Good Samaritan Society Home Health

“Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This Standard is not met as evidenced by: Based on policy and procedure review, QAPI review, and staff interview, the agency failed to conduct a root cause analysis to identify the underlying cause preventing the agency from obtaining regulatory compliance, and failed to develop and implement an action plan to obtain and sustain regulatory compliance for deficiencies cited at G536, G572, and G808 on 1/30/25. Findings are: A. Review of the agency’s policy and procedure titled Quality Assurance and Performance Improvement-QAPI, reviewed 5/20/25, revealed: 1.The Quality Improvement Performance Improvement (QAPI) program will measure, analyze, and track quality indicators to assess processes of care, services and operations. 2. The QAPI committee is responsible to systematically analyze underlying root causes of improvement opportunities, develop and implement action plans, and monitor and evaluate the effectiveness of the action plans and ensure sustainability. B. Review of audits conducted by the agency for correcting the deficiency G536 included 10 admission chart audits conducted to compare discharge summary medications, from the referral source to the patient’s medication list, for March, April, May and June 2025. Audit results, for compliance, were: March 44%, April 50%, May 78% and June 89%. C. Review of audits conducted by the agency for correcting the deficiency G572 included auditing 100% of documentation of physician notifications for missed visits monthly for March, April, May, and June 2025. Audit results, for compliance, were: March 71%, April 44%, May 22%, and June 17%. D. Review of audits conducted by the agency for correcting the deficiency G808 included monthly audits of Home Health Aide Plans of Care for February, March, April, and May 2025. Audit results, for compliance, were: February 21%, March 0%, April N/A (N/A results were patients receiving non-skilled services), and May 0%. E. Review of a summary report of the agency’s correction processes, for deficiencies cited on 1/30/25, revealed RN Clinical Manager shared audit results at QAPI meetings on 4/24/25 and 6/18/25. There was no documentation of the QAPI committee of analyzing the root causes, or developing and implementing an action plan to obtain and sustain regulatory compliance for deficiencies cited at G536, G572, and G808 on 1/30/25. F. During an interview on 8/6/25 at 4:30 PM, the Administrator confirmed the agency failed to follow their policy and procedure to conduct a root cause analysis to identify the underlying cause preventing the agency from obtaining regulatory compliance, and from developing and implementing an action plan to obtain and sustain regulatory compliance for deficiencies cited at G536, G572, and G808 on 1/30/25.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review, policy and procedure review, and staff interview, the agency failed to notify the patient’s physician, when visits were not conducted as ordered on the plan of care, for 2 of 10 clinical records reviewed (Patient 2 and 4). The census was 106. Findings are: A. Review of the agency’s policy and procedure titled Provider Orders and Notification, Home Health – Enterprise, revealed: 1. The agency was to provide services that conform to the provider orders. 2. The provider was to be notified of any missed visits, and documentation in the medical record was to reflect the notification. B. Review of Patient 2’s clinical record revealed: 1.The Home Health Certification and Plan of Care (POC) for the certification period 1/8/25 through 3/8/25, included orders for Physical Therapy (PT) 2 times a week for 3 weeks, then 1 time a week for 3 weeks. 2. There was no documentation the clinical record that PT visits were conducted the week of 1/5/25 through 1/11/25. 3. There was no documentation in the clinical record that the physician was notified of the missed PT visits the week of 1/5/25 through 1/11/25. C. Review of Patient 4’s clinical record revealed: 1. The POC for the certification period 10/11/24 through 12/9/24 and 12/10/24 through 2/7/25, included orders for Home Health Aide 3 times weekly. 2. During the weeks of 12/22/24 through 12/28/24 and 12/29/24 through 1/4/25, Home Health Aide services were provided 2 times weekly. 3. There was no documentation in the clinical record that the physician was notified of the missed Home Health Aide visits, the weeks of 12/22/24 through 12/28/24 and 12/29/24 through 1/4/25. D. During an interview on 1/30/25 at 12:30 PM, the Administrator confirmed` the agency staff failed to follow the agency’s policy and procedure for notifying the patient’s physician of the missed visits for Patients 2 and 4.”

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on record review, policy and procedure review, and staff interview, the agency failed to complete a comprehensive assessment of the patient’s rehabilitative needs within 5 days of the start of care, for 1 of 3 patients who had orders for physical, occupational, and/or speech therapy, included on the plan of care (Patient 1). The total sample size was 10. The census was 106. A. Review of the agency’s policy and procedure titled Comprehensive Assessment, Home Health, Therapy & Rehab – Enterprise, reviewed 4/10/24, revealed the comprehensive assessment was to be completed in a timely manner, but no later than five (5) calendar days following the start of care. B. Review of Patient 1’s clinical record revealed: 1.Home Health Certification and Plan of Care (POC) for the certification period 12/31/24 through 2/28/25, included orders for Occupational Therapy (OT) to evaluate and treat. 2. The start of care (SOC) was 12/31/24. 3. An OT evaluation visit was completed on 1/8/25 (8 calendar days after the SOC). 4. There was no documentation in the clinical record that the patient or the physician requested a delay in the OT comprehensive assessment beyond 5 calendar days after the SOC. C. During an interview on 1/30/25 at 12:30 PM, the Administrator confirmed the comprehensive assessment, of Patient 1’s OT needs, was not completed within 5 calendar days after the patient’s SOC, and the staff failed to follow their policy and procedure for completion of the comprehensive assessment no later than 5 calendar days after the SOC.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on record review, policy and procedure review, and patient and staff interview, the agency failed to ensure the patient’s medication orders, on the Plan of Care and the medication profile (a real-time document used by the agency that lists the patient’s medications), were accurate for 1 or 10 patient records reviewed (Patient 2). The total sample size was 10. The census was 106. Findings are: A. Review of the agency’s policy and procedure titled Comprehensive Assessment Home Health, Therapy & Rehab – Enterprise, reviewed 4/10/24, revealed: 1. The comprehensive assessment was to accurately reflect the patient’s health status and includes information to establish and maintain a Plan of Care. 2. A drug regimen review was required as part of the comprehensive assessment and was to include a current medication list. B. Review of the agency’s policy and procedure titled Medication Management, Home Health – Enterprise, reviewed 10/18/24, revealed: 1. A comprehensive assessment was to include a review of all medications the patient was currently using, and identify any issues, including duplicate drug therapy. 2. The provider responsible for the plan of care, was to be notified regarding issues or discrepancies. 3. Medications were to be assessed/reviewed at the time of the initial assessment and at the time of recertification. 4. All medications the patient was using, was to be entered on the medication profile. C. Review of the agency’s policy and procedure titled, Care Planning and Care Coordination, Home Health and Therapy – Enterprise, reviewed 9/23/24, revealed: 1. The Plan of Care was to include complete medication orders. 2. The Plan of Care was to be reviewed and revised by the team as frequently as the patient’s condition required, but no less frequently than once every 60 days, beginning with the Start of Care. D. During an interview on 1/23/25 at 1:00 PM, Patient 2’s caregiver, who administers medications to the patient, revealed [Gender] applies a Lidocaine patch and Voltaren ointment, for back pain, and gives Ibuprofen (oral medication used for pain) as needed for pain. E. Review of Patient 2’s clinical record revealed: 1.A Continuum of Care Transfer Report, from CHI Health, received via fax to the agency on 11/6/24 at 11:56 AM revealed: a. Lidocaine 4% patch (topical patch used to relieve pain), apply 1 patch onto the skin daily. Remove and discard the patch within 12 hours or as directed by the MD [(Medical Doctor)]. b. May use Voltaren (topical gel used to treat pain) in between Lidocaine patch placements. 2. Review of the Home Health Certification and Plan of Care (POC) for the certification period 11/9/24 through 1/7/25 and 1/8/25 through 3/8/25, and the medication profile dated 1/23/25, revealed both documents failed to include Lidocaine patch, Voltaren and Ibuprofen. F. During an interview on 1/30/25 at 12:30 PM, the Administrator confirmed the agency staff failed to follow the agency’s policy and procedure to ensure the patient’s medication orders for Patient 2 were accurate.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on record review, policy and procedure review, and staff interview, the agency failed to ensure staff followed wound care treatment orders for 1 of 3 patients (Patient 6), who received wound care. The total sample size was 10. The census was 106. Findings are: A. Review of the agency’s policy and procedure titled Wound Care, Home Health, Hospice and Assisted Living – Enterprise, reviewed 7/30/24, revealed: 1. Wound care was to be provided according to a provider’s order. 2. Wound care orders were to include the type of dressing to be used. B. Review of the agency’s policy and procedure titled Provider Orders and Notification, Home Health – Enterprise, reviewed 9/23/24, revealed: 1. All treatments and care were to be ordered by the provider. 2. Treatments were to be administer only as ordered by the provider. 3. Verbal orders were to be put into writing for the purpose of documenting in the electronic medical record, as well as establishing or revising the patient Plan of Care. 4. When a provider made a change in an order, an interim/supplemental order was to be written. 5. The nurse was to document the implementation of order changes in the patient’s medical record. 6. The agency was to provide services that conform to the providers orders. C. Review of Patient 6’s clinical record revealed: 1. The Home Health Certification and Plan of Care (POC) for the certification period 10/8/24 through 12/6/24, included orders for: a. Skilled Nurse (SN) to provide wound care to bilateral lower extremities, knee down [legs]. b. Clean legs with soap and water/wound cleanser, apply coflex (a double layer compression bandage) and superabsorber (a wound dressing with a high absorption capacity) to legs. 2. Review of a SN visit note, dated 12/3/24, revealed the patient had skin tears from an unna boot (a compression bandage treated with zinc oxide paste that is wrapped around the leg, to treat leg wounds and swelling), and the SN switched back from the unna boot to a double layer compression bandage. a. There was no physician order in the clinical record to apply an unna boot. b. The nurse failed to notify the physician when a change in wound care orders was needed. 3. The POC for the certification period 12/7/24 through 2/4/25, included orders for: a. SN to provide wound care to bilateral lower extremities [legs], knee down. b. Clean legs with soap and water/wound cleanser, zinc unna boot (also called an unna boot) and coban (used as an overwrap for zinc unna boot, to hold the dressing secure). 4. Review of SN visit notes, dated 12/24/24, 12/31/24, 1/7/25, 1/14/25, 1/21/25, and 1/28/25, revealed the nurse applied Koflex [sic (coflex)] dressing to bilateral legs. a. There were no orders from the physician in the clinical record, to apply coflex to bilateral legs, starting on 12/24/24 through 1/28/25. b. The nurse failed to notify the physician when a change in wound care orders was needed. D. During an interview on 1/30/25 at 12:30 PM, the Administrator confirmed the agency staff failed to provide wound care for Patient 6 in accordance with the physician’s orders, and failed to notify the physician when a change in orders was needed.”

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on record review, policy and procedure review, and staff interview, the agency failed to ensure staff promptly notify the patient’s physician when a change in wound status occurred for 1 of 3 patient records reviewed (Patient 6), who received wound care. The total sample size was 10, the census was 106. Findings are: A. Review of the agency’s policy and procedure titled Care Planning and Care Coordination, Home Health and Therapy – Enterprise, reviewed 9/23/24, revealed significant changes in the patient’s condition were to be communicated to the patient’s provider in a timely manner and documented in the patient record. B. Review of Patient 6’s clinical record revealed: 1.The Health Certification and Plan of Care (POC) for the certification period 10/8/24 through 12/6/ 24 and 12/7/24 through 2/4/25 included orders for: a. Skilled Nursing (SN) to provide wound cares to bilateral lower extremities [legs], knee down. b. Report to the MD [(Medical Doctor)] any changes in condition including new open areas identified during wound care visits. 2. Review of a SN visit note, dated 12/3/24, revealed the patient’s legs had several skin tears from an unna boot (a compression bandage treated with zinc oxide paste that is wrapped around the leg, to treat leg wounds and swelling). 3. There was no documentation in the clinical record that the patient’s physician was notified of the skin tears on the patient’s legs. C. During an interview on 1/30/25 at 12:30 PM, the Administrator confirmed the agency staff failed to follow the agency’s policy and procedure, and the POC, to report a change in Patient 6’s wound status to the physician.”

“Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This Element is not met as evidenced by: Based on record review, policy and procedure review, and staff interview, the agency failed to include the patient’s progress towards the patient’s measurable outcomes and goals identified by the agency and the patient, for 4 of 6 (Patient 4, 5, 6, and 7) patients who had a revised/updated Plan of Care. The total sample size was 10. The census was 106. Findings are: A. Review of the agency’s policy and procedure titled Care Planning and Care Coordination, Home Health and Therapy – Enterprise, reviewed 9/23/24, revealed: 1. The Plan of Care was to include the patient’s measurable outcomes and goals. 2. The policy and procedure failed to require staff document the patient’s progress towards the patient’s measurable outcomes and goals, identified by the agency and the patient, when the patient had a revised/updated Plan of Care. B. Review of clinical records revealed: 1. Patient 4’s Start of Care (SOC) was 10/11/24. The revised/updated Home Health Certification and Plan of Care (POC) for the certification period 12/10/24 through 2/7/25, did not include the patient’s progress towards the patient’s measurable outcomes and goals as identified by the agency staff and the patient. 2. Patient 5’s SOC was 1/31/24. The revised/updated POC for the certification period 9/7/24 through 11/25/24 and 11/26/24 through 1/24/25, did not include the patient’s progress towards the patient’s measurable outcomes and goals as identified by the agency staff and the patient. 3. Patient 6’s SOC was 10/8/24. The revised/updated POC for the certification period 12/7/24 through 2/4/25, did not include the patient’s progress towards the patient’s measurable outcomes and goals as identified by the agency staff and the patient. 4. Patient 7’s SOC was 10/5/21. The revised/updated POC for the certification period 11/18/24 through 1/16/25 and 1/17/25 through 3/17/25, did not include the patient’s progress towards the measurable outcomes and goals as identified by the agency staff and the patient. C. During an interview on 1/30/25 at 12:30 PM, the Administrator confirmed the patient’s progress, towards the patient’s measurable outcomes and goals as identified by the agency staff and the patient, was not included on the revised/updated POC for Patients 4, 5, 6 and 7.”

“Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient’s plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This Element is not met as evidenced by: Based on record review, policy and procedure review, and staff interview, the agency failed to conduct Registered Nurse (RN) supervisory visits, every 2 weeks, for home health aides providing basic therapeutic care (including, but not limited to measuring vital signs) for 1 or 1 record reviewed that had a Home Health Aide (Patient 4), and the agency’s policy and procedure failed to include these RN supervisory visits in accordance with 14-010.04 (G)(vii). The total sample size was 10. The census was 106. Findings are: A.Review of the agency’s policy and procedure titled Home Health Aide (HHA) Supervision and Delegation of Duties, Home Health – Enterprise, reviewed 6/14/24, revealed: 1. Home Health Aide supervision is to be conducted as required by state/federal guidelines. 2. The Home Health Aide Plan of Care is developed by the Registered Nurse (RN). 3. A patient, receiving skilled services, including nursing, Physical Therapy (PT), Occupational Therapy (OT), or Speech Therapy (ST), and Home Health Aide services, requires an on-site supervisory visit of the Home Health Aide, to be conducted at least every 14 days, with or without the Home Health Aide present. 4. A patient, receiving non-skilled services (one who is not receiving skilled nursing, PT, OT, or ST), requires the RN to conduct an on-site Home Health Aide supervisory at the patient’s home, at least every 60 days. B. Review of Patient 4’s clinical record revealed: 1. The Home Health Certification and Plan of Care (POC) for the certification period 10/22/24 through 12/9/24 and 12/10/24 through 2/7/25, and the team care plan, included orders for: a. HHA 3 times weekly. b. HHA to obtain vital signs (VS) and report VS out of agency parameters to the RN. c. HHA to assist with ambulation, oral hygiene, bathing, dressing/undressing, assist patient with applying cream in hard to reach areas, and housekeeping chores. d. Skilled Nursing to conduct visit for recertification and onsite HHA supervisory visit every 60 days. 2. An onsite HHA supervisory visit by an RN was conducted on 12/9/24. C. During an interview on 1/30/25, the Administrator confirmed: 1. The agency’s policy and procedure for RN supervision of HHA services failed to include HHA services for basic therapeutic care shall include at a minimum, an onsite visit to each patient, with or without the HHA being present, once every 2 weeks. 2. The agency failed to provide onsite RN supervision, every 14 days, when HHAs were providing basic therapeutic care, for Patient 4.”

“In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This Element is not met as evidenced by: Based on record review, policy and procedure review, and staff interview, the agency failed to ensure the Skilled Nurse (SN) followed the agency’s policy and procedure to perform wound measurements weekly for 1 of 3 patients (Patient 6) who received wound care. The total sample size was 10. The census was 106. Findings are: A. Review of the agency’s policy and procedure titled Wound Care, Home Health, Hospice and Assisted Living – Enterprise, reviewed 7/30/24, revealed wounds were to be measured at least weekly. B. Review of the agency’s policy and procedure titled Patient (Vital Signs) Monitoring, Home Health Enterprise, dated 2/2/24, revealed wounds were to be measured weekly or as needed. C. Review of Patient 6’s clinical record revealed: 1. The Home Health Certification and Plan of Care (POC) for the certification period 10/8/24 through 12/6/24 and 12/7/24 through 2/4/25, included orders for SN to provide wound cares 2 times weekly. 2. The agency received an order from the patient’s physician, on 12/22/24, to decrease the SNV [(Skilled Nurse Visits)] to 1 time weekly. 3. SN visit notes, dated 12/3/24, 12/10/24, 12/17/24, 1/7/25, 1/14/25, 1/21/25, and 1/28/25, failed to include weekly wound measurements for Patient 6’s wounds. C. During an interview on 1/30/25 at 12:30 PM, the Administrator confirmed the agency staff failed to follow the agency’s policy and procedure to perform weekly wound measurements for Patient 6.”