Caregivers America Home Health Services, LLC

“Medicaid personal care aide-only services CFR(s): 484.80(i) Standard: Individuals furnishing Medicaid personal care aide-only services under a Medicaid personal care benefit. An individual may furnish personal care services, as defined in §440.167 of this chapter, on behalf of an HHA. Before the individual may furnish personal care services, the individual must meet all qualification standards established by the state. The individual only needs to demonstrate competency in the services the individual is required to furnish. This Standard is not met as evidenced by: Based on review of agency policy,/procedure, clinical records and personnel files and based on interview with the Administrator (Employee #4), the agency failed to ensure 60 hours of home health aide training was completed by two (2) of three (3) home health aides who provided personal care services. (Employees #1 and #3) Findings include: On July 18, 2025 at approximately 1:30 PM, review of agency policy C-124, titled “Home Health Aide Training”” revealed the following under “Procedure”: Per the regulations and guidelines of our sub-contractors, evidence of 60 hours of training may be required before a home health aide can be assigned to a case referred by that sub-contractor Client #1 (Discharge): On July 8, 2025 at approximately 12:19 PM, July 14, 2025 at approximately 2:54 PM and July 17, 2025 at approximately 8:15 AM, review of the clinical record revealed the primary diagnosis is autistic disorder, the client’s age is 4 years old, that home health aide services were to be provided 8 hours per day for 7 days per week to be shared with the client’s sibling (Client #2) as documented on the “Home Health Certification and Plan of Care” for the recertification periods of 01/05/2025 through 03/05/2025, 03/05/2025 through 05/04/2025 and 05/05/2025 through 07/03/2025. Review of HHAeXchange (software) “Patient Calendar” and “Print Visit Detail ENT” forms (home health aide notes) revealed the home health aide (Employee #1), who is the client’s parent, provided personal care services for 171 of 171 shifts completed between 01/01/2025 and 06/20/2025. Client #2 (Discharge): On July 8, 2025 at approximately 1:00 PM, July 14, 2025 at approximately 2:48 PM and July 17, 2025 at approximately 8:25 AM, review of the clinical record revealed the primary diagnosis is compression of brain, the client is 3 years old, that home health aide services were to be provided 8 hours per day for 7 days per week to be shared with the client’s sibling (Client #1) as documented on the “Home Health Certification and Plan of Care” for the recertification periods of 01/05/2025 through 03/05/2025, 03/05/2025 through 05/04/2025 and 05/05/2025 through 07/03/2025. Review of HHAeXchange (software) “Patient Calendar” and “Print Visit Detail ENT” forms revealed the home health aide (Employee #1), who is the client’s parent, provided personal care services for 173 of 173 shifts completed between 01/01/2025 and 06/20/2025. Client #3: On July 8, 2025 at approximately 1:50 PM, July 9, 2025 at approximately 2:05 PM and July 14, 2025 at approximately 3:50 PM, review of the clinical record revealed the primary diagnosis is autistic disorder, the client’s age is 16 years old and that home health aide services are to be provided 8 hours per day for 5 days per week for school/school transport and 8 hours per day for 5 days per week for school preparation, after school care and care on non-school days as documented on the “Home Health Certification and Plan of Care” for the recertification periods of 01/31/2025 through 03/31/2025 and 04/01/2025 through 05/30/2025. Review of “Home Health Aide Weekly Record” documentation revealed the home health aide (Employee #3), who is the client’s parent, provided personal care services for 111 of 111 shifts completed between 01/31/2025 and 07/02/2025. On July 8, 2025 at approximately 1:27 PM, July 9, 2025 at approximately 3:17 PM, July 14, 2025 at approximately 4:15 PMM, July 17, 2025 at approximately 8:05 AM and July 18, 2025 at approximately 9:11 AM, review of personnel file documentation revealed the following: Employee #1: The first day of assignment (work date) of the home health aide was 07/10/2024. Review of training documentation revealed the home health aide completed 26.92 hours of initial home health aide training. Employee #3: The first day of assignment of the home health aide was 12/19/2022. Review of training documentation revealed the home health aide completed 13.42 hours of initial home health aide training. There was no documentation in the personnel files which provided evidence employees #1 and #3 had completed an initial home health aide training program which totaled 60 hours. During Microsoft Teams interview conducted on July 18,2025 at approximately 1:03 PM, the Administrator confirmed there was no documentation in the personnel files which provided evidence employees #1 and #3 had completed an initial home health aide training program which totaled 60 hours.”

“Administrator CFR(s): 484.115(a) Standard: Administrator, home health agency. (1) For individuals that began employment with the HHA prior to January 13, 2018, a person who: (i) Is a licensed physician; (ii) Is a registered nurse; or (iii) Has training and experience in health service administration and at least 1 year of supervisory administrative experience in home health care or a related health care program. (2) For individuals that begin employment with an HHA on or after January 13, 2018, a person who: (i) Is a licensed physician, a registered nurse, or holds an undergraduate degree; and (ii) Has experience in health service administration, with at least 1 year of supervisory or administrative experience in home health care or a related health care program. This Standard is not met as evidenced by: Based on review of agency policy/procedure and clinical records and interview with the Administrator (Employee #4), the Administrator failed to ensure the “Home Health Certification and Plan of Care” was developed in accordance with agency policies/procedures for three (3) of three (3) clients (patients). Clients #1, #2 and #3) Findings include: On July 18, 2025 at approximately 1:20 PM, review of agency policy C-580, titled “Plan of Care”” revealed the following under “Policy”: The plan of care is based on...information provided by...health care team members. Planning for care is a dynamic process that addresses the care, treatment and services to be provided. Client #1 (Discharge): On July 8, 2025 at approximately 12:19 PM, July 14, 2025 at approximately 2:54 PM and July 17, 2025 at approximately 8:15 AM, review of the clinical record revealed the primary diagnosis is autistic disorder, the client’s age is 4 years old, that home health aide services were to be provided 8 hours per day for 7 days per week to be shared with the client’s sibling (Client #2), that a SN visit was ordered to be performed for recertification and that SN interventions and goals were included under the physician orders as documented on the “Home Health Certification and Plan of Care” for the recertification periods of 01/05/2025 through 03/05/2025, 03/05/2025 through 05/04/2025 and 05/05/2025 through 07/03/2025. Review of service authorization documentation revealed home health aide services were to be provided in the home health setting. There was no documentation on the service authorization which provided evidence SN services were to be provided. Client #2 (Discharge): On July 8, 2025 at approximately 1:00 PM, July 14, 2025 at approximately 2:48 PM and July 17, 2025 at approximately 8:25 AM, review of the clinical record revealed the primary diagnosis is autistic disorder, the client’s age is 4 years old, that home health aide services were to be provided 8 hours per day for 7 days per week to be shared with the client’s sibling (Client #2), that a SN visit was ordered to be performed for recertification and that SN interventions and goals were included under the physician orders as documented on the “Home Health Certification and Plan of Care” for the recertification periods of 01/05/2025 through 03/05/2025, 03/05/2025 through 05/04/2025 and 05/05/2025 through 07/03/2025. Review of service authorization documentation revealed home health aide services were to be provided in the home health setting. There was no documentation on the service authorization which provided evidence SN services were to be provided. Client #3: On July 8, 2025 at approximately 1:50 PM, July 9, 2025 at approximately 2:05 PM and July 14, 2025 at approximately 3:50 PM, review of the clinical record revealed the primary diagnosis is autistic disorder, the client’s age is 16 years, that home health aide services are to be provided 8 hours per day for 5 days per week for school/school transport and 8 hours per day for 5 days per week for school preparation, after school care and care on non-school days, that a SN visit was ordered to be performed for recertification and that SN interventions and goals were included under the physician orders as documented on the “Home Health Certification and Plan of Care” for the recertification periods of 01/31/2025 through 03/31/2025 and 04/01/2025 through 05/30/2025. Review of service authorization documentation revealed home health aide services were to be provided in the home health setting. There was no documentation on the service authorization which provided evidence SN services were to be provided. During Microsoft Teams interview conducted on July 18,2025 at approximately 1:03 PM, the Administrator reported the clients #1, #2 and #3 are receiving personal care services only and are not considered skilled cases. The administrator confirmed the “Home Health Certification and Plan of Care” for the aforementioned clients should not include SN orders. The administrator confirmed the “Home Certification and Plan of Care” had not be developed in accordance with agency policies/procedures for clients #1, #2 and #3.”

“Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies. (4) When services are provided on the basis of a physician or allowed practitioner’s verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA’s policies, must document the orders in the patient’s clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies. This Element is not met as evidenced by: Based on review of agency policy and clinical records and interview with the Administrator (Employee #4), the agency failed to ensure the physician’s countersignature was obtained within 30 days of the verbal order date included on the “Home Health Certification and Plan of Care” for three (3) of three (3) clients (patients). (Clients #1, #2 and #3) Findings include: On July 18, 2025 at approximately 1:25 PM, review of agency policy C-635, titled “Physician Orders”” revealed the following under “Policy”: -All orders:...Physician order may be initiated via telephone or in writing and must be countersigned by a licensed physician within 30 days of the verbal or written order date. Client #1 (Discharge): On July 8, 2025 at approximately 12:19 PM, July 14, 2025 at approximately 2:54 PM and July 17, 2025 at approximately 8:15 AM, review of the clinical record revealed the primary diagnosis is autistic disorder, the client’s age is 4 years old, that home health aide services are to be provided 8 hours per day for 7 days per week to be shared with the client’s sibling (Client #2) as documented on the “Home Health Certification and Plan of Care” for the recertification periods of 01/05/2025 through 03/05/2025, 03/05/2025 through 05/04/2025 and 05/05/2025 through 07/03/2025. The physician countersignature for the verbal orders included on the “Home Health Certification and Plan of Care” are as follows: Recertification period 01/05/2025 through 03/05/2025: Verbal order date 01/04/2025. Physician countersignature date was 03/13/2025; Recertification period 03/06/2025 through 05/04/2025: Verbal order date 03/04/2025. Physician countersignature date was 05/19/2025; and Recertification period 05/05/2025 through 07/03/2025: Verbal order date 05/01/2025. Physician countersignature date was 07/06/2025. Client #2 (Discharge): On July 8, 2025 at approximately 1:00 PM, July 14, 2025 at approximately 2:48 PM and July 17, 2025 at approximately 8:25 AM, review of the clinical record revealed the primary diagnosis is compression of brain, the client is 3 years old, that home health aide services are to be provided 8 hours per day for 7 days per week to be shared with the client’s sibling (Client #1) as documented on the “Home Health Certification and Plan of Care” for the recertification periods of 01/05/2025 through 03/05/2025, 03/05/2025 through 05/04/2025 and 05/05/2025 through 07/03/2025. The physician countersignature for the verbal orders included on the “Home Health Certification and Plan of Care” are as follows: Recertification period 01/05/2025 through 03/05/2025: Verbal order date 01/04/2025. Physician typewritten countersignature/received date was 05/12/2025; and Recertification period 03/06/2025 through 05/04/2025: Verbal order date 03/04/2025. Physician countersignature date was 05/19/2025. Client #3: On July 8, 2025 at approximately 1:50 PM, July 9, 2025 at approximately 2:05 PM and July 14, 2025 at approximately 3:50 PM, review of the clinical record revealed the primary diagnosis is autistic disorder, the client’s age is 16 years old and that home health aide services are to be provided 8 hours per day for 5 days per week for school/school transport and 8 hours per day for 5 days per week for school preparation, after school care and care on non-school days as documented on the “Home Health Certification and Plan of Care” for the recertification periods of 01/31/2025 through 03/31/2025 and 04/01/2025 through 05/30/2025. The physician countersignature for the verbal orders included on the “Home Health Certification and Plan of Care” are as follows: Recertification period 01/31/2025 through 03/31/2025: Verbal order date 01/04/2025. Physician typewritten countersignature/received date was 05/07/2025; and Recertification period 03/06/2025 through 05/04/2025: Verbal order date 03/04/2025. Physician countersignature date was 07/08/2025. There was no documentation in the clinical record which provided evidence the physician countersignature had obtained within 30 days of the verbal order date included in the “Home Health Certification and Plan of Care” for clients #1, #2 and #3. During Microsoft Teams interview conducted on July 18,2025 at approximately 1:03 PM, the Administrator confirmed the physician countersignature was not obtained within 30 days of the verbal order date included in the “Home Health Certification and Plan of Care” for the above identified clients.”

“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 review of agency policy/procedure and clinical records, and interview with the Administrator (Employee #4), the agency failed to ensure the “Home Health Certification and Plan of Care” was reviewed and revised by the physician at least every 60 days for one (1) of three (3) clients (patients). (Client #3) Findings include: On July 18, 2025 at approximately 1:20 PM, review of agency policy C-580, titled Plan of Care”, revealed the following under “Instructions”: 4. The individualized plan of care must be reviewed and revised by the agency and physician responsible for the home health plan of care...but no less frequently than once every 60 days beginning with the start of care date... Client #3: On July 8, 2025 at approximately 1:50 PM, July 9, 2025 at approximately 2:05 PM and July 14, 2025 at approximately 3:50 PM, review of the clinical record revealed the primary diagnosis is autistic disorder, the client’s age is 16 years old, that home health aide services are to be provided five (5) days per week and that a skilled nursing (SN) visit for recertification was scheduled to be completed on 05/25/2025 as documented on the “Home Health Certification and Plan of Care” for the recertification period of 04/01/2025 through 05/30/2025. Review of supplemental physician order documentation revealed a verbal order was obtained on 04/10/2025 to reschedule a SN recertification assessment. Review of SN documentation revealed the SN recertification assessment was completed on 04/10/2025. There was no documentation in the clinical record which provided evidence the “Home Health Certification and Plan of Care” had been reviewed and revised by the physician for the recertification period beginning 05/31/2025. During Microsoft Teams interview conducted on July 18,2025 at approximately 1:03 PM, the Administrator confirmed there was no documentation in the clinical record which provided evidence the “Home Health Certification and Plan of Care” had been reviewed and revised by the physician for the recertification period beginning 05/31/2025 for client #3.”

“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 review of agency policy and clinical records and interview with the administrator, the agency failed to ensure home health aide services were provided in accordance with physician orders included on the “Home Health Certification and Plan of Care” for three (3) of three (3) clients. (Clients #1, #2 and #3) Findings include: On July 18, 2025 at approximately 1:20 PM, review of agency policy C-580, titled “Plan of Care”” revealed the following under “Policy”: Home care services are furnished under the supervision and direction of the patient’s physician. Client #1 (Discharge): On July 8, 2025 at approximately 12:19 PM, July 14, 2025 at approximately 2:54 PM and July 17, 2025 at approximately 8:15 AM, review of the clinical record revealed the primary diagnosis is autistic disorder, the client’s age is 4 years old, that home health aide services were to be provided 8 hours per day for 7 days per week to be shared with the client’s sibling (Client #2) and that home health aide services were to include constant supervision due to safety risks and high elopement risk as documented on the “Home Health Certification and Plan of Care” for the recertification periods of 01/05/2025 through 03/05/2025, 03/05/2025 through 05/04/2025 and 05/05/2025 through 07/03/2025. Review of HHAeXchange (software) “Patient Calendar” documentation failed to revealed home health aide services were provided on 06/21, 06/22, 06/23, 06/24 nor 06/25/2025. There was no documentation on the HHAeXchange “Print Visit Detail ENT” forms (home health aide notes) which provided evidence constant supervision had been provided by the home health aide (Employee #1) for 171 of 171 shifts completed between 01/01/2025 and 06/20/2025. Client #2 (Discharge): On July 8, 2025 at approximately 1:00 PM, July 14, 2025 at approximately 2:48 PM and July 17, 2025 at approximately 8:25 AM, review of the clinical record revealed the primary diagnosis is compression of brain, the client is 3 years old, that home health aide services were to be provided 8 hours per day for 7 days per week to be shared with the client’s sibling (Client #1) and that home health aide services were to include constant supervision due to safety risks and high elopement risks as documented on the “Home Health Certification and Plan of Care” for the recertification periods of 01/05/2025 through 03/05/2025, 03/05/2025 through 05/04/2025 and 05/05/2025 through 07/03/2025. Review of HHAeXchange “Patient Calendar” documentation failed to revealed home health aide services were provided on 06/21, 06/22 nor 06/24/2025. There was no documentation on the HHAeXchange “Print Visit Detail ENT” forms (home health aide notes) which provided evidence constant supervision had been provided by the home health aide (Employee #1) for 173 of 173 shifts completed between 01/01/2025 and 06/25/2025. Client #3: On July 8, 2025 at approximately 1:50 PM, July 9, 2025 at approximately 2:05 PM and July 14, 2025 at approximately 3:50 PM, review of the clinical record revealed the primary diagnosis is autistic disorder, the client’s age is 16 years old and that home health aide services are to be provided 8 hours per day for 5 days per week for school/school transport and 8 hours per day for 5 days per week for school preparation, after school care and care on non-school days as documented on the “Home Health Certification and Plan of Care” for the recertification periods of 01/31/2025 through 03/31/2025 and 04/01/2025 through 05/30/2025. Review of “Home Health Aide Weekly Report” documentation failed to revealed that a minimum of 8 hours of home health aide services were provided for 111 of 111 shifts completed between 01/31/2025 and 07/02/2025. During Microsoft Teams interview conducted on July 18,2025 at approximately 1:03 PM, the Administrator confirmed there was no documentation in the clinical records which provided evidence home health aide services were provided in accordance with the aforementioned physician orders for the above identified clients.”

“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, — (A) The registered nurse must make an onsite, in person visit every 60 days to assess the quality of care and services provided by the home health aide and to ensure that services meet the patient’s needs; and (B) The home health aide does not need to be present during this visit. (ii) Semi-annually the registered nurse must make an on-site visit to the location where each patient is receiving care in order to observe and assess each home health aide while he or she is performing non-skilled care This Element is not met as evidenced by: Based on review of agency policy and clinical records, and based on interview with a registered nurse (RN-Employee #5) and the Administrator (Employee #4), the agency failed to ensure onsite supervisory visits of the home health aide were conducted every 60 days for one (1) of three (3) clients for whom the service authorization was for home health aide services only. (Client #3) Findings include: On July 18, 2025 at approximately 1:22 PM, review of agency policy C-340, titled “Home Health Aide Supervision” revealed the following under “Special Instructions”: 4. Supervisory Visits of the home health aides shall be according to the following frequency... e. If home health aide services are provided to a patient who is not receiving skilled nursing care, the registered nurse must make an onsite, in person visit every 60 days. Client #3: On July 8, 2025 at approximately 1:50 PM, July 9, 2025 at approximately 2:05 PM and July 14, 2025 at approximately 3:50 PM, review of the clinical record revealed the primary diagnosis is autistic disorder, the client’s age is 16 years old, that home health aide services are to be provided 8 hours per day for 5 days per week for school/school transport and 8 hours per day for 5 days per week for school preparation, after school care and care on non-school days, that home health aide supervisory visits are to be completed no less frequently than every 60 days as documented on the “Home Health Certification and Plan of Care” for the recertification periods of 01/31/2025 through 03/31/2025 and 04/01/2025 through 05/30/2025. Review of the service authorization form revealed home health aide services are to be provided in the home setting. Review of “Home Health Aide Weekly Report” documentation revealed less than 8 hours of home health aide services were provided for 111 of 111 shifts completed between 01/31/2025 and 07/02/2025. Review of home aide supervision documentation revealed a registered nurse (RN-Employee #5) completed an onsite supervisory visits on 01/27/2025 and 04/10/2025 which was more that 60 days between supervisory visits. There was no documentation in the clinical record which provided evidence an onsite supervisory visit by the RN was completed between 04/10/2025 and 07/04/2025. During interview conducted on 07/18/2025 at approximately 1:03 PM, the RN (Employee #5) reported the onsite supervisory visits exceeded 60 days because of difficulty contacting the client’s parent who is the home health aide (Employee #3). The RN confirmed onsite supervisory visits can be conducted on the dates/times the home health aide is providing services. During Microsoft Teams interview conducted on July 18,2025 at approximately 1:03 PM, the Administrator confirmed there was no documentation in the clinical record which provided evidence onsite home health aide supervisory visits by an RN were not conducted every 60 days for client #3.”

“Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This Standard is not met as evidenced by: Based on review of agency policy/procedure, clinical records and provider reports from the Centers for Medicare/Medicaid Services (CMS) and based in interview with the Administrator/Clinical Manager (Employee #12), the agency failed to ensure home health Outcome and Assessment Information Set (OASIS) data was transmitted to the CMS system (iQIES database) within 30 days of the assessment completion date for two (2) of four (4) adult clients (patients) for whom OASIS data was collected. (Clients #1 and #6) Findings include: On April 1, 2025 at approximately 3:04 PM, review of policy B-250, titled “Encoding/Reporting OASIS Data” revealed the following under “Special Instructions”: Special Instructions...1. Agency will complete patient assessments (encode) and electronically transmit each completed OASIS assessment to the CMS (Centers for Medicare/Medicaid Services) within 30 days of completing the assessment... Client #1 (Parent Office): Between March 25, 2025 at approximately 10:00 AM and March 27, 2025 at approximately 12;30 PM, review of the clinical record revealed the client is 54 years old and that skilled nursing (SN) services are to be provided as ordered on the “Home Health Certification and Plan of Care” for the recertification period of 01/25/2025 through 03/25/2025. Review clinical record revealed the comprehensive recertification assessment visit was completed on 01/21/2025. On March 27, 2025 at approximately 9:10 AM, review of the corresponding patient data included on the OASIS final validation report revealed the aforementioned OASIS data collected at recertification was transmitted to the CMS database on 02/27/2025 which was more than 30 days from the assessment completion date. There was no documentation in the clinical record which provided evidence the OASIS data collected on 01/21/2025 had been transmitted to the CMS system within 30 days of the completion of the assessment. Client #6 (Discharge-Parent Office): On March 27, 2025 at approximately 12;20 PM, review of the clinical record revealed the client was 27 years old and that SN services were to be provided as ordered on the “Home Health Certification and Plan of Care” for the recertification period of 10/29/2024 through 12/27/2024. Review clinical record revealed the comprehensive recertification assessment was completed on 10/25/2024 and the comprehensive discharge assessment was completed on 11/11/2024. On March 27, 2025 at approximately 1:10 PM, review of the corresponding client data included on the OASIS final validation report revealed the OASIS data collected at recertification was transmitted to the CMS database on 02/18/2024 and the OASIS data collected at discharge was transmitted to the CMS database on 02/28/2024 which was more than 30 days from the assessment completion date. There was no documentation in the clinical record which provided evidence the OASIS data collected on 10/25/2024 and 11/11/2024 had been transmitted to the CMS system within 30 days of the completion of the assessment. During interviews conducted between March 28, 2025 at approximately 4:00 PM and April 1, 2025 at approximately 4:32 PM, the Administrator/Clinical Manager confirmed there was no documentation in the clinical record which provided evidence OASIS data was transmitted to the CMS system within 30 days of the assessment completion date for the above identified patients.”

“Program activities CFR(s): 484.65(c) (1) The HHA’s performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This Standard is not met as evidenced by: Based on review of agency policy/procedure, documentation, clinical records and Pennsylvania Department of Health (PA DOH) website and reportable event guidelines and based on interview with the Administrator/Clinical Manager (Employee #12), the agency failed to submit a report of four (4) of four (4) reportable events to the PA DOH Event Reporting System (ERS) website which were received after May 16, 2023. (Clients #1, #5, #8 and #9) Findings include: On April 1, 2025 at approximately 3:05 PM, review of policy B-340, titled “Incident Reporting”, revealed the following under “Special Instructions”: 4. Incidents to be reported include, but are not limited to, the following: a) Reportable to the agency...and the State: -Complaint of patient abuse, confirmed or not -Health Department Reportable Diseases -Patient Neglect... On April 1, 2025 at approximately 3:02 PM, review of the PA DOH website (https://www.health.pa.gov/topics/Reporting-Registries/Pages/Reportable-Diseases.aspx) revealed Respiratory Syncytial Virus (RSV) is a Health Department Reportable Diseases. On April 1, 2025 at approximately 3:03 PM, review of the PA DOH ERS website revealed the following are events reportable to the PA DOH: -Activation of Internal or External Emergency Plan -Complaint of Patient/Resident Abuse, Confirmed or Not -Health Department Reportable Diseases -Patient/Resident Neglect On March 25, 2025 between the approximate times of 9:05 AM and 11:02 AM, review of agency incident report documentation revealed the following client-related incident reports were received by the agency: Client #1 (Parent Office) : 02/17/2025 Activation of the emergency preparedness plan to obtain an adequate supply of supplemental oxygen because a power outage was expected to last overnight. Between March 25, 2025 at approximately 10:00 AM and March 27, 2025 at approximately 12;30 PM, review of the clinical record revealed tracheostomy and ventilator orders are included on the “Home Health Certification and Plan of Care for the recertification period of 01/25/2025 through 03/25/2025. Client #8: 05/14/2024: Protective services report to Children & Youth Services due to neglect. Client #9: 05/14/2024: Protective services report due to client running across highway. Client #5 (Branch Office): Between March 26, 2025 at approximately 1:30 PM and March 28, 2025 at approximately 10:55 AM, review of the clinical record revealed the client was hospitalized from 01/30/2025 through 02/03/2025 due to complications from RSV as documented on the resumption of care supplemental order report dated 02/03/2025. Review of communication documentation On between March 24, 2025 at approximately 9:30 AM and March 28, 2025 at approximately 3:58 PM, review of the PA DOH database website failed to reveal that the agency had submitted a report of the above referenced reportable events for Clients #1, #5, #8 and #9 to the PA DOH ERS website. During interviews conducted between March 28, 2025 at approximately 4:00 PM and April 1, 2025 approximately 4:32 PM, the Administrator/Clinical Manager confirmed the agency failed to submit a report of the above referenced reportable events to the PA DOH ERS website prior to March 24, 2025.”

“Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA’s quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This Standard is not met as evidenced by: Based on review of agency policy/procedure, initial tuberculosis (TB) screening guidance from the Centers for Disease Control (CDC), clinical records and personnel files, and based on interview with the Administrator/Clinical Manager (Employee #12), the agency failed to ensure initial and annual screening for mycobacterium tuberculosis (TB) had been completed in accordance with agency policy/procedure and CDC recommendations for four (4) of eleven (11) agency staff members. (Employees #4, #6, #7 and #10) Findings include: On April 1, 2025 at approximately 3:25 PM, review of agency policy D-240, titled “Health Screening” revealed the following: Policy: Any staff that will have contact with a consumer are required to have a Tuberculosis screening and TB Risk Assessment upon hire...in accordance with CDC guidelines. Procedures: 5. Annually, the employee must complete TB education, which includes how TB spreads, signs/symptoms of TB infection, and TB risk factors, and complete a screening questionnaire. On April 1, 2025 at approximately 3:17 PM, review of CDC recommendations for initial TB screening for health care personnel revealed the following as documented on the CDC website: https://www.cdc.gov/tb-healthcare-settings/hcp/screening-testing/index.html Initial TB screening process for health care personnel includes: -A baseline individual TB risk assessment; -TB symptom evaluation; and -A TB test (TB blood test or a TB skin test (2-Step)). Annual: If health care personnel diagnosed with latent TB infection do not receive treatment:Perform annual screening for symptoms of TB disease. Client #1 (Parent Office): Between March 25, 2025 at approximately 10:00 AM and March 27, 2025 at approximately 12;30 PM, review of the clinical record revealed the registered nurse (RN-Employee #6) provided skilled nursing (SN) services in January, February and March 2025. Client #2 (Parent Office): Between March 25, 2025 at approximately 3:00 PM and March 27, 2025 at approximately 12;45 PM, review of the clinical record revealed the licensed practical nurse (LPN-Employee #7) provided SN services in March 2025. Client #3 (Branch Office): Between March 26, 2025 at approximately 1:14 PM and March 27, 2025 at approximately 12;50 PM, review of the clinical record revealed the registered nurse (RN-Employee #4) completed the recertification assessment on 01/31/2025. Between March 26, 2025 at approximately 11:41 AM and March 28, 2025 at approximately 2:25 PM and on April 1, 2025 at approximately 8:11 AM, review of personnel file documentation revealed the following: Employee #4: The date of hire of the RN was 07/01/2024. Employee #6: The date of hire of the RN was 09/14/2018. Review of health screening documentation revealed the RN had a past history of a positive TB test. Employee #7: The date of hire of the LPN was 07/04/2024. Employee #10: The RN’s initial competency assessment for an infusion nurse was completed on 02/02/2010. Job description documentation revealed the RN functions as the Assistant Clinical Supervisor based on the signature included on the job description dated 03/28/2025. Review of health screening documentation revealed the RN had a past history of a positive TB test. There was no documentation in the personnel file which provided evidence Employees #4 and #7 had completed a baseline individual TB risk assessment and TB symptom evaluation (screening questionnaire) upon hire. There was no documentation in the personnel file which provided evidence Employees #6 and #10 had completed an annual TB symptom evaluation (screening questionnaire) upon in 2024. During interviews conducted on March 28, 2025 at approximately 4:00 PM and April 1, 2025 at approximately 4:32 PM, the Administrator/Clinical Manager confirmed there was documentation which provided evidence that initial and annual TB screening had been conducted in accordance with agency policy/procedure nor CDC recommendations for the above identified employees.”

“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 review of agency policy/procedure, documentation, clinical records, personnel files and based on interview with the Administrator/Clinical Manager (Employee #12), the agency failed to ensure documentation was maintained in the personnel file which provided evidence the initial competency evaluation for two (2) of two (2) home health aides included a skills evaluation via observation while the HHA performed the tasks with a patient or pseudo-patient. (Employee #5) Findings include: On April 1, 2025 at approximately 3:13 PM, review of agency policy B-115 titled “Competency Assessment” revealed the following under “Procedures”: The following procedures are specific to Home Health Aides: 5. The following subject areas must be evaluated by observing an aide’s performance of the task with a patient and/or pseudo-patient. Documentation that these requirements have been met will be indicated on a competency evaluation checklist, which includes the subject area, method of demonstration....Documentation will be maintained in the employee’s personnel file. -Communication skills... -Appropriate and safe techniques in performing personal hygiene and grooming tasks that include: -Bed bath, sponge, tub, and shower bath -Hair shampooing in sink, tub, and bed - Nail and skin care... -Toileting and elimination... -Ambulation On March 24, 2025 between the approximate times of 10:59 AM and 12:20 PM, review of the “Home Health Services Patient Handbook” revealed the following was included under “Home Health Services”: Home Health Aide services...The home health aide will help you care for yourself (bathing...and assistance with activities of daily living...) On 03/24/2025 at approximately 1:10 PM, review of assignment documentation revealed the home health aide (HHA-Employee #5) is assigned to provide HHA services to three (3) active clients (Clients #10, #11 and #12) for whom services are provided from the branch office. Between March 26, 2025 at approximately 11:41 AM and March 28, 2025 at approximately 2:25 PM and on April 1, 2025 at approximately 8:11 AM, review of personnel file documentation revealed the following: Employee #2: The date of hire of the HHA was 02/22/2023. Review of the “Initial Competency-Home Health Aide” checklist dated 03/07/2023 revealed the HHA verbally demonstrated competency for bathing, shampooing and nail and skin care, toileting and ambulation. Employee #5: The date of hire of the HHA was 10/26/2023. Review of the “Initial Competency-Home Health Aide” checklist dated 12/01/2023 revealed the HHA verbally demonstrated competency for communication skills, bathing, shampooing and nail and skin care and that there was no documentation on the checklist which provided evidence the HHA was evaluated for competency for toileting and ambulation. There was no documentation on the “Initial Competency-Home Health Aide” which provided evidence competency demonstration was completed on a patient or pseudo-patient for the aforementioned tasks. During interviews conducted on March 28, 2025 at approximately 4:00 PM and April 1, 2025 at approximately 4:32 PM, the Administrator/Clinical Manager confirmed there was no documentation in the personnel file which provided evidence the initial competency evaluation for Employee #5 included a skills evaluation via observation while the HHA performed the tasks with a patient or pseudo-patient for the above referenced tasks.”

“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 review of agency policy/procedure, clinical records and personnel files and based on interview with the Administrator/Clinical Manager (Employee #12), the agency failed to ensure documentation was maintained in the personnel file which provided evidence one (1) of two (2) home health aides completed 12 annual in-service hours. (Employee #2) Findings include: On April 1, 2025 at approximately 3:45 PM, review of agency policy C-124, titled “Home Health Aide Training” revealed the following under “Procedures”: CareGivers America recognizes the following as acceptable training methods... Evidence of in-services. Client #4 (Branch Office): Between March 26, 2025 at approximately 1:42 PM and March 28, 2025 at approximately 10:30 AM, review of the clinical record revealed the home health aide (HHA-Employee #2) provided HHA services in February and March 2025. Between March 26, 2025 at approximately 11:41 AM and March 28, 2025 at approximately 2:25 PM and on April 1, 2025 at approximately 8:11 AM, review of personnel file documentation revealed the following: Employee #2: The date of hire of the HHA was 02/22/2023. There was no documentation in the personnel file which provided evidence the HHA completed 12 in-service hours in 2024. During interviews conducted on March 28, 2025 at approximately 4:00 PM and April 1, 2025 at approximately 4:32 PM, the Administrator/Clinical Manager confirmed there was no documentation in the personnel file which provided evidence Employee #2 completed 12 in-services hours in 2024.”

“Basis and Scope CFR(s): §484.80(h)(1)(iv) A registered nurse or other appropriate skilled professional must make an annual on-site visit to the location where a patient is receiving care in order to observe and assess each aide while he or she is performing care. This Standard is not met as evidenced by: Based on review of agency policy/procedure, documentation, clinical records, personnel files and based on interview with the Administrator/Clinical Manager (Employee #12), the agency failed to ensure documentation was maintained in the personnel file which provided evidence a registered nurse (RN) completed an annual onsite visit with two (2) of two (2) home health aides. (Employees #2 and #5) Findings include: On April 1, 2025 at approximately 3:45 PM, review of agency policy C-124, titled “Home Health Aide Training” revealed the following under “Procedures”: Competency will be measured annually through a variety of methods including but not limited to the following...Direct observation Client #4 (Branch Office): Between March 26, 2025 at approximately 1:42 PM and March 28, 2025 at approximately 10:30 AM, review of the clinical record revealed the home health aide (HHA-Employee #2) provided HHA services in February and March 2025. On 03/24/2025 at approximately 1:10 PM, review of assignment documentation revealed the home health aide (HHA-Employee #5) is assigned to provide HHA services to three (3) active clients (Clients #10, #11 and #12) for whom services are provided from the branch office. Between March 26, 2025 at approximately 11:41 AM and March 28, 2025 at approximately 2:25 PM and on April 1, 2025 at approximately 8:11 AM, review of personnel file documentation revealed the following: Employee #2: The date of hire of the HHA was 02/22/2023. Employee #5: The date of hire of the HHA was 10/26/2023. There was no documentation in the personnel file which provided evidence an annual onsite visit with by a RN with the above identified HHA’s had been completed in 2024. During interviews conducted on March 28, 2025 at approximately 4:00 PM and April 1, 2025 at approximately 4:32 PM, the Administrator/Clinical Manager confirmed there was no documentation in the personnel file which provided evidence an annual onsite visit with by a RN with the above identified HHA’s had been completed in 2024.”

“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 review of agency policies/procedures, Pennsylvania Department of Human Services (PA DHS) website documentation, clinical records and personnel files, and based on interview with the Administrator/Clinical Manager (Employee #12), the Governing Body failed to ensure background clearances were completed in accordance with agency policy/procedure and PA DHS requirements for two (2) of five (5) direct care staff members who provided care to clients (patients) under the 18 years of age. (Employees #1 and #3) Findings include: On ‘April 1, 2025 at approximately 3:28 PM, review of agency policy B-101, titled “Child Abuse Clearance” revealed the following under “Policy”: 1. All Home Health employees (nurses, aides, therapists, social workers) that will be working with or involved with a pediatric client (up to the age of 18) must have a Child Abuse Clearance check in addition to the Criminal Background Check required of all other employees... On April 1, 2025 at approximately 3:30 PM, review of the PA Department of Human Services website ( https://www.pa.gov/agencies/dhs/resources/keep-kids-safe/child-abuse-clearances.html ) revealed the following guidance regarding clearance requirements is included on the FAQ (Frequently Asked Questions) document with the heading of Employees Having Contact with Children: Which clearances are required? All applicable employees must submit the following three clearances: 1) PA Child Abuse History Certification from DHS (PA Child Abuse); 2) Pennsylvania State Police Criminal History Record Check (PSP); and 3) DHS fingerprint-based Federal Bureau of Investigation Criminal History Background Check (DHS FBI). How often do employment clearances need to be obtained? Employment clearances must be obtained every 60 months. Client #3 (Branch Office): Between March 26, 2025 at approximately 1:14 PM and March 27, 2025 at approximately 12;50 PM, review of the clinical record revealed the registered nurse (RN-Employee #1) provided skilled nursing (SN) services in February and March 2025. Client #5 (Branch Office): Between March 26, 2025 at approximately 1:50 PM and March 28, 2025 at approximately 10:55 AM, review of the clinical record revealed the licensed practical nurse (LPN-Employee #3) provided SN services in February and March 2025. Between March 26, 2025 at approximately 11:41 AM and March 28, 2025 at approximately 2:25 PM and on April 1, 2025 at approximately 8:11 AM, review of personnel file documentation revealed the following: Employee #1: The date of hire of the RN was 09/12/2017. Review of background check reports revealed a DHS FBI report was obtained on 09/18/2017 but there was no documentation that an updated DHS FBI report had been obtained within 60 months (09/2022) of the aforementioned report. Employee #3: The date of hire of the LPN was 08/02/2018. Review of background check reports revealed a PA Child Abuse report was obtained on 08/14/2018 but there was no documentation that an updated PA Child Abuse report had been obtained within 60 months (08/2023) of the aforementioned report. During interview conducted on March 28, 2025, the Administrator reported that some human resource processes are no longer completed at the agency level as those responsibilities have been transferred other parties. During interviews conducted on March 28, 2025 at approximately 4:00 PM and April 1, 2025 at approximately 4:32 PM, the Administrator/Clinical Manager confirmed there was documentation which provided evidence that the aforementioned clearances had been obtained within 60 months of the prior clearance for the above identified employees.”

“HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator’s name, business address, and business phone number in order to receive complaints. This Element is not met as evidenced by: Based on review of agency policies/procedures, documentation, clinical records and Pennsylvania Department of Health (PA DOH) database documentation and based on interview with the Administrator/Clinical Manager (Employee #12), the agency failed to ensure the name of the Administrator, in order to receive complaints, was included in one (1) of one (1) patient handbooks. (“Home Health Services Patient Handbook”) Finding include: On April 1, 2025 at approximately 3:05 PM, review of agency policy C-381, titled “Notice of Patient Rights/Responsibilities and Patient Grievance Procedure” under “Notice of Rights and Responsibilities” revealed the following: 2. The Notice of Patient Rights and Responsibilities can be found in the Patient Handbook. The Patient Handbook shall include, but is not limited to...b. Mean of contacting agency administrator... On March 25, 2025 between the approximate times of 7:30 AM and 11:20 AM, review of organizational chart documentation revealed the Administrator is Employee #12. On March 24, 2025 at approximately 8:45 AM, Review of PA DOH database documentation revealed Employee #12 was appointed to the position of Administrator effective 09/13/2024. On March 24, 2025 between the approximate times of 10:59 AM and 12:20 PM, review of the “Home Health Services Patient Handbook” revealed a staff member’s name, other than Employee #12, was identified as the administrator under “Problem Solving Procedure”. There was no documentation in the “Home Health Services Patient Handbook which provided evidence the name of the current administrator (Employee #12) had been included on the patient rights notification forms. During interviews conducted on March 28, 2025 at approximately 4:00 PM and April 1, 2025 at approximately 4:32 PM, the Administrator/Clinical Manager (Employee #12) confirmed there was no documentation which provided evidence that the name of the current administrator (Employee #12) had been included in the “Home Health Services Patient Handbook”.”

“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 review of agency policies/procedures and clinical records and based on interview with the Administrator/Clinical Manager (Employee #12), the agency failed to ensure the home health plan of care (plan of treatment) included physician orders for a private duty skilled nursing (PDN-skilled nursing shift care) visit frequency and duration for two (2) of seven (7) clients (patients). (Clients #1 and #3) Findings include: On April 1, 2025 at approximately 3:06 PM, review of agency policy C-580, titled “Plan of Care”, revealed the following under “Instructions”: 9. The Plan of Care will include, but not be limited to...h. The amount, frequency and duration of visits to be made... Client #1 (Parent Office): Between March 25, 2025 at approximately 10:00 AM and March 27, 2025 at approximately 12;30 PM, review of the clinical record revealed the skilled nursing (SN) visit frequency order included on the “Home Health Certification and Plan of Care” for the recertification period of 01/25/2025 through 03/25/2025 was for SN services to be provided 03/16/2025 one (1) time a week for one (1) week. Review visit calendar documentation revealed PDN SN services were provided four (4) to six (6) days week between 01/27/2025 and 03/21/2025 and that the hours PDN SN services were provided ranged between 7 hours and 51 minutes to 14 hours and 30 minutes per day between 01/27/2025 through 03/26/2025. There was no documentation in the clinical record which provided evidence the “Home Health Certification and Plan of Care” for the recertification period of 01/25/2025 through 03/25/2025 included a PDN SN visit frequency. Client #3 (Branch Office): Between March 26, 2025 at approximately 1:14 PM and March 27, 2025 at approximately 12;50 PM, review of the clinical record revealed the SN visit frequency order included on the “Home Health Certification and Plan of Care” for the recertification period of 02/05/2025 through 04/05/2025 was for SN services to be provided 03/20/2025 one (1) time a week for one (1) week. Review visit calendar documentation revealed PDN SN services were scheduled to be provided seven (7) days per week between 02/09/2025 and 03/21/2025 and that the hours PDN SN services were provided ranged between 6 hours and 30 minutes to19 hours per day between 02/05/2025 through 03/22/2025. There was no documentation in the clinical record which provided evidence the “Home Health Certification and Plan of Care” for the recertification period of 02/05/2025 through 04/05/2025 included a PDN SN visit frequency. During interviews conducted on March 28, 2025 at approximately 4:00 PM and April 1, 2025 at approximately 4:32 PM, the Administrator/Clinical Manager confirmed orders for a PDN SN visit frequency and duration were not included on the “Home Health Certification and Plan of Care” for the above identified clients.”

“Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies. (4) When services are provided on the basis of a physician or allowed practitioner’s verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA’s policies, must document the orders in the patient’s clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies. This Element is not met as evidenced by: Based on a review of agency policy/procedure and clinical records and based on interview with the Administrator/Clinical Manager (Employee #12), the agency failed to ensure the physician’s countersignature for verbal orders included on the “Home Health Certification and Plan of Care” was obtained in accordance with agency policy/procedure for five (5) of five (5) clients (patients). (Clients #1, #3, #4, #5 and #7) Findings include: On April 1, 2025 at approximately 3:09 PM, review of agency policy C-635, titled Physician Orders” revealed the following under “Policy”: All orders Physician orders may be initiated via telephone or in writing and must be countersigned by a licensed physician within 30 days of the verbal or written order. Client #1 (Parent Office): Between March 25, 2025 at approximately 10:00 AM and March 27, 2025 at approximately 12;30 PM, review of the clinical record revealed the verbal recertification orders included on the “Home Health Certification and Plan of Care” for the recertification period of 01/25/2025 through 03/25/2025 were obtained by the registered nurse (RN) on 01/21/2025. The ordering physician electronically signed the “Home Health Certification and Plan of Care on 03/04/2025 which was greater than 30 days after the verbal order date. There is no documentation in the clinical record which provided evidence the ordering physician countersigned the “Home Health Certification and Plan of Care” within 30 days of the verbal order date. Client #3 (Branch Office): Between March 26, 2025 at approximately 1:14 PM and March 27, 2025 at approximately 12;50 PM, review of the clinical record revealed the verbal recertification orders included on the “Home Health Certification and Plan of Care” for the recertification period of 02/05/2025 through 04/05/2025 were obtained by the RN on 01/31/2025. There is no documentation in the clinical record which provided evidence the ordering physician had countersigned the “Home Health Certification and Plan of Care”. Client #4 (Branch Office): Between March 26, 2025 at approximately 1:42 PM and March 28, 2025 at approximately 10:30 AM, review of the clinical record revealed the verbal recertification orders included on the “Home Health Certification and Plan of Care” for the recertification period of 02/24/2025 through 04/24/2025 were obtained by the RN on 02/23/2025. There is no documentation in the clinical record which provided evidence the ordering physician had countersigned the “Home Health Certification and Plan of Care”. Client #5 (Branch Office): Between March 26, 2025 at approximately 1:50 PM and March 28, 2025 at approximately 10:55 AM, review of the clinical record revealed the verbal recertification orders included on the “Home Health Certification and Plan of Care” for the recertification period of 02/16/2025 through 04/16/2025 were obtained by the RN on 02/14/2025. There is no documentation in the clinical record which provided evidence the ordering physician had countersigned the “Home Health Certification and Plan of Care”. Client #7 (Parent Office-Discharge): On March 28, 2025 at approximately 1:15 PM, review of the clinical record revealed the verbal recertification orders included on the “Home Health Certification and Plan of Care” for the recertification period of 10/08/2024 through 12/06/2024 were obtained by the RN on 10/03/2024. The ordering physician electronically signed the “Home Health Certification and Plan of Care on 12/09/2024 which was greater than 30 days after the verbal order date. There is no documentation in the clinical record which provided evidence the ordering physician countersigned the “Home Health Certification and Plan of Care” within 30 days of the verbal order date. During interviews conducted on March 28, 2025 at approximately 4:00 PM and April 1, 2025 at approximately 4:32 PM, the Administrator/Clinical Manager confirmed there was no documentation in the clinical record which provided evidence the ordering physician countersigned the “Home Health Certification and Plan of Care” within 30 days of the verbal order date for the above identified clients.”

“Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This Element is not met as evidenced by: Based on review of agency policies/procedures and clinical records and based on interview with the Administrator/Clinical Manager (Employee #12), the agency failed to ensure documentation was maintained in the clinical records which provided evidence revisions to the home health plan of care (plan of treatment) were verified by registered nursing staff for four (4) of seven (7) clients (patients) for whom feedings are administered via a gastric tube (GT-feeding tube inserted through the abdominal wall into the stomach). (Clients #3, #4, #5 and #6) Findings include: On April 1, 2025 at approximately 3:07 PM, review of agency policy C-870, titled “Clinical Record/Medical Record Retention”, revealed the following under “Instructions”: 10. When a plan of care is revised, it must reflect current information from the patient’s updated comprehensive assessment, supplemental orders... Client #3 (Branch Office): Between March 26, 2025 at approximately 1:14 PM and March 27, 2025 at approximately 12;50 PM, review of the clinical record revealed the GT nutritional orders obtained by the registered nurse (RN-Employee #4) included the following as documented on the “Home Health Certification and Plan of Care” for the recertification period of 02/05/2025 through 04/05/2025: -Page 2: Prep feed of 10 ounces water with 2/3 cups Alfamino Jr. (Junior) with one (1) scoop of Duoocal daily. Administer 280 milliliters Alfamino Jr (Junior) mix with 1 scoop of Duocal via infinity pump via GT over 1.5 hours; and -Page 3: Prep feed of 10 ounces water with 1/3 cups Alfamino Jr. (Junior) with one (1) scoop of Duoocal daily. Administer 280 milliliters Alfamino Jr (Junior) mix with 1 scoop of Duocal via GT at 210 ml per hour... Review recertification assessment documentation dated 02/25/2025 revealed the GT feeding to be administered was in accordance with the nutritional orders included on page 2 of the “Home Health Certification and Plan of Care”. There was no documentation in the clinical record which provided evidence the RN verified the accuracy of the GT feed mix orders (2/3 cups verses 1/3 cup) nor the feeding rate orders (280 ml over 1.5 hours verses 210 ml per hour) which were included on the “Home Health Certification and Plan of Care”. Client #4 (Branch Office): Between March 26, 2025 at approximately 1:42 PM and March 28, 2025 at approximately 10:30 AM, review of the clinical record revealed the GT nutritional orders obtained by the RN (Employee #14) included the following as documented on the “Home Health Certification and Plan of Care” for the recertification period of 02/24/2025 through 04/24/2025: -Page 1: Overnight Nutren 1K Cal ... -Page 2: GT feeding orders for Nutren Jr. administer 1,000 ml at 250 ml per hour overnight... There was no documentation in the clinical record which provided evidence the RN verified the accuracy of the GT feed orders (Nutren 1K Cal verses Nutren Jr.) which were included on the “Home Health Certification and Plan of Care”. Client #5 (Branch Office): Between March 26, 2025 at approximately 1:50 PM and March 28, 2025 at approximately 10:55 AM, review of the clinical record revealed the GT nutritional orders obtained by the RN (Employee #13) included the following as documented on the “Home Health Certification and Plan of Care” for the recertification period of 02/16/2025 through 04/16/2025: -Pages 1 and 2: Compleat Pediatric Organic Blends formula with 1,200 ml of water, run 120 ml three (3) times a day over 1 hour and 800 ml overnight at 85 ml per hour via GT from 7:30 PM to 5:00 AM; -Medications: Compleat Pediatric Organic Blends formula 450 ml with 1,000 ml of water, run 120 ml three (3) times a day over 1 hour and 800 ml overnight at 85 ml per hour via GT from 7:30 PM to 5:30 AM; There was no documentation in the clinical record which provided evidence the RN verified the accuracy of the GT feed mix orders (1,200 ml of water verses 1,000 of water) nor the overnight feeding time orders (9:30 PM to 5:00 PM verses 9:30 PM to 5:30 AM) which were included on the “Home Health Certification and Plan of Care”. Client #6 (Discharge-Parent Office): On March 28, 2025 at approximately 12:20 PM, review of the clinical record revealed the GT nutritional orders obtained by the RN (Employee #15) included the following as documented on the “Home Health Certification and Plan of Care” for the recertification period of 10/29/2024 through 12/27/2024: -Pages 1 and 3: Peptamen 250 ml two (2) times a day via gravity bolus... -Page 3: Peptamen 250 ml two (2) times a day as needed for poor appetite... There was no documentation in the clinical record which provided evidence the RN verified the accuracy of the GT feed orders (two (2) times a day verses two (2) times a day as needed) which were included on the “Home Health Certification and Plan of Care”. During interviews conducted on March 28, 2025 at approximately 4:00 PM and April 1, 2025 at approximately 4:32 PM, the Administrator/Clinical Manager confirmed orders there was no documentation in the clinical record which provided evidence RN staff verified the accuracy of the above referenced nutritional orders for the above identified clients.”

“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 review of agency policy/procedure, documentation, clinical records, personnel files and Pennsylvania Department of Health (PA DOH) database documentation, and based on interview with the Administrator/Clinical Manager (Employee #12), the Clinical Manager/Administrator failed to ensure documentation was maintained in the personnel file which provided evidence performance appraisals, competency evaluations and certifications were completed/maintained in accordance with agency policy/procedure for five (5) of nine (9) direct care staff. (Employees #1, #3, #5, #7 and #8) Findings include: On April 1, 2025 at approximately 3:33 PM, review of agency policy B-230, titled “Performance Appraisal” revealed the following under “Policy”: All Agency employees are required to have an annual performance appraisal. On April 1, 2025 at approximately 3:13 PM, review of agency policy B-115, titled “Competency Assessment” revealed the following under “Procedures”: Upon hire, prior to patient assignment and provision of services, and annually, all field employees are required to participate in a competency evaluation conducted by an agency Registered Nurse. Competency evaluations can be conducted with a patient in the patient’s place of residence and/or with a pseudo-patient in a simulated home environment in the office. Competency evaluation subject areas for Licensed Professionals...vary dependent upon their specific position and responsibilities.Documentation of competency evaluation will be indicated on a competency evaluation checklist, which includes the subject area, method of demonstration, rating of competency, preceptor’s initials, and date of subject area demonstration. Documentation will be maintained in the employee’s personnel file. On March 27, 2025 at approximately 10:05 AM, review of the “Annual Competency-Licensed Practical Nurse” competency evaluation form revealed tracheostomy care and tube change were included under the following section: Review of Systems: Demonstrates ability to obtain and document appropriate age specific history/assessment for patients in the following categories... On April 1, 2025 at approximately 3:14 PM, review of agency policy C-120, titled “Registered Nurse” revealed the following “Position Qualifications”: 5. Current CPR Certification On April 1, 2025 at approximately 3:15 PM, review of agency policy C-160, titled “Registered Nurse” revealed the following “Position Qualifications”: 4. CPR Certification On March 24, 2025 at approximately 8:45 AM, review of PA DOH database documentation revealed Employee #12 (Registered Nurse) was appointed to the position of Administrator effective 09/13/2024. On March 25, 2025 at approximately 1:30 PM, review of email documentation dated 03/25/2025 revealed the Employee #12 also serves as the Clinical Manager. Client #1 (Parent Office): Between March 25, 2025 at approximately 10:00 AM and March 27, 2025 at approximately 12;30 PM, review of the clinical record revealed the client is 54 years old, that skilled nursing (SN) services are to be provided, the client is a full code (cardiopulmonary resuscitation-CPR- is to be performed) and that SN is to provide tracheostomy (airway created surgically in the neck) maintenance and care as ordered on the “Home Health Certification and Plan of Care” for the recertification period of 01/25/2025 through 03/25/2025. Review of nursing progress note documentation revealed the licensed practical nurse (LPN-Employee #8) provided SN services in February and March 2025. Client #2 (Parent Office): Between March 25, 2025 at approximately 3:00 PM and March 27, 2025 at approximately 12;45 PM, review of the clinical record revealed the client is 28 years old, that SN services are to be provided and that the client is a full code as ordered on the “Home Health Certification and Plan of Care” for the recertification period of 03/25/2025 through 05/23/2025. Review of nursing progress note documentation revealed the LPN (Employee #7) provided SN services in March 2025. Client #3 (Branch Office): Between March 26, 2025 at approximately 1:14 PM and March 27, 2025 at approximately 12;50 PM, review of the clinical record revealed the RN (Employee #1) provided SN services in January, February and March 2025. Client #5 (Branch Office): Between March 26, 2025 at approximately 1:50 PM and March 28, 2025 at approximately 10:55 AM, review of the clinical record revealed the LPN (Employee #3) provided SN services in February and March 2025. On 03/24/2025 at approximately 1:10 PM, review of assignment documentation revealed the home health aide (HHA-Employee #5) is assigned to provide HHA services to three (3) active clients (Clients #10, #11 and #12) for whom services are provided from the branch office. Between March 26, 2025 at approximately 11:41 AM and March 28, 2025 at approximately 2:25 PM and on April 1, 2025 at approximately 8:11 AM, review of personnel file and administrative email documentation revealed the following: Employee #1: The date of hire of the RN was 09/12/2027. There was no documentation in the personnel file which provided evidence an annual performance appraisal had been completed in 2023 nor 2024. Employee #3: The date of hire of the LPN was 08/02/2018. There was no documentation in the personnel file which provided evidence an annual performance appraisal had been completed in 2023 nor 2024. Employee #5: The date of hire of the HHA was 10/26/2023. There was no documentation in the personnel file which provided evidence an annual performance appraisal had been completed in 2024. Employee #7: The date of hire of the LPN was 07/04/2024. Review of CPR certification documentation revealed the LPN’s CPR certification expired in January 2025. There was no documentation in the personnel file which provided evidence CPR certification had been maintained in February and March 2025. Employee #8: The date of hire of the LPN was 01/14/2016. Review of CPR certification documentation revealed the LPN’s CPR certification expired in November 2023. Review of competency evaluation documentation revealed the LPN demonstrated competency to perform tracheostomy care/tube change on 02/09/2021. There was no documentation in the on the “Annual Competency-Licensed Practical Nurse” form which provided evidence the LPN completed a competency evaluation for tracheostomy care/tube change in 2022, 2023 nor 2024. Administrative email documentation dated 03/31/2025 revealed the following: -The LPN completed a CPR exam on 12/18/2024 but that the exam was not scored and there was no evidence the LPN had completed the skills portion of the CPR course; and -The LPN’s competency to perform tracheostomy care/tube change was completed but documentation was not available. There was no documentation in the personnel file of Employees #8 which provided evidence CPR certification had been maintained between December 2023 and March 2025 nor was documentation present which provided evidence the LPN had completed a competency evaluation for tracheostomy care/tube change in 2022, 2023 nor 2024. During interviews conducted on March 28, 2025 at approximately 4:00 PM and April 1, 2025 at approximately 4:32 PM, the Administrator/Clinical Manager confirmed there was no documentation which provided evidence performance appraisals, CPR certification and competency evaluation had been completed/maintained in accordance with agency policy/procedure for the above referenced employees.”