Lasik Home Health Care Inc.

“Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure care coordination with other entities/disciplines providing care for 2 of 3 clinical records reviewed. (Patient #17, 19) The findings include: 1. A clinical record review for Patient #19 evidenced a comprehensive assessment at the SOC on 01/20/2026 which indicated Patient lived alone around the clock and had primary diagnosis was chronic respiratory failure, required 6 liters per minute of oxygen via nasal cannula (plastic tubing inserted into the nose to deliver oxygen). The assessment indicated Patient required assistance with meal set-up, bathing, incontinence care, dressing, ambulating, and grooming due to shortness of breath, high risk for falls, weakness, and requiring frequent breaks between activities of daily living. The assessment indicated the agency would provide services 8 hours a day, 7 days a week. An authorization for HHA services dated 02/01/2026 from Patient’s payer source (non-Medicare government insurance) evidenced Patient was authorized to receive 40 hours a week of HHA services. A communication note dated 02/10/2026 indicated the agency informed Patient that HHA services were to be provided 3:00 PM-11:00 PM Monday through Friday and failed to coordinate care with the Patient for how needs were to be met during the day. A communication note dated 02/26/2026 indicated the agency was to provide HHA services 8:00 AM to 12:00 PM Monday through Friday and Entity 12 would provide services on the weekends. The visit schedule indicated the agency scheduled HHA services on Saturdays 03/07/2026 and 03/14/2026. The visit schedule provided by Entity 12 indicated Entity 12 provided attendant and homemaker services every Saturday from 7:00 AM to 8:30 PM. The service plan from Entity 12 indicated the attendant was to assist with bathing, dressing, grooming, and toileting. The HHA CP dated 02/23/2026 indicated the HHA was to assist with shower, personal care, and dressing. The record failed to evidence care coordination with Entity 12 to determine delineation of care to avoid duplication of services. On 03/09/2026 at 8:29 PM, HHA 8 indicated she was the HHA that provided care from 4:00 PM to 11:00 PM and could not provide services earlier in the day because she was scheduled with another patient. On 03/09/2026 at 4:30 PM, the Administrator indicated she cancelled the HHA visit on 03/07/2026 when HHA 7 was informed there would be another caregiver from Entity 12 present. The Administrator indicated there had not yet been care coordination with Entity 12 to determine which agency was providing care on Saturdays. The Administrator indicated the change in HHA hours from evenings to days was due to a change in staffing and did not provide an answer for why the agency was not providing 40 hours a week of HHA services as authorized. The Administrator did not provide an answer to why the agency did not provide services at the time the agency initially provided HHA services. On 03/10/2025 at 3:10 PM, the Alternate CM indicated Entity 12 informed her of their plan to provide services on Saturdays, so the Alternate CM indicated the agency agreed to provide HHA services during the week. On 03/11/2026 at 8:30 AM, Patient indicated he/she lived alone and needed care during the day hours. Patient indicated the agency at SOC informed him/her that they did not have staffing to provide care during the day. The Patient indicated he/she was not aware of what the difference was between the HHA and attendant services. #A policy, titled “Coordination of Client Services”, indicated that coordination of care should be done in order to identify need to modify the plan of care and may be met with verbal or written interaction. A clinical record review for Patient 17 evidenced a CA, dated 02/06/2026, that identified a surgical incision wound to Patient 17’s left lower extremity amputation site and noted that the wound is non-healing. The CA failed to identify what provider was attending to the wound for care or orders. The record evidenced a physician order written by the Alternate Clinical Manager for wound care, dated 02/06/2026, and signed by Provider 13 on 02/17/2026. A POC, for the episode period of 02/05/2026 to 04/05/2026 indicated a SN frequency of once weekly for one week, then twice weekly for 8 weeks. The clinical record evidenced a SN visit note, authored by LPN 2, dated 02/27/2026, that indicated Patient 17 had an MD appointment a day prior and had a new open area to the existing surgical wound as a result of a procedure performed by the provider. The SN visit note fails to identify who the provider that Patient 17 had an appointment with was, or any communication with said provider about new wound orders. The SN Visit Note, authored by LPN 2, indicated that LPN 2 provided unknown wound care during the visit, provided at the request of the patient primary caregiver. During an interview on 03/09/2026 beginning at 1:44 PM, LPN 2 indicated that during her visit on 02/27/2026, Patient 17’s primary caregiver relayed another family member had taken the patient to a doctor appointment and during the visit a callous was removed from the previous surgical incision site, resulting in a new open area. LPN 2 indicated she reached out to the family member, who relayed they did not have the name of the doctor, indicated there was no paperwork of the appointment. LPN 2 further indicated she did not call the attending provider for wound care orders. During an interview on 03/09/2026 beginning at 2:15 PM, the Alternate Clinical Manager indicated that she performed the initial CA for Patient 17 on 02/06/2026, and Provider 13 was the attending provider, and Provider15 was the provider who was managing Patient 17’s surgical incision wound. The Alternate Clinical Manager indicated she obtained wound care orders upon admission from Provider 13, and not Provider 15. She indicated that the provider who removed the callous mentioned in SN Visit Note 02/27/2026 was Provider 15. At 4:00 PM the Alternate Clinical Manager relayed to the Surveyor she had spoken to Provider 15’s office who let her know that Patient 17 had not been seen by Provider 15 in at least 2 years and was not managing the wound. The Alternate CM indicated that it was her first week as a new employee of the agency and it was an error not to confirm which provider was managing Patient 17’s wound at the SOC and obtain wound care orders from the appropriate provider. Additionally, she was overwhelmed with learning the EMR and being in the field seeing patients as a new employee. During an interview on 03/09/2026 beginning at 12:53, Provider 13 indicated he does not manage wounds for Patient 17 and that Patient 17 should have reported to a wound clinic for wound management. Provider 13 indicated wound care orders are not given by him and he has had no conversations with the agency regarding Patient 17’s wound care or wound monitoring. During an interview on 03/10/2026 beginning at 10:31 AM, the office of Provider 14 indicated that Provider 14 was the provider who removed the callous from Patient 17. Wound care instructions that Patient 17 was given as discharge instructions did not match the order written by the agency. Provider 14’s office confirmed that they had not had contact with this agency, although had regular contact with Patient 17’s previous agency. 1.A policy, titled “Coordination of Client Services”, indicated that coordination of care should be done in order to identify need to modify the plan of care and may be met with verbal or written interaction. 2.A clinical record review for Patient 17 evidenced a CA, dated 02/06/2026, that identified a surgical incision wound to Patient 17’s left lower extremity amputation site and noted that the wound is non-healing. The CA failed to identify what provider was attending to the wound for care or orders. The record evidenced a physician order written by the Alternate Clinical Manager for wound care, dated 02/06/2026, and signed by Provider 13 on 02/17/2026. A POC, for the episode period of 02/05/2026 to 04/05/2026 indicated a SN frequency of once weekly for one week, then twice weekly for 8 weeks. The clinical record evidenced a SN visit note, authored by LPN 2, dated 02/27/2026, that indicated Patient 17 had an MD appointment a day prior and had a new open area to the existing surgical wound as a result of a procedure performed by the provider. The SN visit note fails to identify who the provider that Patient 17 had an appointment with was, or any communication with said provider about new wound orders. The SN Visit Note, authored by LPN 2, indicated that LPN 2 provided unknown wound care during the visit, provided at the request of the patient primary caregiver. During an interview on 03/09/2026 beginning at 1:44 PM, LPN 2 indicated that during her visit on 02/27/2026, Patient 17’s primary caregiver relayed another family member had taken the patient to a doctor appointment and during the visit a callous was removed from the previous surgical incision site, resulting in a new open area. LPN 2 indicated she reached out to the family member, who relayed they did not have the name of the doctor, indicated there was no paperwork of the appointment. LPN 2 further indicated she did not call the attending provider for wound care orders. During an interview on 03/09/2026 beginning at 2:15 PM, the Alternate Clinical Manager indicated that she performed the initial CA for Patient 17 on 02/06/2026, and Provider 13 was the attending provider, and Provider15 was the provider who was managing Patient 17’s surgical incision wound. The Alternate Clinical Manager indicated she obtained wound care orders upon admission from Provider 13, and not Provider 15. She indicated that the provider who removed the callous mentioned in SN Visit Note 02/27/2026 was Provider 15. At 4:00 PM the Alternate Clinical Manager relayed to the Surveyor she had spoken to Provider 15’s office who let her know that Patient 17 had not been seen by Provider 15 in at least 2 years and was not managing the wound. The Alternate CM indicated that it was her first week as a new employee of the agency and it was an error not to confirm which provider was managing Patient 17’s wound at the SOC and obtain wound care orders from the appropriate provider. Additionally, she was overwhelmed with learning the EMR and being in the field seeing patients as a new employee. During an interview on 03/09/2026 beginning at 12:53, Provider 13 indicated he does not manage wounds for Patient 17 and that Patient 17 should have reported to a wound clinic for wound management. Provider 13 indicated wound care orders are not given by him and he has had no conversations with the agency regarding Patient 17’s wound care or wound monitoring. During an interview on 03/10/2026 beginning at 10:31 AM, the office of Provider 14 indicated that Provider 14 was the provider who removed the callous from Patient 17. Wound care instructions that Patient 17 was given as discharge instructions did not match the order written by the agency. Provider 14’s office confirmed that they had not had contact with this agency, although had regular contact with Patient 17’s previous agency. 3. A clinical record review for Patient #19 evidenced a comprehensive assessment at the SOC on 01/20/2026 which indicated Patient lived alone around the clock and had primary diagnosis was chronic respiratory failure, required 6 liters per minute of oxygen via nasal cannula (plastic tubing inserted into the nose to deliver oxygen). The assessment indicated Patient required assistance with meal set-up, bathing, incontinence care, dressing, ambulating, and grooming due to shortness of breath, high risk for falls, weakness, and requiring frequent breaks between activities of daily living. The assessment indicated the agency would provide services 8 hours a day, 7 days a week. An authorization for HHA services, dated 02/01/2026, from Patient’s payer source (non-Medicare government insurance) evidenced Patient was authorized to receive 40 hours a week of HHA services. A communication note dated 02/10/2026 indicated the agency informed Patient HHA services were going to be provided from 3:00 PM to 11:00 PM Monday through Friday. The record failed to coordinate care with Patient for how their needs were to be met during the day. A communication note, dated 02/26/2026, indicated the agency was to provide HHA services 8:00 AM to 12:00 PM Monday through Friday and Entity 12 would provide services on the weekends. The visit schedule indicated the agency scheduled HHA services on Saturdays 03/07/2026 and 03/14/2026. The visit schedule provided by Entity 12 indicated Entity 12 provided attendant and homemaker services every Saturday from 7:00 AM to 8:30 PM. The service plan from Entity 12 indicated the attendant was to assist with bathing, dressing, grooming, and toileting. The HHA CP dated 02/23/2026 indicated the HHA was to assist with shower, personal care, and dressing. The record failed to evidence care coordination with Entity 12 to determine delineation of care to avoid duplication of services. On 03/09/2026 at 8:29 PM, HHA 8 indicated she was the HHA that provided care from 4:00 PM to 11:00 PM and could not provide services earlier in the day because she was scheduled with another patient. On 03/09/2026 at 4:30 PM, the Administrator indicated she cancelled the HHA visit on 03/07/2026 when HHA 7 was informed there would be another caregiver from Entity 12 present. The Administrator indicated there had not yet been care coordination with Entity 12 to determine which agency was providing care on Saturdays. The Administrator indicated the change in HHA hours from evenings to days was due to a change in staffing and did not provide an answer for why the agency was not providing 40 hours a week of HHA services as authorized. The Administrator did not provide an answer to why the agency did not provide services at the time the agency initially provided HHA services. On 03/10/2025 at 3:10 PM, the Alternate CM indicated Entity 12 informed her of their plan to provide services on Saturdays, so the Alternate CM indicated the agency agreed to provide HHA services during the week. On 03/11/2026 at 8:30 AM, Patient indicated he/she lived alone and needed care during the day hours. Patient indicated the agency at SOC informed him/her that they did not have staffing to provide care during the day. The Patient indicated he/she was not aware of what the difference was between the HHA and attendant services.”

“Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical manager ensured the implementation of the plan of care to meet patient’s needs in 3 of 3 clinical records reviewed. (Patient #17, 18, 19) The findings include: 3. A clinical record review for Patient 17 evidenced a CA for the SOC dated 02/06/2026 that identified a need for SN for surgical incision care and monitoring of delayed healing, Physical Therapy assessment, and HHA services to provide personal care. A POC for the episode dates of 02/05/2026 to 04/05/2026 indicated SN visits would be once weekly for 1 week, then twice weekly for 8 weeks; HHA visits would be 8 hours per day, 5 days per week, for 9 weeks; and Physical Therapy would perform an evaluation. A Physical Therapy POC, for the episode period of 02/05/2026 to 04/05/2026 evidenced a Physical Therapy frequency of once weekly for 8 weeks. The clinical record evidenced the SOC visit on 02/06/2026, and failed to evidence a SN visit until 02/24/2026. The clinical record evidenced HHA visits began on 02/23/2026 and failed to evidence any HHA visits prior to 02/23/2026. The clinical record evidenced a Physical Therapy Evaluation on 02/11/2026, and failed to evidence any subsequent Physical Therapy visits. During an interview on 03/06/2026 beginning at 1:23 PM, the representative for Patient 17 indicated that services were unable to be offered by the agency while a preauthorization was processed for payment and it would take approximately 2 weeks, but was unsure of the reason why services took longer than 2 weeks to begin and was not kept informed during the process. The representative for Patient 17 added that other than the Physical Therapy evaluation, no further Physical Therapy visits had been made or scheduled up to the time of interview, and currently had no knowledge of when Physical Therapy services would begin. During an interview on 03/06/2026 beginning at 2:16 PM, the Administrator indicated that upon admission, patients, or their representative, must sign a form that indicates services will be held until preauthorization approval is received and can take several weeks. The Administrator indicated that is a new form as part of a plan of correction for not providing services as ordered on the POC. During an interview on 03/09/2026 beginning at 2:15 PM, the CM indicated that a request for preauthorization was sent on 02/17/2026 and as of time of interview, the agency did not have an approved preauthorization for Physical Therapy Services. 1. A clinical record review for Patient #19 evidenced a comprehensive assessment for the SOC dated 01/20/2026 which indicated Patient’s primary diagnosis was chronic respiratory failure, required 6 liters per minute of oxygen via nasal cannula (plastic tubing inserted into the nose to deliver oxygen), used a non-invasive mechanical ventilator (a medical device to assist breathing), and had shortness of breath that worsened at night causing lack of sleep. A physician’s note dated 12/23/2025 indicated Patient was to continue using a noninvasive ventilator at least 5-6 hours every night with sleep. The POC for the initial certification period 01/20/2026-03/20/2026 failed to be developed to include the use of and interventions related to the non-invasive mechanical ventilator. On 03/09/2026 at 3:53 PM, the CM indicated the POC was not developed to include the non-invasive mechanical ventilator. A physician order dated 01/28/2026 indicated PT and OT would evaluate and then provide services 3 times a week effective 01/20/2026. The record failed to evidence PT evaluated Patient until 02/03/2026. The PT POC for the initial certification period 01/20/2026-03/20/2026 signed by the PT on 02/03/2026 and signed by the physician on 02/09/2026 indicated the agency was to provide PT services 1 time a week for 1 week, 2 times a week for 2 weeks, and 1 time a week for 1 week due to needing assistance with ambulation, severe shortness of breath with exertion, and weakness. The record failed to evidence PT services were provided until 03/03/2026. A letter from the non-Medicare government insurance company dated 02/19/2026 indicated the Patient was approved 24 units of PT services. The clinical record failed to evidence a request for OT authorization was sent to the insurance company. On 03/09/2026 at 4:03 PM, the Administrator indicated she was unsure why PT services were not approved and indicated she was not sure if the authorization for PT services had been approved yet. The administrator indicated the agency had not provided PT services from the evaluation on 02/03/2026 until the re-evaluation on 03/03/2026. On 03/09/2026 at 4:30 PM, the CM indicated she was not sure why the agency had not yet provided OT services. The CM indicated maybe Patient did not want them and indicated there was not an order to revise the POC to discontinue OT services. The POC for the initial certification period 01/20/2026-03/20/2026 indicated the agency would provide HHA services 8 hours a day, 7 days a week for personal care and activities of daily living. The record failed to evidence the agency provided HHA services until 02/10/2026 and failed to evidence the agency provided HHA services 02/14/2026, 02/15/2026, 02/19/2026, 02/21/2026, 02/22/2026, 02/24/2026, 02/25/2026, 02/26/2026, 02/28/2026, 03/01/2026, 03/03/2026, 03/04/2026, 03/05/2026, 03/06/2026, 03/07/2026, and 03/08/2026. The record indicated the agency provided 4 hours of HHA services instead of the 8 hours per day as directed by the POC on 02/27/2026 and 03/09/2026. On 03/11/2026 at 8:30 AM, Patient indicated she did not cancel HHA services and indicated the agency did not have staffing after HHA 8 was no longer employed with the agency. Patient indicated HHA 7 informed her she did not work on Fridays and indicated the agency did not offer to provide HHA services on Fridays and Sundays. On 03/09/2026 at 2:20 PM, HHA 7 indicated the agency did not ask her to work 8 hours a day and was only scheduled for 4 hours 5 days a week. On 03/09/2026 at 4:08 PM, the CM indicated the agency did not provide HHA services 8 hours a day, 7 days a week, because the agency informed Patient they’d provide services 8 hours a day, 5 days a week. The CM indicated the POC was not revised to indicate the reduction in HHA services to be provided. 2. 1. A clinical record review for Patient #18, SOC 2/28/2026, evidenced a Face to Face from the physician dated 02/25/2026 which indicated Patient diagnoses included hypertension (high blood pressure), abnormal weight loss, and Chronic Obstructive Pulmonary Disease (COPD, progressive lung disease that blocks airflow making breathing difficult) and which indicated Patient had unsteady gait, severe pain, limited weight bearing status, and poor endurance. The document indicated Patient was to receive home health services for SN, PT, and OT services. The POC for the initial certification period 02/26/2026 – 04/26/2026 indicated the agency was to provide SN services 1 time a week for 9 weeks and PT and OT for evaluation. The record failed to evidence the agency had provided PT and OT services. The SOC comprehensive assessment completed on 02/28/2026 indicated Patient had fair appetite and Patient’s bed was infested with bugs. The POC failed to evidence the POC was developed to include interventions to address the abnormal weight loss and bug infestation. On 03/06/2026 beginning at 2:55 PM, the CM indicated the agency had not yet provided PT and OT services. The CM indicated the POC with the certification period beginning on 02/26/2026 was not correct since the SOC did not begin until 02/28/2026. On 03/09/2026 at 3:08 PM, the CM indicated the POC did not include interventions for the bug infestation and abnormal weight loss.”

“Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient’s goals of care and treatment preferences. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to follow its policy for implementing the discharge process in 1 of 1 closed record reviewed for a discharge to a hospital. (Patient #3) The findings include: An undated policy titled “Client Discharge Process” indicated agency documentation will include evidence the client no longer qualifies for home care services or there is no payer for ongoing services. A clinical record review for Patient #3 evidenced a communication note completed by the CM and dated 01/06/2026 which indicated Patient transferred to the hospital and discharged from agency due to Patient required increased level of care and not motivated to help self. The comprehensive assessment for recertification signed and dated by RN 1 on 12/29/2026 indicated Patient lived with a caregiver who provided all care and indicated Patient was to be recertified for home health for SN and HHA services. The POC for the recertification period 01/02/2026-03/02/2026 indicated the agency would provide SN services 1 time a week for 9 weeks and HHA services 8 hours a day, 7 days a week for 9 weeks. A PT evaluation completed on 01/03/2026 indicated Patient could benefit from PT services and for weakness and the PT POC was 1 visit for 1 week, 2 visits for 2 weeks, and 1 visit for 1 week. The record failed to evidence documentation per policy to evidence Patient no longer qualified for home care services and no payer source. On 03/09/2026 at 3:00 PM, the CM indicated PT services would have helped with Patient’s motivation and indicated there was no documentation to the Patient’s lack of motivation and increased level of care prior to discharge on 01/06/2026. On 03/09/2026 at 3:03 PM, the Administrator indicated the live-in caregiver could have resumed care upon Patient’s discharge from the hospital, but Patient was not paying for home health and group home services. The Administrator indicated there was no documentation regarding Patient not having a payer source and no documentation regarding care coordination with the hospital regarding the discharge of Patient from home health and group home and the need to find alternate placement upon discharge from the hospital. 410 IAC 17-12-2(i)”

“Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the discharge summary was sent to the physician in 1 of 2 closed clinical records reviewed. (Patient #3) The findings include: An undated policy titled “Discharge Process” indicated a summary including would be sent to the physician to include current medications. A clinical record review for Patient #3 evidenced a physician order dated 01/06/2026 which indicated Patient was discharged from home health services due to a transfer to the hospital. The Transfer Summary signed and dated by the CM on 01/06/2026 failed to evidence Patient’s medications and failed to evidence the transfer summary was sent to the physician prior to 02/27/2026. A Transfer Summary signed and dated by the CM on 01/12/2026 failed to evidence Patient’s medications and to whom and when the discharge summary was sent. The record failed to evidence a transfer summary was sent to the receiving facility (hospital). On 03/05/2026 at 3:01 PM, the CM indicated medications were not included in the Transfer Summary. The CM indicated the Transfer Summary was not sent to the physician prior to 02/27/2026 and there was no documentation the Transfer Summary was sent to the hospital, the receiving facility. 410 IAC 7-13-2(a)(b)(9)”

“Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients received the services outlined in the POC in 1 of 1 active clinical record reviewed. (Patient #1) The findings include: An undated policy titled “Admission Policy” indicated the agency accepts patients for treatment based on the expectation the patient’s medical and nursing needs can be met adequately by the agency. The undated agency referral log indicated Patient #1 was referred on 02/26/2026 for requested services SN, PT, and OT. A clinical record review for Patient #1, SOC 2/28/2026, evidenced a Face to Face from the physician dated 02/25/2026 which indicated Patient diagnoses included hypertension (high blood pressure), abnormal weight loss, and Chronic Obstructive Pulmonary Disease (COPD, progressive lung disease that blocks airflow making breathing difficult) and which indicated Patient had unsteady gait, severe pain, limited weight bearing status, and poor endurance. The document indicated Patient was to receive home health services for SN, PT, and OT services. The POC for the initial certification period 02/26/2026 – 04/26/2026 indicated the agency was to provide SN services 1 time a week for 9 weeks and PT and OT for evaluation. The record failed to evidence the agency had provided PT and OT services. On 03/06/2026 at 2:55 PM, the CM indicated the agency had not yet provided PT and OT services.”

“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 ensure patients who requested discharge from services were educated on risks and potential outcomes with an in-person discharge visit in 1 of 2 clinical record reviews of discharged patients. (Patient 2) Findings include: A policy, titled “Client Discharge Process”, indicated that the discharge CA is required for all discharge situations that result in discharge except to an inpatient facility or client death at home and should be performed in conjunction with a visit if possible. A clinical record review for Patient 2, evidenced a discharge summary, dated 02/26/2026, that indicated Patient 2 was being discharged from the agency due to patient request and that an order was obtained for a non-visit discharge. The record failed to evidence documentation that Patient 2 was offered an in-person discharge visit by the agency or educated to the risks and potential outcomes of not having an in-person discharge visit. During a phone interview on 03/05/2026, Patient 2 indicated that he/she attempted to contact agency several times with messages left and no return calls to inform of desire to discharge. Patient 2 indicated that since he/she was unable to reach agency, he/she informed a case manager that he/she wished to use a different agency. Patient 2 indicated that he/she was not contacted by the agency regarding discharge instructions nor offered to schedule an in-home discharge visit. During an interview on 03/10/2026 beginning at 11:14 AM, the CM indicated that there was no documentation that Patient 2 was offered or refused the opportunity for an in-home discharge visit.”

“Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the discharge summary was sent to the physician in 2 of 2 closed clinical records reviewed. (Patient #1, 2) The findings include: 1 A clinical record review for Patient #1 evidenced a communication note dated 01/05/2026 which indicated Patient died at home. The clinical record failed to evidence a discharge summary and that a discharge summary was sent to the physician. On 02/18/2026 at 11:04 AM, the CM indicated the agency did not generate a discharge summary or send a discharge summary to the physician. 2. A clinical record review for Patient #2 evidenced a discharge summary dated 01/02/2026 which indicated Patient was discharged from the agency’s services on 01/01/2026. The record failed to evidence the agency sent the discharge summary to the physician. On 02/18/2026 at 11:04 AM, the CM indicated the agency did not sent the discharge summary to the physician. 410 IAC 7-13-2(a)(b)(9)”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure clinicians documented accurately in 1 of 2 closed records reviewed with services provided by HHA 1. (Patient #1) The findings include: A clinical record review for Patient #1 evidenced HHA visit notes completed by HHA 1 on 01/02/2026, 01/03/2026, and 01/04/2026 from 8:00 AM to 4:30 PM. A clinical record review for Patient #4 evidenced HHA visit notes completed by HHA 1 on 01/02/2026, 01/03/2026, and 01/04/2026 from 8:00 AM to 4:30 PM. On 02/18/2026 at 11:09 AM, the Administrator indicated HHA 1 said she probably put the wrong times on the visit notes for Patient #1. The Administrator indicated the agency could not provide HHA services for 2 patients at the same time, so the visit notes were not accurate. 410 IAC 17-15-1(b)”

“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 observation, record review, and interview, the agency failed to ensure services were coordinated with all providers to ensure integration and treatment effectiveness in 2 of 3 clinical records reviewed. (Patient #1, 3) Findings include: 1. A clinical record review for Patient #1 evidenced a comprehensive assessment for SOC dated 11/25/2025 indicated Patient was chairbound, incontinent of bowel and bladder, dependent for personal care and activities of daily living, and required assistance with medication administration. The assessment indicated Patient lived in a structured care living assistance home and failed to identify what care was provided and the availability of the caregiver when the agency was not present. The record failed to identify coordination of care with the structured care living assistance home to determine what care was provided and the availability of the caregiver when the agency was not present. The clinical record indicated the agency provided 8 hours a day, 7 days a week of HHA services from 7:00 AM to 3:00 PM from SOC on 11/25/2025 until 12/16/2025 when the agency provided HHA services from 3:00 PM to 11:00 PM until 1/2/2026 when the agency provided HHA services from 8:00 AM to 4:30 PM. The clinical record failed to evidence coordination with the group home regarding the change in HHA services. On 02/17/2026 at 3:19 PM, the Administrator indicated the group home staff provided all care in the absence of the agency and there was no documentation with the group home that care was coordinated to determine the availability of the caregiver in the absence of the agency and regarding the change in the hours the agency provided HHA services. 410 IAC 17-12-2(g) 410 IAC 17-12-2(h) A policy, titled “Comprehensive Client Assessment”, indicated that the CA will identify the availability and schedules of client’s primary caregiver and other available supports. A policy, titled “Coordination of Client Services”, indicated that the agency will integrate services to assure the identification of client needs and factors that could affect client safety and the effectiveness of treatment. The policy indicated coordination of care is performed to assure that the efforts of agency personnel effectively complement one another and support the objectives outlined in the POC, and that the POC should be modified to reflect the needs or changes identified by members of the team to avoid duplication of services. Coordination will include Physicians, SN, HHA, and other agencies. A clinical record review for Patient 3, evidenced a CA, dated 01/07/2026, by RN 1, that indicated Patient 3 lived alone, needed assistance, and had no caregiver available. The record indicated that Patient 3’s daughter assists when she is not working, but failed to evidence a schedule of when daughter is, or is not, working. The record indicated a communication note, dated 01/21/2026, by the CM indicating that Patient 3 receives homemaker services by another agency. The record failed to evidence the name of the homemaker agency, or communication with the homemaker agency in an effort to coordinate care for Patient 3. During a telephone interview with Patient 3’s daughter, she identified Care in Motion as the homemaker agency that Patient 3 also uses. Patient 3’s daughter stated that Care in Motion provides services from 10:00 AM to 2:00 PM Monday through Fridays, and that Patient 3 is alone in the home daily from 5:00 AM to 10:00 AM and 2:00 PM to 9:00 PM, and that Patient 3 is home alone on the weekends. Patient 3’s daughter indicated that she lives nearby to Patient 3, but she is at work often. She indicated that Patient 3 is very limited in mobility and needs to stay in a certain area of the home until the next scheduled caregiver arrives. During an observation on 02/17/2026, at Patient 3’s home visit, Patient 3 indicated that they must remain in certain areas of the home due to limited mobility until the next scheduled caregiver arrives. During the observation, HHA 1 indicated she was unaware that Patient 3 was receiving services from another agency. During an interview on 02/17/2026 beginning at 2:10 PM, the CM indicated that there was no documentation (prior to the current day) of coordination of care with Care in Motion in regard to Patient 3’s services received between both agencies. A review of requested documents from Care in Motion, for Patient 3, evidenced a Care Plan with the same daily tasks to be performed by Care in Motion as the agency. The requested documents included an attempt of Care Coordination by Care in Motion, unanswered by the agency.”

“HH aide training program topics CFR(s): 484.80(b)(3) A home health aide training program must address each of the following subject areas: (i) Communication skills, including the ability to read, write, and verbally report clinical information to patients, representatives, and caregivers, as well as to other HHA staff. (ii) Observation, reporting, and documentation of patient status and the care or service furnished. (iii) Reading and recording temperature, pulse, and respiration. (iv) Basic infection prevention and control procedures. (v) Basic elements of body functioning and changes in body function that must be reported to an aide’s supervisor. (vi) Maintenance of a clean, safe, and healthy environment. (vii) Recognizing emergencies and the knowledge of instituting emergency procedures and their application. (viii) The physical, emotional, and developmental needs of and ways to work with the populations served by the HHA, including the need for respect for the patient, his or her privacy, and his or her property. (ix) Appropriate and safe techniques in performing personal hygiene and grooming tasks that include -- (A) Bed bath; (B) Sponge, tub, and shower bath; (C) Hair shampooing in sink, tub, and bed; (D) Nail and skin care; (E) Oral hygiene; (F) Toileting and elimination; (x) Safe transfer techniques and ambulation; (xi) Normal range of motion and positioning; (xii) Adequate nutrition and fluid intake; (xiii) Recognizing and reporting changes in skin condition; and (xiv) Any other task that the HHA may choose to have an aide perform as permitted under state law. (xv) The HHA is responsible for training home health aides, as needed, for skills not covered in the basic checklist, as described in paragraph (b)(3)(ix) of this section. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA was provided training and demonstrated competence in a task assigned by the agency in 1 of 1 closed clinical record reviewed with a sitz bath (warm, shallow bath to clean the genital and anal area to provide pain/itch relief). (Patient #1) The findings include: A clinical record review for Patient #1 evidenced a physician order dated 12/11/2025 completed by the CM which indicated the HHA was to provide a sitz bath twice a day for a boil to the genital area. The physician order indicated the HHAs watched a video regarding sitz baths and failed to evidence which HHA watched a video. During an interview on 02/18/2026 at 11:43 AM, the CM indicated HHA 1, HHA 2, and HHA 3 provided sitz baths to Patient. Personnel record reviews for HHA 1, HHA 2, and HHA 3 failed to evidence training and competency records for sitz baths. During an interview on 02/18/2026 at 11:43 AM, the CM indicated HHA 1, HHA 2, and HHA 3 were sent a video on their phones regarding sitz baths but there was no documentation the HHAs received, reviewed, and comprehended the video. The CM indicated there was no documentation the HHAs demonstrated competency with the sitz bath.”

“Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the RN developed the POC to include changes as necessary in 1 of 4 active clinical records reviewed. (Patient #14) The findings include: A clinical record review for Patient #14 evidenced SN visit notes, completed by RN 1, dated 1/03/2025, 11/10/2025, 12/24/2025, 01/07/2026, and 01/24/2026 which indicated Patient had poor nutrition and was instructed by the RN to increase fluid intake to 6-8 cups of fluid daily. The POC for recertification period 12/02/2025 -01/30/2025, signed and dated by RN 1 on 11/28/2025, failed to evidence SN interventions and education to be provided related to Patients’ poor hydration and SN intervention of Patient education to increase fluid intake. On 01/28/2026 at 3:03 PM, the CM indicated the poor hydration was an ongoing problem for Patient and was not included in the POC. 410 IAC 17-14-1(a)(1)(C)”

“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 the RN prepared the clinical notes accurately in 1 of 4 active clinical records reviewed. (Patient #14) The findings include: The clinical record review for Patient #14 evidenced a SN visit note dated 01/24/2025, completed by RN 1, which indicated Patient had a new urinary tract infection (UTI). The Infection Log Report, dated 10/23/2025, indicated Patient had a UTI. No other infections report for a UTI was evidenced for Patient. On 01/28/2026 at 3:03 PM, the CM indicated the UTI was not a new infection and had resolved. On 01/28/2026 at 3:03 PM, the Administrator indicated the RN did not document accurately and the documentation of the new infection was a note carry-over on to the clinical note, from previous nurse notes. 410 IAC 17-14-1(a)(1)(E)”

“Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This Condition is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure a skilled nursing professional notified the Director of Nursing nor Reassessed a Patient with low oxygen saturation levels nor followed up with new medications ordered (see G0704); failed to ensure a skilled nursing professional provided interventions per the physician or plan of care orders (see G0710); and failed to ensure a skilled nursing professional notified all physicians of a patient decline in condition (see G0718). 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 484.75 Skilled Professional Services.”

“Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure a skilled nursing professional reassessed patient, notified the Director of Nursing, or followed up on new medication to be ordered by Physician A, nor ensured patient was medically stable prior to leaving Patient’s home when a decline in condition was identified in 1 of 1 Patient’s clinical record reviewed with a patient death (Patient #5). Findings include: An undated policy, titled, “Medical Supervision,” indicated the agency would be responsible for prompt reporting of change in patient’s condition and facilitate patient communication and follow-up. An undated Registered Nurse [RN] job description indicated the RN would provide nursing services that utilized a comprehensive base of nursing theory, and nursing process, and communicates and documentations observations and assessments. The policy indicated the RN would report significant changes in the patient’s status to the physician and other members of the team in a timely manner consistent with patient’s needs, would initiate actions to improve the quality of patient care, and take actions independently and responsively in home care situations. The POC for the recertification period 11/22/2025 to 01/20/2026, for Patient #5, indicated a diagnosis, not limited to, unspecified asthma with acute exacerbation; medications included, but not limited to, Breo Ellipta and Albuterol inhalers. The POC, signed by RN 1 on 11/17/2025, indicated Patient was alert and oriented times 3. The POC Skilled Nurse Summary indicated Patient’s oxygen saturation was at 75% (normal 90-100%) when first checked and went up to 85% after deep breathing and coughing. The POC indicated Physician A was notified of the oxygen saturation, new orders were received, and requested Physician A see Patient as soon as possible regarding low oxygen saturation readings. A Medication Profile indicated 2-3 liters of continuous oxygen was ordered on 11/21/2025. A Skilled Nurse Visit Note, dated 11/21/2025, indicated the visit was added due to the home health aide indicated Patient did not look normal. The Visit Note, completed by RN 1, indicated Patient went outside to smoke and came back into the home with shortness of breath and had an oxygen saturation of 71% (normal oxygen saturation level is 90-100%). The Visit Note indicated RN 1 instructed Patient to put oxygen back on and utilize inhalers. The Visit Note indicated Patient wanted to put oxygen back on after eating, Physician A was notified of the low oxygen level and Physician A indicated they would order a steroid and Patient was to take nebulizer medication when the nebulizer machine arrived. The Visit Note failed to evidence RN 1 reassessed Patient’s oxygen saturation level nor appied Patient’s oxygen and reassessed needs. A Physician Order, dated 11/20/2025, indicated Patient received oxygen concentrator and nasal cannula on 11/20/2025 and a nebulizer machine was to be delivered on 11/24/2025. A Home Health Aide Visit Note, dated 11/23/2025, for time 7:00 AM to 7:00 PM, indicated Patient was very confused. A Physical Therapy Note, dated 11/23/2025, at 2:55 PM, indicated Patient’s oxygen was at 90% and indicated Patient required rest breaks after each task due to shortness of breath. An Emergency Medical Service Patient Care Report, dated 11/23/2025, at 8:10 PM, indicated upon arrival Patient was in wheelchair in threshold of front door, Patient’s lips were blue and jaw was stiff, Patient had lividity to the back side of legs, Patient was dead on arrival, and caregiver indicated Patient was talking 10 minutes prior. The Patient Care Report indicated Patient’s oxygen was off and caregiver indicated Patient wore oxygen all the time except when smoking. The Patient Care Report indicated no cigarettes were found in the Patient’s room, living area, or outside, and none in Patient’s coat pocket. The Patient Care Report indicated Patient was dead at scene and no resuscitation was attempted. A Discharge Summary, dated 11/23/2025, indicated the Administrator notified the Director of Nursing at 8:45 PM, Patient went outside to smoke and once returned inside became unresponsive, with no pulse or respirations, chest compressions were started emergency medical services were called; the summary indicated the coroner went to the residence and Patient was pronounced expired. During an interview, on 12/11/2025 beginning at 1:10 PM, RN 1 indicated during the nurse visit on 11/21/2025, Patient utilized inhaler after smoking, Patient told RN 1 he/she would put oxygen on after breakfast, and oxygen saturation were at 71% on room air. RN 1 indicated Physician A was texted of low oxygen saturation levels and Physician A was to call a steroid into Patient’s pharmacy but did not indicate what steroid was to be ordered. RN 1 indicated the Administrator would be responsible for getting Patient’s medication since Patient resided in a group home or the nurse at the next week’s visit would follow up if Patient received the medication(s). RN 1 indicated she did not recheck Patient’s oxygen level and did not remain with the Patient to ensure oxygen was applied. During an interview, on 12/12/2025 beginning at 1:50 PM, the Director of Nursing indicated RN 1 should have notified the Director of Nursing of Patient’s low oxygen saturation level, RN 1 should have followed up regarding medication Physician A was to call in to pharmacy and should have rechecked oxygen saturation level prior to exiting the home. During an interview, on 12/15/2025 beginning at 2:30 PM, the Administrator indicated she was Patient’s Power of Attorney; the Administrator indicated she was not notified by RN 1 of Patient’s low oxygen saturation level, was not aware a new medication was to be called in by Physician A, and was aware a nebulizer machine was to be delivered on 11/24/2025. During a follow up interview, on 12/15/2025 beginning at 2:30 PM, the Director of Nursing indicated RN 1 did not notify her of Patient’s low oxygen saturation level or new medications to be ordered by Physician A. During a call to the pharmacy identified as Patient’s Pharmacy, on 12/11/2025 at 3:00 PM, the pharmacy technician indicated Patient had no steroids or nebulizer medications orders and relayed Patient did not fill their medications at that pharmacy.”

“Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies. (4) When services are provided on the basis of a physician or allowed practitioner’s verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA’s policies, must document the orders in the patient’s clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies. This Element is not met as evidenced by: Based on record review and interview, the agency failed to obtain verbal orders prior to initiating plan of care orders in 1 of 1 active clinical records reviewed with a provider change to Physician A (Patient #4), and in 2 of 2 discharged clinical records reviewed with Physician A documented as their plan of care physician (Patient #5, Patient #7). Findings include: 1.An undated policy, titled, “Medical Supervision,” indicated the patient’s provider physician would be responsible for providing signed orders and for establishing and reviewing the patient’s Plan of Care throughout the time the patient was receiving services. The policy indicated physician signed Plan of Care would include description of patient’s needs, description of specific services to be provided, and a list of actions to be taken for delivery of care. The policy indicated if a patient changed providers, the agency would not continue services until orders had been obtained from the new provider. 2.A Plan of Care, for certification period 09/04/2025 to 11/02/2025, for Patient #4, indicated Physician C was the plan of care physician. The Plan of Care indicated Patient diagnoses included but not limited to type 2 diabetes, congestive heart failure, chronic obstructive lung disease, anemia, hypothyroidism, dementia, long term use of oral hypoglycemic medications, and schizophrenia. The Plan of Care indicated Patient wore oxygen at 2 liters per minute via nasal cannula, skilled nurse was to notify the physician for weight gain more than 5 pounds per week, and blood sugar and vital sign parameters to notify physician were ordered. The Plan of Care indicated a start of care of 09/04/2025. A Physician Order, dated 09/22/2025, indicated Physician A was to be Patient’s new primary care physician per Patient’s request. A Physician Order, dated 09/22/2025, indicated Physician A gave medication orders to include Claritin, Cholecalciferol, Calcium + Vitamin D, Famotidine, Ferrous Sulfate, Flomax, Folic Acid, Gabapentin, Latanoprost, Levothyroxine, Magnesium Oxide, Melatonin, Memantine, Metformin, Sertraline, Trazodone, Tylenol, Vitamin B-12, and Ventolin inhalation solution. A Face-to-Face Encounter was completed by Physician A on 10/31/2025. A clinical record review failed to evidence Patient specific verbal order(s) were obtained from Physician A, to include blood sugar, vital signs, and weight parameters. During an interview, on 12/10/2025 beginning at 3:00 PM, the Administrator indicated the agency did not obtain physician orders from Physician A when Patient’s plan of care physician was changed on 09/22/2025. The Administrator indicated Patient was first seen by Physician A on 10/31/2025 due to the prior plan of care physician, Physician C, had only seen Patient in a skilled nursing facility and declined to provide home health orders and or refill medications. 3.The POC for the certification period 09/23/2025 to 11/21/2025, for Patient #5, indicated Physician A was the POC; the POC was signed on 10/29/2025. The POC included, but was not limited to, the diagnoses: type 2 diabetes, asthma, long term use of oral hypoglycemics, long term use of opiate analgesic, and aortic valve stenosis. The POC indicated the start of care was 09/23/2025. A Physician Note dated 10/09/2025, indicated Physician A saw Patient in a group home. A clinical record review failed to evidence Patient specific verbal nor written practitioner orders, from Physician A, to begin care nor orders for the care provided until the POC was signed on 10/29/2025. During an interview, on 12/10/2025, beginning at 3:00 PM, the Administrator indicated the agency did not obtain start of care verbal orders from Physician A. The Administrator indicated Patient was first seen by Physician A on 10/09/2025. 4.The POC for the certification period 09/23/2025 to 11/21/2025, for Patient #7, failed to evidence a signature from the POC practitioner, Physician A. The POC included the diagnoses of hypertension and type 2 diabetes, with parameters for blood pressure and blood sugars to notify the physician and a start of care of 09/23/2025. A Physician Order, dated 09/23/2025, indicated verbal start of care orders were received from Physician A; the orders failed to be specific to Patient #7 and specific to the reason for admission and discharge goals. A clinical record review failed to evidence a face-to-face encounter or physician visit was completed by Physician A. During an interview on 12/11/2025, beginning at 12:00 PM, the Administrator indicated Physician A did not see Patient due to Patient refused to be seen by Physician A. She indicated Patient’s POC practitioner was changed to Physician B because Physician A, Patient’s primary care physician refused to sign orders for home health care. 410 IAC 17-14-1(a)(H)”

“Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a skilled nursing professional provided interventions only as ordered in the plan of care in 1 of 1 active clinical record reviewed with a diagnosis of congestive heart failure (Patient #4). Findings include: An undated Licensed Practical Nurse [LPN] job description indicated the LPN would provide professional nursing care as defined in the nurse practice act and under the direction of a RN. An After Visit Summary, dated 11/21/2025, from a hospital indicated Patient #4 went to the emergency room for shortness of breath with a diagnosis of chronic bronchitis. The After Visit Summary indicated Patient was started on Prednisone (steroid anti-inflammatory medication) and increased Albuterol inhaler to 4 puffs every 4 hours as needed. The POC for the certification period 11/03/2025 to 01/01/2026, indicated Patient had diagnoses to include but not limited to type 2 diabetes, chronic obstructive pulmonary disease, and congestive heart failure; the POC indicated the skilled nurse was to monitor for fluid retention, signs such as swelling and weight gain, was to weigh Patient once daily and notify the physician for weight gain more than 2 pounds in 1 day or 5 pounds in a week due to congestive heart failure diagnosis, and was to monitor for signs of pulmonary congestion. A Skilled Nurse Visit Note, dated 11/17/2025, indicated Patient was wearing oxygen at 2 liters per minute via nasal cannula as ordered, had bilateral lower extremity pitting edema (swelling), indicated a weight of 154 pounds, and indicated Patient’s blood sugar was elevated at 443 (normal range 80-110). The skilled nurse Visit Note indicated LPN 1 encouraged Patient to increase fluids during the day, LPN 1 instructed Patient to drink water to help with elevated blood sugar, to help decrease the blood sugar level. The Skilled Nurse Visit Note indicated LPN 1 instructed Patient to “drink as much water as tolerable.” A Skilled Nurse Visit Note dated 11/24/2025, indicated Patient was wearing oxygen at 2 liters per minute via nasal cannula as ordered, had bilateral lower extremity non-pitting edema, and had a weight of 162 pounds, lungs sounds were clear and Patients blood sugar was 211. The visit note indicated LPN 1 encouraged Patient to drink water as tolerated to help lower blood sugar and the Patient began drinking water. A Skilled Nurse Visit Note, dated 12/02/2025, indicated Patient was wearing oxygen at 2 liters per minute via nasal cannula as ordered, had bilateral non-pitting edema to lower extremities, and weight was 167 pounds, indicated Patient’s bilateral feet were swollen with taut skin and socks were too tight. The Skilled Nurse Visit Note indicated LPN 1 encouraged Patient to drink water throughout the day and increase hydration, and Patient drank one and a half bottles of water. The Skilled Nurse Visit Note indicated Patient’s blood sugar level was 200 after drinking water. During an interview on 12/10/2025, beginning at 12:45 PM, the Director of Nursing indicated LPN 1 encouraged Patient to drink water because Patient’s urine was dark and concentrated and he/she did not drink water all day. The Director of Nursing indicated increasing fluids would lower Patient’s blood sugar. The POC and clinical record failed to evidence a physician order to push fluids to lower blood sugars. The clinical record failed to evidence the physician was notified the skilled nurse encouraged Patient to drink as much water as tolerable nor was the physician contacted to obtain orders for daily fluid intake. The record evidenced a note by Physician A, dated 11/06/2025, which indicated Patient’s plan summary would include, but not limited to, start Lasix daily for edema. During an interview, on 12/10/2025, beginning at 12:45 PM, the Administrator indicated Physician A did not notify the agency of any orders following the 11/06/2025 physician visit. During a follow up interview, on 12/15/2025, beginning at 3:00 PM, the Administrator indicated Physician A indicated the physician notes plan summary are not orders. An American Heart Association website for Congestive Heart Failure (heart not pumping as well as it should with the heart not able to meet the body’s needs for blood and oxygen) indicated a heart failure patient may retain fluid and the health care team may recommend limiting fluid intake, taking water pills and reducing sodium. 410 IAC 7-14-1(a)(2)(F)-LPN”

“Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a skilled nursing professional notified physicians of a decline in a patient condition in 1 of 1 clinical record reviewed of a patient hospitalized via emergency medical services (Patient #6). Findings include: An undated Registered Nurse [RN] job description indicated the RN would provide nursing services that utilized a comprehensive base of nursing theory, and nursing process, and communicates and documentations observations and assessments. The policy indicated the RN would report significant changes in the patient’s status to the physician and other members of the team in a timely manner consistent with patient’s needs, would initiate actions to improve the quality of patient care, and take actions independently and responsively in home care situations. An undated policy, titled, “Medical Supervision,” indicated the agency would be responsible for prompt reporting of change in patient’s condition and facilitate patient communication and follow-up. An undated policy, titled, “Administration of Oxygen,” indicated oxygen was to be used conservatively in patients with chronic lung disease because high levels of oxygen could suppress breathing stimuli, signs and symptoms of hypoxia (lack of oxygen) would include confusion and shortness of breath. The policy indicated oxygen via nasal cannula administration may be delivered up to 6 liters per minute. The POC for Patient #6’s certification period 11/03/2025 to 01/01/2026, included the diagnosis, but not limited to, sarcoidosis (a condition that causes lumps to form in lungs, lymph nodes and other parts of the body), acute respiratory failure with hypoxia, and chronic obstructive pulmonary disease, with dependence on supplemental oxygen, oxygen ordered at 10 liters per minute via nasal cannula. The POC indicated skilled nurse to complete physical assessment with emphasis on sarcoidosis, chronic obstructive pulmonary disease, and respiratory failure;the skilled nurse was to recognize and intervene by notifying physician immediately of problems, and the nurse would notify the physician if oxygen saturation was less than 90%. A Skilled Nurse Visit Note, dated 11/07/2025, indicated Patient had abnormal lung sounds with rhonchi and wheezing noted, productive cough, oxygen at 12 liters per minute via nasal cannula, with oxygen saturations at 75% on 12 liters of oxygen. The Visit Note indicated Patient’s oxygen saturation increased to 88% after nebulizer breathing treatment and oxygen turned up to 12 liters per minute. The Visit Note indicated Patient was instructed to take breathing treatment, Patient had appointment to see pulmonologist on 11/10/2025, and Patient was to monitor oxygen levels to ensure remained in upper 80s or low 90s. The Nurse Visit Note failed to evidence RN 1 notified a physician of Patient’s low oxygen saturation, oxygen delivery to 12 liters per minute, nor wheezing and rhonchi noted. A Physician Order, dated 11/07/2025, failed to evidence an order was received, read back or verified; the order form indicated the agency sent: for your information, Patient with rhonchi and wheezing to left lung, Patient turned oxygen up to 12 liters per minute, oxygen level at 75% and increased to 88% after nebulizer breathing treatment, productive cough and had an appointment with the pulmonologist on 11/10/2025. The order was signed by the POC physician on 11/26/2025. A Communication Note, signed by RN 1, dated 11/07/2025, indicated Patient requested nurse does not notify the physician of the breathing problems due to an upcoming appointment with pulmonologist and Patient would notify the physician of breathing problems. A Communication Note, dated 11/21/2025, indicated Patient went to the emergency room at 4:00 AM, from their residence a group home, Group Home A, was intubated for a collapsed right lung, and was on a ventilator. During an interview, on 12/12/2025, beginning at 3:30 PM, RN 1 indicated she should have called Patient’s pulmonologist when Patient’s low oxygen saturation was noted on 11/07/2025, she may have tried to call pulmonologist’s office, but she didn’t think she talked to anybody, did not receive any orders and did not document. 410 IAC 17-14-1(A)(1)(G)-RN”

“Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient’s condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA’s policies and procedures. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a home health aide notified the RN of a change in patient condition in 1 of 1 clinical record reviewed with patient expired / death (Patient #5). Findings include: An undated Home Health Aide job description indicated the home health aide would provide services under the direction of an RN. The policy indicated the home health aide would report any observed or reported changes in the patient’s condition and or needs to a RN. The POC for Patient #5’s certification period 11/22/2025 to 01/20/2026, included the diagnosis, but not limited to, unspecified asthma with acute exacerbation and medications included, but not limited to, Breo Ellipta and Albuterol inhalers. The POC was signed by RN 1 on 11/17/2025 indicated Patient was alert and oriented times 3. A Medication Profile indicated 2-3 liters of continuous oxygen was ordered on 11/21/2025. A Home Health Aide Visit Note, dated 11/23/2025, for time 7:00 AM to 7:00 PM, indicated Patient was very confused. A Discharge Summary, dated 11/23/2025, indicated the Administrator notified the Director of Nursing at 8:45 PM, Patient went outside to smoke and once returned inside became unresponsive, with no pulse or respirations, chest compressions were started emergency medical services were called and coroner went to the residence and Patient was pronounced expired. During an interview on 12/12/2025, beginning at 12:10 PM, Home Health Aide 1 indicated Patient was confused on 11/23/2025 and was asking for family members, and indicated Patient was not normally confused. Home Health Aide 1 indicated Patient wore oxygen at night but not during the day. Home Health Aide 1 indicated she did not notify the Registered Nurse of Patient’s new onset of confusion. During an interview on 12/12/2025, beginning at 1:50 PM, the Director of Nursing indicated Home Health Aide 1 should have notified the case manager of Patient’s confusion.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure documentation was completed timely and accurately in 3 of 3 clinical records reviewed with HHA visit notes completed by HHA 1. (Patient #1, 2, 5) The findings include: 1. An undated agency policy titled “Clinical Documentation” indicated the direct caregivers would accurately record the services provided the day the service was rendered. 2. A clinical record review for Patient #1 evidenced HHA visit notes completed by HHA 1 dated 11/17/2025, 11/18/2025, 11/29/2025, 11/20/2025, 11/21/2025, 11/24/2025, 11/25/2025, 11/26/2025, 11/28/2025, 12/01/2025, 12/02/2025, 12/03/2025, 12/04/2025, 12/05/2025, 12/08/2025, and 12/09/2025 which indicated HHA 1 provided personal care to Patient. On 12/11/2025 at 3:16 PM, Patient’s caregiver indicated Person 1 was the HHA that provided care from the agency and indicated HHA 1 had not been to the home to provide care. Upon review of the video recordings beginning on 12/01/2025 at Patient’s home on 12/11/2025 at 5:25 PM, Patient’s caregiver indicated Person 1 was the person on the video recording entering Patient’s home to provide care for Patient on 12/01/2025, 12/02/2025, 12/03/2025, 12/04/2025, 12/05/2025, 12/08/2025, and 12/09/2025. On 12/11/2025 at 3:28 PM, Person 1 indicated they were the HHA that provided care to Patient Monday through Friday for services such as assistance with feeding and incontinent care for 3 weeks. On 12/12/2025 at 1:44 PM, HHA 1 indicated she had never provided services to Patient and indicated Person 1 told her the care that Person 1 completed which HHA 1 documented as if he was the HHA that provided the care. 3. A clinical record review for Patient #2 evidenced HHA visit notes completed by HHA 1 dated 08/18/2025, 08/19/2025, 08/20/2025, 08/21/2025, 08/22/2025, 08/25/2025, 08/26/2025, 08/27/2025, 08/28/2025, 08/29/2025, 09/02/2025, 09/03/2025, 09/04/2025, 09/05/2025, 09/08/2025, and 09/09/2025 which were created in the electronic health record and completed on 09/12/2025 based on the activity tracking. On 12/12/2025 at 1:42 PM, HHA 1 indicated she completed all of the HHA visit notes on 09/12/2025. On 12/12/2025 at 1:49 PM, the Administrator indicated the HHA visit notes were created and completed all on the same day by HHA 1 on 09/12/2025 since the agency was in their recertification survey on 09/12/2025 and didn’t’ want surveyors to find that visit notes had not been completed. 4. A document titled “Payroll Detail” for HHA 1 from 08/15/2025-09/12/2025 evidenced 4 shifts provided by HHA for Patient #5 and Patient #2 for the same date and time on 08/18/2025, 08/21/2025, 08/22/2025, and 08/25/2025. Clinical record reviews for Patient #5 and Patient #2 evidenced HHA visit notes completed and dated by HHA 1 on 08/18/2025, 08/21/2025, 08/22/2025, and 08/25/2025 which indicated HHA 1 provided assistance with personal care and ADLs. On 12/12/2025 at 1:44 PM, HHA 1 indicated she did not provide care for Patient #5 but completed the documentation for Person 4, a contracted agency HHA, who did not have access to the electronic health record. 410 IAC 17-15-1(b)”

“Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were provided as outlined in the POC in 1 of 1 active clinical record reviewed with HHA notes completed by HHA 1 in a total sample of 1 active clinical record schedule with HHA 1. (Patient #1) The findings include: A clinical record review of Patient #1 evidenced a comprehensive assessment for the SOC which indicated Patient had a primary diagnosis of hereditary ataxia (a group of genetic disorders causing progressive loss of coordination, balance, and speech due to damage to the brain and nervous system). The assessment indicated Patient was incontinent of bowel and bladder; was unsteady and at a high risk of falls; had muscle weakness and unsteady gait; was chair fast; and was dependent for dressing, grooming, bathing, toileting, feeding, and transferring. The POC for the initial certification period 11/05/2025-01/03/2026 indicated the agency would provide HHA services 6 hours a day, 7 days a week for 9 weeks for personal care and assistance with activities of daily living (ADLs). The visit schedule indicated HHA 1 was the HHA scheduled Monday through Friday from 3:00 PM to 9:00 PM with Patient. On 12/11/2025 at 3:16 PM, Patient’s caregiver indicated Person 1 was the HHA that provided care from the agency Monday through Friday 3:00 PM to 9:00 PM. Patient’s caregiver indicated they did not know HHA 1 and indicated HHA 1 had not been to the home to provide care. Upon review of the video recordings at Patient’s home on 12/11/2025 at 5:25 PM, Patient’s caregiver indicated Person 1 was the person on the video recording entering Patient’s home to provide care for Patient as seen on the daily recordings beginning on 12/01/2025, 12/02/2025, 12/03/2025, 12/04/2025, 12/05/2025, 12/08/2025, and 12/09/2025. On 12/11/2025 at 3:28 PM, Person 1 indicated they were the HHA that provided care to Patient Monday through Friday from 3:00 PM to 9:00 PM. Person 1 indicated they were a HHA with the agency for a little over 1 month and had been providing services such as assistance with feeding and incontinent care for Patient for 3 weeks. Review of the active employee list provided by the Administrator failed to evidence Person 1 as an agency employee. On 12/12/2025 at 1:44 PM, HHA 1 indicated she had never provided services to Patient. On 12/12/2025 at 1:44 PM, the Administrator indicated Person 1 had not yet completed HHA training and there was no HHA available to provide care to Patient so the Administrator allowed Person 1 to provide care for Patient even though she was not a qualified HHA. 410 IAC 17-13-1(a)”

“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, §485.542, §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 record review and interview, the agency failed to maintain compliance with the condition of Emergency Preparedness at 42 CFR 494.62. The requirement was not met as evidenced by: the agency failed to include a process for cooperation and collaboration with local, state, and federal emergency preparedness officials to maintain an integrated response during a disaster or emergency situation (See E0009); the agency failed to include policies and procedures that aligned with the facility and community-based risk assessment for use in an emergency (See E0013); the agency failed to include contact information of entities providing services under arrangement for use in an emergency (See E0030); the agency failed to provide training in emergency preparedness policies and procedures to staff providing services under arrangement (See E0037); and agency failed to evidence that exercises were conducted to test the emergency plan, annually at a minimum (See E0039). The cumulative effect of these systemic problems resulted in the 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 condition 42 CfC 494.62 Emergency preparedness.”

“Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This Condition is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure: the initial assessment was completed within 48 hours (see tag G0514); the comprehensive assessment was completed within 5 days of the SOC (see tag G0520); and the comprehensive assessment included a review of all patient medications (see tag G0536). 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 484.55 Comprehensive Assessment of Patients.”

“Discharge Planning CFR(s): 484.58 Condition of Participation: Discharge planning. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to implement an effective discharge process (tag G562) and failed to send a discharge summary to the physician (tag G564). Based on record review and interview, the agency failed to follow agency policy regarding the discharge planning process to include communicating with the physician the possibility of discharge, providing the physician the discharge summary within 5 business days of discharge, and providing a 15 day discharge notice to the patient as required by the State of Indiana in 2 of 2 closed records reviewed. (Patient #6, 7) The findings include: 1. An undated policy titled “Discharge and Transfer of Patients” indicated the agency would communicate with the physician if a discharge was predicted and provide the patients with a 15 day notice of discharge 2. A clinical record review for Patient #6 evidenced a POC for the recertification period 06/27/2025-08/25/2025 which indicated the agency was to provide SN services 1 time weekly and HHA services 1-5 hours a day 5 days a week. The discharge comprehensive assessment dated 08/21/2025 indicated the Patient was discharged due to staffing issues. The record indicated the last day the agency provided HHA services was 07/28/2025 and the last SN visit was 07/23/2025. The record failed to evidence the agency communicated the continued difficulty to provide staffing and the need to discharge and failed to provide the Patient with a 15 day discharge notice. The Discharge Summary dated 09/12/2025 was dated greater than 5 business days from the date of discharge and failed to evidence the agency provided the discharge summary to the physician. On 09/16/2025, the CM indicated the agency last notified the physician of staffing issues on 07/30/2025 and could not recall if the agency contacted the physician for a discharge order from home health services. On 09/16/2025 at 3:21 PM, the Administrator indicated a letter notifying the Patient of the agency’s intent to discharge was left on the Patient’s door but indicated there was no documentation of the day the letter was left on the door or if the Patient received and understood the notice to discharge. The Administrator indicated the discharge summary was not dated within 5 business days from discharge and there was no record it was sent to the physician. 3. A clinical record review for Patient #7 evidenced a POC for recertification period 08/26/2025-10/24/2025 which indicated the agency was to provide SN services 1 time a week and HHA services for 105 hours a day up to 5 days per week. The record failed to evidence the agency provided services after 08/14/2025 for the HHA and 08/21/2025 for the SN. The discharged patient roster indicated the Patient was discharged on 09/06/2025 for refusal of services. The record failed to evidence documentation of communication with the physician of refusal of services and the potential need to discharge, a 15 day discharge notice to the Patient, and a discharge summary that was sent to the physician. On 09/16/2025 at 3:35 PM, the Administrator indicated the Patient wanted a specific HHA who had been terminated by the agency and refused HHA services from any other HHA and refused the SN visits. The Administrator indicated there was no documented communication with the physician regarding the Patient’s refusal of services and the plans to discharge from the agency. The Administrator indicated there was no discharge summary that was sent to the physician, because there was not a discharge comprehensive assessment completed which generates the discharge summary. The cumulative effect of these systemic problems has resulted in the home health agency’s inability to ensure provision of quality health care in a safe environment for the condition of participation 42 CFR 484.58 Discharge Planning.”

“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 record review and interview, the home health agency failed to ensure: the patient’s needs were met (See tag G0570); services were provided per the plan of care (See tag G0572); the plan of care included all required information / elements for the treatment of the patient (See tag G0574); services were provided only as ordered by a physician (See tag G0580); the physician was promptly notified of a change in the patient’s condition (See tag G0590); communicate any changes with the POC to the physician responsible for the POC (See tag G0596); and coordination of care for all services provided to the patient (See tag 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 meet the patient’s needs in 2 of 5 active clinical records reviewed. (Patient #3, 5) The findings include: 1. A clinical record review for Patient #3 evidenced a referral dated 07/24/2025 for home health services which indicated the Patient was referred for HHA and PT services. The SOC comprehensive assessment dated 07/28/2025 indicated the Patient had a history of falls and was assessed to have pain in the left leg with impaired mobility and shortness of breath with moderate exertion. The SOC comprehensive assessment indicated the RN coordinated care for SN, HHA, and PT services. The POC for the initial certification period 07/28/2025-09/25/2025 indicated the agency was to provide services to include HHA services 1-8 hours a day up to 5 days a week for 9 weeks. An agency document titled “Physician Order” dated 08/04/2025 indicated the HHA services were on hold pending insurance approval, and the electronic medical record indicated the document was not created by the agency until 08/08/2025. The record failed to evidence the agency had provided HHA services. On 09/12/2025 at 11:30 AM, the Patient’s caregiver indicated they “need help bad” in regard to HHA services. The Patient’s caregiver indicated the Patient needed assistance with personal care and showering. On 09/12/2025 at 2:07 PM, the Administrator indicated the Patient’s payor source was traditional Medicare and need for authorization was not the reason for the hold. The Administrator indicated the Patient’s wife only wanted one particular person to provide the HHA services who was not yet been trained to be a HHA, the individual would begin HHA training on 10/01/2025. 2. A clinical record review for Patient #5 evidenced a POC for the initial certification period 06/05/2025-08/03/2025 which indicated the primary diagnosis was multiple sclerosis (a degenerative disease affecting the nervous system causing loss of balance, weakness, numbness) and indicated the Patient required assistance with bathing, personal care, and transfers/mobility. The POC indicated the agency was to provide HHA services 1-5 hours a day up to 5 days a week effective 06/09/2025 for personal care. The record failed to evidence the agency provided HHA services prior to 09/03/2025. An agency document titled “Physician Order” dated 06/05/2025 and completed by the CM indicated HHA services were on hold pending insurance approval. The Patient Profile and the active patient roster indicated the Patient’s primary payor source was Medicare. A document from Entity 2 (payor source) dated 06/27/2025 indicated the Patient was approved for service effective 06/17/2025 through 12/13/2025. A Communication Note dated 08/14/2025 indicated the HHA services were on hold due to family’s request of a preferred caregiver to complete HHA training. On 09/16/2025 at 2:29 PM, the CM indicated there was no communication with the physician to report the authorization for services was obtained. On 09/16/2025 at 3:20 PM, the Administrator indicated the authorization for services was obtained but the family wanted one specific caregiver to be the HHA but who was not yet trained and certified as a HHA. 410 IAC 17-13-1(a)”

“Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This Condition is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure: the home health aide was assigned with appropriate written instructions (see tag G0798); the home health aide provide services that were included in the plan of care (see tag G0800); supervision visits of the HHA occurred every 14 days when a skilled service was also provided (see tag G0808); supervision visits were conducted on site (see tag G0810); and the home health aide supervision ensured the care provided followed the plan of care (see tag G0818). 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 484.80 Home Health Aide Services.”

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the administrator was responsible for accurate public information (see tag G0948) and for maintaining the manner in which the services were to be provided under contract (see tag G978). The cumulative effect of these systemic problems has resulted in the home health agency’s inability to ensure provision of quality health care in a safe environment for the condition of participation 42 CFR 484.105 Organization and Administration of Services.”

“Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: Based on record review and interview, the home health agency failed to evidence cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials to maintain an integrated response during a disaster or emergency situation in 1 of 1 dialysis facility. Findings include: A policy, dated 2023-2024, titled “Policy on Emergency Preparedness Program”, indicated that the emergency preparedness plan must include a process of cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. A review of the agency emergency preparedness plan on 09/12/2025 failed to evidence, effort of collaboration and cooperative planning for disasters or emergencies. During an interview on 09/15/2025 beginning at 10:15 AM, the Facility Administrator [FA] indicated that no record of officials spoken to, or collaboration and planning regarding disaster or emergency preparedness events had been recorded or documented.”

“Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] 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. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility 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. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: Based on record review and interview, the home health care agency failed to evidence emergency preparedness policies and procedures that aligned with the facility and community based risk assessment in 1 of 1 home health care agency. A policy, dated 2023-2024, titled “Policy on Emergency Preparedness Program” indicated that the emergency preparedness plan must be based on and include a documented facility-based and community-based risk assessment. A review of the agency emergency preparedness program on 09/12/2025 evidenced a facility and community-based Hazard Vulnerability Assessment, but failed to include any plan that addressed the potential hazardous events that were identified. During an interview on 09/12/2025 beginning at 2:30 PM, the Facility Administrator [FA] indicated that the facility has no policies or procedures on the emergency preparedness plan based on the facility risk assessment.”

“Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: Based on record review and interview, the home health care agency failed to include contact information for entities providing services under arrangement with the agency in the emergency preparedness plan in 1 of 1 home health agency. A policy, titled B-400G, indicated that the communication plan for emergencies and disasters must include names and contact information for entities providing services under arrangement. During review of the emergency preparedness communication plan on 09/12/2025, no contact information was found for entities providing care under arrangement to the agency for use during an emergency. During an interview on 09/15/2025, the Facility Administrator [FA] indicated that the agency is contracted for physical and occupational therapy services with St. John Therapy and that agreed that no contact information for St. John Therapy was documented on the emergency preparedness plan.”

“EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, “Organizations” under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF’s emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to evidence they provided training in emergency preparedness policies and procedures to individuals providing services under arrangement in 5 of 5 records of contracted staff. [OT1, PT1, PT2, PT3, and PT4]. The findings include: The policy dated 2023 -2024 and titled “Policy on Emergency Preparedness Program” indicated initial training in emergency preparedness policies and procedures must be performed with individuals providing services under arrangement. In review of agency’s’ training records of their contracted staff, the records failed to evidence the agency trained these staff to their agency’s Emergency Preparedness Plan. Contracted staff Occupational Therapist 1, date of contract hire of 08/13/2025, failed to evidence emergency preparedness training. Physical Therapist 1, date of contract hire of 07/25/2025, failed to evidence emergency preparedness training. Physical Therapist 2, date of contract hire of 09/03/2025, failed to evidence emergency preparedness training. Physical Therapist 3, date of contract hire of 08/22/2025, failed to evidence emergency preparedness training. Physical Therapist 4, date of contract hire of 08/22/2025, failed to evidence emergency preparedness training. During an interview on 09/15/2025 beginning at 12:55 PM, the Facility Administrator [FA] indicated that emergency preparedness training is not performed with staff under contract.”

“EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to conduct exercises to test the emergency plan, annually, in 1 of 1 home healthcare facility. Findings include: The policy dated 2023 - 2024 and titled “Policy on Emergency Preparedness Program” indicated the agency must conduct exercises to test the emergency plan, at least annually, and participate in a full-scale exercise that is community-based every 2 years. Exercises that may take place include a mock disaster drill, tabletop exercise, or second full-scale exercise. The agency’s Emergency Preparedness Plan failed to evidence documentation of a full-scale or community-based exercise was completed within the last 2 years. The agency failed to provide documentation to demonstrate the tested their plan annually, at minimum, and training on their emergency preparedness plan, with analysis and revisions if need was identified. During an interview on 09/12/2025, beginning at 1:39 PM, the FA indicated she was unaware of any full-scale or community-based training for the agency to participate, in within the last 2 years. Additionally, the FA indicated the most recent training and testing with staff was on 06/01/2023, which was a tabletop; the topic was of a pandemic.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the services were provided as directed in the POC in 4 of 5 active clinical records reviewed. (Patient #2, 3, 4, 5) The findings include: 1. A clinical record review for Patient #2 evidenced a POC for the initial certification period 06/14/2025-08/12/2025 which indicated the agency was to provide HHA services 1-8 hours a day up to 7 days a week effective 06/16/2025. The record failed to evidence the agency provided HHA services until 07/01/2025. The POC for the recertification period 08/13/2025-10/11/2025 which indicated the Patient had a complicated open wound to the left side of the neck, and the agency was to provide SN services 2 times a week to include wound care and medication review and reconciliation at every visit. The record failed to evidence the agency provided the 2nd SN visit the weeks of 08/17/2025 and 08/24/2025 and failed to provide any SN visit the week of 08/31/2025. The record failed to evidence the agency provided wound care and assessment from 08/18/2025 to 09/09/2025. On 09/11/2025 at 4:04 PM, the Administrator indicated the agency did not provide HHA services prior to 07/01/2025; the agency was waiting for Medicaid prior authorization to be approved. On 09/16/2025 at 1:21 PM, the CM indicated there were no other SN visits to meet the ordered visit SN frequency of 2 times a week to include wound care and assessment. The CM indicated there was no documentation of education to the Patient related to the risks of refusing SN services. During an observation of care at the Patient’s home on 09/11/2025 from entering the home at 1:00 PM with the Alternate CM to exiting the Patient’s home at 1:40 PM with the Alternate CM, the Alternate CM failed to review the Patient’s medications during the visit. On 09/11/2025 at 1:45 PM, the Alternate CM indicated she did not ask about or look at the Patient’s medications. 2. A clinical record review for Patient #3 evidenced a POC for the initial certification period 07/28/2025- 09/25/2025 which indicated the agency was to provide SN services 1 time a week for 9 weeks and PT services 1 time a week for 8 weeks. The record failed to evidence SN services were provided the weeks of 08/10/2025 and 08/24/2025 and no PT services were provided the week of 08/10/2025. On 09/16/2025 at 2:01 PM, the CM indicated she would look for patient education on the risks of not receiving services as ordered and attempts to reschedule missed SN and PT visits. No additional information or documentation was provided prior to survey exit on 09/16/2025. 3. A clinical record review for Patient #4 evidence a POC for the initial certification period 07/17/2025-09/14/2025 which indicated the agency was to provide SN services 1 time a week for 1 week and then 2 times a week for 8 weeks. The record failed to evidence the agency provided SN services during the weeks of 07/20/2025, 07/27/2025, and 08/31/2025 and failed to evidence the agency provided the 2nd SN visit during the weeks of 08/10/2025, 08/17/2025, and 08/24/2025. On 09/16/2025 at 2:24 PM, the CM indicated the Patient did not always want a SN to come and indicated there should have been missed visit forms completed, but there were not any documented. No additional documentation or information was received prior to survey exit on 09/16/2025. 4. A clinical record review for Patient #5 evidenced a POC for the initial certification period 06/05/2025-08/03/2025 indicated the agency was to provide SN services 1 time a week for 9 weeks and failed to evidence SN visits were provided during the weeks of 06/08/2025, 06/23/2025, and 07/13/2025. A PT POC for certification period 08/04/2025-10/02/2025 indicated PT services would be provided 2 times a week for 3 weeks and then 1 time a week for 4 weeks effective 08/19/2025. The record failed to evidence the agency provided a 2nd PT visit the week of 08/17/2025. On 09/16/2025 at 2:30 PM, the CM indicated there were no documented SN visits for the weeks of 06/08/2025, 06/23/2025, and 07/13/2025 and indicated there was not a 2nd PT visit the week of 08/17/2025. 410 IAC 17-13-1(a)”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure all employees practiced standard/universal precautions to prevent the transmission of infections and failed to follow agency infection control policies and procedures in 3 of 3 home visits. (#1, 2, 3) The findings include: 1. The undated policy titled “Nursing Bag” indicated hand washing must take place before entering the bag for any reason. 2. During a home visit at the home of Patient #1 on 09/10/2025 at 11:43 AM, before performing hand hygiene, LPN 1 reached into the main entry of her nurse visit bag, removed a paper towel, then performed hand hygiene. At 11:56 AM, after performing an assessment of the Patient to include palpating the Patient’s legs and feet, LPN 1 was observed entering the main opening of the same nurse visit bag and removed sanitizing wipes, without first performing hand hygiene. LPN 1 was observed wiping the stethoscope with a sanitizing wipe and immediately placing the stethoscope back into the nurse bag. The sanitizing wipe container indicated the directions for use indicated to wipe and keep wet for 4 minutes and allow to air dry. On 09/10/2025 at 11:56 AM, LPN 1 indicated she believed the directions were to wipe the equipment for 15 seconds with the sanitizing wipe and was not aware of the directions for use to allow 4 minutes to air dry. 3. During a home visit at the home of Patient #2 on 09/11/2025 at 1:00 PM, the Alternate CM entered the main pocket of the nurse bag to remove soap and a baggie containing paper towel before first performing hand hygiene. At 1:16 PM, the Alternate CM was observed returning the stethoscope to the main pocket of the nurse bag without first performing hand hygiene. At 1:39 PM, the Alternate CM was observed entering the main pocket of the bag to retrieve hand sanitizer without first performing hand hygiene. 4. During an observation of care at the home of Patient #3 on 09/12/2025 at 11:40 AM, PT 5 was observed placing the gait belt used on the Patient’s waist into the main pocket of the visit bag without first performing hand hygiene. At 11:45 AM, PT 5 entered the main pocket of the visit bag to retrieve soap and a paper towel without performing hand hygiene. 5. On 09/16/2025 at 1:35 PM, the CM indicated the clinicians should perform hand hygiene before entering the nurse bag. 410 IAC 17-12-1(m)”

“Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This Standard is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the HHA was provided with written instructions for care in 1 of 3 active clinical records reviewed with HHA services in a total of 5 active clinical records reviewed. (Patient #1) The findings include: During an observation of care at the home of Patient #1 on 09/10/2025 at 12:04 PM, a medication bottle with a prescription label for clopidogrel (to treat/prevent blood clots by thinning the blood) was found for Patient with a date the medication was filled of 07/28/2025. A clinical record review evidenced the HHA Care Plan dated 07/25/2025 failed to evidence the HHA Care Plan included bleeding precautions. On 09/16/2025 at 12:10 PM, the CM indicated the HHA Care Plan did not include bleeding precautions. 410 IAC 17-14-1(m)”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on record review and interview, the agency failed to inform and obtain consent in advance of treatment in 1 of 1 clinical record review of a duplicated skilled admission in a total census of 5 active clinical records reviewed. (Patient #1) The findings include: A clinical record review on 09/10/2025, for Patient 1, indicated the following: A. Patient’s Start of Care [SOC] was dated 07/25/25. B. A Home Health Admission Service agreement was signed by Patient 1 and dated 03/27/2025. C. An Admission Consent signed by Patient 1 was dated 03/27/2025. D. A Patient Rights and Responsibilities form was signed by Patient 1 and dated 03/27/2025. During an interview, on 09/10/2025 beginning at 2:50 PM, Admin 1 indicated that Patient 1 had been discharged and re-admitted due to an insurance problem, and that consents from a prior admission were used instead of obtaining new consents.”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on record review and interview, the agency failed to conduct the initial visit within 48 hours of the referral for home health services in 4 of 4 active clinical records reviewed in a total sample of 5 clinical records reviewed. (Patient #2, 3, 4, 5) The findings include: 1. A clinical record review for Patient #2 evidenced a SOC comprehensive assessment dated 06/14/2025 which indicated the date of referral was 06/10/2025. No evidence of an initial visit prior to the SOC comprehensive assessment or documentation on why the delay in the SOC was noted. On 09/16/2025, at 1:14 PM, the CM indicated there was no documentation regarding the delay of the SOC. 2. A clinical record review for Patient #3 evidenced a referral for home health services dated 07/24/2025 and failed to evidence an initial visit prior to the SOC comprehensive assessment dated 07/28/2025 which indicated the Patient was alert and oriented to person, place, and time. The admission consent dated 07/28/2025 was signed by the Patient. An agency document titled “Physician Order” dated 07/28/2025 indicated the caregiver requested care begin on 07/28/2025. The activity tracking in the electronic health record indicated the physician order was not created until 08/07/2025. The record failed to evidence the Patient requested a delay in the SOC and failed to evidence documentation of communication with the physician for the verbal order to delay the SOC. On 09/16/2025 at 1:45 PM, the CM indicated she would look for additional information and documentation regarding the delay in the SOC, but no additional information or documentation was provided by survey exit on 09/16/2025. 3. A clinical record review for Patient #4 evidenced a referral for home health services dated 07/14/2025 and failed to evidence an initial visit prior to the SOC comprehensive assessment performed on 07/17/2025. On 09/16/2025 at 2:21 PM, the CM indicated she would look for information on why an initial visit was not completed within 48 hours of referral but no additional documentation or information was provided prior to survey exit on 09/16/2025. 4. A clinical record review for Patient #5 evidenced a SOC comprehensive assessment dated 06/05/2025 which indicated the referral date was 05/29/2025 and failed to evidence an initial visit prior to the comprehensive assessment completed on 06/05/2025. On 09/16/2025 at 2:58 PM, the Administrator indicated the delay in the start of care was due to the caregiver’s preference but there was no documentation of the request or of an order for a delayed start date. 5. On 09/16/2025, at 1:14 PM, the CM indicated the agency conducted the initial visit at the time of the SOC comprehensive assessment. 410 IAC 17-14-1(a)(1)(A)”

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was completed within 5 days from the SOC in 1 of 2 active clinical records reviewed with PT services in a total sample of 5 active clinical records reviewed. (Patient #3) The findings include: A clinical record review for Patient #3 evidenced a referral dated 07/24/2025 for home health services which indicated the Patient was referred for PT services. The SOC comprehensive assessment dated 07/28/2025 indicated the SOC date was 07/28/2025 and the Patient had a history of falls and was assessed to have pain in the left leg with impaired mobility and shortness of breath with moderate exertion. The SOC comprehensive assessment indicated the RN coordinated care to include PT services. The POC for the initial certification period 07/28/2025-09/25/2025 indicated the agency was to provide services to include PT to evaluate and treat effective 07/28/2025. An agency document titled “Physician Order” dated 08/04/2025 indicated the PT services were on hold pending insurance approval, and the electronic medical record indicated the document was not created by the agency until 08/08/2025. The PT evaluation dated 08/07/2025 failed to evidence the comprehensive assessment was completed within 5 days of the SOC. On 09/12/2025 at 2:07 PM, the Administrator indicated the Patient’s payor source was traditional Medicare and need for authorization was not the reason for the hold. The Administrator indicated she would check into for the reason for the delay in the PT assessment, but no additional documentation or information was provided prior to survey exit on 09/16/2025.”

“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 drug review for drug reactions in 1 of 3 active clinical records reviewed with a SOC since 07/01/2025 in a total sample of 5 active clinical records reviewed. (Patient #4) The findings include: A clinical record review for Patient #4 evidenced a Medication Profile dated 07/17/2025 which indicated the Patient’s medications included Tramadol (for pain), Baclofen (muscle relaxant), and Gabapentin (for seizures/nerve pain). The Drug-Drug Interactions dated 09/15/2025 indicated major drug interactions between Tramadol and Baclofen and Tramadol and Gabapentin. The initial SOC comprehensive assessment dated 07/17/2025 indicated a medication review was completed, and no issues were identified. The comprehensive assessment failed to include a review of medication to include drug interactions. On 09/16/2025 at 2:17 PM, the CM indicated the drug review to include the drug interactions was not included in the assessment. 410 IAC 17-14-1(a)(1)(B)”

“At discharge CFR(s): 484.55(d)(3) At discharge. This Element is not met as evidenced by: Based on record review and interview, the agency failed to provide a comprehensive assessment at time of discharge in 1 of 1 closed record reviewed where the Patient was available for assessment in a total sample of 2 closed records reviewed. (Patient #7) The findings include: A clinical record review for Patient #7 evidenced the discharge date was 09/06/2025 due to the Patient refusing services, and the record failed to evidence a discharge comprehensive assessment. On 09/16/2025 at 3:35 PM, the Administrator indicated there was no discharge assessment completed.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the POC contained all required components to include patient-specific interventions, safety measures, and goals in 3 of 5 active clinical records reviewed. (Patient #2, 3, 4) The findings include: 1. A clinical record review for Patient #2 evidenced a POC for the recertification period 08/13/2025-10/11/2025 which indicated the Patient’s diagnoses included convulsions, and the medications included Topamax (for seizures). The POC failed to evidence the safety measures included seizure precautions. The POC evidenced the safety precautions included bleeding precautions and failed to evidence a medication or diagnosis requiring bleeding precautions. The POC evidenced blood sugar parameters and failed to evidence a diagnosis of diabetes (a chronic disease which affects blood sugars) and interventions of checking blood sugar. A SN visit note dated 08/14/2025 indicated the nurse filled the Patient’s mediplanner, and the POC failed to include the intervention of a mediplanner fill. On 09/16/2025, at 12:53 PM, the CM indicated the POC failed to include seizure precautions and indicated bleeding precautions were included in error. The CM indicated she was unsure why blood sugar parameters were included in the POC and indicated there was no diagnosis of diabetes. The CM indicated there was not an intervention for a mediplanner fill in the POC. 2. A clinical record review for Patient #3 evidenced a POC for the initial certification period 07/28/2025- 09/25/2025 which evidenced blood sugar parameters for when to call the physician but failed to evidence the frequency of blood sugar monitoring. The POC indicated the Patient’s goal was to have pain less than 10 and failed to indicate an individualized goal. The POC indicated the services to be provided included HHA services 1-8 hours a day up to 5 days a week and failed to be individualized to the assessed needs of the Patient. During an observation of care with PT 5 on 09/12/2025 at 11:18 AM, the Patient complained of pain to the left leg rated 5 out of 10. On 09/12/2025 at 11:29 AM, the Patient’s caregiver indicated the Patient is not on medications to treat high blood sugar and does not monitor blood sugar. The Patient’s caregiver indicated the Patient had so much pain in the left leg the day prior that the Patient could not get up. On 09/16/2025 at 1:50 PM, the CM indicated if the Patient was not checking blood sugar, the blood sugar parameters should not be included in the POC. The CM indicated the pain goal on the POC was not accurate and should be less than 5 out of 10. 3. A clinical record review for Patient #4 evidenced a POC for the initial certification period 07/17/2025-09/14/2025 which indicated the Patient’s medications included Eliquis (a medication used to thin the blood to prevent/treat blood clots) and failed to evidence bleeding precautions. The goals included the Patient was to have optimal pain effectiveness and failed to evidence what was the Patient’s optimal level of pain. On 09/16/2025 at 2:10 PM, the CM indicated the POC did not include bleeding precautions and a patient-specific, measurable pain goal. 4. A clinical record review for Patient #5 evidenced a POC for the initial certification period 06/05/2025-08/03/2025 which evidenced blood sugar parameters for when the physician was to be notified. The record failed to evidence blood sugar monitoring or a diagnosis of diabetes. On 09/16/2025 at 2:32 PM, the CM indicated the blood sugar parameters were not a patient-specific intervention but a pre-set on the POC template. 5. The CM indicated the maximum range of HHA services on the POC was the assessed need for HHA services, but a range was provided in case the Patient had a doctor appointment or per patient request. 410 IAC 17-13-1(a)(1)(D)(xiii)”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were provided only as ordered by a physician in 2 of 4 active clinical records reviewed with only 1 certification period in a total sample of 5 active records reviewed. (Patient #1, 4) The findings include: A clinical record review, on 09/10/2025, for Patient 1, indicated that the Start of Care [SOC] assessment was performed by RN 1 on 07/25/2025 beginning at 3:00 PM and ending at 3:45 PM. An HHA Visit Note, dated 07/25/2025, showed that the Home Health Aide was present for a visit beginning at 9:00 AM and ending at 1:00 PM, prior to the SOC assessment orders received. During an interview on 09/16/2025 beginning at 12:05, Admin 2 indicated that the SOC assessment needs to be completed before HHA services can begin. 1. A clinical record review for Patient #4 evidenced the agency provided SN services to include wound care to the right hip on 07/17/2025, 08/05/2025, 08/07/2025, 08/11/2025, and 08/21/2025. The SOC comprehensive assessment completed by the Alternate CM and dated 07/17/2025 failed to evidence if the order for home care services had been received by the physician and if the POC had been reviewed by the physician. The agency document titled “Physician Order” dated 07/17/2025 and signed by the CM was not signed by the physician. The record failed to evidence a signed physician order for home care services and failed to evidence communication with the physician regarding home care services. On 09/16/2025 at 2:00 PM, the Alternate CM indicated she had not yet talked to the physician or heard back from the physician’s office. On 09/16/2025 at 2:17 PM, the CM indicated she thought the physician refused to sign any orders for the Patient but would check and indicated there were no signed physician orders in the record. The CM indicated she had not spoken with the physician or heard back from the physician’s office. No additional information or documentation was received prior to survey exit on 09/16/2025. 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, a for a need to change the POC, and of identified issues with the medication review per agency policy in 4 of 5 active clinical records reviewed. (Patient #1, 2, 3, 5) The findings include: A policy, titled “C-580 Plan of Care”, indicated that staff shall promptly alert the physician to any changes that suggest a need to alter the plan of care. A policy, titled “C-155 Client Reassessment/Update of Comprehensive Assessment”, indicated that patients should be reassessed when significant changes occur in their condition. A clinical record review on 09/10/2025, for Patient 1, indicated the following: A. A Communication Note, dated 08/26/2025, signed by Admin 2, indicated that Patient 1 had an event after having a medical procedure on 08/25/2025 that caused Patient 1 to be taken to the Emergency Room via ambulance. No evidence of physician notification of event was provided by agency to surveyors. B. A Drug-Drug Interactions form, dated 07/28/2025, for Patient 1, indicated a major drug interaction. The agency failed to provide evidence that the physician was notified of the identified major drug interaction. During an interview on 09/15/2025 beginning at 12:40 PM, Admin 2 indicated that there was no documentation that the physician was notified of Patient 1 going to the emergency room on 08/25/2025. 1.An undated policy titled “Medication Profile” indicated the clinician would promptly report any identified problems with the medication review to the physician. 2. A clinical record review for Patient #2 evidenced a comprehensive assessment for recertification dated 08/08/2025 which indicated the surgical wound on the neck measured 3.0 centimeters (cm) in length and 3.0 cm in width. The SN visit notes indicated the wound measured 3.2 cm in length and 3.2 cm in width on 08/14/2025, 3.5 cm in length and 3.7 cm in width with increased bleeding on 08/18/2025, 5.0 cm in length and 4.0 cm in width on 09/09/2025, and 6.0 cm in length and 4.0 cm in width on 09/11/2025. The record failed to evidence the agency notified the physician of the increased wound size. On 09/16/2025 at 1:31 PM, the CM indicated she would look for physician notification regarding the increased wound size, but no additional documentation or information was provided prior to survey exit on 09/16/2025. 3. A clinical record review for Patient #3 evidenced a referral dated 07/24/2025 which indicated the Patient’s medication pravastatin (for high cholesterol). The POC for the initial certification period 07/28/2025-09/25/2025 failed to evidence pravastatin and indicated the Patient’s medications included atorvastatin (for high cholesterol). The clinical record failed to evidence the agency contacted the physician to clarify the discrepancy in medication. The POC also indicated the Patient’s medications included ibuprofen (to treat pain/swelling). On 09/16/2025 at 1:43 PM, the CM indicated there was no communication with the physician regarding the medication discrepancy. The physician order dated 08/21/2025 indicated hydrochlorothiazide (a mediation to treat high blood pressure) was ordered. A document titled “Drug-Drug Interactions” dated 09/15/2025 indicated a major drug interaction between hydrochlorothiazide and ibuprofen (to treat pain/inflammation). The record failed to evidence the physician was notified of the major drug interaction. On 09/16/2025 at 1:48 PM, the CM indicated she would look for documentation the agency notified the physician of the major drug interaction, but no additional documentation or information was provided prior to survey exit on 09/16/2025. 4. A clinical record review for Patient #5, start of care 06/05/2025, evidenced a Medication Profile dated 06/05/2025 which indicated the Patient’s medications included aspirin (for fever or pain) and Naproxen (for pain/inflammation). The Drug-Drug Interactions report dated 09/15/2025 indicated a major drug interaction between aspirin and Naproxen. The record failed to evidence the physician was notified of the major drug interaction. 5. The clinical record for Patient #1, revealed a Communication Note, dated 08/26/2025, signed by Admin 2, which indicated Patient 1 had an event, after having a medical procedure on 08/25/2025, and was taken to the Emergency Room [ER] via ambulance. The record failed to evidence the attending physician was notified of the event and ER visit. No documentation was provided by survey exit. During an interview on 09/15/2025 beginning at 12:40 PM, Admin 2 indicated that there was no documentation that the physician was notified of Patient 1 going to the emergency room on 08/25/2025. 6. During an interview at the entrance conference on 09/09/2025 at 1:36 PM, the Administrator indicated the physician should be notified of any major or severe drug interactions. 410 IAC 17-13-1(a)(2)”

“Revisions communicated to patient and MDs CFR(s): 484.60(c)(3)(i) (i) Any revision to the plan of care due to a change in patient health status must be communicated to the patient, representative (if any), caregiver, and all physicians or allowed practitioner’s issuing orders for the HHA plan of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to communicate changes to the POC with the physician responsible for the POC in 1 of 2 active clinical records reviewed receiving PT services in a total sample of 5 active clinical records reviewed. (Patient #5) The findings include: A clinical record review for Patient #5 evidenced a referral from Person 4 dated 08/11/2025, for PT to evaluate and treat; the referral was from a physician, other than the attending. The POC for the recertification period 08/04/2025 -10/02/2025 failed to include PT services. The record failed to evidence communication with the attending regarding the order for PT to evaluate and treat from Person 4. The record indicated PT services were provided on 08/26/2025, 08/28/2025, 09/03/2025, and 09/05/2025 prior to the PT POC being signed by the physician on 09/08/2025. On 09/16/2025 at 10:19 AM, PT 5 indicated he left a message with the office of Person 4 about the PT POC but never did get a return phone call. On 09/16/2026 at 3:11 PM, the Administrator indicated she would look for any documentation of communication with Person 4 regarding the order from Person 3 for PT to evaluate and treat prior to Person 4 signing the PT POC on 09/08/2025. No additional documentation or information was provided prior to survey exit on 09/16/2025. 410 IAC 17-14-1(a)(1)(G)”

“Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure care was coordinated with all healthcare providers in 1 of 1 active clinical record reviewed with services provided by a wound clinic (Patient #2) and in 1 of 1 active clinical record reviewed with another agency providing therapy services (Patient #5) in a total sample of 5 active clinical records reviewed. The findings include: 1. A clinical record review for Patient #2 evidenced a comprehensive assessment for recertification dated 08/08/2025 which indicated the Patient had a surgical wound to the neck for which the Patient had an upcoming appointment with the wound clinic. The clinical record failed to evidence coordination of care with the wound clinic. During an interview on 09/11/2025, at 1:29 PM, the Patient’s caregiver indicated the Patient had been attending the wound clinic at Entity 1 a couple of times a month for over a year. A physician order dated 09/10/2025 evidenced a change of wound care to the wound to the neck by the physician responsible for the POC; the record failed to evidence coordination with the wound clinic regarding the change in wound care. On 09/16/2025, at 12:55 PM, the CM indicated there was no coordination with the wound clinic other than the wound care order obtained from the hospital after hospitalization. The CM indicated there was no documentation of coordination with the wound clinic to include which clinic, how often the Patient attended, and coordination regarding the wound care order change. 2. A clinical record review for Patient #5 evidenced an agency document titled “Physician Order” dated 06/12/2025 which indicated PT services were placed on hold due to another agency providing PT services. The record failed to evidence care coordination with the agency providing PT services to include the agency name and frequency of PT services provided. On 09/16/2025 at 2:30 PM, the CM indicated there was no care coordination with the agency providing PT services. 410 IAC 17-12-2(h)”

“Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This Element is not met as evidenced by: Based on record review, observation, and interview, the agency failed to provide services ordered in the plan of care to include reviewing medications in 1 of 3 observations of home visits. [Patient 1] Findings include: A policy, titled “C-700 Medication Profile”, indicated that the medication profile should be updated whenever there is a change or discontinuation in medication. A Home Health Certification And Plan Of Care, dated 07/25/25, for Patient 1, indicated that the skilled nurse should perform a medication review with each skilled nursing visit and reconcile medications as indicated. A Medication Profile, dated 09/10/2025, indicated that Plavix had been added to the medication profile on 09/10/2025. During a home visit observation on 09/10/2025 beginning at 11:43 AM, a medication, Plavix, was observed in Patient 1’s home. The label on the medication indicated that the Plavix prescription was for Patient 1 and had been filled on 07/28/25. At 12:04, LPN 1 indicated that the medication review for the visit was complete. During an interview on 09/10/2025, beginning at 12:13 PM, LPN 1 indicated that Plavix was not a new medication for Patient 1 and was present in Patient 1’s home prior to 09/10/2025.”

“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 provided services as directed in the care plan in 1 of 3 clinical records reviewed of patients receiving HHA services in a total sample of 5 active clinical records reviewed. (Patient #1) The findings include: A Home Health Aide Plan of Care document dated 07/25/25, indicated Patient 1 should receive a shower with chair, shampoo hair, nail care, and linen change weekly. Home Health Aide Visit notes for 07/29/25, 07/30/2025, 07/31/2025, and 08/01/2025 indicated no shower with chair, nor shampoo of hair, nor nail care, nor linen change was performed for the week of 07/27/2025 -08/02/2025. On 09/16/2026 at 12:24 PM, the CM indicated she would look for additional documentation regarding the services not provided by the HHA as directed in the care plan, but no additional documentation or information was provided by survey exit on 09/16/2025.”

“Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient’s plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure supervisory visits were made at least every 14 days when HHA services were provided with a skilled service in 1 of 2 active clinical records with HHA services provided for at least 14 days in a total sample of 5 active clinical records reviewed. (Patient #2) The findings include: A clinical record review for Patient #2 evidenced POC for certification periods 06/14/2025- 08/12/2025 and 08/13/2025 -10/11/2025 which indicated the agency was to provide SN services 2 times a week and HHA services up to 8 hours a day 7 days a week. The record failed to evidence the agency conducted a supervisory visit prior to 08/30/2025. On 09/11/2025, at 3:58 PM, the CM indicated the agency did not conduct a supervisory visit prior to 08/30/2025.”

“If concern identified, direct observation CFR(s): 484.80(h)(1)(ii) The supervisory assessment must be completed onsite (that is, an in person visit), or on the rare occasion by using two-way audio-video telecommunications technology that allows for real-time interaction between the registered nurse (or other appropriate skilled professional) and the patient, not to exceed 1 virtual supervisory assessment per patient in a 60-day episode. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the RN conducted HHA supervisory visits on-site in 1 of 2 records reviewed of patients who had HHA and skilled services for more than two weeks in a total sample of 5 active clinical records reviewed. (Patient #1) Findings include: A policy titled “B-185 Home Health Aide Supervision,” indicated direct supervision of the HHA by a Registered Nurse or Therapist will be completed at least every 2 weeks while the patient is receiving skilled services.2. The clinical record of Patient #1 revealed the clinical manager documented HHA Supervisory Visits, dated 08/06/2025, 08/20/2025, and 09/03/2025, which each indicated she performed the supervisory visit of HHA 2, via telephone. 3. During an interview on 09/10/2025 beginning at 3:23 PM, the Director of Nursing [DON] indicated supervisory visits were done via phone and were not in person.”

“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 observation, the agency failed to ensure that Home Health Aide Supervision oversight included that the HHA followed the patient’s plan of care for completion of tasks assigned to a HHA in 1 of 2 clinical record reviews of patients who had HHA services for at least 2 weeks requiring a supervisory visit in a total sample of 5 active clinical records reviewed. (Patient #1) The findings include: On 09/10/2025 at 3:23 PM, the CM indicated there had not been any re-education of the HHA in an effort to provide supervision to ensure services were provided per the POC. A policy, titled “B-185 Home Health Aide Supervision” indicated that HHA visit records should be reviewed by the supervising nurse before it is filed in the patient record to assure services are being provided according to the care plan. HHA Supervisory Visits, dated 08/06/2025, 08/20/2025, and 09/03/2025, for Patient 1, indicated that HHA 2 Follows the plan of care for completion of assigned tasks. Home Health Aide Visit notes for 07/29/25, 07/30/2025, 07/31/2025, and 08/01/2025 , for HHA 2, indicated that the weekly tasks of shower with chair, shampoo of hair, nail care, linen change were performed with Patient 1 for the week of 07/27/2025-08/02/2025. Home Health Aide Visit notes for 07/29/2025, 07/30/2025, 08/01/2025, and 08/04/2025, for HHA 2, indicated that daily task of equipment care was not performed with Patient 1. Home Health Aide Visit notes for 08/20/2025 and 08/27/2025, by HHA 2 indicated that daily tasks of pericare, incontinence care, and assist with ambulation were not performed with Patient 1. During an interview on 09/16/2025 beginning at 12:05 PM, Admin 2 indicated that the HHA should follow the careplan and complete the tasks in the frequency that they are assigned.”

“Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the administrator provided oversight of the day-to-day operations to include the accuracy of public information. The findings include: An undated job description titled “Administrator” indicated the Administrator’s duties included ensuring the accuracy of public information. The agency’s website lasikhhc.com on 09/15/2025 at 11:14 AM indicated the agency was accredited by Entity 7 and the agency’s hours for business were Monday through Friday from 9:00 AM to 5:00 PM. The Home Health Agencies Report completed by the Administrator on 09/11/2025 indicated the agency’s business hours were Monday through Friday from 10:00 AM to 4:00 PM. On 09/16/2025 at 3:44 PM, the Administrator indicated the agency changed their business hours when the agency renewed its licensure several months ago and indicated the agency was not accredited with any accrediting body. The Administrator indicated the website needed to be updated. 410 IAC 17-12-1(c)(1)”

“Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA’s patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This Element is not met as evidenced by: Based on record review and interview, the agency failed to maintain the overall responsibility of the manner in which services provided under contract were to be provided. The findings include: 1.A contract with Entity 5 dated 11/30/2023 indicated the contracted agency would assist with documentation for patient care plans and assessments and would provide remote assistance to patients, caregivers, and healthcare providers; the contract failed to evidence the manner in which the assistance would be provided and to what extent. The contract indicated the contracted agency would generate reports and summaries and failed to indicate which reports and summaries and from where the reports would be generated. On 09/16/2025 at 2:15 PM, the Administrator indicate the contracted agency did not provide any services other than quality assurance review of documents and sending documents to the physicians and would have the contracts revised to reflect the services provided. 2. A contract with Entity 7 (a home care agency in Illinois) dated 03/10/2023 indicated the contracting agency provided coding, Outcome and Assessment Information Set (OASIS) review, POC for SOC/recertification/resumption, admission order, and medication review and provided the quality assurance review of SN/PT/HHA visit notes. On 09/16/2025 at 2:15 PM, the Administrator indicated Entity 7 did the quality review for the agency. 410 IAC 17-12-2(e)”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on observation, record review, and interview the home health agency failed to ensure the agency failed to ensure services were provided to meet the patients’ needs and the plan of care was individualized (See G0570), failed to ensure each patient received the services that are written in an individualized plan of care (POC) (See G0572), failed to evidence the plan of care included all required elements (See G0574), failed to ensure the primary care physician was promptly alerted of relevant changed in the patient’s condition or needs (See G 590), and failed to evidence integration of all services to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness (See G0606). The cumulative effect of these systemic problems has resulted in the home health agency inability to to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.60 Care Planning, Coordination, Quality of Care. Based on observation, record review, and interview the agency failed to ensure services were provided to meet the patients’ needs in 3 of 4 active clinical records reviewed (Patient #2, 9, and 13). Findings include: 4. A clinical record review for Patient #2 evidenced a comprehensive assessment completed by the Clinical Manager and dated 8/8/2024 which indicated the patient was incontinent of urine, had an unsteady and shuffled gait, had muscle weakness and poor balance, and had a high risk of falls. The assessment indicated the patient required assistance with dressing the lower body, bathing, and toilet hygiene. The comprehensive assessment indicated the patient lived in an assisted living facility (ALF) and failed to evidence any other assistance was provided. The plan of care for certification period 8/4/2024-10/2/2024 evidenced the agency would provide home health aide (HHA) services up to 10 hours a day, 5 days a week and skilled nursing services weekly. The clinical record failed to evidence services were provided on the weekends. During an observation of care at Patient’s home on 8/23/2024 at 9:41 AM, Patient was observed walking with a rolling walker from the bathroom to the living room with a shuffled gait and stand by assistance by the home health aide. Patient was observed to have oxygen tubing inserted into the nose which was connected to the oxygen concentrator (a medical device which supplies oxygen) at 5 liters per minute; Patient was observed breathing loudly and at an increased rate when Patient stated, “I’m out of breath. ”Patient indicated he/she needs assistance with bathing and dressing and has no help on the weekends. Patient indicated he/she did need PT services and was waiting to be re-assessed after a recent hospitalization. On 8/23/2024, at 10:17 AM, Person 21 at Entity 3 (ALF) indicated the ALF did not provide personal care services to Patient. A physical therapy (PT) evaluation dated 7/30/2024 and signed by the PT indicated Patient used a walker and a motorized chair for longer distances due to poor endurance and indicated the treatment plan was for the patient to receive PT services 1 time a week for 9 weeks for balance and gait training. The clinical record failed to evidence the agency provided any PT services after the evaluation visit and failed to evidence any communication with the physician regarding PT services were not provided. On 8/23/2024, beginning at 3:56 PM, the Administrator indicated the PT services were on hold while waiting for insurance approval. The Administrator indicated there was no documentation of follow-up with the insurance company regarding PT services. When queried how Patient received personal care on the weekends, when the HHA was not present, the Administrator indicated Patient made sure to get the care needed from the ALF on the weekends. On 8/23/2024 at 3:57 PM, the Clinical Manager indicated there was no documentation of communication with the physician regarding the hold for PT services while awaiting insurance approval. 410 IAC 17-13-1(a) 1. The agency policy titled “Psychiatric Nursing Assessment,” reviewed 8/2016, indicated each client with mental health problems is appropriately assessed and to receive comprehensive psychiatric home care by qualified staff. Initial and ongoing reassessments were to include an emotional and behavioral assessment. 2. The clinical record of Patient #9 revealed a Transfer assessment dated 7/30/24 by Clinical Supervisor indicated Patient was transferred to Entity 17, a psychiatric hospital; the record included an interdisciplinary discharge plan, dated 8/10/24 from Entity 17, that indicated their admission diagnosis was impulsive suicidal ideation and recurrent major depression. Discharge documentation from Entity 17, revealed Patient had a progressive neurocognitive disorder and there will likely be further decline in function with possible reoccurrence of psychiatric symptoms, ongoing psychiatric follow-up and close monitoring of psychiatric medication was recommended. The clinical record revealed a physician’s order for resumption of home health services, dated 8/10/2024; the record evidenced a comprehensive assessment was completed, dated 8/10/24. The clinical record failed to evidence an individualized plan of care, with interventions and goals related to the hospitalization discharge diagnoses. During an interview on 8/22/24 beginning at 4:30 PM, Clinical Supervisor relayed Patient #9 was hospitalized on 7/30/24 because he/she told the home health aide (HHA) that he/she took a handful of pills because he/she didn’t want to live anymore; 911 was called and Patient was admitted to the hospital. During an interview on 8/26/24 beginning at 12:05 PM, Other #16, Patient #9’s attending physician, relayed their office was not made aware that Patient was hospitalized, nor details / reason for the hospitalization, nor who was currently monitoring Patient and their medications. Other #16 revealed Patient had a hemangioma (benign tumor) in the brain with seizures that may have caused the hospitalization and indicated he would need to follow up with Patient’s caregiver as soon as possible. Other #16 added that Patient’s liquids should be nectar thick. During an interview on 8/22/24 beginning at 4:50 PM, Administrator and Clinical Supervisor were not able to show evidence that they had interventions in place nor evidence of education to the patient, family, or caregivers. 3. The clinical record of Patient #13 revealed a POC dated 7/22/24 to 9/19/24 with physical therapy (PT) visit frequency of once a week for 8 weeks, effective 7/26/24. A PT POC dated 7/22/24 to 9/19/24 revealed a treatment plan of once a week for one week, twice a week for three weeks, then once a week for two weeks. The record revealed PT evaluation done on 7/22/24 and failed to evidence further PT visits. The record failed to evidence physician notification that the physical therapy treatment plan was delayed. During an interview on 8/26/24 beginning at 9:15 AM, Other #20, attending physician for Patient #13, relayed the office was not notified regarding a delay in physical therapy. During an interview on 8/26/24 beginning at 11:26 AM, Entity #4, contracted to provide therapy services, relayed a physical therapy evaluation was ordered and completed for Patient #13 and they were awaiting on approval from the agency to order the physical therapy visits. During an interview on 8/27/24 beginning at 10:30, the Administrator relayed the PT visits are on hold since 7/22/24 due to the lack of authorization from insurance.”

“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 agency failed to: ensure the governing body approved the frequency of the data collection, the quality assessment and performance improvement (QAPI) program utilized quality indicator data to include 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 affecting quality of patient care and safety. The findings include: A review of the hospitalization log, dated 8/22/2024, evidenced 13 patient hospitalizations since 3/28/2024 to include 6 hospitalizations thus far for the 3rd quarter of 2024. A review of the agency’s QAPI program failed to evidence performance improvement activities related to patient hospitalization. The infection log dated 8/28/2024 evidenced 24 patient infections thus far for 2024 to include 13 infections without data of the type of infection. The QAPI program failed to evidence performance improvement activities and aggregation of data related to patient infections. The QAPI program failed to evidence quality indicator data derived from the OASIS (Outcome and Assessment Information Set) assessments. The agency’s performance improvement project was identified to be medication reconciliation, and no other patient data was evidenced in the QAPI program. The Governing Body Minutes dated 8/9/2024 failed to evidence the approval of the detail and frequency of the data to be collected. On 8/28/2024, beginning at 4:05 PM, the Administrator indicated the agency had too many hospitalizations, yet the agency’s focus was on medication reconciliation. The Administrator indicated the governing body did not approve the detail and frequency of the data to be collected and there was no quality indicator data from the OASIS assessments. The Administrator indicated she had misunderstood the purpose of the QAPI program, and indicated the review of the QAPI program was helpful and she knew what to do moving forward for the QAPI program. 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 §484.65 Condition: Quality Assessment/Performance Improvement. 410 IAC 17-12-2(a)”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review, observation, and interview the agency failed to ensure each patient received the services that are written in an individualized plan of care (POC) in 1 of 1 active record reviewed, of a patient who resided in a group setting and a home visit observation was conducted (Patient #2). Findings include: 3. A clinical record review for Patient #2 evidenced a plan of care for certification period 8/4/2024-10/2/2024 which indicated the agency was to provide skilled nursing services 1 time weekly. The clinical record failed to evidence a skilled nursing visit was provided during the week of 8/11/2024-8/17/2024. On 8/23/2024, beginning at 4:10 PM, the Administrator indicated she would check to see if that was the week she performed a skilled nursing visit and would add in the documentation if so. No skilled nurse visit was documented before survey exit on 8/28/2024. 410 IAC 17-13-1(a) 1. The agency policy titled “Plan of Care,” reviewed 8/2016, indicated home care services are furnished under the supervision and directions of the patient’s physician including the type, frequency, and duration of all visits/services. 2. The clinical record of Patient #13 revealed a POC dated 7/22/24 to 9/19/24 with orders for physical therapy (PT) visits, with frequency of once a week for 8 weeks, effective 7/26/24. The clinical record included a separate POC for PT services, dated 7/22/24 to 9/19/24, that revealed a treatment plan of once a week for one week, twice a week for three weeks, then once a week for two weeks. The record revealed a PT evaluation was conducted and dated 7/22/24; the clinical record failed to evidence further PT visits since 7/22/2024. During an interview on 8/26/24 beginning at 11:26 AM, Entity #4, contracted to provided therapy services for agency, relayed a PT evaluation was ordered and completed for Patient #13 and Entity 4 was awaiting approval from the agency, to order the physical therapy visits. During an interview on 8/27/24 beginning at 10:30, Administrator relayed the PT visits are on hold since 7/22/24 due to the lack of authorization from insurance.”

“Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This Standard is not met as evidenced by: Based on record review and interview the Registered Nurse (RN) failed to assign tasks appropriate and provide pertinent patient information to the Home Health Aide (HHA) in 2 of 4 active clinical records reviewed who received aide services (Patient #2, 9). Findings include: 4. A clinical record review for Patient #2 evidenced a HHA care plan for the certification period 8/4/2024 - 10/2/2024, signed by the Clinical Manager, which indicated the HHA could shop for Patient weekly. On 8/23/2024, at 4:11 PM, the Administrator indicated the HHA could shop for Patient as long as Patient did not go with the aide. 410 IAC 17-14-1(m) 1. The agency policy “Home Health Aide Care Plan,” reviewed 8/2016, indicated following a nursing assessment, a written plan identifying personal care and supportive care services that are individualized to his/her specific needs. 2. The agency policy titled “Home Health Aide: Assignment” indicated a designated Registered Nurse (RN) or therapist determines the client’s need for assistance with daily living and personal care then determine and assign tasks on the HHA care plan. The clinical record included an HHA care plan dated 8/11/24 to 10/9/24 included one task assigned to be completed with every visit, shopping. The HHA care plan failed to include personal care assistance or support to include bathing assistance nor assist with feeding. During an interview on 8/27/24 beginning at 10:30 AM, Clinical Supervisor relayed she thought she included a shower in the HHA care plan, for Patient #9. designated Registered Nurse (RN) or therapist determines the client’s need for assistance with daily living and personal care then determine and assign tasks on the HHA care plan. 3. The clinical record of Patient #9 revealed a comprehensive reassessment, dated 8/10/24 that indicated Patient was able to participate in bathing self in shower or tub, though required presence of another person through the bath for assistance or supervision. The assessment indicated Patient was able to use utensils to bring food or liquid to mouth and swallow food once the meal was placed, indicated supervision or touching assist.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to accurately document into the clinical record in 3 of 4 active clinical records reviewed (Patient #9, 11, and 13). The findings include: 4. The clinical record for Patient #9 revealed a transfer assessment, dated 7/30/24 which indicated Patient was transferred to Entity 17. A physician’s order for resumption of home health services and a comprehensive reassessment were completed on 8/10/24 by Clinical Manager. The clinical record revealed Home Health Aide supervisory visit was completed by Clinical Manager, on 8/6/24. During an interview on 8/22/24 beginning at 4:30 PM, when asked how the supervisory visit was completed on 8/6/24 when Patient was hospitalized from 7/30/24 to 8/10/24, the Clinical Supervisor relayed it was a missed visit and she shouldn’t have entered the documentation. 410 IAC 17-15-1(b) 1. The agency policy titled “Clinical Documentation,” reviewed 8/2016, indicated skilled professionals were to ensure there is an accurate record of services provided, client response, and ongoing need for care. 2. A clinical record review for Patient #11 evidenced a plan of care for certification period 6/26/2024-8/24/2024 which indicated the patient’s medications included warfarin (a medication used to thin the blood to prevent/treat blood clots) and did not evidence Plavix (a medication used to thin the blood to prevent/treat blood clots). The plan of care indicated the patient had wounds to the right ankle and right lateral foot requiring wound treatment. The comprehensive assessment dated 8/21/2024 and signed by the Clinical Manager indicated the patient’s anticoagulant therapy (a class of medication used to treat/prevent blood clots) included Plavix and failed to include warfarin. On 8/27/2024, at 3:34 PM, the Clinical Manager indicated Plavix was documented in error and it should have included warfarin. A Skilled nurse visit note completed by the Clinical Manager and dated 8/16/2024 indicated the patient had wounds to the right lateral foot and right heel. On 8/27/2024, at 3:41 PM, the Clinical Manager indicated the wound to the right heel was documented incorrectly and should have been right ankle. 3. During a home visit observation of Licensed Practical Nurse (LPN) 2 providing care to Patient #13, on 8/26/24 beginning at 1:00 PM; during the observation, LPN 2 failed to evidence use of a stethoscope to auscultate (listen for sounds) lungs nor bowels. Patient’s demeanor during the visit was calm and kind and Patient’s voice was clear as he/she asked questions regarding their care and explained their symptoms. Patient reported leg pain at a level of 5 out of 1- 10 scale, [0 being no pain and 10 being severe pain]. The clinical record for Patient #13 revealed a skilled nurse visit note for 8/26/24 by LPN 2 that indicated Patient’s pain level was reported at a 4 out of 10. The record revealed documentation that Patient’s lungs and bowel sounds were not assessed due to anxiety and agitation. During an interview on 8/26/24 beginning at 2:40 PM, LPN 2 relayed she can hear Patient’s bowel sounds when near Patient, so she did not listen with her stethoscope, and she usually does listen to lungs sounds with a stethoscope, though forgot. During an interview on 8/28/24 beginning at 2:50 PM, LPN relayed that she forgot to auscultate Patient’s lungs and bowels and that she cares more for Patient than her lungs. LPN revealed she thought she charted a 5 (out of 10) for pain.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on record review, observation, and interview the agency failed to ensure the content of the comprehensive assessment accurately reflected the patient’s current health, psychosocial, functional, and cognitive status in 3 of 4 active clinical records reviewed (Patients #9, 11, and 13). Findings include: 6. The clinical record review for Patient #11 evidenced a comprehensive assessment dated 8/21/2024 and signed by the Clinical Manager which indicated Patient had a foley catheter (a plastic tube inserted into the bladder and kept in position by an inflated balloon). The assessment failed to include the patency of the catheter, the amount and color and clarity of the urine in the drainage bag. On 8/28/2024, at 2:40 PM, the Clinical Manager indicated the comprehensive did not include though should have included the patency of the tube and urine drainage to include the amount, urine color, and any sediment. 410 IAC 17-14-1(a)(1)(A) 1. The agency policy titled “Admission Policy/Skilled Nursing Services” indicated the nurse admission assessment included a review of all medications and drugs and patient’s response to the drug. 2. The agency policy titled “Comprehensive Client Assessment,” revised 8/2016, indicated the comprehensive assessment should be thorough, consistent with patient needs, and include collecting data about the patient’s physical, functional, and psychological health history. 3. The agency policy titled “Plan of Care,” revised 8/2016, indicated the plan of care (POC) should include all pertinent diagnoses, principle and secondary. 4. The clinical record for Patient #9 revealed a start of care 8/17/23 with a history and physical [H & P] by Other 16 (Patient’s physician) received by agency in July of 2023. The H & P revealed Patient diagnoses included a seizure disorder, severe depression with psychotic features, and a benign hemangioma (tumor). The comprehensive assessment, dated 8/10/24, included the diagnoses of hypertensive heart disease without heart failure, Type 2 diabetes mellitus, and cerebellar stroke syndrome. The clinical record revealed discharge paperwork, received from Entity #17 dated 8/10/24, that included hospitalization discharge diagnoses of impulsive suicidal ideation and recurrent major depression. As of the date of record review on 8/22/24, the clinical record failed to evidence a review of the hospital diagnoses, to include suicidal ideation and recurrent depression nor the previously identified diagnoses of seizures and a tumor. During an interview, on 8/22/24 beginning at 4:30 PM, the Clinical Supervisor relayed she was unaware Patient had a history of seizures nor a brain tumor, revealed she was aware that Patient was suicidal prior to hospitalization in July 2024. During an interview on 8/26/24 beginning at 12:05 PM, Other 16 relayed Patient #9 had an inoperable brain tumor that may have caused suicidal ideation, depression, and seizures. 5. The clinical record of Patient #13 revealed a discharge summary from Entity 5, dated 7/26/24, that indicated the following medications were discontinued: allopurinol (gout medication), Plavix (blood thinning medication), and lisinopril (blood pressure medication). The record included a resumption of care comprehensive assessment, dated 7/29/24, and completed by the Clinical Supervisor, that indicated a medication review was conducted. The clinical record failed to evidence an accurate medication list and review; the medications Allopurinol, Plavix, and Lisinopril were listed as current medications at time of review. During a home visit observation, on 8/26/24 beginning at 1:00 PM, License Practical Nurse (LPN) 2 began a medication review; Patient #13 provided their discharge documentation, dated 7/26/24, and relayed which medications were discontinued at discharge. LPN 2 relayed she did not realize Patient’s medications were changed with their discharge from Entity 5.”

“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 the medications the patient was currently using, to identify any potential adverse effects and / or drug reactions in 2 of 4 active patient records reviewed (Patients #11 and13) and 1 of 2 home visit observation of patient care who received skilled services (Patient #2). Findings include: 4. During an observation of care at the home of Patient #2 on 8/23/2024 at 9:53 AM, lidocaine patches (a topical medication used to treat pain), a tube of diclofenac (a medicated cream used to treat pain), and a bottle of Benadryl (a medication used to treat allergies) were observed on the table next to Patient. Patient indicated he/she applies lidocaine patches and diclofenac cream to his/her back as needed for pain and has done that for “years” and was taking Benadryl for a current sinus infection. A clinical record review of the medication profile, dated 8/8/2024 and signed by the Clinical Manager, failed to evidence diclofenac, lidocaine, and Benadryl. A review of the comprehensive assessment dated 8/8/2024 and signed by the Clinical Manager indicated no issues were found during the medication review. The clinical record failed to evidence lidocaine, diclofenac, and Benadryl were reviewed for adverse side effects and drug interactions, by survey exit. On 8/23/2024, at 4:46 PM, the Clinical Manager indicated she did not review the lidocaine, diclofenac, and Benadryl during the medication review. 5. A clinical record review for Patient #11 evidenced the drug-drug interactions, dated 8/23/2024, which indicated 2 moderate drug interactions between warfarin (a medication used to thin the blood to treat/prevent blood clots) and Tramadol (a medication used to treat pain) which could result in difficulty with blood clotting and between warfarin and Vitamin B3 in the multivitamin which could increase bleeding. The comprehensive assessment dated 8/21/2024 and signed by the Clinical Manager, failed to evidence the assessment included a review of the medications to identify drug interactions. On 8/27/2024, at 3:33 PM, the Clinical Manager indicated there were 2 moderate and 2 minor drug interactions that were not documented on the comprehensive assessment. 410 IAC 17-14-1(a)(1)(B) 1. The agency policy titled “Medication Profile” indicated the clinician should review a complete list of all medications the patient is taking to identify adverse reactions, significant side effects, and contraindicated medications. The clinician shall promptly notify the physician of any identified problems. 2. The record review of Patient #9 revealed a plan of care (POC) for dates 8/17/24 to 10/9/24 that included Patient’s medication list with a total of 28 separate listed medications. The electronic medical record medication interaction review included 3 of the 28 medications and failed to evidence an interaction assessment for 25 of Patients’ medications. 3. The record review of Patient #13 revealed a POC for dates 7/22/24 to 9/19/24 that included Patient’s medication list with a total of 26 medications. The electronic medical record medication reconciliation failed to include aspirin (an anticlotting medication) within the interaction review. During an interview on 8/22/24 beginning at 4:30 PM, the administrator acknowledged all of Patients medications were not reviewed, and referred to a known issue with how medications are entered into the electronic medical record.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the plan of care included all treatments, services, and medications in 3 of 4 active clinical records reviewed. (Patients # 2, 9, and 11) The findings include: 3. The clinical record of Patient #9 included a physician’s order, dated 5/28/24 and signed by Patient’s physician, which revealed Patient was to consume nectar thick fluids, due to diagnosis of dysphagia (difficulty swallowing); the order also indicated Patient may have thin liquids if requested. The plan of care, dated 8/11/24 to 10/9/24, failed to evidence the order for thickened liquids. A physician’s order dated 5/24/24 revealed home health services were being provided by Entity #7 (a home health agency). The POC dated 8/11/24 to 10/09/24 failed to evidence the services provided by Entity 7. Entity 7 provided a plan of care for dated 8/15/24 to 10/15/24 for weekly skilled nurse visits. During an interview on 8/22/24 beginning at 4:30 PM, the administrator indicated they were not aware of the other home health agency and the care they provided to Patient. The Clinical Supervisor indicated Patient preferred to not to consume the nectar thickened liquids, so they did not include within the POC. 410 IAC 17-13.1(a)(1)(c) 1. During an observation of care at the home of Patient #2 on 8/23/2024 at 9:53 AM, lidocaine patches (a topical medication used to treat pain), a tube of diclofenac (a medicated cream used to treat pain), and a bottle of Benadryl (a medication used to treat allergies) were observed on the table next to the patient. On 8/23/2024, beginning at 9:45 AM, the patient indicated Person 22 came to the assisted living facility (ALF), where the patient resided, every Friday and recently prescribed an antibiotic for a sinus infection. The patient indicated he/she applies lidocaine patches and diclofenac cream to his/her back as needed for pain and has done that for “years” and was taking Benadryl for a sinus infection. A clinical record review for Patient #2 evidenced a plan of care for certification period 8/4/2024-10/2/2024 evidenced the medications included, but were not limited to, ibuprofen (to treat pain/inflammation) as needed, ipratropium bromide (for shortness of breath) as needed, and albuterol (for shortness of breath) as needed. The plan of care failed to be individualized to include the indications for use as needed. The plan of care failed to include the diclofenac, lidocaine, and Benadryl. On 8/23/2024, beginning at 3:48 PM, the Clinical Manager indicated the plan of care did not specify for what reasons the medications were to be taken as needed and indicated she did not review the lidocaine, diclofenac, and Benadryl. On 8/25/2024, at 2:35 PM, the Clinical Manager indicated a nurse practitioner provided visits to the patients at the ALF and the plan of care did include the ability to accept orders from the nurse practitioner at the ALF. 2. A clinical record review for Patient #11 evidenced a plan of care for certification period 6/26/2024-8/24/2024 which indicated the patient’s medications included bisacodyl (to treat constipation) as needed, calmoseptine (to treat skin irritation) apply a thin layer and as needed, and Tramadol (for pain) as needed. The plan of care failed to be individualized to include the indications for use for the medications as needed and failed to include to where the calmoseptine was to be applied. On 8/27/2024, at 3:34 PM, the Clinical Manager indicated the plan of care did not include the indications for use as needed and to where the calmoseptine was to be applied.”

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure the primary care physician was promptly alerted of relevant changed in the patient’s condition or needs in 1 of 2 active clinical records with a home visit (Patient #13). Findings include: The agency policy titled “Skilled Nursing Service,” reviewed 8/2016, indicated the nurse regularly reevaluates the patient’s needs, coordinates necessary services, and informs the physician of changes in the patient’s condition or needs. During a home visit observation, on 8/26/24 beginning at 1:00 PM, Patient #13 reported to License Practical Nurse (LPN) 2 a rash to his/her groin, reported feeling dizziness during the night and in the morning, reported nausea, weakness, and feeling tired during the home visit and reported seeing circles in their vision field. On 8/28/24, the clinical record of Patient #13 failed to evidence notification to patients’ physician of their groin rash, visual disturbances, nor their nausea, weakness, and dizziness. During an interview on 8/28/24 beginning at 2:50 PM, LPN 2 relayed Patient spoke to their physician about their rash and elevated blood pressure and indicated they [LPN2] had not reported the assessment findings to the attending physician. 410 IAC 17-13-1(a)(2)”

“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 interview and record review the agency failed to evidence integration of all services to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness in 3 of 4 active clinical records reviewed (Patient #2, 9, 13). Findings include: 4. A clinical record review for Patient #2 evidenced the patient resided in Entity 3 (assisted living facility, ALF). A review of the medication list for 8/1/2024 through 8/31/2024 provided by Entity 3 indicated the patient’s medication included Trazodone (an antidepressant used for sleep), failed to include sertraline (an antidepressant), and indicated Lexapro (an antidepressant) was discontinued on 8/12/2024. The home health plan of care for certification period 8/4/2024-10/2/2024 failed to evidence Trazodone and included sertraline and Lexapro. On 8/23/2024, at 4:38 PM, the Administrator indicated the Trazodone was not included in the patient’s plan of care and both Lexapro and sertraline were included. The Administrator indicated the nurse should coordinate care with the ALF at every visit to include getting a medication list and indicated the agency would have to check into the medications. 410 IAC 17-12-2(h) 1. The agency policy titled “Plan of Care”, reviewed 8/2016, indicated the plan of care (POC) should be individualized to include all services, treatments, and procedures to meet patient specific needs. 2. The clinical record of Patient #13 revealed a plan of care dated 7/22/24 to 9/19/24 that included a heart healthy and renal diet, no concentrated sweets, and included received hemodialysis treatment on Mondays, Wednesdays, and Fridays at Entity #6. The clinical record failed to evidence communication, report, nor integration of services with Entity #6. The clinical record failed to evidence a daily fluid restriction for Patient. During an interview on 8/23/24 beginning at 2:00 PM, Other #18, Registered Nurse (RN) for practitioner at Entity 6 relayed Patient #13 was on a strict fluid restriction of 32 ounces of liquid per day, maximum. On 8/26/24 beginning at 11:13 AM, Other #19, the nurse practitioner at Entity 6 relayed Patient had a fluid restriction of 32 ounces daily. During an interview, after a home visit observation on 8/26/24, beginning at 2:30 PM, Patient #13 relayed they were allowed no more than one bottle of water, per day. During an interview on 8/26/24 beginning at 2:40, License Practical Nurse (LPN) 2 relayed she was unaware Patient had a fluid restriction. During an interview on 8/27/24 beginning at 10:30 PM, the Clinical Supervisor relayed she was unaware Patient had a fluid restriction. 3. The clinical record for Patient #9 revealed a transfer assessment, dated 7/30/24 that indicated Patient was transferred to Entity 17. A physician’s order for the resumption of home health services included home health aide (HHA) services and a resumption of care comprehensive reassessment was completed on 8/10/24 by the Clinical Manager. A HHA visit document, completed by HHA 5 and dated 8/12/24, indicated the visit was not conducted, was missed, because Patient needed to be reassessed, post hospitalization. During an interview on 8/28/24 beginning at 10:20 AM, HHA 5 relayed the HHA services were to start 8/13/24 because Patient needed to be reassessed after a hospitalization. During an interview on 8/22/24 beginning at 11:00 AM, Administrator relayed HHA 4 assists in scheduling other HHA’s. During an interview on 8/28/24 beginning at 1:05 PM, HHA 4 relayed the missed visit for Patient #9 on 8/12 was due to a miscommunication and not being informed that Patient was home and reassessed.”

“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 home health aide (HHA) provided services included in the plan of care in 3 of 4 active clinical records reviewed (Patients #2, 9, 13). Findings include: 4. A clinical record review for Patient #2 evidenced a HHA care plan for certification period 8/4/2024 - 10/2/2024, which indicated the HHA to assist patient with shaving and could shop weekly. The HHA visit notes for the week of 8/11/2024 - 8/17/2024, dated August 13, 14, 15, and 16, 2024 and completed by HHA 4 that failed to evidence the HHA assisted Patient with shaving as assigned. The aide visit notes dated August 14, 15, 16, 19, 20, 21, and 22, 2024 completed by HHA 4 indicated the HHA shopped for Patient. On 8/28/2024, at 2:09 PM, HHA 4 indicated Patient did not request to be shaved so it was not completed. HHA 4 indicated sometimes she shopped for Patient several times a week. On 8/23/2024, at 4:09 PM, the Administrator indicated the HHA was to provide the services as directed in the care plan though could mark “not applicable” if the services were not needed. 1. The agency policy titled “Home Health Aide Care Plan” was to provide means of assigning duties to the HHA for the client’s individualized, specific needs. 2. The clinical record for Patient #9 revealed a HHA plan of care (POC) dated 8/11/24 to 10/9/24 that included the oral care task to complete at every visit. HHA visits 8/13/24, 8/14/24, and 8/15/24 revealed oral care marked as NA (not applicable). During an interview on 8/28/24 beginning at 10:20 AM, HHA 5 relayed making NA on tasks means not applicable because Patient didn’t want to do it, and didn’t want to chart that Patient refused. During an interview on 8/22/24 beginning at 11:00 AM, Administrator relayed HHA 4 assists in scheduling and supervising agency HHA’s. During an interview on 8/28/24 beginning at 12:00 PM, HHA 4 relayed agency HHA are supposed to chart either completed or refused for tasks and not chart NA. 3. The clinical record for Patient #13 revealed a HHA POC dated 7/22/24 to 9/19/24 indicating changes in Patient’s condition should be reported. The HHA visit dated 8/26/24 revealed comments reporting Patient was feeling lightheaded. The record failed to evidence documentation regarding changes in Patient’s condition. During an interview on 8/27/24 beginning at 8:55 AM, HHA 12 relayed Patient was lightheaded but felt better so it was not reported.”

“If concern identified, direct observation CFR(s): 484.80(h)(1)(ii) If an area of concern in aide services is noted by the supervising registered nurse or other appropriate skilled professional, then the supervising individual must make an on-site visit to the location where the patient is receiving care in order to observe and assess the aide while he or she is performing care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse completed the aide supervisory visit on site in 2 of 2 records reviewed with skilled nurse services and aide services for more than 30 days (Patients 2 and 11). Findings include: 1. A clinical record for Patient #2 evidenced a plan of care for recertification period 8/4/2024 - 10/2/2024 which indicated Patient received skilled nursing services 1 time a week and home health aide (HHA) services 5 days weekly. A HHA supervisory visit, dated 8/15/2024 and completed by the Clinical Manager was noted; no skilled nursing note was evidenced within the record. On 8/23/2024, at 4:07 PM, the Clinical Manager indicated she did not perform a skilled nursing visit on 8/15/2024 at the time of the supervisory visit and indicated the supervisory visit was not conducted on site but via the phone. 2. A clinical record for Patient #11 evidenced a plan of care for certification period 6/26/2024 - 8/24/2024 which indicated Patient received skilled nursing services 2 times a week and HHA services 5 days a week. A HHA supervisory visit dated 8/20/2024 and completed by the Clinical Manager was noted, but no skilled nursing note was evidenced. On 8/27/2024, at 3:30 PM, the Clinical Manager indicated the supervisory visit was not completed on-site but over the phone with the patient’s wife.”

“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 home health aide (HHA) was supervised to ensure the aide furnished care that followed the patient’s plan of care in 2 of 4 active clinical records reviewed. (Patients #2 and 9) The findings include: 3. A clinical record review for Patient #2 evidenced a HHA care plan for the certification period 8/4/2024 - 10/2/2024, which indicated the HHA would provide up to 10 hours a day of HHA services to include assist Patient with shaving weekly and shopping for Patient weekly. The HHA visit notes during the week of 8/11/2024-8/17/2024 dated 8/13/2024, 8/14/2024, 8/15/2024, and 8/16/2024, completed by HHA 4, failed to evidence the HHA assisted Patient with shaving as assigned. The visit notes dated 8/14/2024 and 8/15/2024 indicated the HHA shopped for Patient. HHA visit notes dated 8/13/2024 and 8/15/2024 indicated the HHA provided 12 hours of HHA services each day. The HHA supervisory visit note completed by the registered nurse (RN) and dated 8/15/2024, indicated the HHA provided care per the care plan and failed to evidence the RN provided home health aide supervision to ensure the HHA followed the care plan as directed. On 8/23/2024, at 4:30 PM, the Administrator indicated the HHA was not following the care plan and the RN should not have documented that the aide was following the care plan. 410 IAC 17-14-1(n) 1. The agency policy titled “Home Health Aide: Documentation” indicated the Home Health Aides (HHA) document care and services provided to patient on each visit. The designated Registered Nurse (RN) or therapist is responsible for reviewing the HHA charting. 2. The clinical record for Patient #9 revealed a Home Health Aide (HHA) care plan dated 8/11/24 to 10/9/24 that included the task to assist with oral care with every visit. HHA visit documentation for August 13, 14, and 15, 2024 included documentation of NA (not applicable) for the task of oral care. The record included supervisory visit documentation dated 8/15/24, by the Clinical Supervisor. During an interview on 8/28/24 beginning at 10:20 AM, HHA 5 relayed marking NA on tasks means not applicable because Patient didn’t want to do it, and didn’t want to chart that Patient refused. During an interview on 8/28/24 beginning at 12:00 PM, HHA 4 relayed agency the HHA’s are supposed to chart either completed or refused for tasks and are not to chart “NA.” During an interview on 8/22/24 beginning at 4:30 PM, Clinical Manager relayed she was unaware aide tasks were documented as NA for Patient.”

“Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This Condition is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure: the initial assessment was completed within 48 hours of referral (see tag G0514); the comprehensive assessment included the patient’s current health status (see tag G0528); the comprehensive assessment included a review of all patient medications (see tag G0536); and the comprehensive assessment was completed at time of discharge (see tag G0550). 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 484.55 Comprehensive Assessment of Patients.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure: the plan of care was reviewed by the physician, individualized and followed by all agency staff (See tag G0572); the plan of care included all required information / elements for the treatment of the patient (See tag G0574); all treatments provided by agency staff were ordered by a physician (See tag G0580); the plan of care was reviewed by the patients primary care physician at least every 60 days (See tag G0588); physicians were promptly notified of a change in the patient’s condition (See tag G0590); the plan of care was revised to reflect current health status and nursing needs (See tag G0592); coordination of care for all services provided to the patient (See tag G0606); the written visit schedule was provided to patients (See tag G0614); written instructions were provided to the patient for the patient’s medication schedule and instructions (See tag G0616); and the treatments to be administered by agency personnel were provided to the patient and caregiver in writing (See tag G0618). 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 meet the patient’s needs in 4 of 5 active clinical records reviewed. (Patient #1, 3, 4, 5) The findings include: XX. A record review for Patient #3 indicated physical therapy instructions in orders for discipline and treatment for the certification periods of 7/3/23 through 8/31/23, 9/1/23 through 10/30/23, 10/31/23 through 12/29/23, 12/30/23 through 2/27/24, and 2/28/24 through 4/27/24. During an interview on 4/2/24, beginning at 3:34 p.m., the Administrator verbalized that it was believed that Patient #3 went out for therapy but was unsure and unable to provide physical therapy notes. During an interview with the Clinical Manager and Administrator on 4/3/24, beginning at 12:10 p.m., the Administrator was unable to find any physical therapy notes. XX. Clinical record review for Patient #5 indicated an initial order for OT on 12/20/23. Orders for OT and ST were located under the orders for discipline and treatment for certification period of 2/25/24 through 4/24/24. During an interview on 4/4/24, beginning at 1:16 p.m., the Administrator and the Clinical Manager verbalized Patient #5 should have had occupational therapy (OT) sent to the patient’s home and was not done in error. The Administrator indicated speech therapy (ST) was not available and that the patient, family, and physician were all notified. Agency unable to provide documentation of these notifications. During an interview with Patient #5 on 4/4/24, during a home visit observation beginning at 10:48 a.m., Patient #5 verbalized that they had never received occupational therapy or speech therapy. Patient #5 expressed interest in receiving speech therapy due to concerns with speech verbalization at times. 1. A clinical record review for Patient #1 evidenced a referral intake form dated 7/26/2023, which indicated the physical therapy (PT) and occupational therapy (OT) services were ordered. The start of care comprehensive assessment dated 7/25/2023 indicated the patient was at risk for falls, had an unsteady gait and joint stiffness, and required assistance with grooming and dressing, A face-to-face encounter dated 8/9/2023 indicated the physician ordered PT and OT services. Review failed to evidence PT and OT services were provided by the agency. On 4/2/2024, at 2:26 PM, the Administrator indicated the agency had not provided PT or OT services. 2. A clinical record review for Patient #4 evidenced documents from Entity 5 (hospital) dated 12/15/2023, which indicated the physician ordered home health services to include PT and OT services. A face-to-face document signed and dated by the physician on 2/5/2024 indicated the physician deemed PT and OT medically necessary. The start of care comprehensive assessment dated 12/29/2024 indicated the patient had poor balance, muscle weakness, unsteady gait, was a high risk of falls, and required assistance with grooming and dressing. Review failed to evidence PT and OT services were provided by the agency. On 4/3/2024, at 2:53 PM, the Administrator indicated the patient’s family did not want PT and OT services but indicated there was no documentation of the communication with the family regarding therapy and no documentation the physician was notified of the patient’s family refusal of therapy services as ordered. 410 IAC 17-13-1(a)”

“HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA’s patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to include in the comprehensive assessment the patient’s individual emergency preparedness and failed to develop a patient-specific emergency preparedness plan in 2 of 3 home visits. (#1, 2) The findings include: 1. During an observation of care at the home of Patient #1 on 4/2/2024, at 12:43 PM, an agency document titled “Patient Individualized Emergency Plan” was reviewed and found to be blank. 2. During an observation of care at the home of Patient #2 on 4/2/2024, at 10:03 AM, an agency document titled “Patient Individualized Emergency Plan” was reviewed and found to be blank. 3. On 4/2/2024, at 3:02 PM, the Clinical Manager indicated the patient should be assessed for their emergency preparedness and then the nurse should complete the individualized emergency plan with patient-specific information and leave it in the patient’s home folder.”

“Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to electronically transmit the completed OASIS (Outcome and Assessment Information Set) assessment to the CMS (Centers for Medicare and Medicaid Services) system within 30 days of the completion of the patient assessment in 5 of 5 active clinical records reviewed. (Patient #1, 2, 3, 4, 5) The findings include: XX. A review of Patient #3’s record evidenced the patient’s payor source was Medicare and evidenced a start of care OASIS assessment completed on 5/23/23, recertification OASIS assessment completed on 9/26/23, recertification OASIS assessment completed on 12/28/23, and recertification OASIS assessment completed on 2/22/24, none of which were transmitted. XX. Clinical record review for Patient #5 evidenced the patient’s payor source was Medicaid and evidenced a start of care OASIS assessment completed on 7/3/23 and recertification OASIS assessment completed on 2/23/24, neither of which was transmitted. 1. A clinical record review for Patient #1 evidenced the patient’s payor source was Medicaid and evidenced a start of care OASIS assessment completed on 7/25/2023, recertification OASIS assessments completed on 11/21/2023 and 1/18/2024, and a transfer discharge OASIS assessment completed on 3/1/2024, none of which were transmitted. 2. A clinical record review for Patient #2 evidenced the patient’s payor source was Medicaid and evidenced a start of care assessment dated 2/7/2024 which was not transmitted. 3. A clinical record review for Patient #4 evidenced the patient’s payor source was Medicaid and evidenced a start of care OASIS assessment completed on 12/27/2023 and a recertification OASIS assessment completed on 2/26/2024, neither of which were not transmitted. 4. On 4/1/2024, at 4:46 PM, the Administrator indicated the contracted biller was supposed to transmit the OASIS assessments and indicated transmission was only completed for Medicare patients and not patients with Medicaid. 5. On 4/5/2024, at 10:15 AM, the Administrator indicated she could not find any OASIS assessment transmissions since July 2023.”

“Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient’s goals of care and treatment preferences. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to conduct a comprehensive assessment at time of discharge in 1 of 3 closed clinical records reviewed. (Patient #8) The findings include: A review of a policy last reviewed on 8/2/16 titled “Client Discharge Process” indicated the agency would develop a discharge plan in writing which would include all written/verbal instruction regarding the patient’s ongoing care needs and a list of agencies provided to the patient to meet the continuing care needs. The policy indicated the physician would be involved in the discharge plan and the communication with the patient to include the reason for discharge would be documented in the clinical record. A review of the addendum for the policy titled “Client Discharge Process” dated 3/26/2024 indicated the agency would provide the patient a notice of discharge at least 15 days prior to services being stopped. A clinical record review for Patient #8 evidenced a discharge comprehensive assessment dated 3/15/2024, which indicated the patient was discharged from the agency due to the patient’s failure to follow the plan of care and the agency was no longer able to meet the needs of the patient due to acuity level. Review failed to evidence the patient was provided notice of discharge at least 15 days prior to services stopped and failed to evidence communication with the patient and physician regarding the agency’s plans to discharge prior to discharge and patient’s non-compliance with the plan of care. The clinical record failed to evidence the list of agencies provided by the agency to the patient for continuing care needs. On 4/5/2024, at 2:32 PM, the Clinical Manager indicated there was no list of agencies provided to the patient for continuing care needs and no documentation prior to discharge of communication with the physician and patient regarding the plan to discharge and patient non-compliance with the plan of care. The Clinical Manager indicated she could not find that a discharge notice was provided to the patient prior to discharge.”

“Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the discharge and transfer summary included all information pertaining to the patient’s current course of illness and treatment and post-discharge goals and failed to ensure the summaries were sent to the receiving facility or health care practitioner in 1 of 1 active patient with a hospitalization (Patient #1) and 3 of 3 closed clinical records reviewed (Patients #6, 7, and 8). The findings include: XX. Clinical record review of Patient #6 failed to evidence the communication of the discharge summary from the agency to the discharging physician. During an interview on 4/5/24, beginning at 12:15 p.m., the Clinical Manager verbalized they were unable to locate that the discharge summary was sent to the physician. XX. A review of Patient #7’s record failed to evidence notification of discharge to provider and failed to evidence submission of the discharge summary to the attending provider. During an interview on 4/5/24, beginning at 12:15 p.m., the Administrator and the Clinical Manager verbalized nothing was documented in the chart for Patient # 7 except that the discharge OASIS was submitted. The Administrator failed to evidence the submission of the discharge summary to the physician. 1. A clinical record review for Patient #1 evidenced the patient was hospitalized beginning 3/1/2024. The transfer summary dated 3/4/2024 failed to include the patient’s medications and progress to goals and failed to include where the patient was transferred to. Review failed to evidence the transfer summary was sent to the receiving facility. On 4/2/2024, at 2:47 PM, the Administrator indicated the agency does not send transfer summaries to the hospital but just calls to give a verbal report and indicated the transfer summary did not include the patient’s medications and goals. 2. A clinical record review for Patient #4 evidenced a discharge summary dated 4/1/2024, which indicated the patient was discharged from the agency on 3/15/2024 and failed to include the patient’s medications and status of goals. Review failed to evidence the summary was sent to the physician. On 4/5/2024, at 2:33 PM, the Clinical Manager indicated the discharge summary was not complete and was not sent to the physician.”

“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 provide the services as directed in the plan of care in 3 of 5 active clinical records reviewed. (Patient #1, 2, 4) The findings include: 1. A clinical record review for Patient #1 evidenced a plan of care for certification period 3/7/2024-5/5/2024, which indicated the agency would provide home health aide (HHA) services up to 8 hours a day, 7 days a week. The agency failed to provide HHA services 7 days a week during the weeks of 3/10/2024 (5 visits), 3/17/2024 (5 visits), and 3/24/2024 (3 visits). The agency provided more than 8 hours of HHA services on 3/11/2024, 3/12/2024, 3/13/2024, 3/15/2024, 3/18/2024, 3/19/2024, 3/20/2024, 3/22/2024, 3/25/2024, 3/26/2024, 3/27/2024, and 4/1/2024. On 4/2/2024, at 3:25 PM, the Administrator indicated the HHA visits depended on the caregiver’s work schedule and indicated since the agency did not provide visits 7 days a week, the agency spread out the hours of HHA services putting the number of hours a day of HHA services over 8 hours. The Administrator indicated the agency needed to update the order for HHA services. 2. A clinical record review for Patient #2 evidenced a plan of care for certification period 2/6/2024-4/5/2024, which indicated the agency was to provide HHA services up to 10 hours per day, 7 days per week for 9 weeks and skilled nursing services 1 time every other week. Review failed to evidence the agency provided HHA visits prior to 3/6/2024 and failed to evidence the agency provided skilled nursing visits between 2/22/2024 and 3/29/2024. Review indicated the agency did not provide HHA visits 7 days a week during the weeks of 3/3/2024 (3 visits), 3/10/2024 (5 visits), 3/17/2024 (5 visits), and 3/24/2024 (4 visits). On 4/3/2024, at 4:17 PM, the Clinical Manager indicated maybe the agency was waiting on the prior authorization before HHA services could begin. On 4/3/2024, at 4:17 PM, the Office Manager indicated the agency had to wait until HHA 2 was trained before HHA services could begin. On 4/3/2024, at 4:27 PM, the Administrator indicated the patient’s original nurse left without notice and the skilled nursing visits were overlooked since the agency did not have a replacement. The Administrator indicated there were no other HHA visits provided. 3. A clinical record review for Patient #4 evidenced a plan of care for certification period 2/27/2024-4/26/2024, which indicated the agency was to provide skilled nursing services 1 time every other week for 9 weeks and HHA services 7 days a week for 9 weeks. Review failed to evidence skilled nursing services were provided since 2/26/2024 and failed to evidence HHA services were provided between 2/20/2024 and 3/11/2024. On 4/3/2024, beginning at 3:33 PM, the Administrator indicated there were no other skilled nursing visits since 2/26/2024 because the patient’s former nurse was no longer employed. The Administrator indicated the agency was waiting on the prior authorization for HHA services so no HHA services were provided from 2/21/2024 until 3/11/2024. 410 IAC 17-13-1(a)”

“Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This Standard is not met as evidenced by: Based on observation, record review, and interview, the registered nurse (RN) failed to assign tasks appropriately to the home health aide (HHA) in 2 of 5 active clinical records reviewed. (Patient #2, 4) The findings include: 1. During an observation of care at the home of Patient #2 on 4/2/2024, at 10:08 AM, the patient was found to be residing alone in an assisted living facility. A clinical record review evidenced a HHA care plan dated 2/10/2024, which indicated the caregiver status was the patient lived at home with his/her son and the HHA was to limit fluids and obtain vital signs weekly. Review of the plan of care for certification period 2/6/2024-4/5/2024 failed to evidence the patient’s diet included a fluid restriction. On 4/3/2024, beginning at 3:49 PM, the Clinical Manager indicated the patient moved to an assisted living facility in December 2023 and the HHA care plan should have been revised. On 4/3/2024, at 4:23 PM, the Administrator indicated the patient was not on a fluid restriction and fluid restriction should not have been included on the HHA care plan. The Administrator indicated HHAs were not to obtain vital signs and it should not have been assigned to the HHA on the care plan. 2. A clinical record review for Patient #4 evidenced a plan of care for certification period 2/27/2024-4/26/2024, which indicated the agency was to provide home health aide services 7 days a week for 9 weeks and indicated the patient’s safety measures included seizure precautions. A HHA care plan dated 12/29/2023 failed to evidenced seizure precautions were included in the safety measures and indicated the HHA frequency was 2 days per week. On 4/3/2024, at 3:28 PM, the Administrator indicated the HHA frequency was not correct and the seizure precautions were not included. The Administrator indicated the HHA care plan should match the medical plan of care. 410 IAC 17-14-1(m)”

“Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its quality assessment and performance improvement program. This Standard is not met as evidenced by: Based on record review and interview, the governing body failed to develop and review the budget. The findings include: A review of a policy titled “Agency Budget Planning” indicated there should be an operating budget that should include all anticipated income and expenses that is prepared before the beginning of the fiscal year. The policy indicated the Administrator is responsible for reviewing the budget. On 4/2/2024, at 4:38 PM, the Administrator indicated she could not locate the budget and believed it was on a zip drive that she could not find.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the entries in the clinical record were accurate and completed at time of the visit in 2 of 5 active clinical records reviewed. (Patient #2, 4) The findings include: 1. A review of an undated policy titled “Clinical Documentation” indicated documentation would be completed the day services were rendered and would include the actual time and length of the visit. 2. A clinical record review for Patient #2 evidenced home health aide (HHA) visit notes with a visit date of 3/7/2024 from 5:35 PM to 9:39 PM and another visit note from 6:00 PM to 10:00 PM, both completed by HHA 2. HHA visit notes with a visit date of 3/21/2024 from 6:07 PM to 10:11 PM and another visit note from 6:08 PM to 10:20 PM were both evidenced to be completed by HHA 2. A HHA visit on 3/21/2024 was not completed and signed by HHA 2 until 3/30/2024. On 4/3/2024, at 4:12 PM, the Administrator indicated there should only be 1 visit note for each day completed by HHA 2 and indicated the second visit note was completed by the Administrator, as she was training HHA 2 on documentation. The Administrator indicated HHA 2 was late completing her visit notes because she needed training on documentation. 3. A clinical record review for Patient #4 evidenced HHA visit notes completed by HHA 3 dated 3/28/2024 and 4/2/2024, which indicated the visit was 1 minute in length. Visit note dated 4/1/2024 failed to evidence an end time for the visit. On 4/3/2024, at 2:57 PM, the Administrator indicated the ending time of the visit should have been documented and indicated the 1-minute visit length was not accurate and would provide the correct visit times. No additional documentation was provided prior to survey exit on 4/5/2024. 410 IAC 17-15-1(a)(7)”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient was informed of and consented to in advance of care the disciplines that were to furnish care and the frequency of visits in 1 of 5 active clinical records reviewed. (Patient #4) The findings include: A clinical record review for Patient #4, start of care 12/29/2023, failed to evidence the patient was informed of consent to home care services to include the disciplines that were to furnish care and the frequency of visits. On 4/3/2024, at 3:46 PM, the Administrator indicated she could not find the patient’s consent to home care and indicated there were issues with the nurse that did the start of care who was to obtain the patient’s consent. 410 IAC 17-12-3(b)(2)(D)(ii)(AA)”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on record review and interview, the agency failed to conduct an initial assessment within 48 hours of referral for 3 of 5 active clinical records reviewed. (Patient #2, 3, 4) The findings include: 2. A clinical record review for Patient #2 evidenced a referral for home care services from the patient’s physician with a fax received date of 2/6/2024. The start of care comprehensive assessment indicated the referral date was 2/6/2024 and indicated the date of the start of care assessment was 2/10/2024, which was greater than 48 hours. On 4/3/2024, at 4:06 PM, the Administrator indicated there was no documentation on why the start of care was delayed. The Administrator indicated there was no documentation the physician requested was notified of the delay in the start of care and no documentation the patient requested the delay in the start of care. 3. A clinical record review for Patient #4 evidenced a referral for home care services from Entity 5, which was faxed to the agency on 12/15/2023 and indicated the patient was being discharged to home same day. The start of care comprehensive assessment was dated 12/29/2023, which was greater than 48 hours. On 4/3/2024, at 2:51 PM, the Administrator indicated the patient’s family member wanted to be the home health aide and needed to be trained, which delayed the start of care. 4. On 4/3/2024, at 2:55 PM, the Administrator indicated the start of care comprehensive assessment was conducted at the same time as the initial assessment. 410 IAC 17-14-1(a)(1)(A) Findings include: XX. The clinical record for Patient #3 indicated a referral date of 6/29/23 and a referral intake form with a fax receipt date showed 7/11/23. The Plan of Care indicated a start of care date of 7/3/23 as well as a initial RN assessment with that same date. XX. During an interview on 4/2/24, beginning at 3:34 p.m., the Administrator verbalized that the referral was received from the community and that the date of 6/29/23 was most likely the date a verbal referral was received. The Administrator verbalized that the date on the referral intake form was most likely dated from when the referral was sent back to the initiating provider. 410 IAC 17-14-1 (a)(1)(A)”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on record review and interview, the agency failed to evidence the comprehensive assessments were complete and accurately reflected the patient’s health status in 1 of 1 active clinical record reviewed with wounds (Patient #1) and 1 of 1 active clinical record reviewed receiving dialysis (a medical process removing waste products and extra fluid from the blood when kidneys are not operating properly). (Patient #3). The findings include: XX. Record review for Patient #3 evidenced a comprehensive assessment dated 2/23/24 that included documentation of presence of an AV fistula (a surgical connection between an artery and a vein for dialysis access). Record failed to evidence location of AV fistula and assessment of AV fistula. XX. During an interview on 4/2/24, beginning at 3:34 p.m., the Clinical Manager verbalized could not find the documentation of the AV location and verbalized it should be there. 1. A review of an undated policy titled “Assessment/Staging of Pressure Ulcers” indicated the assessment should include the size of the wound to include the depth, drainage, granulation (new tissue), and condition of surrounding tissue. 2. A clinical record review for Patient #1 evidenced a comprehensive assessment completed by registered nurse (RN) 1 and dated 3/7/2024, which indicated the patient had 2 Stage III pressure ulcers (a wound caused by pressure against the skin resulting in damage to the fatty tissue underneath the layers of skin) to the right buttocks and coccyx (lower back above the buttocks) and failed to include the assessment of the depth of the wound, the wound base, the surrounding tissue, and any odor or drainage. On 4/2/2024, at 1:22 PM, RN 1 indicated the wounds to the patient’s right buttocks and coccyx were open and Stage III at the time of the comprehensive assessment dated 3/7/2024. On 4/2/2024, at 3:30 PM, the Clinical Manager indicated wound depth should have been measured.”

“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 all medications were reviewed for potential adverse effects and drug reactions in 1 of 3 home visits. (Patient #2) The findings include: During an observation of care at the home of Patient #2 on 4/2/2024, at 10:24 AM, the patient’s medications were observed in the living room to include: fenofibrate (a medication used to treat high cholesterol) 160 milligrams (mg) at bedtime, magnesium (supplement), acetaminophen (pain reliever), and ibuprofen (pain reliever). A clinical record review evidenced a history and physical dated 1/24/2024 which indicated the patient had a dilaudid pump (a medical device implanted under the skin to deliver pain medication). The medication profile dated 3/29/2024 failed to evidence dilaudid, fenofibrate, magnesium, acetaminophen, and ibuprofen were included in the medication review. On 4/2/2024, at 10:24 AM, the patient indicated there had been no changes in the medications in weeks and not since the last nurse visit. On 4/3/2024, at 4:32 PM, the Administrator indicated dilaudid was not reviewed because she did not know the patient was still having the dilaudid pump filled. On 4/3/2024, at 4:34 PM, the Clinical Manager indicated the medications were not reviewed since they were not included on the medication profile. 410 IAC 17-14-1(a)(1)(B)”

“At discharge CFR(s): 484.55(d)(3) At discharge. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a comprehensive assessment was completed for 2 of 3 closed clinical records reviewed. (Patient #6, 8) The findings include: XX. Record review for Patient #6 evidenced a discharge non-visit, which was completed on 3/7/24. Review of record failed to evidence why in-person discharge OASIS assessment visit was not completed. Review of a policy last reviewed on 8/2/16 titled “Client Discharge Process” indicated the agency would conduct a comprehensive discharge assessment within 48 hours of discharge and should be performed in conjunction with a visit, if possible. If the discharge comprehensive assessment cannot be completed in conjunction with a visit, responses for the discharge assessment would be based on the last skilled visit and the date of the visit used would be documented in the discharge assessment. A clinical record review for Patient #8 evidenced a discharge non-visit, which indicated the patient was discharged on 3/15/2024. Review failed to evidence the reasoning for why a discharge assessment visit was not provided and failed to evidence the date of the last skilled visit used for the assessment per agency policy. On 4/5/2024, at 2:33 PM, the Clinical Manager indicated there was no documentation of whether the patient was offered a discharge assessment visit or why one was not conducted.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the individualized plan of care included all pertinent medical equipment, safety precautions, treatments and services for 5 out of 5 active clinical records reviewed. (Patient #1, 2, 3, 4, 5). Findings include: Based on observation, record review and interview, the agency failed to ensure the plan of care included all treatments, services, and medications in 3 of 5 active clinical records reviewed. (Patient #1, 2, 4) The findings include: 1. During an observation of care at the home of Patient #2 on 4/2/2024, at 10:08 AM, the patient was found to be residing alone in an assisted living facility (ALF) and connected to an oxygen concentrator (a medical device that supplies oxygen) by a tube that was inserted into the nose. At least 25 portable oxygen tanks were found in the patient’s home which the patient indicated were empty and needing to be picked up. A start of care comprehensive assessment indicated the assessment was completed on 2/10/2024, and indicated the patient had difficulty breathing while at rest. The comprehensive assessment indicated the patient had 4+ pitting edema (excess fluid in the tissues causing an indentation when pressure applied to the skin measured from 1+ to 4+ which 4+ being the worst) to both legs and feet. A clinical record review evidenced a plan of care for certification period 2/6/2024-4/5/2024, which indicated the patient’s diagnoses included, but were not limited to, congestive heart failure, and indicated the medications included, but were not limited to, albuterol as needed, which failed to evidence for what patient-specific indication the medication was needed. The plan of care indicated the patient lived at home with son and failed to evidence the care to be provided by the ALF. The plan of care evidenced the patient was to receive continuous oxygen at 3 liters per minute and failed to evidence who was the durable medical equipment (DME) company for the patient’s oxygen equipment. The plan of care failed to include interventions and goals related to the patient’s impaired respiratory status and oxygen use. The plan of care indicated the start date was 10/17/2023 instead of 2/10/2024. The plan of care failed to include interventions and goals related to the patient’s lower extremity edema. On 4/3/2024, beginning at 3:49 PM, the Clinical Manager indicated albuterol was needed for shortness of breath and the plan of care did not include the as needed medication indications. The Clinical Manager indicated the patient moved to an assisted living facility in December 2023 and the plan of care should be revised to reflect the patient’s living situation. The Clinical Manager indicated the patient used to receive services prior to a discharge and readmission at the time of the start of care assessment on 2/10/2024. The Clinical Manager indicated there were no related interventions and goals for the patient’s impaired respiratory status, oxygen use, and lower extremity edema on the plan of care. On 4/3/2024, beginning at 3:52 PM, the Administrator indicated the patient’s DME company for oxygen supplies was not listed on the plan of care. The Administrator indicated the start of care date should be the same as the date of the start of care assessment. 2. A clinical record review for Patient #1 evidenced a plan of care for certification period 3/7/2024-5/5/2024, which indicated the patient’s diagnoses included, but were not limited to, diabetes (a disease that affects the ability to regulate blood sugar) and indicated the nurse was to instruct the patient/caregiver on blood sugar monitoring. The plan of care failed to include the frequency of blood sugar monitoring and blood sugar parameters. Review of the comprehensive assessment dated 3/7/2024 indicated the patient had 2 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 buttocks and coccyx (lower back above the buttocks). The plan of care failed to include the wounds, wound treatment, and goals related to the wounds. On 4/2/2024, 3:05 PM, the Clinical Manager indicated the plan of care did not include the frequency of blood sugar monitoring and indicated blood sugar parameters should be included in the plan of care. The Clinical Manager indicated there was nothing included in the plan of care related to the wounds. 3. A clinical record review for Patient #4 evidenced a plan of care for certification period 2/27/2024-4/26/2024, which indicated the patient’s medications included, but were not limited to, acetaminophen (pain reliever) as needed and loratadine (used to treat seasonal allergies) as needed, and the plan of care failed to be individualized to include the indications for use as needed. On 4/3/2024, at 2:35 PM, the Clinical Manager indicated the indications for use were on the medication profile but not on the plan of care. 410 IAC 17-13-1(a)(1)(D)(ii, ix, xiii) XX. Record review for Patient #3 revealed plan of care for certification period 2/28/24 – 4/27/24 with no documentation of glucometer and/or glucometer supplies. Patient #3 has ICD-10 diagnosis of Type 2 Diabetes Mellitus (during this state, insulin is ineffective and is initially countered by an increase in insulin production to maintain glucose homeostasis, but over time, insulin production decreases). Patient #3’s record review indicated an OASIS recertification completed by a registered nurse on 2/23/24 that revealed the presence of an AV fistula for dialysis access. The plan of care for certification period 2/28/24 through 4/27/24 has no documentation of safety precautions for no blood pressures to be taken on arm containing the AV fistula. During an interview, beginning on 4/2/24 at 3:34 p.m., the Administrator and Clinical Manager verbalized that the glucometer and glucometer supplies as well as a safety precautions to avoid blood pressure in the arm containing the AV fistula were left off the plan of care. XX. Clinical record review for Patient #5 indicated a plan of care for certification period 2/25/24 through 4/24/24 without documentation of the following durable medical equipment: shower bench and elevated toilet seat. During a home visit observation that began on 4/4/24 at 10:48 a.m., observation of a shower bench and elevated toilet seat present in Patient #5’s bathroom. HHA 1 confirmed that these were for the use of Patient #5.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure services and treatments provided only as ordered by a physician in 4 of 5 active clinical records reviewed. (Patient #1, 3, 4, 5) The findings include: XX. Clinical record review for Patient #3 showed plans of care from certification periods 10/31/23 through 12/29/23 and 2/27/24 through 4/27/24 without a provider signature. The record indicated a POC from 12/30/23 through 2/27/24 with a provider signature dated 1/9/24. An interview with the Administrator and the Clinical Manager on 4/2/24, beginning at 3:34 p.m., the Administrator and Clinical Manager were unable to find any verbal orders for care for any of these prior noted periods of time. The Administrator was unable to locate signed plans of care for the certification periods of 10/31/23 – 12/29/23 and 2/27/24 – 4/27/24. XX. Patient # 5’s record indicated a POC from certification period 9/26/23 through 11/24/23 with a provider signature dated 4/3/24, POC from certification period 12/27/23 through 2/24/24 with a provider signature dated 4/3/24, and a POC from certification period 2/25/24 through 4/24/24 without a provider signature. During an interview with the Administrator and the Clinical Manager on 4/3/24, beginning at 1210 p.m., the Clinical Manager verbalized that when a patient’s plan of care is unsigned, the agency process was to obtain a verbal order for care from provider, but it would not be documented. The Clinical Manager verbalized that, going forward, the agency nurse would obtain a provider signature on plan of care or document verbal order for care from provider. 1. A clinical record review for Patient #1 evidenced a plan of care signed by Registered Nurse (RN) 1 for certification period 3/7/2024-5/5/2024 for skilled nursing and home health aide services, which was not signed by the physician until 3/11/2024. Review failed to evidence a verbal order for the continuation of home care services beginning 3/7/2024. On 4/2/2024, at 4:16 PM, RN 1 indicated she was not aware the physician needed to be notified of the continuation of home care services at time of recertification and indicated she did not receive a verbal order. The comprehensive assessment completed by registered nurse (RN) 1 and dated 3/7/2024, which indicated the patient had 2 Stage III pressure ulcers (a wound caused by pressure against the skin resulting in damage to the fatty tissue underneath the layers of skin) to the right buttocks and coccyx (lower back above the buttocks) and indicated the nurse cleansed the area with normal saline and applied a foam dressing. The skilled nurse visit note dated 3/21/2024 indicated the nurse provided a wet-to-dry dressing to the wound to the buttocks. Review failed to evidence any wound treatment orders. On 4/2/2024, at 1:22 PM, RN 1 indicated she did not receive wound care orders from the physician. On 4/2/2024, at 3:10 PM, the Administrator indicated there was no wound treatment order. 2. A clinical record review for Patient #4 evidenced a plan of care for certification period 2/27/2024-4/26/2024 for skilled nursing and home health aide services, which was unsigned by the physician. Review failed to evidence a verbal order for the continuation of home care services beginning 2/27/2024. On 4/3/2024, at 3:15 PM, the Administrator indicated there was no order for continuation of care at time of recertification beginning 2/27/2024.”

“Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care was reviewed by the physician at least every 60 days in 1 of 4 active clinical records reviewed with more than 1 certification period. (Patient #4) The findings include: A clinical record review for Patient #4 evidenced the plan of care for certification period 12/29/2023-2/26/2024 was signed by the physician on 1/17/2024 and failed to evidence the agency sent the plan of care for certification period 2/272024-4/26/2024 to the physician, which was greater than 60 days. On 4/3/2024, at 3:07 PM, the Administrator indicated the plan of care had not yet been sent to the physician for review because the plan of care was still with Quality Assurance (QA) for review. 410 IAC 17-13-1(a)(2)”

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician was notified of changes in the patient’s condition and/or of major drug interactions in 2 of 5 active clinical records reviewed. (Patient #1, 2) The findings include: 1. A clinical record review for Patient #1 indicated the patient was hospitalized beginning 3/1/2024 and the agency resumed services on 3/7/2024. The transfer summary dated 3/4/2024 indicated the patient’s primary care physician recommended the patient be seen in the emergency room and the patient was diagnosed with Covid-19 and pneumonia. Review failed to evidence the agency notified the physician of the patient’s hospitalization. On 4/2/2024, at 2:42 PM, the Clinical Manager indicated she did not see documentation the agency notified the physician of the patient’s hospitalization and would look for it. No additional documentation was provided prior to survey exit on 4/5/2024. On 4/2/2024, at 2:47 PM, the Administrator indicated the transfer summary was not sent to the physician to notify the physician of the hospitalization. 2. A clinical record review for Patient #2 evidenced a medication profile dated 3/29/2024, which indicated the patient’s medications included potassium chloride (a dietary supplement), lisinopril (a medication to treat high blood pressure), fenofibrate (medication to treat high cholesterol), atorvastatin (medication to treat high cholesterol), oxybutynin (medication to relax the bladder), metoclopramide (medication to treat nausea/vomiting), quetiapine (medication to treat depression), and ranolazine (a medication to treat chest pain). The drug-drug interactions dated 4/5/2024 indicated there were 5 major drug interactions between: potassium chloride and lisinopril which could lead to worsening heart failure; atorvastatin and fenofibrate which could lead to liver damage; oxybutynin and potassium chloride which could lead to bleeding and ulcers; metoclopramide and quetiapine which could cause abnormal muscle movements; and atorvastatin and ranolazine which could lead to liver damage. On 4/3/2024, at 4:32 PM, the Administrator indicated there was no documentation the physician was notified of the specific major drug interactions. 410 IAC 17-13-1(a)(2)”

“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 agency failed to revise the plan of care to include the physical therapy (PT) interventions of goals in 1 of 1 active clinical record reviewed with PT services. (Patient #4) The findings include: A clinical record review for Patient #4 evidenced a physician order dated 3/26/2024, which indicated PT was to evaluate and treat. The plan of care for certification period 2/27/2024-4/26/2024 failed to evidence a revision to include PT interventions and goals. On 4/3/2024, at 2:43 PM, the Administrator indicated the PT had not yet completed his documentation from the initial PT evaluation completed on 4/1/2024 and could not revise the plan of care until his documentation was completed.”

“Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This Element is not met as evidenced by: Based on record review and interview, the agency failed to coordinate services and care in 3 of 5 active clinical records reviewed. (Patient #1, 2, 3) The findings include: XX. A review of Patient #3’s record evidenced plan of care from certification period 2/28/24 through 4/27/24 indicating patient receiving dialysis (a procedure to remove waste products and excess fluid in the blood when the kidneys stop working properly) every Tuesday, Thursday, and Saturday. Record review for Patient #3 failed to evidence coordination of care with dialysis center. During an interview on 4/2/24, beginning at 3:44 p.m., the Administrator and the Clinical Manager were unable to show documentation of care coordination with Patient #3’s dialysis center. 1. A clinical record review for Patient #1 evidenced a transfer comprehensive assessment dated 3/1/2024 indicating the patient was hospitalized for Covid 19 and pneumonia. The comprehensive assessment upon patient’s return home dated 3/7/2024, failed to evidence any coordination of care with the hospital regarding discharge orders. Review failed to evidence any documents from the hospital regarding discharge orders and medication. On 4/2/2024, at 3:05 PM, the Clinical Manager indicated she did not see any care coordination or hospital paperwork. 2. On 4/2/2024, at 10:34 AM, Patient #2 indicated he/she received services from Entity 1 (home health agency) to include a home health aide and skilled nursing. A plan of care from Entity 1 indicated the patient’s start of care with Entity 1 was 1/15/2024 and indicated Entity 1 provided skilled nursing services 1 time per week and home health aide services 2 times per week. Entity 1’s plan of care indicated the patient’s medications included, but were not limited to, magnesium (supplement) and metolazone (a medication to remove excess fluid), and Lasik’s plan of care failed to evidence magnesium and metolazone. Review failed to evidence care coordination with Entity 1 prior to 4/2/2024 to include a reconciliation of medication. On 4/2/2024, at 10:59 AM, Person 2 at Entity 1 indicated they were unaware the patient was receiving services from Lasik Home Health and indicated there was no care coordination with the agency. On 4/2/2024, at 3:56 PM, the Administrator indicated they knew the patient was receiving skilled nursing services from Entity 1 but was unaware the patient was receiving home health aide services. The Administrator indicated there was no care coordination with Entity 1 prior to 4/2/2024. The physician orders from Entity 3 (ALF) dated 3/27/2024 indicated the patient’s medications included, but were not limited to, ferosul (used to treat low blood level), fluticasone (used to treat seasonal allergies), metolazone, and nitroglycerin (used to treat chest pain), which were not included on Lasik’s plan of care. Review failed to evidence care coordination with Entity 3 to include a reconciliation of medication. On 4/3/2024, at 4:35 PM, the Administrator indicated the agency’s plan of care did not include the same medications as Entity 3 and indicated there was no care coordination with Entity 3 related to medication. 410 IAC 17-12-2(h)”

“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 record review and interview, the agency failed to provide the patient and caregiver in writing with a copy of the visit schedule in 2 of 3 home visits conducted. (Patient #1, 5) The findings include: XX. During a home visit observation for Patient #5 on 4/4/24, beginning at 10:48 a.m., the home health agency folder was reviewed and there were no visit calendars found inside the folder. There was not a calendar of planned visits by agency staff present at the home. On 4/4/24, during an interview with Patient #5 beginning at 10:48 a.m., the patient verbalized they always know when the agency staff are coming because the staff have their regularly scheduled days. During an observation of care at the home of Patient #1 on 4/2/2024, at 12:43 PM, the agency folder was reviewed and blank calendars were found inside the folder. No written visit schedule was found in the patient’s home. On 4/2/2024, at 12:48 PM, the patient’s caregiver indicated the staff tells her when the visits are going to be but does not receive a written visit schedule. On 4/2/2024, at 3:02 PM, the Clinical Manager indicated the calendar inside the agency folder should be completed with the visit schedule and left 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 record review and interview, the agency failed to ensure the patient was provided with written medication instructions and schedule in 1 of 3 home visits. (Patient #2) The findings include: During an observation of care at the home of Patient #2 on 4/2/2024, at 10:08 AM, the agency folder was reviewed and no written instructions of the patient’s medications were found in the agency folder or the patient’s home. On 4/2/2024, at 10:08 AM, the patient indicated all agency documents were kept inside the agency folder. On 4/2/2024, at 3:02 PM, the Clinical Manager indicated the medication profile should be provided to the patient and left in the patient’s home.”

“Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This Element is not met as evidenced by: Based on record review and interview, the agency failed to provide the patient and caregiver in writing with the treatments to be administered by agency personnel in 2 of 3 home visits. (Patient #1, 5) The findings include: XX. During a home visit observation on 4/4/24 for Patient #5, beginning at 10:48 a.m., the home health agency folder was reviewed and there were no written instructions of treatments to be provided. On 4/4/24, beginning at 10:48 a.m., Patient #5 verbalized the agency information should contained in the folder. During an observation of care at the home of Patient #1 on 4/2/2024, at 12:43 PM, the agency’s folder was reviewed and there was no written instructions of treatments to be provided found in the patient’s home. On 4/2/2024, at 12:48 PM, the patient’s caregiver indicated there was no other documentation from the agency not inside of the agency’s folder. On 4/2/2024, at 3:02 PM, the Clinical Manager indicated the current plan of care should be placed inside of the agency folder as the written instructions of treatments to be provided and left inside the patient’s home.”

“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 registered nurse (RN) and physical therapist (PT) failed to prepare clinical notes accurately, timely, and completely in 3 of 5 active clinical records reviewed. (Patient #1, 2, 4) The findings include: 1. A review of an undated policy titled “Clinical Documentation” indicated documentation would be completed the day services were rendered. 2. A clinical record review for Patient #1, start of care 7/25/2023, indicated a plan of care for certification period 1/21/2024-3/20/2024 and indicated the patient was hospitalized beginning on 3/1/2024. Review indicated RN 1 completed a start of care comprehensive assessment dated 3/7/2023 after the patient returned home from the hospital instead of a resumption of care comprehensive assessment. On 4/2/2024, at 1:22 PM, RN 1 indicated the patient returned home from the hospital on 3/7/2024 and did not go to the patient’s home until 3/9/2024 to complete the comprehensive assessment. RN 1 indicated the Administrator enters the visit date in the electronic health record for the assessment document and RN 1 cannot change the date. On 4/2/2024, at 2:42 PM, the Clinical Manager indicated the RN should have completed a resumption of care comprehensive assessment instead of a start of care comprehensive assessment because the patient was not discharged when the patient was hospitalized. 3. A clinical record review for Patient #2 evidenced a start of care comprehensive assessment signed by RN 2, which indicated the visit date was 2/7/2024 and the date the assessment was completed was 2/10/2024. On 4/3/2024, at 4:06 PM, the Administrator indicated the date of the visit and the date the RN signed the document should be the date the assessment was completed, 2/10/2024. The Administrator indicated 2/7/2024 was most likely the date the assessment was scheduled in the electronic health record. 4. A clinical record review for Patient #4 evidenced a physician order dated 3/26/2024, which indicated PT was to evaluate and treat. Review failed to evidence any documentation completed by the PT. On 4/3/2024, at 2:43 PM, the Administrator indicated the PT had not yet completed his documentation from the initial PT evaluation completed on 4/1/2024. 5. On 4/2/2024, at 2:23 PM, the Administrator indicated staff are unable to change the date of the visit once it is scheduled in the electronic health record and would need to call the office to have the visit date changed. 410 IAC 17-14-1(a)(1)(E) 410 IAC 17-14-1(c)(5)”

“Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This Element is not met as evidenced by: Based on record review and interview, the home health aide (HHA) failed to provide the services as directed in the care plan in 3 of 5 active clinical records reviewed. (Patient #1, 2, 4) The findings include: 1. A clinical record review for Patient #1evidenced a HHA care plan dated 3/11/2024, which indicated the HHA was to record the last bowel movement; provide oral care, hair care, and incontinent care at every visit; report any refusals of care; and report no bowel movement in more than 3 days. Review of HHA visit notes dated 3/12/2024, 3/15/2024, 3/18/2024, 3/19/2024, 3/20/2024, 3/23/2024, 3/26/2024, and 4/1/2024 failed to evidence the record of the last bowel movement. HHA visit notes evidenced the patient refused hair care on 3/11/2024 and 3/18/2024; refused hair care and skin care on 3/13/2024; refused the chair bath on 3/14/2024; refused chair bath and hair care on 3/15/2024; and refused chair bath, skin care, and dressing on 3/19/2024. The HHA visit notes failed to evidence the HHA reported the refusal of care. HHA visit notes evidenced the HHA failed to provide hair care, oral care, and incontinent care on 3/12/2024; failed to provide oral care and incontinent care on 3/13/2024; failed to provide oral care and incontinent care on 3/15/2024; failed to provide oral care and incontinent care on 3/18/2024; and failed to provide hair care, oral care, and incontinent care on 3/19/2024. HHA visit note dated 3/22/2024 indicated the last bowel movement was on 3/18/2024 and failed to evidence the HHA reported the no bowel movement in more than 3 days. On 4/2/2024, beginning at 2:58 PM, the Administrator indicated she did not see the documentation of the last bowel movement documented on the HHA visit notes. The Administrator indicated there was no documentation the HHA reported the patient had not had a bowel movement in more than 3 days. On 4/2/2024, at 3:00 PM, the Clinical Manager indicated she did not see any documentation the HHA reported the refusal of care. 2. A clinical record review for Patient #2 evidenced a HHA care plan dated 2/10/2024 indicated the HHA was to assist with shower and oral care and limit the patient’s fluids at every visit. The HHA care plan indicated the HHA was to obtain vital signs weekly. Review of a HHA visit note failed to evidence the HHA provided a shower or oral care and limit the patient’s fluids on 3/15/2024 Review failed to evidence any vital signs were obtained by the HHA since the start of care on 2/6/2024. On 4/3/2024, at 4:23 PM, the Administrator indicated she did not see documentation the HHA provided a shower and oral care on 3/15/2024 and indicated she did not see the HHA obtained vital signs. 3. A clinical record review for Patient #4 evidenced a HHA care plan dated 12/29/2023, which indicated the HHA was to assist with a shower, dressing, and ambulation; provide incontinent care; and encourage fluids at every visit. Review of HHA visit notes failed to evidence the HHA assisted with a shower, dressing, and ambulation and encouraged fluids and completed hair care and skin care, which was not on the HHA care plan, on 3/27/2024. Visit note for 3/28/2024 failed to evidence the HHA assisted with dressing and ambulation, provided incontinent care, and encouraged fluids. Visit note for 3/29/2024 failed to evidence the HHA provided a shower, assisted with dressing and ambulation, provided incontinent care, and encourage fluids. On 4/3/2024, at 3:23 PM, the Administrator indicated she did not see the HHA provided services per the HHA care plan.”

“Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient’s condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA’s policies and procedures. This Element is not met as evidenced by: Based on record review and interview, the home health aide (HHA) failed to communicate changes in the patient’s condition in 1 of 5 active clinical records reviewed. (Patient #1) The findings include: A clinical record review for Patient #1 evidenced a comprehensive assessment dated 3/7/2024, which indicated the patient could feed self with intermittent assistance or supervision HHA visit note dated 3/15/2024 indicated the patient was not feeding herself and note dated 3/18/2024 indicated the patient was talking abnormally saying things that did not make sense or were difficult to understand. Review failed to evidence the HHA reported the change in the patient’s condition to the nurse case manager. The HHA visit note dated 4/1/2024 indicated the physical therapist provided services during the HHA’s visit and would be providing services 2 times per week and indicated the physical therapist wanted the HHA to assist the patient with exercises on the days the physical therapist was not there. On 4/2/2024, at 3:00 PM, the Clinical Manager indicated she could not find any documentation from the HHA regarding the changes in the patient’s condition. On 4/2/2024, at 3:06 PM, the Administrator indicated the agency was unaware physical therapy had been started with the patient and was unsure with which agency therapy was being provided.”

“Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient’s plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the supervision of the home health aide (HHA) at least every 14 days in 1 of 5 active clinical records reviewed with skilled services and HHA services. (Patient #4) The findings include: A clinical record review for Patient #4 evidenced the agency was providing skilled nursing and HHA services and failed to evidence on site supervision by the registered nurse (RN) since 2/23/2024. On 4/3/2024, at 3:32 PM, the Administrator indicated she did not see any supervisory visit conducted since 2/23/2024.”

“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 supervise the home health aide (HHA) to ensure the aide furnished care that followed the patient’s plan of care in 3 of 5 active clinical records reviewed. (Patient #1, 2, 5) The findings include: XX. Clinical record review for Patient #5 evidenced a home health aide care plan dated 12/29/23, which indicated the home health aide was to take vital signs, perform personal care including showering, bathing, lotion, assisting with dressing, oral care, assist to toilet, and assist with ambulation. A review of home health aide notes failed to evidence home health aide completion of vital signs, shower assistance, bathing, lotion, assisting with dressing, oral care, assistance to toilet, and assistance with ambulation on the following dates: 2/26/24, 2/29/24, 3/4/24, 3/7/24, 3/11/24, 3/14/24, 3/18/24, 3/21/24, 3/25/24, 3/38/24, 4/1/24, and 4/4/24. During an interview on 4/2/24, beginning at 3:34 p.m., the Administrator and the Clinical Manager verbalized that the nursing staff will ask the patient and family if the home health aide is completing the duties on the aide care plan. The Administrator verbalized the home health aide notes are currently being assessed for quality per an outside contractor who has not brought forth any issues. 1. A clinical record review for Patient #1evidenced a HHA care plan dated 3/11/2024, which indicated the HHA was to record the last bowel movement; provide oral care, hair care, and incontinent care at every visit; and report any refusals of care. HHA visit notes dated 3/12/2024, 3/15/2024, 3/18/2024, 3/19/2024, 3/20/2024, 3/23/2024, 3/26/2024, and 4/1/2024 failed to evidence the record of the last bowel movement. HHA visit notes evidenced the patient refused hair care on 3/11/2024 and 3/18/2024; refused hair care and skin care on 3/13/2024; refused the chair bath on 3/14/2024; refused chair bath and hair care on 3/15/2024; and refused chair bath, skin care, and dressing on 3/19/2024. The HHA visit notes failed to evidence the HHA reported the refusal of care. HHA visit notes evidenced the HHA failed to provide hair care, oral care, and incontinent care on 3/12/2024; failed to provide oral care and incontinent care on 3/13/2024; failed to provide oral care and incontinent care on 3/15/2024; failed to provide oral care and incontinent care on 3/18/2024; and failed to provide hair care, oral care, and incontinent care on 3/19/2024. The HHA supervisory visit note completed by the registered nurse (RN) and dated 3/21/2024, indicated the HHA provided care per the care plan and failed to evidence the RN provided home health aide supervision to ensure the HHA followed the care plan as directed. On 4/2/2024, at 3:07 PM, the Clinical Manager indicated the RN should not have marked the HHA as following the plan of care. 2. A clinical record review for Patient #2 evidenced a HHA care plan dated 2/10/2024 indicated the HHA was to assist with shower and oral care and limit the patient’s fluids at every visit. The HHA care plan indicated the HHA was to obtain vital signs weekly. A HHA visit note indicated the HHA did not provide a shower or oral care and did not limit the patient’s fluids on 3/15/2024 Review failed to evidence any vital signs were obtained by the HHA since the start of care on 2/6/2024. The supervisory visit note completed by the RN and dated 3/29/2024 indicated the HHA provided care per the care plan and failed to evidence the RN provided home health aide supervision to ensure the HHA followed the care plan as directed. Onn 4/3/2024, at 4:26 PM, the Administrator indicated the RN should not mark the HHA as following the care plan if the care plan was not followed. 410 IAC 17-14-1(n)”

“Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This Element is not met as evidenced by: Based on record review and interview, the administrator and governing body failed to authorize in writing a qualified person to assume the responsibilities of the administrator in their absence. The findings include: A review of the personnel file for the Alternate Administrator failed to evidence written authorization from the Administrator and Governing Body for the appointment to the Alternate Administrator role. On 4/3/2024, at 12:29 PM, the Administrator indicated she could not find the written authorization and indicated it might be on the zip file she could not locate. 410 IAC 17-12-1(d)(8)”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record included plans of care in 1 of 5 active clinical records reviewed. (Patient #1) The findings include: The clinical record for Patient #1, start of care 7/25/2023, failed to evidence a plan of care for certification period 9/23/2023 - 11/21/2023 and failed to evidence a physician-signed plan of care for certification period 11/22/2023 - 01/20/24. On 4/3/2024, at 12:19 PM, the Administrator indicated the agency could not locate the plan of care for the period 9/23/2023 - 11/21/2023 and indicated the plan of care for the period 11/22/2023 - 01/20/2024 was found in the fax system, which was not part of the clinical record. 410 IAC 17-15-1(a)(1)-(7)”