Every finding on record at Moonlight Home Health Care Inc

Extended Substantial Allegation Survey Substantial Allegation 2639072 At the time of the extended substantial allegation survey completed on 10/17/25 no deficiencies were issued in regard to allegations contained in substantial allegation number 2639072. However, the facility was found not to be in compliance with all requirements for Home Health Agency participation and the following deficiencies are cited. Moonlight Home Healthcare is not in compliance with the requirements found at 42 CFR Part 484, Subpart B, C, Home health Agency. Moonlight Home Healthcare is precluded from providing its own home health aide training and competency testing or competency evaluation program for a period of two years from the date of the receipt of the deficiency report (2567) for this survey.

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 staff interview, the agency failed to ensure the physician was notified of the missed visits. (G572) The agency failed to ensure the home health aides (HHA) provided the services as ordered. (G580) The agency failed to ensure the physician’s plan of care was reviewed and signed by the physician every 60 days. (G588)

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure the physician was notified of the missed visits. This affected three out of three patient records reviewed. (Patient #1, #2 and #3) The census was 223. Findings include: 1. 1. Review of the medical record for Patient #1, and physician’s plan of care dated 08/1525 to 10/13/25, revealed the home health aide (HHA) was to provide service seven days per week to assist with personal care and activities of daily living (ADL). Review of the HHA time sheets from 08/31/25 to 09/28/25 revealed missed visits on 08/31/25, 09/01/25, 09/02/25, 09/04/25, 09/13/25, 09/14/25 and 09/21/25. There was no documented evidence the physician had been notified. 2. Review of the medical record for Patient #2, and physician’s plan of care dated 04/16/25, revealed the HHA was to provide service seven days per week to assist with personal care and ADLs. Review of the HHA time sheets from 05/04/25 through 05/17/25 revealed missed visits on 05/04/25, 05/14/25, 05/15/25, 05/16/25 and 05/17/25. There was no documented evidence the physician had been notified. 3. Review of the medical record for Patient #3, and physician’s plan of care dated 08/17/25, revealed the HHA was to provide services seven days per week to assist with personal care and ADLs. Review of the HHA time sheet for the week of 08/10/25 revealed missed visits on 08/11/25, 08/12/25, 08/14/25 and 08/15/25. Review of the HHA time sheet for the week of 08/17/25 revealed missed visits on 08/18/25, 08/19/25, 08/20/25, 08/21/25 and 08/22/25. There was no documented evidence the physician had been notified of these missed visits. Interview on 10/28/25 at 1:03 PM the Director of Nursing confirmed the physician had not been notified of the missed visits for Patient #1, Patient #2, and Patient #3.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure the home health aides (HHA) provided the services as ordered. This affected three out of three patients’ records reviewed. (Patient #1, #2 and #3) The census was 223. Findings include: 1. Review of the medical record for Patient #1 and physician’s plan of care dated 08/15/25 to 10/13/25 revealed home health aide (HHA) services were to be provided seven days per week for a total of 36 hours per week to assist with personal care and activities of daily living. Review of the HHA time sheets for the week of 08/32/25 revealed the HHA provided 29 ½ hours. The week of 09/07/25 the HHA went 53 hours. The weeks of 09/14/25 and 09/21/25 the HHA went 42 hours. Interview on 10/27/25 at 4:20 PM the Director of Nursing (DON) confirmed the HHA services provided were not as the physician had ordered. 2. Review of the medical record for Patient #2 and physician’s plan of care dated 04/16/25 revealed HHA services were to be provided seven days per week for a total of 28 hours per week to assist with personal care and activities of daily living. Review of the HHA time sheets revealed no service was provided 06/17/25 through 05/04/25 and 05/14/25 through 05/21/25, when Patient #2 was discharged. Interview on 10/28/25 at 2:00 PM the DON confirmed there were no communication notes or time sheets for these dates. 1. Review of the medical record for Patient #3 and physician’s plan of care dated 08/17/25 revealed HHA services were to be provided seven days per week for a total of 49 hours per week to assist with personal care and ADLs. Review of the HHA time sheets for Patient #3 revealed no service was provided from 08/31/25 through 09/13/25. Interview on 10/28/25 at 2:09 PM the DON confirmed the HHA did not go seven days per week as ordered and was unable to provide the time sheets.

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure the physician’s plan of care was reviewed and signed by the physician every 60 days. This affected three out of three records reviewed. (Patient #1, #2 and #3) The census was 223. Findings include: 1. Review of the medical record for Patient #1 revealed the physician’s plan of care dated 05/18/25 to 10/13/25 had not been reviewed or signed by the physician. 2. Review of the medical record for Patient #2 revealed the physician’s plan of care dated 04/16/25 to 06/14/25 had not been reviewed or signed by the physician. 3. Review of the medical record for Patient #3 revealed the physician’s plan of care dated 04/19/25 to 06/17/25 had not been reviewed or signed by the physician. Interview on 10/27/25 at 4:53 PM the Director of Nursing confirmed the physician plan of cares were not signed.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure the home health aide (HHA) care plan was reviewed by a registered nurse every 60 days. This affected two out of three HHA records reviewed. (Patient #1 and #3) The census was 223. Findings include: 1. Review of the medical record for Patient #1 and the HHA care plan revealed it was last reviewed and updated by a registered nurse on 06/27/23. 2. Review of the medical record for Patient #3 and the HHA care plan revealed it was last reviewed and updated by a registered nurse 05/15/25. Interview on 10/27/25 at 4:43 PM the Director of Nursing confirmed the HHA care plans were not reviewed by the RN every 60 days.

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on record review and staff interview the agency failed to provide skilled nursing services. This affected three out of three records reviewed. (Patients #1, #2 and #3) The census was 223. Review of the medical record for Patients #1, #2 and #3 did not reveal skilled nursing care was provided. Interview on 10/27/25 at 8:35 AM the Director of Nursing (DON) stated the agency no longer does skilled nursing care.

SUBSTANTIAL ALLEGATION SURVEY SUBSTANTIAL ALLEGATIONS 110665, 110983, AND 111450 At the time of the substantial allegation survey completed on 12/05/24, no deficiencies were issued in regard to allegations contained in substantial allegation numbers 110665, 10983, and 111450; however, the facility was found not to be in compliance with all requirements for home health care participation and the following deficiencies are cited. Moonlight Home Health Care is not in compliance with the requirements found at 42 CFR Part 484, Subpart B, C, Home Health Agencies.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure the ordered hours of service was provided. This affected two (Patients #1 and #6) of two patients reviewed. The census was 254. Findings include: 1. Review of the medical record for Patent #1 and the physician’s plan of care dated 09/11/24 through 11/09/24 revealed the home health aide (HHA) was to provide 35-40 hours per week to assist with personal care and light housekeeping. Review of the HHA time sheets for the week of 09/29/24 revealed the HHA provided 20 hours of care. Review of the HHA time sheets for the week of 10/06/24 revealed the HHA provided 16 hours of care. Review of the HHA time sheets for the week of 10/13/24 revealed the HHA provided 24 hours of care. 2. Review of the medical record for Patent #6 and the physician’s plan of care dated 10/24/24 through 12/22/24 revealed the home health aide (HHA) was to provide 15 hours per week to assist with personal care and activities of daily living. Review of the HHA time sheets for the week of 11/10/24 revealed the HHA provided six hours of care and the week of 11/24/24 the HHA provided three hours of care. Interview on 12/05/24 at 12:20 PM the Office Administrator confirmed there was no documentation the physician had been notified of these missed visits.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure the home health aides followed the Aide Care Plan. This affected three (Patients #1, #5 and #6) of three patients reviewed. The census was 254. Findings include: 1. Review of the medical record for Patient #1 and home health aide (HHA) Care Plan by the registered nurse (RN) dated 09/10/24 revealed Patient #1 was to receive a shower with chair and shampoo at every visit. Review of the HHA time sheets revealed the HHA provided service 10/09/24 through 10/11/24, three visits, and provided one bed bath on 10/09/24 and no hair was shampooed. Review of the HHA time sheets revealed the HHA provided service 10/14/24 through 10/16/24, three visits, and provided no shower with chair and no hair was shampooed. 2. Review of the medical record for Patient #5 and home health aide (HHA) Care Plan by the registered nurse (RN) dated 10/14/24 revealed Patient #5 was to receive a bed bath and shampoo at every visit. Review of the HHA time sheets revealed the HHA provided service 11/11/24 through 11/15/24, five visits, and provided one bed bath on 11/12/24 and no hair was shampooed. Review of the HHA time sheets revealed the HHA provided service 11/18/24 through 11/23/24, six visits, and provided three bed baths and no hair was shampooed. 3. Review of the medical record for Patient #6 and home health aide (HHA) Care Plan by the registered nurse (RN) dated 10/22/24 revealed Patient #6 was to receive a shower with chair, shampoo and assist with dressing at every visit. Review of the HHA time sheets revealed the HHA provided service 09/18/24 through 09/20/24, three visits, no shower with chair, hair shampoo or assist with dressing were done this week. Review of the HHA time sheets revealed the HHA provided service 11/14/24 through 11/15/24, two visits this week, no hair was shampooed or assist with dressing were done this week. Review of the HHA time sheets revealed the HHA provided service 11/25/24, one visit this week, no hair was shampooed this week. During an interview on 12/05/24 at 11:46 AM, the Office Administrator confirmed these findings.

Substantial Allegation Survey Substantial Allegation MERGEFIELD Complaint_ 105830, 106386, 106008 & 105731 The following deficiencies are based upon substantial allegations MERGEFIELD Complaint_ 105830, 106386, and 106008 completed on MERGEFIELD Date 05/08/24. MERGEFIELD Facility_Name Moonlight Home Health Care Inc, MERGEFIELD CCN 369006, is not in compliance with the requirements found at MERGEFIELD Reg 42 CFR Part 484, Subpart B, C,, MERGEFIELD Type Home Health Agency. An entrance conference was conducted on 05/07/24 at 7:53 AM with the Administrator, an exit conference was conducted on MERGEFIELD Date 05/08/24 at 4:45 PM with administrative staff.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on medical record review, policy review, and staff interview, the agency failed to ensure patients received home health services as written in the plan of care for three (Patient #2, #3 and #4)of four patients reviewed. This has the potential to affect all patients receiving services from the agency. The census was 197. 1. Review of Patient #2's medical record and the physician ordered plan of care for the certification period dated 01/16/24 through 03/15/24 revealed orders for home health aide (HHA) services 10 hours per week. The HHA was to assist with personal care, light housekeeping, making sure patient is safe and surroundings are clear as the patient is blind. Review of the HHA time sheets revealed the agency provided seven hours of aide services the week of 02/04/24 and 17 hours during the week of 02/11/24. The medical record did not contain any aide visits during the week of 01/14/24, 01/21/24, 01/28/24, 02/18/24, 02/25/24, 03/03/24, or 03/10/24. The medical record contained a communication note stating the physician will be notified for missed visits on 01/16/24, 01/18/24, and 01/22/24, however there was no evidence the physician was actually notified. There was no documentation in the medical record that the patient was instructed to activate their back up plan. There was no documentation the physician was notified services were not provided as ordered. Review of the agency policy titled “Plan of Care – CMS #485 and Physician Orders,” revised 2009, revealed the agency staff will promptly alert the physician to any changes that suggest a need to alter the Plan of Care. Interview on 05/08/24 at 9:34 AM Staff C confirmed the findings. 2. Review of Patient #3’s medical record and the physician ordered plans of care for the certification periods of 12/22/23 through 02/19/24, 02/20/24through 04/19/24, and 04/20/24 through 06/18/24 revealed orders for HHA services to provide assistance with personal care and activities of daily living (ADLs) as indicated by limitations on functional and physical status impeding self-care. The medical record contained no evidence the agency provided services from 02/08/24 through 02/19/24. There was no evidence the agency notified the patient, patient’s case manager or the patient’s physician regarding the agency being unable to staff Patient #3’s case from 02/08/24 through 02/19/24. Interview on 05/07/24 at 1:11 PM, Staff B confirmed the findings. Staff C was interviewed on 05/07/24 at 2:18 PM. Staff C reported Patient #3’s aide had quit and the agency did not have a replacement aide. 3. Review of Patient #4's medical record and the physician ordered plan of care for the certification period dated 03/05/24 through 05/03/24 contained orders for the agency to provide 13.5 hours of HHA services every week for nine weeks. The most recent timesheet in Patient #4’s medical record was dated 01/19/24. The medical record did not contain evidence of Patient #4’s physician being notified of the missed visits. Interview on 05/08/24 10:50 AM Staff E reported Patient #4 was no longer receiving services from the agency. Staff E reported Patient #4 has not received services from the agency in about two to three months. Interview on 05/08/24 at 10:55 AM Staff E confirmed Patient #4 had not received the HHA services in the plan of care. The last time HHA was provided was on 01/19/24. The medical record did not contain evidence of Patient #4’s physician being notified of the missed visits.

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 medical record review, policy review and staff interview, the agency failed to ensure the care plans included the frequency and duration of aide visits to be made for two (Patient #1 and Patient #3) of four patients reviewed. This has the potential to affect all patients receiving services from this agency. The agency’s census was 197. 1. Review of Patient #1's medical record and the physician ordered plan of care for certification period dated 12/29/23 through 02/26/24 revealed orders for aide services to provide assistance with personal care and activities of daily living (ADLs) as indicated by limitations on functional and physical status impeding self-care. There was no frequency or duration of visits ordered for the aide services. Review of the agency policy titled, “Plan of Care – CMS #485 and Physician’s Orders,” revised 2009, revealed the plan of care is established in consultation with the physician. The plan of care includes frequency and duration of visits. Staff B was interviewed on 05/07/24 at 1:34 PM and verified the plan of care for the Patient #1 did not contain a frequency or duration for aide services. 2. Review of Patient #3's medical record and the physician ordered plans of care for certification periods dated of 12/22/23 through 02/19/24, 02/20/24 through 04/19/24, and 04/20/24 through 06/18/24 revealed orders for aide services to provide assistance with personal care. There were no frequencies or duration of visits ordered for the aide services. Staff B was interviewed on 05/07/24 at 1:11 PM and confirmed the current plan of care dated 04/20/24 through 06/18/24, contained no frequency or duration for home health aide services. Staff B was interviewed on 05/07/24 at 1:27 PM and confirmed the plan of care from 12/22/23 – 02/19/24 and 02/20/24 – 04/19/24 did not contain ordered frequencies or duration for home health aide services.

Extended Substantial Allegation Survey Substantial Allegation 105028, 105208, 105332 The following deficiencies are based upon the extended substantial allegation survey for substantial allegation 105028, 105208 and 105332 completed on 03/19/24. Moonlight Home Health Agency, 369006, is not in compliance with the requirements found at 42 CFR Part 484, Subpart B, C Home Health Agency. An entrance conference was conducted on 03/18/24 at 8:20 AM with the Director of Nursing. An exit conference was conducted on 03/19/24 at 4:30 PM with administrative staff. Moonlight Home Health Agency is precluded from providing its own home health aide training and competency testing or competency evaluation program for a period of two years from the date of the receipt of the deficiency report (2567) for this survey.

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 personnel file review, staff interview, staffing schedule review, review of the Ohio Administrative Code, and review of policies, the agency failed to 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 agency failed to ensure the Administrator was responsible for day-to-day operations of the agency by not following the agency's policies on criminal background checks for employment for two home health aides (Staff C and Staff D) of two personnel files reviewed for criminal background checks. (G948). The cumulative effects of these systemic practices resulted in the facility's inability to ensure the safety of every patient receiving home care services. This had the potential to affect the agency's 218 patients. See G948.

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 medical record review, policy review, personnel file review, review of staffing schedules, review of Ohio Administrative Codes, and staff interview, the agency failed to ensure the Administrator was responsible for day-to-day operations of the agency by not following the agency's policies on criminal background checks and employment for two home health aides (Staff C and Staff D) out of two personnel files reviewed for criminal background checks. The agency's active census was 218. 1.Review of the personnel file for Staff D revealed a hire date of 10/26/23. Ther was no evidence the background check had been completed and returned to the facility within 60 days. A letter to the agency dated 10/26/23 stated the result from Staff D’s Bureau of Criminal Identification and Investigation (BCII) background check was mailed. The letter stated to please allow 30 days for processing. If you have not received the results after 30 days, please contact and ask for identification department to check on the progress. Review of the BCI report for Staff D, dated 01/30/24, included convictions 03/14/16 conviction for Falsification (Code 2921.13A5) with one year of probation (03/14/17). Review of the Ohio Administrative Code 3701-60-09, “Disqualifying Offenses Exclusionary Periods; Certificates; Pardons,” for Home Health Agencies, revealed Code 2921.13A5 carries a seven year exclusionary employment period from the date fully discharged from probation. Staff E was interviewed on 03/19/24 at 8:40 AM. Staff E reported they thought Staff D was allowed to continue working due to the time that has passed since Staff D’s convictions. Review of the staffing revealed Staff D provided aide services for Patient #2 from 12/06/23 through 12/13/23. 2. Review of the personnel file for Staff C revealed a hire date of 10/15/23. The personnel file contained no evidence of a BCI report being obtained until 03/19/24. The results of the BCII report dated 03/19/24 revealed Staff C was convicted of Theft (Code 2913.02) on 06/11/17 with 180 days jail served. Staff C was convicted on 07/23/21 of Assault (Code 2903.13). Review of the Ohio Administrative Code 3701-60-09, “Disqualifying Offenses Exclusionary Periods; Certificates; Pardons,” for Home Health Agencies, revealed Code 2913. 02 and 2903.13 each carried a five year exclusionary employment period from the date fully discharged from probation. However, if two or more convictions under the five year category occurred on unrelated events there would be a seven year exclusion from employment for Home Health Agencies. Review of the schedule revealed Staff C provided aide services for Patient #1 from 10/17/23 through 02/09/24. Review of the agency policy titled “Personnel Qualifications,” effective 01/05/13, included prior to employment employees must pass a fingerprint criminal background investigation. Review of the agency policy titled “Criminal Background Check,” effective 01/05/13, included the purpose was to ensure all clients are safe from harm and will not be exploited. The agency will not hire any prospective employee as administrator, direct care staff, case worker or, in any position responsible for a client's care who has been convicted of or plead guilty of assault and program felony list in Ohio Department of Aging rules. All employees are required to pass a fingerprint background clearance check prior to employment. The agency will request the Bureau of Criminal Identification and Investigation (BCII) to conduct criminal records check for any employee who has applied for a position. If the agency has not received the results of the criminal records check within sixty (60) days after submission, or the employee has been convicted of or plead guilty to any of the numerated offenses, the agency shall terminate the individual's employment, unless, the nursing supervisor, with the consent of the Administrator, chooses to employ the individual under personal character standards. Review of the agency policy titled “Human Resources: Revised BCI/I Procedures,” effective 01/12/15, included the agency has begun to check all new applicants' criminal backgrounds before any application process begins as part of its revised pre-hire screening process. If applicants are free of criminal records, the Agency will instruct them to provide current background check (fingerprints) results addressed and mailed to the Agency. After the applicant brings the evidence of the background check, the employment application will be processed. Once all the Agency's employment qualifications and requirements are satisfied, the applicant will be allowed to work conditionally until Agency receives fingerprint results within 60 days. All new applicants' fingerprint results will be checked thoroughly to make sure they are eligible to continue working. A week prior to the 60-day wait, the Agency will terminate the conditional employee and request they re-apply as a new applicant. The agency’s process for hiring is to first require that applicants present their social security and identification to allow Agency to look up potential employees’ criminal records before application process starts. Interview with Staff E on 03/19/24 at 2:23 PM confirmed the findings regarding Staff D and Staff C working greater than 60 days without receiving their BCII background checks back and confirmed both had been convicted of disqualifying offenses.

Extended Substantial Allegation Survey Substantial Allegations 103662, 103679, 103735, 103827, 104029, 104306 and 104379 Post Survey Revisit (PSR) to Substantial Allegations 103312, 102404, 102395, 102381, 102380, 102375 completed on 12/20/23 An entrance conference was conducted on 01/29/24 at 7:25 AM with the Administrative Assistant. An exit conference was conducted on 02/06/24 at 5:15 PM with administrative staff. The following deficiencies are based on the extended substantial allegation survey and PSR completed on 02/06/24. Moonlight Home Health Care Inc 369006, is not in compliance with the requirements at 42 CFR Part 484, Subpart B, C for Home Health Agencies. Moonlight Home Health Care Inc is precluded from providing its own home health aide training and competency testing or competency evaluation program for a period of two years from the date of the receipt of the deficiency report (2567) for this survey.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on review of documentation and interview, the agency failed to develop, implement, evaluate, and maintain an effective, ongoing, home health agency (HHA) wide, data-driven Quality Assurance Performance Improvement (QAPI) program per the requirements of: 42 CFR 484.65 On 02/06/24 at 3:00 PM, the surveyor requested information regarding the agency's QAPI program. No documentation was provided. When asked if the agency had a QAPI program at that time, Staff A stated the agency had nothing like that.

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure a qualified home health aide (HHA) was a person who successfully completed a training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or a competency evaluation program that meets the requirements of paragraph (c) of this section; or a nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry (G754). The agency failed to ensure the home health aide (HHA) competency evaluation addressed each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient (G768). The agency failed to ensure the home health aide (HHA) received at least l2 hours of in-service training during each 12-month period (G774). The agency failed to ensure the home health aides (HHA) are assigned to a specific patient by a registered nurse (RN) (G798). The cumulative effect of these systemic practices resulted in the agency’s inability to ensure the patients home health aide needs were met.

A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This ELEMENT is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure a qualified home health aide (HHA) was a person who successfully completed a training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or a competency evaluation program that meets the requirements of paragraph (c) of this section; or a nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry for seven out of seven home health aide personnel files reviewed (Staff D, E, F, J, K, Q and R). This could affect all patients receiving services from the agency. The census was 303. Findings include: Review of the agency's home health aide (HHA) job description revealed under the position qualifications, effective 08/14/1990, the nurse's aide must have successfully completed a state established or other training program that meets the requirements of CFR 484.36(a) and a competency evaluation program, or state licensure program that meets the requirements of CFR 484.36(b), or a competency evaluation program or state licensure program that meets the requirements of 484.36(b). Review of the agency's "New Hire Checklist” revealed that in order for the personnel record to be considered complete, verification of educational documents, competency test results and skills assessment results must be included. 1. Review of the personnel file for Staff E revealed a start date of 12/31/21. Staff E's personnel file included no documentation of HHA training or a competency exam. Staff E is currently providing HHA services to patients. 2. Review of the personnel file for Staff J revealed a hire date of 03/20/23. There was no documentation of HHA training, a competency exam, or HHA skills checklist. Staff J is currently providing HHA services to patients. 3. Review of the personnel file for Staff K revealed a hire date of 06/07/23. There was no documentation of HHA training or a competency exam. Staff K did provide services to Patient #8. 4. Review of the personnel file for Staff Q revealed a hire date of 12/27/23. There was no documentation of HHA training, a competency exam, or HHA skills checklist. Staff Q is currently providing HHA services to patients. 5. Review of the personnel file for Staff F revealed a hire date of 10/26/23. Staff J's personnel filed included no documentation of HHA training or a competency exam. Staff F is currently providing HHA services to patients. 6. Review of the personnel file for Staff D revealed a start date of 06/19/23. Staff D's personnel filed included no documentation of HHA training or a competency exam. Staff D did provide services to Patient #3. 7. Review of the personnel file for Staff R revealed a hire date of 12/14/22. There was no documentation of HHA training or a HHA competency exam. Staff R did provide services to Patient #2. Interview on 02/01/24 at 11:30 AM with Staff B confirmed the missing training, competency exams or competency check list. This deficiency represents non-compliance investigated under Substantial Allegation 104379.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure the home health aide (HHA) competency evaluation addressed each of the subjects listed in paragraph (b)(3) of this section and where indicated, subject areas of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. This could affect all patients receiving services from this agency. The census was 303. Findings include: Review of the agency's personnel files revealed an "Initial On-site competency Checklist" and an "HHA Skills Checklist." Interview on 02/06/24 at 4:26 PM with Staff B revealed the "Initial On-site competency Checklist" and the "HHA Skills Checklist" were just talked through with the aide and then Staff B would check off that skill. The skills were not checked on a live or pseudo-patient. This deficiency represents non-compliance investigated under Substantial Allegation 104379.

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure home health aides (HHA) received at least l2 hours of in-service training during each 12-month period for three of four HHA personnel filed reviewed (Staff D, E, and J). This could affect all patients receiving services from the agency. The census was 303. Findings include: Review of the personnel file for Staff D revealed a hire date of 06/19/23. There was no evidence Staff D completed any inservice training in the remainder of 2023. Review of the personnel file for Staff E revealed a hire date of 12/13/21. There was no evidence Staff E completed any inservice training in 2022 or 2023. Review of the personnel file for Staff J revealed a hire date of 03/20/23. There was no evidence Staff J completed any inservice training in the remainder of 2023. Interview on 02/06/24 at 3:59 PM with Staff AA confirmed Staff D, E, and J did not have any in-service training since hire. This deficiency represents non-compliance investigated under Substantial Allegation 104379.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on staff interviews, the agency failed to ensure the home health aides (HHA) are assigned to a specific patient by a registered nurse (RN). This could affect all patients receiving services from this agency. The census was 303. Findings include: Interview on 02/06/24 at 4:26 PM with Staff B revealed when she opened a new case, she would just leave the HHA care plan in the patient's home and then the Administrative Assistants assigned the HHA's to the patients. Interview on 02/06/24 at 4:36 PM with Staff Z confirmed the Administrative Assistants assigned the HHAs to the patients not the registered nurse.

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 observation, record review and staff interview, the governing body (or designated persons so functioning) failed to 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 (G942). The agency failed to ensure the Administrator was appointed by the Governing Body (G946). The agency failed to ensure the parent agency provides direct support and administrative control of its branches (G974). The cumulative effect of these systemic practices resulted in the agency’s inability to ensure the patients needs would be met.

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 staff interview, the governing body (or designated persons so functioning) failed to 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 could affect all patients receiving services from the agency. The census was 303. Findings include: On 02/05/24 at 1:50 PM, the surveyor requested the Governing Body meeting minutes. Staff A was asked at that time who the members of the Governing Body were. Staff A repled, "What do you mean? There isn't a Governing Body. There is just me and the DON (Director of Nursing)." Interview on 02/06/24 at 5:00 PM with Staff B confirmed there was no Governing Body.

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure the Administrator was appointed by the Governing Body. This could affect all patients receiving services from this agency. The census was 303. Findings include: On 02/05/24 at 1:50 PM, the surveyor requested the Governing Body meeting minutes. On 02/05/24 at 3:30 PM Staff A was unable to provide documentation of being appointed by a Governing Body or the name of the person that would act as the administrator in his absence.

Direct support and administrative control CFR(s): 484.105(d)(2) The parent HHA provides direct support and administrative control of its branches. This ELEMENT is not met as evidenced by: Based on observation, record review and staff interview, the agency failed to ensure the parent agency provides direct support and administrative control of its branches. This could affect all patients receiving services from this agency. The census was 303. Findings include: Review of agency documentation during offsite preparation revealed the agency still did not currently have any approved branch locations. The agency had been cited previously for having unapproved branch locations in Akron and Canton. Interview on 01/30/24 at 12:38 PM with Staff A revealed the locations in Akron and Canton were "drop-off" sites. Interview on 01/30/24 at 12:48 PM with Staff N revealed they worked at the Canton location 9:00 AM-5:00 PM, Monday through Friday. Interview on 01/30/24 at 12:55 PM with Staff P revealed she had a cell phone to monitor the calls at the Akron location. Staff P stated she just stopped by the Akron location to pick up the home health aide (HHA) time sheets and take them to the main location in Austintown. Staff P stated she would take the HHA call offs for the Akron area and answered any problems the HHA's may have. Interview on 02/01/24 at 8:40 AM with Former Staff BB revealed the Akron and Canton locations were actual offices. They did the hiring, scheduling, and everything the main location did. The Akron and Canton offices each had four staff that work there Monday through Friday, 9:00 AM to 5:00 PM. Former Staff BB stated when the State was here, the Administrator would call the Akron and Canton offices and tell them to close and work from home. The Administrator would tell the staff to say, "I only pick up the HHA's time sheets and turn it into the Austintown location". Review of the personnel files for HHAs Staff D and F revealed Staff P, from the Akron office, did the background checks on Staff D and F. Interview on 02/01/24 at 1:06 PM with Staff A revealed Staff P “works at the Akron office”. Interview on 02/05/24 at 10:22 AM with Staff U, office staff in the Akron office, revealed she did hiring at the Akron and Canton offices. She stated each office did their own fingerprinting. Staff U did the payroll at the Akron office. They also did the staffing, faxing to doctors and case managers, and everything needed to run the office. Staff P was the Administrator at the Akron office and Staff U was the Assistant Administrator. Staff U handled the third party oversight entity requests for documentation, got staff statements, and typed up documentation to send to the third party oversight entity. On 02/05/24 at 1:58 PM Staff A called the Akron and Canton offices to find out who the drivers (staff that drove staff without driver's licenses to their assignment) were to put them on the organizational chart. Interview on 02/05/24 at 2:05 PM with Staff A revealed Staff N and P both worked in the Akron area and just picked up the HHA paperwork. Interview on 02/06/24 at 1:13 PM Staff A confirmed not knowing who the drivers in the Akron and Canton offices were. An on-site visit was made to the Akron office on 02/06/24, at 9:48 AM. The Akron location was at 1655 West Market Street Suite 455, Akron, Ohio 44313. The suite was located on the fourth floor. On the wall by the door to the suite was a name plate of this agency. Upon entering there was a receptionist area, a break room, an office with Staff P's name on the door and another office where Staff Y was sitting. Staff Y stated it was the DODD (Department of Developmental Disabilities) office. There was no drop off box or bin (for the HHA's to drop off their time sheets) located outside or inside this office. This deficiency represents non-compliance investigated under Substantial Allegation 104379.

Substantial Allegation Survey Substantial Allegations 103312, 102404, 102395, 102381, 102380, 102375 An entrance conference was conducted 12/12/23 at 9:25 AM with the Director of Nursing. An exit conference was conducted on 12/20/23 at 3:40 PM with administrative staff. The following deficiencies are based upon substantial allegations 103312, 102380, 102404, 102395, 102381, 102375 completed on 12/20/23. Moonlight Home Health Care Inc 369006, is not in compliance with the requirements at 42 CFR Part 484, Subpart B, C for Home Health Agencies.

Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) (i) Investigate complaints made by a patient, the patient's representative (if any), and the patient's caregivers and family, including, but not limited to, the following topics: This ELEMENT is not met as evidenced by: Based on record review and staff interview the agency failed to ensure patient complaints/incidents were investigated for three of five incidents reviewed. This could affect all patients receiving services from the agency. The census was 250. Findings include: Review of the agency policy titled, “Variance/Incident Reporting,” revised 2009, revealed the agency will establish a consistent documentation and reporting process. The agency will document and report all incidents (safety and security, alleged/suspected patient abuse, and motor vehicle accidents) that deviate from routine agency operations. Such incidents may include security incidents involving patients. A Variance/Incident Report will be completed on all incidents. The report will be submitted to the immediate supervisor, who is responsible for immediate investigation of the incident and taking any appropriate action. The supervisor will review the Variance/Incident Report and will document awareness of the incident. Follow-up data needed to resolve the incident, e.g. police reports, will be collected by the supervisor. A file will be maintained of all variance/incident reports. 1. Review of the medical record for Patient #4 revealed an email from Staff F (driver for the Akron area) that the agency was made aware of the incident that occurred with the patient on 08/26/23. Patient #4 reported that her card was used by a home health aide (HHA) to go to the store. Later that evening the patient discovered that the card had been used for Cash app and PayPal which was not authorized. The patient stated the bank was investigating this. There had been no other allegations against this aide. The patient was new to the agency, so the patient had not made accusations against other aides before. Staff F stated there was no investigation done by this agency due to the bank doing their own investigation and the police were called. Staff I was asked to come into the office but did not show up. Review of Staff I's personnel file revealed the Ethical, Professional, Respectful and Legal Service Standards was signed by Staff I on 08/18/23. This document stated the staff shall not engage in any unethical, unprofessional, disrespectful, or illegal behavior including accepting, obtaining, or attempting to obtain money, or anything of value, from the patient or family. There was no documentation regarding this incident or if any disciplinary action was taken. Review of the complaint/incident log did not reveal an incident regarding Staff I taking money or using Patient #4's debit card for their own use. Interview on 12/18/23 at 11:00 AM with Staff C revealed Staff I was terminated but could not remember when or why. On 12/18/23 at 12:25 PM Staff A presented an email, with no date, from the case manager that the agency was notified regarding Patient #4's report of a debit card being used inappropriately on 08/28/23. Further interview with Staff A confirmed this incident was not documented or investigated per policy. Staff A confirmed there was no documentation in the personnel file regarding why Staff I was terminated or when. Staff A stated Staff I didn’t come in to make a statement or return to work. They “just disappeared”. 2. Interview on 12/14/23 at 12:00 PM with Staff A revealed she was aware of an incident where a home health aide drove a patient’s car and hit a fence. Staff A confirmed this incident was not documented or investigated per policy. 3. Review of the document, Ethical, Professional, Respectful and Legal Service Standards, updated 07/01/19, revealed the staff shall not engage in bringing a child, friend, relative or anyone else to the patient’s home. Interview on 12/13/23 at 2:10 PM with Staff C revealed she was not aware of any home health aide (HHA) bringing a child or relative to a patient’s home and stated this was not allowed. On 12/13/23 at 3:50 PM, Staff C provided a verbal warning by Staff F, a driver from the Akron office, dated 08/28/23 that was given to Staff J. The verbal warning issued was to not to bring children or anyone else to the patient’s home. Staff J acknowledged this verbal warning and stated they understood the rules. Staff C could not reply when asked why a driver, who was not a supervisor, was providing the corrective action (verbal warning) to staff. This deficiency represents non-compliance investigated under Substantial Allegations 102395, 103312 and 102381.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure patients received home health services as written in the plan of care for two of five patients reviewed (Patient #1 and #2). This could affect all patients receiving services from the agency. The census was 250. Findings: Review of the agency policy titled, “Plan of Care – CMS #485 and Physician Orders,” revised 2009 revealed the agency staff will promptly alert the physician to any changes that suggest a need to alter the Plan of Care. Review of Patient #1's medical record and the physician ordered plan of care for the certification period dated 07/10/23 to 11/07/23 revealed orders for home health aide (HHA) services 40 hours per week to assist with personal care and light housekeeping. Review of the HHA time sheets revealed the HHA provided 18 hours of care the week of 08/06/23, eight hours the week of 09/17/23, 36 hours the week of 09/24/23 and 36 hours the week of 10/08/23. There was no documentation in the record that the patient was notified to activate their back up plan and no documentation the physician was notified that services were not provided as ordered. Interview on 12/12/23 at 1:50 PM with Staff A revealed they did not have staff available to provided the services and confirmed there was no documentation in the medical record that the patient was notified to activate their back up plan and no documentation the physician was notified that services were not provided as ordered. 2. Review of Patient #2's medical record and physician ordered plan of care for the certification period dated 09/19/22 to 11/17/22 revealed orders for skilled nursing services once a week and home health aide (HHA) services to provide assistance with personal care for 18 hours per week. Review of the HHA time sheets revealed the HHA provided nine hours and 15 minutes the week of 09/25/22, nine hours and 45 minutes the week of 10/02/22, 17 hours and 30 minutes the week of 10/09/22, eight hours the week of 10/16/22, seven hours the week of 10/23/22, two hours and 25 minutes the week of 10/30/22, six hours and 30 minutes the week of 11/05/22, and 10 hours and 40 minutes the week of 11/13/22. Review of the physician ordered plan of care for the certification period dated 01/17/23 to 03/17/23 revealed orders for skilled nursing services once a week and HHA services to provide assistance with personal care and activities of daily living for 20-25 hours per week. Review of the HHA time sheets revealed the HHA provided 18 hours the week of 01/15/23 and 20 hours the week of 01/22/23. No HHA visit sheets were provided from 01/29/23 to 03/17/23. There was no documentation in the record that the patient was notified to activate their back up plan and no documentation the physician was notified that services were not provided as ordered. Interview on 12/20/23 at 12:44 PM with Staff B confirmed there was no documentation in the record that the patient was notified to activate their back up plan and no documentation the physician was notified that services were not provided as ordered. This deficiency represents non-compliance investigated under Substantial Allegation 102395, 102375 and 102380.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure all services were provided only as ordered by the physician or allowed practitioner for three of five patients reviewed (Patient #1, #2 and #3). This could affect all patients receiving services from this agency. The census was 250. Findings include: Review of the agency policy titled, “Plan of Care – CMS #485 and Physician’s Orders,” revised 2009, revealed the plan of care is established in consultation with the physician. Care and services provided will be provided according to physician orders. 1. Review of the medical record for Patient #1 did not reveal a physician ordered plan of care for the certification period dated 09/08/23 to 11/06/23. Review home health aide (HHA) time sheets revealed HHA services were provided for eight hours the week of 09/17/23, 36 hours the week of 09/24/23, 46 hours the week of 10/01/23, and 36 hours the week of 10/08/23. Interview on 12/12/23 at 1:45 PM with Staff C confirmed there was no physician ordered plan of care for the certification period dated 09/08/23 to 11/06/23 and no orders for the visits made for this certification period. 2. Review of Patient #2's medical record and the physician ordered plan of care for certification period dated 11/18/22 to 01/16/23 revealed orders for skilled nursing services once a week and HHA services to provide assistance with personal care. There was no frequency or duration of visits ordered for the HHA services. Review of the HHA time sheets revealed the HHA provided 13 hours of services the week of 11/20/22, 16 hours the week of 11/27/22, 10 hours the week of 12/04/22, six hours the week of 12/11/22, 13 hours the week of 12/08/22, 12 hours and 30 minutes the week of 12/25/22, 14 hours the week of 01/01/23, and 16 hours the week of 01/08/23. Interview on 12/20/23 at 2:58PM with Staff C confirmed there were no physician orders for HHA services for 11/18/22 to 01/16/23. 3. Review of Patient #3's medical record and physician ordered plan of care dated 09/19/23 revealed an order for skilled nursing services but the plan of care did not have a frequency or duration of visits for the skilled nursing services. Review of the skilled nursing visit notes from 09/20/23 to 11/09/23 revealed nurses visited 12 hours per day, Monday through Thursday. Interview on 12/20/23 at 10:36 AM with Staff C confirmed there were no physician orders for the nursing visits provided 09/19/23 to 11/09/23. This deficiency represents non-compliance investigated under Substantial Allegations 102395, 102380 and 102404.

A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This ELEMENT is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure a qualified home health aide (HHA) was a person who has successfully completed a training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or a competency evaluation program that meets the requirements of paragraph (c) of this section; or a nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry for four of four HHA’s reviewed (Staff D, G, I and J). This could affect all patients receiving services from the agency. The census was 250. Findings include: Review of the "HHA job description and Staff Minimum Requirements, minimum qualifications, experience, training, skills and knowledge of client" revealed the nurse's aide must have successfully completed the Competency Evaluation Program conducted by the Ohio Department of Health under section 3721.31 of the Revised Code or the Medicare Competency Evaluation Program Home Health Aides as set forth in 42 CFR 434, without a 24 month lapse in employment. Review of the agency’s “New Hire Checklist” revealed in order for the personnel record to be considered complete verification of Educational Documents and Competency Test Results must be included. Interview on 12/13/23 at 10:38 AM with Staff K revealed the agency only use applicants with one year or more of HHA experience. The HHA then took an HHA Competency test, had an HHA skills check, and then had an on-site skill check by the Director of Nursing (DON) before they worked with a patient. If the HHA did not have documentation of HHA training, then they had to take an HHA training class given by the DON. Interview on 12/13/23 at 11:38 AM with Staff C revealed the only class she taught was just the HHA skills check which was very basic. Staff C stated she did not do any formal class training for the HHA's. 1. Review of the personnel file for Staff G revealed a hire date 06/19/23. Review of the 15 Section answer sheet for the HHA Competency Exam revealed it was blank, but it was signed by Staff G and dated 06/19/23. The personnel file lacked documentation that Staff G had any formal HHA training. 2. Review of the personnel file for Staff I revealed a hire date 08/21/23. The Application of Employment indicated Staff I was a caregiver from 2013 to 2015 (eight years ago) with responsibilities that included a little housekeeping, and a private caregiver from 03/2022 to 10/2022 (seven months) with responsibilities that included laundry, little cooking and Doctor appointments. Both the on-site HHA Competency checklist and HHA skills checklist in Staff I's personnel file were not dated. Review of the 15 Section answer sheet for the home health aide (HHA) Competency Exam revealed it was blank, but it was signed by Staff I and dated 08/18/23. The personnel file lacked documentation that Staff I had any formal HHA training. 3. Review of the personnel file for Staff J revealed a hire date 06/19/23. The Application for Employment revealed Staff J worked from 08/2020 to 09/2021 at a job doing dishes and helping around the house. Review of the on-site HHA competency checklist revealed it was not dated. The personnel file lacked documentation that Staff I had taken the HHA Competency Exam or had formal HHA training. 4. Review of the personnel file Staff D revealed a hire date of 07/25/23. Review of Application for Employment revealed Staff D worked in health care from 2019 to 2020. No other healthcare employment was listed after 2020. Review of the Reference Check revealed Staff D worked in home health care from 2019 to 2020 and was eligible for hire on 07/25/23. Review of the Initial on-site HHA Competency checklist and the HHA skills checklist revealed both were not dated. Review of the 15 Section answer sheet for the home health aide (HHA) Competency Exam revealed it was blank. The personnel file lacked documentation that Staff D had any formal HHA training. Interview on 12/13/23 at 10:44 AM with Staff K confirmed the findings in the personnel files. Interview on 12/13/23 at 3:48 PM with Staff C confirmed the four HHA's had no evidence of any formal training. Staff C also stated they were unaware that the applicant must show documentation of HHA training.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on record review and staff interview, the clinical manager failed to ensure the agency employs qualified personnel for five of five personnel files reviewed (Staff D, G, I, J, and L). this could affect all patients receiving services from the agency. The census was 250. Findings include: 1. Review of the agency policy titled, “Personnel Qualifications,” effective 01/05/13, revealed prior to employment employees must pass a fingerprint criminal background investigation. Review of the “New Hire Checklist” revealed for the personnel record to be considered complete, the Bureau of Criminal Identification and Investigation (BCII) results must be in the employee’s file. Interview on 12/13/23 at 10:09 AM with Staff B revealed if it was not in the personnel file, then the results of the background check were not back. Interview on 12/13/23 at 10:38 AM with Staff K revealed the agency kept a fingerprinting log and the results usually came back in less than 30 days. Review of the BCII log did not reveal the date the fingerprint results were returned or the results of the background check. Review of the personnel file for Staff G revealed a hire date 06/19/23. Review of the “Ohio Automated Registry Check System”, dated 06/22/23, revealed Staff G has not been previously determined eligible for employment and must be fingerprinted. The personnel file did not contain evidence that Staff G was fingerprinted. Review of the personnel file for HHA Staff I revealed a hire date 08/21/23. The personnel did not contain evidence that Staff I was fingerprinted. 2. Review of the Home Health Aide (HHA) Job Description Summary and Position Qualifications revealed the HHA has completed a cardiopulmonary resuscitation (CPR) and First Aide course successfully in the past 12 months. Interview on 12/13/23 at 9:49 AM with Staff C revealed all staff were required to have a current CPR/First Aide certificate. Review of the personnel files for Staff G, Staff I, Staff J, and Staff L revealed no evidence of a current CPR/First Aide card. Interview on 12/13/23 at 10:40 AM with Staff K confirmed there were no CPR/First Aide cards in the personnel files. This deficiency represents non-compliance investigated under Substantial Allegation 102395.

Report all branch locations to SA CFR(s): 484.105(d)(1) The parent HHA is responsible for reporting all branch locations of the HHA to the state survey agency at the time of the HHA's request for initial certification, at each survey, and at the time the parent proposes to add or delete a branch. This ELEMENT is not met as evidenced by: Based on document review and staff interview, the agency failed to report all branch locations to the state survey agency at the time they proposed to add a branch location. This could affect all patients receiving services from the agency. The census was 250. Findings include: Interview on 12/13/23 at 3:30 PM with Staff C revealed that Staff F, who was a driver in the Akron area, drove the home health aides (HHA) to the patients' home. Staff C stated around 90% of the HHA's in that area did not drive or have transportation. Staff F worked from home when not driving staff and assisted with scheduling the HHA's and collecting their time sheets. Staff F did not work at the Austintown location. During the complaint investigation the Administrator, Staff A, had been calling Staff F for missing documentation in the medical records. Interview on 12/18/23 at 1:50 PM with Staff A revealed Staff F was a driver in the Akron area and also picked up the HHA's time sheets. Interview on 12/18/23 at 2:50 PM with Staff F revealed they hired HHA's, completed communication notes, kept in contact with the case managers, reported call offs, and did background checks on new applicants at the location at 1655 West Market Street, Suite 455, Akron, Ohio 44313. Staff F stated they went to this location a couple times a week for a few hours. Review of the job description provided by Staff A for Staff F revealed the position was a “Receptionist/HR Assistant” who reports to the administrator and is under the supervision of the director of nursing. Duties include managing phone lines and prioritizes calls, takes intake and referral information, processes all applications, maintains employee records and schedules orientation. Review of State Agency documentation revealed the agency's main location address of record was still 5900 Roche Drive, Suite 227, Columbus, Ohio 43229. No Centers for Medicare & Medicaid form 855 had been received to update the agency's address to 102 Javit Court, Austintown, Ohio 44515 and no information has been received to add a branch location at 1655 West Market Street, Suite 455, Akron, Ohio 44313.

Substantial Allegation Survey Substantial Allegations 97241 and 99063 An entrance conference was conducted on 07/19/23 at 7:16 AM with administrative staff, and an exit conference was conducted on 07/20/23 at 4:32 PM with administrative staff. The following deficiencies are based upon substantial allegation 97241 and 99063 completed on 07/20/23. Moonlight Home Health Care Inc 369006, is not in compliance with the requirements at 42 CFR Part 484, Subpart B, C for Home Health Agencies.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on medical record review, staff interview and policy review, the agency failed to provide home health services as written in the plan of care for two of two patients reviewed (Patient #2 and #4). This could affect all patients receiving services from the agency. The census was 152. Findings include: Review of the agency's policy titled, Care Planning Process (9.9.1, Revised 2009) revealed in order to assure that care provided is appropriately planned to meet each patient's specific needs and problems, the Agency will utilize data/information gathered during patient assessments in the care planning process. Care will be coordinated initially and ongoing among staff providing care. Care planning for each patient will be individualized to include: Any missed services will be communicated to the physician. The physician must be notified of every visit that is missed on the plan of care. 1. Review of Patient #2’s medical record and physician ordered plan of care for the certification period of 06/04/23 through 08/02/23 revealed orders for home health aide (HHA) services 35 hours per week to assist with personal care. Review of the HHA time sheet for the week ending 07/15/23 revealed only 15 hours of HHA services were provided. Review of the HHA time sheet for the week ending 07/08/23 revealed only 20 hours of HHA services were provided. Review of the HHA time sheet for the week ending 07/01/23 revealed only 28 hours of HHA services were provided. Review of the HHA time sheet for the week ending 06/24/23 revealed only 26 hours of HHA services were provided. Review of the HHA time sheet for the week ending 06/17/23 revealed only eight hours of HHA services were provided. Review of the HHA time sheet for the week ending 06/10/23 revealed only 32 hours of HHA services were provided. There was no documentation that the physician was notified that services were not provided as ordered. The findings were shared in an interview with Staff A on 07/20/23 at 10:08 AM and confirmed. 2. Review of Patient #4’s medical record and physician ordered plan of care for the certification period of 06/07/23 through 08/05/23 revealed orders for home health aide (HHA) services 38 hours per week to assist with personal care. Review of the HHA time sheet for the week ending 06/30/23 revealed only 37.5 hours of HHA services were provided. Review of the HHA time sheet for the week ending 07/08/23 revealed only 25.5 hours of HHA services were provided. There was no documentation that the physician was notified that services were not provided as ordered. On 07/20/23 at 12:50 PM, the findings were shared with Staff A and Staff B in an interview and confirmed. This deficiency represents non-compliance investigated under Complaint Number 97241 and 99063.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure the home health aide (HHA) provided services that are included in the plan of care for one of two patients reviewed (Patient #2). This could affect all patients receiving services from the agency. The census was 152. Findings include: Review of Patient #2's home health aide (HHA) care plan dated 06/07/23 revealed the HHA was to assist with a shower every visit. Review of the HHA visits dated 07/03/23 through 07/07/23 revealed there was no documentation Patient #2 received a shower. The findings were shared with Staff B in an interview on 07/20/23 at 4:30 PM and confirmed.

Substantial Allegation Survey Substantial Allegations 96136 and 96490 An entrance conference was conducted on 03/29/23 at 10:15 AM with the Administrator. An exit conference was conducted on 03/30/23 at 5:00 PM with administrative staff. The following deficiencies are based upon substantial allegation 96490 completed on 03/30/23. No deficiencies were issued as a result of substantial allegation 96136. Moonlight Home Health Care 369006, is not in compliance with the requirements at 42 CFR Part 484, Subpart B, C for Home Health Agencies.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and staff interview, the agency failed to home health services as written in the plan of care for two of three patients reviewed (Patient #2 and #3). This could affect all patients receiving services from the agency. The census was 125. Findings include: 1. Review of Patient #2’s medical record and physician ordered plan of care dated 02/27/23 revealed orders for home health aide (HHA) services 21 hours per week to assist with personal care. Review of the HHA time sheet for the week of 02/05/23 revealed the HHA worked 02/06/23, 02/07/23, 02/08/23 and 02/10/23 from 10:00 AM to 2:00 PM for a total of 20 hours. Review of the HHA time sheet for the week of 02/12/23 revealed the HHA worked 02/14/23, 02/15/23, 02/16/23 and 02/18/23 from 10:00 AM to 2:00 PM for a total of 14 hours. There was no documentation the physician was notified services were not provided as ordered. 2. Review of Patient #3’s medical record and physician ordered plan of care dated 01/13/23 revealed orders for HHA services 31 hours per week to assist with personal care and activities of daily living. Review of the HHA time sheet for the week of 02/05/23 revealed the HHA worked 02/06/23, 02/08/23 and 02/10/23 from 8:50 AM to 11:00 AM and worked 02/11/23 from 8:50 AM to 12:00 PM. The HHA worked 02/06/23 from 3:50 PM to 6:30 PM, 02/08/23 from 4:00 PM to 7:00 PM, 02/10/23 from 3:50 PM to 7:00 PM and 02/11/23 from 1:50 PM to 5:00 PM for a total of 20.5 hours for the week. Review of the HHA time sheet for the week of 02/12/23 revealed the HHA worked 02/13/23, 02/15/23 and 02/17/23 from 8:50 AM to 11:00 AM, 02/13/23 and 02/15/23 from 4:00 PM to 7:00 PM and on 02/17/23 from 3:50 PM to 6:00 PM (left one hour early) for a total of 14 hours for the week. There was no documentation the physician was notified services were not provided as ordered. Interview on 03/29/23 at 3:07 PM with Staff B confirmed the agency did not provide the ordered hours per week and did not notify the physician of the change in plan of care. This deficiency represents non-compliance investigated under Substantial Allegation 96490.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure the home health aide (HHA) provides services that are included in the plan of care for one of three patients reviewed (Patient #3). This could affect all patients receiving services from the agency. The census was 125. Findings include: Review of Patient #3’s home health aide (HHA) care plan dated 01/12/23 revealed the HHA was to assist with a shower, shampoo, skin care, peri care, assist with dressing, incontinence care, assist with transfers, assist with ambulation and medication reminder on every visit. Review of the HHA visit sheet dated 02/06/23 to 02/11/23 and 02/13/23 to 02/17/23 revealed there was no documentation Patient #3 received a shower, shampoo, skin care, peri care, assist with dressing, incontinence care, assist with transfers, assist with ambulation and medication reminder for those two weeks. Interview on 03/29/23 at 3:09 PM with Staff B confirmed there was no documentation the HHA assisted Patient #3 with personal care as written on the HHA plan of care. This deficiency represents non-compliance investigated under Substantial Allegation 96490.

Substantial Allegation Survey Substantial Allegation 94566 An entrance conference was conducted on 01/09/23 at 9:12 AM with the Director of Nursing. An exit conference was conducted on 01/09/23 at 4:00 PM with administrative staff. No deficiencies were cited related to allegations contained in substantial allegation 94566 completed on 01/09/23; however, the facility was found not to be in compliance with all requirements for Home Health Agency participation and the following deficiency was cited. Moonlight Home Health Care Inc 369006, is not in compliance with the requirements found at 42 CFR Part 484, Subpart B, C for Home Health Agencies.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on record review and staff interview, the agency failed to document the existence of the complaint and the resolution of the complaint for two of two records reviewed (Patient #1 and #2). This could affect all patients receiving services from the agency. The census was 148. Findings include: The surveyor reviewed the agency's complaint log and there were no complaints documented. 1. Per interview on 01/09/23 at 8:45 AM, Staff A stated a courtesy call was made to Patient #1 on 08/10/22 and was informed of an allegation of theft by the home health aide (HHA). Staff A stated an investigation would be done. Review of a Communication Note dated 08/11/22 revealed the office staff called the patient for a customer service courtesy call. The Director of Nursing is to follow up with the employee to get a statement. The patient made accusations that the employee stole money from her and apologized for not telling the agency about it. There was no other documentation of the complaint by the agency and no documentation of a follow up resolution completed by the agency. 2. Review of third-party oversight agency documentation dated 11/08/22 revealed an allegation of an unauthorized gas charge for approximately $65 by a second HHA (Staff D) by Patient #2. Staff D's statement revealed she believed it to be retaliation for being late. Staff D stated after many years of working with this patient they were calling her by a different name, like they were confused. Staff D stated Patient #2 did not give a debit card to her but did give the card to a family member. There was no other documentation of the complaint by the agency and no documentation of a follow up resolution completed by the agency. Per interview on 01/09/23 at 11:24 AM, Staff B confirmed there was no documentation of the two patient complaints and no documentation of follow up or resolution.

Extended Substantial Allegation Survey Substantial Allegations 71915, 71580 and 71894 An entrance conference was conducted on 10/03/22 at 8:48 AM with the Director of Nursing, and an exit conference was conducted on 10/04/22 at 5:05 PM with administrative staff. The following deficiencies are based upon substantial allegations 71915, 71580 and 71894 completed on 10/04/22. Moonlight Home Health Care Inc 369006, is not in compliance with the requirements at 42 CFR Part 484, Subpart B, C for Home Health Agencies. Moonlight Home Health Care Inc is precluded from offering its own aide training and/or competency evaluation program for a period of two years from the exit date of this survey.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on policy review, interview and documentation review, the agency failed to document both the existence of a complaint and the resolution of a complaint for one of three patients reviewed with complaint investigations (Patient #1). This could affect all patients receiving services from the agency. The agency's active census was 151 at the time of the survey. Findings include: Review of the agency’s policy titled, Patient’s Bill of Rights/Responsibilities, revised 2009, revealed patients have the right to have complaints investigated made by the patient, patient’s family or guardian regarding treatment or care that is (or fails to be) furnished, or regarding the lack of respect for patient’s property by anyone furnishing services on behalf of the Agency. You will not be subject to discrimination for doing so. Agency must document both the existence of the complaint and the resolution of the complaint; to know about the disposition of such complaints. Interview with Staff A on 10/04/22 at 1:25 PM revealed the agency had conducted an investigation into allegations involving Staff D and Patient #1. A copy of the investigation report was requested from Staff A on 10/04/22 at 1:51 PM. Staff A reported the agency did not have a copy of the investigative report and that Staff E was attempting to reach a separate oversight agency to get evidence of the agency's investigative report. Staff E was unable to provide evidence of the agency having conducted an investigation. On 10/04/22 at 1:51 PM, Staff E verified the agency did not have documentation of the agency’s investigation of the allegations involving Patient #1 and Staff D.

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 interview, policy review, and medical record review, the agency failed to ensure a registered nurse conducted an initial assessment visit to determine the immediate care and support needs for six of nine medical records reviewed (Patient #4, #5, #6, #7, #8 and #9). This could affect all patients receiving services from the agency. The agency's active census at the time of the survey was 151. Findings include: Review of the agency policy titled, Initial Assessments/Comprehensive Assessments, revised 2010, revealed each patient admitted by the Agency will have appropriate initial assessments performed and documented. Each patient admitted will receive a comprehensive assessment. The assessment will reflect the patient’s current health status and include information to demonstrate the patient’s progress toward achievement of desired outcomes. The comprehensive assessment will identify the patient’s need for home care and meet the patient’s need for medical, rehabilitative, nursing, social, discharge planning. For Medicare patients, Agency must verify the patient’s eligibility for home health benefit, including homebound status. The Agency’s comprehensive assessment includes the use of the Outcome and Assessment Information Set (OASIS) items for all patients except patients under the age of 18, patients receiving pre or post-partum services, patients receiving only housekeeping or chore services, private insurance patients. 1. Review of Patient #4's medical record revealed the patient was admitted to the agency on 05/02/22. The agency was unable to provide evidence of an initial assessment. 2. Review of Patient #5's medical record revealed the patient was admitted to the agency on 12/20/21. The agency was unable to provide evidence of an initial assessment. 3. Review of Patient #6's medical record revealed the patient was admitted to the agency on 06/07/22. The agency was unable to provide evidence of an initial assessment. 4. Review of Patient #7's medical revealed the patient was admitted to the agency on 06/24/22. The agency was unable to provide evidence of an initial assessment. 5. Review of Patient #8's medical record revealed the patient was admitted to the agency on 06/01/22. The agency was unable to provide evidence of an initial assessment. 6. Review of Patient #9's medical record revealed the patient was admitted to the agency on 05/03/21. The agency was unable to provide evidence of an initial assessment. Staff A was interviewed on 10/04/22 at 1:58 PM. Staff A reported the six patients (Patient #4, #5, #6, #7, #8 and #9) did not require initial and comprehensive assessments due to their payer source.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on medical record review, policy review, and interview, the agency failed to ensure each patient received home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry for eight of nine medical records reviewed (Patient #1, #3, #4, #5, #6, #7, #8 and #9). This could affect all patients receiving services from the agency. The agency's active census at the time of the survey was 151. Findings include: Review of the agency policy titled, Plan of Care - CMS #485 and Physician Orders, revised 2009, revealed Skilled nursing and other home health services will be in accordance with a Plan of Care based on the patient’s diagnosis and assessment of immediate and long range needs and resources. The Plan of Care is established in consultation with the physician, Agency staff, the patient and members of the patient’s family. The Plan of Care includes diagnoses (primary and relevant secondary); patient’s mental status; types of services and equipment required; frequency of visits and duration; prognosis; rehabilitation potential; functional limitations/homebound status; activities permitted; nutritional requirements; specific procedures deemed essential for the health and safety of the patient; medications and treatments; equipment and supplies required, e.g., enteral and IV pumps and settings, oxygen including flow rate, delivery device, hours of use, and ventilator settings; instructions for timely discharge or referral; expected goals or outcomes to be achieved; the physician’s signature and date; food or drug allergies; safety measures to protect against injury; discharge plan. 1. Review of Patient #4's medical record revealed the patient was admitted on 05/02/22. There was no physician ordered plan of care in the patient's record. 2. Review of Patient #5's medical record revealed the patient was admitted to the agency on 12/20/21. There was no physician ordered plan of care in the patient's record. 3. Review of Patient #6's medical record revealed the patient was admitted to the agency on 06/07/22. There was no physician ordered plan of care in the patient's record. 4. Review of Patient #7's medical record revealed the patient was admitted to the agency on 06/24/22. There was no physician ordered plan of care in the patient's record. 5. Review of Patient #8's medical record revealed the patient was admitted to the agency on 06/01/22. There was no physician ordered plan of care in the patient's record. 6. Review of Patient #9's medical record revealed the patient was admitted to the agency on 05/03/21. There was no physician ordered plan of care in the patient's record. Staff A was interviewed on 10/04/22 at 1:58 PM. Staff A reported the six patients (Patient #4, #5, #6, #7, #8 and #9) did not require plans of care/physician orders due to their payer status and reported the patients did not have plans of care/physician orders. 7. Review of Patient #1's medical record revealed physician ordered plans of care for the certification periods of 04/10/22 through 06/08/22, 06/09/22 through 08/07/22, and 08/08/22 through 10/06/22. Physician orders were for home health aide services 20 hours per week. Further review of the patient's medical record revealed during the weeks of 04/17/22, 04/24/22, 05/15/22, 05/22/22, 05/29/22, 06/05/22, 07/10/22, 07/17/22 and 07/24/22 the agency provided 28 hours of aide services per week. During the weeks of 05/01/22 and 05/09/22 the agency provided 30 hours of aide services. The medical record did not contain physician orders to increase the home health aide hours. On 10/03/22 at 1:34 PM, the findings were shared in an interview with Staff A and confirmed. 8. Review of Patient #3's medical record revealed physician ordered plans of care for the certification period of 05/03/22 through 07/01/22. Physician orders were for home health aide services 21 hours per week. During the week of 06/27/22, the agency provided 24 hours of home health aide services. The medical record did not contain an order to increase home health aide hours.

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 medical record review, policy review, and interview, the agency failed to ensure the individualized plan of care included the patient's mental, psychosocial, and cognitive status, functional limitations, activities permitted, and measurable outcomes and goals identified by the agency and the patient for two of nine patient records reviewed (Patient #2 and #3). This could affect all patients receiving services from the agency. The agency's active census at the time of the survey was 151. Findings include: Review of the agency policy titled, Plan of Care - CMS #485 and Physician Orders, revised 2009, revealed Skilled nursing and other home health services will be in accordance with a Plan of Care based on the patient’s diagnosis and assessment of immediate and long range needs and resources. The Plan of Care is established in consultation with the physician, Agency staff, the patient and members of the patient’s family. The Plan of Care includes diagnoses (primary and relevant secondary); patient’s mental status; types of services and equipment required; frequency of visits and duration; prognosis; rehabilitation potential; functional limitations/homebound status; activities permitted; nutritional requirements; specific procedures deemed essential for the health and safety of the patient; medications and treatments; equipment and supplies required, e.g., enteral and IV pumps and settings, oxygen including flow rate, delivery device, hours of use, and ventilator settings; instructions for timely discharge or referral; expected goals or outcomes to be achieved; the physician’s signature and date; food or drug allergies; safety measures to protect against injury; discharge plan. 1 Review of the physician ordered plan of care for Patient #2 for the certification period of 07/12/22 through 09/09/22 revealed there were no goals listed. 2. Review of the physician ordered plan of care for Patient #3 for the certification period of 08/31/22 through 10/29/22 revealed there were no goals, mental/cognitive status, functional limitations, or activities permitted/restricted listed. On 10/03/22 at 1:34 PM, the findings were shared in an interview with Staff A and confirmed.

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on medical record review, personnel file review, policy review and interview, the agency provided a home health aide training program and competency evaluation program after being precluded (G782). The agency failed to ensure home health aides provided services that were included in the plan of care (G800). The agency failed to ensure a registered nurse made an on-site visit to the location where patients are receiving care no less frequently than every 60 days in order to observe and assess each aide while he or she is performing care (G814). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality home health aide services.

Eligible training/competency evaluation orgs. CFR(s): 484.80(f) Standard: Eligible training and competency evaluation organizations. A home health aide training program and competency evaluation program may be offered by any organization except by an HHA that, within the previous 2 years: This STANDARD is not met as evidenced by: Based on personnel file review, policy review and interview, the agency provided a home health aide training program and competency evaluation program after being precluded for three of three personnel files reviewed (Staff B, C and D). The agency hired approximately 171 staff members since 10/2020. The agency's active census at the time of the survey was 151. Findings include: Review of the agency’s policy titled, Home Health Aide Services and Training Program, revised 2009, revealed the Agency may offer a home health aide training program, unless within the previous two (2) years, the Agency has permitted a person who does not meet the definition of a Home Health Aide to furnish home health aide services (except for volunteers or licensed health professionals); been subjected to a partial extended or extended survey as a result of having been found to have furnished substandard care (or other reasons at the discretion of CMS or the state). Review of the agency's survey history revealed the agency was subjected to an extended survey from 10/13/20 to 10/15/20. As a result of that survey the agency was ineligible to offer a home health agency training and competency program for a period of two years, 10/15/20 through 10/14/22. 1. The personnel file for Staff B was reviewed on 10/04/22. Staff B received a home health aide training and competency evaluation on 07/13/22 by the agency. The findings were shared with Staff F in an interview on 10/04/22 at 9:48 AM and confirmed. 2. The personnel file for Staff C was reviewed on 10/03/22. Staff C received a home health aide training and competency evaluation on 05/18/22 by the agency. The findings were shared with Staff A in an interview on 10/03/22 at 11:00 AM and confirmed. 3. The personnel file for Staff D was reviewed on 10/03/22. Staff D received a home health aide training and competency evaluation on 02/08/22 by the agency. The findings were shared with Staff A in an interview on 10/03/22 at 1:05 PM and confirmed.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on medical record review, policy review and interview, the agency failed to ensure home health aides provided services that were included in the plan of care for one of nine medical records reviewed (Patient #1). This could affect all patients receiving services from the agency. The agency's active census at the time of the survey was 151. Findings include: Review of the agency’s policy titled, Home Health Aide Documentation, revised 2009, revealed the Agency will ensure accurate documentation of home health aide services. The home health aide (HHA) will document services rendered to the patient on the appropriate Home Health Aide charting form. The HHA will be responsible for reporting any changes in the patient’s condition and/or other pertinent observations to the supervising Registered Nurse/Therapist. The Nursing Supervisor or designated Registered Nurse/Therapist is responsible for reviewing the HHA’s charting. The original documentation will be filed in the medical record within seven (7) days of the visit. Review of Patient #1's HHA Care Plan dated 08/13/21 revealed the aide was to provide the following services every visit: shower with chair, shampoo hair, hair care/comb hair, oral care, skin care, peri care, nail care, assistance with dressing, assistance with bed side commode, incontinence care, assistance with transfer, range of motion, assistance with ambulation, make the bed, light housekeeping, and meal set up. The aide was to also change the patient's linens once a week. Further review of the patient's record revealed the patient received home health aide services by Staff D on 05/01/22 through 05/14/22, 05/29/22 through 06/11/22, 06/12/22, 06/13/22, 06/14/22, 06/15/22, 06/23/22, 06/24/22, 06/25/22, 06/26/22, 07/10/22 through 07/23/22, and 07/24/22 through 08/01/22. The time sheets from the dates listed did not contain any documented care. The findings were shared with Staff A in an interview on 10/03/22 at 1:34 PM and confirmed.

Non-skilled direct observation every 60 days CFR(s): 484.80(h)(2) If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy, or speech-language pathology services, the registered nurse must make an on-site visit to the location where the patient is receiving care no less frequently than every 60 days in order to observe and assess each aide while he or she is performing care. This ELEMENT is not met as evidenced by: Based on medical record review, policy review, and interview, the agency failed to ensure a registered nurse made an on-site visit to the location where patients are receiving care no less frequently than every 60 days in order to observe and assess each aide while he or she is performing care for six of nine patients reviewed (Patient #4, #5, #6, #7, #8 and #9). This could affect all patients receiving services from the agency. The agency's census at the time of the survey was 151. Findings include: Review of the agency’s policy titled, Home Health Aide Supervision, revised 2009, revealed if home health aide services are provided by the Agency to a patient who is not receiving skilled care a RN (registered nurse) must make a supervisory visit to the patient’s home no less frequently than every 60 days. Each of these supervisory visits must occur while the Home Health Aide is providing care to the patient. 1. Review of Patient #4's medical record revealed the patient was admitted on 05/02/22. The patient was not receiving skilled care. There was no evidence a Registered Nurse (RN) was making a supervisory visit to the patient's home every 60 days while the aide was providing services to the patient. 2. Review of Patient #5's medical record revealed the patient was admitted to the agency on 12/20/21. The patient was not receiving skilled care. There was no evidence a Registered Nurse (RN) was making a supervisory visit to the patient's home every 60 days while the aide was providing services to the patient. 3. Review of Patient #6's medical record revealed the patient was admitted to the agency on 06/07/22. The patient was not receiving skilled care. There was no evidence a Registered Nurse (RN) was making a supervisory visit to the patient's home every 60 days while the aide was providing services to the patient. 4. Review of Patient #7's medical record revealed the patient was admitted to the agency on 06/24/22. The patient was not receiving skilled care. There was no evidence a Registered Nurse (RN) was making a supervisory visit to the patient's home every 60 days while the aide was providing services to the patient. 5. Review of Patient #8's medical record revealed the patient was admitted to the agency on 06/01/22. The patient was not receiving skilled care. There was no evidence a Registered Nurse (RN) was making a supervisory visit to the patient's home every 60 days while the aide was providing services to the patient. 6. Review of Patient #9's medical record revealed the patient was admitted to the agency on 05/03/21. The patient was not receiving skilled care. There was no evidence a Registered Nurse (RN) was making a supervisory visit to the patient's home every 60 days while the aide was providing services to the patient. Staff A was interviewed on 10/04/22 at 1:58 PM. Staff A reported that based on the patients' payer source, the six patients (Patient #4, #5, #6, #7, #8 and #9) did not require supervisory visits.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on personnel file review, job description review, and interview, the Administrator failed to ensure that the agency employed qualified personnel for two of three personnel files reviewed (Staff B and C). This could affect all patients receiving services from the agency. The agency's active census at the time of the survey was 151. Findings include: The agency's Home Health Aide job description was reviewed. The position qualifications included that the home health aide must not have crimes listed on the Bureau of Criminal Investigation (BCI) report and be free of sex offender upon verification and that the home health aide has completed a cardiopulmonary resuscitation (CPR) and First Aide course successfully in the past 12 months. 1. The personnel file for Staff B was reviewed on 10/04/22. Staff B was hired on 03/29/22. The file did not contain evidence of Staff B having completed a CPR course. The agency did not run the National Sex Offender Public Website registry check until 09/06/22. The findings were shared with Staff F in an interview on 10/04/22 at 9:48 AM and confirmed. 2. Staff C was hired on 05/18/22. The agency was unable to provide evidence that a BCI check was submitted for Staff C. In an interview on 10/04/22 at 1:20 PM, Staff F confirmed the findings.

Report all branch locations to SA CFR(s): 484.105(d)(1) The parent HHA is responsible for reporting all branch locations of the HHA to the state survey agency at the time of the HHA's request for initial certification, at each survey, and at the time the parent proposes to add or delete a branch. This ELEMENT is not met as evidenced by: Based on interview, review of State agency documentation, observation and policy review, the agency failed to report all branch locations of the home health agency (HHA) to the State survey agency at the time the parent proposes to add or delete a branch. This could affect all patients receiving services from the agency. The agency's active census at the time of the survey was 151. Findings include: Review of the agency’s policy titled, Compliance with Laws and Regulations and Disclosure of Information, revised 2009, revealed the Agency will also report changes to the accrediting organization in the information provided in Agency’s application for survey. Such changes will be reported in writing no longer than thirty (30) days after changes and include change in address or location; opening or closing services or branches; change in ownership or control; change in key leadership, e.g., Chief Executive Officer, Administrator or Director of Clinical Services; mergers or acquisitions. Review of State Agency documentation revealed the agency's main location address of record was 5900 Roche Drive, Suite 227, Columbus, Ohio 43229. The agency also submitted documentation on 03/17/21 to add a branch location at 102 Javit Court, Austintown, Ohio 44515. However, no Centers for Medicare & Medicaid form 855 had been received to complete the processing of this request. Staff A was interviewed on 10/03/22 at 10:00 AM. Staff A reported the agency had zero patients at the Columbus, Ohio location. Staff A reported the agency's goal was to discontinue the Columbus, Ohio location once the Austintown, Ohio location was approved. Staff A reported the agency's Austintown, Ohio location was currently pending approval. Staff F was interviewed on 10/03/22 at 10:11 AM. Staff F reported the agency had an office in Canton, Ohio. Further review of State agency records revealed no evidence the agency reported the addition of an office in Canton, Ohio. Staff E was interviewed on 10/04/22 at 1:44 PM. Staff E reported the agency requested approval for both the Austintown, Ohio and Canton, Ohio locations and that both location approvals were pending. Observations made at the Austintown, Ohio location on 10/03/22 and 10/04/22 and the Canton, Ohio location on 10/04/22 revealed both locations were providing services for the agency's patients. On 10/04/22 at 4:12, the findings were shared with Staff E regarding not notifying the State Agency regarding the Canton, OH location and confirmed. This deficiency substantiates Substantial Allegation 71915.

SUBSTANTIAL ALLEGATION SURVEY SUBSTANTIAL ALLEGATION OH00119806 The following deficiency is based on the Substantial Allegation Survey completed on 02/09/21. An entrance conference was conducted on 02/08/21 at 8:41 AM with administrative staff, an exit conference was conducted on 02/09/21 at 4:06 PM with administrative staff.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on medical record review, policy review and interview, the agency failed to ensure one patient (Patient #1) of four medical records reviewed received home health aide services in accordance with the plan of care. The agency's active census was 79 patients. Findings include: The agency's Coordination of Patient Care policy (9.13.1, Revised March 2018) stated: 7. Coordination of Agency's internal resources includes: - Assuring all involved staff members are aware of patient's plan of care. - Making patient information available to all staff. - Limiting the number of staff per discipline who provide care to a patient, when possible. - Notifying the patient in a timely manner about schedule changes. - Notifying the physician and making sure that he/she is aware of missed visits (must document). Patient #1's Plans of Care for the Certification Periods of 11/20/20 through 01/08/21 and 01/09/21 through 03/09/21 contained orders for home health aide services twenty hours per week for nine weeks. The agency did not provide aide services for Patient #1 during the weeks of 11/20/20, 11/22/20 and 11/29/20. The agency did not provide aide services for Patient #1 during the weeks of 12/27/20, 01/03/21, 01/10/21, 01/17/21, 01/24/21 and 01/31/21. The medical record contained evidence of physician notification of missed visits for 0/01/21, 01/06/21, 01/12/21 and 01/13/21. The medical record did not contain evidence of notification to the physician for any additional missed visits. On 02/09/21 at 1:53 PM, the findings were shared with Staff R and confirmed. This deficiency substantiates Substantial Allegation OH00119806

Report all branch locations to SA CFR(s): 484.105(d)(1) The parent HHA is responsible for reporting all branch locations of the HHA to the state survey agency at the time of the HHA's request for initial certification, at each survey, and at the time the parent proposes to add or delete a branch. This ELEMENT is not met as evidenced by: Based on review of the agency's marketing brochure and interview, the agency failed to report all branch locations to the State Agency. The agency's census was 79 total patients. 77 of the 79 patients are located at the unapproved branch location. Findings include: The agency's marketing brochure was reviewed on 02/08/21. The brochure stated: Mahoning County Office 110 Javit Ct Youngstown, Ohio 44515 Staff R was interviewed at the unapproved branch on 02/08/21 at 9:37 AM. Staff R reported the unapproved branch serves patients in Stark, Summit, Mahoning, Trumbull, and Columbiana counties. Staff R was interviewed on 02/08/21 at 9:24 AM. Staff R reported the Administrator visits the unapproved branch location on the 16th of every month. Staff R was interviewed on 02/08/21 at 8:41 AM. Staff R reported "this is a satellite location, the main office is in Columbus". Staff R reported "we do hiring here and patient charts are stored here". Staff R was interviewed on 02/08/21 at 9:51 AM. Staff R reported the unapproved branch location does not provide therapy services. "We had tried to contract for therapies but have not been able to". Staff R reported the Columbus office provides therapy services. This deficiency substantiates Substantial Allegation OH00119806