in edema. On 01/07/2025, at 3:46 PM, RN 1 indicated she could not weigh the patient due to the patient’s inability to stand and did not notify the physician of the increase in edema. A document titled “Physician Telephone/Verbal Order” signed by PT 1 on 11/16/2024 indicated the PT visit frequency was changed to 1 time a week for the next 8 weeks. On 01/09/2025, at 10:30 AM, PT 1 indicated he has never called the physician’s office for orders. PT 1 indicated he documents communication with the physician on a verbal order form and sends it the physician for review and signature. On 01/09/2025, at 3:45 PM, the CM indicated there was no documentation the physician was notified of the change in PT frequency prior to sending the document titled “Physician Telephone/Verbal Order” dated 11/16/2024 and written by PT 1 to the MD office on 12/11/2024. 2. A clinical record review for Patient #3 evidenced a SOC order dated 12/11/2024 and signed by the physician which indicated PT was to evaluate and treat for functional deficit. Documents titled “Physician Telephone/Verbal Order” indicated the PT visit for that day was on hold per patient request for document dated 12/14/2024 and signed by PT 1 and the document dated 12/17/2024 and signed by PT 1 indicated PT services were on hold until further orders per patient request. On 01/09/2025, at 10:30 AM, PT 1 indicated the patient was refusing therapy so he put the PT services on hold. PT 1 indicated he did not speak to the physician or get a verbal order from the physician’s office related to the PT services on hold or to notify the physician the patient was refusing PT services. PT 1 indicated he completed the verbal order form which was then sent to the physician’s office for signature and review. On 01/09/2024, at 11:55 AM, the CM indicated she would look for any communication with the physician that the physician was informed of the patient refusing PT services. No additional information or documentation was provided before survey exit on 1/09/2025. A skilled nurse visit note completed by RN 2 and dated 12/27/2024 which indicated a new deep tissue injury (a type of pressure ulcer causing damage to soft tissue from pressure) to the right great toe and failed to evidence the physician was notified of the new wound. On 01/09/2025, at 12:16 PM, the CM indicated there was no communication with the physician regarding the deep tissue injury. 3. A clinical record review for Patient #5 evidenced a plan of care for the recertification period 09/22/2024-11/20/2024 which indicated the agency was to provide PT services 2 times a week for 8 weeks. A document titled “Physician Telephone/Verbal Order” signed by PT 1 on 10/5/2024 indicated PT frequency was changed to 1 time a week for 8 weeks. On 01/09/2025, at 10:30 AM, PT 1 indicated the patient had refused PT visits so he changed the visit frequency to 1 time a week. PT 1 indicated he did not communicate the patient refusals and the need to change PT visit frequency to the physician. On 01/08/2025, at 4:23 PM, the CM indicated the patient refused PT so often so the PT changed the visit frequency to 1 time weekly and indicated she would look for documentation the agency notified the physician of the PT refusal and need for frequency change. No additional documentation or information was provided before survey exit on 01/09/2025.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on record review and interviews, the agency failed to ensure services were integrated to ensure the identification of patient needs and factors that could affect treatment effectiveness and coordination of care provided by all disciplines in 4 of 6 active clinical records reviewed (Patients #1, 2, 3, 5). Findings include: 3. The clinical record for Patient #1 included an initial POC dated 11/1/2024 to 12/30/2024 indicating RN visits ordered once every other day for 2 visits then once a week for eight weeks and PT to evaluate and treat Patient. A separate PT plan of treatment, signed by PT 1 and dated 11/05/2024 failed to evidence the dates of care and indicated PT services were ordered twice a week for eight weeks. The clinical record revealed documentation dated 11/29/2024, 12/7/2024, and 12/24/2024, documented by PT 1, indicating these scheduled visits were missed visit and each were documented that the patient requested no visit. The clinical record failed to evidence attempts to reschedule PT visits for each missed visit, attempts to schedule another therapist, nor coordination with Patient, nor his daily caregivers, or why Patient was requesting no PT service. During an interview on 01/09/2025 at 9:50 AM, PT 1 relayed the missed visit on 12/24/2024 was due to the holiday and he couldn’t find another time in his schedule to reschedule Patient. PT revealed the missed visits on 11/29/2024 and 12/7/2024 were due to working around Patient’s caregivers who bathe Patient and use a lift to get Patient out of bed. PT 1 relayed he couldn’t find another time in his schedule to reschedule Patient's visits that worked around his caregivers. 4. The clinical record for Patient #2 an initial POC dated 10/23/2024 to 12/21/2024 indicating RN visits once a week for nine weeks and two extra visits if needed and PT to evaluate and treat Patient. A separate PT plan of treatment signed by PT 1 on 10/30/2024 failed to evidence dates of care and indicated PT services once a week for one week then twice a week for eight weeks. A second PT plan of treatment signed by PT 1 on 12/23/2024 indicated PT services twice a week for eight weeks. The clinical record revealed PT missed visit documentation on 11/8/2024, 11/29/2024, 12/7/2024, 12/13/2024, and 12/27/2024, documented by PT 1 and each missed visit was documented as patient requested. The clinical record failed to evidence attempts to reschedule PT visits for each missed visit, attempts to schedule another therapist, nor care coordination communication with RN. During an interview at 1/9/2025 beginning at 9:50 AM, PT relayed Patient #2 requested to be receive one service per day and several PT missed visits were due to multiple services self-scheduling to see Patient on the same day. 5. The agency policy titled “Coordination of Client Services” indicated all personnel furnishing services shall assure efforts are coordinated effectively and support the objectives in the plan of treatment to ensure the agency was providing quality care. 410 IAC 17-12-2(g), 17-12-2(h) 1. A clinical record review for Patient #3 evidenced a POC for an initial certification period of 12/11/2024-02/08/2025 which indicated the skilled nurse would coordinate care with the paid help. The skilled nurse visit note completed by RN 2 dated 12/20/2024 indicated the patient lived alone and laid in soiled briefs all night since there was no caregiver available after the evening caregiver leaves. The visit note indicated RN 2 spoke with the patient’s primary caregiver urging the primary caregiver to speak to Entity F about providing additional services. On 01/09/2025, at 10:44 AM, the patient’s primary caregiver indicated Entity F provided personal care services 4 hours in the morning and in the evening 7 days a week. The clinical record failed to evidence any coordination of care with Entity F. On 01/09/2025, at 10:59 AM, RN 2 indicated she had not coordinated care with Entity F regarding the need for additional services. On 01/09/2025, at 11:55 AM, the CM indicated she would look for care coordination with Entity F. No additional information or documentation was provided prior to survey exit on 01/09/2025. 2. A clinical record review for Patient #5 evidenced POCs for the recertification periods of 09/22/2024-11/20/2024 and 11/21/2024-01/19/2025 indicating the agency was to provide SN and PT services. Communication notes dated 11/16/2024 and 01/03/2025 signed by the CM indicated the patient had a fall on 11/16/2024 and 01/02/2025 and failed to evidence the skilled nurse and PT were notified of the falls. On 01/09/2025, beginning at 2:36 PM, the CM indicated there was no documentation the nurse and PT were notified of the falls on 11/16/2024 and 01/02/2025.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure: measure, analyze, and track quality indicators (G0642); utilize data to identify opportunities for improvement (G0644); improvement activities must focus on high risk or problem prone areas (G0646); performance improvement activities analyze patient adverse events and implement preventative actions (G0654); and the Governing Body must approve the data detail and frequency of collection (G0660). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.65 Quality Assessment and Performance Improvement (QAPI). A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview, the agency failed to: ensure the governing body approved the frequency of the data collection, QAPI program utilized quality indicator data to include updated OASIS (Outcome and Assessment Information Set) data to identify opportunities for improvement, the QAPI program focused on high risk areas, and the agency implemented performance improvement actions. The findings include: A review of an undated policy titled “Performance Improvement” indicated the agency would develop and maintain an ongoing performance improvement program by collecting and evaluating data and implementing performance improvement actions. The review of QAPI binder and the governing body meeting minutes dated 01/05/2024 failed to evidence the governing body approved the frequency and detail of the data collection. The most recent Measure Performance Summary dated April 2023 indicated the agency did not meet the benchmark for timely initiation of care, improvement in dyspnea (difficulty breathing), drug regimen review, and patient falls with major injury. The infection log indicated dated in 2024 evidenced 38 infections, the hospitalization log in 2024 evidenced 30 hospitalizations, and the fall log evidenced 17 falls in 2024. The reported average census in 2024 was 18. There was no assessment of the data to determine trends or cause and current level of performance and areas to be improved, and the QAPI program failed to evidence performance improvement actions. No QAPI meeting minutes were present for 2024 and 2025. On 01/09/2025, at 4:25 PM, the CM indicated there was no assessment of the QAPI data for falls, hospitalizations, and infections to determine trends and areas for improvement. The CM indicated there were no performance improvement action plans and the governing body did not approve the data detail and frequency to be collected. The CM indicated meetings to review the QAPI were to take place quarterly, but she was behind in getting data together and have another meeting. 410 IAC 17-12-2(a)

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure: standard precautions and agency policies were followed to prevent infection (see tag 0682) and infection surveillance was maintained to prevent infection (See G0684). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR 484.70 Infection Prevention and Control.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to follow standard precautions and agency policy to prevent the transmission of infections in 2 of 3 active clinical records reviewed with a home visit (Patient #1, 2). Findings include: 5. During a home visit on 1/8/2024 beginning at 11:51 AM, PT 1 used a blood pressure cuff, thermometer, and oxygen saturation monitor to assess Patient’s vitals signs. At the end of the home visit, PT 1 used Clorox disinfectant wipes to cleanse the supplies and the supplies were placed directly into PT’s supply bag in under 8 seconds each. PT failed to evidence appropriate drying time needed to disinfect the supplies. During an interview at the home visit, PT 1 relayed the drying time for Clorox disinfectant wipes was 4 minutes and he thought it was thirty seconds. 410 IAC 17-12-1(m) 1. A review of an undated policy titled “Foley Catheter Care” indicated sterile gloves should be worn for the insertion of the new catheter. 2. A review of an undated policy titled “Infection Prevention/Control” indicated hands were to be washed immediately after gloves were removed and equipment used for patient care was to be properly cleaned. 3. A review of an undated policy titled “Handwashing/Hand Hygiene” indicated staff should wash their hands with soap and water for 15 seconds. 4. On 01/06/2025, between 3:54 PM and 4:52 PM, at the home of Patient #1, RN 2 was observed to have placed the nurse bag on top of the patient’s bed on top of the agency folder with the edges of the bag touching the patient’s bed. RN 2 obtained the patient’s vital signs by using a blood pressure cuff applied to the patient’s left arm and pulse oximeter (a medical devise measuring the amount of oxygen in the blood) on the left index finger. RN 2 placed the stethoscope to the patient’s chest, abdomen, and back. RN 2 removed her gloves and did not perform hand hygiene. RN 2 wiped the stethoscope, blood pressure cuff, and pulse oximeter with disposable sanitizing wipes and placed each item immediately into the nurse bag. The directions on the disposable wipe container indicated the surface should be wiped and left to air dry for 4 minutes. RN 2 then removed the agency folder to document vital signs and placed the nurse bag directly on the patient’s bed. RN 2 was observed deflating the balloon and removing foley catheter (a plastic tube inserted into the bladder and anchored by an inflated balloon to drain urine from the body), removing gloves from both hands, cleansing the tip of the penis with premoistened cotton swabs, and then opening a package of sterile gloves, touching the outside of the sterile gloves and not maintaining sterility before applying gloves to both hands, and inserting the new catheter into the penis. RN 2 was not observed performing hand hygiene after removing gloves after removing the catheter and before applying sterile gloves and cleansing the penis and inserting the new catheter. RN 2 removed gloves and washed hands with soap and water for 8 seconds. A clinical record review evidenced a POC for recertification period 12/31/2024-02/28/2025 which indicated the skilled nurse was to change the foley catheter monthly. A communication note indicated the agency received a physician order dated 12/30/2024 for a urinalysis and culture (a laboratory test on a urine sample to detect infection/bacteria). A communication note dated 01/02/2025 indicated the patient was started on antibiotic and a laboratory report dated 12/31/2024 indicated the patient’s urine contained multiple organisms consistent with contamination. On 01/09/2025, at 10:59 AM, RN 2 indicated hands should be washed for 20 seconds and equipment should be left to dry for 20-30 seconds before returning to nurse bag. RN 2 indicated she was not aware the disposable sanitizing wipe container indicated equipment was to dry for 4 minutes after use. On 01/09/2025, at 12:32 PM, the CM indicated hands should be washed for at least 20 seconds and indicated the nurse bag should not be placed on the patient’s bed. The CM was not sure if the agency policy required staff to use sterile gloves for catheter insertion.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases. The findings include: A review of an undated agency policy titled “Infection Control Surveillance” indicated the agency would maintain a continuous data collection and monitoring system to identity to identify infection trends and investigate trends to determine source of contamination. The agency would maintain an infection log and implement follow-up actions based on infections. The infection log provided by the CM on 01/06/2025 evidenced 14 infections logged and failed to evidence any logged infections since 06/17/2024. The infection log evidenced 8 of the 14 infections through 06/17/2024 were urinary tract infections and the infection program failed to include any investigation or follow-up actions. On 01/06/2025, at 10:55 AM, the CM indicated no additional infections were logged since 06/17/2025 and indicated she would need to go pull the additional infections from the clinical records. On 01/09/2025, at 4:25 PM, the CM indicated there were no follow-up actions or investigations related to infections.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure skilled professionals assumed responsibility for prepared clinical notes in 5 of 6 active clinical records reviewed (Patient s#1, 2, 3, 5, 8). Findings include: # The agency policy titled “Clinical Documentation” indicated each direct contact with patients would be documented by skilled professionals and incorporated into the clinical records within 7 days. # The clinical record for Patient #1 included an initial POC dated 11/1/2024 to 12/30/2024 indicating RN visits ordered once every other day for 2 visits then once a week for eight weeks and PT to evaluate and treat Patient. The clinical record included RN visit documentation on 12/27/2024 and failed to evidence a scheduled nor documented RN visit the week of 12/30/2024 and 1/6/2025. During an interview on 1/8/2025 at 11:15 AM, RN 2 # The clinical record for Patient #2 an initial POC dated 10/23/2024 to 12/21/2024 indicating RN visits once a week for nine weeks and two extra visits if needed and PT to evaluate and treat Patient. The clinical record included RN visit documentation on 12/26/2024. The record failed to evidence a scheduled nor documented RN visit the week of 12/30/2024 and 1/6/2025. During an interview on 1/8/2025 at 11:15 AM, RN 2 relayed she had seen Patient every week as ordered, including the week of 12/30/2024 and 1/6/2025. RN revealed the documentation had not yet been completed. # The clinical record review of Patient #8 revealed a POC dated 11/19/2024 to 1/17/2025, signed by RN 2, that included RN visits once a week for 9 weeks with 2 visits that can be done as needed. The clinical record included RN visit documentation on 12/19/2024. The record failed to evidence a scheduled nor documented RN visit the week of 12/23/2024, 12/30/2024, and 1/6/2025. During an interview on 1/8/2025 at 11:15 AM, RN 2 relayed she had seen Patient every week as ordered, including the week of 12/23/2024, 12/30/2024, and 1/6/2025. RN revealed the documentation had not yet been completed. 410 IAC 17-14-1(a)(1)(E) 1. A clinical record review for Patient #3 evidenced a POC from the initial certification period 12/11/2024-02/08/2025 which indicated the agency was to provide skilled nursing services 1 time a week for 9 weeks. The clinical record on 01/09/2025 failed to evidence nursing visits since 12/27/2024. On 01/09/2025, at 12:00 PM, the CM indicated RN 2 provided skilled nurse visits on 01/03/2024 and 01/07/2025 but had not yet documented the visit notes. 2. A clinical record review for Patient #5 evidenced a POC for the recertification period 11/21/2024-01/19/2025 indicating the agency was to provide skilled nursing services 1 time a week. The clinical record on 01/09/2024 failed to evidence skilled nursing visits were provided since 12/17/2024. On 01/08/2025, at 4:23 PM, the CM indicated there were no other nursing visits documented since 12/17/2024 and indicated RN 2 provided a visit last week but had not documented it yet.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interviews, the agency failed to ensure the RN assigned tasks appropriately to the HHA in 2 of 2 active clinical records reviewed with HHA services (Patients #4, 8). Findings include: # The clinical record review of Patient #8 revealed a POC dated 11/19/2024 to 1/17/2025 that included RN visits once a week for 9 weeks with 2 visits that can be done as needed and HHA services once a week for one week then twice a week for eight weeks. The clinical record for Patient #8 revealed an initial comprehensive assessment, completed on 11/19/2024 that indicated Patient was alert to person place and time with forgetfulness and confusion with new and complex situations. The HHA care plan, signed by RN 2 on 11/19/2024, revealed a sponge bath as requested, a tub bath as requested, a shower as requested, shampoo/grooming as requested, and mouth care as requested. The HHA care plan failed to evidence patient specific duties assigned by RN 2. During an interview on 1/7/2025 at 9:50 AM, Administrator relayed the care plan says ‘as requested’ so Patient can choose care, but it does not provided direction for care frequency. 410 IAC 17-14-1(m) 1. A clinical record review for Patient #4 evidenced an initial plan of care signed by the physician for certification period 09/10/2024-11/08/2024, which indicated the patient had a diagnosis of epilepsy (seizures) and the safety measures included seizure precautions. The plan of care indicated the agency was to notify the physician if the heart rate was less than 60 beats per minute (bpm). The HHA care plans dated 09/10/2024 and 11/06/2024 and signed by the RN failed to evidence seizure precautions and indicated the HHA was to notify the RN if the heart rate was less than 50 bpm and not 60 bpm as ordered in the plan of care signed by the physician. The HHA care plans indicated the HHA was to assist the patient with ambulation and transfers with the use of a wheelchair, walker, and cane and indicated the HHA was to assist with a home exercise program as directed by the therapist. Bathing and oral care were assigned per request and failed to evidence the RN directed the care based on the patient’s assessed need. During an observation of care at the patient’s home on 01/07/2025, at 3:09 PM, no cane was observed in the patient’s home. The agency folder was observed to include diagrams and instructions of home exercises the patient was to complete created by PT 1 and dated 11/01/2023. On 01/07/2025, at 3:15 PM, the patient’s caregiver indicated the patient did not ambulate with a cane. On 01/09/2025, at 10:52 AM, HHA 1 (the patient’s scheduled HHA) indicated she was never instructed about the seizure precautions and indicated the patient had a difficult time walking so did not use a cane. HHA 1 indicated she was not aware of a cane in the patient’s home and was not aware of any home exercise program provided by the therapist. HHA 1 indicated she only performed range of motion exercises. On 01/09/2025, at 10:30 AM, PT 1 indicated the patient did not ambulate with a cane and the home exercises on the agency folder were old and the patient was no longer able to complete those exercises as directed. On 01/09/2025, at 3:23 PM, the CM indicated there were no seizure precautions on the HHA care plan and the task to assist with ambulation with the use of a cane should not be included on the care plan. The CM indicated the HHA plan of care should match the plan of care signed by the physician related to the heart rate parameters.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA completed tasks per the care plan in 1 of 2 active clinical record reviewed with HHA services. (Patient #4) The findings include: A clinical record review for Patient #4 evidenced HHA visit notes completed by HHA 1 and dated 11/12/2024, 11/14/2024, 11/20/2024, 11/23/2024, 11/26/2024, 11/29/2024, 12/04/2024, 12/07/2024, 12/10/2024, 12/17/2024, 12/19/2024, 12/31/2024, and 1/03/2025 which indicated the HHA performed active and passive range of motion to upper and lower extremities. The HHA care plan dated 11/06/2024 failed to evidence the HHA was directed to perform range of motion exercises. On 01/09/2025, at 10:52 AM, HHA 1 (the patient’s scheduled HHA) indicated she completed active and passive range of motions during the patient’s personal care and was not aware it was not indicated as a task to perform on the HHA care plan. On 01/09/2025, at 3:23 PM, the CM indicated there were no seizure precautions on the HHA care plan and the task to assist with ambulation with the use of a cane should not be included on the care plan.

HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient's condition; and (vi) Honoring patient rights. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA supervision included the aide’s compliance with infection control, reported changes in the patient’s condition, and honored the patient’s rights in 2 of 2 active clinical records reviewed with HHA services. (Patient #4, 8) The findings include: # The clinical record review of Patient #8 revealed a POC dated 11/19/2024 to 1/17/2025 that included RN visits once a week for 9 weeks with 2 visits that can be done as needed and HHA services once a week for one week then twice a week for eight weeks. The RN visit documentation 12/19/2024, 12/12/24, and 12/5/2024 revealed the following supervision goals as ‘met’: patient clean and comfortable, established good rapport with patient, appropriate and necessary personal care given, environment is safe and clean, and progress towards personal care. The HHA supervision documentation failed to address honoring Patient’s rights, infection prevention, nor if the HHA care plan was being followed. During an interview on 1/8/2025 at 9:50 AM, Administrator revealed the HHA supervisory documentation did not include evaluation if the plan of care was followed, patient rights, nor infection control. 410 IAC 17-14-1(n) 1. The clinical record review for Patient #4 evidenced HHA supervision visits completed by RN 1 and dated 11/13/2024, 11/18/2024, 11/25/2024, 12/02/2024, 12/09/2024, and 12/23/2024 which failed to include the supervision of the HHA to include compliance with infection control, reporting changes of the patient’s condition, and honoring the patient’s rights. On 01/09/2025, at 3:31 PM, the CM indicated the form used for supervision visits was not comprehensive to include all of the required elements of HHA supervision so there was no documentation of HHA supervision of a complete supervision visit.

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on record reviews and interview, the CM failed to demonstrate oversight of the nursing services and monitoring to ensure nursing services were provided to patients as ordered, to include making patient and personnel assignments in 3 of 6 active records reviewed with nursing services ordered. Findings include: The clinical record review of Patient #8 revealed a POC dated 11/19/2024 to 1/17/2025 that included RN visits once a week for 9 weeks with 2 visits that can be done as needed. The clinical record included RN visit documentation on 12/19/2024. The record failed to evidence a scheduled nor documented RN visit the week of 12/23/2024, 12/30/2024, and 1/6/2025. The clinical record review of Patient #2 revealed a POC dated 10/23/2024 to 12/30/2025 that included RN visits once a week for 9 weeks with 2 visits that can be done as needed. The clinical record included RN visit documentation on 12/27/2024. The record failed to evidence a scheduled nor documented RN visit the week of 12/30/2024 and 1/6/2025. The clinical record review of Patient #1 revealed a POC dated 12/22/2024 to 2/19/2025 that included RN visits once a week for 9 weeks with 2 visits that can be done as needed. The clinical record included RN visit documentation on 12/26/2024. The record failed to evidence a scheduled nor documented RN visit the week of 12/30/2024 and 1/6/2025. During an interview on 1/8/2025 at 9:50 AM, Administrator relayed she does not schedule patient visits and agency staff make their own schedule for patient visits.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure agency services were provided in accordance with current clinical practice guidelines and accepted professional standards of practice in 5 of the 5 clinical records reviewed with more than 60 days of admission (Patient #1, 2, 4, 5, 6). Findings include: # The agency policy titled “Physician Summary” indicated a summary report will be provided to the physician no less than every sixty days to include the patient’s current condition, response to current treatment or medications, and changes in the patient’s condition since the prior report. During an interview on 1/8/2025 at 10:20 AM, Administrator relayed the 60 day summary was included in the comprehensive assessments patients that was not sent to the physicians. She revealed the agency has not sent 60-day summaries to physicians. The clinical record for Patient #1 revealed an initial POC dated 11/1/2024 to 12/30/2024 and POC dated 12/31/2024 to 2/28/2025. The clinical record failed to evidence 60-day summary documentation sent to the physician. The clinical record for Patient #2 revealed an initial POC dated 10/23/2024 to 12/21/2025 and a POC dated 12/22/2024 to 2/19/2025. The clinical record failed to evidence 60-day summary documentation sent to the physician. The clinical record for Patient #6 revealed a start of care comprehensive assessment on 8/30/2023 and a discharge date of 12/22/2024. The review of the clinical record failed to evidence 60-day summary documentation sent to the physician for the 14 months of agency admission. 1. A clinical record review for Patient #4, start of care 09/10/2024, failed to evidence a summary of care had been sent to the physician since SOC. 2. A clinical record review for Patient #5, start of care 11/27/2023, failed to evidence a summary of care had been sent to the physician since certification period beginning 9/22/2024.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a completed discharge summary was provided to the physician in 2 of 2 closed clinical records reviewed (Patient #6, 7). Findings include: 1 .The agency policy titled “Discharge Summary” indicated when a patient was discharged from the agency, a discharge summary will be completed that includes instructions provided to the family and unmet needs. The skilled professional would assure that if goals have not been met, appropriate referrals were made to meet continuing needs of the patient. 2. The clinical record for Patient #6 revealed an initial SOC comprehensive assessment dated 8/30/2023 and a POC dated 8/24/2024 to 10/22/2024 that included orders for RN visits once a week. The clinical record included a verbal order dated 10/22/2024 indicating Patient may be discharged, signed by the physician 11/15/2024. The patient was discharged on 10/22/2024. The discharge summary, signed by the physician 11/5/2024, failed to evidence Patient discharge instructions nor goals that are met. During an interview on 1/8/2024 beginning at 9:50 AM, Administrator relayed the Patient’s discharge instructions are in the discharge comprehensive assessment which is not sent to the physician and the discharge summary did not include the goals. 2. The clinical record for Patient #7 revealed an initial comprehensive assessment on 9/26/2024 and an initial POC for dates 9/26/2024 to 11/24/2024 for RN visits once a week for 9 weeks and PT to evaluate and treat. The clinical record included a verbal physician’s order to discharge Patient per Patient request dated 11/8/2024 and signed by the physician 11/15/2024 and a discharge summary report signed by the physician on 11/15/2024. The discharge summary failed to evidence progress in goals nor discharge instructions provided to Patient. During an interview on 1/8/2025 beginning at 9:50 AM, Administrator relayed the discharge summary for Patient #7 did not include progress in goals nor discharge instructions provided to Patient. 410 IAC 17-15-1(a)(7)

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interviews the agency failed to ensure all entries in the clinical record are appropriately authenticated in 6 of 6 active clinical records reviewed (Patients #1, 2, 3, 4, 5, 8). Findings include: 1. A clinical record review for Patient #3 evidenced a document titled “Physician Telephone/Verbal Order” dated 12/11/2024 and signed by RN 2 which was identified as the SOC orders from the physician indicating skilled nursing was to provide a skilled assessment and patient education. On 01/09/2024, at 10:59 AM, RN 2 indicated she wrote the SOC orders which were sent to the physician for review and signature, but there was no communication with the physician’s office to receive or verify verbal SOC orders or review the POC. 2. A clinical record review for Patient #4 evidenced the plan of care for the recertification period of 11/09/2024-01/07/2025 signed by the physician which indicated the agency was to provide PT services 2 times a week for 6 weeks and HHA services 2 times a week for 8 weeks. Documents titled “Physician Telephone/Verbal Order” indicated the patient requested a hold of PT services on 11/16/2024 and PT visit frequency was changed to 1 time a week for the next 8 weeks and was signed by PT 1 and the document dated 12/25/2024 completed by RN 1 indicated the patient requested the HHA visits be held for the week. On 1/07/2025, at 3:15 PM, the patient’s caregiver indicated neither the caregiver nor the patient refused PT or HHA services. On 01/07/2025, at 3:15 PM, RN 1 indicated she left a message with the medical assistant at the physician’s office on 12/24/2024 related to the aide services on hold and did not speak with the physician nor did she get a return message from the physician’s office for a verbal order for the patient’s HHA hold. 3. A clinical record review for Patient #5 evidenced a plan of care for the recertification period 09/22/2024-11/20/2024 which indicated the agency was to provide PT services 2 times a week for 8 weeks. A document titled “Physician Telephone/Verbal Order” signed by PT 1 on 10/5/2024 indicated PT frequency was changed to 1 time a week for 8 weeks. 4. On 01/09/2025, at 10:30 AM, PT 1 indicated he has never called the physician’s office for orders. PT 1 indicated he documents communication with the physician on a verbal order form and sends it to the physician for review and signature. 1 .The agency policy titled “Physician Orders” indicated all medications, treatments and services for patients would be ordered by a physician. Verbal orders may be taken in accordance State and Federal laws and be read back to the physician to verify the accuracy of the orders. 2. During an interview on 1/8/2025 at 9:50 AM, Administrator revealed she did not collaborate with the physician for initial orders for patient care and a verbal order was sent to obtain orders for care. In an interview on 1/9/2025 at 4:08 PM, Administrator relayed a verbal order was created for a service visit is missed to notify the physician, and the physician was not contacted for the verbal order. During an interview on 1/9/2025 at 9:50 AM, PT 1 relayed the physician was not called for the missed visit verbal orders rather the verbal orders were created to notify the physician. The clinical record for Patient #1 revealed an initial comprehensive assessment, completed on 11/1/2024 by Administrator. The record included a verbal ordered dated 11/1/2024 for a comprehensive assessment, RN visits once a week for 9 weeks plus two extra visits as needed with specified assessments, and PT to evaluate and treat patient; the verbal order dated 11/1/2025 was signed by a physician on 11/19/2024. The verbal order failed to be authenticated by consulting with the physician prior to the physician’s signature. The clinical record for Patient #1 revealed verbal orders, signed by PT 1, to hold PT service visits and resume PT services the following week on 11/29/2024 (signed by a physician 12/12/2024) and 12/7/2024 (signed by a physician on 12/12/2024). A verbal order for a missed visit on 12/24/2024, signed by PT 1, indicated Patient may resume PT visits on 12/26/2024 and was not signed by a physician. The verbal orders failed to evidence authentication by a physician prior to being signed. 3. During an interview on 1/9/2025 at 4:08 PM, Administrator relayed a verbal order was created for a service visit is missed in order to notify the physician, and the physician was not contacted for the verbal order. During an interview on 1/9/2025 at 9:50 AM, PT 1 relayed the physician was not called for the missed visit verbal orders rather the verbal orders were created to notify the physician. During an interview on 1/8/2025 beginning at 11:15 AM, RN 2 relayed that after the initial comprehensive assessment for Patient #2, a physician verbal order was created and sent to the physician to be signed as orders for care. RN 2 relayed that the physician was not consulted for the documentation on the verbal order. The clinical record for Patient #2 revealed an initial assessment completed 10/23/2024 by RN 2. A verbal order dated 10/23/2024 for a comprehensive assessment, RN services once a week for nine weeks plus two visits if needed, with specified assessments and evaluations to provided to Patient; the verbal order included PT services to evaluate and treat. The verbal order was signed by the physician 11/8/2024. The verbal order failed to be authenticated by consulting with the physician prior to the physician’s signature. The clinical record for Patient #2 revealed verbal orders to hold PT service visits and resume PT services the following week on 11/8/2024 (signed by a physician 11/15/2024), 11/29/2024 (signed by a physician 12/9/2024), 12/7/2024 (signed by a physician on 12/13/2024), 12/13/2024 (signed by a physician 12/23/2024), and 12/27/2024 (not signed by a physician as of 1/8/2024), signed by PT 1. The verbal orders failed to evidence authentication by a physician prior to being signed. 4. During an interview on 1/8/2025 beginning at 11:15 AM, RN 2 relayed that after the initial comprehensive assessment for Patient #8, a physician verbal order was created and sent to the physician to be signed as orders for care. RN 2 relayed that the physician was not consulted for the documentation on the verbal order. During an interview on 1/9/2025 at 4:08 PM, Administrator relayed a verbal order is created when a service visit is missed in order to notify the physician, and the physician was not contacted for the verbal order. During an interview on 1/9/2025 at 9:50 AM, PT 1 relayed the physician was not called for the missed visit verbal orders rather the verbal orders were created to notify the physician. The clinical record for Patient #8 revealed an initial assessment completed 11/19/2024 by RN 2. A verbal order dated 11/19/2024 for a comprehensive assessment, RN services once a week for nine weeks plus two visits if needed, with specified assessments and evaluations to provided to Patient, PT services to evaluate and treat, and an HHA once a week for one week then twice a week for eight weeks. The verbal order was signed by the physician 11/26/2024. The verbal order failed to be authenticated by consulting with the physician prior to the physician’s signature. The clinical record for Patient #8 revealed verbal orders to hold PT service visits and resume PT services the following week on 11/23/2024 and 12/6/2024. The verbal orders failed to evidence authentication by a physician. 410 IAC 17-15-1(b)

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review, and interview, the home health agency failed to ensure the home health aide followed the care plan as instructed by the registered nurse for 2 of 2 patient records reviewed with a home health aide, from a total of 4 clinical records reviewed. The findings include: 1. Record review of an undated agency policy titled “Home Health Aide Services” retrieved on 3/31/2022, stated “Policy Home Health Aide [HHA] services will be provided to appropriate clients on an intermittent, part-time or full-time basis, under the direct supervision of an agency Registered Nurse/Therapist in accordance with a medically approved Plan of Treatment … Purpose To abide by state/federal guidelines to the agency staff, physicians, and community for the appropriate utilization of Home Health Aide services … Special Instruction 1. Home Health Aide services may include: a. Providing personal care services including bathing, dressing, feeding, weighing, backrubs, skin care and shampoos as directed by the treatment plan and licensed professional … 3. The Aide will follow the treatment plan and will not initiate new services or discontinue services without contacting the supervising Nurse/therapist … 8. All services provided by the Home Health Aide shall be documented in the clinical record ….” 2. Record review of an undated agency policy titled “Home Health Aide: Documentation” stated “Policy Home health aides will document care/services provided on the home health aide charting form. Care/services provided should be in accordance with direction provided in the Home Health Aide Treatment plan … Purpose To provide documentation of the care performed by the Home Health Aide on each visit … Special Instructions 1. The Home Health Aide shall utilize the appropriate Home Health Aide flow sheet or charting form to document services rendered to the patient ….” 3. Clinical record review on 3/31/2022, for patient #1, start of care 3/4/2022, primary diagnosis of Type 2 diabetes with diabetic neuropathy (pain, weakness, and numbness from damaged nerves), evidenced an untitled agency document that was electronically signed by clinical manager B on 3/4/2022. This document indicated HHA E was the assigned for patient #1, and stated “Check all the [sic] apply: Change to this care plan requires completion of another HH [home health] aide plan …” This document had tasks including but not limited to sponge bath, mouth care, and skin care were assigned. Record review evidenced an agency document titled “Home Health Aide Note” from 3/28/2022, which was electronically signed by HHA E. This document had an area subtitled “Home Health Aide Checklist with Intervention” that stated “… Oral Hygiene ….” Review of this document failed to evidence oral hygiene was selected to indicate the task was completed. Record review failed to evidence the HHA care plan was followed as instructed by the skilled nurse. 4. Clinical record review on 3/31/2022, for patient #4, start of care 4/23/2021, primary diagnosis of chronic obstructive pulmonary disorder (COPD; a condition that involves constriction of the airways and difficulty or discomfort breathing), evidenced an untitled agency document which was electronically signed by alternate clinical manager C on 12/15/2021. This document indicated HHA G was assigned and stated “Check all the [sic] apply: Change to this care plan requires completion of another HH [home health] aide plan …” This document had tasks including but not limited to sponge bath, mouth care, and skin care were assigned. Record review evidenced agency documents titled “Home Health Aide Note” from 2/7/2022, 2/11/2022, and 2/14/2022, that were electronically signed by HHA G. These documents had an area subtitled “Home Health Aide Checklist with Intervention” that stated “… Oral Hygiene ….” Review of these documents failed to evidence oral hygiene was selected to indicate the task was completed. Record review failed to evidence the HHA care plan was followed as instructed by the skilled nurse. 5. During an interview on 3/31/2022, at 1:15 PM, clinical manager B indicated the HHA care plan should state the tasks can be completed per the patient’s request. Clinical manager B indicated if oral care is on the care plan, the HHA should document it was completed.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure all clinicians' documentation was clear and complete to provide an accurate description of the assessment for 1 of 2 closed records reviewed. (#3) The findings include: Record review of an undated agency policy titled “Clinical Documentation” retrieved on 3/31/2022, stated “Policy AMERICAN HOME HEALTH SERVICES, INC., INC. [sic] will document each direct contact with the client. The documentation will be completed by the direct caregivers and monitored by the skilled professional responsible for managing client’s care … Purpose To ensure that there is an accurate record of the services provided, client response, and ongoing need for care … Special Instructions 1. All skilled services provided by Nursing, Therapy, or Social Services will be documented in the clinical record … 3. Additional information that is pertinent to the client’s care or condition may be documented on the Progress Note or Flow Sheet ….” Record review of an undated agency policy titled “Skilled Nursing Services” retrieved on 3/31/2022, stated “Policy Skilled nursing services will be provided by a Registered Nurse … in accordance with a medically approved Plan of treatment (physician’s orders) … Special Instructions 1. The registered nurse: … g. Prepares clinical and progress notes … 3. Skilled nursing activities in the home care setting may include: observation and assessment, teaching and training activities. Management and evaluation of the treatment plan and routine and complex skilled procedures … 4. The nurse will demonstrate competency in providing procedures such as: … c. Documenting and implementing physician orders ….” Clinical record review on 3/31/2022, for patient #3, start of care 8/5/2021, primary diagnosis of type 2 diabetes, evidenced an agency document titled “Skilled Nursing Visit Note” which was electronically signed by Registered Nurse (RN) H on 2/21/2022. This document had an area subtitled “Skin” in which boxes were checked to indicate the patient’s skin was warm, moist, and dry. This area stated “Skin intact, warm to touch; no open wounds or redness; noted +2 edema [swelling caused by excess fluid] on bilateral anklesand [sic] feet , instructed to protect from injury and maintain good skin care ….” Record review evidenced an agency document titled “Skilled Nursing Visit Note” which was electronically signed by RN H on 2/28/2022. This document had an area subtitled “Skin” in which boxes were checked to indicate the patient’s skin was warm, moist, and dry. This area stated, “Skin warm to touch; 2+ edema bilateral ankle and foot ….” Record review evidenced an agency document titled “Skilled Nursing Visit Note” which was electronically signed by RN H on 3/7/2022. This document had an area subtitled “Skin” in which boxes were checked to indicate the patient’s skin was warm, moist, and dry. This area stated, “No skin alterations, open wounds or redness ….” Record review evidenced the patient’s skin was assessed to be moist and dry, which required more explanation for. Record review failed to evidence comments or narrative about the patient’s moist and/or dry skin as indicated in the agency’s policy for pertinent information. Review evidenced contradictory descriptions of the patient’s skin. Record review failed to evidence clear, concise, and accurate documentation of the skin assessment. During an interview on 3/31/2022, at 1:31 PM, clinical manager B indicated RN H probably referred to the patient’s underarms and abdominal folds as moist, and dry for other areas. 410 IAC 17-15-1(a)(7)

An Emergency Preparedness survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: 2/15/2022, 2/16/2022, 2/17/2022, and 2/18/2022. Facility ID: 004699

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on observation, record review, and interview the home health agency failed to develop an emergency preparedness plan that was individualized to the location of the facility (See tag E0004). Ensure a Hazard Vulnerability Analysis (HVA) was conducted to reflect the probability of events that would occur in the location of the agency (See tag E0006). Ensure each patient was provided with an individualized emergency preparedness plan for 3 of 3 clinical records where a home visit was conducted (See tag E0017). Ensure the emergency preparedness plan included the contact information for local officials in the event of an emergency (See tag E0031). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment and resulted in the agency being found out of compliance with the condition 42 CFR 484.102 Emergency preparedness. .

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to develop an emergency preparedness plan that was individualized to the location of the facility. The findings include: Record review of an undated agency document titled “Emergency Management Policy” stated “Policy American Home Health Services, Inc. will have an identified plan in place to insure the safety and well-being of clients and employees during periods of an emergency or disaster that disrupts agency services … The plan considers the agency’s commitment to provide service while ensuring the safety of its employees and clients. The Agency will implement this Emergency Preparedness Policy as soon as the agency becomes aware of the existence of an emergency … An emergency or human made event that significantly disrupts the environment of care … American Home Health Services, Inc. conducts an analysis to identify potential emergencies and the direct and indirect effects these emergencies may have on agency operations and the demand for services … Purpose To establish guidelines for client care during periods of emergency or disaster … To provide direction and instruction for staff to follow in the event of a life-threatening situation that disrupts delivery of home care services … To establish a structure that identifies the agency’s relationship to a community wide emergency management program … Special Instructions 1. Situations that would constitute an emergency include, bur are not limited to: a. Adverse weather such as floods, tornadoes, hurricanes, blizzards, and storms … b. Natural disasters … c. Internal emergencies such as communications systems or utilities failure due to outages of telephone and/or electricity … 3. All staff members and volunteers will be oriented to the emergency preparedness plan and their associated responsibilities … 12. Clients determined to be at risk in their homes would be evacuated to the nearest shelter, if appropriate … 15. An evacuation plan will be developed and communicated to all staff … 16. The emergency plan will identify the links to local community organizations that may be needed to assist the agency in responding to client needs or who may need to utilize agency staff and resources to respond to community needs …." Record review on 2/15/2022, of the agency's emergency preparedness plan, which was a binder the agency stored in the common area of the office for all to have access to the information, as indicated by clinical manager B. The binder evidenced an agency document titled "Internal Disaster Plan" that stated "Command Center ... [Entity A] ..." Another area of the emergency preparedness plan stated "Emergency Preparedness Guidelines: ... Maintain up-to-date contact lists of staff and key agency contacts such as local health unit, local emergency management team (shelter identification), local law enforcement and Regional, [Entity B] staff ..." Another section titled "Communications" stated "External communications: Notification plans to ensure all outside agencies are notified. This requires the maintenance and distribution of an updated list of all key agencies [i.e. [Entity C], if applicable, the [Entity B] (regional), local emergency management services and City/County Emergency Management Office] ..." Another section of the emergency preparedness plan titled "Comprehensive Emergency Management Plan Checklist" stated "Communication ... Up-to-date contact information of key agencies, local emergency management offices, EMS [emergency medical services], law enforcement, and [Entity B] ..." An area of the agency's emergency preparedness plan binder evidenced a section subtitled "Waivers" which stated "During an emergency event, it may be necessary for regulatory bodies to issue waivers to health care providers to temporarily streamline the process and ensure patients have access to care ... It is important to understand that federal waivers: ... (2) do not waive any [Entity B] regulations, waivers for which much [sic] be requested individually through your Regional Department of Health Office ...." Review of the agency's emergency preparedness binder evidenced Entity A, Entity B, and Entity C were not located in the same state or region as American Home Health Services, Inc. Review evidenced multiple references to Entity B, as previously listed. Review failed to evidence the emergency preparedness plan was developed and individualized to meet the emergent needs for the patients being serviced by American Home Health Services, in Merrillville, Indiana. During an interview on 2/18/2022, at 11:03 AM, clinical manager B indicated the emergency preparedness plan should be individualized to the location of American Home Health Services in Merrillville, Indiana.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure a Hazard Vulnerability Analysis (HVA) was conducted to reflect the probability of events that would occur in the location of the agency. The findings include: Record review of an undated agency document titled “Emergency Management Policy” retrieved on 2/18/2022, stated “Policy American Home Health Services, Inc. will have an identified plan in place to insure the safety and well-being of clients and employees during periods of an emergency or disaster that disrupts agency services … An emergency or human made event that significantly disrupts the environment of care … American Home Health Services, Inc. conducts an analysis to identify potential emergencies and the direct and indirect effects these emergencies may have on agency operations and the demand for services … Purpose To establish guidelines for client care during periods of emergency or disaster … To provide direction and instruction for staff to follow in the event of a life-threatening situation that disrupts delivery of home care services … To establish a structure that identifies the agency’s relationship to a community wide emergency management program … Special Instructions 1. Situations that would constitute an emergency include, bur are not limited to: a. Adverse weather such as floods, tornadoes, hurricanes, blizzards, and storms … b. Natural disasters … c. Internal emergencies such as communications systems or utilities failure due to outages of telephone and/or electricity ….” Record review on 2/15/2022, of the agencies emergency preparedness binder evidenced an area subtitled "Hazard Vulnerability Analysis Worksheet" that stated "Instructions: ... Please review each potential event in the worksheet and assign numbers evaluating ... 1) the probability of that event happening ... 2) how disruptive that event happening ... 3) how prepared your agency is ... This worksheet will help you prioritize and develop your plan based on the risks identified ...." Review of the agencies emergency preparedness plan, evidenced agency document titled "Hazard Vulnerability Analysis Worksheet" which was a spreadsheet of all hazards events including, but not limited to flooding, fire, ice/snow and hurricane. The Hazard Vulnerability Analysis Worksheet rated flooding and fire as a low probability, and ice/snow and hurricane as a high probability in the region of Northwest Indiana. Review of the website "www.lakecounty.in.gov" evidenced a link to a document titled "Multi-Hazard Mitigation Plan" which was last updated in December 2018. This document indicated flooding and ice/snow was a severe/high probability, and flooding was a moderate probability. Review of this document failed to evidence hurricane was a probable hazardous event for the areas being serviced by American Home Health Services. Review failed to evidence the Hazard Vulnerability Analysis was individualized to the location of the home health agency and the area where patient's were being serviced. During an interview on 2/18/2022, at 10:59 AM, clinical manager B indicated common hazardous events for the region surrounding the agency included but were not limited to winter weather, tornadoes, and heat waves. The clinical manager indicated hurricanes were not common for Indiana.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure each patient was provided with an individualized emergency preparedness plan for 7 of 7 clinical records where a home visit was conducted. (#1, #2, #3, #4, #5, #6, #7) The findings include: 1. Record review of an undated agency document titled “Emergency Management Policy” retrieved on 2/18/2022, stated “Policy American Home Health Services, Inc. will have an identified plan in place to insure the safety and well-being of clients and employees during periods of an emergency or disaster that disrupts agency services … The plan considers the agency’s commitment to provide service while ensuring the safety of its employees and clients … An emergency or human made event that significantly disrupts the environment of care … Purpose To establish guidelines for client care during periods of emergency or disaster … To provide direction and instruction for staff to follow in the event of a life-threatening situation that disrupts delivery of home care services … Special Instructions 1. Situations that would constitute an emergency include, but are not limited to: a. Adverse weather such as floods, tornadoes, hurricanes, blizzards, and storms … b. Natural disasters … c. Internal emergencies such as communications systems or utilities failure due to outages of telephone and/or electricity … h. Staffing shortages … 12. Clients determined to be at risk in their homes would be evacuated to the nearest shelter, if appropriate … 15. An evacuation plan will be developed and communicated to all staff … 16. The emergency plan will identify the links to local community organizations that may be needed to assist the agency in responding to client needs or who may need to utilize agency staff and resources to respond to community needs ….” 2. Record review of an undated agency policy titled “Plan of Treatment” retrieved on 2/18/2022, stated “Policy Home care services are furnished under the supervision and direction of the clients physician. The plan of treatment is based on a comprehensive assessment and information provided by the client/family and health team members … Purpose To provide guidelines for agency staff to develop a plan of treatment individualized to meet specific identified needs … To reflect client’s ability to make choices and actively participate in establishing and following the plan designated to attain personal health goals … Special Instructions … 2. The Plan of treatment shall be completed in full to include: … o. Instructions to client/caregiver, as applicable … t. Other items such as disaster and emergency preparedness/plan … u. All of the above items must always be addressed on the Plan of treatment … 9. Professional staff should be provided a copy to be reviewed with the patient or patient representative … 3. Observation of a home visit was conducted on 02/16/2022 at 9:00 AM, with patient #1, start of care 01/18/2022, and Home Health Aide (HHA) F. During this home visit at 9:47 AM the patient’s home health agency home folder was reviewed. Review of patient #1’s home folder evidenced general tips and guidelines for weather alerts including but not limited to heatwave, winter storms, and floods. The home folder evidenced a document which indicated areas for the patient or clinician to fill out, to include, phone numbers for emergency contact, physician, DME [durable medical equipment], and pharmacy. The patient’s home folder failed to evidence specific evacuation plans, to include, but not be limited to, transportation and shelter information in the event of an emergency. Clinical record review on 2/18/2022, for patient #1, start of care 1/18/2022, diagnoses include but were not limited to spinal stenosis (narrowing of the spaces within the spine), chronic pain and hypertension (high blood pressure), evidenced an agency document titled “Home Health Certification and Plan of Treatment” for certification period 1/18/2022 – 3/18/2022, which was signed by the physician on 1/20/2022. Review of this document failed to evidence an emergency preparedness/disaster plan, created from the comprehensive assessment as stated in the agency policy. 4. Observation of a home visit was conducted on 02/16/2022 at 3:55 PM, with patient #2, start of care 2/1 2022, and administrator A. During this home visit at 4:37 PM the patient’s home health agency home folder was reviewed. Review of patient #2’s home folder evidenced general tips and guidelines for weather alerts including but not limited to heatwave, winter storms, and floods. The home folder evidenced a document which indicated areas for the patient or clinician to fill out, to include, phone numbers for emergency contact, physician, DME, and pharmacy. The patient’s home folder failed to evidence specific evacuation plans, to include, but not be limited to, transportation and shelter information in the event of an emergency. Clinical record review on 2/18/2022, for patient #2, start of care 2/1/2022, primary diagnosis of hypertension, evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 2/1/2022 - 4/1/2022, which was signed by the physician on 2/10/2022. Review of this document failed to evidence an emergency preparedness/disaster plan, created from the comprehensive assessment as stated in the agency policy. 5. Observation of a home visit was conducted on 02/16/2022 at 9:00 AM, with patient #3, start of care 12/13/2021, and administrator A. During this home visit at 9:20 AM the patient’s home health agency home folder was reviewed. Review of patient #3’s home folder evidenced general tips and guidelines for weather alerts including but not limited to heatwave, winter storms, and floods. The home folder evidenced a document which indicated areas for the patient or clinician to fill out, to include, phone numbers for emergency contact, physician, DME, and pharmacy. The patient’s home folder failed to evidence specific evacuation plans, to include, but not be limited to, transportation and shelter information in the event of an emergency. Clinical record review on 2/18/2022, for patient #3, start of care 12/13/2021, primary diagnosis of spondylosis [age related degeneration of the bones in the spine], evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 12/13/2022 - 2/10/2022, which was signed by the physician on 12/22/2021. Review of this document failed to evidence an emergency preparedness/disaster plan, created from the comprehensive assessment as stated in the agency policy. 6. Clinical record review on 2/18/2022, for patient #4, start of care 1/21/2022, primary diagnosis of hydronephrosis [condition of excess fluid in a kidney due to a backup of urine], evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 1/21/2022 - 3/21/2022, which was signed by the physician on 1/25/2022. Review of this document failed to evidence an emergency preparedness/disaster plan, created from the comprehensive assessment as stated in the agency policy. 7. Clinical record review on 2/18/2022, for patient #5, start of care 1/15/2021, primary diagnosis of osteoarthritis of the right knee (type of arthritis that occurs when flexible tissue at the ends of the bone wears down), evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 1/10/2022 - 3/10/2022, which was signed by the physician on 1/24/2022. Review of this document failed to evidence an emergency preparedness/disaster plan, created from the comprehensive assessment as stated in the agency policy. 8. Clinical record review on 2/18/2022, for patient #6, start of care 10/15/2021, primary diagnosis of dementia, evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 12/14/2021 - 2/11/2022, which was signed by the physician on 12/16/2021. Review of this document failed to evidence an emergency preparedness/disaster plan, created from the comprehensive assessment as stated in the agency policy. 9. Clinical record review on 2/18/2022, for patient #7, start of care 1/12/2021, primary diagnosis of Type 2 Diabetes with hyperglycemia (high blood sugar), evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 9/9/2021 - 11/7/2021, which was signed by the physician on 9/20/2021. Review of this document failed to evidence an emergency preparedness/disaster plan, created from the comprehensive assessment as stated in the agency policy. 10. During an interview on 2/18/2022, at 10:51 AM, when queried where the patient's individualized emergency preparedness plans were kept, administrator A indicated phone numbers for different shelters in the area are in the patient's home folders. Clinical manager B indicated if a patient needed to be relocated, it is usually to the home of the patient's next of kin.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on record review, and interview, the home health agency failed to ensure the emergency preparedness plan included the contact information for local officials in the event of an emergency. The findings include: Record review of an undated agency document titled “Emergency Management Policy” retrieved on 2/18/2022, stated “Policy American Home Health Services, Inc. will have an identified plan in place to insure the safety and well-being of clients and employees during periods of an emergency or disaster that disrupts agency services … The plan considers the agency’s commitment to provide service while ensuring the safety of its employees and clients. The Agency will implement this Emergency Preparedness Policy as soon as the agency becomes aware of the existence of an emergency … Purpose To establish guidelines for client care during periods of emergency or disaster … To provide direction and instruction for staff to follow in the event of a life-threatening situation that disrupts delivery of home care services … To establish a structure that identifies the agency’s relationship to a community wide emergency management program … 12. Clients determined to be at risk in their homes would be evacuated to the nearest shelter, if appropriate …16. The emergency plan will identify the links to local community organizations that may be needed to assist the agency in responding to client needs or who may need to utilize agency staff and resources to respond to community needs ….." Record review was conducted of the agency’s emergency preparedness binder on 02/15/2022. Clinical manager B indicated this binder was stored in an agency common area for staff to review information at their leisure. The emergency preparedness binder failed to evidence the contact information for local officials in the event of an emergency, as required by federal regulations and agency policy. During an interview on 2/18/2022, at 10:51 AM, clinical manager B indicated the information for local emergency officials was not in the emergency preparedness binder at the time of review, but stated "Will get them in there now.”

This survey was a Federal Re-certification, Focused Infection Control and State licensure survey for a home health agency, conducted by the Indiana Department of Health. Survey Dates: 2/15/2022, 2/16/2022, 2/17/2022, and 2/18/2022 Facility ID: 004699 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. American Home Health Services, Inc. is precluded from providing its own home health aide training and competency evaluation for a period of two years from 02/18/2022 - 02/18/2024, due to being found out of compliance with Conditions of Participation 484.70 Infection Prevention and Control. Quality Review Completed 03/09/2022

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the clinical record for each patient was accurate and current for 1of 3 patient home visits conducted. (#1) The findings include: Record review of an undated agency policy titled “Plan of Treatment” retrieved on 2/18/2022, stated “Policy Home care services are furnished under the supervision and direction of the clients physician. The plan of treatment is based on a comprehensive assessment and information provided by the client/family and health team members … The plan will be consistently reviewed to ensure that client needs are met, and will be updated as necessary, but at least every 60 days … Purpose To provide guidelines for agency staff to develop a plan of treatment individualized to meet specific identified needs … Special Instructions … 2. The Plan of treatment shall be completed in full to include: … l. Medications, treatments, and procedures … o. Instructions to client/caregiver, as applicable … u. All of the above items must always be addressed on the Plan of treatment….” Record review of the agency’s home folder on 2/15/2022, evidenced an agency document titled “Patient’s Rights and Responsibilities” which stated “All patients and patients’ representatives of American Home Health Services, Inc. have the right to be informed in advance of the services provided by the Agency and their responsibilities related to home health services. All information shall be provided in a manner understandable to the person … A. Patient’s Rights: As a part of American Home Health Services, you have the right to: 1. Be fully informed in advance about the care and treatment to be furnished including the skilled staff that will furnish the care and the proposed number of visits they will make to your home ….” Observation was conducted of a home visit on 02/16/2022, at 9:00 AM, with patient #1, start of care 01/18/2022, and Home Health Aide (HHA) F. During this home visit patient #1’s home health agency home folder was observed next to a tube of Voltaren gel [Non Steroidal Anti Inflammatory Drug (NSAID) topical gel] and A&D ointment [topical skin protectant containing zinc and dimethicone]. Record review of the home folder at 9:47 AM evidenced a document titled “Medication Profile” which failed to indicate the patient’s use of Voltaren gel and A&D ointment. Review of the patient’s medication profile failed to evidence the topical ointments evidenced in his/her home. Clinical record review on 2/18/2022, for patient #1, diagnoses include but were not limited to spinal stenosis (narrowing of the spaces within the spine), chronic pain and hypertension (high blood pressure), evidenced an agency document titled “Home Health Certification and Plan of Treatment” for certification period 1/18/2022 – 3/18/2022, which was signed by the physician on 1/20/2022. This document had an area subtitled “10. Medications: Dose/Frequency/Route …” which failed to evidence Voltaren gel and A&D ointment listed. Record review of an agency document titled "Medication Profile" which was received on 2/15/2022, and was indicated to be a list of the patient's active medications. This document indicated the patient was taking Voltaren topical gel twice a day to the left knee, as needed for pain. Review of the clinical record failed to evidence A&D topical ointment. During an interview on 2/18/2022, at 11:43 AM, clinical manager B indicated patients are made aware of medication instructions from the medication list in the home and reviewed with the patient at every visit. During an interview on 2/18/2022, at 11:49 AM, clinical manager B indicated Voltaren gel and A&D ointment were recently added for the patient. 410 IAC 17-14-1(a)(1)(B)

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review, and interview, the home health agency failed to ensure the plan of care contained patient specific indications for all medications prescribed for 6 of 7 clinical records reviewed. (#1, #2, #3, #4, #6, #7) The findings include: 1. Record review of an undated agency policy titled “Plan of Treatment” retrieved on 2/18/2022, stated “Policy Home care services are furnished under the supervision and direction of the clients physician. The plan of treatment is based on a comprehensive assessment and information provided by the client/family and health team members … The plan will be consistently reviewed to ensure that client needs are met, and will be updated as necessary, but at least every 60 days … Purpose To provide guidelines for agency staff to develop a plan of treatment individualized to meet specific identified needs … To reflect client’s ability to make choices and actively participate in establishing and following the plan designated to attain personal health goals … Special Instructions … 2. The Plan of treatment shall be completed in full to include: … c. Type, frequency, and duration of all visits/services … l. Medications, treatments, and procedures … o. Instructions to client/caregiver, as applicable … u. All of the above items must always be addressed on the Plan of treatment … 4. Orders for therapy services shall include the specific procedures and modalities to be used and the amount, frequency, and duration … 9. Professional staff should be provided a copy to be reviewed with the patient or patient representative … 11. The PRN [as needed] orders will be accompanied by a description of the client’s needs that could warrant a visit….” 2. Clinical record review on 2/18/2022, for patient #1, start of care 1/18/2022, diagnoses include but were not limited to spinal stenosis (narrowing of the spaces within the spine), chronic pain and hypertension (high blood pressure). Review evidenced an agency document titled “Home Health Certification and Plan of Treatment” for certification period 1/18/2022 – 3/18/2022, which was signed by the physician on 1/20/2022. This document had an area subtitled “10. Medications: Dose/Frequency/Route …” which stated “Acetaminophen [Non-Steroidal Anti-Inflammatory Drug (NSAID) used to treat mild to moderate pain and fevers] 325 MG [milligram] 1-2 tablet-every 6 hours as needed … Furosemide [diuretic medication to treat fluid retention and swelling caused by heart failure and other medical conditions] 40 MG 1 tab [tablet]- daily PRN [as needed] …” An area subtitled “21. Orders For Discipline and Treatment (Specify Amount/Frequency/Duration)” stated “… Skilled Nursing: … SN [skilled nurse] to perform medication review each skilled nursing visit and reconcile medications as indicated, SN to instruct on all new and changed medications and teach medication regimen as to use/ indication, dosage, frequency, side effects and adverse reactions as part of the disease process, and/ or demonstration of knowledge deficit as it relates to management of medications ... SN to instruct patient/ caregiver regarding, recording and reporting pain; strategies to mitigate pain including nonpharmacological measures such as positioning, massage, visualization, distraction, warm compress, and when to use pain medication- Acetaminophen (Tylenol) to maximize therapeutic effectiveness … SN to instruct patient on disease process & symptom management of the essential (primary) hypertension, chronic venous hypertension with ulcer of left lower leg, and history of TIA [transient ischemic attack; stroke-like attack] teach regarding importance of compliance to dietary measures- low fat low cholesterol no added salt heart healthy diet- to avoid salty, cured processed food, exercise regimen and medication education & management- daily doses of metoprolol succinate [medication used to treat hypertension] & Furosemide ....." Record review failed to evidence indications for acetaminophen and furosemide to be taken as needed. Review failed to evidence the plan of care was individualized to the patient’s needs. 3. Clinical record review on 2/18/2022, for patient #2, start of care 2/1/2022, primary diagnosis of hypertension, evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 2/1/2022 - 4/1/2022, which was signed by the physician on 2/10/2022. This document had an area subtitled “Medications: Dose/Frequency/Route …” which stated “Tylenol Caplet Extra Strength 500 MG 2 tabs daily PRN ...” An area subtitled “21. Orders For Discipline and Treatment (Specify Amount/Frequency/Duration)” stated “… Skilled Nursing: … SN to perform medication review each skilled nursing visit and reconcile medications as indicated, SN to instruct on all new and changed medications and teach medication regimen as to use/ indication, dosage, frequency, side effects and adverse reactions as part of the disease process, and/ or demonstration of knowledge deficit as it relates to management of medications ... SN to instruct patient/ caregiver regarding … recording and reporting pain; strategies to mitigate pain including nonpharmacological measures such as positioning, massage, visualization, distraction, warm compress, and when to use pain medication Tylenol ES [extra strength] to maximize therapeutic effectiveness....." Record review failed to evidence indications for acetaminophen to be taken as needed. Review failed to evidence the plan of care was individualized to the patient’s needs. 4. Clinical record review on 2/18/2022, for patient #3, start of care 12/13/2021, primary diagnosis of spondylosis [age related degeneration of the bones in the spine], evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 12/13/2022 - 2/10/2022, which was signed by the physician on 12/22/2021. This document had an area subtitled “Medications: Dose/Frequency/Route …” which stated “Hydrocodone-Acetaminophen (Norco) [opioid pain medication combined with NSAID medication used to treat moderate to severe pain] 5 - 325 mg [5 mg hydrocodone - 325 mg acetaminophen] 2 tabs- as directed ... Acetaminophen (Tylenol) 325 mg every 4 hours as needed ..." An area subtitled “21. Orders For Discipline and Treatment (Specify Amount/Frequency/Duration)” stated “… Skilled Nursing: … SN to perform medication review each skilled nursing visit and reconcile medications as indicated, SN to instruct on all new and changed medications and teach medication regimen as to use/ indication, dosage, frequency, side effects and adverse reactions as part of the disease process, and/ or demonstration of knowledge deficit as it relates to management of medications ... SN to instruct patient/ caregiver regarding, recording and reporting pain; strategies to mitigate pain including nonpharmacological measures such as positioning, massage, visualization, distraction, warm compress, and when to use pain medication – Hydrocodone- Acetaminophen (Norco) & Acetaminophen (Tylenol) ....." Record review failed to evidence indications for Hydrocodone-Acetaminophen and acetaminophen to be taken as needed. Review failed to evidence the plan of care was individualized to the patient’s needs. 5. Clinical record review on 2/18/2022, for patient #4, start of care 1/21/2022, primary diagnosis of hydronephrosis [condition of excess fluid in a kidney due to a backup of urine], evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 1/21/2022 - 3/21/2022, which was signed by the physician on 1/25/2022. This document had an area subtitled “Medications: Dose/Frequency/Route …” which stated “Melatonin [a hormone released at night and associated with the control of sleep-wake cycle; supplement] 5 mg 1 tab @ [at] bedtime as needed ..." An area subtitled “21. Orders For Discipline and Treatment (Specify Amount/Frequency/Duration)” stated “… Skilled Nursing: … SN to perform medication review each skilled nursing visit and reconcile medications as indicated, SN to instruct on all new and changed medications and teach medication regimen as to use/ indication, dosage, frequency, side effects and adverse reactions as part of the disease process, and/ or demonstration of knowledge deficit as it relates to management of medications ... SN to instruct regarding importance of compliance to … Melatonin ...." Review failed to evidence indications for for the need of Melatonin documented on the plan of care. Review failed to evidence the plan of care was individualized to the patient’s needs. 6. Clinical record review on 2/18/2022, for patient #6, start of care 10/15/2021, primary diagnosis of dementia, evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 12/14/2021 - 2/11/2022, which was signed by the physician on 12/16/2021. This document had an area subtitled “Medications: Dose/Frequency/Route …” which stated “... Nystatin [antifungal medication] Topical Cream ... twice a day as needed ... Nystatin Powder 1 application - twice a day as needed ..." An area subtitled “21. Orders For Discipline and Treatment (Specify Amount/Frequency/Duration)” stated “… Skilled Nursing: … SN to perform medication review each skilled nursing visit and reconcile medications as indicated, SN to instruct on all new and changed medications and teach medication regimen as to use/ indication, dosage, frequency, side effects and adverse reactions as part of the disease process, and/ or demonstration of knowledge deficit as it relates to management of medications ...." Record review failed to evidence indications for indications for Nystatin topical cream and Nystatin powder, as well as where they were to be applied. Review failed to evidence the plan of care was individualized to the patient’s needs. 7. Clinical record review on 2/18/2022, for patient #7, start of care 1/12/2021, primary diagnosis of Type 2 Diabetes with hyperglycemia (high blood sugar), evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 9/9/2021 - 11/7/2021, which was signed by the physician on 9/20/2021. This document had an area subtitled “Medications: Dose/Frequency/Route …” which stated “Lomotil (Diphenoxylate-Atrop) [used to treat diarrhea] ... four times a day as needed ... Imodium A-D [used to treat diarrhea] ... 1 tab - BID [twice daily] PRN ... Tramadol [narcotic medication used to treat moderate to severe pain] ... 1 tab- BID PRN ... Cyclobenzaprine [medication used to treat pain and stiffness caused by muscle spasms] ... 1 tab - three times a day as needed ...." Record review failed to evidence indications for Lomotil, Imodium, Tramadol, and Cyclobenzaprine to be taken as needed. Review failed to evidence the plan of care was individualized to the patient’s needs. 8. During an interview on 2/18/2022, at 11:49 AM, clinical manager B indicated why and when a patient should take a PRN medication should be included on the plan of care. The clinical manager indicated the indications for all PRN medications should be on the plan of care addendums. Review failed to evidence instructions and indications for all PRN medications on the patient's plan of care. 410 IAC 17-13-1(a)(1)(D)(i-xiii)

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the plan of care was revised to reflect the most current frequencies and durations for all disciplines for 4 of 4 patients who received PT [physical therapy] services, from a total of 5 active clinical records reviewed. (#1, #2, #3, #4) The findings include: 1. Record review of an undated agency policy titled “Plan of Treatment” retrieved on 2/18/2022, stated “Policy Home care services are furnished under the supervision and direction of the clients physician. The plan of treatment is based on a comprehensive assessment and information provided by the client/family and health team members … The plan will be consistently reviewed to ensure that client needs are met, and will be updated as necessary, but at least every 60 days … Purpose To provide guidelines for agency staff to develop a plan of treatment individualized to meet specific identified needs … Special Instructions … 2. The Plan of treatment shall be completed in full to include: … c. Type, frequency, and duration of all visits/services … l. Medications, treatments, and procedures … o. Instructions to client/caregiver, as applicable … u. All of the above items must always be addressed on the Plan of treatment … 4. Orders for therapy services shall include the specific procedures and modalities to be used and the amount, frequency, and duration ….” 2. Clinical record review on 2/18/2022, for patient #1, start of care 1/18/2022, diagnoses include but were not limited to spinal stenosis (narrowing of the spaces within the spine), chronic pain and hypertension (high blood pressure), evidenced an agency document titled “Home Health Certification and Plan of Treatment” for certification period 1/18/2022 – 3/18/2022, which was signed by the physician on 1/20/2022. This document had an area that stated “Frequency and Duration: SN [skilled nurse] 1 wk 9 wk(s) [once a week, for 9 weeks] …” An area subtitled “21. Orders For Discipline and Treatment (Specify Amount/Frequency/Duration)” stated “For PT [physical therapy] evaluation and treatment …." Review evidenced the plan of care signed by the physician, ordered SN and PT services to visit the patient. Review failed to evidence frequency and duration of PT skilled services. Review of an agency document titled "Physician Telephone/Verbal Order" from 1/27/2022, and was signed by the physician on 1/31/2022. This document stated "May provide HHaide [home health aide] services: 2x/week x 7 weeks [twice a week for 7 weeks] ... To start next week per patient request ....." Review evidenced an order for home health aide services after the patient's start of care. Review of the agency's EMR [electronic medical record] on 2/18/2022, evidenced an area that indicated the frequencies and duration of services for SN and home health aide. Review of the EMR failed to evidence frequency and duration for PT services. Clinical record review failed to evidence the plan of care was revised to include the current frequency and duration for every discipline. 3. Clinical record review on 2/18/2022, for patient #2, start of care 2/1/2022, primary diagnosis of hypertension, evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 2/1/2022 - 4/1/2022, which was signed by the physician on 2/10/2022. This document had an area that stated “Frequency and Duration: SN [skilled nurse] 1 wk 9 wk(s) …” An area subtitled “21. Orders For Discipline and Treatment (Specify Amount/Frequency/Duration)” stated “PT to evaluate and treat ... For Physical Therapy ... For re-evaluation and to continue treatment for functional deficit; To teach body mechanics and use of supportive devices/equipment for home safety; To teach safety measures and therapeutic exercises for transfer and gait balance, strengthen muscles and joints to increase range of motion (ROM), mobility and decrease pain; provide education based on deficits; and to teach home exercise program …." Review evidenced the plan of care signed by the physician, ordered SN and PT services to visit the patient. Review failed to evidence frequency and duration of PT skilled services. Review of the agency's EMR on 2/18/2022, evidenced an area that indicated the frequencies and duration for SN services. Review of the EMR failed to evidence frequency and duration for PT services. Clinical record review failed to evidence the plan of care was revised to include the current frequency and duration for every discipline. 4. Clinical record review on 2/18/2022, for patient #3, start of care 12/13/2021, primary diagnosis of spondylosis [age related degeneration of the bones in the spine], evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 12/13/2022 - 2/10/2022, which was signed by the physician on 12/22/2021. This document had an area that stated “Frequency and Duration: SN 1 wk 1 wk(s) [once a week for one week], SN 2 wk 8 wk(s) [twice a week, for 8 weeks] …” An area subtitled “21. Orders For Discipline and Treatment (Specify Amount/Frequency/Duration)” stated “For PT to evaluation and treatment ... For Physical Therapy ... Evaluation and treatment for functional deficit; To teach body mechanics and use of supportive devices/equipment for home safety; To teach safety measures and therapeutic exercises for transfer and gait balance, strengthen muscles and joints to increase range of motion (ROM), mobility and decrease pain; provide education based on deficits; and to teach home exercise program (HEP) …." Review evidenced the plan of care signed by the physician, ordered SN and PT services to visit the patient. Review failed to evidence frequency and duration of PT skilled services. Record review of an agency document titled "Home Health Certification and Plan of Treatment" for certification period 2/11/2022 - 4/11/2022, which was not yet signed by the physician. This document stated “Frequency and Duration: SN [skilled nurse] 1 wk 8 wk(s) [once a week for 8 weeks] …” An area subtitled “21. Orders For Discipline and Treatment (Specify Amount/Frequency/Duration)” stated “PT to re-evaluate and treat ... For Physical Therapy ... Re-evaluation and to continue treatment for functional deficit; To teach body mechanics and use of supportive devices/equipment for home safety; To teach safety measures and therapeutic exercises for transfer and gait balance, strengthen muscles and joints to increase range of motion (ROM), mobility and decrease pain; provide education based on deficits; and to teach home exercise program …." Review failed to evidence frequency and duration of PT skilled services. Review of the agency's EMR on 2/18/2022, evidenced an area that indicated the frequencies and duration for SN services. Review of the EMR failed to evidence frequency and duration for PT services. Clinical record review failed to evidence the plan of care was revised to include the current frequency and duration for every discipline. 5. Clinical record review on 2/18/2022, for patient #4, start of care 1/21/2022, primary diagnosis of hydronephrosis [condition of excess fluid in a kidney due to a backup of urine], evidenced an agency document titled "Home Health Certification and Plan of Treatment" for certification period 1/21/2022 - 3/21/2022, which was signed by the physician on 1/25/2022. This document had an area that stated “Frequency and Duration: SN 1 wk 9 wk(s) …” An area subtitled “21. Orders For Discipline and Treatment (Specify Amount/Frequency/Duration)” stated “PT to evaluate and treat ... For Physical Therapy ... Evaluation and treatment for functional deficit; To teach body mechanics and use of supportive devices/equipment for home safety; To teach safety measures and therapeutic exercises for transfer and gait balance, strengthen muscles and joints to increase range of motion (ROM), mobility and decrease pain; provide education based on deficits; and to teach home exercise program …." Review evidenced the plan of care signed by the physician, ordered SN and PT services to visit the patient. Review failed to evidence frequency and duration of PT skilled services. Review of the agency's EMR on 2/18/2022, evidenced an area that indicated the frequencies and duration for SN services. Review of the EMR failed to evidence frequency and duration for PT services. Clinical record review failed to evidence the plan of care was revised to include the current frequency and duration for every discipline. 6. During the entrance conference on 2/15/2022, at 10:25 AM, clinical manager B stated the agency considers the Plan of Care to be "The 485 [Home Health Certification and Plan of Care] that is signed and dated by the physician" and indicated revisions would be detailed in the EMR. 7. During an interview on 2/18/2022, at 11:45 AM, clinical manager B indicated discipline frequencies and durations would be on the plan of care or in the EMR system, documented under "Frequency/Duration."

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure each patient was provided a written visit schedule for 2 of 3 patient home visits conducted. (#2, #3) The findings include: 1. Record review of the agency’s home folder on 2/15/2022, evidenced an agency document titled “Patient’s Rights and Responsibilities” which stated “All patients and patients’ representatives of American Home Health Services, Inc. have the right to be informed in advance of the services provided by the Agency and their responsibilities related to home health services. All information shall be provided in a manner understandable to the person … A. Patient’s Rights: As a part of American Home Health Services, you have the right to: 1. Be fully informed in advance about the care and treatment to be furnished including the skilled staff that will furnish the care and the proposed number of visits they will make to your home … 9. Be informed upon initial evaluation visit, before the initiation of treatment, and or upon request, a listing of all individuals furnishing care ….” 2. An observation of a home visit was conducted on 2/16/2022, at 3:55 PM, for patient #2, start of care 2/1/2022, and administrator/physical therapist (PT) A. At 4:37 PM, the patient's home folder was reviewed for the required information and failed to evidence the frequencies for PT services provided by the agency. Review failed to evidence the patient was provided with a written schedule of all disciplines and frequencies being provided by the agency. 3. An observation of a home visit was conducted on 2/17/2022, at 9:00 AM, for patient #3, start of care 12/13/2021, and Registered Nurse (RN) G. At 9:20 AM, the patient's home folder was reviewed for the required information and failed to evidence the frequencies for skilled nursing services provided by the agency. Review failed to evidence the patient was provided with a written schedule of all disciplines and frequencies being provided by the agency. 4. During an interview on 2/18/2022, at 11:43 AM, administrator A indicated patients are made aware of the disciplines and frequencies that would provide care upon admission and reviewed at every visit. She also indicated staff should write the days next to the clinician's name they plan to be in the patient's home.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure each patient was provided a current and complete written medication list with instructions for 1 of 3 patient home visits conducted. (#1) The findings include: Record review of the agency’s home folder on 2/15/2022, evidenced an agency document titled “Patient’s Rights and Responsibilities” which stated “All patients and patients’ representatives of American Home Health Services, Inc. have the right to be informed in advance of the services provided by the Agency and their responsibilities related to home health services. All information shall be provided in a manner understandable to the person … A. Patient’s Rights: As a part of American Home Health Services, you have the right to: 1. Be fully informed in advance about the care and treatment to be furnished including the skilled staff that will furnish the care and the proposed number of visits they will make to your home ….” During an observation of a home visit on 2/16/2022, at 9:00 AM, for patient #1, start of care 1/18/2022, and Home Health Aide (HHA) F was observed providing a bath. On a coffee table near the television, the patients home folder was evidenced next to a tube of Voltaren gel [over the counter (OTC) Non Steroidal Anti Inflammatory Drug (NSAID) topical gel] and A&D ointment [topical skin protectant containing zinc and dimethicone]. At 9:47 AM, the patient's home folder was reviewed for the required information and evidenced a document titled "Medication Profile" which failed to evidence Voltaren gel and A&D ointment. Review evidenced medicated topical ointments in the patient's home that were not on the medication list provided by the agency. Review failed to evidence the patient had a medication list with instruction for all medications. During an interview on 2/18/2022, at 11:43 AM, clinical manager B indicated patients are made aware of medication instructions from the medication list in the home and reviewed with the patient at every visit. During an interview on 2/18/2022, at 11:49 AM, clinical manager B indicated Voltaren gel and A&D ointment were recently added for the patient.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure each patient was provided information about the treatments and services being provided for 3 of 3 patient home visits conducted. (#1, #2, #3) The findings include: 1. Record review of the agency’s home folder on 2/15/2022, evidenced an agency document titled “Patient’s Rights and Responsibilities” which stated “All patients and patients’ representatives of American Home Health Services, Inc. have the right to be informed in advance of the services provided by the Agency and their responsibilities related to home health services. All information shall be provided in a manner understandable to the person … A. Patient’s Rights: As a part of American Home Health Services, you have the right to: 1. Be fully informed in advance about the care and treatment to be furnished including the skilled staff that will furnish the care and the proposed number of visits they will make to your home … 9. Be informed upon initial evaluation visit, before the initiation of treatment, and or upon request, a listing of all individuals furnishing care ….” 2. An observation of a home visit was conducted on 2/16/2022, at 9:00 AM, for patient #1, start of care 1/18/2022. At 9:47 AM, the patient's home folder was reviewed for the required information including but not limited to patient #1's schedule, medication list, and plan of treatment. The home folder failed to evidence a plan of treatments being provided by the agency. 3. An observation of a home visit was conducted on 2/16/2022, at 3:55 PM, for patient #2, start of care 2/1/2022. At 4:37 PM, the patient's home folder was reviewed for the required information including but not limited to patient #2's schedule, medication list, and plan of treatment. The home folder failed to evidence a plan of treatments being provided by the agency. 4. An observation of a home visit was conducted on 2/17/2022, at 9:00 AM, for patient #3, start of care 12/13/2021. At 9:20 AM, the patient's home folder was reviewed for the required information including but not limited to patient #3's schedule, medication list, and plan of treatment. The home folder failed to evidence a plan of treatments being provided by the agency. 5. During an interview on 2/18/2022, at 11:43 AM, administrator A indicated the patients are made aware of the treatments and services being provided by the agency upon admission and reviewed at every visit.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure all clinicians practiced standard precaution to prevent the transmission of infectious and communicable diseases during patient care (See tag G0682), develop and implement policies and procedures to ensure that all staff are fully vaccinated against COVID-19 (See tag G0687). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.70 Infection Control.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure all clinicians practiced standard precaution to prevent the transmission of infectious and communicable diseases during patient care in 1 of 1 home visit with a home health aide (HHA). (HHA F) The findings include: Record review of an undated agency policy titled “Infection Prevention and Control Program” retrieved on 2/18/2022, stated “Policy 1. The Agency has a program, defined and overseen by the state, federal and local laws and guidelines … 2. The Agency’s program will focus on: … a. Prevention … b. Control … Purpose The Agency will maintain and document an infection control program which has its goal, the prevention and control of infections and communicable diseases … Procedure for Infection Prevention … 2. Standard Precautions will be used to prevent transmission of infectious agents … Definition: a. Standard precautions are a group of infection practices that apply to all patients regardless of suspected or confirmed infection status when health care is delivered. b. Standard precautions are based on the principle that blood, body fluids, secretions, excretions, may contain transmissible infectious agents … 3. The following are six elements identified by the Center for Disease Control and Prevention which will be applied during an episodes of patient care … a. Hand Hygiene … d. Appropriate use of personal protective equipment … 4. Hand Hygiene/Washing should be performed at a minimum: a. Before contact with a patient … c. After contact with the patient or objects in the immediate vicinity of the patient … d. After contact with blood, body fluids or contaminated surfaces … e. Moving from contaminated body site to a clean body site during patient care … f. After removal of personal protective equipment (PPE) …." Record review of an undated agency policy titled “Standard Precautions” retrieved on 2/18/2022, stated “Policy Blood and body fluid precautions will be followed for all patients … Purpose To prevent transmission of communicable diseases … Procedure … 2. The principles of Standard Precautions are to be followed by all employees when contacting any such substances or areas. Standard Precautions include the following procedures: … Gloves will be changed, and hands washed after contact with each patient …." Record review of an undated agency policy titled “Hand Hygiene” retrieved on 2/18/2022, stated “Policy Hand hygiene will be done by all employees to reduce the transfer of microbes to patients and to prevent the growth of microorganisms on the nails, hands, and forearms … Purpose To prevent transfer of germs and transmission of infections to patients and caregivers … Procedure 1. Indications for hand hygiene are: … Before and after direct care … Before and after each procedure … When hands are soiled … After any contact with contaminated materials … Before re-entering nursing bag or patient’s clean supplies … 2. All employees are responsible for implementing hand hygiene procedures in an ongoing attempt to prevent and/or contain infectious processes and communicable diseases ….” During an observation of a home visit on 2/16/2022, at 9:00 AM, HHA F was observed providing a sponge bath to patient #1, start of care 1/18/2022. At 9:18 AM, HHA F transferred the patient from the recliner chair to the rollator walker seat. HHA F placed a protective pad onto the seat of the recliner chair and placed a towel on the floor in front of the chair. Then, HHA F removed their gloves and donned a new pair, without performing hand hygiene in between, and pushed the patient into a small bathroom, next to the sink. At 9:23 AM, HHA F covered the patient with towel for privacy, then wiped the patients face with a warm washcloth twice, then cleaned the inside of the patients ears. HHA F applied lotion to the patient's face, wearing the same pair of gloves. At 9:27 AM, patient #1 leaned forward and HHA F wiped their back twice, applied lotion, covered with a towel and sat the patient back up. At 9:29 AM, HHA F wiped under the patient's neck, bilateral arms, underarms, and covered the patient with a towel. Then HHA F applied lotion to the bilateral arms, hands, under breasts, and removed gloves. At 9:33 AM, HHA F donned new gloves, did not hand sanitize in between glove changes, and applied deodorant to the patient's underarms. At 9:35 AM, HHA F removed the patients socks and compression stocking, removed her gloves and then donned a new pair without performing hand hygiene in between glove changes. HHA F wiped the bilateral lower extremities from above the knee to the feet and toes, then wiped the same areas dry. At 9:39 AM, HHA F applied lotion the the bilateral lower extremities, then removed gloves and donned a new pair without performing hand hygiene in between. At 9:50 AM, HHA F applied clean socks and cut a new compression stocking to fit the patient's left calf. HHA F removed her gloves, used alcohol based hand rub (ABHR), and applied a new brief to the patient without gloves on. Observation failed to evidence the HHA performed hand hygiene in between every glove change. Observation failed to evidence the HHA changed gloves after moving from dirty area task to a clean area. Observation failed to evidence the HHA practiced standard precautions during patient care per the agency policy. During an interview on 2/18/2022, at 11:41 AM, clinical manager B indicated the agency policy for hand washing was scrubbing with soap and water for 30 seconds, or with hand sanitizer. Hand hygiene should be performed every time there is a dirty to clean process, and in-between glove changes. During an interview on 2/18/2022, at 11:47 AM, administrator A indicated they would expect every clinician to perform hand hygiene after taking off their gloves. 410 IAC 17-12-1(m)

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 (HHA) failed to develop and implement policies and procedures to ensure that all staff are fully vaccinated against COVID-19. The findings include: Record review of an undated agency policy titled “Infection Control Plan” retrieved on 2/18/2022, stated “Policy The Agency has developed and implemented infection control practices that conform to OSHA [Occupational Safety and Health Administration] regulations, CDC [Center for Disease Control and Prevention] guidelines, the Joint Commission requirements, state and local regulations and currently accepted standard of practice. The Clinical Manager is assigned responsibility for the management of infection prevention and control activities … Purpose To prevent or decrease the exposure of patients and employees to diseases and infections and to establish and maintain a surveillance program of identifying, reporting, and analyzing infections … Procedure 1. The Agency Infection Control Plan conforms to OSHA regulations, CDC guidelines, the Joint Commission requirements, state and local regulations and currently accepted standards of practice … Provides record keeping in accordance with regulations … Establishes policies/procedures that will reduce the spread of infections to employees and patients … Monitors staff adherence to recommended policies, procedures, and protective measures. When monitoring reveals to follow recommended precautions: … Counseling, education and/or retraining will be provided … If necessary, appropriate disciplinary action will be taken … Screens staff as required by law and regulation for exposure and/or immunity to infectious diseases that staff may come in contact with … Refers staff who are exposed to or who potentially have an infectious disease to physicians for assessment, testing, prophylaxis treatment, counseling, and/or immunization ….” Record review of an undated agency policy titled “Surveillance Strategy” retrieved on 2/18/2022, stated “American Home Health Serviuces [sic], Inc Shall collaborate with public health and private partners on tracking and reporting identified COVID 19 patients on regular data collection of visiting staff and timely documentation … Purpose … The aim of surveillance for COVID-19 is to limit the spread of disease … to diagnose and manage patients with other respiratory infections … To guide control measures, such as social distancing … To provide more complete estimate of how common COVID-19 is (or the incidence of infection) … Staff Practice: Monitor temperature daily prior to visits … Wearing of mask (and PPE if the patient is positive for COVID 19) ….” Record review of agency policies failed to evidence the required components for COVID-19 vaccination mandates including, but not limited to who is affected by the mandate, procedures to follow, religious/medical exemptions, tracking and securely documenting COVID-19 related information, and a contingency plan for staff that is not fully vaccinated. Personnel record review on 2/18/2022, evidenced the agency had 10 of 11 employees that were fully vaccinated. Record review evidenced 1 employee had not begun the vaccination series. Record review failed to evidence religious/medical exemptions for unvaccinated staff. Record review failed to evidence 100% staff compliance of the COVID-19 Vaccination mandate. During the entrance conference on 2/15/2022, at 10:25 AM, clinical manager B indicated the agency required staff to be vaccinated for COVID-19. During an interview on 2/18/2022, at 11:27 AM, clinical manager B indicated the unvaccinated employee did not have a religious or medical exemption, it was a personal preference. During an interview on 2/18/2022, at 11:31 AM, clinical manager B indicated there was not a policy adopted or developed by the agency in regards to the COVID-19 vaccine, but since it is mandated, they will put one in.

Documentation of competency evaluation CFR(s): 484.80(c)(5) The HHA must maintain documentation which demonstrates that the requirements of this standard have been met. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure every home health aide (HHA) was competent in the required categories prior to patient contact for 1 of 2 HHA personnel records reviewed. (HHA F) The findings include: Review of an undated, agency policy titled “Competency Evaluation of Home Care Staff” retrieved on 2/18/2022, stated “Policy 1. The agency will establish a program that allows for objective, measurable, assessment of the person’s ability to perform required activities. Individuals working in the agency must be licensed, registered or certified as required by law , policy or standards of practice. 2. The assessment will verify and focus on the individual staff knowledge and skill appropriate to assigned responsibilities, communication skills, and the ability to respond to client needs within their scope of responsibility. a. Competencies will address: b. Age/type of client … c. Scope of services offered by Agency … d. High risk procedures … 3. Competency evaluations will be completed by individuals who have the knowledge and skills to assess performance and ability … 4. All competencies will be documented, and actions will be taken when opportunities for improvement are identified … Purpose To assure the personnel providing services to home care clients are trained, competent and able to respond to needs of clients in safe effective manner … Special Instructions 1. All new employees will be assessed for competency based on the expected requirements for the position. The qualifications for the positions will be identified in the position description given at time of hire … 2. Skills tests including written tests and direct observation of skill will be completed as determined by the agency policies and individual assessments. Certifications or verification of skill from other employers will be considered in determining competency … Home Health Aide Competency: … 3. A Home Health Aide will not be permitted to provide Home Health Aide services until evidence of adequate training and/or competency has been determined by the designated professional in the agency … 4. … b. Successful completion of a competency evaluation program. The Home Health Aide will have successfully completed the competency evaluation program if he/she demonstrates competency in a minimum of eleven of the twelve areas required in federal guidelines ... 9. Documentation of the individual Home Health Aide training and/or competency shall be maintained in the Home Health Aide’s personnel file ….” Personnel record review on 2/18/2022, for HHA F, date of hire 4/17/2014, evidenced a first patient contact date of 4/21/2014 and failed to evidence documentation of a written test competency. Record review failed to evidence documentation of HHA F successfully completed a test competency prior to patient contact per the agency’s policy. During an interview on 2/18/2022, at 11:09 AM, administrator A and clinical manager B indicated HHA's have a test competency on the date of hire. During an interview 2/18/2022, at 11:19 AM, administrator A indicated they were looking through HHA F's old file for the test competency and would submit for review when found. During the exit conference on 2/18/2022, at 1:04 PM, employee D, office manager, indicated there was no additional information to submit for review. 410 IAC 17-14-1(l)(2)