Every finding on record at Golden Care of Northeast PA, Inc

Based on the findings of an unannounced, onsite Medicare complaint investigation survey conducted on January 8, 2026, with the off-site portion of the survey being conducted on January 9 and 13, 2026, Golden Care of Northeast PA, Inc. was found not to be in compliance with the following requirements of 42CFR, Part 484, Subparts B &;; C, Conditions of Participation: Home Health Agencies.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on review of agency policy, documentation and clinical records and based on interview with the Administrator (Employee #1), the agency failed to ensure the parent of three (3) of three (3) pediatric patients were involved in the care planning (coordination) process. (Patient #1, #2 and #3) Findings include: On January 8, 2026 at approximately 2:28 PM, review of agency policy 1-007, titled "Care Planning Process" revealed the following under "Policy": The patient and family/caregiver will participate in the decisions regarding the plan of care whenever possible. The care planning process will be documented in the...clinical notes...care conference/summary forms... Patient #1: On January 8, 2026 at approximately 11:15 AM and January 13, 2026 at approximately 12:30 PM, review of the clinical record revealed the start of care (SOC) was 07/16/2024, the patient is 2 years old and that skilled nursing (SN) visit frequency orders are/were as follows as documented on the "Home Health Certification and Plan of Care": -Recertification Periods 09/09 through 11/07/2025 and 11/08/2025 through 01/06/2026: Up to 16 hours per day Monday through Friday -Recertification Periods 05/12 through 07/10/2025 and 07/11 through 09/08/2025: Up to 9.5 hours per day Monday through Friday -The aforementioned SN visit frequencies were ordered to be provided to cover parent's work schedule and to provide assistance in the home while parents are caring for four (4) other children in the home. Review of electronic medical record (EMR) schedule tab documentation revealed the SN visit schedule is/was as follows: -Time period of 09/02 through 03/07/2026: 9 hours per day Monday through Friday -Time period of 07/11 through 08/31/2025: 8.5 hours per day Monday through Friday -Time period of 06/20 through 06/27/2025: 8 hours per day Monday through Friday -Time period of 06/01 through 07/10/2025: 7.25 hours per day Monday through Friday Review of case conference/team communication note documentation dated 06/13/2025 revealed the patient was hospitalized due to suffering cardiac arrest (loss of heart function-heart stop) during a magnetic resonance imaging scan (MRI). Review of visit calendar and missed visit documentation revealed SN services were not scheduled/provided on 06/12, 06/13, 06/17, 06/18 and 06/19/2025 due to the patient's hospitalization. Review of the resumption of care SN comprehensive assessment dated 06/20/2025 revealed a registered nurse (RN-Employee #3) documented the SN frequency and duration was eight (8) hours per day Monday through Friday for patient's work schedule. Review of the agency "Social Letter" letter dated 06/18/2025 revealed the Private Duty Director/Licensed Practical Nurse (Employee #2-PPD/LPN) requested an increase in the SN visit frequency to up to 16 hours per day Monday through Friday. Review of a payor source letter revealed that the SN service authorization request was approved effective 07/10/2025. Review of EMR service authorization documentation revealed that for the time period of 09/01/2025 through 08/31/2026 revealed SN services are to be provided up to 16 hours per day. Review of case conference/team communication documentation revealed the following: -08/26/2025: Authorization was received for 16 hours of services (SN) per day and that an additional caregiver would be needed. -10/20/2025: Still advertising for a SN to fill hours. No concerns. Review of missed visit reports revealed that between 29.5 and 61.25 hours of SN service hours were not provided due to no nurse available, nurse scheduled off or "caregiver" unavailable for the time period of the week ending 08/09/2025 through the week ending 12/27/2025. Beginning with the missed visit report dated 08/15/2025, the agency documented the agency was seeking/recruiting for an additional and qualified SN to cover the remaining hours for the case. On January 13, 2026 at approximately 12:03 PM, review of the agency email dated 01/13/2026 revealed the following: -Text message documentation: An undated text message revealed the patient's parent indicated that the parent would attempt to contact a SN friend to determine if the friend would be interested in part-time employment. -Human Resource (HR) Department statement: That prior to December 2025, the agency HR Department and Administrator had not discussed the 16-hour/day coverage need. After being contacted by the patient’s parent, the agency took immediate action to review staffing availability and begin recruitment efforts. The agency did not have any current nurses available who could fill the increased hours. As a result, the agency initiated recruitment efforts to support the increased authorized hours, including posting the case and contacting applicants/candidates already in process. Recruitment efforts began on 12/22/2025, including an advertisement posted on the agency’s social media page with the specific hours and location, as well as a listing on recruitment website. Despite these efforts, the agency received no qualified applicants for this case during the referenced period. The agency remained in communication with the patient’s parent. The first date the agency advertised for the SN position to seek coverage for the increased SN hours was 12/22/2025. There was no documentation in the clinical record which provided evidence the agency involved the parent in the care planning process as there was no documentation that the parent was notified of an in agreement with the SN visit schedule established under the EMR schedule tab nor was documentation present which provided evidence the agency coordinated the SN recruitment efforts with the parent between 07/10/2025 and prior to the patient's parent contacting the HR Department in December 2025. Patient #2: On January 8, 2026 at approximately 12:35 PM, review of the clinical record revealed the SOC was 07/22/2024, the patient is 2 years old and that SN services are to be provided 9.5 hours per day Monday through Friday to cover parent's work schedule and to accompany to medical appointments as ordered on the "Home Health Certification and Plan of Care" for the recertification period of 11/14/2025 through 01/12/2026. Review of electronic medical record (EMR) schedule tab documentation revealed the SN visit schedule was as follows: -Time period of 07/17/2025 through 12/31/2025: 8.5 hours per day Monday through Friday. Review of missed visit report documentation for the week ending 11/22/2025 revealed 16 hours of SN services were not provided, for the week ending 12/06/2025, 8 hours of SN services were not provided and for week ending 12/13/2025, 47.5 hours of SN services were not provided because the nurse was not available. There was no documentation in the clinical record which provided evidence the agency involved the parent in the care planning process as there was no documentation that the parent was notified and in agreement with the SN visit schedule established under the EMR schedule tab nor was documentation present which provided evidence the agency provided the parent with prior notification that a SN was unavailable to provide services per the ordered visit frequency for the weeks ending 11/22, 12/06 and 12/13/2025. Patient #3 (Discharge): On January 8, 2026 at approximately 2:17 PM, review of the clinical record revealed the SOC was 07/04/2024, the patient is 12 years old and that home health aide (HHA) services are to be provided up to 8 hours per day Monday through Friday for school, school transportation, extended school year, home and accompaniment to medical appointments as ordered on the "Home Health Certification and Plan of Care" for the recertification period of 10/26/2025 through 12/24/2025. Review of missed visit report documentation revealed for the week ending 10/11/2025 revealed 4.75 hours of HHA services were not provided, for the week ending 11/08/2025, 8.5 hours of HHA services were not provided and for week ending 12/20/2025, 32 hours of HHA services were not provided because the caregiver (HHA) was not available. There was no documentation in the clinical record which provided evidence the agency involved the parent in the care planning process as there was no documentation which provided evidence the agency provided the parent with prior notification that a HHA was unavailable to provide services per the ordered visit frequency for the weeks ending 10/11, 11/08 and 12/20/2025. During telephone interview conducted on January 13, 2026 at approximately 3:35 PM, the Administrator confirmed there was no documentation in the clinical record which provided evidence the parent of patients #1, #2 and #3 had been involved in the care planning process for the above referenced reasons and on/during the aforementioned dates/time periods.

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 review of agency policy/procedure and documentation and based on interview with the Administrator (Employee #1), the Administrator failed to ensure two (2) of two (2) skilled nursing (SN) staff maintained patient confidentiality in accordance with agency policy/procedures. (Employees #2 and #3) Findings include: On January 8, 2026 at approximately 3:1`8 PM, review of agency policy 6-019, titled "Sanctions for Privacy and Security Violations" revealed the following under "Procedure": A. Level 1 Carelessness...1. This level of violation occurs when an employee unintentionally or carelessly accesses...discloses to another person an individual's PHI (Personal Health Information) and there is no legitimate reason for such...disclosure. Examples included are not limited to...A. Discussing an individua's PHI in a public place... On January 13, 2026 at approximately 3:33 PM, review of agency privacy procedures revealed the following: Accordingly...you must maintain the confidentiality of clients' (patients')...treatment... Sharing a client's protected health information with others, including family members, without...authorization, is prohibited. On January 8, 2026 at approximately 1:55 PM, review of agency personnel details included on the "Emergency Preparedness Call Tree" revealed the following: Employee #2: The SN is a licensed practical nurse for whom the job title is Private Duty Manager (PDM/LPN) Employee #3: The SN is a registered nurse for whom the job title is PDN Clinical Manager (PDN CM/RN) On January 8, 2026 at approximately 2:37 PM, review of agency documentation dated "October 31" revealed the PDM/LPN (Employee #2) added a HHA (Employee #5) to a chat for patient #4. The chat included patient #4's name, details regarding hiring a parent to be the caregiver of patient #4, the proposed number of hours services would be provided. Chat documentation revealed the HHA left the chat on "December 2". During interview con On January 8, 2026 at approximately 12:18 PM, review of agency documentation dated 12/08/2025 revealed the Administrator received a complaint from a home health aide (Employee #5) that a SN had spoken about a patient at another patient's home. During interview conducted on January 8, 2026 at approximately 2:06 PM, the Administrator reported that the while performing a SN visit in the presence of the HHA (Employee #5), the PDN CM/RN (Employee #3) had reported that the PDN CM/RN did not wish to perform a scheduled SN visit for a patient for whom the HHA (Employee #5) was not assigned to provide care. During interview conducted on January 8, 2026 at approximately 3:25 PM, the Administrator confirmed Employee #2 and #3 failed to maintain patient confidentially in accordance with the above referenced policies procedures.

Based on the findings of an unannounced, onsite Medicare complaint investigation survey conducted on July 25 and July 28, 2025, with the off-site portion of the survey being conducted on July 31, August 4, August 5 and August 8, 2025, Golden Care of Northeast PA, Inc. was found not to be in compliance with the following requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on review of agency policy/procedure and clinical records and based in interview with the Administrator (Employee #1) and the Operations Consultant (Employee #16), the agency failed to ensure discharge planning was conducted in accordance with agency policy/procedure for two (2) of three (3) patients/clients who were discharged from the agency. (Patients #4 and #5) Findings include: On August 8, 2025 at approximately 2:53 PM, review of agency policy 1-024, titled "Discharge Criteria and Process" revealed the following under "Policy": When the patient's plan of care changes and this change results in discharge..., the patient or his/her representative, as well as his/her primary physician...will be involved in discharge planning decisions. Patient #4 (Adult/Intermitted Skilled Services/Discharge): Between July 25, 2025 at approximately 2:14 PM and July 28, 2025 at approximately 11:28 AM, review of the clinical record revealed physical therapy (PT) services were to be provided three (3) times a week for two (2) weeks followed by two (2) times a week for two (2) weeks as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 05/05/2025 through 07/03/2025. Review of PT visit documentation revealed seven (7) PT visits were completed between 05/06/2025 and 05/20/2025. Review of the clinical record revealed a agency discharge assessment was completed on 05/27/2025. Review of the "Agency Discharge Ord" dated 06/02/2025 revealed the Administrator (registered nurse) obtained a physician order to discharge the patient from all services effective 06/02/2025. There was no documentation in the clinical record which provided evidence the patient, nor the patient's physician, had been involved in the discharge planning process prior to completion of agency discharge comprehensive assessment on 05/27/2025. Patient #5 (Adult/Intermitted Skilled Services/Discharge): On July 28, 2025 at between the approximate times of 9:00 AM and 11:16 AM, review of the clinical record revealed skilled nursing (SN) services were to be provided one (1) time a week for nine (9) weeks as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/05/2025 through 08/03/2025. Review of SN documentation revealed one (1) skilled nursing visit was completed on 06/05/2025. Review of communication log documentation revealed the agency was unable to reach the patient by telephone on 06/09, 06/10, 06/11 and 06/16/2025. Review of the clinical record revealed a agency discharge assessment was completed on 06/26/2025. A physician order to discharge the patient was obtained on 06/26/2025. There was no documentation in the clinical record which provided evidence the patient had been involved in the discharge planning process (failure to receive notification of the agency's intent to discharge) prior to completion of agency discharge comprehensive assessment which was completed on 06/26/20205. During Teams interview conducted on August 8, 2025 at approximately 3:02 PM, the Administrator and OC confirmed there was no documentation in the clinical record which provided evidence discharge planning had been completed in accordance with agency policy/procedure for the above identified patients.

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 review of agency policy/procedure and clinical records and based in interview with the Administrator (Employee #1) and the Operations Consultant (Employee #16), the agency failed to ensure home health services were provided in accordance with visit frequency orders included on the "Home Health Certification and Plan of Care" for four (4) of five (5) patients for whom intermittent skilled services were provided. (Patients #1, #2, #3 and #4) Findings include: On August 8, 2025 at approximately 2:51 PM, review of agency policy 1-007, titled "Care Planning Process" revealed the following: Purpose...To provide clinical direction to the clinicians providing direct patient care. Procedure...14. Services to be provided will be based on the prioritized needs of the patient. Each patient will be monitored for his/her response to care or services provided against established patient goals and outcomes to determine if goals have been achieved. Patient #1 (Adult/Intermitted Skilled Services): Between July 25, 2025 at approximately 12:18 PM and July 28, 2025 at approximately 10:20 AM, review of the clinical record revealed skilled nursing (SN) services were to be provided two (2) times a week for one (1) week followed by one (1) time a week for eight (8) weeks as documented on the "Home Health Certification and Plan of Care" for the recertification period of 05/13/2025 through 07/11/2025. There was no documentation in the clinical record which provided evidence a SN visit had been completed during the treatment week of 05/25/2025 through 05/31/2025. There was no documentation in the clinical record which provided evidence the patient had refused a SN visit during the aforementioned treatment week. Patient #2 (Adult/Intermitted Skilled Services): Between July 25, 2025 at approximately 1:09 PM and July 28, 2025 at approximately 10:47 AM, review of the clinical record revealed SN services were to be provided one (1) time a week for nine (9) weeks as documented on the "Home Health Certification and Plan of Care" for the recertification period of 05/18/2025 through 07/16/2025. There was no documentation in the clinical record which provided evidence a SN visit had been completed during the treatment week of 06/29/2025 through 07/05/2025. There was no documentation in the clinical record which provided evidence the patient had refused a SN visit during the aforementioned treatment week. Patient #3 (Adult/Intermitted Skilled Services/Discharge): Between July 25, 2025 at approximately 1:38 PM and July 28, 2025 at approximately 11:03 AM, review of the clinical record revealed SN services were to be provided two (2) times a week for one (1) week followed by one (1) time a week for six (6) weeks as documented on the "Home Health Certification and Plan of Care" for the recertification period of 05/03/2025 through 07/01/2025. There was no documentation in the clinical record which provided evidence a SN visit had been completed during the treatment week of 06/08/2025 through 06/14/2025. There was no documentation in the clinical record which provided evidence the patient had refused a SN visit during the aforementioned treatment week. Patient #4 (Adult/Intermitted Skilled Services/Discharge): Between July 25, 2025 at approximately 2:14 PM and July 28, 2025 at approximately 11:28 AM, review of the clinical record revealed physical therapy (PT) services were to be provided three (3) times a week for two (2) weeks followed by two (2) times a week for two (2) weeks as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 05/05/2025 through 07/03/2025. Review of PT visit documentation revealed two (2) of three (3) PT visits were performed during the first week of the certification period 05/05/2025 through 05/10/2025. There was no documentation in the clinical record which provided evidence the patient had refused the third PT visit during the aforementioned treatment week. During Teams interview conducted on August 8, 2025 at approximately 3:02 PM, the Administrator and OC confirmed there was no documentation in the clinical record which provided evidence skilled services were provided in accordance with the aforementioned orders included on the "Home Health Certification and Plan of Care" for above identified patients.

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/procedure, clinical records and the Pennsylvania (PA) Health Care Facilities Act, and based on interview with the Administrator (Employee #1) and Operations Consultant (Employee #16), the agency failed to ensure verbal orders included on the "Home Health Certification and Plan of Care" were countersigned by the primary care physician within 30 days of the verbal order date for four (4) of eight (8) patients for whom skilled services were ordered on the plan of care. (Patients #1, #2, #3 and #5) Findings include: On August 8, 2025 at approximately 2:55 PM, review of agency policy 8-024, titled "Internal Control Systems/Accountabilities" revealed the following under "Procedure": 3. Clinical Documentation Compliance...C. Physician Orders: Mechanisms are currently in place to assure timely signed physician orders prior to billing. On August 8, 2025 at approximately 3:25 PM, review PA state regulations included under the Health Care Facilities Act revealed the following under Section 806. Licensure...d) Home health care agency regulations: (4) Within 30 days of issuance, an order of home health care services must be signed and dated by a physician, nurse practitioner or physician assistant. Patient #1 (Adult/Intermitted Skilled Services): Between July 25, 2025 at approximately 12:18 PM and July 28, 2025 at approximately 10:20 AM, review of the clinical record revealed verbal orders for skilled nursing (SN) and home health aide (HHA) services were obtained by a registered nurse (RN) on 05/13/2025 as documented on the "Home Health Certification and Plan of Care" for the recertification period of 05/13/2025 through 07/11/2025. The physician countersignature for the verbal orders included on the above referenced "Home Health Certification and Plan of Care" was obtained on 06/23/2025 which was more than 30 days after the verbal order date. There was no documentation in the clinical record which provided evidence the physician countersignature had been obtained within 30 days of the verbal order date for the aforementioned verbal orders. Patient #2 (Adult/Intermitted Skilled Services): Between July 25, 2025 at approximately 1:09 PM and July 28, 2025 at approximately 10:47 AM, review of the clinical record revealed verbal orders for SN services were obtained by a RN on 05/16/2025 as documented on the "Home Health Certification and Plan of Care" for the recertification period of 05/18/2025 through 07/16/2025. There was no documentation in the clinical record which provided evidence the physician countersignature had been obtained for the aforementioned verbal orders. Patient #3 (Adult/Intermitted Skilled Services/Discharge): Between July 25, 2025 at approximately 1:38 PM and July 28, 2025 at approximately 11:03 AM, review of the clinical record revealed verbal orders for SN and HHA services were obtained by a RN on 04/30/3035 as documented on the "Home Health Certification and Plan of Care" for the recertification period of 05/03/2025 through 07/01/2025. The physician countersignature for the verbal orders included on the above referenced "Home Health Certification and Plan of Care" was obtained on 06/19/2025 which was more than 30 days after the verbal order date. There was no documentation in the clinical record which provided evidence the physician countersignature had been obtained within 30 days of the verbal order date for the aforementioned verbal orders. Patient #5 (Adult/Intermitted Skilled Services/Discharge): On July 28, 2025 at between the approximate times of 9:00 AM and 11:16 AM, review of the clinical record revealed verbal orders for SN services were 06/05/2025 as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/05/2025 through 08/03/2025. There was no documentation in the clinical record which provided evidence the physician countersignature had been obtained for the aforementioned verbal orders. During Teams interview conducted on August 8, 2025 at approximately 3:02 PM, the Administrator and OC confirmed there was no documentation in the clinical record which provided evidence a physician countersignature had been obtained within 30 days of the verbal order date included on the "Home Health Certification and Plan of Care" for the above identified patients.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on review of agency policy/procedure and clinical records and based in interview with the Administrator (Employee #1) and the Operations Consultant (Employee #16), the agency failed involve the patient in the care planning process for two (2) of two (2) patients for whom an visit frequency reduction had occurred. (Patients #1 and #4) Findings include: On August 8, 2025 at approximately 2:51 PM, review of agency policy 1-007, titled "Care Planning Process" revealed the following: Purpose...To provide clinical direction to the clinicians providing direct patient care. Procedure...8...The patient/representative/caregiver will be involved in any change in care or services. Patient #1 (Adult/Intermitted Skilled Services): Between July 25, 2025 at approximately 12:18 PM and July 28, 2025 at approximately 10:20 AM, review of the clinical record revealed home health aide (HHA) services were to be provided two (2) times a week as documented on the skilled nursing recertification assessment dated 05/13/2025. Review of the "Home Health Certification and Plan of Care" for the recertification period of 05/13/2025 through 07/11/2025 revealed the HHA visit frequency had been reduced to one (1) time a week for nine (9) weeks. There was no documentation in the clinical record which provided evidence the patient was notified of or in agreement with the reduction in the HHA visit frequency. There was no documentation in the clinical record which provided evidence the patient was involved in the care planning process related to the reduction in the HHA visit frequency. Patient #4 (Adult/Intermitted Skilled Services/Discharge): Between July 25, 2025 at approximately 2:14 PM and July 28, 2025 at approximately 11:28 AM, review of the clinical record revealed skilled nursing (SN) services were to be provided two (2) times a week for one (1) week followed by one (1) time a week for eight weeks as documented on the "Client Agreement Form" which was signed by the patient on 05/05/2025. Review of the "Home Health Certification and Plan of Care" for the initial certification period of 05/05/2025 through 07/03/2025 revealed the SN visit frequency had been reduced to one (1) time a week for nine (9) weeks. There was no documentation in the clinical record which provided evidence the patient was notified of or in agreement with the reduction in the SN visit frequency for week one (1) of the certification period. There was no documentation in the clinical record which provided evidence the patient was involved in the care planning process related to the reduction in the SN visit frequency for week one (1) of the certification period. During Teams interview conducted on August 8, 2025 at approximately 3:02 PM, the Administrator and OC confirmed there was no documentation in the clinical record which provided evidence patients #1 and #4 had been involved the care planning related to the reduction in the aforementioned visit frequencies.

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) Standard: Administrator. The administrator must: (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on review of agency policy/procedure and documentation and interview with the Administrator (Admin-Employee #1) and the Operations Consultant (OC-Employee #16), the Governing Body failed to ensure one (1) of one (1) administrator completed an orientation for the duties of administrator upon employment. (Employee #1) Findings include: On August 8, 2025 at approximately 2:45 PM, review agency policy 8-002, titled "Governing Body" revealed the following under "Procedure": 8. The Governing Body will appoint a qualified administrator... On August 8, 2025 at approximately 2:46 PM, review agency policy 1-02, titled "Orientation" revealed the following under "Policy": All personnel will be required to attend an orientation program upon employment... On July 28, 2025 at approximately 1:54 PM and between August 4, 2025 at approximately 10:50 AM and August 8, 2025 at approximately 8:24 AM, review of personnel file documentation revealed the following: Employee #1: The date of hire of the administrator was 02/15/2025. Review of the administrator orientation form revealed the Administrator completed a self-evaluation for administrative qualifications but there was no documentation in the personnel file which provided evidence the Administrator completed an orientation program for the duties of an administrator upon employment. During interview conducted on August 8, 2025, the Administrator and OC confirmed there was no documentation in the personnel file which provided evidence the Administrator completed an orientation program for the duties of an administrator upon employment.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on review of agency policy/procedure and clinical record and interview with the Administrator (Employee #1) and Operations Consultant (Employee #16), the agency failed to ensure clinical record contents were maintained in accordance with agency policy/procedure for four (4) of eight (8) patients for whom skilled services were provided. (Patients #2, #3, #7 and #8) Findings include: On August 8, 2025 at approximately 3:26 PM, review of agency policy 6-022, titled "Clinical/Service Data Collection" revealed the following: Policy: Documentation in the clinical/service record will be...timely...accurate... Procedure: 1. A clinical/service record will be initiated and maintained for each patient receiving care or services...and will include at a minimum: I. Current patient status and progress towards goals... 6. Entries into the clinical/service record will be made the day care/service is provided to the patient. All documentation will be turned into the office at the end of the work day. 7. The clinical/service note will include...B. Treatment...performed... Patient #2 (Adult/Intermitted Skilled Services): Between July 25, 2025 at approximately 1:09 PM and July 28, 2025 at approximately 10:47 AM, review of the clinical record revealed a registered nurse (RN-Employee #18) provided skilled nursing services on 05/23/2025. The SN visit note dated 05/23/2025 was not available for review in the electronic medical record (EMR). Patient #3 (Adult/Intermitted Skilled Services/Discharge): Between July 25, 2025 at approximately 1:38 PM and July 28, 2025 at approximately 11:03 AM, review of the clinical record revealed a RN provided skilled nursing services on 05/14/2025. The SN visit note for 05/14/2025 was not available for review in the EMR. Patient #7 (Pediatric Client/Private Duty Nursing (PDN)): On July 28, 2025 at between the approximate times of 12:29 PM and 3:15 PM, review of the clinical record revealed the gastric tube (feeding tube) feeding is to be administered at 380 milliliters per hour (ml/hr) for a total feed volume of 190 ml as documented on the "Home Health Certification and Plan of Care" for the recertification period of 06/02/205 through 07/31/2025. Review of 22 of 22 SN visit notes between 06/03/2025 and 07/22/2025 revealed the LPN (Employee #4) documented the GT feeding rate was 155 ml/hr but the gastric tube feeding rate documented by the LPN on the Medication Administration Record was 380 ml/hr. The LPN failed to document the total volume administered during the GT feedings administered on 07/15 and 07/16/2025. Review of SN visit documentation revealed the LPN (Employee #4) provided SN services on 07/16/2025. The complete SN visit note dated 07/16/2025 was not available for review in the EMR as the SN assessment findings were not included on the visit note. During interview conducted on 07/28/2025 at approximately 3:15 PM, the Director of PDN (Employee #11) reported the LPN's assessment findings did not capture on the EMR note but that the LPN had documented the assessment findings in a journal located in the client's home. The Director of PDN confirmed the LPN's assessment findings for 07/16/2025 SN visit were not maintained and available for review in the EMR. Patient #8 (Pediatric Client/PDN): On July 28, 2025 at approximately 1:12 PM, review of the clinical record revealed the gastric tube feeding is to be administered at 600 ml/hr for a total feed volume of 380 ml as documented on the "Home Health Certification and Plan of Care" for the recertification period of 05/17/205 through 07/15/2025. Review of 30 of 31 SN visit notes between 06/02/2025 and 07/18/2025 revealed the LPN (Employee #9) failed to document the GT feeding rate on the SN visit note nor the MAR. The LPN failed to document the total volume administered during the GT feedings administered on 06/02, 06/03 nor 06/04/2025. There was no documentation which provided evidence the contents included in the clinical records for patients #2, #3, #7 and #8 had been maintained in accordance with the above referenced policy/procedure. During Teams interview conducted on August 8, 2025 at approximately 3:02 PM, the Administrator and OC confirmed the contented of clinical/service records were not maintained in accordance with agency policy/procedure for the above identified patients.

Based on the findings of an unannounced, onsite Medicare recertification survey conducted February 11 through February 14, 2025, with the off-site portion of the survey being conducted on February 18, 19 and 21, 2025, Golden Care of Northeast PA, Inc. was found not to be in compliance with the following requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on a review of agency policy/procedure, documentation, and clinical records and based on interview with the Private Duty Nursing (PDN) Director (Employee #5) and the Administrator (Employee #2), the agency failed to ensure the emergency preparedness plan included a risk assessment review of three (3) of seven (7) facility or community-based hazards. (Care-Related Emergencies, Cyber-Attacks and Loss All/Portion of Facility) Findings include: On February 11, 2025 at approximately 2:05 PM and February 13, 2025 at approximately 9:25 AM, review of "Emergency Preparedness Policy" revealed the following: The Incident Command Center will be located at the main office unless emergency results in unusable office space... After Receiving Notification of an Emergency-Direct Care Staff...1. All services will cease... Client (Patient) #1: On February 12, 2024 at approximately 9:05 AM, February 14, 2024 between the approximate times of 10:01 AM and 12:11 PM and February 19, 2025 at approximately 3:32 PM, review of the clinical record revealed the client is 12 years old, the client is a full code (CPR to be initiated) and that oxygen is to be administered for decreased oxygen saturation levels as documented on the "Home Health Certification and Plan of Care"/Addendum to Plan of Treatment for the recertification period of 01/01/2025 through 03/01/2025. On February 13, 2025 at approximately 1:03 PM, review of the February 13, 2025 letter signed by the agency's CEO (Employee #13) revealed the agency's access to the former electronic medical record (EMR) software system was removed by the previous CEO effective 09/29/2024 because the EMR software program was being terminated by the previous CEO. During interview conducted on February 13, 2025 at approximately 11:48 AM, the PDN Director confirmed access to the prior EMR software system was not available which resulted in the inability of agency staff to access clinical record documentation prior to 09/29/2024. On February 11, 2025 at approximately 2:05 PM and February 13, 2025 at approximately 9:25 AM, review of agency's emergency preparedness plan/program failed to reveal that care-related emergencies, cyber-attacks and loss of all or portion of a facility had been included in the risk assessment review of facility and community-based hazards conducted in 2023 and 2024. During interviews conducted on February 14, 2025 at approximately 4:01 PM and February 21, 2025 at approximately 3:30 PM, the PDN Director and the Administrator confirmed that care-related emergencies, cyber-attacks and loss of all or portion of a facility had not been included in the risk assessment review of facility and community-based hazards conducted in 2023 and 2024.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on a review of agency policy/procedure and documentation and based on interview with the Private Duty Nursing (PDN) Director (Employee #5) and the Administrator (Employee #2), the agency failed to ensure the emergency preparedness plan included the contact information for two (2) of three (3) Federal or state agencies. (Federal Emergency Management Agency (FEMA) and Pennsylvania Department of Health-Division of Home Health (PA DOH/DHH licensing agency)). Findings include: On February 11, 2025 at approximately 2:05 PM and February 13, 2025 at approximately 9:25 AM, review of "Emergency Preparedness Policy" revealed the following: Planning....Administration: A current list of contact information will be maintained for...emergency services...and other community services. On February 11, 2025 at approximately 2:05 PM and February 13, 2025 at approximately 9:25 AM, review of agency's emergency preparedness plan/program (EPP/P) failed to reveal the contact information for FEMA nor the PA DOH/DHH (licensing agency) had been included in the agency's EPP/P. During interviews conducted on February 14, 2025 at approximately 4:01 PM and February 21, 2025 at approximately 3:30 PM, the PDN Director and the Administrator confirmed the contact information for FEMA and the PA DOH/DHH (licensing agency) had not been included in the agency's EPP/P.

Based on the findings of an unannounced, onsite Medicare recertification survey conducted February 11 through February 14, 2025, with the off-site portion of the survey being conducted on February 18, 19 and 21, 2025, Golden Care of Northeast PA, Inc. was found not to be in compliance with the following requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies. As a result of the Medicare recertification survey, one (1) Condition level and 19 standard level deficiencies were cited which did not result in immediate jeopardy.

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 and clinical records and based in interview with the Private Duty (PDN) Director (Employee #5), Administrator (Employee #2) and the Chief Executive Officer (CEO-Employee #13), the agency failed to ensure home health Outcome and Assessment Information Set (OASIS) data was transmitted to the Centers for Medicare and Medicaid Services (CMS) system within 30 days of the completion date for two (2) of five (5) adult patients for whom OASIS data was collected. (Patients #4 and #6) Findings include: On February 21, 2025 at approximately 3:48 PM, review of policy 1-028, titled "OASIS Data Collection" revealed the following: Procedure...Home Health Agency will submit the OASIS data...within 30 days of the completion of the OASIS. Patient #4 (Private Duty (PDN) Client): On February 12, 2025 at approximately 10:03 AM, February 14, 2025 between the approximate times of 11:25 AM and 2:10 PM and February 18, 2025 between the approximate times of 12:47 PM and 2:51 PM, review of the clinical record revealed the client is 22 years old and that SN services are to be provided 10.5 hours per day as ordered on the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment for the recertification period of 01/16/2025 through 03/16/2025. Review clinical record revealed the comprehensive reassessment visit was completed on 01/06/2025 and OASIS data collection was completed on 01/14/2025. There was no documentation in the clinical record which provided evidence the OASIS data collected on 01/14/2025 had been transmitted to the CMS system within 30 days of the completion of the assessment. Patient #6 (PDN Client): On February 14, 2025 at approximately 12:38 PM and February 18, 2025 at approximately 1:08 PM, review of the clinical record revealed the patient is 19 years old and that SN services are to be provided as documented on the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment for the recertification period of 01/17/2025 through 03/17/2025. Review clinical record revealed comprehensive reassessment and OASIS data collection was completed on 01/16/2025. There was no documentation in the clinical record which provided evidence the OASIS data collected on 01/16/2025 had been transmitted to the CMS) system within 30 days of completion of the assessment. During interview conducted on February 21, 2025 at approximately 3:30 PM, the PDN Director, Administrator and CEO confirmed there was no documentation in the clinical record which provided evidence OASIS data transmitted to the CMS system within 30 days of the assessment completion date for the above identified patients.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on review of agency policies/procedures, documentation and clinical records, and based on interview with the Private Duty (PDN) Director (Employee #5) and the Administrator (Employee #2), the agency failed to ensure the patient rights forms included notification of the right to be notified of expected outcomes of care, including patient-identified goals, and anticipated benefits for two (2) of two (2) active patients/clients whose start of care date was after September 29, 2024. (Patients #3 and #8) Findings include: On February 13, 2025 at approximately 11:40 AM, review of agency policy titled "Bill of Rights" revealed the following: Purpose...To encourage awareness of patient rights and provide guidelines to assist patients in making decisions regarding care and for active participation in care planning... Procedure...1. The patient will be informed verbally and in writing during the initial evaluation visit and in advance of furnishing care of their rights. On February 11, 2025 at approximately 10:35 AM, review of the skilled nursing visit (SNV-skilled intermittent visits) service line admission packet failed to reveal the patient rights forms included notification of the right to be informed of the expected outcomes of care, including patient-identified goals, and anticipated benefits. On February 11, 2025 at approximately 11:11 AM, review of the PDN (pediatric/adult shift care) service line admission packet failed to reveal the patient rights forms included notification of the right to be informed of the expected outcomes of care, including patient-identified goals, and anticipated benefits. Patient #3 (SNV): On February 12, 2025 at approximately 9:45 AM, review of the clinical record revealed the start of care date was 11/11/2024 and that goals included for the patient to "walk better" and to experience "less pain" as documented on the "Home Health Plan of Care & Certification" for the recertification period of 01/10/2025 through 03/10/2025. Patient (Client) #8 (PDN): On February 14, 2025 at approximately 2:55 PM, February 18, 2025 at approximately 12:49 PM and February 19, 2025 at approximately 3:30 PM, review of the clinical record revealed the start of care date was 01/29/2025 and that goals included for the client to maintain adequate hydration and nutrition status as documented on the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment for the initial certification period of 01/29/2025 through 03/29/2025. There was no documentation in the clinical record which provided evidence patients #3 and #8 received written notification of the right to be informed of the expected outcomes of care, including patient-identified goals, and anticipated benefits. During interviews conducted on February 14, 2025 at approximately 4:01 PM and February 21, 2025 at approximately 3:30 PM, the PDN Director and the Administrator confirmed there was no documentation in the clinical record which provided evidence the above referenced patients received written notification of the right to be informed of the expected outcomes of care, including patient-identified goals, and anticipated benefits.

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on review of agency policies/procedures, documentation and clinical records, and based on interview with the Private Duty (PDN) Director (Employee #5) and the Administrator (Employee #2), the agency failed to ensure the patient rights forms included notification of the right to be notified of the right to receive all services outlined in the plan of care for two (2) of two (2) active patients/clients whose start of care date was after September 29, 2024. (Patients #3 and #8) Findings include: On February 13, 2025 at approximately 11:40 AM, review of agency policy titled "Bill of Rights" revealed the following: Purpose...To encourage awareness of patient rights and provide guidelines to assist patients in making decisions regarding care and for active participation in care planning... Procedure...1. The patient will be informed verbally and in writing during the initial evaluation visit and in advance of furnishing care of their rights. On February 11, 2025 at approximately 10:35 AM, review of the skilled nursing visit (SNV-skilled intermittent visits) service line admission packet failed to reveal the patient rights forms included notification of the right to receive all services outlined in the plan of care. On February 11, 2025 at approximately 11:11 AM, review of the PDN (pediatric/adult shift care) service line admission packet failed to reveal the patient rights forms included notification of the right to receive all services outlined in the plan of care Patient #3 (SNV): On February 12, 2025 at approximately 9:45 AM, review of the clinical record revealed the start of care date was 11/11/2024 and that skilled nursing services are to be provided two (2) times a week for one (1) week followed by one (1) time a week for eight weeks as documented on the "Home Health Plan of Care & Certification" for the recertification period of 01/10/2025 through 03/10/2025. Patient (Client) #8 (PDN): On February 14, 2025 at approximately 2:55 PM, February 18, 2025 at approximately 12:49 PM and February 19, 2025 at approximately 3:30 PM, review of the clinical record revealed the start of care date was 01/29/2025 and that home health aide services ate to be provided eight (8) hours per day for a total of 40 hours per week as documented on the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment for the initial certification period of 01/29/2025 through 03/29/2025. There was no documentation in the clinical record which provided evidence patients #3 and #8 received written notification of the right to receive all services outlined in the plan of care. During interviews conducted on February 14, 2025 at approximately 4:01 PM and February 21, 2025 at approximately 3:30 PM, the PDN Director and the Administrator confirmed there was no documentation in the clinical record which provided evidence the above referenced patients received written notification of the right to receive all services outlined in the plan of care

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on review of agency policy/procedure and clinical records and based in interview with the Private Duty (PDN) Director (Employee #5), Administrator (Employee #2) and the Chief Executive Officer (CEO-Employee #13), the agency failed to ensure a comprehensive assessment was completed by a registered nurse (RN) within five (5) days of the start of care date (SOC) for two (2) of three (3) patients for whom the initial certification period was reviewed. (Patients #7 and #8) Findings include: On February 21, 2025 at approximately 3:46 PM, review of policy 1-016, titled "Initial and Comprehensive Assessment" revealed the following under "Policy": A comprehensive patient assessment will be completed by the registered nurse within five (5) calendar days of the patient's start of care... Patient #7 (Private Duty (PDN) Client-Discharge): On February 14, 2025 at approximately 1:32 PM, February 18, 2025 between the approximate times of 1:04 PM and 2:55 PM and February 19, 2025 at approximately 3:27 PM, review of the clinical record revealed the SOC date was 10/15/2024 and that home health aide (HHA) services were to be provided as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 10/15/2024 through 12/13/2024. Review of the "Web Pediatric Assessment", for which a handwritten note of "RN Admission Assessment" was documented on the top of page 1 of the form, revealed an initial nursing assessment was completed by the PDN Assistant Clinical Nurse Manager/RN (Employee #7) on 10/11/2024 which was four (4) days prior to the start of SOC date. There was no documentation which provided evidence a comprehensive nursing assessment had been completed by an RN within five (5) days of the SOC. Patient #8 (PDN) Client): On February 14, 2025 at approximately 2:55 PM, February 18, 2025 between at approximately 12:49 PM and February 19, 2025 at approximately 3:30 PM, review of the clinical record revealed the SOC date was 01/29/2025 and that HHA services are to be provided as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 01/29/2025 through 03/29/2025. Review of the "Web Pediatric Assessment", for which a handwritten note of "RN Comp Assessment" was documented on the top of page 1 of the form, revealed an initial comprehensive assessment was completed by the PDN Clinical Manager/RN (Employee #8) on 01/27/2025 which was two (2) days prior to the start of SOC date. There was no documentation which provided evidence a comprehensive nursing assessment had been completed by an RN within five (5) days of the SOC. During interview conducted on February 21, 2025 at approximately 3:30 PM, the PDN Director, Administrator and CEO confirmed there was no documentation in the clinical record which provided evidence a comprehensive assessment had been completed by an RN within five (5) days of the SOC for the above referenced patients.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on review of agency policy/procedure and clinical records and based in interview with the Private Duty (PDN) Director (Employee #5), Administrator (Employee #2) and the Chief Executive Officer (CEO-Employee #13), the agency failed to ensure home health Outcome and Assessment Information Set (OASIS) data was collected during the comprehensive re-assessment for two (2) of five (5) adult patients who received skilled nursing (SN) services. (Patients #4 and #6) Findings include: On February 21, 2025 at approximately 3:48 PM, review of policy 1-028, titled "OASIS Data Collection" revealed the following: Policy...OASIS data will be collected for all Medicare and Medicaid patients who are 18 years or older. RN (registered nurse) will collect OASIS data at...recertification... Procedure...14. Services to be provided will be based on the prioritized needs of the patient. Each patient will be monitored for his/her response to care or services provided against established patient goals and outcomes to determine if goals have been achieved. Patient #4 (PDN Client): On February 12, 2025 at approximately 10:03 AM, February 14, 2025 between the approximate times of 11:25 AM and 2:10 PM and February 18, 2025 between the approximate times of 12:47 PM and 2:51 PM, review of the clinical record revealed the client is 22 years old and that SN services are to be provided 10.5 hours per day as ordered on the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment for the recertification period of 01/16/2025 through 03/16/2025. Review OASIS data collection documentation dated 01/14/2025 revealed the patient's payer source is a Medicaid Managed Care Plan. There was no documentation which provided evidence OASIS data was collected with the comprehensive recertification assessments completed on 09/22/2024 and 11/17/2024. Patient #6 (PDN Client): On February 14, 2025 at approximately 12:38 PM and February 18, 2025 at approximately 1:08 PM, review of the clinical record revealed the patient is 19 years old and that SN services are to be provided as documented on the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment for the recertification period of 01/17/2025 through 03/17/2025. Review OASIS data collection documentation dated 01/16/2025 revealed the patient's payer source was Medicaid There was no documentation which provided evidence OASIS data was collected with the comprehensive recertification assessments completed on 09/18/2024 and 11/15/2024. During interview conducted on February 21, 2025 at approximately 3:30 PM, the PDN Director, Administrator and CEO confirmed there was no documentation in the clinical record which provided evidence OASIS data was collected during the aforementioned comprehensive recertification assessments for the above identified patients.

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 review of agency policy/procedure and clinical records and based in interview with the Private Duty (PDN) Director (Employee #5), Administrator (Employee #2) and the Chief Executive Officer (CEO-Employee #13), the agency failed to ensure skilled nursing (SN) services were provided in accordance with orders included on the home plan of care for two (2) of eight (8) patients. (Patients #1 and #4) Findings include: On February 21, 2025 at approximately 3:47 PM, review of policy 1-007, titled "Care Planning Process" revealed the following: Purpose...To provide clinical direction to the clinicians providing direct patient care. Procedure...14. Services to be provided will be based on the prioritized needs of the patient. Each patient will be monitored for his/her response to care or services provided against established patient goals and outcomes to determine if goals have been achieved. Patient #1 (Private Duty (PDN) Client): On February 12, 2025 at approximately 9:05 AM, February 14, 2025 between the approximate times of 10:01 AM and 12:11 PM and February 19, 2025 at approximately 3:32 PM, review of the clinical record revealed the client is 12 years old, the primary diagnosis is epilepsy (seizures), that SN services are to be provided eight (8) hours per day and that SN is to assess vital signs (temperature, pulse and respirations) every shift as ordered on the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment for the recertification period of 01/01/2025 through 03/01/2025. Review of "Web Pediatric Visit Assessment" documentation failed to reveal the registered nurse (RN-Employee #4) assessed the patient's respiratory rate during 39 shifts between 01/01/2025 and 02/09/2025. Review of visit calendar documentation revealed less than eight (8) hours of SN services were provided on 01/02/2025 and 01/20/2025. There was no documentation in the clinical record which provided evidence the patient's responsible party had requested a reduction in the SN visit hours on 01/02/2025 and 01/20/2025. Patient #4 (PDN Client): On February 12, 2025 at approximately 10:03 AM, February 14, 2025 between the approximate times of 11:25 AM and 2:10 PM and February 18, 2025 between the approximate times of 12:47 PM and 2:51 PM, review of the clinical record revealed the client is 22 years old, the primary diagnosis is type-1 diabetes mellitus and that SN services are to be provided 10.5 hours per day as ordered on the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment for the recertification period of 01/16/2025 through 03/16/2025. Review of visit calendar documentation revealed less than 10.5 hours of SN services were provided for 17 SN shifts completed between 01/16/2025 and 02/11/2025. There was no documentation in the clinical record which provided evidence the patient's responsible party had requested a reduction in the SN visit hours between 01/16/2025 and 02/11/2025. During interview conducted on February 21, 2025 at approximately 3:30 PM, the PDN Director, Administrator and CEO confirmed there was no documentation in the clinical record which provided evidence the SN services were provided in accordance with the aforementioned orders included on the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment for above identified patients.

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 policy/procedure and clinical records and based in interview with the Private Duty (PDN) Director (Employee #5), Administrator (Employee #2) and the Chief Executive Officer (CEO-Employee #13), the agency failed to ensure a home health certification and plan of care included 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, for four (4) of six (6) active patients. (Patients #1, #4, #6 and #8) Findings include: On February 21, 2025 at approximately 3:47 PM, review of policy 1-007, titled "Care Planning Process" revealed the following under "Policy": Definitions...1. Individualized Plan of Care: The patient-specific plan of care includes... V. 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. Patient #1 (Private Duty (PDN) Client): On February 12, 2025 at approximately 9:05 AM, February 14, 2025 between the approximate times of 10:01 AM and 12:11 PM and February 19, 2025 at approximately 3:32 PM, review of the clinical record revealed there was no documentation which provided evidence the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment for the recertification period of 01/05/2025 through 03/01/2025 included 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. Patient #4 (PDN Client): On February 12, 2025 at approximately 10:03 AM, February 14, 2025 between the approximate times of 11:25 AM and 2:10 PM and February 18, 2025 between the approximate times of 12:47 PM and 2:51 PM, review of the clinical record revealed there was no documentation which provided evidence the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment for the recertification period of 01/16/2025 through 03/16/2025 included 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. Patient #6 (PDN Client): On February 14, 2025 at approximately 12:38 PM and February 18, 2025 at approximately 1:08 PM, review of the clinical record there was no documentation which provided evidence the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment for the recertification period of 01/17/2025 through 03/17/2025 included 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. Patient #8 (PDN Client): On February 14, 2025 at approximately 2:55 PM, February 18, 2025 between at approximately 12:49 PM and February 19, 2025 at approximately 3:30 PM, review of the clinical record revealed there was no documentation which provided evidence the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment for the initial certification period of 01/29/2025 through 03/29/2025 included 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. During interview conducted on February 21, 2025 at approximately 3:30 PM, the PDN Director, Administrator and CEO confirmed there was no documentation in the clinical record which provided evidence the "Home Health Certification and Plan of Care"/Addendum to the Plan of Treatment included 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 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, documentation and Pennsylvania Department of Health (PA DOH) website reports and based on interview with the Private Duty (PDN) Director (Employee #5) and the Administrator (Employee #2), the agency failed to submit a report of four (4) of five (5) reports of Health Department Reportable Diseases to the PA DOH Event Reporting System (ERS) website which were received after October 10, 2023. (Influenza and Respiratory Syncytial Virus (RSV)) Findings include: On February 11, 2025 at approximately 2:02 PM, review of policy 7-001, titled "Infection Control Plan", revealed the following under "Procedure": 6. The Performance Improvement Coordinator will be responsible for...reporting infection control activities to...other appropriate authorities. On February 11, 2025 at approximately 1:25 PM, review of the PA DOH website (https://www.health.pa.gov/topics/Reporting-Registries/Pages/Reportable-Diseases.aspx) revealed influenza and RSV are Health Department Reportable Diseases. On February 11, 2025 between the approximate times of 1:20 PM and 1:47 PM, review of agency incident/adverse event report documentation revealed the following client-related contagious disease reports were received by the agency: 02/01/2025, 02/08/2025: Influenza 01/30/2025 and 01/24/2025: RSV. On February 11, 2025 at approximately 1:30 PM, review of the PA DOH database website failed to reveal that the agency had submitted a report of the above referenced Health Department Reportable Diseases to the PA DOH ERS website. During interviews conducted between February 14, 2025 at 4:01 PM and February 21, 2025 approximately 3:30 PM, the PDN Director and the Administrator confirmed the agency failed to submit a report of the above referenced Health Department Reportable Diseases to the PA DOH ERS website.

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, Centers for Disease Control and Prevention (CDC) and the Pennsylvania Department of Health (PA DOH) tuberculosis screening recommendations and/or requirements, clinical records and personnel files, and based on interview with the Private Duty (PDN) Director (Employee #5) and the Administrator (Employee #2), the agency failed to ensure TB screening was completed in accordance with agency policy/procedure, CDC and PA DOH recommendations for four (4) of four (4) agency staff whose date of hire was after October 10, 2023. (Employees #7, #8, #9 and #10) Findings include: On February 11, 2025 at approximately 2:02 PM, review of policy 7-001, titled "Infection Control Plan", revealed the following under "Purpose": 5. Comply with all applicable local, state, and federal regulations including, but not limited to: A. State...mandates B. CDC recommendations and guidelines. On February 21, 2025 at approximately 1:34 PM, review of agency policy 2-051, titled Initial TB Screening for Employees" revealed the following under "Policy": Golden Care shall ensure that each direct care worker...prior to consumer contact, provide documentation that the individual has been screened for and is free from active TB. On February 21, 2025 at approximately 1:35 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 The 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)). On February 21, 2025 at approximately 1:38 PM, review the PA DOH webpage ( https://www.pa.gov/agencies/health/diseases-conditions/infectious-disease/tuberculosis/tb-testing-health-care-workers.html ) revealed the following: Tuberculosis Testing Health Care Workers...On May 17, 2019 the Centers for Disease Control and Prevention (CDC) issued updated recommendations for TB testing of health care personnel. Key points include: The updated recommendations call for health care personnel to be screened for TB upon hire with an individual risk assessment(opens in a new tab), a symptom evaluation, and a TB test (either the interferon gamma-release assay, or IGRA, blood test or the tuberculin skin test-). On February 21, 2025 at approximately 1:45 PM, review of the PA DOH TB manual ( https://www.pa.gov/content/dam/copapwp-pagov/en/health/documents/topics/documents/diseases-and-conditions/tb/CMHD%20TB%20Manual%202023.pdf ) revealed the following: LAWS PERTAINING TO TB CONTROL...Pennsylvania laws on TB can be found in the Administrative Code of 1929 and the Disease Prevention and Control Law of 1955, 35 P.S. Sec. 521.1 . Under the provisions of the Pennsylvania Administrative Code of 1929 and the Disease Prevention and Control Law of 1955, DOH has the authority to "protect the health of the people of this Commonwealth, and to determine and employ the most efficient and practical means for the prevention and suppression of disease." Patient #6 (PDN Client): On February 14, 2025 at approximately 12:38 PM, February 18, 2025 at approximately 1:08 PM, review of the clinical record revealed the two (2) home health aides (HHA-Employees #9 and #10) provided HHA services in January and February 2025. Patient #7 (Discharge-PDN Client): On February 14, 2025 at approximately 1:32 PM, February 18, 2025 at approximately 1:04 PM and February 19, 2025 at approximately 3:27 PM, review of the clinical record revealed the registered nurse (RN-Employee #7) completed the pediatric start of care assessment on 10/11/2024. Patient #8 (PDN Client): On February 14, 2025 at approximately 2:55 PM, February 18, 2025 at approximately 12:49 PM and February 19, 2025 at approximately 3:30 PM, review of the clinical record revealed the RN (Employee #8) completed the pediatric start of care assessment on 01/27/2025. On February 12, 2025 at approximately 12:55 PM, February 13, 2025 at approximately 11:58 AM, February 14, 2025 between the approximate times of 9:47 AM and 3:15 PM, February 18, 2025 between the approximate times of 12:30 PM and 1:13 PM and February 20, 2025 at approximately 3:45 PM, review of personnel file documentation revealed the following: Employee #7: The date of hire of the RN was 03/05/2024. The first date of assignment to provide SN services was 04/15/2024. There was no documentation in the personnel file which provided evidence a TB individual risk assessment has been completed prior to the assignment to perform SN assessments. Employee #8: The date of hire of the RN was 01/15/2024. There was no documentation in the personnel file which provided evidence a TB individual risk assessment nor TB symptom screening had been completed prior to the assignment to perform SN assessments. Employee #9: The date of hire of the HHA was 02/05/2024. The first date of assignment (clock-in date) to provide HHA services was 02/09/2024. Review of the TST results revealed the first step TST was completed on 02/16/2024 and that on 02/14/2025, the TB individual risk assessment and TB symptom screening was completed by the HHA. There was no documentation in the personnel file which provided evidence the first step TST and TB individual risk assessment and TB symptom screening had been completed prior to the assignment to provide HHA services. Employee #10: The date of hire of the HHA was 01/15/2024. The first date of assignment (clock-in date) to provide HHA services was 01/18/2024. A chest x-ray was completed on 01/18/2024 for TB screening but there was no documentation in the personnel file which provided evidence the HHA had a past history of a positive TB screening result. TB blood screening was completed on 03/07/2024 which was after the first date of assignment. There was no documentation which provided evidence the TB individual risk assessment nor TB symptom screening had been completed prior to the assignment to provide HHA services. There was no documentation in the personnel files which provided evidence TB screening (TB individual risk assessment, TB symptom screening and TB skin or blood tests) had be completed in accordance with CDC and/or PA DOH recommendations and/or requirements prior to the assignment of Employees #7, #8, #9 and #10 to provide home health services. During interviews conducted on February 14, 2025 at approximately 4:02 PM and February 21, 2025 at approximately 3:30 PM, the PDN Director and the Administrator confirmed initial TB screening was not conducted in accordance with agency policy/procedure, CDC and PA DOH recommendations and/or requirements for the above referenced employees.

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 review of agency policy/procedure, documentation, clinical records and personnel files and the Pennsylvania Department of Health database, and based on interview with the Private Duty (PDN) Director (Employee #5), the Administrator (Employee #2) and the Chief Executive Officer (CEO-Employee #13), the agency failed to ensure 75 hours of home health aide (HHA) training, including16 hours of classroom and 16 hours of supervised practical training had been completed by HHA's whose date of hire was after October 10, 2023 (G0762), the agency failed to ensure the home health aide (HHA) competency evaluation program included all required subject matter (G0764), the agency failed to ensure HHA's completed a HHA competency evaluation program prior to the assignment to provide HHA services (G0768), the agency failed to ensure 12 hours of in-service training had been completed by a HHA who provides HHA services to adults requiring intermittent visits (SNV) (G0774), and the agency failed to ensure documentation was maintained which provided evidence an eligible home health agency conducted the initial HHA training and competency evaluation program (G0782). Cross Reference Tags: §484.80(b) Standard (Non-Level 1): Content and duration of home health aide classroom and supervised practical training: Minimum hours of training (G0762) §484.80(b) Standard (Non-Level 1): Content and duration of home health aide classroom and supervised practical training: HHA training program topics (G0764) §484.80(c) Standard (Level 1): Competency evaluation (G0768) §484.80(d) Standard (Non-Level 1): In-service training: 12 hours In-service every 12 months (G0774) §484.80(f) Standard (Non-Level 1): Eligible training and competency evaluation organizations (G0782)

Minimum hours of training CFR(s): 484.80(b)(2) A minimum of 16 hours of classroom training must precede a minimum of l6 hours of supervised practical training as part of the 75 hours. This ELEMENT is not met as evidenced by: Based on review of agency policy/procedure, clinical records and personnel files, and based on interview with the Private Duty (PDN) Director (CEO-Employee #5), the Administrator (Employee #2) and the Chief Executive Officer (Employee #13), the agency failed to ensure 75 hours of home health aide (HHA) training, including 16 hours of classroom and 16 hours of supervised practical training had been completed by two (2) of two (2) HHA's whose date of hire was after August 21, 2023. (Employees #9 and #10) Findings include: On February 21, 2025 at approximately 1:50 PM, review of policy 2-952, titled "Home Health Aide Training/Competency Evaluation", revealed the following: Policy...Home health aide employees' skill training will be performed upon hire... Procedure...Pass competency test... Patient #6 (PDN Client): On February 14, 2025 at approximately 12:38 PM, February 18, 2025 at approximately 1:08 PM, review of the clinical record revealed the two (2) home health aides (HHA-Employees #9 and #10) provided HHA services in January and February 2025. On February 12, 2025 at approximately 12:55 PM, February 13, 2025 at approximately 11:58 AM, February 14, 2025 between the approximate times of 9:47 AM and 3:15 PM, February 18, 2025 between the approximate times of 12:30 PM and 1:13 PM and February 20, 2025 at approximately 3:45 PM, review of personnel file documentation revealed the following: Employee #9: The date of hire of the HHA was 02/05/2024. The first date of assignment (clock-in date) to provide HHA services was 02/09/2024 which was the four (4) days after the date of hire. Review of personnel file documentation revealed the "Home Health Aide Skills Check List-Golden Care of NEPA" and "HHA Training Quiz" were completed on 02/12/2024 which was after the first date of assignment. There was no documentation on the personnel file which provided evidence the HHA completed a total of 75 hours of HHA training, including 16 hours of classroom and 16 hours of supervised practical training. Employee #10: The date of hire of the HHA was 01/15/2024. The first date of assignment (clock-in date) to provide HHA services was 01/18/2024 which was the three (3) days after the date of hire. Personnel file documentation revealed the "Home Health Aide Skills Check List-Golden Care of NEPA" was completed on 01/15/2024 but the personnel file did not include documentation the "HHA Training Quiz" had been completed. Review of the "SwiftShift" Certificate of Completion revealed the HHA completed 75 hours of HHA training, which included 16 hours of in-person training but there was no documentation on the personnel file which provided evidence the HHA completed a total of 16 hours of classroom and 16 hours of supervised practical training. During interview conducted on February 21, 2025 at approximately 3:30 PM, the PDN Director, the Administrator and the CEO confirmed there was no documentation in the personnel file which provided evidence Employees #9 and #10 had completed a total of 75 hours of HHA training and/or 16 hours of classroom and 16 hours of supervised practical training.

HH aide training program topics CFR(s): 484.80(b)(3) A home health aide training program must address each of the following subject areas: (i) Communication skills, including the ability to read, write, and verbally report clinical information to patients, representatives, and caregivers, as well as to other HHA staff. (ii) Observation, reporting, and documentation of patient status and the care or service furnished. (iii) Reading and recording temperature, pulse, and respiration. (iv) Basic infection prevention and control procedures. (v) Basic elements of body functioning and changes in body function that must be reported to an aide's supervisor. (vi) Maintenance of a clean, safe, and healthy environment. (vii) Recognizing emergencies and the knowledge of instituting emergency procedures and their application. (viii) The physical, emotional, and developmental needs of and ways to work with the populations served by the HHA, including the need for respect for the patient, his or her privacy, and his or her property. (ix) Appropriate and safe techniques in performing personal hygiene and grooming tasks that include -- (A) Bed bath; (B) Sponge, tub, and shower bath; (C) Hair shampooing in sink, tub, and bed; (D) Nail and skin care; (E) Oral hygiene; (F) Toileting and elimination; (x) Safe transfer techniques and ambulation; (xi) Normal range of motion and positioning; (xii) Adequate nutrition and fluid intake; (xiii) Recognizing and reporting changes in skin condition; and (xiv) Any other task that the HHA may choose to have an aide perform as permitted under state law. (xv) The HHA is responsible for training home health aides, as needed, for skills not covered in the basic checklist, as described in paragraph (b)(3)(ix) of this section. This ELEMENT is not met as evidenced by: Based on review of agency policy/procedure, clinical records and personnel files and based on interview with the Private Duty (PDN) Director (Employee #5), the Administrator (Employee #2) and the Chief Executive Office (CEO-Employee #13), the agency failed to ensure the home health aide (HHA) competency evaluation program completed by one (1) of two (2) HHA's included all required subject matter. (Employee #10) Findings include: On February 21, 2025 at approximately 1:50 PM, review of policy 2-952, titled "Home Health Aide Training/Competency Evaluation", revealed the following: Policy...Home health aide employees' skill training will be performed upon hire... Procedure...Pass competency test... Patient #6 (PDN Client): On February 14, 2025 at approximately 12:38 PM, February 18, 2025 at approximately 1:08 PM, review of the clinical record revealed the two (2) home health aides (HHA-Employees #9 and #10) provided HHA services in January and February 2025. Tasks included on the HHA Plan of Care included, but were not limited to, the following: -Check skin condition; check pressure areas -Fall precautions; -Bath-assist patient; shower with assistance; and -Encourage fluids. On February 12, 2025 at approximately 12:55 PM, February 13, 2025 at approximately 11:58 AM, February 14, 2025 between the approximate times of 9:47 AM and 3:15 PM, February 18, 2025 between the approximate times of 12:30 PM and 1:13 PM and February 20, 2025 at approximately 3:45 PM, review of personnel file documentation revealed the following: Employee #10: The date of hire of the HHA was 01/15/2024. The first date of assignment (clock-in date) to provide HHA services was 01/18/2024. Review of the "Home Health Aide Skills Check List-Golden Care of NEPA" and the undated "SwiftShift" Certificate of Completion failed to provide evidence the following subject matter was included in the HHA's training/competency evaluation program: v) Basic elements of body functioning and changes in body function that must be reported to an aide’s supervisor. (vi) Maintenance of a clean, safe, and healthy environment (ix) Tub bath and shower (xii) Adequate fluid intake. During interview conducted on February 21, 2025 at approximately 3:30 PM, the PDN Director, the Administrator and the CEO confirmed there was no documentation which provided evidence the HHA competency training/evaluation program completed by Employee #10 included the above referenced subject matter.

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, clinical records and personnel files, and based on interview with the Private Duty (PDN) Director (Employee #5), the Administrator (Employee #2) and the Chief Executive Officer (CEO-Employee #13), the agency failed to ensure two (2) of two (2) home health aides (HHA) completed a HHA competency evaluation program prior to the assignment to provide HHA services. (Employees #9 and #10) Findings include: On February 21, 2025 at approximately 1:50 PM, review of policy 2-952, titled "Home Health Aide Training/Competency Evaluation", revealed the following: Policy...Home health aide employees' skill training will be performed upon hire... Procedure...Pass competency test... Patient #6 (PDN Client): On February 14, 2025 at approximately 12:38 PM, February 18, 2025 at approximately 1:08 PM, review of the clinical record revealed the two (2) home health aides (HHA-Employees #9 and #10) provided HHA services in January and February 2025. On February 12, 2025 at approximately 12:55 PM, February 13, 2025 at approximately 11:58 AM, February 14, 2025 between the approximate times of 9:47 AM and 3:15 PM, February 18, 2025 between the approximate times of 12:30 PM and 1:13 PM and February 20, 2025 at approximately 3:45 PM, review of personnel file documentation revealed the following: Employee #9: The date of hire of the HHA was 02/05/2024. The first date of assignment (clock-in date) to provide HHA services was 02/09/2024 which was the four (4) days after the date of hire. Review of personnel file documentation revealed the "Home Health Aide Skills Check List-Golden Care of NEPA" and "HHA Training Quiz" were completed on 02/12/2024 which was after the first date of assignment. There was no documentation on the personnel file which provided evidence the HHA completed a competency evaluation program prior to the assignment to provide HHA services. Employee #10: The date of hire of the HHA was 01/15/2024. The first date of assignment (clock-in date) to provide HHA services was 01/18/2024 which was the three (3) days after the date of hire. Personnel file documentation revealed the "Home Health Aide Skills Check List-Golden Care of NEPA" was completed on 01/15/2024 but the personnel file did not include documentation that the "HHA Training Quiz" had been completed. Review of the "SwiftShift" Certificate of Completion revealed the HHA completed 75 hours of HHA training, which included 16 hours of in-person training, but the certificate was undated; therefore, there was no documentation on the personnel file which provided evidence the HHA completed a competency evaluation program prior to the assignment to provide HHA services. During interview conducted on February 21, 2025 at approximately 3:30 PM, the PDN Director, the Administrator and the CEO confirmed there was no documentation in the personnel file which provided evidence Employees #9 and #10 had completed a competency evaluation program prior to the assignment to provide HHA services.

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 Private Duty (PDN) Director (Employee #5) and the Administrator (Employee #2), the agency failed to ensure 12 hours of in-service training had been completed by one (1) of one (1) home health aides (HHA) who was employed for since 2017. (Employee #3) Findings include: On February 21, 2025 at approximately 1:50 PM, review of policy 2-952, titled "Home Health Aide Training/Competency Evaluation", revealed the following under "Procedure": 2. Attend scheduled training, and at least 12 hours of in-services per year. Patient #2 (Adult Skilled Nursing Visit): On February 12, 2025 at approximately 9:09 AM, review of the clinical record revealed the HHA (Employees #3) provided HHA services in January and February 2025. On February 12, 2025 at approximately 12:55 PM, February 13, 2025 at approximately 11:58 AM, February 14, 2025 between the approximate times of 9:47 AM and 3:15 PM, February 18, 2025 between the approximate times of 12:30 PM and 1:13 PM and February 20, 2025 at approximately 3:45 PM, review of personnel file documentation revealed the following: Employee #3: The date of hire of the HHA was 08/22/2017. In-service record documentation revealed the HHA completed six (6) hours of in-service training in 2024. There was no documentation in the personnel file which provided evidence the HHA completed 12 hours of in-service training in 2024. During interviews conducted on February 14, 2025 at approximately 4:02 PM and February 21, 2025 at approximately 3:30 PM, the PDN Director and the Administrator confirmed there was no documentation which provided evidence Employee #3 completed 12 hours of in-service training in 2024.

Eligible training/competency evaluation orgs. CFR(s): 484.80(f) 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: (1) Was out of compliance with the requirements of paragraphs (b), (c), (d), or (e) of this section; or (2) Permitted an individual who does not meet the definition of a "qualified home health aide" as specified in paragraph (a) of this section to furnish home health aide services (with the exception of licensed health professionals and volunteers); or (3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or (4) Was assessed a civil monetary penalty of $5,000 or more as an intermediate sanction; or (5) Was found to have compliance deficiencies that endangered the health and safety of the HHA's patients, and had temporary management appointed to oversee the management of the HHA; or (6) Had all or part of its Medicare payments suspended; or (7) Was found under any federal or state law to have: (i) Had its participation in the Medicare program terminated; or (ii) Been assessed a penalty of $5,000 or more for deficiencies in federal or state standards for HHAs; or (iii) Been subjected to a suspension of Medicare payments to which it otherwise would have been entitled; or (iv) Operated under temporary management that was appointed to oversee the operation of the HHA and to ensure the health and safety of the HHA's patients; or (v) Been closed, or had its patients transferred by the state; or (vi) Been excluded from participating in federal health care programs or debarred from participating in any government program. This STANDARD is not met as evidenced by: Based on review of agency policy/procedure, documentation, clinical records and personnel files, and Pennsylvania Department of Health (PA DOH) database documentation, and based on interview with the Private Duty (PDN) Director (Employee #5), the Administrator (Employee #2) and the Chief Executive Office (CEO-Employee #13), the agency failed to ensure documentation was maintained which provided evidence an eligible home health agency conducted the initial home health aide (HHA) training and competency evaluation program for two (2) of two (2) HHA's whose date of hire was after October 10, 2023. (Employees #9 and #10) Findings include: On February 21, 2025 at approximately 1:50 PM, review of policy 2-952, titled "Home Health Aide Training/Competency Evaluation", revealed the following: Policy...Home health aide employees' skill training will be performed upon hire... Procedure...Pass competency test... On February 14, 2025 at 3:51 PM, review of PA DOH database documentation revealed a letter dated 08/08/2022 was forwarded to the Administrator (Employee #5). The letter provided notice to the agency that an extended survey was completed on 07/28/2022 and that the agency was advised a home health agency may not have had any Conditions of Participation identified as being out of compliance within the 24-month period of beginning a home health aide training and competency evaluation program. Patient #6 (PDN Client): On February 14, 2025 at approximately 12:38 PM, February 18, 2025 at approximately 1:08 PM, review of the clinical record revealed the two (2) home health aides (HHA-Employees #9 and #10) provided HHA services in January and February 2025. On February 12, 2025 at approximately 12:55 PM, February 13, 2025 at approximately 11:58 AM, February 14, 2025 between the approximate times of 9:47 AM and 3:15 PM, February 18, 2025 between the approximate times of 12:30 PM and 1:13 PM and February 20, 2025 at approximately 3:45 PM, review of personnel file documentation revealed the following: Employee #9: The date of hire of the HHA was 02/05/2024. The first date of assignment (clock-in date) to provide HHA services was 02/09/2024. Review of personnel file documentation revealed the "Home Health Aide Skills Check List-Golden Care of NEPA" and Golden Care Pediatrics "HHA Training Quiz" completed on 02/12/2024 were signed by a registered nurse (RN-Employee #14). The agency's name was included on the top portion of the skills checklist and training quiz. Employee #10: The date of hire of the HHA was 01/15/2024. The first date of assignment (clock-in date) to provide HHA services was 01/18/2024. Personnel file documentation revealed the "Home Health Aide Skills Check List-Golden Care of NEPA" completed on 01/15/2024 and the undated "SwiftShift" Certificate of Completion were signed (hand-written or electronically) by an RN (Employee #14). The agency's name was included on the top portion of the skills checklist. On February 11, 2024 at approximately 2:05 PM and February 13, 2025 at approximately 9:25 AM, review of the April 2023 "Emergency Preparedness Policy" revealed the above referenced RN (Employee #14) served as the agency's alternate PDN clinical nurse manager. During interview conducted on February 14, 2025 at approximately 4:20 PM, the PDN Manager reported the RN (Employee #14) had been employed by both the agency and a second home health agency (Agency #2). The PDN Manager reported the RN conducted the HHA training and competency evaluation program as an employee of Agency #2. On February 18, 2025 at approximately 2:40 PM, review of documentation forwarded by the licensed practical nurse/PD specialist (LPN/PDS-Employee #6) revealed the RN (Employee #14) and the agency's former CEO signed a contract in which the RN responsibilities under Agency #2 included home health aide and direct care worker training as documented in Appendix A. The effective date of the contract between the RN and Agency #2 was 11/10/2023. Review of compensation documentation under Appendix B and the 1099-NEC tax form revealed the RN was compensated for 8 hours of services in 2024 but the 1099-NEC form did not include the dates the RN provided HHA training and competency evaluation services under Agency #2. During interview conducted on February 21, 2025 at approximately 3:30 PM, the PDN Director, the Administrator and the CEO confirmed there was no documentation which provided evidence that the HHA competency training and evaluation programs for Employees #9 and #10 had been completed by Agency #2.

Disclosure of ownership and management info. CFR(s): 484.100(a) The HHA must comply with the requirements of part 420 subpart C, of this chapter. The HHA also must disclose the following information to the state survey agency at the time of the HHA's initial request for certification, for each survey, and at the time of any change in ownership or management: (1) The names and addresses of all persons with an ownership or controlling interest in the HHA as defined in §420.201, §420.202, and §420.206 of this chapter. (2) The name and address of each person who is an officer, a director, an agent, or a managing employee of the HHA as defined in §420.20l, §420.202, and §420.206 of this chapter. (3) The name and business address of the corporation, association, or other company that is responsible for the management of the HHA, and the names and addresses of the chief executive officer and the chairperson of the board of directors of that corporation, association, or other company responsible for the management of the HHA. This STANDARD is not met as evidenced by: Based on a review of agency policy/procedures, documentation and the Pennsylvania Department of Health (PA DOH) database and based on interview with the Private Duty (PDN) Director , Administrator (Employee #2), Consultant (Employee #12)) and the Chief Executive Officer (CEO-Employee #13), the Governing Body (Board of Directors) failed to submit written notice to the PA DOH/Division of Home Health for three (3) of three (3) organizational changes which occurred in 2024. (Change in the Chief Executive Officer, Board of Directors (Governing Body) and Administrator) Findings Included: On February 13, 2025 at approximately 11:32 AM,, review of the policy 8-002, titled "Governing Body", revealed the following: Policy: The Governing Body will assume full legal authority, responsibility and accountability for the overall management and operations... On February 13, 2025 at approximately 1:16 PM, review of the "Governing Body Approval of New Administrator Meeting" minutes dated 07/19/2024 revealed a registered nurse (Employee #2) was appointed as administrator effective 07/23/2024. On February 13, 2025 at approximately 3:01 PM, review of agency documentation revealed the following organizational changes occurred in October 2024: "Golden Care Resignation" letter: The former Chief Executive Officer resigned as sole director of the Board of Directors effective 10/09/2024. "Action by Unanimous Written Consent of the Sole Director of Golden Care of Northeast Pennsylvania, Inc.": A new Chief Executive Officer and President (Employee #13), Secretary (Employee #5) and Treasurer (Employee #12) were appointed to the Board of Directors (Governing Body) effective 10/01/2024. On February 13, 2025 at approximately 3:12 PM, review of the PA DOH database failed to reveal that written notice of the above referenced organizational changes had been submitted to the PA DOH/Division of Home Health prior to 02/11/2025. During interview conducted on February 14, 2025 at approximately 4:01 PM, the Administrator, PDN Director and Consultant confirmed there was no documentation which provided evidence that written notice of the above referenced organizational changes had been submitted to the PA DOH/Division of Home Health prior to 02/11/2025. During interview conducted on February 21, 2025 at approximately 3:30 PM, the CEO confirmed there was no documentation which provided evidence that written notice of the above referenced organizational changes had been submitted to the PA DOH/Division of Home Health prior to 02/11/2025.

Laboratory services/CLIA waivers CFR(s): 484.100(c)(1) Laboratory services. If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient's equipment when assisting with self-administered tests. This STANDARD is not met as evidenced by: Based on review of agency policy, Federal regulations under the Clinical Laboratory Improvement Amendment of 1988 (CLIA) and clinical records and based on interview with a licensed practical nurse (LPN-Employee #1) and the Private Duty (PDN) Director (Employee #5) and the Administrator (Employee #2), the agency failed to maintain a CLIA Certification of Waiver for 6 of 6 months after expiration of the CLIA Certification of Waiver. (September 2024 through February 2025) Findings include: On February 13, 2025 at approximately 11:42 AM, review of agency policy 2-022, titled "Waived Testing" revealed the following under "Procedure": Golden Care will apply for and maintain a CLIA Waiver on file. On February 21, 2025 at 1:15 PM, review of the Centers for Disease Control website ( https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/apply ) revealed the following as included under the CLIA regulatory requirements: Under CLIA, a facility is a laboratory if it performs even one test on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings.” Patient #4: On February 14, 2025 at approximately 10:23 AM, February 14, 2025 at approximately 11:25 AM and February 18, 2025 between the approximate times of 12:47 PM and 2:51 PM, review of the clinical record revealed diagnoses include Type-1 diabetes mellitus and spastic cerebral palsy and that skilled nursing (SN) is to perform blood glucose monitoring via a glucometer every shift and as needed as documented on the Addendum to the Plan of Treatment for the recertification period of 01/16/2025 through 03/16/2025. An interview was conducted with the LPN (Employee #1) during the home visit conducted on February 12, 2025 at approximately 10:25 AM. The LPN confirmed the LPN performs blood glucose monitoring via a glucometer at least one (1) time per SN shift. On February 11, 2025 at approximately 11:50 AM, review of the CLIA Certificate of Waiver revealed the CLIA waiver was issued on 09/01/2022 and expired on 08/31/2024. There was no documentation which provided evidence that the agency obtained a CLIA Certificate of Waiver after 08/31/2024. During interview conducted on February 14, 2025 at approximately 4:01 PM and February 21, 2025 at approximately 3:30 PM, the PDN Director and the Administrator confirmed the agency failed to obtain a CLIA Certification of Waiver after 08/31/2024.

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on a review of agency policy/procedures and documentation and based on interview with the Private Duty (PDN) Director, Administrator (Employee #2), Consultant (Employee #12)) and the Chief Executive Officer (CEO-Employee #13), the Governing Body (Board of Directors) and the Administrator failed to appoint one (1) of one (1) qualified alternate to the administrator. (Assistant Administrator) Findings Included: On February 13, 2025 at approximately 11:34 AM, review of policy 8-008, titled "Designation of Individual in Absence of Executive Director/Administrator" revealed the following under "Policy"...will have an Executive Director/Administrator or designee available at all times. On February 13, 2025 at approximately 11:32 AM,, review of the policy 8-002, titled "Governing Body", revealed the following: Policy: The Governing Body will assume full legal authority, responsibility and accountability for the overall management and operations... On February 13, 2025 at approximately 1:34 PM, review of the "Administrator" job description revealed the following: The Administrator is responsible for the overall leadership, management and operational oversight of the agency. This includes compliance with Federal, state and local regulations. On February 11, 2025 at approximately 11:38 AM, review of the "Organizational Chart" revealed the Assistant (Alternate) Administrator position was "vacant at present time". On February 11, 2025 at approximately 1:38 PM, review of Governing Body meeting minutes documentation dated 10/15/2024 and 01/16/2025 failed to reveal the Governing Body appointed a qualified designated alternate to the administrator (Assistant Administrator). During interview conducted on February 14, 2025 at approximately 4:01 PM, the Administrator, PDN Director and Consultant confirmed there was no documentation which provided evidence that a qualified alternate to the administrator had been appointed by the Governing Body nor the Administrator. During interview conducted on February 21, 2025 at approximately 3:30 PM, the CEO confirmed there was no documentation which provided evidence a qualified alternate to the administrator had been appointed by the Governing Body nor the Administrator.

Based on the findings of an unannounced, onsite Medicare complaint investigation survey conducted June 5 through June 7, 2023, with the off-site portion of the survey being conducted on June 8 and June 9, 2023, Golden Care of Northeast PA, Inc. was found not to be in compliance with the following requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

At discharge CFR(s): 484.55(d)(3) At discharge. 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/Director of Clinical Excellence, the agency failed to ensure a comprehensive nursing assessment was completed upon agency discharge for one (1) of two (2) private duty nursing (PDN-adult/pediatric shift care) clients (patients). (Client #4) Findings included: On June 7, 2023 at approximately 12:21 PM, review of the agency policy titled "Medical Record/Documentation" revealed the following under "RN Clinical Managers": 3. Discharge...comprehensive assessment... Client #4: Between June 6, 2023 at approximately 7:13 AM and June 7, 2023 at approximately 8:59 AM, review of the clinical record revealed the client is 12 years old and resided in Sullivan County, the start of care date was 05/26/2022, the primary diagnosis was respiratory failure and that the following orders were included on the "Home Health Certification and Plan of Care" for the recertification period which ended on 05/24/2023: -Skilled nursing (SN) services to be provided for up to eight (8) hours for seven (7) nights per week for parent's sleep. Co-vending services with another home health agency which provides SN services up to eight (8) hours per night for five (5) days per week. Review of the "Physician Order" dated 06/05/2023 revealed the PDN Clinical Supervisor/RN (Employee #2) obtained a physician order to discharge the client from home health services effective 05/30/2023 at the parent's request. There was no documentation in the clinical record which provided evidence that the PDN Clinical Supervisor/RN (Employee #2) completed a comprehensive nursing assessment upon the client's discharge from the agency. During interview conducted on June 6, 2023 at approximately 2:37 AM, the Administrator/Director of Clinical Excellence reported that the client's father refused further home health services due to the termination of the nurse who was assigned to provide SN services but the Administrator/Director of Clinical Excellence confirmed there was no documentation in the clinical record which provided evidence that Employee #2 attempted to schedule a discharge nursing assessment visit nor that Employee #2 completed a comprehensive nursing assessment upon discharge from the agency. During interview conducted on June 7, 2023 at approximately 12:35 PM, the Administrator/Director of Clinical Excellence confirmed a comprehensive nursing assessment was not completed upon agency discharge for client #2.

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 Centers for Disease Control and Prevention (CDC) recommendations and personnel files and based on interview with the Administrator/Director of Clinical Excellence (Employee #1), the agency failed to ensure tuberculosis (TB) screening was completed for one (1) of two (2) health care staff members who began employment in 2023. (Employee #1) Finding include: On June 7, 2023 at approximately 3:42 PM, review of the CDC TB screening guidance for health care personnel revealed the following as documented on the Frequently Asked Question page (https://www.cdc.gov/tb/topic/infectioncontrol/healthcarepersonnel-faq.htms): CDC and the National TB Controllers Association (NTCA) recommend that all U.S. health care personnel be screened for TB upon hire...screening should include a TB risk assessment, a TB symptom screen, and a TB test. These recommendations should be used for people who work or volunteer in health care settings, including...home-based health care...settings... Between 06/06/2023 at approximately 1:43 PM and 06/09/2023 at approximately 8:13 AM, review of personnel file documentation revealed the following: Employee #1: The date of hire of the administrator/Director of Clinical Excellence was 03/15/2023. There was no evidence in the personnel file which provided evidence TB screening had been completed. During interview conducted on June 7, 2023 at approximately 12:35 PM, the Administrator/Director of Clinical Excellence (Employee #1) confirmed TB screening had not been completed for Employee #1.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on review of agency policies/procedures and clinical records and based on interview with the Administrator/Director of Clinical Excellence (Employee #1), the agency failed to ensure a discharge summary was forwarded to the physician within 5 business days of the agency discharge date for two (2) of two (2) private duty nursing (PDN-shift care of adult/pediatric patients). (Clients #2 and #6) Findings included: On June 9, 2023 at approximately 2:45 PM, review of the agency policy titled "Discharge Policy" revealed the following: a) Notify the treating physician of the request to discharge and obtain an order. There was no documentation which provided evidence that the agency "Discharge Policy" included a requirement that a discharge summary would be forwarded to the physician within 5 business days of a client's/patients discharge from the agency. Client #4: Between June 6, 2023 at approximately 7:13 AM and June 7, 2023 at approximately 8:59 AM, review of the clinical record revealed the client is 12 years old and resided in Sullivan County, the start of care date was 05/26/2022, the primary diagnosis was respiratory failure and that the following orders were included on the "Home Health Certification and Plan of Care" for the recertification period which ended on 05/24/2023: -Skilled nursing (SN) services to be provided for up to eight (8) hours for seven (7) nights per week for parent's sleep. Co-vending services with another home health agency which provides SN services up to eight (8) hours per night for five (5) days per week. Review of "Physician Order" dated 06/05/2023 revealed the client was discharged from the agency effective 05/30/2023 at the parent's request. There was no documentation in the clinical record which provided evidence that a discharge summary was forwarded to the physician within 5 business days of the client's discharge. Client #7: On June 7, 2023 at approximately 8:40 AM, review of the clinical record revealed the client is 13 years old and resided in Monroe County, the start of care date was 05/23/2022, the primary diagnosis was other reduction deformities of the brain and that the following orders were included on the "Home Health Certification and Plan of Care" for the recertification period of 04/11/2023 through 06/10/2023: -SN services to be provided for up to eight (8) hours for seven (7) nights per week for parent's sleep and up to 10 hours per day Monday through Friday for home assistance, school assistance...Golden Care currently covers 10 hours per day Monday through Friday. Review of the "Physician Order" dated 05/17/2023 revealed the client was discharged from the agency and transferred to another home health agency effective 05/18/2023. There was no documentation in the clinical record which provided evidence that a discharge summary was forwarded to the physician within 5 business days of the client's discharge. During interview conducted on June 7, 2023 at approximately 12:35 PM, the Administrator/Director of Clinical Excellence confirmed the agency policy titled "Discharge Summary" did not include a requirement for a discharge summary to be forwarded to the physician within five (5) business days of the patient/client discharge date. The Administrator/Director of Clinical Excellence confirmed a discharge summary was not forwarded to the physician within five (5) days of the discharge date for the above referenced clients.

Based on the findings of an unannounced, onsite Medicare and state licensure complaint investigation and state re-licensure survey conducted April 26 and April 27, 2023, with the off-site portion of the survey being completed on April 28, 2023, Golden Care of Northeast PA, Inc. was found not to be in compliance with the following requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

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 review of agency policies and procedures and clinical records, and based on interview with the agency administrator (Employee #1) and the agency owner (Employee #11), the agency failed to ensure the initial nursing assessment was completed by the registered nurse (RN) on the physician ordered start of care date for three (3) of three (3) PDN (pediatric shift care) clients (patients) who were admitted to services after March 6, 2023. (Clients #3, #6 and #7) Findings include: On April 28, 2023 at approximately 12:57 PM, review of the agency policy titled "New Patient Admission" revealed the following: 4, Physician order obtained for a specific start of care date. 5. RN to make visit to the home to admit to home care completing the following: a. Comprehensive assessment... Client #3: Between April 26, 2023 at approximately 1:04 PM and April 27, 2023 between the approximate times of 11:25 AM and 2:55 PM, review of the clinical record revealed the client is 5 years old and resides in Lackawanna County, the start of care date was 03/29/2023, the primary diagnosis is Atresia of Foramina of Magendie and Luschka (cyst formation in the fourth ventricle of the brain) and that the following orders were included on the "Home Health Certification and Plan of Care" for the initial certification period of 03/29/2023 through 05/27/2023: Registered nurse (RN) to visit for evaluation and assessment for admission. Review of "Comprehensive Nursing Assessment with Plan of Treatment/485 Information" revealed the initial skilled nursing (SN) assessment was completed by an RN (Employee #9) on 03/28/2023 which was one (1) day before the start of care date (03/29/2023) ordered on the "Home Health Certification and Plan of Care" for the initial certification period of 03/29/2023 through 05/27/2023. Client #6: On April 27, 2023 at approximately 1:28 PM, review of the clinical record revealed the client is 10 years old and resides in Lackawanna County, the start of care date was 03/28/2023, the primary diagnosis is autism spectrum disorder and that the following orders were included on the "Home Health Certification and Plan of Care" for the initial certification period of 03/28/2023 through 05/25/2023: RN to visit every other month to assess and evaluate for care. Review of "Comprehensive Nursing Assessment with Plan of Treatment/485 Information" revealed the initial SN assessment was completed by an RN (Employee #5) on 03/27/2023 which was one (1) day before the start of care date (03/28/2023) ordered on the "Home Health Certification and Plan of Care" for the initial certification period of 03/28/2023 through 05/25/2023. Client #7: On April 27, 2023 at approximately 2:06 PM, review of the clinical record revealed the client is 7 years old and resides in Lackawanna County, the start of care date was 04/12/2023, the primary diagnosis is Trisomy 21 (Down syndrome) and that the following orders were included on the "Home Health Certification and Plan of Care" for the initial certification period of 04/20/2023 through 06/18/2023: Registered nurse (RN) to visit for evaluation and assessment for admission. Review of "Comprehensive Nursing Assessment with Plan of Treatment/485 Information" revealed the initial SN assessment was completed by an RN (Employee #9) on 04/20/2023 which was eight (8) days after the start of care date (04/12/2023) ordered on the "Home Health Certification and Plan of Care" for the initial certification period of 04/20/2023 through 06/18/2023. During remote (Zoom) interview conducted on April 28, 2023 at approximately 2:38 PM, the administrator and agency owner confirmed there was no documentation in the clinical record which provided evidence that the initial SN assessment was completed by the RN on the start of care date included on the "Home Health Certification and Plan of Care" for the above identified clients.

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 review of an agency policies/procedures and clinical records, and based on interview with the administrator (Employee #1) and the agency owner (Employee #11), the agency failed to ensure the primary home health service was initiated on the physician ordered start of care date for two (2) of three (3) PDN (pediatric shift care) clients (patients) for whom home health services were initiated after March 6, 2023. (Clients #6 and #7) Findings include: On April 28, 2023 at approximately 12:57 PM, review of the agency policy titled "New Patient Admission" revealed the following: 2. The team is responsible for ensuring that there will be staff that are available in the correct areas for the correct times in order to admit to services.... Client #6: On April 27, 2023 at approximately 1:28 PM, review of the clinical record revealed the client is 10 years old and resides in Lackawanna County, the start of care date was 03/28/2023, the primary diagnosis is autism spectrum disorder and that the following orders were included on the "Home Health Certification and Plan of Care" for the initial certification period of 03/28/2023 through 05/25/2023: -Home health aide (HHA) services to be provided six (6) hours per day Monday through Friday for school, 13 hours per day on non-school days for parent/caregiver's work and eight (8) hours a day on Saturday for patient's work and eight (8) hours per week for essential household duties (EHHD). Co-vending HHA services with another home health agency which provides a majority of the care. Review of clinical record documentation revealed HHA services were initiated on 04/05/2023 which was eight (8) days after the start of care date (03/28/2023) ordered on the "Home Health Certification and Plan of Care" for the initial certification period of 03/28/2023 through 05/25/2023. Client #7: On April 27, 2023 at approximately 2:06 PM, review of the clinical record revealed the client is 7 years old and resides in Lackawanna County, the start of care date was 04/12/2023, the primary diagnosis is Trisomy 21 (Down syndrome) and that the following orders were included on the "Home Health Certification and Plan of Care" for the initial certification period of 04/20/2023 through 06/18/2023: -Home health aide (HHA) services to be provided up to eight (8) hours per day Monday through Friday on school days and 10 hours a week for EHHD for parent. Review of clinical record documentation revealed HHA services were initiated on 04/20/2023 which was eight (8) days after the start of care date (04/12/2023) ordered on the "Home Health Certification and Plan of Care" for the initial certification period of 04/20/2023 through 06/18/2023. During remote (Zoom) interview conducted on April 28, 2023 at approximately 2:38 PM, the administrator and agency owner confirmed there was no documentation in the clinical record which provided evidence that the primary home health service was initiated on the physician ordered start of care date included on "Home Health Certification and Plan of Care" for the above referenced patients.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on review of an agency policies/procedures and clinical records, and based on interview with the administrator (Employee #1) and the agency owner (Employee #11), the agency failed to ensure skilled nursing (SN) services were provided per the frequency ordered on the "Home Health Certification and Plan of Care" for two (2) of three (3) active PDN (pediatric shift care) clients (patients). (Clients #3 and #4) Findings include: On April 28, 2023 at approximately 12:57 PM, review of the agency policy titled "New Patient Admission" revealed the following: 2. The team is responsible for ensuring that there will be staff that are available in the correct areas for the correct times... Client #3: Between April 26, 2023 at approximately 1:04 PM and April 27, 2023 between the approximate times of 11:25 AM and 2:55 PM, review of the clinical record revealed the client is 5 years old and resides in Lackawanna County, the start of care date was 03/29/2023, the primary diagnosis is Atresia of Foramina of Magendie and Luschka (cyst formation in the fourth ventricle of the brain) and that the following orders were included on the "Home Health Certification and Plan of Care" for the initial certification period of 03/29/2023 through 05/27/2023: -Skilled nurse (SN) to attend school with client Monday, Thursday and Friday from 8:30 AM to 10:15 AM; -Hours are not completely staffed for this client. At this time, Golden Care is actively attempting to hire more appropriate staff for this case, and parent is considering co-vending for further care. There was no documentation in the clinical record which provided evidence that a SN accompanied the client to school the following dates: Monday, 04/03, 04/10 and 04/17/2023, Thursday, 03/30, 04/06, 04/13, 04/20 and 04/27/2023 nor Friday 03/31, 04/07, 04/14 nor 04/21/2023. Client #4: Between April 26, 2023 at approximately 1:48 PM and April 27, 2023 at approximately 12:09 PM, review of the clinical record revealed the client is 12 years old and resides in Sullivan County, the start of care date was 05/26/2022, the primary diagnosis is respiratory failure and that the following orders were included on the "Home Health Certification and Plan of Care" for the current recertification period: -SN services to be provided for up to eight (8) hours for seven (7) nights per week for parent's sleep. Co-vending services with another home health agency which provides SN services up to eight (8) hours per night for five (5) days per week. Review of SN documentation revealed the agency provided SN services Friday through Sunday between 03/31 through 04/02/2023, 04/14 through 04/16/2023 and 04/21 through 04/23/2023. There was no documentation in the clinical record which provided evidence that SN services were provided on Saturday, 04/08/2023. During remote (Zoom) interview conducted on April 28, 2023 at approximately 2:38 PM, the administrator and agency owner confirmed there was no documentation in the clinical record which provided evidence the agency provided SN services per the frequency ordered by the physician on the "Home Health Certification and Plan of Care" for the above referenced clients.

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 review of agency policies and procedures and clinical records, and based on interview with a home health aide (Employee #7), the administrator (Employee #1) and agency owner (Employee #11), the agency failed to ensure the home health aide (HHA) plan of care was developed in accordance with agency policies/procedures for two (2) of two (2) PDN (pediatric shift care) clients (patients) for whom HHA services were provided . (Clients #6 and #7) Findings include: On April 28, 2023 at approximately 1:06 PM, review of the agency policy titled "Home Health Aide Plan of Care" revealed the following: 1. RN (registered nurse) will create a plan of care at the start of care visit to include duties... On April 28, 2023 at approximately 2:11 PM, review of the agency policy titled "Writing a 485" ("Home Health Certification and Plan of Care") revealed the following: HHA will assist client with personal hygiene...and all other ADL's (Activities of Daily Living-Bathing, toileting, dressing, grooming, walking, transferring and feeding). Client #6: On April 27, 2023 at approximately 1:28 PM, review of the clinical record revealed the client is 10 years old and resides in Lackawanna County, the start of care (SOC) date was 03/28/2023, the primary diagnosis is autism spectrum disorder and that the following orders were included under on the "Home Health Certification and Plan of Care" for the initial certification period of 03/28/2023 through 05/25/2023: -Registered nurse to visit every other month to assess and evaluate for care and as needed for problems or concerns; -Home health aide (HHA) services to be provided six (6) hours per day Monday through Friday for school, 13 hours per day on non-school days for parent/caregiver's work and eight (8) hours a day on Saturday for patient's work and eight (8) hours per week for essential household duties (EHHD); and -Home health aide (HHA) care to provide assistance with toileting, clothing (dressing), ADL's and eating. HHA will provide care within scope of practice. A RN (Employee #5) obtained the above referenced plan of care orders as evidenced by the RN's electronic signature which was entered under locator 23 "Nurse's Signature and Date of Verbal SOC Where Applicable" on the "Home Health Certification and Plan of Care". Review of the "Treatment List" dated 03/27/2023 revealed the following tasks were to be performed: -Assist with ADL's; and -Medications to be administered daily: Sertraline, Abilify and Trazodone (anti-depressants), Children's Tylenol, Guanfacine (medication utilized to treat ADHD), Melatonin (sleep aid), Senna (stool softener), Lamotrigine (anti-seizure medication) and Diphenhydramine (Benadryl). Review of clinical record documentation between 04/05/2023 and 04/25/2023 revealed HHA tasks performed by the HHA (Employee #7) included, but were not limited to, the following: Shampoo hair, hair care and skin condition checks. During telephone interview conducted on April 27, 2023 at approximately 3:45 PM, the HHA (Employee #7) reported that the HHA does not administer medications. There was no documentation in the clinical record which provided evidence that agency policy/procedure authorized medication administration to be included on the "Treatment List" for clients for whom HHA services are the primary home health service. There was no documentation on the "Home Health Certification and Plan of Care" which provided evidence that the RN (Employee #5) included a complete list of the ADL duties to be performed by the HHA. Client #7: On April 27, 2023 at approximately 2:06 PM, review of the clinical record revealed the client is 7 years old and resides in Lackawanna County, the start of care date was 04/12/2023, the primary diagnosis is Trisomy 21 (Down syndrome) and that the following orders were included on the "Home Health Certification and Plan of Care" for the initial certification period of 04/20/2023 through 06/18/2023: -RN to visit to assess and evaluate for admission then every other month to assess and evaluate for care and as needed for problems or concerns; -Home health aide (HHA) services to be provided up to eight (8) hours per day Monday through Friday on school days and 10 hours a week for EHHD for parent; and -Home health aide (HHA) care to provide assistance with toileting, clothing, ADL's and assist with meals and snacks. A RN (Employee #9) obtained the above referenced plan of care orders as evidenced by the RN's electronic signature which was entered under locator 23 "Nurse's Signature and Date of Verbal SOC Where Applicable" on the "Home Health Certification and Plan of Care". Review of the "Treatment List" dated 03/27/2023 revealed the following tasks were to be performed: -Assist with toileting, clothing, meals/snacks and ADL's. Review of clinical record documentation between 04/20/2023 and 04/25/2023 revealed HHA tasks performed by the HHA (Employee #7) included, but were not limited to, the following: Skin condition checks. There was no documentation on the "Home Health Certification and Plan of Care" which provided evidence that the RN (Employee #9) included a complete list of the ADL duties to be performed by the HHA. During remote (Zoom) interview conducted on April 28, 2023 at approximately 2:38 PM, the administrator and agency owner confirmed there was no documentation in the clinical record which provided evidence that assignment of HHA duties had been complete as per agency policy/procedures for the above referenced patients.

Contents of clinical record CFR(s): 484.110(a) Standard: Contents of clinical record. The record must include: This STANDARD is not met as evidenced by: Based on review of agency policies and procedures and clinical records, and based on interview with the administrator (Employee #1) and agency owner (Employee #11), the agency failed to ensure clinical record entries were completed as per agency policy and procedure for two (2) of five (5) PDN (pediatric shift care) clients (patients). (Clients #4 and #7) Findings include: On April 28, 2023 at approximately 1:05 PM, review of the agency policy titled "Medical Record/Documentation" revealed the following: -First Paragraph of the Policy: Documentation must be clear, concise, professional, unbiased...and accurately reflective of the care provided... -Nursing Required Documentation Per Shift...13. For ventilator (mechanical device utilized to assist patients with breathing) patients: Your ventilator settings must be documented in the nurses note or in ventilator flow sheet every shift. Client #4: Between April 26, 2023 at approximately 1:48 PM and April 27, 2023 at approximately 12:09 PM, review of the clinical record revealed the client is 12 years old and resides in Sullivan County, the start of care date was 05/26/2022, the primary diagnosis is respiratory failure and that the following orders were included on the "Home Health Certification and Plan of Care" for the current recertification period: -Ventilator Settings: Inspiratory time 0.7 and sensitivity 5. There was no documentation in the clinical record which provided evidence verification of the above referenced ventilator settings had been documented by the licensed practical nurse (LPN-Employee #10) on the nursing visit note nor the ventilator flow sheet for 12 of 12 skilled nursing visits completed between 03/26/2023 and 04/23/2023. Client #7: On April 27, 2023 at approximately 2:06 PM, review of the clinical record revealed the client is 7 years old and resides in Lackawanna County, the start of care date was 04/12/2023, the primary diagnosis is Trisomy 21 (Down syndrome) as documented the "Home Health Certification and Plan of Care" for the initial certification period of 04/20/2023 through 06/18/2023. Review of general "Posts" documentation revealed the administrator documented the following in response to client related message which was forwarded by a registered nurse (RN-Employee #9): "Did you see my post about a $400 for readmitting that boy in Easton?" During interview conducted on April 27, 2023 at approximately 4:00 PM, the administrator reported that the above referenced reply was in regard to a separate client for which the RN had volunteered to complete a readmission assessment. During remote (Zoom) interview conducted on April 28, 2023 at approximately 2:38 PM, the administrator and agency owner confirmed clinical record documentation was not completed in accordance with agency policies/procedures for the above identified clients.

Based on the findings of an unannounced, onsite Medicare recertification survey conducted on July 20, 21, 22, 27 and 28, 2022, Golden Care of Northeast PA, Inc. was found not to be in compliance with the following requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on a review of agency documentation and interview with the Administrator/Skilled Nursing Visit (SNV) Clinical Manager/Registered Nurse (RN-Employee #1), the Director of Clinical Excellence/Alternate Administrator/Private During Nursing (PDN) Clinical Manager/RN (Employee #2) and the Chief Executive Officer (Employee #14), the facility failed to complete a facility and community based all-hazard risk analysis review ("Hazard and Vulnerability Assessment Tool") after February 17, 2020. Findings include: On July 27, 2022 at approximately 9:59 AM, review of agency emergency preparedness plan/program (EP/P) revealed the following: -The "Hazard and Vulnerability Assessment Tool" was last reviewed/updated on 02/17/2020. -"Actual Response to Event Coronavirus Outbreak" form documentation revealed the EP/P was activated in January 2020, January 2021 and January 2022 due to the Coronavirus outbreak. -"Emergency Preparedness Drill..." form documentation revealed a flood emergency drill was completed on dated 07/26/2020 and 07/30/2021. -"Emergency Preparedness Plan": There was no documentation which provided evidence that the EP/P included a provision that the "Hazard and Vulnerability Assessment Tool" review is to be conducted every two (2) years. There was no documentation in the EP/P which provided evidence that the "Hazard and Vulnerability Assessment Tool" was reviewed/updated after 02/17/2020. During interview conducted on July 28, 2022 at approximately 4:00 PM, the Administrator/SNV Clinical Manager/RN (Employee #1), the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN (Employee #2) and the CEO (Employee #14) confirmed there was no agency documentation which provided evidence that the "Hazard and Vulnerability Assessment Tool" was reviewed/updated after 02/17/2020.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on review of agency policies/procedures, documentation, clinical records and personnel files and based on interview with the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/RN (Employee #2) and the Chief Executive Officer (CEO-Employee #14), the agency failed to ensure initial emergency preparedness training was completed by four (4) of eight (8) staff members who were hired after February 12, 2020. (Employees #4, #8, #11 and #12) Findings include: On July 27, 2022 at approximately 9:59 AM, review of "Emergency Preparedness Plan" revealed the following was documented under "Performance Improvement": 2. Communications and education by emergency management centers will be provided to all staff at least annually. The "Emergency Preparedness Plan" failed to include the timeframe for which initial emergency preparedness training would be provided to/completed by newly hired staff. On July 27, 2022 at approximately 4:15 PM, review of scheduling calendars revealed the following: -Employee #4: A complete visit calendar for part-time PDN Alternate Clinical Manager/RN was not available/provided but review of handwritten entries documented by employee #2 revealed employee #4 completed start of care assessments on June 13 and June 26, 2022. Patient #2: On July 20, 2022 at approximately 2:10 PM, July 21, 2022 at approximately 11:22 AM and July 28, 2022 at approximately 10:33 AM, review of the private duty nursing (PDN) clinical record revealed the start of care date was 06/10/2022, the patient/client is 18 years old, the diagnoses include trachea (windpipe) reconstruction and that skilled nursing (SN) is to care for and maintain the tracheostomy (surgically created airway in the front of the neck) and the gastrostomy (feeding) tube as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/10/2022 through 08/08/2022. Review of "Nurse Visit Notes" revealed the LPN (employee #8) provided skilled nursing services on 22 days between 06/13/2022 and 07/27/2022 and that the LPN had performed tracheostomy care/management including re-insertion of the tracheostomy tube. Patient #5: On July 22, 2022 at approximately 1:07 PM and July 28, 2022 at approximately 12:15, review of the PDN clinical record the start of care date was 05/26/2022, the patient/client is 12 years old, the diagnoses included respiratory failure and that SN is to care for and maintain the tracheostomy, ventilator (mechanical device which assists with breathing) and the gastrostomy tube as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 05/26/2022 through 07/24/2022. Review of "Nurse Visit Notes" revealed the LPNs (employee #11 or #12) provided skilled nursing services on 38 days between 05/31/2022 and 07/20/2022 and that the LPN's had provided tracheostomy and ventilator care/management. On July 27, 2022 at approximately 12:20 PM and July 28, 2022 at between the approximate times of 9:12 AM and 2:55 PM, review of personnel files revealed the following: Employee #4: The date of hire of the Alternate PDN Clinical Manager/RN was 02/09/2022. Employee #8: The date of hire of the PDN LPN was 11/17/2021. Employee #11: The date of hire of the PDN LPN was 06/01/2021. Employee #12: The date of hire of the PDN LPN was 06/17/2022. There was no documentation in the personnel files which provided evidence that employees #4, #8, #11 and #12 completed an initial emergency preparedness training program. During interview conducted on July 28, 2022 at approximately 4:00 PM, the Director of Clinical Excellence/PDN Clinical Manager/RN (Employee #2) and the CEO (Employee #14) confirmed there was no documentation in the personnel files which provided evidence that employees #4, #8, #11 and #12 completed an initial emergency preparedness training program.

Based on the findings of an unannounced, onsite Medicare recertification survey and focused infection control survey was conducted on July 20, 21, 22, 27 and 28, 2022, Golden Care of Northeast PA, Inc. was found not to be in compliance with the following requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies. As a result of the Medicare recertification and focused infection control survey, one (1) Condition level and twelve (12) standard level deficiencies were cited but did not result in immediate jeopardy.

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, personnel files and clinical records, and based on interview with the Administrator (Employee #1), the Alternate Administrator (Employee #2) and the Chief Executive Officer (CEO-Employee #14), the agency failed to ensure the name of the administrator, in order to receive complaints, was included on the patient rights forms provided to three (3) of three (3) patients whose admission folder/binder was available for review during the onsite home visit. (Patients #1, #2 and #3) Findings include: On July 28, 2022 at approximately 3:20 PM, review of agency policy titled "Patient Rights & Responsibilities" revealed the following on page 3: The Administrator shall conduct an investigation of the complaint in a timely manner... On July 27, 2022 at approximately 12:20 PM and July 28, 2022 at between the approximate times of 9:12 AM and 2:55 PM, review of personnel files revealed the following: Employee #1: The date of hire of the Administrator/Skilled Nursing Visit (SNV) Clinical Manager/RN was 01/29/2007. Employee #2: The date of hire of the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/RN was 04/09/2021. Employee #5: The date of hire of the Branch Office Manager/Licensed Practical Nurse (LPN) was 10/14/1997. On July 27, 2022 at approximately 9:12 AM, review of the revised July 2022 "Organizational Chart" (ORG CHART #2) revealed the following: -Administrator: Employee #1 (RN) -Alternate Administrator: Employee #2 (RN) Patient #1: On July 20, 2022 at approximately 1:32 PM, review of the SNV clinical record revealed the start of care date was 02/24/2022, the primary diagnosis is Type-2 Diabetes Mellitus (adult onset diabetes) and that skilled nursing services are to be provided as documented on the "Home Health Plan of Care & Certification" for the recertification period of 06/24/2022 through 08/22/2022. During home visit conducted on July 21, 2022 at approximately 11:00 AM, review of the agency admission packet/patient rights notification forms revealed the Office Manager/Licensed Practical Nurse (LPN-Employee #5) was identified as the contact person for patient complaints. There was no documentation in the patient's copy of the agency admission packet which provided evidence that the name of the Administrator (Employee #1) had been included on the patient rights notification forms. Patient #2: On July 20, 2022 at approximately 2:10 PM, July 21, 2022 at approximately 11:22 AM and July 28, 2022 at approximately 10:33 AM, review of the PDN clinical record revealed the patient/client is 18 years old, the diagnoses include trachea (windpipe) reconstruction and that skilled nursing (SN) is to care for and maintain the tracheostomy (surgically created airway in the front of the neck) and the gastrostomy (feeding) tube as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/10/2022 through 08/08/2022. During home visit conducted on July 21, 2022 at approximately 2:05 PM, review of the agency admission binder/patient rights notification forms revealed the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN (Employee #2) was identified as the administrator/contact person for patient complaints. There was no documentation in the patient's copy of the agency admission binder which provided evidence that the name of the Administrator (Employee #1) had been included on the patient rights notification forms. Patient #3: On July 20, 2022 at approximately 2:31 PM, July 21, 2022 at approximately 9:17 AM and July 27, 2022 at approximately 9:15 AM, review of the SNV clinical record revealed the start of care date was 04/08/2022, the primary diagnosis is Type-2 Diabetes Mellitus and that skilled nursing and home health aide services are to be provided as documented on the "Home Health Plan of Care & Certification" for the recertification period of 06/07/2022 through 08/05/2022. During home visit conducted on July 22, 2022 at approximately 10:10 AM, review of the agency admission packet/patient rights notification forms revealed the Office Manager/Licensed Practical Nurse (LPN-Employee #5) was identified as the contact person for patient complaints. There was no documentation in the patient's copy of the agency admission packet which provided evidence that the name of the Administrator (Employee #1) had been included on the patient rights notification forms. During interview conducted on July 28, 2022 at approximately 4:00 PM, the Administrator (Employee #1), Alternate Administrator (Employee #2) and the CEO (Employee #14) confirmed there was no agency documentation which provided evidence that the Administrator's name (Employee #1) had been included on the patient rights notification forms provided to patients #1, #2 and #3.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on review of agency documentation, personnel files and clinical records, and based on interview with the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/Registered Nurse (RN-Employee #2) and the Chief Executive Officer (CEO-Employee #14), the agency failed to ensure a comprehensive nursing assessment was completed aa RN at the start of care for three (3) of three (3) active PDN patients, (Patients #2, #5 and #6) Findings include: On July 27, 2022 at approximately 11:35 AM, review of the agency document titled "Home Health Regulatory Compliance Audit Report of ShiftShift Golden Care Private Duty Nursing Home Care Agency" revealed the following on page 3: Audit Indicators...5. Comprehensive Assessment is completed within 5 calendar days after the start of care. 6. Comprehensive assessment accurately reflects the patient's status and includes all of the required content... On July 27, 2022 at approximately 4:05 PM, review of the agency "Job Description: Director of Clinical Excellence" (Employee #2) revealed the following: Role...The regional coach also ensures compliance with state and any other governmental regulation... On July 27, 2022 at approximately 12:20 PM and July 28, 2022 at between the approximate times of 9:12 AM and 2:55 PM, review of personnel files revealed the following: Employee #2: The date of hire of the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN was 04/09/2021. Patient #2: On July 20, 2022 at approximately 2:10 PM, July 21, 2022 at approximately 11:22 AM and July 28, 2022 at approximately 10:33 AM, review of the PDN clinical record revealed the start of care date was 06/10/2022, the patient/client is 18 years old, the diagnoses include trachea (windpipe) reconstruction and that skilled nursing (SN) is to care for and maintain the tracheostomy (surgically created airway in the front of the neck) and the gastrostomy (feeding) tube as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/10/2022 through 08/08/2022. "Home Health Certification and Plan of Care" documentation revealed the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN (Employee #2) performed the start of care visit on 06/08/2022 and that a summary of the assessment findings were documented by Employee #2 on the "Home Health Certification and Plan of Care". There was no documentation on the 06/08/2022 nursing assessment summary which provided evidence that Employee #2 assessed the patient's urinary-reproductive, integumentary (skin) and endocrine (glands/organs with produce hormones) systems, the patient's psychosocial status nor the status of the patient's sight (eyes) and hearing (ears). Patient #5: On July 22, 2022 at approximately 1:07 PM and July 28, 2022 at approximately 12:15, review of the PDN clinical record revealed the start of care date was 05/26/2022, the patient/client is 12 years old, the diagnoses included respiratory failure and that skilled nursing (SN) is to care for and maintain the tracheostomy (surgically created airway in the front of the neck), ventilator (mechanical device which assists with breathing) and the gastrostomy (feeding) tube as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 05/26/2022 through 07/24/2022. "Home Health Certification and Plan of Care" documentation revealed the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN performed the start of care visit on 05/26/2022 and that a summary of the assessment findings were documented by Employee #2 on the "Home Health Certification and Plan of Care". There was no documentation on the 05/26/2022 nursing assessment summary which provided evidence that Employee #2 assessed the patient's urinary-reproductive and endocrine systems, the patient's psychosocial status nor the status of the patient's sight (eyes) and hearing (ears). Patient #6: On July 28, 2022 at approximately 12:42 PM, review of the PDN clinical record revealed the start of care date was 12/13/2021, the patient/client is 19 years old, diagnoses include Type 1 Diabetes Mellitus (juvenile diabetes) and that skilled nursing (SN) is to assess and treat blood glucose (sugar) readings as documented on the "Home Health Certification and Plan of Care" for the recertification period of 06/14/2022 through 08/12/2022. "Home Health Certification and Plan of Care" documentation revealed the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN (Employee #2) performed a skilled nursing assessment (12/14/2021) after admission to the agency and that a summary of the assessment findings were documented by Employee #2 on the "Home Health Certification and Plan of Care". There was no documentation on the 12/14/2021 nursing assessment summary which provided evidence that Employee #2 assessed the patient's urinary-reproductive, integumentary and endocrine systems, the patient's psychosocial status nor the status of the patient's sight (eyes) and hearing (ears). During interview conducted on July 28, 2022 at approximately 4:00 PM, the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN (Employee #2) and the CEO (Employee #14) confirmed that there was no agency documentation which provided evidence that a comprehensive nursing assessment was completed at the start of care for patients #2 ,#5 and #6.

Incorporate OASIS items CFR(s): 484.55(c)(8) Incorporation of the current version of the Outcome and Assessment Information Set (OASIS) items, using the language and groupings of the OASIS items, as specified by the Secretary. The OASIS data items determined by the Secretary must include: clinical record items, demographics and patient history, living arrangements, supportive assistance, sensory status, integumentary status, respiratory status, elimination status, neuro/emotional/behavioral status, activities of daily living, medications, equipment management, emergent care, and data items collected at inpatient facility admission or discharge only. This ELEMENT is not met as evidenced by: Based on review of agency policy/procedures, personnel files and clinical records, and based on interview with the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/Registered Nurse (RN-Employee #2) and the Chief Executive Officer (CEO-Employee #14), the agency failed to ensure OASIS data collection was completed for one (1) of one (1) patient who was 18 years old at the time of admission to the agency. (Patient #6) Findings include: On July 27, 2022 at approximately 11:56 AM, review of the agency policy titled "Clinical Process" revealed the following under "OASIS Completion": Our current process allows for the clinician to have time in the home to complete the majority of the OASIS document... On July 27, 2022 at approximately 4:05 PM, review of the agency "Job Description: Director of Clinical Excellence" (Employee #2) revealed the following: Role...The regional coach also ensures compliance with state and any other governmental regulation... On July 27, 2022 at approximately 12:20 PM and July 28, 2022 at between the approximate times of 9:12 AM and 2:55 PM, review of personnel files revealed the following: Employee #2: The date of hire of the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN was 04/09/2021. Patient #6: On July 28, 2022 at approximately 12:42 PM, review of the PDN clinical record revealed the start of care date was 12/13/2021, the patient/client was 18 years old at the time of admission to the agency, diagnoses include Type 1 Diabetes Mellitus (juvenile diabetes) and that skilled nursing (SN) is to assess and treat blood glucose (sugar) readings as documented on the "Home Health Certification and Plan of Care" for the recertification period of 06/14/2022 through 08/12/2022. "Home Health Certification and Plan of Care" documentation revealed the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN (Employee #2) performed a skilled nursing assessment (12/14/2021) after admission to the agency and that nursing recertification assessments were completed by employee #2 in February, April and June 2022. There was no documentation in the clinical record which provided evidence that OASIS data was collected with the start of care nursing assessment nor with the above referenced nursing recertification assessments. During interview conducted on July 28, 2022 at approximately 4:00 PM, the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN (Employee #2) and the CEO (Employee #14) confirmed that there was no agency documentation which provided evidence that OASIS data had been collected by Employee #2 with the start of care nursing assessment nor with the above referenced nursing recertification assessments.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on review of agency documentation, personnel files and clinical records, and based on interview with the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/Registered Nurse (RN-Employee #2) and the Chief Executive Officer (CEO-Employee #14), the agency failed to ensure three (3) of three (3) licensed practical nursing (LPN) staff notified the PDN Clinical Manager (Employee #2) of the need to alter patient/client treatments or documentation procedures. (Employees #8, #11 and #12) Findings include: On July 28, 2022 at approximately 4:33 PM, review of the "LPN Job Description" revealed the following: Essential Duties and Responsibilities include the following... -Observes patients for changes in condition and communicates/coordinates with...clinical management. Supervisory Responsibilities: -Oversees patient's care and is responsible for the overall direction, coordination and evaluation of patient care... -Responsibilities include...resolving problems... On July 27, 2022 at approximately 4:05 PM, review of the agency "Job Description: Director of Clinical Excellence" (Employee #2) revealed the following: Role...The regional coach also ensures compliance with state and any other governmental regulation... The regional coach...also helps ensure that teams have the registered nurse (RN) resources that they require... On July 27, 2022 at approximately 11:35 AM, review of the agency document titled "Home Health Regulatory Compliance Audit Report of ShiftShift Golden Care Private Duty Nursing Home Care Agency" revealed the following on page 7: Audit Indicators...35. Evidence of coordination between disciplines... 35b. Documentation of case conferencing between disciplines is present in the clinical record... On July 27, 2022 at approximately 12:20 PM and July 28, 2022 at between the approximate times of 9:12 AM and 2:55 PM, review of personnel files revealed the following: Employee #2: The date of hire of the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN was 04/09/2021. Employee #8: The date of hire of the PDN LPN was 11/17/2021. Employee #11: The date of hire of the PDN LPN was 06/01/2021. Employee #12: The date of hire of the PDN LPN was 06/17/2022. Patient #2: On July 20, 2022 at approximately 2:10 PM, July 21, 2022 at approximately 11:22 AM and July 28, 2022 at approximately 10:33 AM, review of the PDN clinical record revealed the start of care date was 06/10/2022, the patient/client is 18 years old, the diagnoses include trachea (windpipe) reconstruction and that skilled nursing (SN) is to care for and maintain the tracheostomy (surgically created airway in the front of the neck) and that physician orders allow the tracheostomy to be "out up to" 4 hours per day as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/10/2022 through 08/08/2022. Review of "Nurse Visit Notes" revealed the LPN (employee #8) provided skilled nursing services on 22 days between 06/13/2022 and 07/27/2022. Review of LPN (employee #8) documentation entered on the "Nurse Visit Notes" form revealed the patient was able remove (decannulate) the tracheostomy. Review of the "Nurse Visit Notes" dated 06/22, 06/27, 06/28, 6/29 and 06/30/2022 and 07/05, 07/11, 07/12, 07/13, 07/18 and 07/20/2022 failed to reveal that the LPN re-inserted the tracheostomy within 4 hours of the second decannulation on the aforementioned dates. There was no documentation in the clinical record which provided evidence that the LPN (Employee #8) notified the PDN Clinical Manager (Employee #2) that the tracheostomy remained out for more than 4 hours on the aforementioned dates. Patient #5: On July 22, 2022 at approximately 1:07 PM and July 28, 2022 at approximately 12:15, review of the PDN clinical record revealed the start of care date was 05/26/2022, the patient/client is 12 years old, the diagnoses included respiratory failure, that skilled SN is to care for and maintain the tracheostomy (surgically created airway in the front of the neck) and ventilator (mechanical device which assists with breathing) and that physician orders for the Trilogy 100 ventilator settings included, but were not limited to the following, as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 05/26/2022 through 07/24/2022: High alarm 40, low alarm 10, Pressure support 10, sensitivity 5, tidal volume 130, inspiratory time 0.7, SIMV (volume control) 25 and PEEP (setting to maintain airway pressure) 8.332 Review of "Nurse Visit Notes" documentation revealed the LPN's (employee #11 or #12) provided skilled nursing services on 38 days between 05/31/2022 and 07/20/2022 and that the LPN's had provided tracheostomy and ventilator care/management. Review of "Nurse Visit Notes" revealed ventilator settings were documented as being maintained as per physician orders between 05/31/2022 and 07/20/2022. Review of ventilator flow sheet documentation revealed verification of the specific ventilator settings were documented on 07/01, 07/12, 07/13, 07/14, 07/15, 07/19 and 07/22/2022. During interview conducted on 07/22/2022 at approximately 2:13 PM, the PDN Clinical Manager (Employee #2) reported specific ventilator settings are to be documented on the ventilator flow sheet. Employee #2 reported that notification was first provided on 07/22/2022 that the ventilator flow sheet function in the agency software program was not functioning properly; therefore, the LPN's (Employees #11 and #12) were documenting that ventilator settings were per physician orders. During interview conducted on July 28, 2022 at approximately 4:00 PM, the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN (Employee #2) and the CEO (Employee #14) confirmed that there was no agency documentation which provided evidence that the LPN"s (Employees #8, #11, #12) had notified the PDN Clinical Manager (Employee #2) of the need to alter patient/client treatments or documentation procedures for the above identified patients.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on review of agency policies/procedures, documentation and clinical records, and based on interview with the licensed practical nurse (LPN-employee #8), the Administrator/Skilled Nursing Visit (SNV) Clinical Manager/Registered Nurse (RN-Employee #1), the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/RN (Employee #2) and the Chief Executive Officer (CEO-Employee #14), the agency failed to ensure a written visit frequency was provided to three (3) of three (3) patients whose admission folder was available for review during the onsite home visit. (Patients #1, #2 and #3) Findings include: On July 28, 2022 at approximately 3:20 PM, review of agency policy titled "Patient Rights & Responsibilities" revealed the following on page 1: To be notified in writing of the care to be furnished... Patient #1: On July 20, 2022 at approximately 1:32 PM, review of the SNV clinical record revealed the start of care date was 02/24/2022, the primary diagnosis is Type-2 Diabetes Mellitus (adult onset diabetes) and that skilled nursing (SN) services are to be provided as documented on the "Home Health Plan of Care & Certification" for the recertification period of 06/24/2022 through 08/22/2022. Review of clinical record documentation revealed the following visit frequencies were included on the "Home Health Plan of Care & Certification": -Initial Certification Period 02/24/2022 through 04/22/2022: SN services-one (1) time a day for one (1) day then two (2) times a week for eight (8) weeks; -Recertification Period 04/25/2022 through 06/23/2022: SN services--two (2) times a week for nine (9) weeks: and --Recertification Period 06/24/2022 through 08/22/2022: SN services--two (2) times a week for one (1) week followed by one (1) time a week for eight (8) weeks. During home visit conducted on July 21, 2022 at approximately 11:00 AM, review of the agency admission packet/patient rights notification/yellow communication forms failed to reveal the above referenced SN visit frequencies had been provided to patient #1 in writing. Patient #2: On July 20, 2022 at approximately 2:10 PM, July 21, 2022 at approximately 11:22 AM and July 28, 2022 at approximately 10:33 AM, review of the PDN clinical record revealed the patient/client is 18 years old, the diagnoses include trachea (windpipe) reconstruction, that SN is to care for and maintain the tracheostomy (surgically created airway in the front of the neck) and the gastrostomy (feeding) tube and that 120 hours of SN services are to be provided weekly as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/10/2022 through 08/08/2022. During home visit conducted on July 21, 2022 at approximately 2:05 PM, the LPN (employee #8) reported SN services are provided from 7:00 AM to 3:00 PM-Monday through Thursday. Review of the agency admission binder failed to reveal the above referenced SN visit frequency had been provided to patient #2 in writing. Patient #3: On July 20, 2022 at approximately 2:31 PM, July 21, 2022 at approximately 9:17 AM and July 27, 2022 at approximately 9:15 AM, review of the SNV clinical record revealed the start of care date was 04/08/2022, the primary diagnosis is Type-2 Diabetes Mellitus and that SN and home health aide (HHA) services are to be provided as documented on the "Home Health Plan of Care & Certification" for the recertification period of 06/07/2022 through 08/05/2022. Review of clinical record documentation revealed the following visit frequencies were included on the "Home Health Plan of Care & Certification": -Initial Certification Period 04/08/2022 through 06/06/2022: SN services-one (1) time a day for one (1) day then two (2) times a week for two (2) weeks, followed by one (1) time a week for seven (7) weeks; and -Recertification Period 06/07/2022 through 08/05/2022: SN services--two (2) times a week for one (1) week followed by one (1) time a week for eight (8) weeks and HHA services two (2) times a week for nine (9) weeks. During home visit conducted on July 22, 2022 at approximately 10:10 AM, review of the agency admission packet/patient rights notification/yellow communication forms failed to reveal the above referenced SN and HHA visit frequencies had been provided to patient #3 in writing. During interview conducted on July 28, 2022 at approximately 4:00 PM, the Administrator/SNV Clinical Manager/RN (Employee #1), Director of Clinical Excellence Alternate Administrator/PDN Clinical Manager/RN (Employee #2) and the CEO (Employee #14) confirmed there was no agency documentation which provided evidence that the referenced SN and HHA visit frequencies had been provided to patients #1, #2 and #3 in writing.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on review of agency policies/procedures, documentation and clinical records, and based on interview with the licensed practical nurse (LPN-employee #8), the Administrator/Skilled Nursing Visit (SNV) Clinical Manager/Registered Nurse (RN-Employee #1), the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/RN (Employee #2) and the Chief Executive Officer (CEO-Employee #14), the agency failed to ensure a written treatment instructions were provided to two (2) of two (2) patients whose admission folder was available for review during the onsite home visit. (Patients #2 and #3) Findings include: On July 28, 2022 at approximately 3:20 PM, review of agency policy titled "Patient Rights & Responsibilities" revealed the following on page 1: To be notified in writing of the care to be furnished... Patient #2: On July 20, 2022 at approximately 2:10 PM, July 21, 2022 at approximately 11:22 AM and July 28, 2022 at approximately 10:33 AM, review of the PDN clinical record revealed the patient/client is 18 years old, the diagnoses include trachea (windpipe) reconstruction, that SN is to care for and maintain the tracheostomy (surgically created airway in the front of the neck) and the gastrostomy (feeding) tube and that treatment orders included, but were not limited to, the following as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/10/2022 through 08/08/2022: -Maintain 6 cm (centimeter) Bivona flex tracheostomy (trach) tube, change trach weekly and as needed, trach may be out for up to four (4) hours per day; -Suction as needed with 14 Fr (French-refers to catheter size) catheter to a depth of 1.0 mm (millimeter); and -Gastrostomy: Maintain Mickey button (feeding tube) 16 Fr with a 8 cc (cubic centimeters) to a length of 2.7 cm. Client is NPO (nothing by mouth). Flush gastric tube with 30 ml of water post medication administration. Nestle Complete 500 ml (milliliters) bolus by gravity five (5) times a day via gastric tube. During home visit conducted on July 21, 2022 at approximately 2:05 PM, the LPN (employee #8) reported the treatment orders included on the "Home Health Certification and Plan of Care" are maintained electronically in the agency's software program. Review of the agency admission binder failed to reveal the above referenced treatment orders had been provided to patient #2 in writing. Patient #3: On July 20, 2022 at approximately 2:31 PM, July 21, 2022 at approximately 9:17 AM and July 27, 2022 at approximately 9:15 AM, review of the SNV clinical record revealed the start of care date was 04/08/2022, the primary diagnosis is Type-2 Diabetes Mellitus (adult onset diabetes) and that SN services are to be provided as documented on the "Home Health Plan of Care & Certification" for the recertification period of 06/07/2022 through 08/05/2022. Review of the interim physician order dated 06/09/2022 revealed the following treatment was to be provided to the buttocks wound: Cleanse with soap and water, apply Duoderm (wound dressing), change every five (5) to seven (7) days and as needed. During home visit conducted on July 22, 2022 at approximately 10:10 AM, the RN (Employee #1) reapplied the Duoderm to the buttock area after the patient had showered. Review of the agency admission packet/yellow communication forms failed to reveal the above referenced treatment order had been provided to patient #3 in writing. During interview conducted on July 28, 2022 at approximately 4:00 PM, the Administrator/SNV Clinical Manager/RN (Employee #1), Director of Clinical Excellence Alternate Administrator/PDN Clinical Manager/RN (Employee #2) and the CEO (Employee #14) confirmed there was no agency documentation which provided evidence that the above referenced treatment orders had been provided to patients #2 and #3 in writing.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on review of agency policies/procedures, documentation, personnel files and clinical records, and based on interview with the Administrator/Skilled Nursing Visit (SNV) Clinical Manager/Registered Nurse (RN-Employee #1) and the Chief Executive Officer (CEO-Employee #14), the agency failed to ensure the name of the SNV clinical manager (Employee #1) was provided to two (2) of two (2) SNV patients whose admission folder was available for review during the onsite home visit. (Patients #1 and #3) Findings include: On July 28, 2022 at approximately 3:20 PM, review of agency policy titled "Patient Rights & Responsibilities" revealed the following on page 1: To jointly participate with...staff in developing their plan of care... On July 27, 2022 at approximately 12:20 PM and July 28, 2022 at between the approximate times of 9:12 AM and 2:55 PM, review of personnel files revealed the following: Employee #1: The date of hire of the Administrator/SNV Clinical Manager/RN was 01/29/2007. Patient #1: On July 20, 2022 at approximately 1:32 PM, review of the SNV clinical record revealed the start of care date was 02/24/2022, the primary diagnosis is Type-2 Diabetes Mellitus (adult onset diabetes) and that skilled nursing services are to be provided as documented on the "Home Health Plan of Care & Certification" for the recertification period of 06/24/2022 through 08/22/2022. During home visit conducted on July 21, 2022 at approximately 11:00 AM, review of the agency admission packet/patient rights notification/yellow communication forms failed to reveal that the name of the SNV Clinical Manager (Employee #1) had been provided to patient #1 in writing. Patient #3: On July 20, 2022 at approximately 2:31 PM, July 21, 2022 at approximately 9:17 AM and July 27, 2022 at approximately 9:15 AM, review of the SNV clinical record revealed the start of care date was 04/08/2022, the primary diagnosis is Type-2 Diabetes Mellitus and that skilled nursing and home health aide services are to be provided as documented on the "Home Health Plan of Care & Certification" for the recertification period of 06/07/2022 through 08/05/2022. During home visit conducted on July 22, 2022 at approximately 10:10 AM, review of the agency admission packet/patient rights notification/yellow communication forms failed to reveal that the name of the SNV Clinical Manager (Employee #1) had been provided to patient #1 in writing. During interview conducted on July 28, 2022 at approximately 4:00 PM, the Administrator/SNV Clinical Manager/RN (Employee #1) and the CEO (Employee #14) confirmed there was no agency documentation which provided evidence that the name of the SNV Clinical Manager (Employee #1) had been provided in writing to patients #1 and #3 in writing.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on review of agency policies/procedures, documentation, clinical records and personnel files and based on interview with the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/RN (Employee #2) and the Chief Executive Officer (CEO-Employee #14), the agency failed to ensure infection control education was provided to/completed by four (4) of eight (8) nursing staff members who were hired after February 12, 2020. (Employees #4, #8, #11 and #12) Findings include: On July 28, 2022 at approximately 9:55 AM, review of the agency policy titled "Infection Control Program" revealed the following under "Goals": 8. Provide education to employees, patients and caregivers... On July 27, 2022 at approximately 4:15 PM, review of scheduling calendars revealed the following: -Employee #4: A complete visit calendar for the part-time PDN Alternate Clinical Manager/RN was not available/provided but review of handwritten entries documented by employee #2 revealed employee #4 completed start of care assessments on June 13 and June 26, 2022. Patient #2: On July 20, 2022 at approximately 2:10 PM, July 21, 2022 at approximately 11:22 AM and July 28, 2022 at approximately 10:33 AM, review of the PDN clinical record revealed the start of care date was 06/10/2022, the patient/client is 18 years old, the diagnoses include trachea (windpipe) reconstruction and that skilled nursing (SN) is to care for and maintain the tracheostomy (surgically created airway in the front of the neck) and the gastrostomy (feeding) tube as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/10/2022 through 08/08/2022. Review of "Nurse Visit Notes" revealed the LPN (employee #8) provided skilled nursing services on 22 days between 06/13/2022 and 07/27/2022 and that the LPN had performed tracheostomy care/management including re-insertion of the tracheostomy tube. Patient #5: On July 22, 2022 at approximately 1:07 PM and July 28, 2022 at approximately 12:15, review of the PDN clinical record revealed the start of care date was 05/26/2022, the patient/client is 12 years old, the diagnoses include respiratory failure and that SN is to care for and maintain the tracheostomy (surgically created airway in the front of the neck), ventilator (mechanical device which assists with breathing) and the gastrostomy (feeding) tube as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 05/26/2022 through 07/24/2022. Review of "Nurse Visit Notes" revealed the LPN's (employee #11 or #12) provided skilled nursing services on 38 days between 05/31/2022 and 07/20/2022 and that the LPN's had provided tracheostomy and ventilator care/management. On July 27, 2022 at approximately 12:20 PM and July 28, 2022 at between the approximate times of 9:12 AM and 2:55 PM, review of personnel files revealed the following: Employee #4: The date of hire of the Alternate PDN Clinical Manager/RN was 02/09/2022. Employee #8: The date of hire of the PDN LPN was 11/17/2021. Employee #11: The date of hire of the PDN LPN was 06/01/2021. Employee #12: The date of hire of the PDN LPN was 06/17/2022. There was no documentation in the personnel files which provided evidence that employees #4, #8, #11 and #12 were provided with nor completed infection control education/training. During interview conducted on July 28, 2022 at approximately 4:00 PM, the Director of Clinical Excellence/PDN Clinical Manager/RN (Employee #2) and the CEO (Employee #14) confirmed there was no documentation in the personnel files which provided evidence that employees #4, #8, #11 and #12 were provided with/completed infection control education/training.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on observation and review of agency policies/procedures, the Centers for Disease Control (CDC) COVID-19 guidelines, personnel files and clinical records, and based on interview with the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/Registered Nurse (RN-Employee #2) and the Chief Executive Officer (Employee #14), the agency failed to ensure COVID-19 mitigation precautions were implemented for two (2) of two (2) unvaccinated staff members who were observed during the survey. (Employees #2 and #8) Findings include: On July 28, 2022 at approximately 3:55 PM, review of the agency policy titled "COVID-19 Policy" revealed the following: 1. Purpose and Scope...Swiftshift Golden Care is committed to providing safe and healthy working environment for all our employees and clients. Swiftshift Golden Care has developed the following COVID-19 plan, which includes policies and procedures to minimize the risk of transmission of COVID-19, in accordance with CDC guidelines... 2. Roles and Responsibilities...Swiftshift Golden Care's goal is to prevent the transmission of COVID-19. Managers as well as non-managerial employees and their representatives are all responsible for supporting and complying with this COVID-19 plan... Medical and Religious Exemptions...All employees with approved medical or religious exemptions, not fully vaccinated (according to CDC guidelines) must have at a minimum, a weekly negative Covid test and wear a mask at all times during patient care... Personal Protective Equipment (PPE)...Facemasks must be worn by all employees not fully vaccinated (according to CDC guidelines) when on shift... On July 28, 2022 at approximately 8:30 AM, review of the CDC website (https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html) revealed the following COVID-19 guidance was included on the page titled "Infection Control Guidance": Source control options for HCP include: -A NIOSH-approved N95 or equivalent or higher-level respirator OR -A respirator approved under standards used in other countries that are similar to NIOSH-approved N95 filtering facepiece respirators (Note: These should not be used instead of a NIOSH-approved respirator when respiratory protection is indicated) OR -A well-fitting facemask. When used solely for source control, any of the options listed above could be used for an entire shift... Source control and physical distancing (when physical distancing is feasible and will not interfere with provision of care) are recommended for everyone in a healthcare setting... Between July 27, 2022 at approximately 12:20 PM and 07/28/2022 at between the approximate times of 9:12 AM and 2:55 PM, review of personnel file documentation revealed the following: Employee #2: The date of hire of the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/RN was 04/09/2021. Employee #8: The date of hire of the PDN licensed practical nurse (LPN) was 11/17/2021. On July 27, 2022 at approximately 11:33 AM, review of COVID-19 exemption request documentation revealed the following: Employee #2: A COVID-19 vaccine religious exemption request was approved on 02/23/2022. Employee #8: A COVID-19 vaccine religious exemption request was approved on 02/21/2022. Patient #2: On July 20, 2022 at approximately 2:10 PM, July 21, 2022 at approximately 11:22 AM and July 28, 2022 at approximately 10:33 AM, review of the PDN clinical record revealed the start of care date was 06/10/2022, the patient/client is 18 years old, the diagnoses include trachea (windpipe) reconstruction and for skilled nursing (SN) to care for and maintain the tracheostomy (surgically created airway in the front of the neck) as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/10/2022 through 08/08/2022. Review of physician order documentation dated 07/11/2022 and 07/18/2022 revealed an antibiotic (Ciprofloxacin) was ordered for an upper respiratory infection. Review of "Nurses Visit Notes" documentation revealed the LPN (Employee #8) provided SN services 2 to 4 times a week between 06/13/2022 and 07/27/2022. During home visit conducted on 07/21/2022 at approximately 2:05 PM, observation of the LPN (Employee #8) revealed the LPN was not wearing a facemask. Review of clinical record documentation revealed the LPN submitted a negative COVID-19 result on 07/21/2022 but there was no documentation in the clinical record which provided evidence that the LPN provided documentation that the LPN submitted a negative for COVID-19 result for the treatment weeks beginning 06/12/2022, 06/19/2022, 06/26/2022, 07/03/2022 and 07/10/2022. During the onsite Medicare recertification and state re-licensure survey conducted on 07/20, 07/21, 07/22, 07/27 and 07/28/2022, observation of the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/RN (Employee #2) revealed employee #2 did not wear a facemask when onsite at the agency office. During interview conducted on July 28, 2022 at approximately 4:00 PM, the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/RN (Employee #2) and the CEO (Employee #14) confirmed there was no documentation which provided evidence that the LPN (employee #8) had submitted a negative COVID-19 result during the above referenced treatment weeks and that the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/RN (Employee #2) and LPN (Employee #8) failed to comply with the agency's COVID-19 facemask requirements for unvaccinated staff.

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 review of Pennsylvania (PA) Department of Health (DOH) state licensure regulations, agency job descriptions, documentation, professional recommendations/guidance, clinical records and personnel files, and based on interview with the Administrator/Skilled Nursing Visit (SNV) Clinical Manager/Registered Nurse (RN-Employee #1), the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager (Employee #2) and the Chief Executive Officer (CEO-Employee #14), the governing body failed to ensure lines of authority included on organizational charts were approved by the governing body (G0942), the administrator failed to maintain documentation which provided evidence that the supervising RN (clinical manager) or similarly qualified alternate was available during the regular operating hours of the agency (G0950), and the administrator/alternate administrator failed to ensure a competency evaluation/hands-on skills demonstration was completed prior to the assignment of PDN nursing staff to provide skilled nursing (SN) care to or oversight of tracheostomy (artificial airway created in the front of the neck) and ventilator (mechanical device which assists with breathing) dependent patients/clients (G0952). Cross Reference Tags: §484.105 (a) Standard: Governing body (G0942) §484.105 (b)(1)(iii) Ensure Clinical Manager is Available (G0950) §484.105(b)(1)(iv): Ensure that HHA Employs Qualified Personnel (G0952)

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 Pennsylvania (PA) Department of Health (DOH) state licensure regulations, agency documentation and personnel files, and based on interview with the Administrator/Skilled Nursing Visit (SNV) Clinical Manager/Registered Nurse (RN-Employee #1), the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/RN (Employee #2) and the Chief Executive Officer (CEO-Employee #14), the governing body failed to ensure lines of authority included on two (2) of two (2) organizational charts were approved by the governing body. (ORG CHART #1 and ORG CHART #2) Findings include: During interview conducted on 07/28/2022 at approximately 3:03 PM, the CEO (Employee #14) reported that the agency had not developed a Governing Body policy. On July 28, 2022 at approximately 8:35 AM, review of the PA DOH state licensure regulations 28 PA Code, Part IV, Health Facilities, Subpart G. Chapter 601 revealed the following under "GOVERNANCE AND MANAGEMENT": § 601.21. Organization, services and administration. (a) Writing requirements. Organization, services provided, administrative control and lines of authority for the delegation of responsibility to the patient care level shall be clearly set forth in writing and shall be readily identifiable. On July 27, 2022 at approximately 12:20 PM and July 28, 2022 at between the approximate times of 9:12 AM and 2:55 PM, review of personnel files revealed the following: Employee #1: The date of hire of the Administrator/SNV Clinical Manager/RN was 01/29/2007. Employee #2: The date of hire of the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN was 04/09/2021. Employee #3: The date of hire of the Alternate SNV Clinical Manager/RN Supervisor was 02/28/2021. Employee #4: The date of hire of the Alternate PDN Clinical Manager/RN was 02/09/2022. Employee #5: The date of hire of the Branch Office Manager/Licensed Practical Nurse (LPN) was 10/14/1997. Employee #6: The date of hire of the Nurse Success Manager/LPN was 02/04/2021. On July 22, 2022 at 12:22 PM, review of the agency's "Organizational Chart 2022" (ORG CHART #1) revealed the following: -Administrator/Supervising Registered Nurse (RN) for Skilled Nursing Visit (SNV) Division--Employee #1 (RN) -Administrator/Supervising RN for the Private Duty Nursing (PDN) Division: Employee #2 (RN) -Alternate Administrator/Office Supervisor: Employee #5 (LPN) -Alternate Supervising RN SNV Division: Employee #3 (RN) -Alternate Administrator PDN Division: Employee #6 (LPN) -Supervising RN PDN Division: Employee #4 (RN) On July 27, 2022 at approximately 9:12 AM, review of the revised July 2022 "Organizational Chart" (ORG CHART #2) revealed the following: -Administrator: Employee #1 (RN) -Clinical Manager for SNV Division-- Employee #1 (RN) -Alternate Administrator: Employee #2 (RN) -Clinical Manager for the PDN Division: Employee #2 (RN) -Alternate Clinical Manager SNV Division: Employee #3 (RN) -Alternate Clinical Manager PDN Division: Employee #4 (RN) On July 27, 2022 at approximately 11:50 AM, review of the "Governing Body Meeting Minutes" dated 10/01/2020, 01/08/2021 and 06/17/2022 failed to reveal that the Governing Body approved the agency's organizational structure included on ORG CHART #1 nor ORG CHART #2. During interview conducted on July 28, 2022 at approximately 4:00 PM, the Administrator/SNV Clinical Manager/RN (Employee #1), the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/RN (Employee #2) and the CEO (Employee #14) confirmed there was no agency documentation which provided evidence the Governing Body reviewed/approved the organizational structure included on ORG CHARG #1 nor ORG CHART #2.

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on observation and review of agency job descriptions, documentation, clinical records, personnel files and Pennsylvania (PA) Department of Health (DOH) state licensure regulations 28 Pa. Code, Part IV, Health Facilities, Subpart G. Chapter 601, and based on interview with the Administrator/Skilled Nursing Division (SNV) Clinical Manager/Registered Nurse (RN-Employee #1), the Director of Clinical Excellence/Alternate Administrator/Private Duty Nursing (PDN) Clinical Manager/RN (Employee #2) and the Chief Executive Officer (CEO--Employee #14), the administrator failed to maintain documentation which provided evidence that the supervising RN (clinical manager) or similarly qualified alternate was available during the regular operating hours of the agency for three (3) of three (3) months in 2022. (May, June and July 2022) Findings include: On July 27, 2022 at approximately 4:05 PM, review of the agency "Job Description: Director of Clinical Excellence" (Employee #2) revealed the following: Role...The regional coach also ensures compliance with state and any other governmental regulation... The regional coach...also helps ensure that teams have the registered nurse (RN) resources that they require... On July 27, 2022 at approximately 4:06 PM, review of the agency "RN Supervisor" (Employee #3) job description revealed the following: Job Summary...The RN Supervisor is available at all times during operating hours (or appoints a similarly qualified alternate) and participates in all activities relevant to professional services furnished, including the development of qualifications and assignment of personnel. On July 27, 2022 at approximately 4:10 PM, review of 28 Pa. Code, Part IV, Health Facilities, Subpart G. Chapter 601 revealed the following: (e) Supervising physician or registered nurse. The skilled nursing and other therapeutic services provided shall be under the supervision and direction of a physician or a registered nurse with at least 1 year of nursing experience. This person, or a similarly qualified alternate, shall be available at all times during the operating hours and participate in activities relevant to the professional services provided, including the development of qualifications and assignments of personnel. On July 22, 2022 at 12:22 PM, review of the agency's "Organizational Chart 2022" (ORG CHART #1) revealed the following: Employee #1: Supervising Registered Nurse (RN) for the Skilled Nursing Visit (SNV) Division; Employee #2: Supervising RN for the PDN Division; Employee #3: Alternate Supervising RN SNV Division; and Employee #4: Supervising RN PDN Division. On July 27, 2022 at approximately 9:12 AM, review of the revised JULY 2022 "Organizational Chart" (ORG CHART #2) revealed the following: Employee #1: Clinical Manager for SNV Division; Employee #2: Clinical Manager for the PDN Division; Employee #3: Alternate Clinical Manager SNV Division; and Employee #4: Alternate Clinical Manager PDN. On July 27, 2022 at approximately 12:20 PM and July 28, 2022 at between the approximate times of 9:12 AM and 2:55 PM, review of personnel files revealed the following: Employee #1: The date of hire of the Administrator/SNV Clinical Manager/RN was 01/29/2007. Employee #2: The date of hire of the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN was 04/09/2021. Employee #3: The date of hire of the Alternate SNV Clinical Manager/RN was 02/28/2021. Employee #4: The date of hire of the Alternate PDN Clinical Manager/RN was 02/09/2022. Employee #5: The date of hire of the Branch Office Manager/Licensed Practical Nurse (LPN) was 10/14/1997. Employee #6: The date of hire of the PDN Nurse Success Manager/LPN was 02/04/2021. On July 27, 2022 at approximately 1:08 PM, review of the agency "Admission Booklet" revealed the agency's operating hours were Monday through Friday from 8:00 AM to 4:00 PM. Upon arrival at the agency office on July 20, 2022 at approximately 10:02 AM, one (1) staff member (Branch Manager/LPN--Employee #5) was present. Employee #5 reported that the Administrator/SNV Clinical Manager/RN (Employee #1) was currently performing patient visits. Employee #5 proceeded to contact agency staff about the survey. At approximately 10:38 AM, the Nurse Success Manager/LPN (Employee #6) arrived at the agency office. The Administrator/SNV Clinical Manager/RN (Employee #1) arrived at the agency at approximately 10:50 AM. The Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN (Employee #2) arrived at the agency at approximately 11:03 AM. On 07/20/2022 at approximately 1:35 PM, review the active patient list revealed the current SNV census was 40 and that the patients resided in Luzerne and Lackawanna Counties. On 07/20/2022 at approximately 3:29 PM, review the PDN patient list revealed the current PDN census was 32 and that the PDN patients resided in the following counties: Luzerne, Lackawanna, Clinton, Columbia, Lycoming, Monroe, Northampton, Northumberland, Schuylkill or Sullivan Counties. Patient #2: On July 20, 2022 at approximately 2:10 PM, July 21, 2022 at approximately 11:22 AM and July 28, 2022 at approximately 10:33 AM, review of the PDN clinical record revealed the patient/client resides in Lackawanna County, the start of care date was 06/10/2022, the patient/client is 18 years old, the diagnoses include trachea (windpipe) reconstruction and that skilled nursing (SN) is to care for and maintain the tracheostomy (surgically created airway in the front of the neck) and the gastrostomy (feeding) tube as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/10/2022 through 08/08/2022. "Home Health Certification and Plan of Care" documentation revealed the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN (Employee #2) performed the start of care visit on 06/08/2022. Patient #5: On July 22, 2022 at approximately 1:07 PM and July 28, 2022 at approximately 12:15, review of the PDN clinical record revealed the patient/client resides in Sullivan County, the start of care date was 05/26/2022, the patient/client is 12 years old, the diagnoses included respiratory failure and that skilled nursing (SN) is to care for and maintain the tracheostomy (surgically created airway in the front of the neck), ventilator (mechanical device which assists with breathing) and the gastrostomy (feeding) tube as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 05/26/2022 through 07/24/2022. "Home Health Certification and Plan of Care" documentation revealed the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN performed the start of care visit on 05/26/2022. Patient #6: On July 28, 2022 at approximately 12:42 PM, review of the PDN clinical record revealed the patient/client resides in Luzerne County, the start of care date was 12/13/2021, the patient/client is 18 years old, diagnoses include Type 1 Diabetes Mellitus (juvenile diabetes) and that skilled nursing (SN) is to assess and treat blood glucose (sugar) readings as documented on the "Home Health Certification and Plan of Care" for the recertification period of 06/14/2022 through 08/12/2022. "Home Health Certification and Plan of Care" documentation revealed the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN (Employee #2) performed recertification visit on 06/14/2022. On July 27, 2022 at approximately 4:15 PM, review of scheduling/visit calendars revealed the following: -Employee #1: The full-time Administrator/SNV Clinical Manager/RN was assigned to provide skilled nursing services for 20 of 22 weekdays in May 2022, 16 of 22 weekdays in June 2022 and 16 of 17 weekdays between July 1 and July 22, 2022. - Employee #2: The printed calendar for the full-time Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN failed to provide a complete list of days when employee #2 was assigned to perform patient start of care/recertification assessments and supervisory visits but handwritten documentation revealed employee #2 documented that start of care assessments were performed by employee #2 on May 12, 20 and 26, 2022, June 8 and June 20, 2022 and on July 15, 2022. Calendar documentation revealed that employee #2 was on leave from 06/24/2022 through 07/02/2022. -Employee #3: The part-time SNV Division Alternate Clinical Manager/RN was assigned to provide skilled nursing services for 17 of 22 weekdays in May 2022, 18 of 22 weekdays in June 2022 and 12 of 17 weekdays between July 1 and July 22, 2022. -Employee #4: A complete calendar for the part-time PDN Alternate Clinical Manager/RN was not available/provided for May, June and July 2022 but review of handwritten entries documented by employee #2 revealed employee #4 completed start of care assessments on June 13 and June 26, 2022. There was no documentation on the above listed scheduling/visit calendars which provided evidence that a supervising RN (Clinical Manager-Employees #1 or #2) or an alternate supervising RN (Alternate Clinical Manager-Employees #3 or #4) was available at all times during the regular operating hours of the agency for three (3) of three (3) months in 2022. (May, June and July 2022) During interview conducted on July 28, 2022 at approximately 4:00 PM, the Administrator/SNV Clinical Manager/RN (Employee #1), the Director of Clinical Excellence/Alternate Administrator/PDN Clinical Manager/RN (Employee #2) and the CEO (Employee #14) confirmed that there was no agency documentation which provided evidence that the clinical manager/supervising RN or alternate clinical manager/supervising RN was available at all times during the agency's regular operating days/hours in May, June and July 2022.

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 job descriptions, documentation, professional recommendations/guidance, clinical records and personnel files, and based on interview with the Administrator/Registered Nurse/Skilled Nursing Visit (SNV) Clinical Manager (Employee #1), the Director of Clinical Excellence/Alternate Administrator/Registered Nurse/Private Duty Nursing (PDN) Clinical Manager (Employee #2) and the Chief Executive Officer (CEO--Employee #14), the administrator/alternate administrator (Employees #1 and #2) failed to ensure a competency evaluation/hands-on skills demonstration was completed prior to the assignment of six (6) of six (6) nursing staff to provide skilled nursing (SN) care to or oversight of tracheostomy (artificial airway created in the front of the neck) and ventilator (mechanical device which assists with breathing) dependent patients/clients. (Employees #2, #4, #6, #8, #11 and #12) Findings include: On July 27, 2022 at approximately 12:22 PM, review of the agency "Administrator" job description revealed the following: Job Summary...The administrator ensures quality and safe delivery of home health services... Responsibilities...2. Employees qualified personnel and ensure adequate staff education and evaluations... On July 27, 2022 at approximately 4:05 PM, review of the agency "Job Description: Director of Clinical Excellence" revealed the following under "Role": Training and Empowerment: We want to provide the best care possible and to do so we need our caregivers to have the best knowledge and tools. As the regional coach, you will help identify areas of training and development that could help teams succeed, put together training plans in collaboration with the platforms support... On July 28, 2022 at approximately 4:55 PM, review of the Nursing Times article titled "Tracheostomy 1: caring for patients with a tracheostomy" revealed the following: Conclusion...Training is essential in all acute and community care settings to ensure that patients with tracheostomies receive appropriate care... On July 28, 2022 at approximately 4:57 PM, review of the American Association for Respiratory Care (AARC) and University Health System Consortium's (UHC) Respiratory Care Network article titled "Safe Initiation and Management of Mechanical Ventilation" revealed the following: Background and Purpose...Mechanical ventilators are very complex and require training and competency to ensure positive patient outcomes and to avoid patient harm. Inappropriate setting changes, failure to change alarms when ventilator settings are changed, changing settings without appropriate orders, and failure to communicate changes to the interdisciplinary team are under reported... Competency...Competency is the ability of a practitioner to integrate the professional attributes required to perform in a given role, situation, or practice setting. These professional attributes include knowledge, skill, judgment, attitudes, values, and beliefs. Many acute care and long term care facilities as well as home care/DME providers require annual competency testing for staff to document knowledge and skills regarding a multitude of procedures...Any clinician initiating and caring for home ventilators in a post-hospital setting should also maintain regular competency evaluations... Patient #2: On July 20, 2022 at approximately 2:10 PM, July 21, 2022 at approximately 11:22 AM and July 28, 2022 at approximately 10:33 AM, review of the private duty nursing (PDN) clinical record revealed the patient/client resides in Lackawanna County, the start of care date was 06/10/2022, the patient/client is 18 years old, the diagnoses include trachea (windpipe) reconstruction and that skilled nursing (SN) is to care for and maintain the tracheostomy (surgically created airway in the front of the neck) and the gastrostomy (feeding) tube as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 06/10/2022 through 08/08/2022. "Home Health Certification and Plan of Care" documentation revealed the alternate administrator/RN/PDN Clinical Manager RN (employee #2) performed the start of care assessment on 06/08/2022. Review of "Nurse Visit Notes" revealed the LPN (employee #8) provided skilled nursing services on 22 days between 06/13/2022 and 07/27/2022 and that the LPN had performed tracheostomy care/management including re-insertion of the tracheostomy tube. Patient #5: On July 22, 2022 at approximately 1:07 PM and July 28, 2022 at approximately 12:15, review of the PDN clinical record revealed the patient/client resides in Sullivan County, the start of care date was 05/26/2022, the patient/client is 12 years old, the diagnoses included respiratory failure and that SN is to care for and maintain the tracheostomy (surgically created airway in the front of the neck), ventilator (mechanical device which assists with breathing) and the gastrostomy (feeding) tube as documented on the "Home Health Certification and Plan of Care" for the initial certification period of 05/26/2022 through 07/24/2022. "Home Health Certification and Plan of Care" documentation revealed the alternate administrator/RN/PDN Clinical Manager (employee #2) performed the start of care assessment on 05/26/2022. Review of "Nurse Visit Notes" revealed the LPN's (employee #11 or #12) provided skilled nursing services on 38 days between 05/31/2022 and 07/20/2022 and that the LPN's had provided tracheostomy and ventilator care/management. During observational tour conducted with alternate administrator/RN/PDN clinical manager on 07/27/2022 at approximately 2:10 PM, the training equipment available/utilized to perform a tracheostomy skills evaluation was an infant mannequin. An adult CPR (cardiopulmonary resuscitation) mannequin was available to perform a CPR competency evaluation. There was no evidence that equipment was available/maintained which could be utilized to perform a ventilator competency evaluation/hands-on skills demonstration. On July 27, 2022 at approximately 12:20 PM and July 28, 2022 at between the approximate times of 9:12 AM and 2:55 PM, review of personnel files revealed the following: Employee #1: The date of hire of the Administrator/SNV Clinical Manager/Registered Nurse (RN) was 01/29/2007. During home visit conducted on July 21, 2022 at 11:00 AM, employee #1 reported that employee #1 did not provide oversight of the PDN service division. There was no documentation in the personnel file which provided evidence that employee had previous experience providing care to tracheostomy/ventilator dependent patients/clients. Employee #2: The date of hire of the Alternate Administrator/PDN Clinical Manager/RN was 04/09/2021. Review of resume documentation revealed the RN documented that the most recent employment position (11/2020 to present) was at an adult skilled nursing facility (nursing home) for which the RN's duties included the following job titles: Director of Quality Assurance, staff development, RN supervisor and infection prevention. Additional resume documentation revealed the RN was employed at a local hospital from 12/2012 through 07/2019 for which the RN documented that the RN obtained pediatric experience. Review of the "Nursing Skills Checklist" dated 05/04/2021 revealed the RN completed a self-evaluation of skills competency but a signature was not entered under "Supervisor Signature". Review of a second "Nursing Skills Checklist", which was also dated 05/04/2021, revealed the RN completed a self-evaluation of skills competency and that the signature of the administrator/RN/clinical manager of the SNV division was entered on page 2 of the form. During interview conducted on 07/27/2022 at approximately 2:10 PM, employee #2 reported the RN's past experience included care/management of tracheostomy patients/clients but that the RN did not have prior ventilator experience. Employee #4: The date of hire of the Alternate PDN Clinical Manager/RN was 02/09/2022. Review of the "Nursing Skills Checklist" dated 02/04/2022 revealed the RN completed self-evaluation of skills competency and that the Alternate Administrator/PDN Clinical Manager/RN (Employee #2) signed page 2 of the form. Employee #6: The date of hire of the PDN Nurse Success Manager/Licensed Practical Nurse (LPN) was 02/04/2021. Review of resume documentation revealed the LPN documented that the most recent nursing position (10/2015 to present) included tracheostomy and ventilator management and care. Employee #8: The date of hire of the PDN LPN was 11/17/2021. Review of resume documentation revealed the LPN documented that the most recent nursing position (2005 to present) was as a pre-certification payor liaison for a healthcare provider. There was no documentation on the resume which provided evidence that the LPN had previous work experience providing care to tracheostomy/ventilator dependent patients/clients. Employee #11: The date of hire of the PDN LPN was 06/01/2021. Review of the "Nursing Skills Checklist" dated 05/26/2021 revealed the LPN completed self-evaluation of skills competency and that the Alternate Administrator/PDN Clinical Manager (Employee #2) signed page 2 of the form. There was no documentation on the resume which provided evidence that the LPN had previous work experience providing care to tracheostomy/ventilator dependent patients/clients. Employee #12: The date of hire of the PDN LPN was 06/17/2022. Review of the "Nursing Skills Checklist" dated 06/20/2022 revealed the LPN completed a self-evaluation of skills competency and that the Nurse Success Manager/LPN of the PDN division (Employee #6) signed page 2 of the form. There was no documentation on the resume which provided evidence that the LPN had previous work experience providing care to tracheostomy/ventilator dependent patients/clients. There was no documentation in the personnel files which provided evidence that PDN employees #2, #4, #6, #8, #11 and #12 had completed a tracheostomy and/or ventilator competency evaluation and hands-on skills demonstration. On July 28, 2022 at approximately 9:48 AM, the Alternate Administrator/PDN Clinical Manager/RN (Employee #2) presented the "Pediatric and Infant Care Nursing Skills Checklist". Employee #2 reported the form was developed in response to an internal audit but employee #2 reported the form had not yet been implemented. Review of the "Pediatric and Infant Care Nursing Skills Checklist" revealed the following "Instructions" were included on the form: Check the boxes for the skills/procedures listed that "you" have performed within the last 3 years for a child birth to 18 years of age. Fill in the types of equipment when requested. You may add clarifying information in the explanations/updates section. There was no documentation on the "Pediatric and Infant Care Nursing Skills Checklist" form which provided evidence that a qualified RN would perform a competency evaluation/hands-on skills demonstration prior to the assignment of nursing staff to provide care to or oversight of patients/clients who are ventilator dependent. During interview conducted on July 28, 2022 at approximately 4:00 PM, the Administrator/SNV Clinical Manager/RN (Employee #1), the Director of Clinical Excellence/PDN Clinical Manager/RN (Employee #2) and the CEO (Employee #14) confirmed that there was no agency documentation which provided evidence that the above referenced RN's/LPN's had completed a competency evaluation/hands-on skills assessment for tracheostomy and ventilator care/management prior to assignment to provide care to or oversight of tracheostomy/ventilator dependent patients/clients.