Every finding on record at Heritage Home Health Services of Indiana LLC

The Indiana Department of Health conducted an Emergency Preparedness survey, conducted in accordance with 42 CFR §484.102, for a Home Health Provider. Survey Dates: July 10, 11, and 12, 2024. Census: 0 During this Emergency Preparedness survey, Heritage Home Health Services of Indiana, LLC was found to be out of compliance with Conditions of Participation at 42 CFR §484.102: Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers. QR: 7/15/24, A1

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 home health agency failed to develop an emergency preparedness plan, (E0004); failed to ensure the plan included a current facility-based or community-based risk assessment, or strategies for addressing emergency events identified by a risk assessment of the agency (E0006); failed to ensure they developed a procedure to follow up with on-duty staff and patients to determine services that were needed, in the event that there was an interruption in services during or due to an emergency (E0021); failed to ensure they developed and maintained an emergency preparedness communication plan which included the use of volunteers or other emergency staffing in the event of an emergency to ensure the healthcare needs of the patients were met (E0024); failed to ensure the agency developed and maintained an emergency preparedness communication plan which included names and contact information for other entities providing services under arrangement (E0030); failed to develop and maintain an emergency preparedness communication plan which included primary and alternate means for communicating with agency staff (E0032); failed to evidence they developed and maintained an emergency preparedness a training and testing program (E0036); failed to ensure an emergency preparedness training was provided and maintained documentation of all emergency preparedness training (E0037), and failed to ensure they conducted exercises to test the emergency plan annually (E0039). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment and resulted in the agency being found out of compliance with the condition 42 CFR §484.102: Emergency Preparedness Requirements for Medicare Participating Providers. The findings include: 1. An Emergency Preparedness policy titled, “Emergency Management Plan, Policy No. 6-37.1,” identified it was a corporate policy with a revision date of May 2022. The policy indicated the purpose of the policy was to establish an emergency preparedness plan. 2. The Administrator provided and identified documents as the agency’s Emergency Preparedness {EP] Plan on 07/12/2024 at 11:48 AM. A. The Emergency Preparedness documents provided, were reviewed; the documents failed to evidence it included / represented this agency. The documents provided were the EP plan for another home health agency and included a list of their personnel and patients along with their addresses and phone numbers. B. During an interview on 7/12/24 beginning at 2:00 p.m. the administrator indicated they did not have an EP plan for this agency, and he would need to develop one. Corporate Compliance 1 indicated they were in the process of developing the agency's emergency preparedness plan, and ready to admit patients. C. During an interview on 7/12/24 beginning at 2:20 p.m., the Administrator deferred questions and contacted Corporate Compliance Officer 1, by telephone. The administrator and Corporate Compliance Officer 1 indicated there was not an EP plan for this agency.

This visit was for a federal recertification survey of a home health agency. Survey dates: July 10, 11, and 12, 2024. State agency arrived on site on 07/10/24 at 09:00 AM, to complete a federal recertification and state re-licensure survey. Office Manager 1 was on site and relayed the home health agency [HHA] did not have any patients; relayed all patients were discharged on 9/07/2022, and no patients were admitted since. During an entrance conference on 07/10/24, Administrator 1 indicated he was the facility administrator for this agency and another home health agency, same ownership in anther county. It was relayed that all home health referrals go through a triage line, and referrals for this agency have been sent to their sister agency in Indianapolis. The administrator relayed when they begin to admit patients, they would pull staff from their Indianapolis agency. When requested their personnel list, the Administrator relayed when they begin admitting patients, they would then use staff from the Indianapolis agency. During this recertification survey, Heritage Home Health Services of Indiana LLC was found to be out of compliance with the Conditions of Participation at 42 CFR 484.1 Basis and scope, 484.50 Patient Rights, 484.58 Discharge Planning, and 484.105 Organization and administrative services. Based on the Condition-level deficiencies during the 07/12/2024 survey, your HHA was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 7/10/2024. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating or being the site of a home health aide training, skills competency and/or competency evaluation program for a period of two years beginning 7/12/2024 and continuing through 7/11/2026. QR: A 1 7/16/2024

Basis and Scope CFR(s): §484.1 Basis and Scope (a) Basis. This part is based on: (1) Sections 1861(o) and 1891 of the Act, which establish the conditions that an HHA must meet in order to participate in the Medicare program and which, along with the additional requirements set forth in this part, are considered necessary to ensure the health and safety of patients; and (2) Section 1861(z) of the Act, which specifies the institutional planning standards that HHAs must meet. (b) Scope. The provisions of this part serve as the basis for survey activities for the purpose of determining whether an agency meets the requirements for participation in the Medicare program. This CONDITION is not met as evidenced by: Based on record review and interview the agency failed to evidence they met all requirements in order to participate in the Medicare Program when they failed to accept and admit patients and provide skilled services since 09/07/2022. The cumulative effect of this systemic problem resulted in the agency being out of compliance with §484.1 Basis and Scope Findings include: During an the entrance conference on 7/10/24, the Administrator indicated the agency has not accepted or provided patient care since the change of ownership, with effective date November 22, 2022. During the interviews, the agency relayed they did not have access to the agency's discharged records, indicated only Office Manager 1 had access, as was the previous owner of the agency, and relayed any referrals are sent to a sister agency, in another county until this agency begins to admit patients. During an interview on 7/11/24 beginning at 9:00 AM, Office Manager 1 indicated she was the previous owner and closed the agency suddenly in September 2022, due to financial hardship, and relayed patients on service on 9/02/2022, were informed on 9/02/22 of the agency's closure effective 9/07/22. The CMS database indicated on 12/12/2023, the state agency received as email from Corporate Person 1 who relayed the agency's Medicare Administrative Contractor (MAC) [a private health care insurer that has been awarded a geographic jurisdiction to process Medicare Part A and Part B (A/B) medical claims or Durable Medical Equipment (DME) claims for Medicare Fee-For-Service (FFS) beneficiaries] notified the agency that this home health agency's change of ownership [CHOW] was approved in May of 2023. The database indicated the agency's MAC provided the agency's 855, to advise the state agency that the CHOW took place between the previous owner and Heritage Home Health Services of Indiana LLC, effective 11/22/2022.

Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure their promoted and protected patients' rights when the agency failed to ensure a safe and appropriate transfer to other health care entities when the needs of the patients exceed the agency’s capabilities (G 454) and failed to ensure their patients were provided sufficient notice of the cessation of business and assisted with planning for Patients' care post discharge for 16 of 23 focused discharged records reviewed from a sample of 37 patient discharged on or after 9/02/22 through 9/07/22 (G474). The cumulative effect of this systemic problem resulted in the agency being out of compliance with 42 CFR 484.50 Condition of participation: Patient Rights. 18. The clinical record for Patient #1 with a start of care date of 5/6/22, revealed a diagnosis of cerebral palsy, left buttock and sacral wounds requiring wound care. The POC for the recertification period 9/3/22 - 11/1/22, revealed orders for skilled nursing services 3 times a week for 9 weeks. The record evidenced Patient’s last SN visit with wound care was on 8/31/22, and Patient was discharged on 9/2/22. The record failed to evidence patient was provided notice of discharge, prior to 9/02/22 and failed to evidence coordination of care with the attending to discharge the patient, prior to 9/02/22, and failed to evidence the plan for Patients wound care after discharge. 19. The clinical record for Patient #5 with a start of care date of 3/8/22, revealed a diagnosis of congestive heart failure, left ankle wound and cellulitis requiring wound care. The POC for recertification period 7/16/22-9/13/22, revealed orders skilled nursing 1 time per week for 6 weeks (8/9/22-9/13/22). The record failed to evidence a SN visit, with wound care, after 8/26/22 and that Patient was discharged without a SN visit on 9/2/22. The record failed to evidence patient was provided notice of discharge, prior to 9/02/22. The record failed to evidence coordination of care with their attending, prior to discharge. The record failed to evidence documentation who or how the Patients’ wound care would be completed nor education to any known or available caregiver, post discharge. On 7/11/22 beginning at 11:50 a. m. during a witnessed interview with Entity 3, they indicated Patient #5 was admitted to services on 9/8/22. Patient #5 was without wound care for 13 days, 8/26/22 to 9/08/22. 20. The clinical record for Patient #38 with a start of care date of 7/5/22, revealed a diagnosis of hemiplegia of right dominate side. The POC for recertification period 9/3/22 - 11/1/22, revealed orders for OT 1 time per week for 3 weeks (9/4/22 to 9/24/22). The record indicated patient’s last visit was on 9/06/22, and was discharged on 9/6/22, indicated Patient was to be transferred to another home health agency, the specific agency was not identified. The record failed to evidence patient was provided notice of discharge, prior to 9/06/22, failed to evidence coordination of care with the attending and failed to evidence an appropriate transfer of their services to another provider. 1. During an interview on 7/10/24, during the entrance conference the administrator indicated they have had no patients since the change of ownership. Office Manager 1 indicated she was the previous owner and that on 9/02/22 she issued a letter to all her patients on service at the time, approximately 40 patients, to notify them the agency would cease operation on 9/07/22. 2. During an interview on 7/10/22 beginning at 4:00 PM, Office Manager 1 revealed the discharges were sudden and unplanned due to financial issues at that time and provided a list of 40 patients, 37 of which were discharged on 9/2/22 through 9/07/22. 3. The clinical record for Patient #13 revealed a recertification plan of care [POC] dated 8/12/22 to 10/10/22 for a SN to complete wound care 3 times a week through 10/10/22, included diagnosis of an amputation, difficulty walking, agoraphobia (fear of leaving home or another safe environment), chronic pain, and the need for assistance for personal care, activities of daily living [ADL’s]. The record revealed the last skilled nurse [SN] visit was conducted on 8/26/2022, and indicated Patient was discharged on 9/2/22. The record included a copy of a letter, dated 9/02/22, to notify Patient that the agency would cease operation on 9/07/22. The record failed to evidence the patient received the information on 9/02/22, if or how patient received care and assistance after discharge, failed to evidence Patient was provided a list of available agencies, nor evidence another health care provider accepted and was able to provide services, nor what information was provided, if any, for a safe and appropriate transfer. During an interview on 7/11/24 beginning at 10:00 AM, Patient #13 revealed his/her home health care was discontinued when the agency closed, and no further health care continued under another provider a year later. During an interview on 7/11/24 beginning at 4:00 PM, Entity 3, a home health agency [HHA], revealed Patient #13 was admitted for care on 11/02/23. 4. The clinical record for Patient #15 revealed an initial POC for the certification period 7/18/22 to 9/15/22 for SN 3 times a week through 9/15/22 for wound care, pain management, disease management, and medication education and management, diagnosis included wound with cellulitis (skin infection). The record indicated Patient was discharged 9/2/22, failed to evidence if a caregiver was available and able to provide Patient’s wound care after discharge, failed to evidence coordination of care with the attending physician prior to discharge. 5. The clinical record of Patient #36 revealed recertification POC dated 8/9/22 to 10/7/22 for SN three times a week for wound care, pain and medication management, and weight monitoring through 10/7/22, home health aide twice a week through 10/7/22 for assistance with ADL’s, revealed Patient was severely weak with heart failure, daily wound care, and had a history of multiple falls. The record included a document titled “Home Health Change of Care Notice [HHCCN] that evidenced Patient was notified, by phone on 9/02/2022, their services were ending due to cessation of the agency and Patient was discharged 9/2/22. Patient signed acknowledged the notification on 9/12/22. A communication note indicated Patient was admitted to Entity #3 on 9/7/22. The record failed to evidence coordination of care with the attending physician, before discharge, and the plan as to who would provide Patients wound care and ADL assistance after discharge from the agency until another provider was found. 6. The clinical record for Patient #16 revealed a POC dated 8/2/22 to 9/30/22 for SN visits weekly through 9/17/24 for medication management, education, and edema (swelling) management; physical therapy was ordered weekly through 9/17/22 for fall prevention and balance issues. The record indicated Patient was discharged 9/2/22. The record failed to evidence coordination of care with the attending physician before discharge, nor assistance to receive and continue services through another provider. The record included a document titled HHCCN indicated Patient was notified, by phone on 9/02/2022, their services were ending. A communication note, dated 9/08/22, indicated Patient was admitted to Entity #3 on unknown date. The record failed to evidence coordination of care with the attending physician, before discharge and the plan as to who would assist Patient after discharge. During an interview on 7/11/24 beginning at 4:00 PM, Entity 3, a home health agency, revealed Patient #16 was not admitted for home health care services in 2022; was admitted on 6/17/23. 7. The clinical record of Patient #23 revealed an initial certification POC dated 8/22/22 to 10/20/22 for a SN weekly through 10/20/22 for wound care, pain management, and disease management; physical therapy and occupational therapy [OT] was ordered through 9/24/22 for balance issues and fall prevention, and a home health aide to assist bathing Patient twice a week through 10/20/22. The POC indicated Patient had a wound to the right leg, severely impaired mobility, and a cognitive deficit. A communication note indicated a referral was sent to Entity 6. The record indicated Patient was discharged on 9/2/22. The record failed to evidence coordination of care with the attending physician before discharge, nor evidence Entity 6 accepted and was able to provide services, nor what information was provided, if any, for transfer to any other provider to continue services. 8. The clinical record of Patient #12 revealed a recertification POC dated 8/10/22 to 10/8/22 for a weekly SN for pain management, diabetes (blood sugar disorder) education and safety for home glucose monitoring, and edema (swelling) management through 10/8/22. The POC indicated Patient required oxygen at home, with swelling to legs, an unsteady gait and needed assist to ambulation. Patient was discharged 9/6/22 and failed to evidence coordination of care with the attending physician, nor evidence of another provider was able to provide services, nor what information was provided, if any, for transfer to any other provider to continue services. The record failed to evidence the plan to meet Patients care needs after discharge. 9. The clinical record for Patient #17 revealed a recertification POC dated 8/21/22 to 10/19/22 with a SN visit ordered weekly through 9/17/24 to assess for complications of a feeding tube, a urinary catheter, and recent infections, indicated Patient was bedbound with minimal movement and a severe fall risk, was dependent on others for all ADL, goals included to return to pre hospital [discharged 6/20/22] status and remain free of complications related to urinary tract infection by 10/19/22. The record indicated Patient was discharged on 9/7/24. The record failed to evidence if or how patient received care and assistance after discharge, failed to evidence coordination of care with the attending physician prior to discharge, that the patient was provided a list of available agencies, nor evidence whether another health care provider accepted and was able to provide services, nor what information was provided, if any, for transfer. A communication note, entered by OT 2, previous staff, and dated 9/07/22 indicated Patient was notified of agency discharge, Patient met maximum rehab potential, and MD was notified. 10. The clinical record for Patient #19 revealed a recertification POC dated 7/19/22 to 9/16/22 for OT through end of certification period and indicated Patient had a right heel wound and lymphedema (chronic swelling). The record indicated Patient was discharged on 9/02/22. The record included a copy of a letter, dated 9/02/22, to notify Patient that the agency would cease operation on 9/07/22. The record failed to evidence the patient received the information on 9/02/22, failed to evidence Patient was provided a list of available agencies, nor evidence another health care provider accepted and was able to provide services, nor the information provided, if any, for a safe and appropriate transfer. The record included a communication note entered by OT 2 a clinical note dated 9/02/2022 indicated Patient requested transfer to Entity 6 and information was faxed to Entity #6. During an interview on 7/12/24, beginning at 9 AM, Entity #6 relayed Patient was not admitted for services. 11. The clinical record for Patient #27 revealed an initial certification POC dated 7/29/22 to 9/26/22 for SN weekly visits for edema (swelling) management, pain management, and medication monitoring. Physical therapy and OT were ordered through 9/17/22 for strengthening and energy conservation/pacing. The record failed to evidence services were provided after 8/26/22 and indicated Patient was transferred to an unknown agency on 9/2/22. The record failed to evidence a Clinical Note dated 9/02/22, which indicated Patient request discharge on same date. The record failed to evidence coordination of care with the attending physician. The record failed to evidence Patient was provided notice of cessation of the agency services on or before 9/02/22. 12. The clinical record of Patient #28 revealed an initial certification POC dated 8/16/22 to 10/14/22 for physical therapy through 9/17/22, with diagnosis was a concussion with loss of consciousness, a pelvis fracture, and required taxing effort and assistive devices for mobility. The record indicated Patient was discharged on 9/4/22 with goals met. A Clinical Note dated 9/02/22, by OT 2, indicated Patient was notified “of agency dc this week,” patient met goals, no further services needed. The record failed to evidence coordination of care with the attending physician, nor evidence Patient was provided notice of the discharge. 13. The clinical record for Patient #39 revealed a recertification POC dated 8/11/22 to 10/9/22 for a SN to see Patient weekly through 9/17/22 for pain management, edema (swelling) monitoring, weight monitoring, with care to include medication and disease management/education, with kidney and heart failure. Patient was discharged 9/2/22 and failed to evidence coordination of care with the attending physician nor what information was provided to the patient regarding other providers of care to meet their care needs. 14. The clinical record for Patient #2, included a POC for the recertification period 8/13/22 to 10/11/22, revealed Patient was oriented and forgetful, indicated Patient was homebound due to weakness and impaired mobility, and included orders for SN visits weekly through 9/10/22 and home health aide services for ADL’s twice a week X 4 weeks through 9/10/22. The record failed to evidence services were provided after 9/02/22 with discharge of the same date. The record included 2 copies of the same letter, each dated 9/02/22, notifying Patient that the agency would be closing on 9/07/22. Handwritten on a letter indicated Patient chose to be transferred to Entity 6; another notation indicated Entity 6 was not within Patient’s insurance network, Patient then chose Entity 3. Patient was without services from 9/02/2022 through 9/17/22, when they were admitted to Entity 3 on 9/17/22. The record failed to evidence sufficient notice of discharge and a safe and appropriate transfer. 15. The clinical record for Patient #9, included a POC for the recertification period 8/28/22 to 10/26/22, revealed Patient had orders for SN 3 times a week for 9 weeks and to include wound care to patients right lower extremity, left elbow, and left forearm. The record failed to evidence care was provided after 9/02/22. The record included a copy of a letter dated 9/02/22, notifying Patient that the agency would be closing on 9/07/22; the letter included a handwritten note that Patient chose to be transferred to Entity 8, that Entity 8 was unable to accept to do lack of staff. The EMR included an entry by a previous staff RN, dated 9/05/2022 that indicated they reviewed medications and orders with Patient and Patient agreed to the POC and transfer to Entity 4. Entity 4 indicated they admitted patient on 9/14/22. The record failed to evidence coordination of care with the attending nor a plan for patients’ wound care from 9/02/22 through 9/14/22, for a total of 12 days. 16. The clinical record for Patient #29 revealed an initial certification POC dated 8/19/22 to 10/17/22 for the following services: SN weekly through 9/17/22 for assessment, physical therapy through 9/24/22 for balance training and fall prevention, OT through 9/17/22 for pacing and energy conservation, and a home health aide 2 times a week through 9/17/24 for ADL assistance. Patient was discharged 9/2/22. The record failed to evidence coordination of care with their attending, prior to discharge, nor evidence the patient received adequate notice to have care transferred to an agency, nor evidence a list of available agencies was provided. During an interview on 7/12/24 beginning at 10:00 AM, Patient #29 relayed the agency closed and the agency referred Patient to another agency with higher out of pocket costs. Patient did not continue services from another health care provider following discharge from agency. 17. The clinical record of Patient #31 revealed an initial POC dated 8/3/22 to 10/1/22 for SN weekly through 9/10/24 for assessment, physical therapy through 9/17/22 for balance issues, and OT through 9/10/22 for training in activity of daily living. Patient had recently fallen, required a wheelchair for mobility, noted as unable to walk 10 feet without requiring a rest due to fatigue. The record indicated Patient was discharged 9/2/22. The record failed to evidence coordination of care with the physician before discharge. A “Patient Note” entered by previous office staff member, dated 9/02/22, indicated the office staff spoke with patient’s family member regarding patients ”services being suspended due to unforeseen circumstances.” The note indicated the family member had no preference in another home health agency. The record included a copy of the agency letter, dated 9/02/22, to notify Patient that the agency would cease operation on 9/07/22. Handwritten on the letter was the name of Entity 6. The record failed to evidence Entity 6 was accepted and was able to provide services, nor that information was provided, for a safe and appropriate transfer of services.

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 home health agency failed to evidence failed to evidence they provided necessary medical information pertaining to the patient’s current course of illness and treatment to the receiving health care practitioner and receiving facility, if any, to ensure a safe and effective transition of care (See G0564) and failed to evidence the agency provided clinical information ensure a discharge summary was provided to the attending in 22 of 23 focused discharged records reviewed from a sample of 37 patient discharged on or after 9/02/22 through 9/07/22. The cumulative effect of these systemic problems resulted in the home health agency's failed to ensure continuation and effective transition of patient care for the condition of participation 42CFR 484.58 Discharge Planning. Findings include: 23. The clinical record for Patient #1 with a start of care date of 5/6/22, revealed a diagnosis of cerebral palsy, left buttock and sacral wounds requiring wound care. The plan of care for the recertification period 9/3/22 - 11/1/22, revealed orders for skilled nursing services 3 times a week for 9 weeks. The record evidenced Patient’s last skilled nurse visit with wound care was on 8/31/22, and Patient was discharged on 9/2/22. On 7/11/22 beginning at 11:50 a. m. during a witnessed interview with Entity 3, a home health agency, they indicated Patient #1 was admitted to services on 9/6/22. The record failed to evidence coordination of care with the attending physician prior to discharge, nor evidence that a discharge summary was sent to the attending post discharge. 24. The clinical record for Patient #5 with a start of care date of 3/8/22, revealed a diagnosis of congestive heart failure, left ankle wound and cellulitis requiring wound care. The plan of care for recertification period 7/16/22-9/13/22, revealed orders skilled nursing 1 time per week for 6 weeks through 9/13/22. The record failed to evidence a skilled nurse visit, with wound care, after 8/26/22 and Patient was discharged without a skilled nurse visit on 9/2/22. The record failed to evidence coordination of care with the attending prior to discharge and failed to evidence a discharge summary was sent to the provider post discharge. The record failed to provide evidence of who or how Patients’ wound care would be completed nor education to any known or available caregiver. On 7/11/24 beginning at 11:50 a. m. during a witnessed interview with Entity 3, a home health agency, indicated Patient #5 was admitted to services on 9/8/22. Patient #5 went 13 days without wound care. The record failed to evidence coordination of care with the attending physician, nor evidence that a discharge summary was sent to the attending post discharge. 25. The clinical record for Patient #38 with a start of care date of 7/5/22, revealed a diagnosis of hemiplegia of right dominate side. The plan of care for recertification period 9/3/22 - 11/1/22, revealed orders for Occupational Therapy 1 time per week for 3 weeks (9/4/22 to 9/24/22). The record indicated patient’s last visit was on 9/06/22, and was discharged on 9/6/22, indicated Patient was to be transferred to another home health agency, the specific agency was not identified. The record failed to evidence coordination of care with the attending prior to discharge nor that a discharge summary of Patient care was sent to the attending post discharge. 1. During an interview on 7/10/24, during the entrance conference the administrator indicated they have had no patients since the change of ownership. Office Manager 1 indicated she was the previous owner and that on 9/02/22 she issued a letter to all her patients on service at the time, to notify them the agency would cease operation on 9/07/22; Office Manager 1 indicated approximately 40 patients were discharged. 2. During an interview on 7/10/22 beginning at 4:00 PM, Office Manager 1 revealed the discharges were sudden and unplanned due to financial issues at that time. Office Manager 1 provided a list of 40 patients, 37 of which were discharged on 9/2/22 through 9/07/22. 3. The clinical record for Patient #13 revealed a plan of care [POC] dated 8/12/22 to 10/10/22 for a skilled nurse to complete wound care 3 times a week until 10/10/22, with diagnosis of an amputation, difficulty walking, agoraphobia (fear of leaving home or another safe environment), chronic pain, and the need for assistance for personal care. Patient was discharged 9/2/22 and failed to evidence care was transferred to another Entity. The record failed to evidence their attending was provided an information pertaining to patients’ course of treatment, through 9/02/22. 4. The clinical record for Patient #15 revealed an initial POC for the certification period 7/18/22 to 9/15/22 for skilled nurse 3 times a week until 9/15/22 for wound care, pain management, disease management, and medication education and management. Patient had a wound with cellulitis (skin infection). Patient was discharged 9/2/22 and admitted to Entity #3 on 9/9/22. The record failed to evidence coordination of care with the attending physician, nor any other health care provider. The record failed to evidence the plan as to who would provide Patients wound care after discharge. The record failed to evidence their attending was provided an information pertaining to patients’ course of treatment, through date of discharge. 5. The clinical record of Patient #36 revealed recertification POC dated 8/9/22 to 10/7/22 for skilled nurse three times a week for wound care, pain and medication management, and weight monitoring until 10/7/22, home health aide twice a week until 10/7/22 for personal care and showers, Patient noted as severely weak with heart failure, needed assistance for all activities of daily living, daily wound care, and had a history of multiple falls. Patient was discharged 9/2/22 and admitted to Entity #3 on 9/7/22, a period without home health care noted as five days. The record failed to evidence coordination of care with the attending physician and the plan as to who would provide Patients wound care after discharge from the agency. The record failed to evidence their attending was provided an information pertaining to patients’ course of treatment, through discharge. 6. The clinical record for Patient #16 revealed a plan of care dated 8/2/22 to 9/30/22 for skilled nurse visits weekly until 9/17/24 for medication management, education, and edema (swelling) management; physical therapy was ordered weekly through 9/17/22 for fall prevention and balance issues. Patient was discharged 9/2/22. The record failed to evidence coordination of care with the attending physician, nor an order to discharge from the agency, nor assistance to receive and continue services through another provider, and failed to evidence their attending was provided an information pertaining to patients’ course of treatment, through discharge. 7. The clinical record of Patient #23 revealed an initial certification plan of care dated 8/22/22 to 10/20/22 for a skilled nurse weekly until 10/20/22 for wound care, pain management, and disease management; physical therapy and occupational therapy was ordered through 9/24/22 for balance issues and fall prevention, and a home health aide to assist with bathing twice a week through 10/20/22. The POC indicated Patient had a wound to the right leg, severely impaired mobility, and a cognitive deficit. A communication note indicated a referral was sent to Entity 6. The record indicated Patient was discharged on 9/2/22. The record failed to evidence coordination of care with the attending physician, an order to discharge from the agency, nor evidence if Entity 6 accepted and was able to provide services, nor what information was provided, if any, for transfer to any other provider to continue services. The record failed to evidence their attending was provided an information pertaining to patients’ course of treatment, through discharge. 8. The clinical record of Patient #33 revealed a diagnosis of impaired mobility and a cognitive deficit, requiring 24-hour supervision. A POC dated 8/22/22 to 10/20/22 revealed a weekly skilled nurse visit to monitor blood pressure and medication management until 9/24/22 and physical therapy once a week until 10/8/24 for balance issues. The record failed to evidence coordination of care with the attending physician, nor an order to discharge from the agency, nor evidence information was provided to another agency to assist patient with transfer to continue home health services. A communication note, dated 9/02/22, indicated Entity 6 was chosen by patient as an option for transfer. During an interview on 7/12/2024 starting at 9:00 AM, Entity 6, a home health agency, indicated they admitted Patient #33 on 9/09/22. The record failed to evidence their attending was provided an information pertaining to patients’ course of treatment, through discharge. 9. The clinical record of Patient #37 revealed an initial certification plan of care dated 8/31/22 to 10/29/22 for a weekly skilled nurse until 10/1/22 to monitor and manage edema (swelling), pain management, disease management and medication education. Physical therapy was ordered until 10/15/22 for fall prevention and balance issues and occupational therapy ordered until 10/1/22 for energy conservation and training activities of daily living. Patient record indicated he/she had impaired mobility, weakness, recent falls, and needed assistance to ambulate. The record failed to evidence coordination of care with the attending physician, nor an order to discharge from the agency, nor a plan with primary caregiver to meet Patient's care needs. A handwritten note indicated Patient chose to be transferred to Entity 6. The record failed to evidence if Entity 6 accepted and was able to provide services, nor what information was provided, if any, for transfer to any other provider to continue services. The record failed to evidence their attending was provided an information pertaining to patients’ course of treatment, through discharge. During an interview on 7/12/2024 starting at 9:00 AM, Entity 6, a home health agency, indicated they admitted Patient #37 on 9/9/22. 10. The clinical record of Patient #12 revealed a recertification POC dated 8/10/22 to 10/8/22 for a weekly skilled nurse for pain management, diabetes (blood sugar disorder) education and safety for home glucose monitoring, and edema (swelling) management until 10/8/22. The POC indicated Patient required oxygen at home, with swelling to legs, an unsteady gait and needed assist to ambulate. Patient was discharged 9/6/22 and failed to evidence coordination of care with the attending physician, an order to discharge from the agency, nor a summary of the care provided through discharge was sent to the attending physician, nor evidence of another provider was able to provide services, nor what information was provided, if any, for transfer to any other provider to continue services. The record failed to evidence a plan to meet Patients care needs after discharge. 11. The clinical record for Patient #17 revealed a recertification POC dated 8/21/22 to 10/19/22 with a skilled nurse visit ordered weekly through 9/17/24 to assess for complications of a feeding tube, a urinary catheter, and recent infections. The record indicated Patient was bedbound with minimal movement and a severe fall risk, was dependent on others for all activities of daily living, and was discharged on 9/7/24. The record failed to evidence if or how patient received care and assistance after discharge, if there was a care giver, failed to evidence coordination of care with the attending physician prior to discharge, that the patient was provided a list of available agencies, nor evidence that a discharge summary was sent to the attending post discharge, nor evidence if another health care provider accepted and was able to provide services, nor what information was provided, if any, for transfer. 12. The clinical record for Patient #19 revealed a recertification POC dated 7/19/22 to 9/16/22 for occupational therapy through end of certification period and indicated Patient had a right heel wound and lymphedema (chronic swelling). The record included a clinical note which indicated on 9/02/2022, Patient was notified of the Patient requested transfer and information was faxed to Entity #6 and that Patient was discharged on 9/2/2022. The record failed to evidence coordination of care with the attending physician, failed to evidence a discharge summary was provided to the attending physician with summary of care through discharge, nor an order to discharge from the agency, nor evidence if Entity 6 accepted and was able to provide services, nor what information was provided, if any, for transfer to any other provider to continue services. On 7/12/22, beginning at 9 AM, Entity 6 relayed Patient was not admitted in 2022. 13. The clinical record for Patient #20 revealed an initial certification plan of care dated 8/23/22 to 10/21/22 for physical therapy through 9/24/22, Patient had a nasogastric tube (feeding tube in the nose) and required assistance to do feeding, bathing, dressing, and ambulating. The record indicated Patient was discharged 9/5/22 and no other admission on record. The record failed to evidence coordination of care with the attending physician, failed to evidence a summary of care was provided through discharge was sent to the attending. 14. The clinical record for Patient #27 revealed an initial certification plan of care dated 7/29/22 to 9/26/22 for skilled nurse weekly visits for edema (swelling) management, pain management, and medication monitoring. Physical therapy and occupational therapy were ordered until 9/17/22 for strengthening and energy conservation/pacing; the record indicated Patient was discharged 9/2/22. The record failed to evidence coordination of care with the attending physician, nor coordination of care with another provider, nor evidence a summary of the care provided through discharge was sent to the attending. 15. The clinical record of Patient #28 revealed an initial certification plan of care dated 8/16/22 to 10/14/22 for physical therapy until 9/17/22. Patient diagnosis was a concussion with loss of consciousness, a pelvis fracture, and required taxing effort and assistive devices for mobility; the record indicated Patient was discharged 9/4/22 with goals met. The record failed to evidence coordination of care with the attending physician, nor a summary of the care provided through discharge. 16. The clinical record for Patient #35 revealed an initial plan of care dated 8/3/22 to 10/1/22 for physical therapy until 9/24/22 for fall prevention and balance issues occupational therapy until 9/10/22 for balance issues. The record indicated Patient was discharged 9/6/22, goals met. The record failed to evidence coordination of care with the attending physician, nor evidence a summary of the care provided through discharge was sent to the attending. 17. The clinical record for Patient #39 revealed a recertification plan of care dated 8/11/22 to 10/9/22 for a skilled nurse to see Patient weekly until 9/17/22 for pain management, edema (swelling) monitoring, weight monitoring, with care to include medication and disease management/education. Patient had kidney and heart failure Patient was discharged 9/2/22 with no further admission on record. The record failed to evidence coordination of care with the attending physician, nor a discharge summary for the care provided through discharge, nor evidence if patient was accepted by another agency and able to provide services, what information was provided, if any, for transfer to any other provider to continue services. 18. The clinical record for Patient #2, included a Plan of care for the recertification period 8/13/22 to 10/11/22, revealed Patient was oriented and forgetful, indicated Patient was homebound due to weakness and impaired mobility, and included orders for skilled nurse visits weekly through 9/10/22 and home health aide services for ADL’s twice a week X 4 weeks through 9/10/22. The record failed to evidence services were provided after 9/02/22. The record indicated, Patient chose to be transferred to Entity 6; a handwritten notation indicated Entity 6 was not within Patient’s insurance network, Patient then chose Entity 3. The record evidenced Patient was discharged on 9/02/22 and admitted to Entity 3 on 9/17/22. The record failed to evidence what information was provided to Entity 3 and when. The record failed to evidence coordination of care with the attending physician, nor nor evidence that a discharge summary was sent to the attending post discharge. 19. The clinical record for Patient #9, included a Plan of care for the recertification period 8/28/22 to 10/26/22, and included orders for skilled nurse 3 times a week for 9 weeks and to include wound care to patients right lower extremity, left elbow, and left forearm. The record included a copy of a letter dated 9/02/22, notifying Patient that the agency would be closing on 9/07/22; the letter included a handwritten note that Patient chose to be transferred to Entity 8, and that Entity 8 was unable to accept to do lack of staff. The EMR included an entry by a previous staff RN, dated 9/05/2022 that they reviewed medications and orders with Patient and agreed to the POC and transfer to Entity 4. The record failed to evidence the discharge plan for patient, if or how patient could receive wound care from 9/05/22 through 9/14/22, 9 days, until admitted by Entity 4 on 9/14/22. The record failed to evidence coordination of care with the attending physician, , nor evidence that a discharge summary was sent to the attending post discharge. 20. The clinical record for Patient #29 revealed an initial certification plan of care dated 8/19/22 to 10/17/22 for the following services: skilled nurse weekly until 9/17/22 for assessment, physical therapy until 9/24/22 for balance training and fall prevention, occupational therapy until 9/17/22 for pacing and energy conservation, and a home health aide 2 times a week until 9/17/24 to shower Patient. The record indicated Patient was discharged on 9/2/22. The record failed to evidence if patient was transferred to another Entity. The record failed to evidence coordination of care with the attending physician, , nor evidence that a discharge summary was sent to the attending post discharge. 21. The clinical record of Patient #31 revealed an initial plan of care dated 8/3/22 to 10/1/22 for skilled nurse weekly until 9/10/24 for assessment, physical therapy until 9/17/22 for balance issues, and occupational therapy until 9/10/22 for training in activity of daily living. Patient had recently fallen, required a wheelchair for mobility, noted as unable to walk 10 feet without requiring a rest due to fatigue. The record indicated Patient was discharged 9/2/22. A clinical note indicated a referral for care was sent to Entity #6; no evidence if patient was accepted for care. The record failed to evidence coordination of care with the attending physician, nor evidence that a discharge summary was sent to the attending post discharge. 22. During an interview on 7/12/24 beginning at 12 PM, Office Manager 1 indicated no discharge orders were written for the discharges and transfers from the agency, indicated assessments completed were based on the last skilled visit provided, and no discharge summaries were provided to the attending physicians for the last patients discharged between 8/31/2022 through 9/07/22. She relayed a letter was sent out to 40 patients on 9/2/22 to inform them that patient care will end on 9/7/22. She relayed a few letters were returned, they have no evidence all patients received their letters and all phone calls made to patients were not documented. 410 IAC 17-12-2(i), 17-12-2(k), 17-12-3(b)(2)(D)(iii)

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, observation and interview, the agency failed to organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity as well as assure that administrative and supervisory functions are not delegated to another agency or organization, (G0940); failed to evidence a governing body or designated persons so functioning, assumed full legal authority and responsibility for the agency’s overall management and operation, the provision of home health services, fiscal operations, review of the agency’s operational plans (G0942); failed to ensure the administrator was appointed by and reported to the governing body (G0946); failed to evidence the administrator was responsible for day-to-day operations of the home health agency (G0948); failed to evidence the clinical manager provided oversight in the coordination of referrals (G0964). The Findings Include: The agency policy titled “Mission Statement,” revised 5/2022, reveals the commitment to extend the highest level of service to patients and the individualized physical, emotional, and spiritual needs of each patient. The agency policy titled “Organizational Planning,” revised 5/2022, indicated the leaders will be responsible for developing and implementing an effective organization wide planning process that includes operational plans consistent with the organization’s mission statement and patient needs. During the entrance interview on 7/10/24 beginning at 10:00 AM, Corporate Compliance Officer 1 indicated the company is ready for patient care and can admit a patient any day, “possibly even tomorrow”. She revealed the agency was purchased in November of 2022 and has have no patients admitted since. Office Manager 1 revealed the agency had no website, no admission paperwork or folder specific to the agency, no pamphlets or public information and no signage on the building yet. She indicated the agency would use the admission packet from their sister agency, anther home health agency, Other Entity A, until new admission paperwork specific to this agency is printed. A review of the admission packet provided by the Administrator revealed the name, location, telephone number for Other Entity A, and the resource information for the location of Other Entity A. During an interview on 7/11/24 beginning at 9:00 AM, Office Manager 1, the previous owner, relayed all patients were suddenly discharged in September of 2022 due to company financial hardship. The Administrator and Office Manager 1 revealed no patient care has been conducted since 9/6/22 through current date. The administrator provided Personnel files for the Administrator, physical therapist 1, occupational therapist 1, Clinical Supervisor, and Alternate Clinical Supervisor; each file indicated a hire date of 10/11/2023. 410 IAC 17-12-1(a)(2), 17-12-1(b) 1. On 7/10/24 at 9:00 a. m., Office Manager 1 and previous owner of the agency relayed all patients on service on 9/02/22, were discharged by 9/07/22 due to closing of the agency effective 9/07/22. She relayed the agency did not accept nor provide any home health services after 9/07/22. On 7/10/24 at 10:00 a.m., upon the administrator’s arrival to the agency, observed the administrator contacted Corporate Compliance Officer 1, via telephone, for the purpose of conducting the entrance conference. The administrator signed and acknowledged the request for the governing body meeting minutes. On 7/10/24 at 10:30 a. m., the administrator relayed the agency has not admitted patients since the change of ownership occurred, effective date 11/20/22. The administrator further indicated all referrals are sent to a sister agency, Entity 1. During an interview on 7/10/24 beginning at 3:00 p.m. a 2nd request to the administrator for governing body minutes was made. The Administrator indicated he had a binder with the requested information at their other office, Entity 1, not at this agency. On 7/11/24 at 1:00 p.m., a request for access to the electronic health record which contained discharged records was made to the administrator. The administrator contacted Corporate Compliance Officer 1, the administrator deferred questions to Corporate Compliance officer 1. Corporate Compliance officer 1 indicated they did not have access to the discharged records and indicated Office Manager 1 was the only person with access and Office Manager 1 should not have given access to the discharged records for review. On 7/12/24 at 9:30 a.m., observed the administrator contacted Corporate Compliance Officer 1 via telephone to obtain agency policies. On 7/12/24 beginning at 11:30 a.m., observed the administrator contacted Corporate Compliance Officer 1 via telephone. The administrator deferred questions to corporate compliance officer 1 who indicated the governing body had a meeting every quarter with the most recent meeting being in January or February of 2024. A 3rd request for governing body minutes to Corporate Compliance Officer 1; Corporate Compliance Officer 1 indicated they would send governing body minutes to the Administrator. On 7/12/24 at 3:30 p.m. as of survey exit, the governing body minutes were not received for review.

Skilled professional performs assessment CFR(s): 484.55(a)(2) When rehabilitation therapy service (speech language pathology, physical therapy, or occupational therapy) is the only service ordered by the physician or allowed practitioner, who is responsible for the home health plan of care, and if the need for that service establishes program eligibility, the initial assessment visit may be made by the appropriate rehabilitation skilled professional. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to perform an initial assessment within 48 hours of a physician order to perform an initial assessment visit for 1 of 3 active records reviewed of therapy only cases. (Patient #1) Findings include: The clinical record for patient #1 was reviewed on 3/31/2021. The record contained an order dated 03/18/21 with a fax time stamp of 12:57 PM on this same date, from Entity 1 (hospital) to Excel. A review of an agency's intake form for patient #1, revealed the intake form was completed on 03/22/21 with a referral date listed as 03/19/21. The clinical record failed to evidence any correspondence or an order from the physician to delay the initial assessment or start of care. Further review of patient #1's clinical record revealed that the initial start of care assessment took place on 03/22/21 by physical therapy. During an interview on 03/31/21 at 11:00 AM, the Clinical Manager confirmed the initial assessment took place for Patient #1 on 03/22/21. The Clinical Manager stated, "Sometimes we don't get all the information from the actual referral and we waited on more information." The Clinical Manager confirmed that the agency did receive the order on 03/18/21 and did not notify the physician that the initial assessment or admission would not occur within 48 hours following the referral. 410 IAC 17-14-1(c)(1)

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 produce evidence of a physician order to delay initial assessment visit for 1 (Patient #1) of 3 records reviewed and failed to ensure topical medications included completion directions on application for 1 (Patient #3) of 1 record reviewed of a patient receiving wound care. Findings include: 1. The clinical record for patient #1 was reviewed on 3/31/2021. The record contained an order dated 03/18/21 with a fax time stamp of 12:57 PM on this same date, from Entity 1 (hospital) to Excel. A review of an agency's intake form for patient #1, revealed the intake form was completed on 03/22/21 with a referral date listed as 03/19/21. Further review of patient #1's clinical record revealed that the initial start of care assessment took place on 03/22/21 by physical therapy. The clinical record failed to evidence any correspondence or an order from the physician to delay the initial assessment or start of care. During an interview on 03/31/21 at 11:00 AM, the Clinical Manager confirmed the initial assessment took place for Patient #1 on 03/22/21. The Clinical Manager stated, "Sometimes we don't get all the information from the actual referral and we waited on more information." The Clinical Manager confirmed that the agency did receive the order on 03/18/21 and did not notify the physician that the initial assessment or admission would not occur within 48 hours following the referral. 2. The clinical record of patient #2, start of care 3/26/21, was reviewed on 3/31/21. Review of a physician order dated 3/28/21 indicated "Lidocaine Hydrochloride, Topical 4% solution 1 application topical once a day [Wound care for right and left shoulder]." The directions failed to evidence if the the lidocaine was to be applied to the surrounding edges of the wound or if should be applied inside the wound, or how long to wait until the lidocaine to take affect before providing treatment. The findings were reviewed on 3/31/21 at 3:00 PM, in which no further information was provided. 410 IAC 17-13-1(a)(2)

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on record review and interview, the Clinical Manager failed to ensure clinicians followed professional standards by including diabetic lower extremity/ foot assessments for 2 of 2 records reviewed of patients with diabetes and complete pain assessments for 2 of 3 records reviewed. (Patient #2 and 3) Findings include: 1. According to a professional article on endocrine disorders at https://patient.info/doctor/assessment-of-patient-with-established-diabetes, last edited on January 20, 2016, indicated " ... Examination ... Neuropathy: Examine the legs for evidence of diabetic neuropathy. Check peripheral limb sensation - eg, using a 10 g [gram] nylon monofilament probe ... Inspect footwear [for suitability] and the feet carefully for any evidence of peripheral neuropathy causing deformity and ulceration, or hypoperfusion due to peripheral vascular disease .... " 2. According to a professional article titled "Nursing Assessment of Pain" at https://mynursingtutors.com/nursing-assessment-of-pain/#:~:tex..." indicated " ... Assessment Procedure ... Onset health concern, location of pain, duration of pain, characteristics of the pain felt; is it a burning pain or a stingy pain, aggravating pain triggers, relieving factors that you have noticed, treatments that have been tried before to eliminate the pain ... Key Considerations: It is crucial to assess pain when at rest as well as when the patient is mobile. You also need to evaluate pain when the patient is on pain medication to know how pain is reacting and responding to medications .... " 3. The clinical record of patient #2, start of care 3/19/2021, was reviewed on 3/31/21. A review of the start of care assessment dated 3/19/21 at 10:23 AM, failed to evidence that the patient's lower extremity/ feet were assessed. The pain assessment revealed the patient has knee pain, severity was a 6 (0 no pain and 10 extreme pain), aching, aggravated by general activity, alleviated by rest. The assessment failed to indicate if the pain interfered with general activity, mobility, sleep, concentration, appetite, therapy, or exercise. Review of a physical therapy evaluation dated 3/19/21 at 12:48 PM, revealed the patient had generalized arthritic pain, severity of 1, description of aching, aggravated by general activity and alleviated by positioning. The assessment failed to indicate if the pain interfered with general activity, mobility, sleep, concentration, appetite, therapy, or exercise. A review of the skilled nursing visit note dated 3/22/21, failed to evidence that the patient's lower extremity/ feet were assessed. The pain assessment revealed the patient had discomfort and soreness when ambulating. The assessment failed to be complete and indicate a level of pain and type of pain when ambulating, if the pain interfered with general activity, mobility, sleep, concentration, appetite, therapy, or exercise. A review of the skilled nursing visit note dated 3/29/21 failed to evidence that the patient's lower extremity/ feet were assessed. 4. The clinical record of patient #3, start of care 3/26/21, was reviewed on 3/31/21. The record contained a physician order dated 3/25/21, to provide wound care services daily due to a ruptured sebaceous cyst to the left posterior right shoulder. The medication list revealed the patient was on medication for neuropathy, and had an insulin pump. A review of an agency document titled "Initial Discharge Planning" dated 3/26/21, included, but not limited to, the patient's diagnoses of diabetes mellitus, hyperlipidemia, morbid obesity, coronary artery disease, and difficulty walking. A review of the start of care comprehensive assessment dated 3/26/21, the pain assessment was incomplete and failed to evidence duration, frequency, and if pain interferes with specific activity. The cardiovascular assessment failed to failed to evidence an assessment the patient's pedal pulses. The endocrine assessment for diabetes failed to evidence that the patient had an insulin pump, and failed to evidence a diabetic foot exam. A review of a skilled nursing visit note dated 3/27/21, stated the patient had pain with wound and rated it at a 7/10. The pain assessment failed to be complete to include the type of pain, duration, frequency, if aggravated by general activity, how the pain is alleviated, and if the pain interfered with general activity, mobility, sleep, concentration, appetite, therapy, or exercise. The visit note failed to evidence that the patient's lower extremity/ feet were assessed. A review of a skilled nursing visit note dated 3/28/21, stated the patient had no pain but stated later in the day, is when the pain the develops. The pain assessment failed to be complete to include a pain rating, the type of pain, duration, frequency, if aggravated by general activity, how the pain is alleviated, and if the pain interfered with general activity, mobility, sleep, concentration, appetite, therapy, or exercise. The visit note failed to evidence that the patient's lower extremity/ feet were assessed. A review of a skilled nursing visit note dated 3/29/21, stated the patient had pain at a level of 1, description was aching, aggravated by wound care, alleviated by rest, duration was "tolerable". The assessment failed to indicate if the pain interfered with general activity, mobility, sleep, concentration, appetite, therapy, or exercise. The visit note failed to evidence that the patient's lower extremity/ feet were assessed. A review of a skilled nursing visit note dated 3/30/21, failed to evidence that the patient's lower extremity/ feet were assessed. 5. During an interview on 3/31/21 at 11:00 AM, when queried if it was the agency's expectation and policy to inspect the lower extremity/ feet of diabetic patients upon admission and subsequent visits, the Clinical Manager stated "Yes."

A Focused Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 494.102 due to recent developments of the COVID-19 pandemic. Survey dates: 2/1/2021 to 2/8/2021 Facility #: 011393 Provider #: 157594 At this Focused Infection Control Emergency Preparedness survey, in regards to staffing and implementation of staffing, Excel Home Health Care, LLC was found not to be in compliance with 42 CFR 484.102 Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers for Home Health Agencies.

Development of EP Policies and Procedures CFR(s): 484.102(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. *[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 Governing Body failed to develop a COVID- 19 emergency preparedness policies and procedures in relation to staffing strategies during an emergency, e.g. the COVID-19 pandemic, which affected the delivery of services to 8 of 8 patient records reviewed (Patient #4, 5, 9, 10, 11, 12, 13, 14) and failed to ensure they had a COVID-19 screening policy and procedure in place for those entering the office. The findings include: 1. During the entrance conference on 2/1/21 at 8:45 a.m., the Administrator and Alternate Director of Nursing indicated Employee E, Clinical Manager, had been off the last few weeks due to illness (COVID-19.) 2. Review of the agency's emergency preparedness binder on 2/3/2021, failed to evidence a policy and procedure for staffing strategies during and COVID- 19 emergency. When queried during an interview on 2/3/2021 at 3:50 p.m., if the agency had a policy/procedure which addressed staffing strategies during an emergency, the administrator indicated there was not a policy and procedure which addressed staffing strategies in the event of an emergency included in the agency's emergency preparedness binder. or elsewhere. 3. On 2/4/21 at 10:10 a.m., the Administrator provided a policy titled "Staffing Emergencies" effective 3/2020 and last reviewed date of 2/3/21. The policy indicated "Partner with other healthcare providers: Entity A [skilled nursing facility] and Entity B [Home Health provider] ... to cover visits for existing caseload and, or refer to them and vice-versa. Utilize office nurses for patient visits. Utilize Excel Personal Services nurses for patient visits ... Utilize PT to collaborate with nursing to perform simple wound care such as dressing changes 1x/week .... " Review of the policy presented revealed, at the bottom of the page, signatures of approvals were left blank, the areas for name, title, and date, were also blank. 4. A review of the Governing Body minutes for 2020, failed to evidence any documentation of discussion and approval of any policies related to the COVID-19 pandemic. 5. The clinical record of patient #4 was reviewed and revealed a hospital discharge physician order dated 1/5/21, indicating the need for skilled nursing. Review of the start of care comprehensive assessment and consents, revealed the admission assessment was completed by Employee I, a physical therapist. Further record review revealed skilled nursing visits had not started until 2/2/21. The clinical record failed to evidence any documentation of the patient's and physician approval to delay skilled nursing care, and failed to evidence an order which authorized skilled nursing to start on 2/2/21. During an interview on 2/3/2021 at 1:45 PM, employee I, PT (physical therapy) stated that he was aware that patient #4 had an order for skilled nursing and when he received the referral from the office, he informed the office the referral order had SN, PT, HHA services ordered, but was told that Employee E was out sick, so they had him (PT) open the case. 6. Review of the Clinical Manager's patient list and the retrospective clinical records revealed the following: Patient #5 - Missed skilled nursing visits on 1/21 and 1/28/21 Patient #9 - Missed skilled nursing visits on 1/20 and 1/27/21 Patient #10 - Missed skilled nursing visits on 1/21 and 1/28/21 Patient #11 - Missed skilled nursing visits on 1/21 and 1/28/21 Patient #12 - Missed skilled nursing visits on 1/21 and 1/28/21 Patient #13 - Missed skilled nursing visits on 1/20 and 1/27/21 Patient #14 - Missed skilled nursing visits on 1/20/21 7. During an interview with the Administrator, Alternate Administrator, and Clinical Manager on 2/8/2021 at 12:15 PM, when asked about the policy that was provided on 2/4/2021, which indicated partnering with other providers to cover visits for existing caseload, the Administrator stated she did not reach out to them for staffing assistance, because previous requests had been unsuccessful. When asked about accepting patients when there were only 3 full-time nurses, with one being the Clinical Manager for a census of 80 patients, when the Clinical Manager was off due to illness, the Administrator stated the agency had sign-ups. The Administrator further indicated only one (1) patient of the Clinical Manager's did not get seen while the Clinical Manager, employee E, had been off work. The agency failed to have a policy approved by the Governing Body in regards to staffing and implementation of staffing to ensure care visits were not missed and care was provided as ordered on the plan of care as per the physician authorized plan of care. 8. Upon entering the agency on 2/1/21 to 2/4/21 and 2/8/21, the agency failed to ask screening questions and complete an assessment of symptoms/ illness when surveyors arrive. On 2/3/21 at approximately 2:30 p.m., an UPS (United Parcel Service) delivery person was observed coming through the back door of the agency and placed boxes of paper in the agency's shelf. During an interview on 2/8/2021 at 12:15 p.m., when asked if the agency has a policy and procedure on screening visitors who come into the agency, the Administrator stated the agency does not have a policy and procedure.

This visit was for a Federal Recertification and State Re-Licensure Survey of a Medicare Home Health provider. Survey Dates: 2/1/2021 - 2/8/2021 Facility #: 011393 These deficiencies reflect State Findings cited in accordance with 410 IAC 17. A fully extended survey was announced on 2/4/2021 at 11 AM. Excel Home Healthcare is precluded from conducting a home health aide training or competency evaluation program for a period of two years beginning February 8, 2021 through February 7, 2023 for being out of compliance with §484.60 Condition of participation: Care planning, coordination of services, and quality of care. Quality Review completed on 3/4/2021 A4

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, interview, and observation, the agency failed to inform the patients in advance of disciplines which would be furnished and frequency in establishing the start of care (SOC) in 2 of 3 active patients (#4, #6) from a sample of 8. Findings include: 1. Review of an undated agency policy titled " Patient Rights," Excel Home Healthcare, LLC patients have the right to be informed in advance of services, rights, and responsibilities related to home health care serves. You Have The Right To: Be fully informed in advance about the care and treatment to be furnished including the disciplines that will furnish care and the proposed frequency visits." 2. The clinical record of patient #4 was reviewed on 02/02/2021. The clinical record included a hospital discharge physician order dated 01/05/2021, indicating the need for skilled nursing, physical therapy, and home health aide. The review of the clinical record revealed an admission consent form dated 1/21/2021, with the proposed visit frequency per discipline was: marked checked for SN (skilled nurse) and PT (physical therapy) with no frequency documented. During a home visit observation 2/3/2021 at 1:00 PM the patient's admission folder included a consent form dated 1/21/2021, with the proposed visit frequency per discipline was: marked checked for SN and PT with no frequency documented. 3. The clinical record of patient #6 was reviewed on 2/2/2021. Review of a physician signed SOC plan of care 12/11/2020-2/8/2021 indicated orders for SN. The clinical record included an admission consent form dated 12/11/2020, with the proposed visit frequency per discipline was: marked with a 0 Master of Social Work (MSW) and 0 for Home Health Aide (HHA), SN was blank. 4. During an interview on 2/4/2021 at 10:25 AM, the clinical manager stated the discipline and frequency was to be written on the consent form by the clinician on admission. 17-12-3(b)(2)(D)(i)(AA) 17-12-3(b)(2)(D)(i)(BB)

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 home health agency failed ensure skilled nursing initiated care per hospital discharge orders for 1 of 3 records reviewed (#4). from a sample of 8. Findings include: An undated agency policy titled Physician orders, indicated, but was not limited to, "Home Care staff will administer care and treatment according to specific instructions.... The physician will be notified immediately of any changes to the patient's condition which would indicate changes to the plan of care." The clinical record of patient #4, start of care (SOC) date of 1/21/2021, was reviewed on 2/2/2021 and contained a referral and physician order dated 1/5/2021, upon discharge from a hospital, for home health to evaluate and treat for initial visit and ongoing treatment until Primary Care Physician (PCP) is able to follow up with resident's care. The requested services: were Skilled Nursing (SN), Physical Therapy (PT), and Home Health Aide (HHA). Review of a start of care assessment dated 1/21/2021, revealed the assessment was completed by PT. Review of the clinical record revealed the skilled nurse assessed the patient for the first time on 2/2/2021. The record failed to reveal a physician order for delay of the initial SN visit dated 2/2/2021. During a home visit 2/3/2021 at 1:30 PM, the patient's admission packet was reviewed and contained a consent form dated 1/21/2021, indicating SN would be provided on 1/21/2021. During an interview on 2/3/2021 at 1:45 PM, employee I, PT stated that he was aware that patient #4 had an order for SN and HHA. Employee I stated he received the referral from the office, and he told the office it had SN, PT, HHA services ordered but was told that employee E, RN was out sick, the office told him open the case. During a home visit on 2/3/21 at 1:00 PM, patient #4 stated she recently had stents placed and currently had appointments for blood draws and iron transfusion. 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 ensure the comprehensive assessment was complete and accurately reflected the patient's status, including current health, psychosocial, functional, and cognitive status for 3 of 8 reviewed (#5, #7, #4). Findings include: 1. Review of a of an undated agency policy titled "Comprehensive Client Assessment," stated "POLICY: A thorough, well-organized, comprehensive, and accurate assessment, consistent with the client's immediate needs will be completed...PURPOSE: To include in general health status/system assessment." 2. A review of the clinical record for patient #5 revealed an untimed OASIS (Outcome and Assessment Information Set - a patient specific standardized assessment tool) document dated 1/8/2021. The OASIS revealed a primary diagnosis of chronic obstructive pulmonary disease, low back pain, weakness, and shortness of breath, poorly controlled with current risk factors listed as multiple co-morbidities, history of falls, multiple medications, morbid obesity, oxygen dependence, decline in mental, emotional, or behavioral status, difficulty complying with medical instructions, polypharmacy, and reported exhaustion. The patient's emergency room and hospitalization risks were moderate, which failed to accurately reflect the listed risk factors. The OASIS failed to incorporate a comprehensive assessment and failed to evidence the patient's height, weight, basal metabolic rate. The OASIS failed to include assessment of infection, supportive assistance. An assessment of emergency needs revealed required durable medical equipment (DME) of rollator, transportation of "private auto" and "relative". Emergency evacuation plans evidenced "home of a friend" and a location of "Lebanon". Review of the patient's environment evidenced no issues at this time. The OASIS failed to include a full emergency assessment including all DME/supplies needed, failed to address the patient's oxygen needs and shortness of breath, pain, obesity, and difficulty with mobility and failed to include details, including name/address of evacuation location and individuals. The OASIS revealed the patient had no change in pain since the last assessment, had a current pain level of 8/10 all of the time, with general activity. The OASIS failed to include further assessment for pain and failed to address a significant pain level that remained ongoing since the last certification. The lung sounds were diminished bilaterally, patient had a productive cough with thick, white mucus, and shortness of breath with minimal exertion. The OASIS failed to evidence the clinician contacted the physician(s) to discuss a significant pain level and respiratory issues and failed to complete a medication review and contact the physician to confirm duplicate therapy, correct route/dose/frequency, interactions, side effects, and appropriateness of therapy. The OASIS evidenced the patient required a full cardiac assessment but evidenced only "skin unremarkable". Patient #5 evidenced a nutritional risk of 3 but failed to address the morbid obesity. The patient's timed up and go was >13.5 at 21 seconds and the MAHC-10 (a fall risk assessment) was 6 but failed to include the previously mentioned history of falls, environmental hazards, and cognitive impairment. The patient was dependent and/or required assist with all activities and instrumental activities of daily living, was full weight bearing, and utilized a rollator. The OASIS failed to evidence documentation of either limitation. The clinical findings indicated the patient had limited mobility, balance/coordination issues, was a fall risk, experienced chronic pain, had shortness of breath with minimal exertion on 6 liters continuous oxygen, decreased strength, poor endurance, and required extensive effort to leave the home. The stated therapy need was "0". The OASIS failed to evidence pertinent interventions and goals related to the patient's current needs, failed to evidence all pertinent diagnoses, failed to include a complete and accurate comprehensive assessment, and failed to accurately reflect the patient's current status. A review of a "Skilled Nurse Clinical Note" dated 1/8/2021 from 12:09 PM - 12:42 PM revealed the document was completed on the same day as the OASIS assessment. The document repeated OASIS information but failed to include a comprehensive assessment of the patient's systems, a complete review of medications, failed to evidence the patient's care preferences, available caregivers, individualized goals and interventions related to the patient's current needs, and failed to evidence communication with the physician(s) related to immediate care needs or a continued plan of care. 3. A review of the clinical record for patient #7, start of care date 9/21/2020, revealed an untimed document titled OASIS Recertification dated 1/15/2021 from . The OASIS evidenced a primary diagnosis code of acute and chronic respiratory failure with hypoxia and secondary diagnoses of chronic combined systolic and diastolic congestive heart failure, pneumonia, unspecified organism, fluid overload, pulmonary hypertension, and iron deficiency anemia. Current "risk profile" included multiple comorbidities, advanced age, history of falls, open wounds, recent emergency room use and recent hospitalization, and multiple medications with a secondary "risk profile" including history of falls, unintentional weight loss of a total of 10 pounds or more, history of difficulty complying with medical instructions, and currently taking 5 or more medications, was on 6 liters/minute continuous oxygen via nasal cannula, and was hard of hearing, The assessment evidenced safety concerns including cluttered areas, narrow doors, and oxygen. The patient evidenced no change in pain with a pain level of 3, daily but not constantly. There was a bilateral lower extremity score of +2 pitting edema (swelling caused by excess fluid) with a stasis (an ulcer that develops in an area where circulation is sluggish and venous return is poor) wound to the left lateral ankle. The Braden score (a pressure risk score) was 16, which indicated patient was at mild risk for pressure sores. Lungs were bilaterally diminished with shortness of breath with minimal exertion. Pt (patient) incontinent and forgetful. The OASIS further indicated the patient was compromised in balance, comfort level, fall risk, strength, endurance, limited weight bearing, had shortness of breath with minimal exertion, required assist with or was dependent in all activities and instrumental activities of daily living, and utilized a rolling walker with 1 person assist for ambulation. The OASIS failed to evidence the affected extremity and reason for partial weight bearing. Patient #7 evidenced a high fall risk, but with a moderate risk for rehospitalization but failed to evidence the need for therapy evaluation and evidenced a therapy need of "0". The assessment failed to include emergency preparedness special needs including oxygen, failed to include a complete medication review including correct route/dose/frequency, duplicate therapy, side effects, effectiveness of therapy, and failed to include wound measurements and failed to note if the wound was packed per orders during the dressing change. The assessment failed to include a review of the patient's cardiac and elimination systems and failed to include a thorough pain and pulmonary assessment. The OASIS evidenced patient #7 had unexplained weight loss of >10 pounds but failed to include a height, weight, BMI (basal metabolic rate), and failed to include all risk factors for nutrition. The document failed to address the patient's dietary needs/special diet related to diagnoses of congestive heart failure, hypertension, fluid overload, and pulmonary hypertension. The assessment failed to incorporate a full comprehensive assessment, failed to include the patient's care preferences, available caregivers, and plans to support caregivers. The OASIS failed to include accurate and pertinent diagnoses related to the patient's current need for home care, failed to include a diagnosis related to wound care, failed to include individualized goals and interventions related to the patient's current needs, and failed to evidence communication with the patient's physician/physicians related to immediate care needs or a continued plan of care. A review of a document titled "SN (skilled nurse) Clinical Note", dated 1/15/2021 from 1:41 PM-2:13 PM revealed the document was completed during the OASIS assessment. The "SN Clinical Note" included wound measurements and repeated OASIS information. The document failed to include a comprehensive assessment of the patient's systems and failed to evidence the patient's care preferences, available caregivers, individualized goals and interventions related to the patient's current needs, and failed to evidence communication with the physician(s) related to immediate care needs or a continued plan of care. During a home visit on 2/3/21 at 9:00 AM patient #7 stated she had a right frozen shoulder and a torn rotator cuff on the left shoulder, both which happened over a year ago. The patient stated she could not lift her right arm at all and could not lift her left arm greater than halfway. 4. The clinical record of patient #4, start of care (SOC) 1/21/2021, was reviewed on 2/2/2021. The hospital physician order for home care dated 1/5/2021 listed diagnoses of, but not limited to, anemia, atherosclerotic heart disease of native coronary, gastrointestinal hemorrhage, other specified abnormalities of plasma proteins, unspecified abdominal pain, palpitations, diverticulosis of large intestine without perforation, personal history of other diseases of the nervous, presence of coronary angioplasty implant and graft, and old myocardial infarction. The record contained a start of care comprehensive assessment dated 1/21/2021. Review of the comprehensive assessment completed 1/21/2021, revealed diagnoses including, gastrointestinal hemorrhage, unspecified, anemia, unspecified, Other specified abnormalities of plasma proteins, diverticulosis of large intestine without perforation or abscess without bleeding, old myocardial infarction, peripheral vascular disease, unspecified. The active diagnoses comorbidities and co existing conditions was marked yes for diabetes mellitus. The Endocrine system assessment indicated the patient had no issues, the cardiovascular assessment indicated "none reported", respiratory and gastrointestinal assessment was marked "no assessment." Further review of the Comprehensive Assessment revealed the patient was short of breath with moderate exertion. The comprehensive assessment failed to include blood sugar norms, frequency of accuchecks, what the patient had been running since hospitalization, or complete a diabetic foot assessment. The cardiovascular assessment failed to identify the patient's cardiac history, including the myocardial infarction and stents that was placed recently. The agency failed to identify and complete an assessment of the gastrointestinal due to the patient's recent hospitalization of gastrointestinal hemorrhage.

Strengths, goals, and care preferences CFR(s): 484.55(c)(2) The patient's strengths, goals, and care preferences, including information that may be used to demonstrate the patient's progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure comprehensive assessment contained individual patient goals, strengths, and care preferences identified by the patient for 4 of 6 active records (patients 4, 5, 6, 7) from a sample of 8. Findings included: 1. A review of an undated agency policy titled "Comprehensive Client Assessment" revealed "A thorough, well-organized, comprehensive, and accurate assessment, consistent with the client's immediate needs will be completed...PURPOSE: To include information that may be used to demonstrate progress toward achievement of desired outcomes."" 2. A review of the clinical record for patient #5, start of care date 4/15/2015, revealed an OASIS recertification document dated 1/8/2021 for certification period 1/13/2021-3/13/2021. A subsection titled "Care Details/Risk Profile/Care Preferences: Patient Care Preferences/Comments" was blank. A review of the "SN Clinical Note", dated/timed 1/8/2021 from 12:09 PM - 12:42 PM revealed a section titled "Care Preferences" which evidenced "Patient Strengths: Knowledge of disease process ... Patient Stated Goals: pt wants to stay stable ...." The documents failed to evidence documentation patient care preferences were assessed or discussed., and failed to include individualized, pertinent, and measurable goals. 3. A review of the clinical record for patient #7, start of care date 9/20/2020, revealed an OASIS recertification document dated 1/15/2021 for certification period 1/19/2021 - 3/19/2021. A subsection titled "Care Details/Risk Profile/Care Preferences: patient Care Preferences/Comments" was blank. A review of a "SN Clinical Note" dated/timed 1/15/2021 from 1:41 PM - 2:13 PM revealed a section titled "Care Preferences", which evidenced "Patient Strengths: Knowledge of medications ... Patient Stated Goal: Heal my wound." The documents failed to evidence documentation that patient care preferences were assessed or discussed, and failed to include individualized, pertinent, and measurable goals. 4. The clinical record of patient #4, start of care (SOC) 1/21/2021, was reviewed on 2/2/2021. Review of start of care comprehensive assessment dated 01/21/2021, failed to evidence patient weaknesses and care preferences as the sections were blank. 5. The clinical record of patient #6, SOC 12/11/2020, was reviewed on 2/2/2021. Review of the start of care comprehensive assessment dated 12/11/2020, failed to evidence patient weaknesses and care preferences as the sections were left blank. 6. During interview with clinical manager and administrator 2/8/2021 at 3:22 PM, they stated in services have been given to the clinicians upon completing the comprehensive assessment.

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 clinician completed a review of all medications the patient was using in order to identify any potential adverse effects and drug reactions, including ineffective therapy, adverse effects/reactions, side effects, drug interactions, duplicate therapy, and noncompliance in 3 of 6 active records reviewed in a sample of 8. (patients 4, 5, 7) Findings included: 1. A review of an undated policy titled "Comprehensive Client Assessment" revealed "The comprehensive assessment will include a review of all medications the client is using. This assessment will identify potential adverse effects and drug reactions, including ineffective therapy, significant side effects, significant drug interactions, duplicate drug therapy, and non-compliance with therapy ... In addition to general health ... assessment, the agency comprehensive assessment tool with OASIS will include ... Medications." 2. A review of the agency policy manual, last reviewed 7/24/2016 revealed an undated policy titled "Medication Profile". The policy evidenced the medication profile procedures as follows: " ...Review and record any changes that occur ... Carefully review and update the documented medication every month and or as needed ...." 3. A review of a document for patient #5 titled "Home Health Certification and Plan of Care" dated 1/13/2021-3/13/2021 and signed by the physician on 2/2/2021 revealed the following medications: Albuterol-Iapratropium Bromide 0.5 milligram inhalation every 4 hours as needed; Aspir [sic] 81 1 tablets by mouth once a day; B 12 1000 micrograms once a day; Benadryl Allergy 12.5 milligram by mouth once a day as needed; Calcitriol 0.25 mg cap(s) by mouth 3 times a week (MWF@HS) [Monday, Wednesday, Friday at bedtime];Celebrex 200 mg capsule 1 cap(s) by mouth every other day; frequency Cymbalta 60 milligram by mouth 2 times a day hs (at bedtime); febuxostat 40 mg tablet 1 tablets by mouth once a day (1 in PM); Gabapentin 300 milligram by mouth 3 times a day (1 in am 2 in pm); Klor-Con M10 10 milliequivalents by mouth 2 times a day (1 in morning 2 in evening); Lasix 40 milligram by mouth once a day for Heart; Levothyroxine Sodium 200 microgram by mouth once a day; Lidoderm 5 gram topical every 12 hours as needed; Magnesium oxide 400 mg tablet 1 tablets by mouth once a day; metolazone 5 mg tablet 2 tablets by mouth 3 times a week; Metoprolol Tartrate 25 milligram by mouth 2 times a day changed; midodrine 5 milligram by mouth 2 times a day; miralax-powder for reconstitution 17 grams by mouth once a day as needed for constipation; multivitamin One Daily once a day; Myrbetric 50 milligram oral once a day; Norco 325 mg - 5 mg 1/2 -1 tablet oral once a day; pantoprazole 40 mg delayed release tablet 1 tablet by mouth once a day; sildenafil 25 mg tablet 1 tablets by mouth once a day; skelaxin 800 milligram by mouth 3 times a day;spironolactone 50 milligram by mouth once a day;symbicort 160 microgram inhalation 2 times a day; tramadol 50 mg tablet 1 tablets by mouth 2 times a day as needed pain;trazodone hydrochloride 50 milligram by mouth once a day as needed; Ventolin HFA 90 microgram inhalation every 4 hours as needed shortness of breath; voltaren topical 1% application topical once a day as needed pain (neck and shoulder). The document revealed allergies of "lisinopril, codeine, Codeine Sulfate, lisinopril, Albuterol Sulfate". The document evidenced the patient was taking Albuterol, failed to include the correct dose for Aspir [sic], failed to verify if Albuterol and Ventolin inhalations were nebulizer or puffs, failed to included the "as needed" reason for Benadryl, lidoderm, and trazadone, and failed to identify Lidoderm as a patch, the affected area to apply, and the correct dosing including to remove old patch and replace with new over affected area. The document failed to include oxygen in the medication list. A review of an OASIS document and comprehensive assessment tool for Patient #5, dated 1/8/21 for certification period 1/13/2021- 3/13/2021 evidenced the patient had an unchanged pain level of 8/10 all of the time and was short of breath with minimal exertion, despite pain and respiratory medication. The OASIS failed to evidence a medication review was completed that included duplicate therapy, high risk medication, effectiveness of therapy, side effects/reactions, interactions, accurate dosage/route/frequency, and compliance with ordered medication. 4. A review of the "Home Health Certification and Plan of Care" for patient #7, start of care date 9/21/20 for certification period 1/19/2021-3/19/2021 revealed the following medications: B 12 1000 microgram intramuscularly every 3 weeks; Calcium 500 milligram oral 2 times a day; Gabapentin 100 milligram oral 3 times a day (1 in morning, 1 at noon, and 2 at night); Omeprazole 20 milligram oral once a day; Prolia 60 milligram SUBCUT (subcutaneous) every 6 months; Timolol Maleate, Ophthalmic 0.5 gram OPH once a day;Triamcinolone Acetonide Topical 0.5 gram topical 2 times a day; Tylenol extra Strength 500 milligram oral 3 times a day (2 tabs); Tylenol Extra Strength 500 mg tablet 2 tablets oral every 6 hours PRN pain; Vitamin D3 1 tablets chewed once a day. The document failed to include the who provided the B12 and Prolia injections, failed to identify whether calcium was a pill, liquid, capsule, failed to give the correct route for Timolol Maleate, and failed to give the location for topical application. The document also evidenced duplication of Tylenol with different doses/frequency and failed to include oxygen in the medication list. A review of an OASIS for Patient #7, dated 1/15/2021, revealed that the patient was assessed as unable to take injectable medication unless administered by another person, was short of breath with minimal exertion despite pain and respiratory medication. The document failed to evidence further review of the patient's medications, failed to identify duplicate therapy, questionable dosage, high risk medications, the effectiveness of therapy, significant side effects and interactions, accurate dosage/route/frequency, and compliance with ordered medications. 5. During an interview on 2/8/2021 at 12:51 PM the Clinical Manager confirmed that the physician was not contacted to verify medications. The Clinical Manager stated the medications were listed on the plan of care and could be reviewed by the physician when the plan of care was sent for signature. The Clinical Manager confirmed that plans of care were not sent for signature for at least 5 days and confirmed that incorrect medications, duplicate therapy, accurate dosage/route/frequency could go unidentified for extended periods of time. 6. The clinical record of patient #4, start of care (SOC) 1/21/2021, was reviewed on 2/2/2021. The record contained a plan of care dated 1/21/2021 for certification 1/21/2021-3/21/2021 listing the following medications: Aspirin, Atorvastatin Calcium, Carvedilol, Clopidogrel, Docusate-Senna, Ferrous Gluconate, Gabapentin, Levothyroxine Sodium, Metformin Hydrochloride, Nitroglycerin, Polyethylene Glycol, Tramadol, and Ventolin HFA. The clinical record listed the following allergies: Gadolinium, Iopamidol, Tetracycline, and Levofloxacin. The hospital discharge dated 1/5/2021, listed allergies as: Levofloxacin, Gadolinium, Iopamidol, Tetracycline, Codeine, and IVP dye and listed the discharge medications as follows: Nitroglycerin, Albuterol Sulfate, Furosemide, Atorvastatin, Calcium Carbonate, Polyethylene Glycol, Clopidogrel, Isosorbide Mononitrate, Metformin, Sennosides, Loratadine, Calcium Carb-vit D2 Minerals, Guaifenesin, and Aspirin. Review of the OASIS start of care comprehensive assessment dated 1/21/202, page 46 of 53 (M2001) asks if a complete drug regimen review identify potential clinically significant medication issues in which the answer was "0" (No - No issue found during review). Review of Drugs.com drug interactions report indicated there were 2 major drug interactions between Gabapentin and Tramadol, and Albuterol and Carvedilol. The report revealed 14 moderate drug interactions between Multivitamin with Minerals and Carvedilol, Senna, and Polyethylene Glycol, Tramadol and Polyethylene Glycol, Albuterol and Polyethylene Glycol, Atorvastatin and Clopidogrel, Tramadol and Clopidogrel, Aspirin and Clopidogrel, Albuterol and Tramadol, Senna and Tramadol, Levothyroxine and Ferrous Gluconate, Levothyroxine and Metfomin, Albuterol and Metfomin, Levothyroxine and Multivitamin with Minerals, and Albuterol and Senna. The medication list failed to contain all prescribed medications, allergies, failed to appropriately be reconciled and checked for drug interactions. 7. During an interview 2/3/2021 at 11:05 AM, the clinical manager stated that she reviewed all therapy medication lists and she did not notify the physician of interactions. The clinical manager stated," He is their doctor he should know what he prescribes and if it is high risk." 17-15-1(a)(3)

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 agency failed to ensure they could meet the patient needs at home for 2 of 6 (#4, #5) active patients, from a sample of 8, who went without skilled nursing visits as ordered by the physician, which had the potential to affect all patients (See G0570); the agency failed to ensure the plan of care was individualized and included all correct and pertinent diagnoses and their onset date and status, all supplies and equipment, all treatment orders, diet, safety measures, all medications the patient was taking, accurate medications including frequency, route, dose, an accurate description of the patient's risk for emergency department visits and hospitalization, all necessary interventions to address underlying risk factors, and measurable outcomes and goals (See G0574); and failed to ensure skilled nursing was provided without delay per hospital discharge orders (See G0578). The cumulative effect of these systemic problems resulted in the agency being out of compliance with §484.60 Condition of participation: Care planning, coordination of services, and quality of care. In regard to G0570 Findings Include: 1. An undated agency policy titled "Twenty Four Hour On Call Coverage," stated "POLICY: Skilled nursing services and Administrators are available on a twenty-four hour bases, seven days per week." 2. During the entrance conference on 02/01/2021 at 8:45 a.m., the Alternate Clinical Manager indicated the Clinical Manager had been off the last few weeks due to illness. 3. The clinical record of patient #4 was reviewed on 02/02/2021. The clinical record revealed a hospital discharge physician order dated 01/05/2021, indicating the need for skilled nursing. Review of the start of care comprehensive assessment and consents, the admission assessment was completed by Employee I, a physical therapist (PT). Further record review revealed skilled nursing did not start until 02/02/2021. The clinical record failed to evidence any documentation of the patient's and physician approval to delay skilled nursing (SN) and failed to evidence any orders indicating SN to start care on 02/02/2021. During an interview on 02/03/2021 at 1:45 PM, employee I, stated that he was aware that patient #4 had an order for SN and HHA. Employee I stated he received the referral from the office and he told the office it had SN, PT, Home Health Aide (HHA) services ordered but was told that employee E, RN was out sick, so they had him open the case. During an interview with patient #4 after the home visit with Employee I on 02/03/2021 at 1:50 PM, when asked about the discharge orders from the hospital for SN, patient #4 stated the Clinical Manger had started seeing her "this week." The agency failed to ensure patient #4 was not accepted for treatment when there was a nursing shortage and without approval from the referring physician and/ or from the physician responsible for the patient's care. 4. During an interview with Employee A on 2/8/21 at 11:40 AM, Employee A stated Employee E was off for 2 weeks due to contracting Covid 19. Employee A confirmed there were visits missed during this time period due to having no staff to complete the visits. 5. A review of an untitled report provided by Employee A, with a heading of "To Be Reviewed", evidenced 6 individual missed visit dates for skilled nursing. During an interview with employee E on 2/8/21 at 2:06 PM, Employee E stated the document did not provide a complete list of all patients she was scheduled to see and missed while off. Employee E added 7 additional patients with a total of 13 missed skilled nurse visits for dates 1/20/21, 1/21/21, 1/27/21, and 1/28/21. Patient #5 was included with this list for dates 1/21/21 and 1/28/21. 17-13-1(a)

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care was individualized and included all correct and pertinent diagnoses and their onset date and status, all supplies and equipment, all treatment orders, diet, safety measures, all medications the patient was taking, accurate medications including frequency, route, dose, an accurate description of the patient's risk for emergency department visits and hospitalization, all necessary interventions to address underlying risk factors, and measurable outcomes and goals for 3 of 6 active records (patients 4, 5, 7) in a sample of 8. Findings included: 1. Review of a revised dated 09/08/2009 agency policy titled " Policy and Procedure For Plan of Care Procedure" indicated, "..."The plan of care shall include all services to be provided, cover all pertinent diagnosis and include the following: Mental status, Types of Services and equipment required, Frequency and duration of visits, Prognosis, Rehabilitation Potential, Functional limitations, Activities permitted, Nutritional requirements, Medications and treatments, Any safety measures to protect against injury, Instructions for a timely discharge or referral, Therapy modalities specifying length of treatment, Any appropriate items ..." 2. The clinical record of patient #4, start of care (SOC) 1/21/2021, was reviewed on 2/2/2021. The hospital physician order for home care dated 1/5/2021 listed diagnoses of anemia, atherosclerotic heart disease of native coronary, gastrointestinal hemorrhage, other specified abnormalities of plasma proteins, unspecified abdominal pain, palpitations, diverticulosis of large intestine without perforation, personal history of other diseases of the nervous, acquired absence of other specified parts of digestive system, presence of coronary angioplasty implant and graft, old myocardial infarction. The record contained a start of care comprehensive assessment dated 1/21/2021. Review of the comprehensive assessment completed 1/21/2021, revealed diagnoses including, gastrointestinal hemorrhage, unspecified, anemia, unspecified, Other specified abnormalities of plasma proteins, diverticulosis of large intestine without perforation or abscess without bleeding, old myocardial infarction, peripheral vascular disease, unspecified. The active diagnoses comorbidities and co existing conditions was marked yes for diabetes mellitus. Endocrine system comments no issues documented, cardiovascular none reported, pain patient denies pain not needed, respiratory status and gastrointestinal status was marked no assessment conducted on comprehensive assessment. Further review the Comprehensive Assessment revealed patient is short of breath with moderate exertion. PT (physical therapist) did not ask about blood sugar norms, frequency of accu checks, what the patient has been running, and diabetic foot assessment. The cardiovascular assessment failed to identify the patient's cardiac history, including the MI and stents that was placed recently. The PT failed to identify and complete an assessment of the gastrointestinal, lungs, cardiac, and location of pain. The record contained a plan of care for the certification 1/21/2021-3/21/2021 included, but not limited to, diagnoses of iron deficiency anemia secondary to blood loss, and chronic diastolic heart failure, diabetes 2 mellitus. Ordered services on the plan of care were Physical Therapy 1 time a week for 1 week, 2 times a week for 4 weeks; Goals established were...increased strength to 4/5 in hips and knees at all times so patient is safer with gait by 2-27-2021. The POC failed to evidence blood sugar parameters, vital sign parameters, weight parameters, a measurable cardiovascular goal, gastrointestinal measurable goals, diabetic measurable goals and DME glucometer, and lancets. Further review of the plan of care (POC) for the certification period 1/21/2021-3/21/2021, revealed other patient diagnoses that were all coded with E (exacerbation) and their onset dates including, but not limited to, displacement of femoral arterial graft (bypass) 10/28/2020, encounter for surgical aftercare following surgery on the circulatory system 10/28/2020, iron deficiency anemia secondary to blood loss 10/28/2020, acute post hemorrhagic anemia 10/28/2020, lower abdominal pain 10/28/2020, melena 10/28/2020, atherosclerotic heart disease 9/2/2020, chronic diastolic heart failure 9/8/2020, essential hypertension 9/8/2020, weakness 9/9/2020, presence of coronary angioplasty 08/14/2018, hypothyroidism 9/8/2020, other specified depressive disorder 9/8/2020, gastro-esophageal reflux disease 9/8/2020, constipation 9/8/2020, obesity 9/8/2020, chest pain 8/14/2018, abnormal electrocardiogram 8/14/2018, syncope and collapse 8/14/2018, muscle weakness 8/15/2018, acute upper respiratory infection 8/14/2018, nausea and vomiting 8/14/2018, other abnormalities of gait and mobility 5/11/2016, cyst of pancreas 5/11/2016,non-ST elevation myocardial infarction 1/14/2016, unspecified systolic heart failure 1/14/2016, unspecified abdominal pain 5/11/2018, urinary tract infection 5/11/2016, and cystitis 5/11/2016. The diagnoses, exacerbation, and onset on this POC failed to be supported by the comprehensive assessment. 3. A review of the clinical record for Patient #5 included a document titled "Outcome and Assessment Information Set" (OASIS) for patient #5, start of care date 4/15/2015, for certification period 1/13/2021 - 3/13/2021 revealed a primary diagnosis of chronic obstructive pulmonary disease and secondary diagnoses of unspecified diastolic congestive heart failure, peripheral vascular disease, low back pain, weakness, and shortness of breath labeled as exacerbations. Patient #5 utilized continuous oxygen at 6 liters per minute via nasal cannula and bipap at night. There were no changes in pain since the last comprehensive assessment, and the patient evidenced a current pain level of 8 in the patient's back all of the time. The patient had a history of falls, a decline in mental/emotional status in the last 3 months, had a Braden risk assessment score of 16. Breath sounds were diminished bilaterally and the patient was short of breath with minimal exertion. The patient had a rollator, grab bars, straight cane, reacher, long handled sponge, non-skid surface, a tub seat, a raised toilet seat, power recliner, oxygen concentrator, oxygen tank, nebulizer, and blood pressure cuff. The patient required assistance with all activities/ instrumental activities of daily living including bathing, dressing, grooming. The patient presented as a high fall risk and a moderate hospitalization risk. A review of the plan of care for patient #5, for certification period 1/19/2021- 3/19/2021 revealed 39 additional diagnoses dated 2017-2019 and labeled as exacerbations, including abnormalities of gait, hypothyroidism heart failure, incontinence, chronic systolic congestive heart failure, other fatigue, constipation, obesity, acute renal failure, ventricular tachycardia, cramp and spasm, headache, rotator cuff tear, and pain in leg. The following medications were listed: Albuterol-Iapratropium Bromide 0.5 milligram inhalation every 4 hours as needed; Aspir [sic] 81 1 tablets by mouth once a day; B12 1000 micrograms once a day; Benadryl Allergy 12.5 milligram by mouth once a day as needed; Calcitriol 0.25 mg cap(s) by mouth 3 times a week (MWF@HS) [Monday, Wednesday, Friday at bedtime]; Celebrex 200 mg capsule 1 cap(s) by mouth every other day; Cymbalta 60 milligram by mouth 2 times a day hs (at bedtime); febuxostat 40 mg tablet 1 tablets by mouth once a day (1 in PM); Gabapentin 300 milligram by mouth 3 times a day (1 in am 2 in PM); Klor-Con M10 10 milliequivalents by mouth 2 times a day (1 in morning 2 in evening); Lasix 40 milligram by mouth once a day for Heart; Levothyroxine Sodium 200 microgram by mouth once a day; Lidoderm 5 gram topical every 12 hours as needed; Magnesium oxide 400 mg tablet 1 tablets by mouth once a day; metolazone 5 mg tablet 2 tablets by mouth 3 times a week; Metoprolol Tartrate 25 milligram by mouth 2 times a day changed; midodrine 5 milligram by mouth 2 times a day; miralax-powder for reconstitution 17 grams by mouth once a day as needed for constipation; multivitamin One Daily once a day; Myrbetric50 milligram oral once a day; Norco 325mg - 5 mg 1/2 -1 tablet oral once a day; pantoprazole 40 mg delayed release tablet 1 tablet by mouth once a day; sildenafil 25 mg tablet 1 tablets by mouth once a day x 60d [sic]; skelaxin 800 milligram by mouth 3 times a day;spironolactone 50 milligram by mouth once a day;symbicort 160 microgram inhalation 2 times a day; tramadol 50 mg tablet 1 tablets by mouth 2 times a day as needed pain;trazodone hydrochloride 50 milligram by mouth once a day as needed; Ventolin HFA 90 microgram inhalation every 4 hours as needed shortness of breath; voltaren topical 1% application topical once a day as needed pain (neck and shoulder). The document revealed allergies of "lisinopril, codeine, Codeine Sulfate, lisinopril, Albuterol Sulfate". The document evidenced the patient was taking Albuterol, failed to include the correct dose for Aspir [sic], failed to verify if Albuterol and Ventolin inhalations were nebulizer or puffs, failed to included the "as needed" reason for Benadryl, lidoderm, and trazadone, and failed to identify Lidoderm as a patch, the affected area to apply, and the correct dosing including to remove old patch and replace with new over affected area and failed to include oxygen as a medication. The plan of care failed to include all of the patient's equipment and supplies, including the straight cane, reacher, long handled sponge, non-skid surface, power recliner, oxygen concentrator, oxygen tank, nebulizer, bipap/tubing/mask, nasal cannula, and blood pressure cuff; failed to include all safety limitations including infection control precautions related to Covid 19; failed to include functional limitations related to the patient's frozen shoulder, torn rotator cuff; failed to include all medications the patient was taking; failed to include accurate dose/route/frequency; failed to identify duplicate and ineffective therapy; and failed to include goals the were patient specific, measurable, and pertinent to current home health needs. 4. A review of the clinical record for patient #7, start of care date 9/21/2020, revealed the patient was treated in an inpatient setting in September 2020 for acute respiratory failure with hypoxia and pneumonia, organism unspecified. The patient was transferred to a rehabilitation facility for diagnosis of acute and chronic respiratory failure with hypoxia, chronic pain syndrome, difficulty in walking, fluid overload, history of falling, orthopnea, other malaise, personal history of malignant neoplasm, pneumonia, osteoarthritis, allergic rhinitis, cognitive communication deficit, essential hypertension, gastroesopageal reflux, iron deficiency anemia, other idiopathic peripheral autonomic neuropathy, other specified abnormal findings of blood chemistry, personal history of other diseases of the digestive system, pulmonary hypertension, and weakness. The patient was discharged to home on 9/15/2020. A review of the comprehensive assessment dated 1/15/2021 for certification period 1/13/2021-3/13/2021 revealed patient #7 was recertified for a third episode, dates 1/19/2021-3/19/2021, with the diagnoses of acute and chronic respiratory failure with hypoxia, chronic combined systolic and diastolic heart failure, pneumonia (unspecified organism), fluid overload, pulmonary hypertension, and iron deficiency anemia, all labeled as exacerbations. The OASIS evidenced the patient had a high risk for rehospitalizion, unintentional weight loss of >10 pounds, had environmental hazards, was hard of hearing, had a wound to the ankle, and had pain of 3/10 daily but not constantly. The patient had a Braden score of 16, and had limitations in balance, strength, and endurance and was partial weight bearing. The patient utilized oxygen via a nasal cannula and required wound care. A review of the plan of care for certification 1/19/2021 - 3/19/2021 revealed 13 additional diagnoses dated 9/18/2020 and listed as exacerbations. The plan of care failed to include all durable medical equipment and supplies including a reacher, non-skid surface, oxygen concentration and tubing, wound supplies, and shower chair; failed to include infection control precautions related to Covid 19; failed to include the patient's mental status as forgetful; failed to include all medications the patient was taking; failed to include accurate dose/route/frequency; failed to identify duplicate and ineffective therapy; failed to include goals the were patient specific, measurable, and pertinent to current home health needs; and failed to include goals and interventions that were pertinent, patient specific, and measurable. 17-13-1(a)(1)(B) 17-13-1(a)(1)(C) 17-13-1(a)(1)(D)(i-xiii)

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure skilled nursing was provided without delay per hospital discharge orders for 1 of 3 records reviewed (#4) from a sample of 8. Findings include: 1. An undated agency policy titled " Physician orders, " Home Care staff will administer care and treatment according to specific instructions... The physician will be notified immediately of any changes to the patient's condition which would indicate changes to the plan of care." 2. The clinical record of patient #4, start of care (SOC) date of 1/21/2021, was reviewed on 2/2/2021 contained a referral and physician order dated 1/5/2021, upon discharge from a hospital, for home health to evaluate and treat for initial visit and ongoing treatment until Primary Care Physician (PCP) is able to follow up with resident's care. The requested services: were Skilled Nursing (SN), Physical Therapy (PT), and Home Health Aide (HHA). Review of the Hospital discharge history and physical dated 1/5/2021 revealed patient #4 diagnoses were acute gastrointestinal bleeding requiring blood transfusion, elevated troponin requiring telehealth and cardiology consult, coronary artery disease, and chronic anemia. Medical problems heart palpitations, abdominal pain, elevated troponin, acute gastrointestinal bleeding, chronic anemia. Review of a start of care assessment dated 1/21/2021, revealed the assessment was completed by PT. Review of the plan of care for the certification period of 1/21/2021-3/21/2021, included but is not limited to, diagnoses of Gastrointestinal hemorrhage, Displacement of femoral arterial graft, Type 2 diabetes mellitus with other specified complications, and Iron deficiency anemia secondary to blood loss. The plan of care failed to evidence skilled nursing orders. Review of the clinical record revealed the skilled nurse saw the patient for the first time on 2/2/2021. The record failed to reveal a physician order for delay of the initial SN visit dated 2/2/2021. During a home visit 2/3/2021 at 1:30 PM, the patient's admission packet was reviewed and contained a consent form dated 1/21/2021, indicating SN would be provided on 1/21/2021. 4. During an interview on 2/3/2021 at 1:45 PM, employee I, PT stated that he was aware that patient #4 had an order for SN and HHA. Employee I stated he received the referral from the office, and he told the office it had SN, PT, HHA services ordered but was told that employee E, RN was out sick, so they had him open the case. Employee I stated he let the office know that patient #4 refused home health aide and the office handle the orders. 5. During an interview with patient #4 after the home visit with Employee I on 2/3/2021 at 1:50 PM, when asked about the discharge orders from the hospital for skilled nursing and home health aide services, patient #4 stated she didn't want home health aide services and she knew Employee E had COVID and had started seeing her "this week." 6. During an interview with the employee E on 2/2/2021 at 3:20 PM, regarding hospital discharge orders for SN not being initiated upon start of care and home health aide services not being provided for patient #4, employee E stated, that the clinicians are to document in a call log and discontinue (dc) the home health aide if the patient refuses and put in a new order for skilled nursing order. When asked for a copy of the call log and the order to discontinue home health aide services and for skilled nursing to be delayed, employee E stated "I did not put one in." 17-14-1(a)(1)(H)

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure their QAPI (Quality Assessment Performance Improvement) program included agency complaints/ grievance and utilized quality indicator data, including measures derived from OASIS. Findings include: Review of an agency undated policy titled "Excel Home Healthcare, LLC Quality Improvement Plan" indicated "The purpose of the Quality Improvement Plan is to define the process used by the Agency to monitor, evaluate and implement any necessary actions to improve the quality of care, management of information or operating systems. This policy failed to evidence how the agency will utilize quality indicator data, such as measures derived from OASIS, and other relevant data in order to monitor the effectiveness and safety of services and quality of care. A review of the complaint binder evidenced multiple complaints about quality of care, such as wound care, catheter changes, assessments, infection control, and concerns of staff interaction with patients. During an interview with the Administrator and Alternate Administrator on 2/8/2021 at 11:40 a.m., when asked if complaints are part of their QAPI program, the Administrator responded "Not currently." When asked what quality indicator data is being collected, the Alternate Administrator referred to the PIP (performance improvement) binders which consisted of fall risk, infection control, diabetic foot care, Face to Face, missed visits, plans of care, medication management, congestive heart failure, chronic obstructive pulmonary disease, and OASIS scoring in relation to the new payment model and not relation to quality of care. When asked how the data is used to monitor the effectiveness and safety of services and quality of care, the Alternate Administrator stated everyone is assigned a topic to audit, they talk as a group and look at the numbers to see if selected topics are improved or not. When asked how data is used to identify opportunities for improvement, the Alternate Administrator stated everyone comes to the meetings with their program/ topic. 17-12-2-(a)

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure performance improvement projects (PIP) identified, took/ updated actions and failed to ensure projects initiated in the first quarter of 2020 were followed up on to ensure improvements were achieved and/ or sustained. Findings include: 1. Review of an undated agency policy titled "Excel Home Healthcare, LLC Quality Improvement Plan" indicated "The purpose of the Quality Improvement Plan is to define the process used by the Agency to monitor, evaluate and implement any necessary actions to improve the quality of care, management of information or operating system." 2. A review of an agency PIP document titled "Analysis of January and February 2020 Results in regards to "A) Timeliness of Documentation" included information in regards to "OASIS completed within 24 hours, OASIS not completed within 24 hours, OASIS N/A due to phone discharge." This document failed to evidence any actions to be taken in order to measure its success to ensure improvements are sustained. No further reports were provided for the remaining 2020 year. A review of an agency PIP document titled "Analysis of January and February 2020 Results in regards to " B) Accuracy of OASIS charting" which failed to include specifically what was being monitored for accuracy. The end result indicated "There was an overall improvement in accuracy from November [2019] to December [2019]; however January [2020] had a decrease in accuracy from December and then February increased in accuracy from January." This document failed to evidence any actions to be taken in order to measure its success to ensure improvements are sustained. No further reports were provided for the remaining 2020 year. 3. A review of an agency PIP document titled "Rehospitalizations with patient diagnosed with CHF (congestive heart failure) for Q4 2019" was reviewed and indicated there were "30 incidents where patient's sought emergency care" with 16 of the 30 were patients diagnosed with CHF with 3% was diagnosed with an exacerbation and then goes on to say 6% of patients with CHF sought emergent care for an exacerbation. No further reports were provided for the remaining 2020 year to measure its success to ensure improvements are sustained. 4. A review of an agency document titled "PDGM Preparation To Do List" undated that was located in a PIP binder, revealed possible actions but failed to include any measurable information to ensure improvements are achieved. 5. A review of an agency PIP document titled "Process for Intake" dated 9/17 (no year) revealed issues that need immediately resolution, which includes primary diagnoses to be billable. The document went on to indicate was must be completed, but failed to provide any measurable actions to be taken in order to ensure improvement are achieved. 6. A review of three (3) agency PIP documents titled "Performance Improvement Project/ QAPI-... Improvement in OASIS Diagnosis. 485 Review/ Timely Submission" for the 1st, 2nd, and 3rd quarter of 2020, identified problem with getting field staff to check their work before signing off and submitting, educate doctors on PDGM (Patient Driven Groupings Model" for 2020 in regards to primary diagnosis changes, and meetings with manager on update of computer problems. The data source, expected outcomes, goal, current barriers, analysis and plan for each quarter was verbatim. The "Stage" and "Actions" for each quarter was also verbatim. "Staff Problems" for 1st quarter revealed "37.5%", 2nd quarter revealed "40.5%" and 3rd quarter revealed "40.5%." Another agency PIP document titled "Performance Improvement Project/ QAPI-... Improvement in OASIS Diagnosis. 485 Review/ Timely Submission" review period of 6/1/20 to 9/28/20, indicated a problem of "Taking too long to review sign/ submit oasis and 485's." Goal indicated "Review sign and submit oasis within 15 days. **Previous goal of 10 days has not been achievable due to nursing shortage and Covid. Increase number of days to 15 instead of 10.... Current barriers: 1. Clinicians not completing documentation correctly to start with. [going to fast] 2. Shortage of nursing staff. 3. Clinicians not getting corrections done timely. 4. Dr's not sending the correct PDGM diagnosis timely [diagnosis change form]." Plan/ Actions indicated to "ask clinicians to complete corrections right after the care conference meetings. Create mandatory meetings if necessary...." The agency failed to put new actions in place to ensure goals are achieved as evidenced by the following: A review patient records 1-8, identified multiple unrelated diagnoses, symptoms, and procedures being listed on the Plan of Care, being identified as an "E" (exacerbation) when they are not being supported by the comprehensive assessment. A review of 2019 and 2020 staff education binders, failed to evidence documentation that education had been provided to the clinicians in regards to appropriately determining patient diagnoses, onset, and exacerbations. During an interview with Employee E, Clinical Manager on 2/3/21 at 11:55 a.m., indicated the Employee G, Alternate Clinical Manager, was responsible for all the diagnoses and labeling of "E" on the plan of care. During an interview on 2/3/21 at 12:15 p.m., when queried about the unrelated diagnoses, symptoms, and procedures listed on the Plan of Care and being identified as an "E", Employee G stated the intake person is responsible for inputting all the diagnoses that is received from the referral source, the clinician completing the admission is responsible for reviewing the diagnoses and deciding what is the onset (O) and what is an exacerbation, and what needs to be listed and what needs to be removed. Employee G stated she doesn't correct any of the diagnoses because she doesn't know the patients. When queried on reaching out to the clinicians on correcting the errors before sending the plan of care to the physician, Employee G indicated she doesn't do it any longer for the employees have been educated multiple times. Employee G stated she informs the Clinical Manger (Employee E) of the ongoing issues and she is responsible to ensure staff is correcting the documents. During an interview on 2/8/21 at 10:30 a.m., when queried if he/ she is aware of reviewing and updating diagnoses and identifying onsets and exacerbations, Employee F indicated she has not been educated to understand how to determine the appropriate diagnoses. During an interview with the Administrator, Alternate Administrator, and Clinical Manager on 2/8/21 from 11:40 a.m. to 1:30 p.m., when queried on staff being educated updating the diagnoses, the Administrator stated they have discussed this during case conferences. When asked for documentation of this education being provided, the Administrator stated she didn't think they had any meeting minutes and a binder for 2019 and 2020 was provided to review but no inservices in regards to how to determine pertinent diagnoses/ updates to the plan of care was found. 7. A review of an agency document titled "Performance Improvement Project Improvement In - Missed Visits Quarter 2 [2020]" identified missed visits turned in asap from the clinicians, and missed visits are not found until the claim is ready to be sent. Expected Outcome indicated "Talking to clinicians on the importance of doing their messed visits before I start doing the billing audit to save time." Plan/ Action indicated a monthly missed visit report will be created to keep track of how many clinicians have missed in a quarter. The PIP failed to put measures in place to ensure visits are not missed and patient received the services as ordered on the plan of care. No further reports were provided for the remaining 2020 year to measure its success to ensure improvements/ goals are achieved. 8. A review of an agency document titled "Performance Improvement Project Improvement In - Obtaining Physician signature on 485s and Interim Orders" for 2nd and 3rd quarter of 2020. The problem identified, data sources, expected outcome, goal, current barriers, plan, and monitoring is verbatim. The analysis failed to evidence that the measurable actions were achieved or sustained. The agency failed to put new actions in place to ensure the goals are achieved. 9. A review of an agency document titled "Diabetic Foot Care Q4 2019" revealed 25 patients were admitted with a diagnosis of diabetes in quarter 1 and of those 25 patients, 9 did not have diabetic foot care education. A review of an agency document titled "Diabetic Foot Care Q1 2020" revealed 36 patients were admitted with a diagnosis of diabetes in quarter 1 and of those 36 patients, 13 did not have diabetic foot care education. The data source, interventions/ actions, and barriers for both quarters were verbatim. The interventions included: Clinicians to add education on foot care to every diabetic patient, do additional education of staff to teach every patient with a diagnosis of diabetes, and written education to be provided to every diabetic regarding foot care. The agency failed to put new actions in place to ensure the goals are achieved. No further reports were provided for the remaining 2020 year to measure its success to ensure improvements/ goals are achieved. 10. A review of an agency document titled "Infection Control Q1 2020" indicated 19% average of admissions had infections of some sort, which was a 5% increase from "quarter 1 2020." Eight occurrences were urinary tract infections, 1 occurrence was respiratory infections and 2 occurrences were soft tissue infection. This was an increase from quarter 4 2019, which revealed 14% was the average and this was an increase from quarter 3 2019 of 6% average. No further reports were provided for the remaining 2020 year to measure its success to ensure improvements/ goals are achieved. 11. A review of an agency document titled "Improvement of oral medication management Q1 2020" revealed out of 65 discharged patients, 39 or 60% improved their oral medication management, 25 or 38% stayed the same from admission to discharge, and 1 decline. This was a 2% decrease from quarter 4, 2019. No further reports were provided for the remaining 2020 year to measure its success to ensure improvements/ goals are achieved. 12. A review of an agency document titled "Performance Improvement Project Fall Prevention Quarter 1 2019" identified too many falls of clients while in the agency's care. The plan indicated nursing to be notified weekly of clients needing a fall prevention assessment and to monitor monthly fall reports, correlation of missed visits and clinician compliance with program. No further reports were provided for the entire 2020 year to measure its success to ensure improvements/ goals are achieved. 13. A review of an agency document titled "Performance Improvement Project Improvement in - Face to Face documentation Quarter 2" identified that face to face encounters were not being received timely. Goal was to receive these documents within 7 days. No further reports were provided for the remaining 2020 year to measure its success to ensure improvements/ goals are achieved. 14. On 2/3/2021 at approximately 3:30 p.m., a request was made to the Clinical Manager for the agency's QAPI program. During this time, the Clinical Manager stated that she had not completed her PIP documents for at least 6 months. 15. During an interview with the Administrator and Alternate Administrator on 2/3/2021 at 4:30 p.m., when asked about meeting minutes notes in regards to the QAPI meetings and how they reviewed the Clinical Manger's PIPs when no updates has been made since 1st quarter of 2020, both stated they do not keep meeting minutes and was not aware that the Clinical Manager's PIP binders had no updated information since 1st quarter of 2020. 17-12-2-(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 record review, observation, and interview, the agency failed to ensure it followed accepted standards of practice, including use of standard precautions when practicing bag technique and performing hand hygiene, to prevent the transmission of infections and communicable diseases in 1 of 1 (#3) patients from a sample of 8. Findings included: 1. A review of an undated agency policy titled "Standard/Universal/Infectious Waste Materials Precautions", policy manual last updated revealed "Hands must be washed before and after contact with each client under a steady stream of water and antibacterial soap for at least 15 seconds. In the absence of water or soap an appropriate antibacterial solution must be used (Hand Sanitizer)... Gloves must be changed after each client." 2. A review of an undated document titled "Bag Technique Competency Evaluation" evidenced " ... Washes hands before entering the bag. Equipment used is cleansed before use and is cleansed prior to returning to bag if appropriate. Clean and dirty supplies are maintained separately...." 3. During a home visit with patient #3 on 2/3/2021 the home health aide was observed completing hand hygiene and donning non-sterile gloves. The home health aide reached into an open tote bag and withdrew a thermometer, obtained the patient's oral temperature, and replaced the thermometer into the open tote. She withdrew a clipboard and pen and documented the patient's temperature, then replaced the clipboard back into the tote. She proceeded to assist the patient with ambulation into the bathroom to complete a shower. The home health aide failed to change gloves and complete hand hygiene before and after all patient contact and failed to ensure accepted standards of infection control in the use of a supply bag. 17-12-1(m)

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 clinical notes prepared documented how a patient tolerated procedures in 1 out 2 active records (patient 6) reviewed of a patient receiving wound care in a sample of 8. Finding include: The clinical record of patient #6, start of care 12/11/2020, was reviewed on 2/2/2021, and contained a revision to plan of care for the certification of 12/11/2020-2/8/2021, revealed 1-21-21 skilled nurse (SN) wound care orders; right lower leg ulcers; cleanse saline, apply santyl collagen and mepitel to right dorsal foot. Apply collagen to all other open ulcers, cover with non-bordered foam, secure with kerlix, apply ace wrap for compression change daily. Continue to wear off loading heel boot left lower leg keep tupigrip sock on for compression therapy. Review of a SN Clinical note dated 2/1/2021, failed to evidence how the patient tolerated the wound care/ treatment. During interview with the clinical manager on 2/8/2021 at 3:45 PM, when queried if patient tolerance to a procedure or treatment should be documented in the narrative of the clinical note, the Clinical Manager stated it should be documented. 17-14-1(a)(1)(E)

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 the clinician communicated with the patient's physician(s) to establish plans of care, review medical findings, or discuss changes in condition for 2 of 2 (#5, #7) active patients reviewed in a sample of 8. Findings include: 1. A review of an agency policy, revised 9/8/2009, titled "Policy and Procedure for Physician Orders" revealed "The physician will be notified immediately of any changes in the patient's condition which would indicate changes to the plan of care." 2. A review of an agency policy, revised 9/8/2009, titled "Policy and Procedure for Plan of Care" revealed "The Home Health professional staff shall promptly alert the person responsible for the medical component of the patient's care to any changes that suggest a need to alter the medical plan of care." 3. A review of an undated agency policy titled "Coordination of Services" revealed "Changes in patient's condition during the course of care and brought to the attention of the physician and the specific disciplines." 4. A review of an OASIS (Outcome and Assessment Information Set - a patient specific standardized assessment tool) assessment for patient #5, dated 1/8/2021 for certification period 1/13/2021-3/13/2021. The patient had a pain level of 8/10 all of the time, despite pain medication. The patient evidenced an unsteady gait and decreased mobility, chronic pain to left shoulder, pain in back and all joints, decreased strength, and was a high fall risk. The document failed to evidence the clinician contacted the physician(s) to discuss findings of the comprehensive assessment, establish goals, confirm medications, and confirm continuing orders for the plan of care. A review of a "Skilled Nurse Clinical Note" dated 1/8/2021 evidenced the patient had diminished breath sounds, a productive cough with thick, white mucus, and was dyspnea with minimal exertion. The patient had a pain level of 8/10 all of the time, despite pain medication. The patient evidenced an unsteady gait and decreased mobility, chronic pain to left shoulder, pain in back and all joints, decreased strength, and was a high fall risk. The document failed to evidence the clinician contacted the physician(s) to discuss the patient's ongoing pain, respiratory status, and possible need for therapy. 5. A review of an OASIS assessment for patient #7, dated 1/15/2021 for certification period 1/19/2021 - 3/19/2021 revealed the patient had diminished breath sounds, was dyspneic with minimal exertion, had an open wound, and was a high fall and rehospitalization risk. The patient evidenced a timed up and go of 35, impaired functional mobility, pain affecting level of function, prior history of falls, incontinence, and environmental hazards. The document failed to evidence the clinician contacted the physician(s) to discuss the patient's respiratory status and possible need for therapy. A review of a "Skilled Nurse Clinical Note" dated 1/15/2021 evidenced the patient had diminished breath sounds, was was dysgenic with minimal exertion, had an open wound, and was a high fall and rehospitalization risk. The patient evidenced a timed up and go of 35, impaired functional mobility, pain affecting level of function, prior history of falls, incontinence, and environmental hazards. The document failed to evidence the clinician contacted the physician(s) to discuss the patient's respiratory status and possible need for therapy. 6. During an interview on 2/8/21 at 12:51 p.m., the Clinical Manager stated the agency does not contact the physician(s) after the comprehensive assessment to discuss the findings and obtain further orders. 17-14-1(a)(1)(G)

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 agency failed to ensure policies and procedures created in regards to the pandemic, were signed/ approved by the Governing Body and failed to ensure policies and procedures were reviewed and revised (when needed) to ensure the agency was operating with current professional practices and standards. Findings include: 1. The Emergency Preparedness Binder Policy and Procedure Binder in regards to the COVID-19 pandemic, was reviewed on 2/3/2021 and again on 2/8/2021. In review of the policies created and reviewed, revealed the following policies: Policy and Procedure for Emergency Cancellations and Staff Back-Up Plans. This policy failed to evidence a date of when the policy was instituted and failed to evidence a signature of approval from the Governing Body. Policy and Procedure titled "Current Covid-19 CMS, ISDH, CDC Guidelines. Effective 3-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Using Personal Protective Equipment" Effective 3-2020 and revised on 4-3-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "PPE Use for Home Care Staff Visits for Covid-19 or Suspected Covid-19 Patients" Effective 3-2020 and reviewed on 4-3-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Covid-19 Patient Information Sheet" Effective 3-2020 and reviewed on 5-1-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Home Care of People Not Requiring Hospitalization for Coronavirus Disease 2019" Effective 3-2020 and reviewed/ revised on 6-242020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Agency Discharge of Known or Suspected Covid-19 Patient for Non-Compliance" Effective 3-2020, revised on 4-23-2020, and reviewed on 6-24-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Agency Discharge Planning/ Transfer of Known or Suspected Covid-19 Patient" Effective 3-2020, revised on 4-23-2020, and reviewed on 6-24-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Home Health Care Patients Residing in an Assisted Living or Independent Living Facility" Effective 3-2020, revised on 4-23-2020, and reviewed on 6-24-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Transfer to Hospital for the Confirmed or Suspected Covid-19 Patient" Effective 3-2020, revised on 4-23-2020, and reviewed on 6-24-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Medical Glove Conservation Strategies" Effective 3-2020, revised on 3-31-2020, and reviewed on 6-25-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Covid-19 Self and Patient Education Publications" Effective 3-2020 and reviewed on 6-26-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Optimizing the Supply of Facemasks, Eye Protection, and Isolation Gowns" Effective 3-2020, revised on 4-2-2020, and reviewed on 6-29-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Excel Home Health Care Employee's Covid-19 Information Sheet Policies and Procedures" Effective 3-2020, revised on 7-3-2020, and reviewed on 7-3-2020. This form revealed the policy and procedure was only approved/ signed by the Administrator and Alternate Administrator and failed to evidence the approval dates and signatures of all Governing Body members. The policy number was left blank. Policy and Procedure titled "Excel HHC Patient Exposure to Person with Known or Suspected Covid-19" Effective 3-2020 and revised on 10-12-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "CDC Covid-19 Isolation Guidelines" Effective 3-2020 and revised on 11-3-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Patient/ Client Infection Control Additions" Effective 11-23-2020. This form revealed the policy and procedure was only approved/ signed by the Alternate Administrator and failed to evidence the date and approval signatures of all Governing Body members. The policy number was left blank. Two Policy and Procedures titled "Covid-19 Pre-Screening Tool for all Referrals, and Covid-19 Positive Symptomatic Patient Referral/ Admission Process" Effective 2-2020 and revised on 12-3-2020. One document was approved/ signed by the Administrator and the second policy and procedure was only approved/ signed by the Alternate Administrator. Both policy and procedures failed to evidence the dates and approval signatures of all Governing Body members. The policy number was left blank. Policy and Procedure titled "All Excel HHC Covid-19 Policies and Procedures" Effective 3-2020 and revised on 12-3-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Excel HHC Patient Exposure to Person with Known or Suspected Covid-19" Effective 3-2020 and revised on 12-3-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "New Referrals for Covid-19 Patients" Effective date 3-2020 and revised on 12-3-2020. The procedure stated to follow Excel HHC Policy #10. This policy failed to evidence exactly the procedure to follow and the policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "New CDC Quarantine Guidance" Effective 12-2-2020 and revised on 12-3-2020. This form revealed the policy and procedure was only approved/ signed by the Administrator and Alternate Administrator and failed to evidence the approval signatures of all Governing Body members. The policy number was left blank. Policy and Procedure titled "Restricted Home Visits for Healthcare Personnel" Effective 3-2020 and revised on 12-3-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Return to Work for Healthcare Personnel with Confirmed or Suspected Covid-19" Effective 3-2020 and revised on 12-3-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Clinical Field Staff Tests Positive for Covid-19" Effective 3-2020 and revised on 12-7-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Office Employees Tests Positive for Covid-19" Effective 3-2020 and revised on 12-7-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Office Employee Exposed to Covid-19 or Suspected Covid-19 Patient" Effective 3-2020 and revised on 12-7-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Clinical Exposure to Covid-19 Positive or Suspected Covid-19 Patient: Effective 3-2020 and revised on 12-7-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Agency Reporting Covid-19 Cases" Effective 3-2020 and revised on 12-10-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled "Employee Monitoring Tool for Covid-19" Effective 3-2020 and revised on 12-10-2020. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. Policy and Procedure titled"Staffing Emergencies" Effective 3-2020 and revised on 2-3-2021. The policy number, date, signature, and title of when this policy was approved by the Governing Body was left blank. 2. Review of the agency's policy and procedure binder on 2/8/2021, revealed a document at the front binder, which indicated the last review/ update was in 2016. 3. Review of the agency's Governing Body minutes dated 1/30/20, 6/29/20, and 12/7/2020, failed to evidence any documentation of the members discussing policies and procedures to put into place during the Covid-19 pandemic. The 12/7/2020 meeting minutes stated "Members Present: Due to increase in Covid cases in county, Board members approved to a meeting via email." This document failed to evidence who was sent an email to review the "Old" and "New" Business listed on the meeting minutes. 4. During an interview on 2/8/2021 at 12:55 p.m., when queried on the last time the agency/ Governing Body reviewed their agency's policy and procedures, the Administrator was not able to answer the question. The Administrator indicated since the pandemic happened, the Governing Body has not been able to meet in person and emails are being sent to one another. 17-12-1(b)

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 Administrator failed to ensure they were responsible for all day to day operations of the agency in regards to ensuring patients are accepted on the basis that the agency can meet their needs, visits are provided per the physician ordered plan of care, the Clinical Manager's inability to perform her duties as a Clinical Manager, failing to ensure a Registered Nurse with a restricted license complied with a judgement which prevented her from providing services with any patient prescribed a narcotic. Findings include: A. In regards to Quality of Care and Meeting the Needs of Patients During the entrance conference on 2/1/21 at 8:45 a.m., the Administrator and Alternate Director of Nursing indicated the Clinical Manager had been off the last few weeks due to illness. Review of a census document, completed by the Administrator on 2/1/21, indicated the agency has 80 active patients. A review of the Home Health agency Survey and Deficiencies Report indicated the agency had 5 full time Registered Nurses (RN) and 1 part-time Licensed Practical Nurse (LPN). Review of an agency PIP document on 2/3/2021 titled "Performance Improvement Project/ QAPI-... Improvement in OASIS Diagnosis. 485 Review/ Timely Submission" review period of 6/1/20 to 9/28/20, identified a "Shortage of nursing staff as a reason for the lack of 485 Review/ Timely Submissions." The clinical record of patient #4 was reviewed on 2/2/21, and contained a hospital discharge physician order dated 1/5/21, indicating the need for skilled nursing. Review of the start of care comprehensive assessment and consents, the admission assessment was completed by Employee I, a physical therapist. Further record review revealed skilled nursing did not start until 2/2/21. The clinical record failed to evidence any documentation of the patient's and physician approval to delay skilled nursing and failed to evidence any orders indicating skilled nursing to start on 2/2/21. During an interview on 2/3/2021 at 1:45 PM, employee I, PT stated that he was aware that patient #4 had an order for SN and HHA. Employee I stated he received the referral from the office and he told the office it had SN, PT, HHA services ordered but was told that employee E, RN was out sick, so they had him open the case. During an interview with patient #4 after the home visit with Employee I on 2/3/2021 at 1:50 PM, when asked about the discharge orders from the hospital for skilled nursing, patient #4 stated she knew Employee E was ill and the employee had started providing services to her "this week." The patient mentioned to the therapist of all her upcoming appointments for blood work to be done and transfusions. During an interview on 2/3/21 at 11:55 a.m., when asked to clarify her patient load and how long she had been case managing, the Clinical Manager stated she had approximately "13" patients she is the case manages and had been continuing to case manage since she took on the position of Clinical Manger since May 2019. During an interview with the Administrator, Alternate Administrator, and Clinical Manager, on 2/8/2021 from 11:40 a.m. to 1:30 p.m., the Administrator and Clinical Manager both confirmed that the office RNs, except for the Clinical Manager, don't see patients and that they are office only. They also confirmed that the LPN currently had only 1 patient and that was all she desired due to working another job. When asked if there was any flexibility to either situation, in which they responded no, and stated the office nurses would not see patients and the LPN might, on a rare occasion, see a second patient but this would be unlikely, per her choice. When asked about how the agency determines "essential visits", the Administrator indicated patients who have wound care or who are unstable. When asked about accepting patients when there are only 3 full time nurses, with one being the Clinical Manger for a census of 80, and the Clinical Manager being off due to illness, the Administrator stated the agency has sign-ups and went on to state that only one patient of the Clinical Managers did not get seen while she was off. The Administrator was asked to provide a report of missed visits at 1:30 p.m. On 2/8/21 at 2:00 p.m., the patient list provided by the Administrator was reviewed with the Clinical Manager. A review of the Clinical Manager's patient records revealed the following missed visits: Patient #5 - Missed visits on 1/21 and 1/28/21 Patient #9 - Missed visits on 1/20 and 1/27/21 Patient #10 - Missed visits on 1/21 and 1/28/21 Patient #11 - Missed visits on 1/21 and 1/28/21 Patient #12 - Missed visits on 1/21 and 1/28/21 Patient #13 - Missed visits on 1/20 and 1/27/21 Patient #14 - Missed visits on 1/20/21 The agency failed to ensure they only accepted patients on the bases that the agency is able to meet the needs of the patient and able to provide skilled nursing services as ordered per the plan of care. B. In regards to Quality Assessment Performance Improvement (QAPI)/ Performance Improvement Programs (PIPS) being completed by the Clinical Manager: A review of an agency PIP document titled "Rehospitalizations with patient diagnosed with CHF (congestive heart failure) for Q4 2019" was reviewed and indicated there were "30 incidents where patient's sought emergency care" with 16 of the 30 were patients diagnosed with CHF with 3% was diagnosed with an exacerbation and then goes on to say 6% of patients with CHF sought emergent care for an exacerbation. No further reports were provided for the remaining 2020 year to measure its success to ensure improvements are sustained. A review of an agency document titled "Performance Improvement Project Improvement In - Missed Visits Quarter 2 [2020]" identified missed visits turned in asap from the clinicians, and missed visits are not found until the claim is ready to be sent. Expected Outcome indicated "Talking to clinicians on the importance of doing their missed visits before I start doing the billing audit to save time." Plan/ Action indicated a monthly missed visit report will be created to keep track of how many clinicians have missed in a quarter. The PIP failed to put measures in place to ensure visits are not missed and patient received the services as ordered on the plan of care. No further reports were provided for the remaining 2020 year to measure its success to ensure improvements/ goals are achieved. A review of an agency document titled "Diabetic Foot Care Q4 2019" revealed 25 patients were admitted with a diagnosis of diabetes in quarter 1 and of those 25 patients, 9 did not have diabetic foot care education. A review of an agency document titled "Diabetic Foot Care Q1 2020" revealed 36 patients were admitted with a diagnosis of diabetes in quarter 1 and of those 36 patients, 13 did not have diabetic foot care education. The data source, interventions/ actions, and barriers for both quarters were verbatim. The interventions included: Clinicians to add education on foot care to every diabetic patient, do additional education of staff to teach every patient with a diagnosis of diabetes, and written education to be provided to every diabetic regarding foot care. The agency failed to put new actions in place to ensure the goals are achieved. No further reports were provided for the remaining 2020 year to measure its success to ensure improvements/ goals are achieved. A review of an agency document titled "Infection Control Q1 2020" indicated 19% average of admissions had infections of some sort, which was a 5% increase from "quarter 1 2020." Eight occurrences were urinary tract infections, 1 occurrence was respiratory infections and 2 occurrences were soft tissue infection. This was an increase from quarter 4 2019, which revealed 14% was the average and this was an increase from quarter 3 2019 of 6% average. No further reports were provided for the remaining 2020 year to measure its success to ensure improvements/ goals are achieved. A review of an agency document titled "Improvement of oral medication management Q1 2020" revealed out of 65 discharged patients, 39 or 60% improved their oral medication management, 25 or 38% stayed the same from admission to discharge, and 1 decline. This was a 2% decrease from quarter 4, 2019. No further reports were provided for the remaining 2020 year to measure its success to ensure improvements/ goals are achieved. On 2/3/2021 at approximately 3:30 p.m., a request was made to the Clinical Manager for the agency's QAPI program. During this time, the Clinical Manager stated that she had not completed her PIP documents for at least 6 months. When asked when she is able to perform her duties as a Clinical Manager when she has patients to case managed, the Clinical Manager stated that she is in the office part time and also has to work when she is at home. During an interview with the Administrator and Alternate Administrator on 2/3/2021 at 4:30 p.m., when asked about meeting minutes notes in regards to the QAPI meetings and how they reviewed the Clinical Manger's PIPs when no updates has been made since 1st quarter of 2020, both stated they do not keep meeting minutes and was not aware that the Clinical Manager's PIP binders had no updated information since the 1st quarter of 2020. C. In regards to Audits of Pertinent Diagnoses being addressed by the Clinical Manager and Education being provided to staff Review of an agency PIP document titled "Performance Improvement Project/ QAPI-... Improvement in OASIS Diagnosis. 485 Review/ Timely Submission" review period of 6/1/20 to 9/28/20, indicated a problem of "Taking too long to review sign/ submit oasis and 485's." Goal indicated "Review sign and submit oasis within 15 days. **Previous goal of 10 days has not been achievable due to nursing shortage and Covid. Increase number of days to 15 instead of 10.... Current barriers: 1. Clinicians not completing documentation correctly to start with. [going to fast] 2. Shortage of nursing staff. 3. Clinicians not getting corrections done timely. 4. Dr's not sending the correct PDGM diagnosis timely [diagnosis change form]." Plan/ Actions indicated to "ask clinicians to complete corrections right after the care conference meetings. Create mandatory meetings if necessary...." The agency failed to put new actions in place to ensure goals are achieved as evidenced by the following: A review patient records 1 - 8 (Closed Records #1, 2 and Open Records #3 - 8), identified multiple unrelated diagnoses, symptoms, and procedures listed on the Plan of Care, being identified as an "E" (exacerbation) when the diagnoses are not being supported by the comprehensive assessment. A review of 2019 and 2020 staff education binders, failed to evidence documentation that education had been provided to the clinicians in regards to appropriately determining patient diagnoses, onset, and exacerbations. During an interview on 2/3/21 at 11:55 a.m., the Clinical Manager stated stated Employee G, Alternate Clinical Manager, was responsible for all the diagnoses and labeling of "E" on the plan of care. During an interview on 2/3/21 at 12:15 p.m., when queried about the unrelated diagnoses, symptoms, and procedures listed on the Plan of Care and being identified as an "E", Employee G stated the intake person is responsible for inputting all the diagnoses that is received from the referral source, the clinician completing the admission is responsible for reviewing the diagnoses and deciding what is the onset (O) and what is an exacerbation, and what needs to be listed and what needs to be removed. Employee G stated she doesn't correct any of the diagnoses because she doesn't know the patients. When queried on reaching out to the clinicians on correcting the errors before sending the plan of care to the physician, Employee G indicated she doesn't do it any longer for the employees have been educated multiple times. Employee G stated she informs the Clinical Manger (Employee E) of the ongoing issues and she is responsible to ensure staff is correcting the documents. During an interview on 2/8/21 at 10:30 a.m., when queried if he/ she is aware of reviewing and updating diagnoses and identifying onsets and exacerbations, Employee F indicated she has not been educated to understand how to determine the appropriate diagnoses. During an interview with the Administrator, Alternate Administrator, and Clinical Manager on 2/8/21 from 11:40 a.m. to 1:30 p.m., when queried on staff being educated updating the diagnoses, the Administrator stated they have discussed this during case conferences. When asked for documentation of this education being provided, the Administrator stated she didn't think they had any meeting minutes and a binder for 2019 and 2020 was provided to review but no inservices in regards to how to determine pertinent diagnoses/ updates to the plan of care was found. D. In regards to ensure a Registered Nurse was not assigned or provided services to patients prescribed narcotics On 2/3/2021, the personnel records were reviewed. Review of a Employee F's personnel record, it was noted that the employee was working on a restricted license. In reviewing her Indiana State Board of Nursing order dated 9/24/19, " .... Respondent shall not work in an unsupervised setting, including home health care, hospice or as a charge nurse; however, Respondent may work in home health care if her patients are not prescribed any narcotics, if her supervisor conducts unannounced visits of her patients whether she is there or not, and this information is included in the quarterly reports ...." Review of clinical record #6, revealed the patient was prescribed a narcotic. During an interview on 2/3/2021 at 4:00 p.m., when queried on the patient #6 being prescribed a narcotic and Employee F's restrictions, the Clinical Manager stated the agency felt it was ok to have Employee F as the Case Manager/ RN since the Assisted Living, where the patient resides, manages the patient's medications. The clinical record failed to evidence any documentation if the patient's prescribed narcotics were being kept in a locked box in the patient's room, in a medication cart, or nurses station. On 2/4/2021, the agency was asked to provide a list of current and former patients assigned to Employee F. During this review, in the last 6-7 months, Employee F has provided services to at least 11 (Patients #1, 2, 15, 16, 17, 18, 19, 20, 21, 22, 23) former patients who were prescribed hydrocodone or tramadol and currently providing services to 2 active patients (Patient #6 and 24) who are prescribed either hydrocodone or tramadol. During an interview on 2/8/2021 at 11:40 a.m. to 1:30 p.m., when queried on is concern was brought to the Administrator, Alternate Administrator, and Director of Clinical Services attention in which they felt that Pamela has done a good job informing them of patients being assigned to her who are prescribed narcotics and are generally reassigned when this issue is identified. The agency indicated they were not aware of patients, who are on narcotics, being assigned to Pamela even though some of the documentation that was electronically signed by their Alternate Director of Clinical Services indicated Pamela was the case manager. Review of the quarterly reports only indicated Pamela had not passed, wasted, nor counted any narcotics. The quarterly reports does not include if any of her patients are prescribed narcotics. Review of the "Supervised Visits" conducted on 2/7/20, 7/22/20, and 11/17/20, were patients who were not prescribed narcotics. Documentation reflected observations of the treatments being provided and one interaction between Pamela and family. 17-12-1(b)(3) 17-12-1(c)(1)