Every finding on record at Gibraltar Home Health Services LLC

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey from 2/2/2026 to 2/6/2026. Complaint: 112443 and 116617 Census: 133 Unduplicated admissions: 409 Sample Size: 10 Home Visits: 4 On 2/5/2026 at 3:26 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the provider's non-compliance with one or more requirements of participation has caused, or likely to cause, serious injury, harm impairment, or death to a patient) in the presence of the agency’s Administrator (ADM) and the Director of Patient Care Services (DPCS) related to the Home Health Agency (HHA - an organization that delivers skilled nursing and other therapeutics service to a patient at home) failure to ensure one of 10 sampled patient’s (Patient 1’s) plan of care was followed. On 2/6/2026 at 3:00 p.m., the Home Health Agency was unable to submit an acceptable IJ removal plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely). On 2/6/2026 at 12:55 p.m., the Department called an Immediate Jeopardy in the presence of the agency’s ADM and the DPCS related to the Home Health Agency failure to ensure clinical records were written and authenticated by the author of the note for six of 10 sampled patients (Patient 1, Patient 6, Patient 7, Patient 8, Patient 9, and Patient 10). The non-compliance resulted in unauthorized patient information entries that did not reflect Patient 1, Patient 6, Patient 7, Patient 8, Patient 9, and Patient 10 current medical condition and needs, which is likely to result in inappropriate treatment, delayed or incorrect diagnoses, and fatal medical errors that can lead to serious injury, harm, impairment, or death. On 2/6/2026 at 3:00 p.m., the Home Health Agency was unable to submit an IJ removal plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely). On 2/6/2026, at 3 p.m., the Department completed the survey tasks and conducted an exit conference in the presence of the ADM and DPCS with the IJ situation not removed. On 2/24/2026, the agency submitted an IJ removal plan, reviewed and was accepted. The following IJ removal indicated: For: IMMEDIATE JEOPARDY REMOVAL PLAN FOR G572 The Home Health Agency failed to ensure the plan of care was followed for Patient 1: The agency's Administrator, the previous and newly hired Director of Patient Care Services (DPCS), Wound Specialist and the newly contracted RN consultant were on telephone Conference on February 10, 2026, after the five (5) day complaint survey conducted by the Los Angeles CDPH Evaluators with regards to their findings on patient 1 on Immediate Jeopardy status that needs immediate plan of action. 1.Failing to ensure that Patient l's plan of care certification period of 11/21/2025 to 1/19/2026 were implemented for right foot wound care when there was no evidence of: a. Patient 1 being taught how to do daily wound care in between home visits b. Patient l's wound was assessed completely and accurately c. Patient l's physician being notified when there was a change in patient l's wound condition d. Patient 1 being assessed and monitored for bl_ood sugar levels e. Patient 1 was provided with wound care as ordered three times a week consistently 2. Failing to ensure that Patient 1 had a plan of care developed for Right foot wound care for certification period of 1/16/2026 to 3/16/2026 and that the following care provided to Patient I: a. Patient l's wound was assessed completely and accurately b. Patient 1 received wound care treatment as indicated in the hospital referral order c. Patient l's physician was notified when there was change In Patient l's wound condition d. Patient 1 was assessed and monitored for blood sugar levels. The following Plan of Action are as follows based on the findings above: a.Since the certification period of 11/21/2025 to 1/19/2026 plan of care was not followed, it was emphasized by the Administrator during their in-service conducted on 02/09/2026 and attended by the following disciplines RNs, LVNs, Administrator, QA, DPCS, Intake staff, Medical Record staff, Case Managers (RN,LVN), Wound Care Socialists, IT staff and RN/PHD Consultant and RN consultant during the meeting conducted on 02/12/2026 attended by Administrative and Clinical leadership (RN, Administrator, Governing Board members), moving forward that all patients no matter what the diagnoses especially DM and with wound must be properly assessed, provide and deliver the proper and ordered wound care, coordinate, report with the PCP/AMD on their current condition or any change In condition if wound is responding or not responding to current treatment, patients and/or PCGs are educated, taught and do a return demonstration if able and willing to do wound care observing proper disposal of contaminated supplies and universal precautions such as proper hygiene and disposal of sharps and the SN are following frequency of wound care and visits and to documents what care were provided and taught on their clinical visit notes and following the Plan of Care. b. An SN (RN) visit was conducted on 02/07/2026 from 9am-10am (attached) for Patient 1. On page 7 /9 of the SN Note- It was documented that Patient 1 was 'Instructed on how to care for the wound himself, as he has no one to help him; but he says he cannot do it himself'. An MD order was created on 02/14/2026 for Wound Care Specialist every Monday visit and agency's SN of x/week visit every Tuesdays, Thursdays, and Saturdays, In addition, Instructed patient by the SN during the visit on 2/07/2026, to call the agency for any signs and symptoms of Infection on the wound site such as fever, pain and significant drainage and can call 911 or seek medical attention immediately, checking BS, observing proper hand hygiene, keeping right foot elevated, home safety, medications, diet and keeping MD appointments. c. On the SN Note dated 02/07 /2026- the wound of the Right foot- was properly assessed completely and accurately as indicated on page 4/9 (Wound Documentation) & page 8/9 under the Narratives Section. An MD order was created on 02/14/2026 for the wound care treatment recommended by the wound specialist starting 02/06/2026 to 02/26/2026 for 3 weeks. d. Several MD orders were created on 02/14/2026 as follows: Addendum to the Plan of Care and MD order for clarification of wound care treatment and frequency of visits by SN and Wound Specialist, MD order for Medication Reconciliation and MSW evaluation for community resources (attached) and SN note on 02/07/2026 under the narrative section 'Report the patient's condition to their PCP'. e. RN note on 02/07/2026 under the Blood Sugar Section - 'FBS 140 at 8:30 reported by patient. The patient measures his FBS at home by himself, he has a glucometer and test strips at home', Vital signs/Blood Sugar/Insulin Flow Sheet attached. f. In addition, all BS taken by the patient will be recorded by the SN during the scheduled frequency of visit. The visiting SN will report BS results to MD to further assess needs and treatment necessary to maintain BS levels within the patient's acceptable level. For all patient admitted with diagnosis of Diabetes Mellltus and ordered by MD of BS check with or without insulin must be monitored and have and maintain a Diabetic Flow Sheet. The agency conducted and Educational in-service In the Conference room on February 9, 2026 conducted by the Wound Care Specialist focusing on Wound Classification, Measurement and Documentation from 9am-12 pm and attended by staff (sign In attached), The Administrator did discuss the findings of the survey conducted by CDPH. The newly hired RN Consultant who Is to assist the agency In their plan of action for the 11 and COPS Incurred In coordination with the Administrator and DPCS, during their complaint survey conducted a meeting In person on February 12, 2026 from 10am-1pm, to further discuss the findings of the CDPH Evaluators, to the administrative and clinical leadership of the agency. Attached is the resume of the RN Consultant, agenda, and sign sheet for the in-service. The Plan of Care (POC) was updated for patient 1 and sent out to MD as an order and other MD orders (attached) dated 02/14/2026 for signature for the following: The updated Addendum to the Plan of Care for the Certification Period of 1/16/2026 to 3/16/2026 is sent out to Dr. Lim the Attending MD (attached). The Wand Care Specialist, RN Consultant along with the DPCS did put emphasis the education and teachings of patient and PCG If avallable on the disease process and management of Diabetes Mellitus, proper and complete documentation and complete and accurate assessment of any wound location, size, the status of the wound, how to do and follow wound care and treatment ordered and measure to prevent complications of Infection on the wound site and having Diabetes Mellltus as one of the diagnosis, Including effects and side effects of Insulin (if applicable) and diabetic oral medications, and the BS checking daily as ordered, recording and administration of ordered medications and reporting to the agency and MD results of BS results or any sudden change In condition and when to call 911 emergency, AMO and the agency. There were other patients or recipients identified during the conducted survey by CDPH who were affected or who have suffered or are likely to suffer, a serious adverse outcome as a result of the Immediate Jeopardy. There were ten (10) reviewed and identified by the evaluator and six (6) Identified by the agency by way of chart review by the QA staff. The agency is working on having a system in place by doing and starting chart audit using a chart audit tool effective 2/16/2026 on active and current charts, closed charts focusing on patients with Wound and DM diagnoses to ensure that all patient's physician orders are followed, plan of care is current, updated, completed, and signed by the AMD/PCP and the RN Evaluator Including provision of copies to following SN and patient and family are involved their Plan of Care, the Start of Care and Recertification assessments are completed and signed on time by the author. Policies and procedures for diabetic management and for wound care, are strictly followed to prevent patients from serious harm that could lead to hospitalization or even death. During the in-services conducted the following were discussed and reviewed on 02/09/2026 by the Administrator to the following RNs, LVNs, QA, DPCS, Intake staff, Medical Record staff, Case Managers (RN, LVN), Wound Care Socialists, IT staff and RN/PHD Consultant and 02/12/2026 Administrator and RN consultant to Administrative and Clinical leadership (RN, Administrator, Governing Board members), 1. Policies and procedures on Verification of Physician Orders, 2. Emphasis on following the Plan of Care and Physician Participation in the Plan of Care 3. Care Planning Process 4. Discussion and provision on Diabetic Management a. Blood Glucose Monitoring b. The use of the Diabetic Flow Sheet c, Wound Care Polley and Wound Assessment/Staging of Pressure Ulcers d. Continue to educate patient and PCG on the prevention of possible hospitalization by adhering to the plan of care. Monitoring Process: 1. Concurrent/continuous compliance and on-going monitoring process by the DPCS In coordination with QA staff during medical record or chart audit done monthly to ensure a patient's physician orders and plan of care are followed, complete and accurate wound assessment are documented, reporting to AMP/PCP any changes in condition Including responses to current treatment If effective or not effective, BS check are check and results documented and to Include how often and who will check BS, supplies are provided or ordered for patient's need and care for wound and Diabetic needs, frequency of visits by the SN Including frequency of wound care by the SN and on non-SN visits and policies for diabetic management are strictly followed to prevent patients from serious harm that could lead to hospitalization or death Including medication review or reconciliation Is documented on the skilled clinical notes on SOC, Recertification, every visit and on discharge. 2. The QA staff In coordination with the DPCS all patients with diagnosis of diabetes medical charts/records must be audited monthly for three (3) months starting 2/16/2026 until the threshold is met at 100%. All data collected will be reported to the Quality committee and the Governing Board and it will be monitored monthly for three (3) consecutives months to arrive at 100% compliance. Once the 100% threshold Is reached and attained, chart audit will be done quarterly. 3. Moving forward, all patients with diagnosis of DM and with wound care/treatment orders -must document in the Skilled clinical notes (RNs, LVNs, NP, MD, Wound Care Specialist) regarding teaching, educating and knowledge of patient or PCG Is willing, able and available to do wound care with ease and confidence, observation of Infection control such as proper hand hygiene and proper disposal of contaminated supplies and sharps, physician ls/was notified of any changes In condition, following MD's order including order from the referring provider, BS checks are assessed and monitored including frequency of SN visits and frequency of wound care to be provided. In addition, the Administration decided to hold any new admissions at this time to continue to review charts for completion of all assessments accurately, Plan of Care are individualized and with measurable goals, MD orders and Plan of Care are carried out accurately and as ordered especially wound treatments and signed In a timely manner and proper documentation in the skilled clinical notes of all treatments and care provided. 4. The QA staff who audit medical records for non-compliance, a corrective action plan will be submitted to the DPCS and the re-education of all staff. 5. The implementation of concurrent monitoring by the Director of Patient Care Services in coordination with the Quality Assurance staff starting 2/16/2026 for three (3) months and this will be a part of the QAPI Meeting to be held quarterly. For: IMMEDIATE JEOPARDY REMOVAL PLAN FOR G1024 The Home Health Agency failed to ensure clinical records were written and authenticated (verifying accuracy, authorship, and validity of documentation) by the author of the note for 10 of 10 sample patients (Patient I, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, Patient 9 and Patient 10) when: The agency's Administrator, the previous DPCS and newly hired Director of Patient Care Services (DPCS), and the newly contracted RN consultant were on telephone Conference on February 10, 2026, after the five (5) day complaint survey conducted by the Los Angeles CDPH Evaluators with regards to their findings on ten (10) sample patients on Immediate Jeopardy status that needs Immediate plan of action. 1.The HHA hired Subcontractor 1 (Sl) who amended the comprehensive nursing assessment for the patients, despite not having assessed the patients. 2. The Director of Patient Care Services (DPCS) used Registered Nurse 1 (RN1) nursing credential to document the nursing assessment of the patients. 3. The plan of care of the patients was not developed, documented and authenticated by a Registered Nurse and the Medical Director. 4. The physician orders for the patients were not signed by the ordering physician. The following Plan of Action are as follows based on the findings above: 1.The Sl was verbally and written counseling was completed on 2/9/2026 by the Administrator after the scheduled meeting for not amending, changing or altering any SOC and or Recertification assessments completed by the RN evaluator since Sl had not seen and evaluated and assessed patient. And for any Issues or question to coordinate with the RN evaluator for any clarification on any Items on the OASIS assessment/s. Refer to the attached written counselling document. In addition. Sl ls a Registered Nurse licensed by the CA BRN from 12/09/2003 to 02/28/2027, lives locally In Valencia, CA and Is not being outsource outside of USA. Attached CDL and online RN license verification. The agency wlll stlll utilize Sl services as QA staff and made aware by the Administrator and the DPCS that she cannot amend or change any assessments completed by the RN evaluator and coordinate with the RN evaluator for any c/arlflcatlon on any Items on the OASIS assessments. Sl w/11 report to DPCS for any findings on the RN assessments and the DPCS will coordinate with the RN evaluator who assessed the patient for any findings. 2. The DPCS resigned effective 2/16/2026 (resignation letter dated 2/12/2026 attached). It was emphasized by the Administrator and the newly hired consultant who Is to assist the agency In their Plan of Action for their IJ and COPs Incurred during their complaint survey, to all attendees on 02/09/2026 and 2/12/2026 (RNs, LVNs, office staff-Medical Record staff, Intake staff and Case Managers Staff and Administrative and Clinical leadership to remember not to use anybody's login and password to access Information and completion of any work on the agency's software due to HIPAA Confidentiality. The newly hired DPCS was effective 02/09/2026 and HS 215a was completed and to be submitted to Centralized Application Branch (CAB} In Sacramento on 02/17/2026 due to the federal holiday on 2/16/2026. HS 215a attached. In addition, after the in-service conducted by the Wound Specialist on February 9, 2025, the Administrator instructed every Individual discipline who attended the In­service to change effective today 2/9/2026, their login and password on the software utilized by the agency and the Administrator did put more emphasis not to share their login and password to anybody. And for anyone who is not incompliance will be terminated and reported to the licensing agency. 3. It was emphasized by the RN consultant during the meeting held on 02/12/2026 to both administrative and clinical leadership that plan of care must be developed, documented and authenticated by a Registered Nurse and the Medical Director or patient's Primary MD or Attending MD. All MD orders, Plan of Care and Physician Attestation of Face to Face Encounter not signed are to be sent out for signature and for those signed on or after 02/09/2026 and marked as late entry In a handwritten method by the newly hired DPCS. a. Patient 1-AII documents are marked 'late entry' 1. Certification Period 11/21/2025-01/19/2026-was signed by the RN electronically on 11/21/2025 and MD signed on 12/10/2025 2. Certification Period 01/16/2026-03/16/2026 was signed by the RN electronically on 01/16/2026 and MD signed on 2/13/2026 3.An addendum to the POC was created on 02/14/2026 signed by RN and signed by the PMD b. Patient 2-AII documents are marked 'late entry' 1. Certification Period 01/06/2026-03/06/2026 was electronically signed by RN on 01/03/2026 and signed by MD on 02/05/2026 and stamped received by the agency. c. Patient 3-All documents are marked 'late entry' 1. Certification Period 01/14/2026-03/14/2026 was signed by the RN electronically on 01/14/2026 and signed by MD on 2/4/2026 and received stamped by the agency. d. Patient 4-All documents are marked 'late entry' 1. Certification Period 11/05/2025-01/03/2026 was signed by the RN electronically on 11/05/2025 and signed by MD page 1/5 with no date and received stamped by the agency. e. Patient 5-All documents are marked 'late entry' 1. Certification Period 06/09/2025-08/07 /2025 was signed by RN on 02/16/2026 and MD signed on 02/16/2026 and received stamped by the agency. 2. Certification Period 12/25/2025-02/20/2026 was signed by RN electronically on 12/25/2025 and MD signed on 02/16/2026 and received stamped by the agency. f. Patient 6-All documents are marked 'late entry' 1. Certification Period 10/23/2025-12/21/2025 was signed by the RN electronically on 10/23/2025 and MD signed but no date when It was signed 2. Certification Period 12/22/2025-02/10/2026 was signed by the RN electronically on 12/21/2025 and MD signed but no date when It was signed and agency received stamped on 1/19/2026. g. Patient 7-AII documents are marked 'late entry' 1. Certification Period 11/18/2024-01/16/2025 was signed by RN electronically on 11/18/2024 and signed by MD on 03/24/2025 and received stamped by the agency 2. Certification Period 01/17 /2025-03/17 /2025 was signed by the RN electronically on 01/15/2025 and MD signed on 5/19/2025 and received stamped by the agency 3. Certification Period 03/18/2025-05/16/2025 was signed by the RN electronically on 03/16/2025 and MD signed on 5/19/2025 and received stamped by the agency. 4. Certification Period 11/13/2025-01/11/2026 was signed by RN electronically on 11/13/2025 and sent out for MD's signature 5. Certification Period 01/12/2026-03/12/2026 was signed by RN electronically on 01/11/2026 and sent out for MD's signature h. Patient 8 -All documents are marked 'late entry' 1. Certification Period 05/17/2025-07/15/2025 was signed by the RN on 5/17/2025 and MD signed on 02/05/2026 (pages2-5) and received stamped by the agency 2. Certification Period 07 /16/2025-09/13/2025 was handwritten signed by the RN on 02/13/2026 at 6:30 pm and MD signed with no date on page 1/4 only and received stamped by the agency 3. Certification Period 09/14/2025 -11/12/2025 was electronically signed by the RN on 09/13/2025 and MD signed with no date on page 1/4 only and received stamped by the agency 4. Certification Period 01/12/2026-03/12/2026 was signed by the RN electronically on 01/11/2026 and MD signed on 2/5/2026 and received tamped by the agency on 2/5/2026. i. Patient 9-All documents are marked 'late entry' 1. Certification Period 11/14/2024-01/12/2025 was signed by the RN electronically on 11/14/2024 and no date for MD signature noted. j. Patient 10-All documents are marked 'late entry' 1. Certification Period 08/29/2025-10/27 /2025 was signed by the RN electronically on 08/29/2025 and MD signed electronically and no date and received stamped by the agency. 4. It was emphasized by the RN consultant during the meeting held on 02/12/2026 to both administrative and clinical leadership that physician orders for patients must be signed by the ordering physician. a. Patientl -All documents are marked 'late entry' 1. MD order dated 11/21/2025 was signed by MD on 12/10/2025 and electronically signed by RN and stamped received by the agency 2. Face to Face Encounter form was signed by MD on 12/17/2025 and stamped received by the agency 3. MD order dated 12/18/2025 was signed by the clinician on 12/18/2025 and signed by MD on 12/10/2025 4. MD order dated 12/30/2025 signed by MD on 2/19/2026 and signed by the clinician on 12/30/2025 5. MD order dated 01/16/2026 was signed by MD on 02/13/2026 and electronically signed by the RN 6. MD order dated 01/27/2026 was signed by MD on 02/04/2026 and signed by the clinician on 01/07/2026 7. MD orders dated 02/06/2026 and 02/14/2026 was signed by the RN and signed by MD on 2/19/2026 b. Patient 2-AII documents are marked 'late entry' 1. Physician Certification of Face-to-Face Encounter for 02/01/2021- 04/01/2021 was signed by MD on 02/05/2026 and blank form and stamped received by agency. c. Patient 3-All documents are marked 'late entry' 1. MD order dated 01/14/2025 signed by MD on 2/4/2026 and the clinician on 01/14/2026 and stamped received by the agency 2. Communication note dated 1/20/2026 signed by MD on 02/04/2026 and the clinician on 01/20/2026 and stamped received by the agency d. Patient 4-AII documents are marked 'late entry' 1. Physician Certification of Face-to-Face Encounter for Certification Period 11/5/2025-01/03/2025 was not signed by MD and with blank form 2. Referral MD order dated 11/05/2025 was signed by MD on 11/21/2025 and signed by the clinician on 11/05/2025 and received stamped by the agency. 3. MD order dated 11/22/2025 was signed by MD on 02/08/2026 and signed by the clinician on 11/22/2025 and sent out for signature 4. MD order dated 12/06/2025 was signed by MD on 02/06/2026 and signed by the clinician on 12/06/2025 and received stamped by the agency. 5. MD order dated 12/06/2025 was signed by the clinician on 12/06/2025 and sent out for MD's signature. e. Patient 5-All documents are marked 'late entry' 1. Physician Certification of Face-to-Face Encounter for Certification Period 12/23/2025-02/20/2026 was signed by MD dated 02/05/2026 and stamped received by the agency 2. MD order dated 06/09/2025 was signed by MD dated 2/16/2026 and by the clinician on 06/09/2025 and received stamped by the agency 3. MD order dated 07/23/2025 was signed by MD dated 2/16/2026 and by the clinician on 07/23/2025 and received stamped by the agency 4. MD order dated 12/23/2025 was signed by MD dated 1/7/2026 and signed by clinician and stamped received by the agency 5. MD order dated 01/12/2026 was signed by MD on 02/05/2026 and the clinician on 1/12/2026 and stamped received by the agency f. Patient 6-All documents are marked 'late entry' 1. MD order dated 10/23/2025 was not signed by MD and electronically signed by the RN 2. MD order dated 01/05/2026 was signed by ND and no date and signed by the clinician on 01/05/2026 and stamped received by the agency 3. MD order dated 02/14/2025 as late entry signed by the clinician on 2/13/2026 and sent out for MD's signature. g. Patient 7-All documents are marked 'late entry' 1. MD order for referral dated 11/18/2024 was signed by MD with no date and signed by the clinician on 11/18/2024 and stamped received by the agency. 2. Physician Certification of Face-to-Face Encounter form was signed by MD for Certification Period of 11/18/2024-01/16/2025 on 03/24/2025 with blank form and stamped received by the agency 3. Physician Certification of Face-to-Face Encounter form was signed by MD for Certification Period of 12/12/2024-01/9/2025 (handwritten) on 05/19//2025 and stamped received by the agency 4. MD order dated 01/15/2025 was signed by MD with no date and electronically signed by RN and stamped received by the agency 5. MD order dated 03/16/2025 not signed by MD and electronically signed by the RN and stamped received by the agency. h. Patient 8-All documents are marked 'late entry' 1. Referral MD order dated 05/17/2025 signed by MD on 06/03/2025 and signed by clinician on 5/17/2025 and stamped received by the agency 2. Physician Certification of Face-to-Face Encounter Form was signed by MD on 2/5/2026 for Certification Period of 05/17 /2025-07 /15/2025 and stamped received by the agency 3. MD order dated 05/17/2025 was signed by MD dated 02/05/2026 and electronically signed by the RN and stamped received by the agency 4. MD order dated 09/13/2025 was signed by MD but no date and electronically signed by the RN and stamped received by the agency 5. MD order dated 01/24/2026 was signed by MD on 02/05/2026 and signed by the clinician on 01/24/2026 and stamped received by the agency on 02/05/2026. i. Patient 9- All documents are marked 'late entry' 1. Physician Certification of Face-to-Face Encounter Form signed by MD and was filled out and no date. 2. MD Orders referral dated 11/14/2024- was signed by the cllnlclan and MD signature and no date when It was signed and the other MD order was signed by the clinician and MD with no date 3. MD order dated 11/20/2024 was electronically signed MD 4, MD order dated 01/12/2025 was signed by the clinician and MD signed as late entry and no date when It was signed. J. Patient 10-- All documents are marked 'late entry' 1. Face to Face Encounter Form was received stamped by the agency but no MD signature and a blank form 2. MD Orders dated 08/29/2025 one (1) order for referral signed by RN and was signed by MD but no date when It was signed and stamped received by the agency 3. MD order dated 10/23/2025 as a phone call was signed by the clinician and signed by MD but no date when It was signed and stamped received by the agency. The newly hired RN Consultant who is to assist the agency In their plan of action for the /J and COPS incurred during their complaint survey conducted a meeting in person on February 12, 2026 from 10am-1pm, to further discuss the findings of the CDPH Evaluators, to the administrative and clinical leadership of the agency. Attached is the resume of the RN Consultant, agenda, and sign sheet for the in-service. The agency is working on having a system In place to ensure a patient's physician orders, plan of care, Start of Care and Recertification assessments are completed and signed in a timely manner by the author and policies and procedures for diabetic management and for wound care, are strictly followed to prevent currently affected and future patients from serious harm that could lead to hospitalization or even death. In-service were conducted by the Wound Specialties and the Administrator the following were discussed and reviewed on 02/09/2026 and attended by the following disciplines RNs, LVNs, Administrator, QA, DPCS, Intake staff, Medical Record staff, Case Managers {RN,LVN), Wound Care Socialists, IT staff and RN/PHD Consultant and RN consultant during the meeting conducted on 02/12/2026 attended by Administrative and Clinical leadership {RN, Administrator, Governing Board members), 1. Policies and procedures on Verification of Physician Orders, 2. Safeguarding/Retrieval of Clinical Records 3. Entries Into the Clinical Record 4. Initial and Comprehensive Assessment 5. Reassessment/Recertification 6. Ongoing Assessments 7. M lssed Visit 8. Discharge Criteria 9. Discharge Summary 10. Monitoring Patient's Response/Reporting to Physician 11. Ethical Issue 12. Admission Criteria and Process Monitoring Process: 1. Concurrent/continuous compliance and on-going monitoring process by the DPCS In coordination with QA staff during medical record or chart audit done monthly to ensure a patient's physician orders and plan of care are developed, documented and authenticated, to include a complete and accurate wound assessment are documented, reporting to AMP/PCP any changes In condition Including responses to current treatment if effective or not effective, BS check are check and results documented and to include how often and who will check BS, supplies are provided or ordered for patient's need and care for wound and Diabetic needs, frequency of visits by the SN Including frequency of wound care by the SN and on non-SN visits and policies for diabetic management are strictly followed to prevent patients from serious harm that could lead to hospitalization or death including medication review or reconciliation is documented on the skilled clinical notes on SOC, Recertification, every visit and on discharge. 2. For Patient 1, MD orders were created Including updating an addendum to the Plan of Care, Wound specialist does once a week visit and the SN are going 3x/week to do wound care. Patient is on PO antibiotic as ordered. Since patient lives alone and unbale to do his own wound care, MSW was ordered for referral to community resources. BS check is checked by patient and recorded by the SN results of BS taken by patient. All necessary supplies are delivered and patient's condition is reported to PMD. 3. Admissions of new patients are put on hold for the agency's staff to do chart audit to prevent and avoid recurrence of findings by CDPH, federal or local agencies and to be incompliance with all regulations guiding the home health agency. 4. That the only Individual who can amend any assessment is the RN or SN who did assess the patient and everyone is prohibited to use login and password or access of any discipline working for the agency. During the 02/09/2026 in-service, all discipline did change their password for the EMR (software), 5. The individual (Sl) was counseled by the Administrator for amending the comprehensive assessment for patients not having assessed the patient in 2/9/206 (attached). The Administrator reminded her not to do any amendment or any revision to any assessments of the SN or RN. Si is a Registered Nurse licensed by the CA BRN from 12/09/2003 to 02/28/2027, lives locally In Valencia, CA and is not being outsource outside of USA. Attached CDL and online RN license verification. 6. The current DPCS did resigned effective 02/16/2026 and the new DPCS HS 215a Is completed and to be submitted to CAB In Sacramento and attached with this Plan of Action/Correction. 7. Patients with diagnosis of diabetes medical charts/records must be audited monthly for three (3) months starting 2/16/2026 until the threshold Is met at 100%. All data collected will be reported to the Quality committee and the Governing Board and It will be monitored monthly for three (3) consecutlves months to arrive at 100% compliance. Once the 100% threshold is reached and attained, chart audit will be done quarterly. 8. The MSW referral was completed on 02/16/2026 for patient 1 referral to community resources, (attached}. 9. The Wound Specialist did visit the patient 1 today 02/16/2026 and patient is going to the hospital. MD notified by the agency. 10. Moving forward, all Plan of Care must be developed, documented and authenticated by the Registered Nurse (RN) and MD Including all MD orders must be signed by the ordering physician and file accordingly. In addition, the Administration decided to hold any new admissions at this time to continue to review charts for completion of all assessments accurately, Plan of Care are created, developed, individualized and with measurable goals and authenticated by MD and the RN, MD orders and Plan of Care are carried out accurately and as ordered especially wound treatments and signed in a timely manner and proper documentation In the skilled clinical notes of all treatments and care provided. 11. The QA staff In coordination with the DPCS all patients with diagnosis of diabetes medical charts/records must be audited monthly for three (3) months starting 2/16/2026 until the threshold Is met at 100%. All data collected wlll be reported to the Quality committee and the Governing Board by the DPCS and It w/ll be monitored monthly for three {3) consecutlves months to arrive at 100% compliance. Once the 100% threshold Is reached and attained, chart audit will be done quarterly 12. And for non- compliance a corrective action plan will be submitted to the DPCS by the QA staff and the re-education of all staff. 13. The implementation of concurrent monitoring by the Director of Patient Care Services In coordination with the Quality Assurance staff starting 2/16/2026 for three (3) months and this will be a part of the QAPI Meeting to be held quarterly. On 2/25/2026 the survey team conducted an onsite verification of the IJ removal plan implementation. The survey team conducted an interview and review of the evidence/documents of the IJ removal plan. The IJ for G572 was removed on 2/25/2026 at 12:28 pm, in the presence of the ADM, new DPCS, and new DPCS designee. The IJ for G1024 was removed, on 2/25/2026 at 2:05 pm, in the presence of the ADM, new DPCS and new DPCS designee. The following Conditions of Participation (COP) were not met: 484.55 Condition of Participation: Comprehensive Assessment of Patients 484.60 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care 484.75 Condition of Participation: Skilled Professional Services 484.110 Condition of Participation Clinical Records

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes.) failed to meet the Condition of Participation for Comprehensive Assessment of Patients as follows: 1. The HHA failed to ensure a Registered Nurse completed a comprehensive assessment for three of ten sampled patients (Patient 6, Patient 9, and Patient 10). This deficient practice had the potential to result in decline in health status by not assessing the patient’s needs. (Refer to G520) 2. The HHA failed to ensure the comprehensive assessment included all information required for four of ten sampled Patients (Patient 1, Patient 3, Patient 5, and Patient 6). This deficient practice resulted in inaccurate baseline information that can affect the plan of care for the patients. (Refer to G528). 3. The HHA failed to review and document all the medications and treatments for four of ten sampled patients (Patient 1, Patient 2, Patient 6 and Patient 7) were currently being used. This deficient practice placed the patients at risk of drug-to-drug interaction and harm by not knowing which medications the patients were taking. (Refer to G536). 4. The HHA failed to ensure a Registered Nurse updated the comprehensive assessment for the recertification period for three of ten sampled patients (Patient 6, Patient 7, and Patient 8). This deficient practice had the potential to result in decline in health status by not assessing the patient’s needs. (Refer to G544). 5. The HHA failed to ensure the comprehensive assessment was updated at discharge for five of ten sampled patients (Patient 4, Patient 5, Patient 8, Patient 9, and Patient 10). This deficient practice resulted in lack of information to determine if patients achieved their goals of care. (Refer to G550). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with the Federal regulations for Comprehensive Assessment of patients to ensure home health care benefits are verified for eligibility to patients provided home health services.

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 interview and record review, the Home Health Agency (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes.) failed to ensure a Registered Nurse completed a comprehensive assessment for three of ten sampled patients (Patient 6, Patient 9, and Patient 10). This deficient practice had the potential to result in a decline in health status by not assessing the patient’s needs. During an interview on 2/4/2026 at 3:38 p.m. with Subcontractor 1 (S1), S1 stated that she (S1) was a registered nurse and has been contracted by the HHA since 2023 to assist with coding and developing patients’ plans of care. S1 stated Office Manager 1 (OM1) emails her (S1) a list of the patients that require plans of care to be drafted. S1 stated she logs into the HHAs electronic medical record (EMR) patients comprehensive nursing assessments and drafts a care plan with the information that is documented there. S1 stated she (S1) submits the plan of care (POC) draft into the HHA’s EMR, then “someone in the office” reviews and edits the POC if needed. S1 stated that she (S1) does not sign the POC because she (S1) does not assess the patients. During an interview on 2/4/2026 at 3:45 p.m. with S1, S1 stated that she (S1) does not document or edit patients initial or recertification comprehensive nursing assessments because she (S1) was told not to and she (S1) did not feel comfortable editing them. S1 stated that the documentation of the patients’ comprehensive assessments was the admitting nurses’ responsibility because the admitting nurse saw and assessed patients. During an interview on 2/4/2026 at 3:53 p.m. with S1, S1 was made aware of the patients document history function in the HHAs’ EMR. S1 stated that she (S1) has not shared her (S1) EMR log in information with anyone. S1 stated that the HHA never asked her (S1) to change any documentation. S1 stated that she (S1) does not remember if she (S1) decided to change patients comprehensive nursing assessments. S1 stated that if the EMR’s document history indicated that she (S1) changed patients’ comprehensive assessments, she (S1) does not remember. S1 stated, “If the system says that I changed it, then what can I say.” During an interview on 2/5/2026 at 12:35 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated that the Subcontractor 1 (S1) was a registered nurse hired as a contractor to complete patients plans of care and coding. The DPCS stated that S1 was not allowed to make changes to comprehensive nursing assessments. During an interview on 2/5/2026 at 1:37 p.m. with the DPCS, the DPCS stated patients nursing assessment are to be signed by the visiting nurse to confirm the visiting nurse documented findings. The DPCS stated an author’s signature indicates it was documented by the author. The DPCS stated that if a document does not have the author’s signature, that document is not valid. 1. During a record review of Patient 6’s undated medical record form titled “Patient Information”, indicated a start of care date (SOC) of 10/23/2025 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During a record review on 2/4/2026 at 3:27 p.m. of Patient 6’s medical record form titled “Start of Care (SOC) Assessment” dated 10/23/2025, the SOC record indicated Registered Nurse 3 (RN3) had Patient 6’s SOC assessment in progress on 10/24/2025. The form also indicated the Subcontractor 1 (S1) had Patient 6’s SOC assessment in progress from 10/30/2025 till 11/4/2025. Patient 6’s SOC assessment was submitted by RN3 on 11/17/2025. Patient 6’s SOC assessment was approved by the Director of Patient Care Services (DPCS) on 11/17/2025. During a record review on 2/4/2026 at 3:17 p.m. of Patient 6’s medical record form titled “Document History – Start of Care Assessment” dated 10/23/2025, indicated there were changes made to Patient 6’s SOC assessment by S1. RN3’s last entry made on 10/24/2025 was compared to the last entry made by S1 on 11/4/2025. The form Document History indicated that S1 made changes to the documented findings of RN3 SOC Assessment of Patient 6. These are some of the changes made by S1: Grooming from 1 to 2 Ability to dress upper body safely from 1 to 2 Ability to dress lower body safely from 1 to 2 Bathing from 1 to 3 Toileting from 1 to 2 Transferring from 1 to 2 Ambulating from 1 to 2 Mobility from 5 to 4 Pain comments from blank to no pain during this visit Verbalizes understanding from 0 to 1 SN interventions Performed: S1 added Patient 6’s wound treatment order which was not documented by RN3 2. During a record review of Patient 9’s undated medical record form titled “Patient Information” , the patient information form indicated a start of care date (SOC) of 11/14/2024 and an end of care date of 1/12/2025 with a primary diagnosis of hyperglycemia (high blood sugar) unspecified. During a record review of Patient 9’s medical record form titled “Start of Care (SOC) Assessment” dated 11/14/2024, the SOC indicated Patient 9’s primary diagnosis was type 2 diabetes mellitus with a foot ulcer. The form did not indicate the author’s name. During a record review on 2/5/2026 at 11:53 a.m. of Patient 9’s medical record form titled “Document History – Start of Care Assessment” dated 11/14/2024, indicated RN3 created the document on 11/15/2024 and submitted on 11/29/2024. The form also indicated that the Subcontractor (S1) accessed Patient 9’s Start of Care Assessment form from 12/11/2024 to 12/31/2024. Lastly, the form indicated the Clinical Supervisor/Intake Review (CS1) accessed Patient 9’s Start of Care Assessment form on 2/3/2026. During a record review on 2/5/2026 at 11:57 a.m. of Patient 9’s medical record form titled “Document History”, the document history indicated there were changes made to Patient 9’s SOC assessment by S1. RN3’s last entry made on 11/29/2024 was compared to the last entry made by S1 on 12/31/2024. The form Document History indicated that S1 made changes to the documented findings of RN3 SOC Assessment for Patient 9. These are some of the changes made by S1: Ambulating from 1 to 2. Primary diagnosis with severity from blank to 3 Diabetes management FSBS (fasting blood sugar) from 0 to 1. Diabetes management FSBS Memo from blank to “110-250 mg/dl.” Diabetes management Glucometer from 0 to 1. Diabetes management knowledge deficit from 0 to 1. Diabetes management knowledge deficit Memo “disease process.” Patient Category Risk Disaster from “low risk or Low priority” to Medium Risk or Medium priority. Prognosis from good to fair. During a concurrent interview and record review on 2/5/2026 at 1:37 p.m. with the DPCS of Patient 9’s medical record, the DPCS stated that S1 made changes to RN3’s documentation on Patient 9’s Start of Care Assessment. The DPCS stated that S1 did not visit or assess Patient 9, therefore, she (S1) should not be making any changes to the document. 3. During a record review of Patient 10’s undated medical record form titled “Patient Information," indicated a start of care date (SOC) of 8/29/2025 and an end of care date of 10/23/2025 with a primary diagnosis of hemothorax (accumulation of blood in the space between the chest wall and the lung). During a record review of Patient 10’s medical record form titled “Start of Care (SOC) Assessment” dated 8/29/2025, indicated it was electronically signed by the DPCS. During a record review of Patient 10’s medical record form titled “Document History – Start of Care Assessment” dated 8/29/2025, the Document History/Start of Care Assessment indicated it was created and submitted by RN1 on 10/3/2025. The form also indicated that S1 accessed Patient 10’s SOC Assessment form on 10/10/2025 to 11/3/2025. Lastly, the form was resubmitted and approved on 2/3/2026 by the DPCS. During a record review on 2/5/2026 at 12:31 p.m. of Patient 10’s medical record form titled “Document History - Start of Care Assessment” dated 8/29/2025, the SOC Assessment indicated there were changes made to Patient 10’s SOC assessment by S1. RN1’s last entry made on 10/3/2025 was compared to the last entry made by S1 on 11/3/2025. The form Document History indicated that S1 made changes to the documented findings of RN1’s SOC Assessment for Patient 10. These are some of the changes made by S1: Mobility from 6 to 4. Height from blank to 70. Describe risk other memo from blank to “Traumatic pneumothorax, anxiety disorder, multiple fracture sites. Patient input into care goals from blank to “Pt. verbalizes that he wants to get well soon.” Patient input into care outcomes from blank to “Patient will have good response to all medications and have no exacerbation of disease processes POC overall summary from blank to “Skilled assessment done…. Prognosis from blank to “fair” Genitourinary amount and color from blank to "adequate and clear New SN interventions performed from blank to “SN arrive at patients’ home…. During a concurrent interview and record review on 2/5/2026 at 1:03 p.m. with the DPCS of Patient 10’s medical record, the DPCS stated that he (DPCS) was aware that S1 changed RN1’s documentation of Patient 10’s SOC Assessment. During a concurrent interview and record review on 2/5/2026 at 1:05 p.m. with the DPCS of Patient 10’s medical record, the DPCS stated that he (DPCS) “usually ask the RNs for their log in information, to be able to sign when a signature is required. The DPCS stated that he (DPCS) was asked to complete patients’ documentation when he began his (DPCS) DPCS role. The DPCS stated that he (DPCS) should not have signed or completed patients notes because he (DPCS) did not visit the patients. The DPCS stated he (DPCS) did not know if Patient 10 was “ok” for discharge because he did not visit the patient. The DPCS stated that his (DPCS) signature indicated he approved Patient 10’s assessment. The DPCS stated that he was unaware that S1 was changing the nurse’s documentation.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: (1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on interview and record review, the HHA failed to ensure the comprehensive assessment included all required elements for four of ten sampled Patients (Patient 1, Patient 3, Patient 5, and Patient 6). This deficient practice resulted in incomplete and inaccurate baseline information, which had the potential to affect the development and implementation of an appropriate and individualized plan of care for these patients. A). During a record review of Patient 1’s undated medical record form titled Patient Information indicated a start of care date (SOC) of 1/16/2026 with a primary diagnosis of acute osteomyelitis (an infection-induced inflammatory condition of the bone) of the right ankle and foot. During a concurrent interview and record review on 2/4/2025, at 11:58 a.m., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 1’s initial comprehensive assessment titled, OASIS, dated 11/21/2025. The DPCS indicated the baseline wound assessment on the SOC, was measured as L (Length) 11.0 cm (cm-centimeter, unit of measurement) x W (width) 1.5 cm x D (depth) 1.0 cm. The wound did not have odor, there was loose yellow-tan slough, and the surrounding tissue was hyperpigmented, with no drainage. During a concurrent interview and record review on 2/4/26 at 12:47 p.m., with the DPCS, the DPCS reviewed the photo of Patient 1’s right foot wound, taken on 11/21/2025. The DPCS stated the picture of the wound did not look good. The wound looked like it was draining fluids. The DPCS compared the photo to what the nurse had documented on Patient 1’s OASIS, dated 11/21/2025 and stated the wound assessment was not accurate. B. During a record review of Patient 3’s undated medical record form titled Patient Information indicated a start of care date (SOC) of 1/14/2026 with a diagnosis of pressure ulcer (skin wound) unspecified site. During a record review of Patient 3’s medical record titled Plan of Care for the certification period 1/14/2026-3/14/2026, the POC indicated provide management of the stage 4 pressure ulcer (skin loss extending to fat, muscle, bone). During a concurrent interview and record review on 2/4/26 at 3:27 p.m., with the DPCS, the DCPS reviewed Patient 3’s initial comprehensive assessment titled OASIS, dated 1/14/2026. The record indicated Patient 3’s wound was unstageable and the assessment was incomplete because there were no wound measurements taken. The DPCS then reviewed the photo taken of Patient 3’s wound, dated 1/17/2026 and stated the wound could be measured. The DPCS stated the purpose of a complete wound assessment was to provide a baseline and to be able to monitor the condition of the wound to determine if it is improving or worsening and to know if the treatment needs to change. C. During a record review of Patient 5’s undated medical record form titled Patient Information indicated a start of care date (SOC) of 6/9/2025, with a diagnosis of type 2 diabetes mellitus (too much sugar in the blood). During a concurrent interview and record review on 2/6/2026 at 11:06 a.m., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 5’s undated Referral/Authorization Request. The document indicated a diagnosis of type 2 diabetes mellitus, with hyperglycemia (high blood sugar levels) and s stage 2 pressure ulcer to the sacral region (skin loss extending to the dermis/epidermis skin layer). The referral further noted that the patient had a significant pressure ulcer to the sacrum and required an urgent referral to a home health agency for wound care assessment and treatment. The DPCS stated that Patient 5 had been referred to the HHA for skilled nursing services for wound care management and diabetes management. ------------------------Start here tomorrow 2/19/2026 During a concurrent interview and record review on 2/6/2026, at 11:13 a.m., with the DPCS, the DPCS reviewed Patient 5’s initial comprehensive assessment titled, OASIS, dated 6/9/2025. The record indicated an unstageable wound with a description of “other” for odor, tissue wound base, tissue surrounding wound, and drainage type. The DPCS stated this was not an accurate assessment because there is use of a lot of “other”, it was not well described. The DPCS stated he did not know what the nurse meant by other. There were no measurements, but that is because the nurse said it was closed in the report sheet. The DPCS continued to review the record and stated the OASIS did not have blood sugar assessment findings. There was no information on blood sugar number. The record indicated she was insulin/oral agent controlled. The DPCS stated the narrative indicated she had a sore in sacral region. She forgot to put that it was closed. If the skin was closed, it should not be called pressure sore. During a concurrent interview and record review on 2/6/26 at 11:26 a.m., with the DPCS, the DPCS reviewed a picture of Patient 5’s wound, dated 6/16/2025. The DPCS stated the picture did not indicate the wound was closed. The DPCS stated the nurse’s initial comprehensive assessment was not accurate. The importance of having an accurate wound assessment was: the information gathered would be the basis of plan of care, to indicate what treatment the patient needed, so everyone is on the same page. Another importance was to get a baseline of the status of the wound: for monitoring, to make sure the treatment was working. D. During a record review of Patient 6’s medical record form titled “Patient Information” undated, indicated a start of care date (SOC) of 10/23/2025 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During a record review of Patient 6’s medical record form titled “Recertification Assessment” dated 12/21/2025, indicated Patient 6 primary diagnosis was malignant neoplasm of unspecified site of right female breast (right breast cancer). During a record review of Patient 6’s medical record form titled “Home Health Certification and Plan of Care” dated from 12/22/2025 to 2/19/2026, indicated it was left incomplete. The form also indicated it did not have a nurses or physician signature. During a record review of Patient 6’s February calendar, provided by Patient 6 at her home, the calendar indicated Patient 6 was scheduled to have chemotherapy February 4, 11, 18, and 25. During a joint visit on 2/3/2026 at 9 a.m. with License Vocational Nurse 2 (LVN2) at Patient 6’s residence, Patient 6’s face was noted to be red and swollen. Patient 6 stated that she had been receiving chemotherapy since last month. LVN2 stated that she found out Patient 6 was receiving chemotherapy yesterday, 2/2/2026, when she (LVN2) conducted a home visit. LVN2 provided Patient 6’s plan of care dated 10/23/2025 to 12/21/2025 and stated that she printed Patient 6’s plan of care before visiting her today, 2/3/2026. LVN2 stated that there were no interventions mentioned for Patient 6’s chemotherapy. LVN2 stated will call the DPCS to inform him (DPCS) of Patient 6’s chemotherapy. During a record review of the HHA’s document titled, Initial and Comprehensive Assessment, dated November 2017, indicated, “…During the initial and comprehensive patient assessments, all baseline data to be used in measuring the patient’s progress toward goals and other relevant information will be documented in the patient’s clinical record…”

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 observation, interview, and record review, the Home Health Agency (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes.) failed to ensure that all medications and treatments were reviewed and documented for four of ten sampled patients (Patient 1, Patient 2, Patient 6 and Patient 7). This deficient practice resulted in incomplete medication profiles and placed the patients at risk of drug-to-drug interactions and medication-related harm due to the lack of accurate knowledge of all medications being taken. 1. During a record review of Patient 1’s undated medical record form titled Patient Information, the form indicated a start of care date (SOC) of 1/16/2026 with a primary diagnosis of acute osteomyelitis (an infection-induced inflammatory condition of the bone) of the right ankle and foot. During a concurrent observation, interview and record review on 2/3/2026, at 9:51 a.m., with Licensed Vocational Nurse 1 (LVN 1), LVN 1 reviewed the medications Patient 1 was taking using Patient 1's Medication Profile, dated 1/16/2026. LVN 1 stated that the listed medication, Levofloxacin (an antibiotic used to treat serious infections) was not available in the home, and Patient 1 reported that he was no longer taking the medication. Additionally, Patient 1 reported currently taking Ferrous Sulfate 325 milligrams (mg unit of measurement); however, this medication was not listed on the Medication Profile. 2. During a record review of Patient 2’s undated medical record titled, "Patient Information," the record indicated a start of care (SOC) date of 2/1/2021, with a diagnosis of cellulitis (a bacterial skin infection). During a concurrent observation, interview and record review conducted on 2/3/2026, at 11:05 a.m., with Licensed Vocational Nurse 4 (LVN 4), LVN 4 reviewed the medications Patient 2 was taking using Patient 2’s Medication Profile, dated 2/2/2026. The following medications were listed on the Medication Profile; however, LVN 4 stated that Patient 2 reported no longer taking these medications, and they were not available in the home: 1). Probiotic capsule (supplement)- Patient 2 reported discontinuing use one month ago. 2). Potassium Chloride tablet (an electrolyte supplement)- Patient 2 reported discontinuing use one year ago. 3). Ondansetron tablet (an anti-nausea medication)- Patient 2 reported discontinuing use last year. During an interview on 2/3/2026 at 11:20 a.m., with LVN 4, LVN 4 stated the medication review occurred every visit. LVN 4 stated she informed the office of the updates because LVN 4 did not have the ability to update the medication profile, the office had to do it. LVN 4 further stated It was important to update the medication profile to make sure the caregiver knows how to give the medication to the patient. Also to monitor for medication effectiveness and side effects and to address any issues with the medication. It is also the patients’ right to receive the right medication and the right dosage. 3. During a record review of Patient 6’s undated medical record titled “Patient Information,” the record indicated a start of care date (SOC) of 10/23/2025, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During a record review of Patient 6’s medical record titled “Home Health Certification and Plan of Care” dated from 10/23/2025 to 12/21/2025, the plan of care indicated it had a wet signature under “attending physician signature” but it did not indicate the date the attending physician signed the form. The form also indicated Patient 6’s medications included: acetaminophen (pain medication), ibuprofen (pain medication), metoprolol (high blood pressure medication), tramadol (pain mediation), Vitamin D3, and Whole Mega fish oil. During a record review of Patient 6’s medical record titled “Home Health Certification and Plan of Care” dated from 12/22/2025 to 2/19/2026, the plan of care indicated it was left incomplete, as a DRAFT,” without a nurses or physician signature. The form also indicated Patient 6’s medications included: acetaminophen, ibuprofen, metoprolol, tramadol, Vitamin D3, and Whole Mega fish oil. During a record review of Patient 6’s medical record form titled “Medication Profile” printed 2/2/2026, indicated Patient 6’s current medications were acetaminophen, ibuprofen, metoprolol, tramadol, Vitamin D3, and Whole Mega fish oil. During a concurrent interview and record review on 2/2/2026 at 2:35 p.m. with the DPCS of Patient 6’s medical record, the DPCS stated that Patient 6’s plan of care dated 12/22/2025 to 2/19/2026 was to be completed by 12/28/2025. During a joint visit on 2/3/2026 at 9 a.m. with License Vocational Nurse 2 (LVN2) in Patient 6’s residence, Patient 6 provided her current medication bottles. Patient 6’s medications included acetaminophen, ibuprofen, metoprolol, tramadol, Vitamin D3, Whole Mega fish oil, esomeprazole (filled 9/16/2025), and ammonium Lactate (filled 12/29/2025). LVN2 stated that she did not have Patient 6’s current medication profile now. LVN2 stated she (LVN2) checked Patient 6’s medication bottle labels for expiration and asked Patient 6 if there were any new medications prescribed. LVN2 stated that medication reconciliation was important to update and make changes to patients’ medication profile and to also let the team know of any changes in patients’ medications. LVN2 stated that if patient’s medications are not reconciled, the patient runs the risk of taking the wrong medication or taking too much or too little. 4. During a record review of Patient 7’s undated medical record titled “Patient Information,” the record indicated a start of care date (SOC) of 11/18/2024 with a primary diagnosis of type 2 diabetes mellitus (high blood sugar resulting from the body’s inability to produce and/or properly use insulin) with foot ulcer (an open sore or wound on the foot that fails to heal). During a record review of Patient 7’s medical record titled “Home Health Certification and Plan of Care,” for the certification period dated 1/12/2026 through 3/12/2026, the record indicated the document was labeled “DRAFT,” and was not completed or signed by a physician or registered nurse. The form also listed Patient 7’s medications, which included acetaminophen, aspirin, atorvastatin 40 mg, Ferrous Sulfate (iron supplement), Jardiance 10 mg, lisinopril 10 mg, and Meropenem (antibiotic) IV (intravenous). During a record review of Patient 7’s medical record titled “Medication Profile” printed 2/2/2026, the record indicated Patient 7’s current medications were acetaminophen, aspirin, atorvastatin 40 mg, Ferrous Sulfate, Jardiance 10 mg, and lisinopril 10 mg. During a joint visit conducted on 2/3/2026 at 10:30 a.m. with License Vocational Nurse 3 (LVN3) at Patient 7’s residence, Patient 7 provided his current medication bottles for review. Discrepancies were identified during the medication reconciliation between the medication bottle labels and the current Medication Profile. These discrepancies included Atorvastatin 20 mg, Jardiance 25 mg, and lisinopril 2.5 mg. Additionally, Patient 7 reported taking Midodrine HCL 2.5 mg (a medication used to treat low blood pressure medication) as needed. The prescription for Midodrine was filled on 9/26/2025. During an interview on 2/3/2026 at 11:10 a.m. with LVN3, LVN3 stated he reconciles Patient 7’s medications three times a week, during his home visits. The last time was on Friday 1/30/2026. LVN3 stated that it was important to reconcile patient’s medications to ensure they are taking their medications correctly. LVN3 stated it was also important to prevent mistakes, overdosing, and underdosing. LVN3 stated he used the medication list printed on 2/2/2026, to reconcile Patient 7’s medications today. During a record review of the HHA’s policy and procedure titled, "Initial and Comprehensive Assessment," dated November 2017, the policy indicated, “…During the initial and comprehensive patient assessments, all baseline data to be used in measuring the patient’s progress toward goals and other relevant information will be documented in the patient’s clinical record, including at least the following information...Review of medication history, as applicable to care and service and current medication use, including prescription, over-the-counter medications and herbal medications, and...significant side effects and noncompliance with therapy.”

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 interview and record review, the Home Health Agency (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes.) failed to ensure a Registered Nurse updated the comprehensive assessment for the recertification period for three of ten sampled patients (Patient 6, Patient 7, and Patient 8). This deficient practice had the potential to result in a decline in health status by not assessing the patient’s needs. During an interview on 2/4/2026 at 3:38 p.m. with Subcontractor 1 (S1), S1 stated that she (S1) was a registered nurse and has been contracted by the HHA since 2023 to assist with coding and developing patients’ plans of care. S1 stated Office Manager 1 (OM1) emails her a list of the patients that require plans of care to be drafted. S1 stated she logs into the HHAs electronic medical record (EMR) patients comprehensive nursing assessments and drafts a care plan with the information that is documented there. S1 stated she submits the plan of care (POC) draft into the HHA’s EMR, then “someone in the office” reviews and edits the POC if needed. S1 stated that she does not sign the POC because she (S1) does not assess the patients. During an interview on 2/4/2026 at 3:45 p.m. with S1, S1 stated that she (S1) does not document or edit patients initial or recertification comprehensive nursing assessments because she was told not to and she did not feel comfortable editing them. S1 stated that the documentation of the patients’ comprehensive assessments was the admitting nurses’ responsibility because the admitting nurse saw and assessed patients. During an interview on 2/4/2026 at 3:53 p.m. with S1, S1 was made aware of patients document history function in the HHAs’ EMR. S1 stated that she has not shared her EMR login information with anyone. S1 stated that the HHA never asked her to change any documentation. S1 stated that she does not remember if she decided to change patients comprehensive nursing assessments. S1 stated that if the EMR’s document history indicated that she changed patients’ comprehensive assessments, she does not remember. S1 stated, “If the system says that I changed it, then what can I say.” During an interview on 2/5/2026 at 12:35 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated that the Subcontractor 1 (S1) was a registered nurse hired as a contractor to complete patients plans of care and coding. The DPCS stated that S1 was not allowed to make changes to comprehensive nursing assessments. During an interview on 2/5/2026 at 1:37 p.m. with the DPCS, the DPCS stated patients nursing assessment are to be signed by the visiting nurse to confirm the visiting nurse documented findings. The DPCS stated an author’s signature indicates it was documented by the author. The DPCS stated that if a document does not have the author’s signature, that document is not valid. 1. During a record review of Patient 6’s undated medical record titled “Patient Information” indicated a start of care date (SOC) of 10/23/2025 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During a record review of Patient 6’s medical record titled “Recertification Assessment” dated 12/21/2025, the record indicated the form was not complete and the authors name or signature was not documented. The form also indicated under section “Diagnosis and Symptom Control," Patient 6’s primary diagnosis was malignant neoplasm of unspecified site of right female breast (right breast cancer). During a record review of Patients 6’s medical record titled “Document History – Recertification Assessment” dated 12/21/2025, the record indicated Registered Nurse 3 (RN3) was assigned and schedule to assess Patient 6 on 12/21/2025. The form also indicated that the Director of Patient Care Services (DPCS) was the only clinician that documented Patient 6’s form on 12/31/2025. During a concurrent interview and record review on 2/2/2026 at 2:35 p.m. with the DPCS of Patient 6’s medical record, the DPCS stated that Patient 6’s recertification nursing assessment dated 12/21/2025 was still in progress and did not contain the author’s signature. The DPCS stated that Patient 6’s recertification nursing assessment should have been completed by 12/31/2025. 2. During a record review of Patient 7’s undated medical record titled “Patient Information” indicated a start of care date (SOC) of 11/18/2024 with a primary diagnosis of type 2 diabetes mellitus (high blood sugar resulting from the body’s inability to produce and/or properly use insulin) with foot ulcer (an open sore or wound on the foot that fails to heal). During a record review of Patient 7’s medical record titled “Recertification Assessment” dated 1/13/2026, the record indicated Patient 7's date of assessment was on 1/13/2026. During a record review of Patient 7’s medical record titled “Document History – Recertification Assessment” dated 1/11/2026, the record indicated that on 2/2/2026 the Office Manager 1 (OM1) logged into Patient 7’s medical record and changed the assessment date from 1/13/2026 to 1/11/2026. During a concurrent interview and record review on 2/2/2026 at 1:10 p.m. with the DPCS of Patient 7’s medical record, the DPCS stated that Patient 7 did not have recertification orders after 5/16/2025. During a concurrent interview and record review on 2/2/2026 at 1:20 p.m. with the DPCS of Patient 7’s medical record, the DPCS stated that Patient 7’s comprehensive nursing recertification assessment for certification period 11/13/2025 to 1/11/2026, was not completed. The DPCS stated the recertification assessment should have been completed by 11/18/2025. The DPCS stated it was important to have the comprehensive nursing recertification assessment completed to demonstrate the patients updated condition. The DPCS stated that since it was not done, Patient 7 had the risk of receiving improper care due to not being assessed. 3. During a record review of Patient 8’s undated medical record titled “Patient Information” the record indicated a start of care date (SOC) of 5/17/2025 and an end of care date of 1/24/2026 with a primary diagnosis of cellulitis (acute, spreading inflammation, presenting as swollen, red, tender, and warm skin) of the left lower limb. During a record review of Patient 8’s medical record titled “Recertification Assessment” date 9/13/2025, the record indicated Patient 8’s primary diagnosis was type 2 diabetes with peripheral angiopathy without gangrene. The form did not indicate who the author was. During a record review of Patient 8’s undated medical record titled “Chart Navigation” the record did not indicate there was an assessment for Patient 8 for the period of 11/13/2025 to 1/11/2026. During a record review of Patient 8’s medical record titled “Recertification Assessment” dated 1/11/2026, the record indicated it was not completed. The record did not indicate the author’s name or signature. During a record review on 2/5/2026 at 11:04 a.m. of Patient 8’s undated medical record titled “Document History,” the history indicated Patient 8’s Recertification Assessment dated 1/11/2026 was in progress on 2/4/2026 by RN3. During a record review on 2/5/2026 at 11:26 a.m. of Patient 8’s undated medical record title “Document History," the record indicated Patient 8’s Recertification Assessment dated 1/11/2026 was submitted on 2/4/2026 by RN3. During a concurrent interview and record review on 2/2/2026 at 3 p.m. with the DPCS of Patient 8’s medical record, the DPCS stated that Patient 8’s current comprehensive nursing recertification assessment dated 1/11/2026 and plan of care were in process. The DPCS stated that Patient 8’s medical record did not contain comprehensive nursing recertification assessments or plans of care for certification periods 9/14/2025 to 11/12/2025 and 11/13/2025 to 1/11/2026.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on interview and record review, the HHA failed to ensure the comprehensive assessment was updated upon discharge for five of ten sampled patients (Patient 4, Patient 5, Patient 8, Patient 9, and Patient 10). This deficient practice resulted in lack of information to determine if patients achieved their goals of care. 1 During a record review of Patient 4’s undated medical record titled Patient Information, the record indicated a start of care date (SOC) of 11/5/2025 with a diagnosis of shortness of breath. During a record review of the HHA’s census on 2/2/2026, Patient 4 was listed on the active list. During a record review of the HHA’s electronic medical record (EMR) on 2/5/2026, Patient 4 was listed as discharged. During a concurrent interview and record review on 2/5/2026, at 2:10 p.m., with Registered Nurse 2 (RN 2), RN 2 reviewed Patient 4’s medical records. RN 2 stated that Patient 4 was discharged from the HHA on 12/6/2025. RN 2 stated the DC OASIS was supposed to be done by the Physical Therapist (PT) because the PT had discharged the patient. RN 2 stated she did not know what PT did because the HHA did not have access to PT’s forms. During a record review of Patient 4’s medical records on 2/5/2026, at 2:11 p.m., Patient 4’s records indicated a DC OASIS, dated 12/6/2025. Patient 4’s document history for the DC OASIS, dated 12/6/2025, indicated the document was entered in Patient 4’s medical records on 2/4/2026. During an interview on 2/5/2026, at 2:20 p.m., with RN 2, RN 2 stated the DC OASIS was required to be completed within 30 days of discharge. 2. During a record review of Patient 5’s undated medical record titled Patient Information, the record indicated a start of care date (SOC) of 6/9/2025, with a diagnosis of type 2 diabetes mellitus (too much sugar in the blood). During a concurrent interview and record review on 2/6/2026, at 12:09 p.m., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 5’s medical records and stated that there was no DC OASIS done. The DPCS stated Patient 5 was discharged on 7/23/2025. The DPCS stated that a Registered Nurse was required to update the comprehensive assessment on discharge, with the DC OASIS assessment. The purpose of the DC OASIS was to access the patient’s condition at discharge. To confirm there was no more care needed. The DC OASIS assessment was then used to write the DC summary. The purpose of the DC summary was to recap the patient care. This was used to notify the doctor of the services provided and the condition of the patient upon discharge. During a record review of the HHA’s policy titled, Discharge Criteria and Process, dated November 2017, the policy indicated, “An update to the comprehensive assessment, including required OASIS data elements, will be completed, as required by regulation…A discharge summary will be completed for all discharged patients. A copy will be mailed to the primary physician…All discharge paperwork will be due in the office within 72 hours of the discharge date. This will include the discharge order, discharge summary, plan of care, medication profile, and OASIS…The discharge record will be organized according to the organization policy regarding clinical record contents. Documentation will be reviewed by the Clinical Supervisor or designee and completed within 30 days of the discharge, at which time it will be removed from the active files.” 3. During a record review of Patient 8’s undated medical record titled “Patient Information” the record indicated a start of care date (SOC) of 5/17/2025 and an end of care date of 1/24/2026 with a primary diagnosis of cellulitis (acute, spreading inflammation, presenting as swollen, red, tender, and warm skin) of left lower limb. During a record review of the Patient Census Report” dated 2/2/2026, the report indicated Patient 8’s name was listed as a current patient, with a status of admitted. During a record review of Patient 8’s medical record form titled “Discharge Assessment” dated 1/24/2026, the discharge assessment did not indicate Patient 8’s vital signs. The assessment indicated it was electronically signed by Registered Nurse 3 (RN3). During a record review on 2/5/2026 at 11:01 a.m. of Patient 8’s “Document History” dated 1/24/2026, the history indicated Patient 8’s Discharge Assessment was created on 2/3/2026 by Case Manager 1 (CM1) and submitted on 2/5/2026 by Registered Nurse 3 (RN3). During a record review of Patient 8’s “Discharge Summary” dated 1/24/2026, the discharge summary indicated it was signed by RN3. The summary also indicated that Patient 8 was instructed to continue wound care as instructed. During a record review on 2/5/2026 at 11:38 a.m. of Patient 8’s medical record titled “Document History” dated 1/24/2026, the history indicated Patient 8’s Discharge Summary was created and submitted on 2/5/2026 by RN3. During a concurrent interview and record review on 2/2/2026 at 3 p.m. with the Director of Patient Care Services (DPCS) of Patient 8’s medical record, the DPCS stated that Patient 8’s current nursing comprehensive assessment was in progress. During a concurrent interview and record review on 2/5/2026 at 10:40 a.m. with the DPCS of Patient 8’s medial record, the DPCS stated that Patient 8 was discharged on 2/2/2026. The DPCS stated that he (DPCS) did not know why Patient 8’s name was on the current HHA census. During further review the DPCS stated that Patient 8 was discharged on 1/24/2026 and not 2/2/2026. 4. During a record review of Patient 9’s medical record titled “Patient Information," the patient information record indicated a start of care date (SOC) of 11/14/2024 and an end of care date of 1/12/2025, with a primary diagnosis of hyperglycemia (high blood sugar) unspecified. During a record review of Patient 9’s medical record titled “Discharge Assessment,” dated 1/12/2025, the Discharge Assessment did not include documented vital signs or a wound assessment. Despite these omissions, the assessment indicated Patient 9 had clear lung sounds, regular heart sounds, strong peripheral and pedal pulses, good skin turgor, and warm , dry skin. The assessment further documented that Patient 9 was informed of discharge (DC) plans, patient rights and responsibilities, medication schedule, emergency plan, state or county hotline information. Additionally, the assessment noted that Patient 9’s wound was healing and that the caregiver was able to manage the wound care. Documentation also indicated that discharge instructions were provided. The Discharge Assessment was electronically signed by RN3. During a record review on 2/5/2026 at 11:49 a.m. of Patient 9’s “Document History – Discharge Assessment” dated 1/12/2025, the assessment indicated Clinical Supervisor/Intake Review (CS1) created the document on 2/3/2026. The form also indicated the Discharge Assessment dated 1/12/2025 was in progress. During a concurrent interview and record review on 2/5/2026 at 1:45 p.m. with the DPCS of Patient 9’s medical record, the DPCS stated that Patient 9 was discharged from the HHA on 1/12/2025. During a record review of Patient 9’s "SN (skilled nurse) DC (discharge) Summary” dated 1/12/2025, the summary indicated Patient 9 was discharged from the HHA on 1/12/2025 due to “no further authorized visits”. During a concurrent interview and record review on 2/5/2026 at 2:44 p.m. with the CS1 of Patient 9’s medical record, CS1 stated that (CS1) was not a Licensed Vocational Nurse or a Registered Nurse. CS1 stated that she created Patient 9’s DC Summary on 2/3/2026. CS1 stated that she completed the DC summary based on the nurses’ documentation. CS1 stated she asked RN3 to review the DC summary then sign it. CS1 stated that she documented Patient 9’s DC Summary because she (CS1) followed instructions. CS1 did not state who instructed her to create Patient 9’s Discharge Summary or Assessment. 5. During a record review of Patient 10’s undated “Patient Information” indicated a start of care date (SOC) of 8/29/2025 and an end of care date of 10/23/2025 with a primary diagnosis of hemothorax (accumulation of blood in the space between the chest wall and the lung). During a record review of Patient 10’s medical record titled “Discharge Assessment” dated 10/23/2025, the assessment indicated Patients 10 identification was verified by “response to name," The assessment indicated Patient 10 was verbally provided with a current medication list. The record further assessed Patient 10’s mental status by having him (Patient 10) verbalize the current date and year and repeat spoken words. The assessment also indicated Patient 10 had limited range of motion to his left arm, had bowel sounds in four abdominal quadrants, capillary refill was less than 3 seconds, heart sounds were regular, pedal and peripheral pulses were strong, and visiting nurse utilized personal protective equipment during visit. Lastly, the assessment was electronically signed by Registered Nurse 1 (RN1). During a record review on 2/5/2026 at 1:17 p.m. of Patient 10’s “Document History – Discharge Assessment” dated 10/23/2025, the document history indicated the form was created by the DPCS and submitted by RN1 on 2/3/2026. During a concurrent interview and record review on 2/5/2026 at 1:03 p.m. with the DPCS of Patient 10’s medical record, the DPCS stated that he created and submitted Patient 10’s Discharge Assessment dated 10/23/2025 on 2/3/2026 based on Patient 10’s Start of Care (SOC) Assessment dated 8/29/2025. During a concurrent interview and record review on 2/5/2026 at 1:05 p.m. with the DPCS of Patient 10’s medical record, the DPCS stated that RN1 was no longer working for the HHA. The DPCS stated that he used RN1’s electronic log in information to log into Patient 10’s medical record to be able to document Patient 10’s Discharge Assessment. The DPCS stated that he “usually ask the RNs for their login information, to be able to sign when a signature is required. The DPCS stated that he was asked to complete patients’ documentation when he began his DPCS role. The DPCS stated that he should not have signed or completed patients notes because he did not visit the patients. The DPCS stated he did not know if Patient 10 was “ok” for discharge because he did not visit the patient. The DPCS stated that his signature indicated he approved Patient 10’s assessment. The DPCS stated that he was unaware that S1 was changing the nurse’s documentation. During a concurrent interview and record review on 2/5/2026 at 1:15 p.m. with the DPCS of Patient 10’s medical record, the DPCS stated that Patient 10’s Discharge Assessment was not valid because he (Patient 10) was not visited by HHA staff on 10/23/2025. The DPCS stated that the HHA had no choice but to discharge Patient 10 because Patient 10 did not answer his (Patient 10) phone. The DPCS stated that the proper thing to have done was to document a communication note stating that Patient 10 did not answer his (Patient 10) phone.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: This CONDITION is NOT MET as evidenced by: Based on interview and record review, the Home Health Agency (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes.) failed to ensure the Condition of Participation regarding Care Planning, Coordination, and Quality of Care was met as follows: 1.Based on observation, interview, and record review, the Home Health Agency (HHA - an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure the plan of care (POC) was followed for Patient 1 by: a. Failing to ensure that Patient 1’s plan of care for certification period of 11/21/2025 to 1/19/2026 was implemented for right foot wound care when there was no evidence of: Patient 1 being taught how to do daily wound care in between nursing home visits Patient 1’s wound was assessed completely and accurately Patient 1’s physician being notified when there was a change in Patient 1’s wound condition. Patient 1 being assessed and monitored for blood sugar levels. Patient 1 was provided with wound care as ordered three times a week consistently. b. Failing to ensure that Patient 1 had a plan of care developed for right foot wound care for certification period of 1/16/26 to 3/16/26 and that the following care was provided to Patient 1: Patient 1’s wound was assessed completely and accurately Patient 1 received wound care treatment as indicated in the hospital referral order Patient 1’s physician was notified when there was a change in Patient 1’s wound condition. Patient 1 was assessed and monitored for blood sugar levels. (Refer to G 572). 2. The HHA failed to include information required in the plan of care for five of ten sampled patients (Patient 3, Patient 6, Patient 7, Patient 8, and Patient 9). This failure had the potential to result in patients not receiving the identified needs and services, and having a decline in health status, that could affect their quality of care and well-being. (Refer to G574). 3. The HHA failed to ensure one of ten sampled patients (Patient 1) received treatment according to the doctor’s orders. This deficient practice resulted in the patients’ goals not being met. (Refer to G580). 4. The HHA failed to ensure verbal orders were accepted by licensed staff for two of ten samples patients (Patient 4 and Patient 5). This deficient practice resulted in a risk of wrong treatment by not having licensed people verify the orders received. (Refer to L584). 5. The HHA failed to ensure one of ten sample patients (Patient 9) plans of care were reviewed and approved by a physician. This failure had the potential to result in missed or inappropriate care for patients. (Refer to G588). 6. The HHA failed to ensure the physician was notified of change of condition for one of ten sampled patients (Patient 1). This deficient practice resulted in the physician not being aware of the patient’s change in condition. (Refer to G590). The cumulative effect of these systemic practices resulted in non-compliance to ensure Patient 1’s plan of care was followed. As a result of the non-compliance for certification period 11/21/2025 to 1/19/2026, Patient 1 was hospitalized on 12/16/2025 with worsening wound infection resulting in the amputation of Patient 1’s right 3rd toe and surgical debridement of his wound. Also, certification period 1/16/2026 to 3/16/2026, Patient 1’s right foot wound worsened, increasing the risk of infection, amputation, and complications of diabetes which can result in hospitalization and death. The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care is provided to patients assessed to receive home health services.

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 observation, interview, and record review, the Home Health Agency (HHA - an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure that he plan of care (POC) was implemented and followed for Patient 1 by failing to: Ensure implementation of Patient 1's POC for right food wound care during the certification period of 11/21/2025 to 1/19/2026, as evidenced by the lack of documented evidence of: 2. Patient 1 being instructed on how to perform daily wound care between skilled nursing home visits 3. A complete and accurate wound assessment. 4. Notification of Patient 1’s physician of a change in Patient 1’s wound condition. 5. Assessment and monitoring of Patient 1's blood sugar levels. 6. Provision of wound care treatment as ordered three times per week on a consistent basis. 2. Ensure a plan of care(POC) was developed and implemented for right foot wound care during the certification period of 1/16/26 to 3/16/26, as evidenced by the lack of documented evidence that the following care was provided to Patient 1: 1. A complete and accurate wound assessment; 2. Wound care treatment provided in accordance with the hospital referral order. 3. Physician notification when there was a change in Patient 1’s wound condition. 4. Patient 1 was assessed and monitored for blood sugar levels. The cumulative effect of these systemic failures resulted in the agency's inability to ensure Patient 1's POC was implemented and followed. As a result of the noncompliance during the certification period of 11/21/2025 through 1/19/2026, Patient 1 was hospitalized on 12/16/2025 due to a worsening wound infection, which resulted in amputation of the right third toe and surgical debridement of the wound. Additionally, during the certification period of 1/16/2026 through 3/16/2026, Patient 1's right foot wound continued to worsen, increasing the risk for infection, further amputation, complications related to diabetes, hospitalization, and death. During a record review of Patient 1’s ” undated "Patient Information" record, the record indicated a start of care date (SOC) of 1/16/2026 with a primary diagnosis of acute osteomyelitis (an infection-induced inflammatory condition of the bone) of the right ankle and foot. 1a). During a record review of Patient 1’s General Acute Care Hospital (GACH) documents, dated 11/19/2025, page 23 of 41, the records indicated Patient 1 had his second right toe amputated and his right foot wound surgically cleaned to promote healing. During an interview with the Director of Patient Care Services (DPCS) on 2/4/2026, at 10:15 a.m., the DPCS stated for wound care, the HHA followed the instructions from the hospital records. During a concurrent interview and record review on 2/4/2026, at 10:22 a.m., with the DPCS, the DPCS reviewed Patient 1’s GACH records, dated 11/19/2025, page 5 of 41. The record indicated, “Clean wound with normal saline and betadine, pack wound with wound packing strips, cover with gauze soaked betadine, cover with abdominal pad and wrap with kerlix wrap with kerlix once daily”. The DPCS stated the order was to do the wound care daily. The DPCS the HHA was constrained in resources and could not provide daily wound care. What is followed is whatever the insurance authorized. During a concurrent interview and record review on 2/4/2026, at 10:25 a.m., with the DPCS, the DPCS reviewed Patient 1’s Start of Care (SOC-a one-page written paper that indicates what is needed for the patient) report, dated 11/21/2025. The DPCS stated the record indicated the SOC nurse recommended Skilled Nurse (SN) visits 3 times a week for 1 week. The DPCS stated, that there was not enough visits authorized by the insurance and the HHA did not request authorization for more SN visits because Patient 1 went to the hospital on 12/18/2025. During an interview on 2/4/2026, at 10:36 a.m., with the DPCS, the DPCS stated he could not find documentation that Medical Doctor 3 (MD 3), the responsible doctor listed in Patient 1’s plan of care, dated 11/21/2025 to 1/19/2026, was informed that wound care could not be done daily due to insurance limitations. The DPCS stated it was very seldom when an HHA could provide daily wound care. The DPCS stated it was standard HHA practices not to follow the hospital frequency order, which is why the HHA educated the family or patient to do their own wound care. The DPCS stated the doctors were aware HHA’s could not provide daily wound care. The DPCS stated it was standard to not let the doctor know that the patient could not get daily wound care. During an interview on 2/4/2026, at 10:42 a.m., with the DPCS, the DPCS stated the expectation was for the nursing staff to educate the patient (if able), or the caregiver, on how to do wound care daily. The expectation was for the nurse to visit the patient 3 times a week for wound care, and the patient or caregiver to do the wound care the other days. During a concurrent interview and record review on 2/4/2026, at 10:50 a.m., with the DPCS, the DPCS reviewed Patient 1’s SN visit notes, dated 11/27/2025, 11/29/2025, 12/1/2025, 12/3/2025, 12/5/2025, 12/8/2025, 12/8/2025, 12/11/2025, and 12/13/2025. The DPCS stated the notes did not specify patient was instructed to do daily wound care. The notes did not specify the patient was competent and demonstrated wound care. The DPCS stated it was important to instruct Patient 1 about daily wound care to ensure somebody will take over the wound care. To ensure the daily wound care order from the hospital was being followed. If daily wound care was not done, the wound can get infected. That is why the hospital did it daily. So the wound doesn’t get infected. If Patient 1’s wound got infected, Patient 1 could get sepsis (a whole body infection), Patient 1’s life might be at risk, the wound could get worse and toes can get amputated, especially if the patient has diabetes. During a concurrent interview and record review on 2/4/2026, at 11 :15 a.m., with the DPCS, the DPCS reviewed of Patient 1’s Home Health Certification and Plan of Care (POC), dated 11/21/2025 to 1/19/2026. The record indicated, “Site: Right foot Wound care: Using aseptic technique, cleanse with saline solution and Betadine, pack with packing strips, cover with gauze soaked in Betadine, cover with 2 pads, and wrap with Kerlix, secure with tape. Change wound dressing once daily and as needed if soiled or wet. SN to instruct family/caregiver to change dressing during non-SN visit days after return demonstration performed for competency.” The DPCS stated based on the documentation he could not say that the SN followed the POC. b and c During a concurrent interview and record review on 2/4/2026 at 11:22 a.m., with the DPCS, the DPCS reviewed of Patient 1’s POC, dated 11/21/2025 to 1/19/2026. The record indicated, “Skilled Nurse to assess the severity of the wound on right foot area and its response to the current treatment, and signs/symptoms of infection...Skilled nurse to notify MD (doctor) of any significant changes in the patient’s condition”. The DPCS stated the expectation was for the SN to assess the wound once a week for size, description, drainage, and surrounding tissue. The DPCS stated the wound size gave information if the wound was improving. A smaller size meant the wound was improving; larger size meant worsening. Taking a picture of the wound helped to determine if there was slough. Slough indicated infection. If the wound had signs of infection, the doctor needed to be notified. The DPCS stated sometimes wounds were already infected, and the goal was to continue providing treatment and notify the doctor if the infection worsened. During a concurrent interview and record review on 2/4/2025, at 11:58 a.m., the DPCS reviewed Patient 1’s initial comprehensive assessment titled, OASIS, dated 11/21/2025. The DPCS indicated the baseline wound assessment on SOC, was L (Length) 11.0 cm (cm-centimeter, unit of measurement) x W (width) 1.5 cm x D (depth) 1.0 cm. The wound did not have odor, there was loose yellow-tan slough, and the surrounding tissue was hyperpigmented, with no drainage. During a concurrent interview and record review on 2/4/2025, at 12:03 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 11/27/2025. The record indicated, a wound assessment of L 11.0 cm x D 1.5 cm. There was no documentation of depth. The DPCS stated this was an element of wound assessment because the depth showed the gravity, situation of the wound. If the depth was deep, it meant it took time to heal. The DPCS continued to review the record and indicated there was no documentation of the odor and surrounding skin. The record did, however, indicated the presence of large, saturated drainage. The DPCS stated this meant the wound was not in good condition and needed constant dressing changes. The DPCS compared the baseline assessment (OASIS, dated 11/21/2025) to the wound assessment documented and stated it seemed the wound was getting worse; it could mean there was an infection or the patient did not change the dressing. Either way, the nurse needed to reinforce daily dressing changes. Since the nurse documented there was signs of infection, the SN needed to continue to monitor the wound. If on the next visit, there was still drainage, it needed to be reported to the doctor. The DPCS stated signs of infection were swelling, pain, and fever. During a concurrent interview and record review on 2/4/2025, at 12:15 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 11/29/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS stated this was an incomplete assessment. The elements missing were depth measurement, surrounding tissue, odor, and assessment of bed wound. The purpose of a complete wound assessment was the information gathered supported the status of the wound, to determine if it was improving or worsening. The DPCS stated that the presence of large saturation was a change of condition, and this required notification to the doctor. The DPCS stated the doctor was not informed. The DPCS stated the SN did not follow the POC. During a concurrent interview and record review on 2/4/2025, at 12:28 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 12/1/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS stated this was an incomplete assessment. The elements missing were depth measurement, surrounding tissue, odor, and wound bed assessment. Assessment of the wound base was important because it tells the condition of the wound. If there was blood flow to the wound, there was granulation (healing). If there was slough on the wound bed, it meant worsening infection. The DPCS continued to review the note and stated the doctor had not been informed of the status of the wound. During a concurrent interview and record review on 2/4/2025, at 12:37 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 12/3/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS stated this was an incomplete assessment. The elements missing were depth measurement, surrounding tissue, odor, and wound bed assessment. The DPCS stated there was no notification to the doctor because the nurse thought there was no need to notify due to no signs and symptoms of infection. During a concurrent interview and record review on 2/4/2025, at 12:40 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 12/5/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS stated this was an incomplete assessment. The elements missing were depth measurement, surrounding tissue, odor, and wound bed assessment. The DPCS stated there was no notification to the doctor because the nurse thought there was no need to notify due to no signs and symptoms of infection. The DPCS stated the note looked like it was copied from the previous visit and pasted to the current visit note because all the notes reviewed so far showed the same wound assessment. During a concurrent interview and record review on 2/4/2025, at 12:41 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 12/8/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS stated this was an incomplete assessment. The elements missing were depth measurement, surrounding tissue, odor, and wound bed assessment. The DPCS stated there was no notification to the doctor because the nurse thought there was no need to notify due to no signs and symptoms of infection. During a concurrent interview and record review on 2/4/2025, at 12:43 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 12/11/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS stated this was an incomplete assessment. The elements missing were depth measurement, surrounding tissue, odor, and wound bed assessment. The DPCS stated there was no notification to the doctor because the nurse thought there was no need to notify due to no signs and symptoms of infection. During a concurrent interview and record review on 2/4/2025, at 12:45 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 12/13/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS stated this was an incomplete assessment. The elements missing were depth measurement, surrounding tissue, odor, and wound bed assessment. The DPCS stated there was no notification to the doctor because the nurse thought there was no need to notify due to no signs and symptoms of infection. During a record review of Patient 1’s GACH records, dated 12/16/2025, the record indicated, “...with past medical history of diabetes mellitus recent admission for osteomyelitis requiring metatarsal amputation and recurrent diabetic right foot infection who presented to the emergency department after worsening wound noted to have concern for worsened cellulitis and therefore referred for admission.” During a concurrent interview and record review on 2/4/2025, at 1:10 p.m., the DPCS reviewed Patient 1’s GACH records, dated 1/8/2026. The record indicated Patient 1’s wound area was 23.5 cm x 9.5 cm x 2.7 cm, and had another toe amputated, this time the 3rd right toe. The DPCS stated the HHA SN’s did not provide quality care to prevent hospitalization and complications. The DPCS stated amputation was a complication of poor wound management. d. During a record review of Patient 1’s GACH documents, dated 11/19/2025, indicated Patient 1’s Hemoglobin A1c (a test to check blood sugar levels) was 10.2 (this is an abnormal value, indicating diabetes). During a concurrent interview and record review on 2/4/2025, at 11:30 a.m., the DPCS reviewed Patient 1’s POC for certification period 11/21/2025-1/19/2026. The record indicated, “Skilled Nurse to perform and teach patient/caregiver on blood sugar testing, insulin preparation and administration, observing aseptic technique, universal precautions and proper disposal of sharps. Teach proper skin/foot care and hygiene, safety and infection control measures. Teach patient to report to MD blood sugar less than 70 mg/dl and greater than 250 mg/dl.” Skilled Nurse to check blood sugar using patient's own glucometer (a machine that checks blood sugar levels) machine on each SN visit.” The DPCS stated the SN needed to use the glucometer of the patient, in the process of teaching, the nurse needs to check blood sugar of the patient. If the patient is checking his own blood sugar, the nurse needed to ask what the blood sugar is and document the value. During a concurrent interview and record review on 2/4/2026 at 11:58 a.m. to 12:45 p.m., with the DPCS, the DPCS reviewed Patient 1’s SN visit notes dated, 11/27/2025, 11/29/2025, 12/1/2025, 12/3/2025, 12/5/2025, 12/8/2025, 12/8/2025, 12/11/2025, and 12/13/2025. The records did not indicate blood sugar assessment and monitoring. The DPCS stated the records blood sugar section was left blank and there was no mention of blood sugar values or management. The DPCS stated the SN’s did not follow the POC. During an interview on 2/4/2026 at 12:52 p.m. with the DPCS, the DPCS stated blood sugar affects wound healing. It affects the blood flow. If the blood sugar is not controlled it affects the blood flow to the wound. Diabetes affects wound healing. Patients who have diabetes have slower wound healing. The blood sugar needs to be controlled. The nurse might have asked and monitored about the blood sugar, but it was not documented. The nurse might have forgotten to document. If blood sugar is not controlled wound can get worse, more infection, risk of amputation, losing a limb, and sepsis. e. During a concurrent interview and record review on 2/4/2026 at 11:45 p.m., with the DPCS, the DCPS reviewed Patient 1’s POC, dated 11/21/2025 to 1/19/2026. The record indicated Patient 1 was supposed to receive SN services 3 times a week. The DPCS stated there was a missed visit on the week of 11/23/2025. Patient 1 was supposed to be seen on 11/25/2025. The DPCS stated there was no communication note to explain what happened or the reason the visit was missed. The missed visit process required a missed visit note to explain why the visit was missed. The visit should have been rescheduled for the following day and the doctor was supposed to be notified. The DPCS stated there was no documentation in Patient 1’s record to validate the doctor was notified of the missed visit. The DPCS further reviewed Patient 1’s medical records and stated there was another missed visit on the week of 12/14/2025. Patient 1 was supposed to be seen on 12/15/2025, but there was nothing documented to indicate the reason of the missed visit and/or doctor notification. 2. During a record review of Patient 1’s GACH records, dated 1/8/2026, the record indicated Patient 1’s wound area was 23.5 cm x 9.5 cm x 2.7 cm, and had another toe amputated, this time the 3rd right toe. a. During a concurrent interview and record review on 2/2/2026, at 2:56 p.m., with Registered Nurse 2 (RN 2), RN 2 reviewed Patient 1’s POC dated 1/16/2026 to 3/16/2026. The record did not indicate a POC was developed. RN 2 stated the document was in draft mode and this meant it was not finished. The POC needed to be completed 5 to 7 days from the SOC, by 1/23/2026. The purpose of the POC was to bring all the information, what the doctor ordered, to complete what needed to be done, and instructions on what the nurses was supposed to do. b. During a record review on 2/2/2026, of Patient 1’s medical records, there was no nursing notes in the record for certification period beginning on 1/16/2026. During an observation of the home visit on 2/3/2026 from 9:05 a.m., to 9:17 a.m. with Licensed Vocational Nurse 1 (LVN 1), LVN 1 provided wound care. Patient 1’s wound on the right foot was: right foot and wound were swollen; there was heavy amounts of yellow drainage on the dressing. The wound edges were swollen, and pale yellow, full of slough, and the great right toe base had necrotic tissue. The wound was observed from the top foot to the mid foot area on the plantar foot. The wound measured 23cm L x 2 cm W x 3.5 cm D. During an interview on 2/4/2026 at 11:22 a.m., with the DPCS, the DPCS stated the expectation was for the SN to assess the wound once a week for size, description, drainage, and surrounding tissue. The DPCS stated the wound size gave information if the wound was improving. A smaller size meant the wound was improving; larger size meant worsening. Taking a picture of the wound helped to determine if there was slough. Slough indicated infection. If the wound had signs of infection, the doctor needed to be notified. The DPCS stated sometimes wounds were already infected, and the goal was to continue providing treatment and notify the doctor if the infection worsened. During a concurrent interview and record review on 2/4/2026, at 2:21 p.m., with the DPCS, the DPCS reviewed Patient 1’s initial comprehensive assessment titled, OASIS, dated 1/16/2026. The DPCS stated the record indicated the wound assessment was: 20 cm x 6.0 cm x 2.0 cm. There was no wound odor, there was pink-red granulation at the wound base, the surrounding wound area was pink-normal, and there was presence of large-saturated dressing. During an interview on 2/4/2026, at 2:46 p.m., with the DPCS, the DPCS stated visit notes were supposed to be documented in the patients record within 7 days of the visit, so the HHA knows the patient condition. The HHA needed to be aware of any condition that requires intervention, so the doctor is notified of any change of condition promptly. During a concurrent interview and record review on 2/4/2026, at 2:52 p.m., with the DPCS, the DPCS reviewed Patient 1’s medical records. There was now 2 skilled visit notes documented: 1/22/2026 and 1/27/2026. The DPCS reviewed the record titled, SN visit note, dated 1/22/2026. The SN visit note indicated a wound measurement of 20 cm x 6.3 cm x 2.0 cm. The DPCS stated the wound assessment was incomplete because the assessment of the surrounding tissue was missing. The DPCS continued to review Patient 1’s SN visit note, dated 1/27/2026. The SN visit note indicated a wound measurement of 20 cm x 6.3 cm x 2.0 cm. The DPCS stated the wound assessment was incomplete because the assessment of the surrounding tissue and wound base assessment were missing. During an interview on 2/4/2026 at 2:52 p.m., with the DPCS, the DPCS was informed of the home visit wound assessment: measurement of 23 cm x 2 cm x 3.5 cm, dead tissue in between toes, yellow slough. The DPCS stated although the width decreased the depth increased to 3.5 cm. The presence of slough, large amounts of discharge, indicated the wound was getting worse. The risk for Patient 1 was re-hospitalization, complications of the wound requiring more amputations, and sepsis. During an interview on 2/5/2026, at 10:48 a.m., with the DPCS, the DPCS obtained a copy of the wound picture taken on the home visit on 2/3/2026. The DPCS stated the wound was not healing. The picture showed slough and slough indicated infection. The foot and wound edges was swollen. There was necrotic tissue on the great toe. The necrotic tissue was spreading to the great toe, which meant the infection was spreading, placing Patient 1 at risk of losing his toe. c. and d. During an interview at the home visit on 2/3/2026, at 8:55 a.m., with Patient 1, Patient 1 stated he had gone to the clinic on 1/30/2026, and the podiatrist (foot doctor)-MD 5) gave him a prescription. The prescription read, “Please arrange follow up appointments with patients surgeon, arrange for all prescriptions, wound care, home health... PT is not receiving care for wound vac and irregular home health...” During a concurrent observation and interview at the home visit on 2/3/2026, at 9:05 a.m., with LVN 1, there was no wound vacuum (a device placed on the wound, to absorb fluids) observed on Patient 1’s right foot. Patient 1 stated the wound vacuum had been removed on 1/27/2026, the last time wound care was done. LVN 1 stated he had removed the wound vacuum because the wound had a lot of necrotic tissue and the patient was uncomfortable with the vacuum. LVN 1 stated wound vacuums were contraindicated when there was a lot of necrotic tissue. Durin a record review of Patient 1’s SN visit note dated 1/27/2026, indicated Patient 1 had requested a wet to dry dressing until his follow up visit with the doctor on 1/31/2026. During an observation of the home visit on 2/3/2026 from 9:05 a.m., to 9:17 a.m. with Licensed LVN 1, LVN 1 provided wound care. LVN 1 cleaned the wound with dermal wound cleanser (a type of solution made of purified water, surfactants, and other ingredients), applied betadine (a topical antiseptic) around the wound and the necrotic tissue, applied A&D ointment around the tissue to protect the skin, applied adaptic dressing (a special dressing), covered with 4x4 gauzes, applied an abd pad (a thicker type of bandage) and wrapped the wound and ankle with kerlix dressing (a type of bandage). LVN 1 stated Patient 1 needed special dressing that did not stick to the wound. During the wound care, LVN 1 stated to Patient 1 it was up to Patient 1 if he wanted the wound vacuum placed or if LVN 1 should leave the wound without the vacuum so the doctor could see it on the visit of 2/4/2026. Patient 1 stated to LVN 1 he agreed with LVN 1 to leave the wound without a vacuum. LVN 1 stated he had done a wet to dry dressing for Patient 1. During an interview on 2/3/2026, at 9:17 a.m., with LVN 1, LVN 1 stated there was no POC done for Patient 1. During an interview on 2/3/2026, at 9:45 a.m., with Patient 1, Patient 1 stated he needed to have wound care done twice a week. Patient 1 stated he had received 4 visits since SOC. Patient 1 stated he only cancelled a visit once because he had an appointment with medical, otherwise, he had not cancelled any other visits. During an interview on 2/3/2026, at 10:00 a.m., with LVN 1, LVN 1 stated the wound orders he used to provide care to Patient 1 were from the handwritten report in the medical record. LVN 1 stated he did not get an order to discontinue the wound vacuum on Patient 1’s right foot wound. LVN 1 stated he had never spoken to Patient 1’s doctor because he did not have the doctor’s information. LVN 1 stated if the information was available for Patient 1’s doctor, he would have called to get a telephone order for wound care and to give report on the wound. LVN 1 stated he thought the wound was improving. LVN 1 stated he based this statement based on his nursing knowledge. LVN 1 further stated his decision to give a wet to dry wound treatment was based on being a standard order for wound care. LVN 1 stated he did not need a doctor’s order for a wet to dry dressing. It was a first aid type of standard care. During an interview on 2/3/2026, at 10:05 a.m., with LVN 1, LVN 1 was asked how he knew what to report to the doctor if no POC was available. LVN 1 stated that if Patient 1’s wound was complicated or had issues, he would send Patient 1 to the emergency room (ER) because LVN 1 knew that a doctor would send Patient 1 to the ER. During a concurrent interview and record review on 2/4/2026 at 2:31 p.m., with the DPCS, the DPCS reviewed Patient 1’s GACH records, dated 1/8/2026. The record indicated: “Right foot wound vac: -Cleanse with normal saline -Then apply no-sting skin barrier and wound drapes to peri wound skin and areas for bridging if needed. -Apply cut-to-fit non-adherent strip (adaptic/curad) to the wound bed. -Then apply silver foam to wound base and area for bridging if needed. -Seal with wound drapes and apply suction. Setting at 125 mmHg low continuous. -Dressing change: 2 times a week or Mon/Thu. On discharge: “May use BLACK FOAM 3x/week, 125 mmgHg low continuous pressure.” The DPCS stated LVN 1 had not followed the doctor’s order during the home visit. The DPCS stated based on the GACH records, Patient 1 was supposed to be visited for wound care 3 times a week. The DPCS stated based on the SOC evaluation, the Registered Nurse (RN) recommended to have the patient seen twice a week for wound care. The DPCS stated the doctor’s recommendation needed to be followed, not the RN. During a concurrent interview and record review on 2/4/2026, at 2:43 p.m., with the Staffing Coordinator (SC 1), the SC 1 stated she had scheduled Patient 1’s visits of 2 times a week based on the hospital record. The SC 1 was then shown Patient 1’s GACH records, dated 1/8/2026, focusing on the area indicating “on discharge...3x/week...” SC 1 stated she had read the order wrong. During an interview on 2/4/2026, at 2:45 p.m., with the DPCS, the DPCS stated it was important to schedule Patient 1 for wound care 3 times a week because the HHA needed to monitor Patient 1’s wound more often. Patient 1’s wound needed more monitoring. During a concurrent interview and record review on 2/4/2026, at 3:03 p.m., with the DPCS, the DPCS reviewed Patient 1’s visit schedule and records. The DPCS stated missed a wound care visit on 1/24/2026 and 1/29/2026. The was no attempts made to re-schedule the missed visits. During an interview on 2/5/2026, at 11:54 a.m., with Patient 1’s primary care doctor (MD 6), MD 6 stated that on 12/12/2025 was the first time MD 6 had seen Patient 1 at the medical clinic. MD 6 stated she reviewed Patient 1’s clinic records and the note indicated Patient 1 was not getting regular home visits: the HHA was only coming once a week. MD 6 stated Patient 1 told MD 6 the HHA was refusing to help him. MD 6 stated she had not spoken to anyone from the HHA and the HHA had not told him he was hospitalized back in December 2025. MD 6 stated the first time the HHA contacted her was on 2/4/2026, not to report on Patientt 1, but to sign orders. e. During a record review of Patient 1’s GACH records, dated 1/8/2026, the records indicated Patient 1’s Hemoglobin A1C levels were 9 (level indicates presence of diabetes). During an observation at the home visit on 2/3/2026, at 9:55 a.m., LVN 1 did not assess Patient 1’s blood sugar levels. During an interview on 2/3/2026, at 3:40 p.m., with Patient 1, Patient 1 stated he needed a machine to check his blood sugar (glucometer) because he wanted to make sure his blood sugar levels remained fine. During an interview on 2/4/2026, at 1:40 p.m., with the DPCS, the DPCS stated Patient 1 did not have a glucometer. The DPCS stated the HHA needed to get an order from the doctor for a glucometer. The DPCS stated he did not know if the HHA had done this. During an interview on 2/5/2026, at 11:54 a.m., with MD 6, MD 6 stated that Patient 1 told MD6, on the clinic visit of 12/12/2025, that he was not checking his blood sugar because he did not have a glucometer. MD 6 stated Patient 1 needed to check his blood sugar twice a day. MD 6 stated she did not understand why the hospital or home health agency did not arrange for a glucometer. MD 6 stated Patient 1’ diabetes was not under control. MD 6 stated Patient 1’s wound would not heal if his diabetes was not controlled. During a record review of the HHA’s form titled, “Rights/Responsibilities” revised 11/2017, indicated “The completion of all assessments and care to be furnished, based on the comprehensive assessment. The organization shall ensure that the patient receives all services outlined in the plan of care.” During a record review of the HHA’s form titled, “Wound Care Policy” undated, indicated “To provide wound care treatment/services (using a multidisciplinary approach) based on evidence-based standards of care under the direction of a physician.” During a record review of the HHA’s form titled, “Care Planning Process” revised 11/2017, indicated “At the time of the initial assessment, the clinician, along with the physician and other involved disciplines, will develop the patient plan of care based upon the patients’ identified needs and will review it with the patient and family/caregiver”. During a record review of the HHA’s form titled, “Wound Care Policy” undated, indicated “The admitting clinician will document each wound status including, (at least every week) location and etiology, measurement of length, width and depth, undermining and tunneling, if present, description of the wound bed, drainage, signs and symptoms of infection, healing and peri wound skin condition.” The form also indicated, “Nurse will provide wound care per physician orders and continue to implement and evaluate the plan of care based on the effectiveness of treatment regimen, response to treatment, effectiveness of interdisciplinary services, need for assessment by Wound Care Specialist, patient/caregiver participation and identification of obstacles/risk factors interfering with wound healing. The nurse will notify the physician for any change in the patient’s condition or lack of progress. At each visit the patient's skin will be assessed.” Lastly, “If patient is not responding to established treatment regimen, the nurse/therapist shall evaluate for: a. Need for treatment change. b. Referral to Wound Care Specialist for wound assessment. c. Referral for consultation by physician or wound clinic. d. Re-assess need for interdisciplinary services and/or appropriate DME (durable medical equipment).” During a record review of the HHA’s form titled, “Physician Participation in Plan of Care” revised 11/2017, indicated “A physician will direct the care of every home health patient admitted for service…The attending physician will participate in the care planning process by reviewing and revising the plan of care (therapeutic and diagnostic orders). The care will be provided in compliance with his/her therapeutic and diagnostic orders and accepted standards and practice.” During a record review of the HHA’s form titled, “Reassessment/Recertification” revised 11/2017, indicated “The total plan of care must be renewed at least every 60 days, or more often as warranted by the condition of the patient. Any assessment findings that suggest a need to alter the plan of care will be reported to the patient's physician.” During a record review of the HHA’s form titled, “Monitoring Patients Response/Reporting to Physician”, revised 10/2011, indicated “Clinicians will monitor, document, and report the patient's response to care and treatment provided on each home visit. Progress toward goals will be measured at regular intervals. Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient.”

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 observation, interview and record review the Home Health Agency (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes.) failed to include information required in the care plan for five of ten sampled patients (Patient 3, Patient 6, Patient 7, Patient 8, and Patient 9). This failure had the potential to result in patients not receiving the identified needs and services, and having a decline in health status, that could affect their quality of care and well-being. During an interview on 2/2/2026 at 1:10 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated the HHA uses subcontractors to complete patients’ care plans. The DPCS stated that a list is sent to the subcontractors of the patients that require plans of care. The DPCS stated that the “office” reviews, corrects, and finalize the plans of care received from the subcontractors. The DPCS stated that after finalizing the care plans, he (DPCS) asks the nurses to sign it. The plans of care are drafts because they are not complete. Plans of care are completed once the nurse reviews and signs it. During an interview on 2/4/2026 at 2:47 p.m. with Registered Nurse 4 (RN4), RN4 stated that she (RN4) has been employed by the HHA for 7-8 years. RN4 stated that she (RN4) assesses and admits 3-4 patients per day for the HHA. RN4 stated that she documents her assessments within 48 hours of the visit. RN4 stated that she was not responsible to formulate patients’ plans of care. During an interview on 2/4/2026 at 3:38 p.m. with Subcontractor 1 (S1), S1 stated that she (S1) was a registered nurse and has been contracted by the HHA since 2023 to assist with coding and developing patients’ plans of care. S1 stated Office Manager 1 (OM1) emails her (S1) a list of the patients that require plans of care to be drafted. S1 stated she logs into the HHAs electronic medical record (EMR) patients comprehensive nursing assessments and drafts a care plan with the information that is documented there. S1 stated she (S1) submits the plan of care (POC) draft into the HHA’s EMR, then “someone in the office” reviews and edits the POC if needed. S1 stated that she (S1) does not sign the POC because she (S1) does not assess the patients. During an interview on 2/5/2026 at 1:37 p.m. with the DPCS, the DPCS stated an author’s signature indicates it was documented by the author. The DPCS stated that if a document does not have the author’s signature, that document is not valid. 1. During a record review of Patient 3’s medical record form titled Patient Information undated, indicated a start of care date (SOC) of 1/14/2026 with a diagnosis of pressure ulcer (skin wound) unspecified site. During a record review of Patient 3’s medical record titled Plan of Care (POC) for certification period 1/14/2026-3/14/2026, indicated management of stage 4 pressure ulcer (skin loss extending to fat, muscle, bone). Further review of the record indicated Patient 3 was to receive SN (Skilled Nurse) visit 3 times a week for 9 weeks (3w9). During a concurrent interview and record review on 2/4/26 at 3:20 p.m., with the Director of Patient Care Service (DPCS), the DPCS reviewed Patient 3’s record titled Home Health Consult, dated 1/7/2026. The record indicated, “Sacral wound-wound vac at 125 mmgHg (millimeters of mercury, unit of measurement) continuous change 2x (times)/week.” The DPCS stated the POC frequency should have been 2 times a week because that is what the order was. The correct frequency was not in the POC. 2. During a record review of Patient 6’s undated medical record titled “Patient Information," the record indicated a start of care date (SOC) of 10/23/2025 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During a record review of Patient 6’s medical record form titled “Home Health Certification and Plan of Care” dated from 12/22/2025 to 2/19/2026, indicated the form was a “Draft”. The form was incomplete and was not signed by a registered nurse or a physician. During a concurrent interview and record review on 2/2/2026 at 2:35 p.m. with the DPCS of Patient 6’s medical record, the DPCS stated that Patient 6’s plan of care dated 12/22/2025 to 2/19/2026 was to be completed by 12/28/2025. 3. During a record review of Patient 7’s medical record form titled “Patient Information” undated, indicated a start of care date (SOC) of 11/18/2024 with a primary diagnosis of type 2 diabetes mellitus (high blood sugar resulting from the body’s inability to produce and/or properly use insulin) with foot ulcer (an open sore or wound on the foot that fails to heal). During a record review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 11/18/2024 to 1/16/2025, indicated it was not completed or signed by a physician. During a record review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 1/17/2024 to 3/17/2025 and 3/18/2025 to 5/16/2025, indicated it both forms were signed by a physician on 5/19/2025. During a record review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 9/14/2025 to 11/12/2025, indicated it was not completed or signed by a physician or a nurse. The form also indicated it was a draft. During a record review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 11/13/2025 to 1/11/2026, indicated it was not completed or signed by a physician or a nurse. The form also indicated it was a draft. During a record review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 1/12/2026 to 3/12/2026, indicated it was not completed or signed by a physician or a nurse. The form did not identify orders for treatments, education, or recertification. The form also indicated it was a draft. During a concurrent interview and record review on 2/2/2026 at 1:10 p.m. with the DPCS of Patient 7’s medical record, the DPCS stated that there were two doctors signed plans of care for Patient 7 dated 11/18/2024 to 1/16/2025 and 3/18/2025 to 5/16/2025. The DPCS stated the two plans of care were Patient 7’s recertification orders. The DPCS stated that Patient 7 did not have recertification orders after 5/16/2025. Lastly, the DPCS stated that Patient 7’s plans of care dated 9/14/2025 to 11/12/2025, 11/13/2025 to 1/11/2026, and 1/12/2026 to 3/12/2026 are not completed. The DPCS stated, “I don’t know what happened here.” 4. During a record review of Patient 8’s medical record form titled “Patient Information” undated, indicated a start of care date (SOC) of 5/17/2025 and an end of care date of 1/24/2026 with a primary diagnosis of cellulitis (acute, spreading inflammation, presenting as swollen, red, tender, and warm skin) of left lower limb. During a record review of Patient 8’s medical record form titled “Home Health Certification and Plan of Care” dated 7/16/2025 to 9/13/2025, indicated it was not completed or signed by a physician or a nurse. The form also indicated it was a draft. During a record review of Patient 8’s medical record form titled “Home Health Certification and Plan of Care” dated 9/14/2025 to 11/12/2025, indicated it was not completed or signed by a physician or a nurse. The form also indicated it was a draft. During a record review of Patient 8’s medical record form titled “Home Health Certification and Plan of Care” dated 11/13/2025 to 1/11/2026, indicated it was not completed or signed by a physician or a nurse. The form also indicated it was a draft. During a record review of Patient 8’s medical record form titled “Home Health Certification and Plan of Care” dated 1/12/2026 to 3/12/2026, indicated it was not completed or signed by a physician or a nurse. The form also indicated it was a draft. During a concurrent interview and record review on 2/2/2026 at 3 p.m. with the DPCS of Patient 8’s medical record, the DPCS stated that Patient 8’s current comprehensive nursing recertification assessment dated 1/11/2026 and plan of care were in process. The DPCS stated that Patient 8’s medical record did not contain comprehensive nursing recertification assessments or plans of care for certification periods 9/14/2025 to 11/12/2025 and 11/13/2025 to 1/11/2026. During an interview on 2/5/2026 at 10:40 a.m. with Patient 8, Patient 8 stated that he (Patient 8) was being seen by the HHA once a week, with last visit being last Monday 2/2/2026. Patient 8 stated that the HHA nurse cleans and bandages his wounds on the buttocks and back. 5. During a record review of Patient 9’s medical record form titled “Patient Information” undated, indicated a start of care date (SOC) of 11/14/2024 and an end of care date of 1/12/2025 with a primary diagnosis of hyperglycemia (high blood sugar) unspecified. During a record review of Patient 9’s medical record form titled “Home Health Certification and Plan of Care” dated from 11/14/2024 to 1/12/2025, indicated it was not signed by a physician. During a concurrent interview and record review on 2/5/2026 at 1:50 p.m. with the DPCS of Patient 9’s medical record, the DPCS stated that Patients 9’s plan of care dated 11/18/2024 to 1/12/2025 was created on 1/20/2025, after Patient 9 was discharged. The DPCS stated that he (DPCS) did not know what the visiting nurses were using to care for Patient 9. The DPCS stated that Patient 9 was at risk of receiving improper treatment, which can affect the patient’s condition, for example the wound getting worse. The DPCS stated Patient 9 needed a plan of care to be taken care of properly. During a record review of the HHA’s document titled, Care Planning Process, dated November 2017, indicated, “The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan. Documents include plan of care treatment (485) and plans of care (all disciplines).

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 observation, interview, and record review, the HHA (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes) failed to ensure that one of ten sampled patients (Patient 1), received treatment in accordance with physician orders. This deficient practice had the potential to result in the patients care needs not being met and the established goals of the plan of care not being achieved. Findings: During a record review of Patient 1’s undated medical record titled "Patient Information” indicated a start of care date (SOC) of 1/16/2026 with a primary diagnosis of acute osteomyelitis (an infection-induced inflammatory condition of the bone) of the right ankle and foot. During a concurrent interview and record review on 2/2/2026, at 2:56 p.m., with Registered Nurse 2 (RN 2), RN 2 reviewed Patient 1’s POC for the certification period of 1/16/2026 through 3/16/2026. The record did not indicate a completed POC had been developed. RN 2 stated that the document was in draft mode, which indicated it had not been finalized. RN 2 further stated that the POC was required to be completed within five to seven days from the start of care (SOC) date by 1/23/2026. RN 2 stated that the purpose of the POC was to incorporate physician-ordered services, outline the patients care needs, and provide instructions for nursing staff regarding the care and treatment to be provided. During a concurrent observation and interview at the home visit on 2/3/2026, at 9:05 a.m., with Licensed Vocational Nurse 1 (LVN 1), no wound vacuum device (a therapy device used to apply negative pressure to a wound to promote healing by removing fluid and infectious material) was observed on Patient 1’s right foot. Patient 1 stated that the wound vacuum had been removed on 1/27/2026, the last time wound care was performed. LVN 1 stated that he removed the wound vacuum due to the presence of necrotic tissue and because the patient was experiencing discomfort with the device. LVN 1 further stated that wound vacuum therapy is contraindicated when necrotic tissue is present. During a record review of Patient 1’s SN visit note dated 1/27/2026, the note indicated Patient 1 had requested a wet to dry dressing until his follow up visit with the doctor on 1/31/2026. During an observation of the home visit on 2/3/2026 from 9:05 a.m., to 9:17 a.m. with LVN 1, LVN 1 provided wound care. LVN 1 cleaned the wound with a dermal wound cleanser (a type of solution made of purified water, surfactants, and other ingredients), applied betadine (a topical antiseptic) around the wound and the necrotic tissue, applied A&D ointment around the tissue to protect the skin, applied adaptic dressing (a special dressing), covered with 4x4 gauzes, applied an Abd pad (a thicker type of bandage) and wrapped the wound and ankle with kerlix dressing (a type of bandage). LVN 1 stated Patient 1 required a special dressing that did not stick to the wound. During wound care, LVN 1 stated to Patient 1, that it was up to Patient 1 if he wanted the wound vacuum placed or if LVN 1 should leave the wound without the vacuum so the doctor could see it on the visit of 2/4/2026. Patient 1 stated to LVN 1 he agreed with LVN 1 to leave the wound without a vacuum. LVN 1 stated he had performed a wet to dry dressing for Patient 1. During an interview on 2/3/2026, at 9:17 a.m., with LVN 1, LVN 1 stated there was no POC developed for Patient 1. During an interview on 2/3/2026, at 9:45 a.m., with Patient 1, Patient 1 stated he needed to have wound care performed twice a week. Patient 1 stated he had received 4 visits since the start of care (SOC). During an interview on 2/3/2026, at 10:00 a.m., with LVN 1, LVN 1 stated the wound care orders used to provide care to Patient 1 were obtained from the handwritten report in the medical record. LVN 1 stated he did not receive an order to discontinue the wound vacuum on Patient 1’s right foot wound. LVN 1 further stated that he had never spoken with Patient 1’s doctor because he did not have the doctor’s contact information. LVN 1 stated if the physician's information had been available, he would have contacted the physician to obtain a telephone order for wound care and to provide a report on the wound. LVN 1 stated that he believed the wound was improving based on his nursing knowledge. LVN 1 further stated that his decision to perform a wet-to-dry wound treatment was based on a standard wound care order and that he did not require a physician's order to perform a wet-to-dry dressing, as it was considered a first-aid type of standard care. During a concurrent interview and record review conducted on 2/4/2026 at 2:31 p.m., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 1’s General Acute Care records, dated 1/8/2026. The record included physician orders for the right foot wound vacuum therapy as follows: -Cleanse with normal saline; -Then Apply no-sting skin barrier and wound drapes to peri wound skin and areas for bridging if needed. -Apply cut-to-fit non-adherent strip (adaptic/curad) to the wound bed. -Then apply silver foam to wound base and area for bridging, if needed. -Seal with wound drapes and apply suction. Setting at 125 mmHg low continuous. -Dressing change: Two times a week or Mon/Thu. On discharge: “May use BLACK FOAM 3x/week, 125 mmgHg low continuous pressure.” The DPCS stated LVN 1 had not followed the physician's wound care orders during the home visit. The DPCS further stated that based on the GACH records, Patient 1 was to receive wound care three times per week. The DPCS stated that although, based on the SOC evaluation, the Registered Nurse (RN) recommended weekly wound care at the start of care, the physicians orders were required to be followed. During a concurrent interview and record review on 2/4/2026, at 2:43 p.m., with the Staffing Coordinator (SC 1), the SC 1 stated she had scheduled Patient 1’s visits for two times a week based on the hospital record. SC 1 was then shown Patient 1’s GACH records, dated 1/8/2026, focusing on the area indicating “on discharge...3x/week...” SC 1 stated she had read the order wrong. During an interview on 2/4/2026, at 2:45 p.m., with the DPCS, the DPCS stated it was important to schedule Patient 1 for wound care 3 times a week because the HHA needed to monitor Patient 1’s wound more often. Patient 1’s wound needed more monitoring. During an interview on 2/5/2026, at 10:48 a.m., with the DPCS, the DPCS obtained and reviewed a copy of the wound photograph taken during the home visit on 2/3/2026. The DPCS stated the wound was not healing. The photograph showed slough which indicated infection. The foot and wound edges appeared swollen, and necrotic tissue was present on the great toe. The DPCS stated that the necrotic tissue appeared to be spreading, which indicated progression of infection and placed Patient 1 at risk for further tissue loss or amputation. A record review of the HHA policy titled, “Physician Participation in Plan of Care,” revised 11/2017, indicated “A physician will direct the care of every home health patient admitted for service…The attending physician will participate in the care planning process by reviewing and revising the plan of care (therapeutic and diagnostic orders). The care will be provided in compliance with his/her therapeutic and diagnostic orders and accepted standards and practice.”

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 interview and record review, the HHA (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes) failed to ensure that verbal physician orders were received and accepted by licensed staff for two of ten samples patients (Patient 4 and Patient 5). This deficient practice had the potential to result in a risk of wrong treatment by not having licensed people verify the orders received. 1. During a record review of Patient 4’s undated, "Patient Information" record, the record indicated a start of care date (SOC) of 11/5/2025 with a diagnosis of shortness of breath. During a concurrent interview and record review on 2/5/26 at 1:59 p.m., with the Staffing Coordinator (SC 1), SC 1 reviewed Patient 4’s record titled, Doctor’s order, dated 11/22/2025. The record indicated, “No further skilled nurse needed. Patient will continue with physical therapy. Verified orders with MD (doctor) as written below. Discontinue Skilled Nurse (SN). Continue with Physical Therapy as ordered.” The SC 1 stated she had put in the order because the nurse who took care of the patient told SC 1 no further SN visits were needed. SC 1 stated she was not a licensed nurse, and she did not speak to the doctor to obtain the order. Further review of the record indicated the record was not signed by RN 6 or the doctor to validate the order. 2. During a record review of Patient 5’s undated "Patient Information" record, the record indicated a start of care date (SOC) of 6/9/2025, with a diagnosis of type 2 diabetes mellitus (too much sugar in the blood). During a record review of Patient 5’s record titled, Doctor’s order, dated 7/23/2025, the record indicated, “DC (discharge) No further care needed. Verified orders with MD (doctor) as written below…read back and verified." Further review of the record indicated the clinician was Registered Nurse 3 (RN 3). The order was created by SC 1. The record was not signed by RN 3 and the doctor to validate the order. During a record review of the HHA’s policy titled, Verification of Physician Orders, dated January 2006, the policy indicated, “Verbal orders will be taken and documented only by professional, licensed home health personnel...signed order will be placed in the clinical record within 30 days of initiation of the order, unless otherwise specified by applicable state law and regulation.”

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes) failed to ensure one of ten sample patients (Patient 9) plans of care were reviewed and approved by a physician. This failure had the potential to result in missed or inappropriate care for patients. During an interview on 2/2/2026 at 1:20 p.m. with the DPCS, the DPCS stated that a patient’s plan of care was a guide for nurses to follow. The DPCS stated patient’s services to be provided are outlined in their plan of care. The DPCS stated a doctor’s signature in the patients plans of care, signifies the doctor is aware and approved the patients’ care. The DPCS stated that if a patient’s plan of care is not signed by a doctor, the patient can receive the wrong care. The DPCS stated that the HHA will not know the direction to take with a patient that does not have a signed plan of care. The DPCS stated that without a physician signature on the plan of care, the HHA does not have orders to see or treat the patient. A record review of Patient 9’s undated medical record titled “Patient Information” indicated a start of care date (SOC) of 11/14/2024 and an end of care date of 1/12/2025 with a primary diagnosis of hyperglycemia (high blood sugar) unspecified. A record review of Patient 9’s medical record titled “Home Health Certification and Plan of Care – (POC)” dated from 11/14/2024 through 1/12/2025, indicated it was not signed by a physician. During a concurrent interview and record review on 2/5/2026 at 3 p.m. with the Director of Patient Care Services (DPCS) of Patient 9’s medical record, the DPCS stated that he did not know why Patient 9’s POC dated 11/14/2024 was not signed by a physician. The DPCS stated that he does not know if a physician reviewed Patient 9’s POC. The DPCS stated that a document is not valid unless it has a signature, in this case the physician’s signature. The DPCS stated that a physician signature is required to authenticate and agree with the plan.

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 observation, interview and record review, the Home Health Agency (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes.) failed to ensure the physician was notified of one of ten sampled patients change of condition which resulted in hospitalization resulting in a 3rd toe amputation. This deficient practice resulted in delayed treatment, infection progression, avoidable hospitalization, surgical intervention, and compromised patient outcomes. During a concurrent interview and record review on 2/4/2026 at 11:22 a.m., with the DPCS, the DPCS reviewed Patient 1’s POC, dated 11/21/2025 through 1/19/2026. The record indicated, “Skilled Nurse to assess the severity of the wound on the right foot and its response to current treatment, and monitor for signs/symptoms of infection. Skilled nurse to notify the physician of any significant changes in the patient’s condition." The DPCS stated the expectation was for the SN to assess the wound once per week for size, description, drainage, and surrounding tissue. The DPCS further stated wound measurements provide information regarding wound improvement with a decrease in size indicating deterioration. A smaller size meant the wound was improving; A larger size meant the wound is worsening. The DPCS stated that obtaining a photograph of the wound assists in determining the presence of slough, which may indicate infection. The DPCS further stated if signs of infection are present, the physician is required to be notified. The DPCS stated that is some cases wounds may already be infected, and the goal is to continue providing treatment and notify the physician if the infection worsens. During a concurrent interview and record review on 2/4/2026, at 11:58 a.m., the DPCS reviewed Patient 1’s initial comprehensive assessment titled, OASIS, dated 11/21/2025. The DPCS indicated the baseline wound assessment on SOC, was L (Length) 11.0 cm (cm-centimeter, unit of measurement) x W (width) 1.5 cm x D (depth) 1.0 cm. The wound did not have odor, had no loose yellow-tan slough, and the surrounding tissue was hyperpigmented, with no drainage. During a concurrent interview and record review on 2/4/2026, at 12:03 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 11/27/2025. The record indicated a wound assessment of L 11.0 cm x D 1.5 cm. The record further indicated the presence of large, saturated drainage. The DPCS stated this meant the wound was not in good condition and needed constant dressing changes. The DPCS compared the baseline assessment (OASIS, dated 11/21/2025) to the wound assessment documented and stated it seemed the wound was getting worse; it could mean there was an infection, or the patient did not change the dressing. Either way, the nurse needed to reinforce daily dressing changes. Since the nurse documented there were signs of infection, the SN needed to continue to monitor the wound. If on the next visit, there was still drainage, it needed to be reported to the doctor. During a concurrent interview and record review on 2/4/2026, at 12:15 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 11/29/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS stated that the presence of large saturation was a change of condition, and this required notification to the doctor. The DPCS stated the doctor was not informed. The DPCS stated the SN did not follow the POC. During a concurrent interview and record review on 2/4/2026, at 12:28 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 12/1/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS continued to review the note and stated the doctor had not been informed of the status of the wound. During a concurrent interview and record review on 2/4/2026, at 12:37 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 12/3/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS stated there was no notification to the doctor because the nurse thought there was no need to notify due to no signs and symptoms of infection. During a concurrent interview and record review on 2/4/2026, at 12:40 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 12/5/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS stated there was no notification to the doctor because the nurse thought there was no need to notify due to no signs and symptoms of infection. During a concurrent interview and record review on 2/4/2026, at 12:41 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 12/8/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS stated there was no notification to the doctor because the nurse thought there was no need to notify due to no signs and symptoms of infection. During a concurrent interview and record review on 2/4/2026 at 12:43 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 12/11/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS stated there was no notification to the doctor because the nurse thought there was no need to notify due to no signs and symptoms of infection. During a concurrent interview and record review on 2/4/2026, at 12:45 p.m., the DPCS reviewed Patient 1’s record titled, SN visit note, dated 12/13/2025. The record indicated a wound assessment of 11.0 cm x 1.5 cm., and continued presence of large saturation. The DPCS stated there was no notification to the doctor because the nurse thought there was no need to notify due to no signs and symptoms of infection. During a record review of Patient 1’s GACH records, dated 12/16/2025, the record indicated, “...with past medical history of diabetes mellitus recent admission for osteomyelitis requiring metatarsal amputation and recurrent diabetic right foot infection who presented to the emergency department after worsening wound noted to have concern for worsened cellulitis and therefore referred for admission.” During a concurrent interview and record review on 2/4/2026, at 1:10 p.m., the DPCS reviewed Patient 1’s GACH records, dated 1/8/2026. The record indicated Patient 1’s wound area was 23.5 cm x 9.5 cm x 2.7 cm, and had another toe amputated, this time the 3rd right toe. The DPCS stated the HHA SN’s did not provide quality care to prevent hospitalization and complications. The DPCS stated amputation was a complication of poor wound management. During a record review of the HHA’s document titled, Monitoring Patient’s Response/Reporting to Physician, dated October 2011, indicated, “Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient...The patient’s physician will be contacted on the same day when any of the following occur: A. Changes in the patient’s condition.”

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes.) failed to ensure the Condition of Participation regarding Clinical Records was met as follows: 1.The HHA failed to ensure the Skilled Nurse (SN) followed the plan of care for four of ten sampled selected patients (Patient 3, Patient 4, Patient 5, and Patient 7). This deficient practice placed the patients at risk of complications, and hospitalization by not following the plan of care. (Refer to G710). 2. The Home Health Agency failed to perform supervisory visits for License Vocational Nurse (LVN) services for one of ten sampled patients (Patient 5). This deficient practice resulted in the LVN not being evaluated to ensure the plan of care was followed. (Refer to G726). The cumulative effect of these systemic practices resulted in the failure of the HHA to ensure the provision of a quality health care in a safe environment.

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 interview and record review, the Home Health Agency (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes) failed to ensure the Skilled Nurse (SN) followed the plan of care for four of ten sampled selected patients (Patient 3, Patient 4, Patient 5, and Patient 7). This deficient practice placed the patients at risk of complications, and hospitalization by not following the plan of care. 1. A record review of Patient 3’s undated "Patient Information" indicated a start of care date (SOC) of 1/14/2026 with a diagnosis of pressure ulcer (skin wound) unspecified site. During concurrent interview and record review on 2/4/2026, at 3:36 p.m., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 3’s medical record titled Plan of Care (POC), for certification period 1/14/2026-3/14/2026. The POC indicated, “Nurse to assess signs and symptoms of hyper/hypoglycemia (high blood sugar/low blood sugar), skin/foot care and hygiene. Skilled Nurse to check blood sugar using patient's own glucometer machine on each SN (skilled nurse) visit.” The DPCS stated the DPCS was supposed to check, assess, and monitor the patients blood sugar levels. During a concurrent interview and record review on 2/4/2026 between 3:37 p.m., to 3:43 p.m., with the DPCS, the DPCS reviewed Patient 3’s record titled, SN visit note, dated 1/17/2026, 1/20/2026, and 1/23/2026. The DPCS stated the SN did not monitor Patient 3’s blood sugar levels at any of the home visits forementioned. During an interview on 2/4/2026, at 3:49 p.m., with the DPCS, the DPCS stated the risk of not monitoring diabetes included wound healing. Diabetes affects wound healing. If the diabetes is not controlled, the wound can worsen. Since Patient 3 had a stage 4 (skin loss extending to fat, muscle, bone) wound, worsening of the wound could place Patient 3 at risks for complications such as sepsis (full body/blood infection), infection, and re-hospitalization. 2. A record review of Patient 4’s undated "Patient Information," indicated a start of care date (SOC) of 11/5/2025 with a diagnosis of shortness of breath. During concurrent interview and record review on 2/5/2026, at 1:30 p.m., with Registered Nurse 2 (RN 2), RN 2 reviewed Patient 4’s record titled, Plan of Care, for the certification period 11/5/2025 through 1/3/2026. The record indicated, “Skilled Nurse to perform blood sugar each visit unless done by patient/PCG and document the results done by patient/caregiver from patient's own glucometer to ensure accurate blood sugar results in skilled nursing notes. Report abnormal blood sugar results per parameters to MD. Skilled Nurse to teach all interventions to prevent risk factor to hospitalization and ER." RN 2 stated this meant that the nurse needed to check blood sugar, monitor the results, notify MD (doctor) based on the parameters. Perform interventions if needed for hypo/hyperglycemia. Teach on diabetes management, signs of high blood sugar (hyper) and signs of low blood sugar (hypo). During a concurrent interview and record review on 2/5/26 between 1:35 p.m., to 1:49 p.m., with RN 2, RN 2 reviewed Patient 4’s record titled, SN visit note, dated 11/8/2025, 11/11/2025, 11/14/2025, 11/18/2025, and 11/22/2025. RN 2 stated Patient 4’s blood sugar monitoring and teaching related to diabetes was not done for any of the SN visits forementioned. RN 2 stated the importance of checking the blood sugar was as follows: Patient can lose consciousness if patient has complications such as hypo/hyperglycemia. Complications of hypoglycemia: Patient can die, due to blood sugar too low. Complications of hyperglycemia: Patient can get dehydrated (need IV-intravenous fluids). Kidney failure affects heart function, brain function. Hypertrophy of the heart, which can lead to MI (heart attack), ketoacidosis. The First thing that is affected by poorly controlled DM is eyes and kidneys. 3. A record review of Patient 5’s undated "Patient Information" record indicated a start of care date (SOC) of 6/9/2025, with a diagnosis of type 2 diabetes mellitus (too much sugar in the blood). During a concurrent interview and record review on 2/6/2026, at 11:06 a.m., with the DPCS, the DPCS reviewed Patient 5’s undated Referral/Authorization Request. The document indicated, a diagnosis of type 2 diabetes mellitus, with hyperglycemia (high blood sugar levels) and pressure ulcer sacral region stage 2 (skin loss extending to the dermis/epidermis skin layer) …with significant pressure ulcer on sacrum, needs urgent referral to home health agency that does wound care assessment and treatment. The DPCS stated Patient 5 had been referred to the HHA for skilled nursing services for wound care and diabetes management. During a concurrent interview and record review on 2/6/26 at 11:25 a.m., with the DPCS, the DPCS reviewed Patient 5’s record titled, SN Visit note, dated 6/12/2025. The DPCS stated the document indicated a check mark on the entry Patient is not diabetic. The DPCS stated this was inaccurate. Based on the referral and report of the Registered Nurse, Patient 5 was diabetic. The DPCS stated the record did not indicate blood sugar monitoring and teaching was done. During a concurrent interview and record review on 2/6/26 between 11:25 a.m., to 12:08 p.m., with the DPCS, the DPCS reviewed Patient 5’s record titled, SN visit note, dated 6/12/2025, 6/16/2025, 6/18/2025, 6/23/2025, 6/25/2025, 6/30/2025, 7/2/2025, 7/9/2025, 7/16/2025, and 7/23/2025. The DPCS stated the SN did not monitor Patient 5’s blood sugar levels at any of the home visits. The DPCS stated the nurse did not follow the plan of care. 4. A record review of Patient 7’s undated “Patient Information” record indicated a start of care date (SOC) of 11/18/2024 with a primary diagnosis of type 2 diabetes mellitus (high blood sugar resulting from the body’s inability to produce and/or properly use insulin) with foot ulcer (an open sore or wound on the foot that fails to heal). A record review of Patient 7’s “Home Health Certification and Plan of Care” dated 1/12/2026 to 3/12/2026, received on 2/2/2026, indicated it was not completed or signed by a physician or a nurse. The POC also indicated it was a draft. The form indicated under section DME (durable medical supplies) diabetic supplies… A record review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 1/12/2026 to 3/12/2026, brought by Licensed Vocational Nurse 3 (LVN3) during the home visit, indicated it was complete, but it was not signed by a physician or a nurse. The form indicated “Skilled nurse to continue to instruct patient/caregiver on blood sugar monitoring techniques using patients own glucometer to ensure accurate blood sugar results in skilled nursing notes, the importance of recording and compliance, and skin and diabetic foot care. SN to continue to assess and teach patient/pcg (patient caregiver) … importance of blood sugar monitoring/recording, proper blood sugar testing, glucometer calibration… and to report abnormal blood sugar results per parameters to MD.” The form also indicated “Skilled nurse to report to Medical Doctor if …. blood sugar is less than 70mg/dl (milligrams per deciliter – unit of measure) or greater than 400 mg/dl…”. During an interview on 2/3/2026 at 11:10 a.m. with LVN3, LVN3 brought Patient 7’s plan of care dated 1/12/2026 to 3/12/2026, which was filled out but not signed by a nurse or a physician. LVN3 stated that he (LVN3) has been seeing Patient 7 three times a week for about 2 years. Patient 7 stated he had diabetes and is currently taking Jardiance (high blood sugar medication). Patient 7 stated that his (Patient 7) blood sugar is checked at his primary doctor’s office because he does not have diabetic supplies at home. Patient 7 stated that he (Patient 7) has not been asked about his blood sugar levels by the HHA or offered to have diabetic supplies brought to his home. During an interview on 2/3/2026 at 11:20 a.m. with LVN3, LVN3 stated that Patient 7 does not have diabetes supplies at home because his primary doctor has not supplied them. LVN3 stated that Patient 7 has never checked his blood sugar at home, since he (LVN3) has been with him (Patient 7). LVN3 stated that he (LVN3) does not ask Patient 7 about his (Patient 7) blood sugar because his primary doctor will take care of that. LVN3 was asked if he communicated with the HHA about Patient 7’s plan of care diabetes monitoring interventions. LVN3 stated that he (LVN3) does not contact the HHA to discuss Patient 7’s plan of care. LVN3 stated that he (LVN3) prints Patient 7’s plan of care from the HHA electronic medical record system and does Patient 7’s wound care. A record review of the HHA’s form titled, “Physician Participation in Plan of Care” revised 11/2017, indicated “A physician will direct the care of every home health patient admitted for service…The attending physician will participate in the care planning process by reviewing and revising the plan of care (therapeutic and diagnostic orders). The care will be provided in compliance with his/her therapeutic and diagnostic orders and accepted standards and practice.”

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes) failed to perform supervisory visits for License Vocational Nurse (LVN) services for one of ten sampled patients (Patient 5). This deficient practice resulted in the LVN not be evaluated to ensure the plan of care was followed. A record review of Patient 5’s undated "Patient Information" indicated a start of care date (SOC) of 6/9/2025, with a diagnosis of type 2 diabetes mellitus (too much sugar in the blood). During a concurrent interview and record review on 2/6/2026, at 11:06 a.m., with the DPCS, the DPCS reviewed Patient 5’s undated Referral/Authorization Request. The document indicated, a diagnosis of type 2 diabetes mellitus, with hyperglycemia (high blood sugar levels) and Pressure Ulcer Sacral Region Stage 2 (skin loss extending to the dermis/epidermis skin layer) …with significant pressure ulcer on sacrum, needs urgent referral to home health agency that does wound care assessment and treatment. The DPCS stated Patient 5 had been referred to the HHA for skilled nursing services for wound care and diabetes management. During a concurrent interview and record review on 2/6/26 at 11:25 a.m., with the DPCS, the DPCS reviewed Patient 5’s record titled, SN Visit note, dated 6/12/2025. The DPCS stated the document indicated a check mark on the entry Patient is not diabetic. The DPCS stated this was inaccurate. Based on the referral and report of the Registered Nurse Patient 5 was diabetic. The DPCS stated the record did not indicate blood sugar monitoring and teaching was done. During a concurrent interview and record review on 2/6/26 between 11:25 a.m., to 12:08 p.m., with the DPCS, the DPCS reviewed Patient 5’s record titled, SN visit note, dated 6/12/2025, 6/16/2025, 6/18/2025, 6/23/2025, 6/25/2025, 6/30/2025, 7/2/2025, 7/9/2025, 7/16/2025, and 7/23/2025. The DPCS stated the SN did not monitor Patient 5’s blood sugar levels at any of the home visits. The DPCS stated the nurse did not follow the plan of care. During an interview on 2/6/2026 at 11:44 a.m., with the DPCS, the DPCS stated it was the responsibility of the Registered Nurse (RN) to supervise the Licensed Vocational Nurse (LVN) to make sure the SN was following the plan of care. The RN’s were required to supervise the LVN once a month. During an interview on 2/6/26 at 11:55 a.m., with the Clinical Supervisor/Intake Review (CS1), the CS 1 stated she had reviewed Patient 5’s medical records and stated there were no LVN supervisory notes.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: 1.Based on interview and record review, the Home Health Agency (HHA - an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure clinical records were written and authenticated (verifying accuracy, authorship, and validity of documentation) by the author of the note for 6 of 10 sampled patients (Patient 1, Patient 6, Patient 7, Patient 8, Patient 9, and Patient 10) when: a. The HHA hired Subcontractor 1(S1), who amended the comprehensive nursing assessment for the patients, despite not having assessed the patients. b. The Director of Patient Care Services (DPCS) used Registered Nurse 1 (RN 1) nursing credential to document the nursing assessment of the patients. c. The plan of care of the patients was not developed, documented and authenticated by a Registered Nurse and the Medical Director. d. The physician orders for the patients were not signed by the ordering physician. These failures resulted in unauthorized patient information entries that did not reflect patients’ current medical condition and needs were entered into patient medical records, which increased the risk for inappropriate treatment, delayed or incorrect diagnoses, and medical errors that can lead to serious injury, harm, impairment, or death. (Refer to G1024). 2. The HHA failed to send all necessary medical information to the primary care practitioner within 5 days of discharge for three of ten sampled patients (Patient 4, Patient 5, and Patient 10). This deficient practice resulted in the primary care practitioner not receiving information regarding the services and care provided by the HHA. (Refer to G1022). 3. The HHA failed to ensure patient care records were safeguarded against unauthorized used for four of ten sampled patients (Patient 6, Patient 7, Patient 9, and Patient 10). This failure resulted in records being modified by people not involved in the patients’ care. (Refer to G1028). The cumulative effect of these systemic practices resulted in the failure of the HHA to ensure the provision of quality health care in a safe environment. On , 2/6/2026 at 12:55 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the provider's non-compliance with one or more requirements of participation has caused, or likely to cause, serious injury, harm impairment, or death to a patient) in the presence of the agency’s Administrator (ADM) and the Director of Patient Care Services (DPCS) related to the HHA failure to ensure clinical records were written and authenticated by the author of the note. The non-compliance resulted in unauthorized patient information entries that did not reflect patients’ current medical condition and needs, which is likely to result in inappropriate treatment, delayed or incorrect diagnoses, and fatal medical errors that can lead to serious injury, harm, impairment, or death. On 2/6/2026 at 3:00 p.m., the HHA was unable to submit an IJ removal plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely).

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 interview and record review, the Home Health Agency (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes) failed to send all necessary medical information to the primary care practitioner within 5 days of discharge for three of ten sampled patients (Patient 4, Patient 5, and Patient 10). This deficient practice resulted in the primary care practitioner not receiving information regarding the services and care provided by the HHA. 1. A record review of Patient 4’s undated "Patient Information" record indicated a start of care date (SOC) of 11/5/2025 with a diagnosis of shortness of breath. During a record review of the HHA’s census on 2/2/2026, Patient 4 was listed on the active list. During a record review of the HHA’s electronic medical record (EMR) on 2/5/2026, Patient 4 was listed as discharged. During a concurrent interview and record review on 2/5/2026, at 2:10 p.m., with Registered Nurse 2 (RN 2), RN 2 reviewed Patient 4’s medical records. RN 2 stated that Patient 4 was discharged from the HHA on 12/6/2025. RN 2 stated the DC OASIS was supposed to be done by the Physical Therapist (PT) because the PT had discharged the patient. RN 2 stated she did not know what PT did because the HHA did not have access to PT’s forms. During a record review of Patient 4’s medical records on 2/5/2026, at 2:11 p.m., Patient 4’s records indicated a DC OASIS, dated 12/6/2025. Patient 4’s document history for the DC OASIS, dated 12/6/2025, indicated the document was entered in Patient 4’s medical records on 2/4/2026. Further review of the record indicated, Patient 4’s PT(Physical Therapy) DC summary, dated 12/6/2025 was documented by the PT on 12/16/25: the record did not indicate the summary was sent to the doctor. During an interview on 2/5/2026, at 2:20 p.m., with RN 2, RN 2 stated the DC OASIS and DC Summary was supposed to be completed within 30 days of discharge. The DC summary was supposed to be sent with the doctor within 30 days of discharge, so the doctor knows what services were given to the patient. 2. During a record review of Patient 5’s undated "Patient Information", the record indicated a start of care date (SOC) of 6/9/2025, with a diagnosis of type 2 diabetes mellitus (too much sugar in the blood). During a concurrent interview and record review on 2/6/2026, at 12:09 p.m., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 5’s medical records and stated that there was no DC OASIS done. The DPCS stated Patient 5 was discharged on 7/23/2025. The DPCS stated that a Registered Nurse was supposed to update the comprehensive assessment on discharge, with the DC OASIS assessment. The purpose of the DC OASIS was to access the patient’s condition at discharge. To confirm there was no more care needed. The DC OASIS assessment was then used to write the DC summary. The purpose of the DC summary was to recap the patient care. This was used to notify the doctor of the services provided and the condition of the patient upon discharge. 3. A record review of Patient 10’s undated medical record form titled “Patient Information” indicated a start of care date (SOC) of 8/29/2025 and an end of care date of 10/23/2025 with a primary diagnosis of hemothorax (accumulation of blood in the space between the chest wall and the lung). During a concurrent interview and record review on 2/5/2026 at 1:05 p.m. with the DPCS of Patient 10’s medical record, the DPCS stated that he (DPCS) “usually ask the RNs for their login information, to be able to sign when a signature is required. The DPCS stated that he (DPCS) was asked to complete patients’ documentation when he began his (DPCS) DPCS role. The DPCS stated that he (DPCS) should not have signed or completed patients notes because he (DPCS) did not visit the patients. The DPCS stated he (DPCS) did not know if Patient 10 was “ok” for discharge because he did not visit the patient. The DPCS stated that his (DPCS) signature indicated he approved Patient 10’s assessment. The DPCS stated that he was unaware that S1 was changing the nurse’s documentation. During a record review of the HHA’s document titled, Discharge Criteria and Process, dated November 2017, indicated, “An update to the comprehensive assessment, including required OASIS data elements, will be completed, as required by regulation…A discharge summary will be completed for all discharged patients. A copy will be mailed to the primary physician…All discharge paperwork will be due in the office within 72 hours of the discharge date. This will include the discharge order, discharge summary, plan of care, medication profile, and OASIS…The discharge record will be organized according to the organization policy regarding clinical record contents. Documentation will be reviews by the Clinical Supervisor or designee and completed within 30 days of the discharge, at which time it will be removed from the active files.”

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA - an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure clinical records were written and authenticated (verifying accuracy, authorship, and validity of documentation) by the author of the note for 6 of 10 sampled patients (Patient 1, Patient 6, Patient 7, Patient 8, Patient 9, and Patient 10) when: The HHA hired Subcontractor 1(S1), who amended the comprehensive nursing assessment for the patients, despite not having assessed the patients. The Director of Patient Care Services (DPCS) used Registered Nurse 1 (RN 1) nursing credential to document the nursing assessment of the patients. The plan of care of the patients was not developed, documented and authenticated by a Registered Nurse and the Medical Director. The physician orders for the patients were not signed by the ordering physician.. These failures resulted in unauthorized patient information entries that did not reflect patients’ current medical condition and needs were entered into patient medical records, which increased the risk for inappropriate treatment, delayed or incorrect diagnoses, and medical errors that can lead to serious injury, harm, impairment, or death. (Refer to G1024). 6. During a record review of Patient 1’s medical record form titled Patient Information” undated, indicated a start of care date (SOC) of 1/16/2026 with a primary diagnosis of acute osteomyelitis (an infection-induced inflammatory condition of the bone) of the right ankle and foot. a. During a concurrent interview and record review on 2/2/2026, at 2:56 p.m., with Registered Nurse 2 (RN 2), RN 2 reviewed Patient 1’s POC dated 1/16/2026 to 3/16/2026. The record did not indicate a POC was developed. RN 2 stated the document was in draft mode and this meant it was not finished. The POC needed to be completed 5 to 7 days from the SOC, by 1/23/2026. The purpose of the POC was to bring all the information, what the doctor ordered, to complete what needed to be done, and instructions on what the nurses were supposed to do. RN 2 further stated the process of creating a POC was as follows: the admitting nurse provides the SOC information to the HHA. The HHA sends the information to the coders in the Philippines. Once the coders process the POC, the coders will send the POC back to the HHA, so the HHA reviews the POC, the nurse who opened the case is expected to sign the POC. During an interview on 2/2/2026, at 3:18 a.m., with the Administrator (ADM), the ADM stated RN 2 was new to the HHA and the ADM needed to clarify regarding the POC being done in the Philippines. The ADM stated the HHA used to hire a company in the Philippines 8 years ago, but no loner uses the company in the Philippines. During a record review of Patient 1’s POC, dated 1/16/2026 to 3/16/2026, the POC had information on Patient 1’s address, date of birth, and diagnosis. Further review of the record did not indicate the staff who had entered the information. b. During an interview on 2/3/2026, at 3:15 p.m., with Medical Assistant 1 (MA 1), MA 1 stated that Medical Doctor 6 (MD 6) was Patient 1’s primary care doctor. MA 1 stated that Medical Doctor 3 (MD 3) was not Patient 1’s doctor. During a concurrent interview and record review on 2/4/2026, at 10:15 a.m., with the DPCS, the DPCS reviewed Patient 1’s record titled, Doctor’s Order, dated 11/21/2025. The record indicated an admission order to HHA services, by MD 3. The DPCS stated the order had not been signed. The purpose of the signature was to get clearance from the doctor for the primary care doctor to be aware that the patient had been referred to HHA services from the hospital. Since MD 3 gave the order, MD 3 was the one responsible for the care of Patient 1 while in HHA services. MD 3’s signature meant MD 3 was aware the HHA is providing services, approving the order. The DPCS stated the orders needed to be signed within 30 days of receiving the order. During a record review of Patient 1’s document history, for Doctor’s Order, dated 11/21/2025, indicated the Clinical Supervisor/Intake Review (CS 1) had entered the order in Patient 1’s record on 2/3/2026. Further review of the record indicated Registered Nurse 5 (RN 5) had signed the order on 2/3/2026. During a record review of Patient 1’s record titled, Doctor’s Order, dated 11/21/2025, the record indicated RN 5 was the person who had taken the order on 11/21/2025 at 3:47 p.m. c. During a concurrent interview and record review on 2/4/2026 at 10:34 a.m. with the DPCS, the DPCS reviewed Patient 1’s record titled, Home Health Certification and Plan of Care (POC), for certification period 11/21/2025 to 1/19/2026. The DPCS stated the record indicated MD 3 was Patient 1’s doctor responsible for Patient 1s care. The DPCS stated the record did not indicate MD 3 had signed the POC. The DPCS stated the POC was sent to the wrong clinic and the HHA would send it to the right clinic today, 2/4/2026. During a record review on 2/4/2026, the HHA staff submitted a signed POC for Patient 1’s certification period 11/21/2025 to 1/19/2026. The record had a signature dated 12/10/2025. During an interview on 2/5/2026, at 11:54 a.m., with Patient 1’s primary care doctor (MD 6), MD 6, MD 6 stated the first time the HHA contacted her was on 2/4/2026, not to report on Patient 1, but to sign orders. MD 6 stated when the documents were sent, she had put the date she signed the documents, which was 2/4/2026. MD 6 stated the HHA called back, spoke to the medical assistant and where yelling at her questioning why I had dated the document. The HHA told the medical assistant for me to sign again, but not date the documents. I told the medical assistant to inform the HHA that I would sign the date that I signed the document. MD 6 was then informed that the POC, dated 11/21/2025 to 1/19/2026, was dated 12/10/2025. MD 6 stated she did not back date the document. MD 6 stated she did not know the document was for November. MD 6 stated she did not see Patient 1 in November 2025. d. During a concurrent interview and record review on 2/4/2026, at 3:14 p.m., with the DPCS, the DPCS reviewed Patient 1’s record titled Physician Order, dated 1/16/2026. The DPCS stated the record indicated the MD 3’s order for the plan of care. This was supposed to be done at the time of the plan of care, on 1/16/2026. The DPCS then reviewed Patient 1’s record titled Document history, for the Physician’s Order, dated 1/16/2026. The record indicated the order was documented on 2/3/2026, by the DPCS. The DPCS stated, that the DPCS had not received the order from MD 3, as the DPCS had not spoken to MD 3. The DPCS stated this was a standard order, what we attach to the plan of care. I was told by somebody (I forgot by whom) that I need to do this order for the plan of care. This is not an order I got from MD 3. Its an order that is written and sent to MD 3 for signature. During an interview on 2/2/2026 at 1:10 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated the HHA uses subcontractors to complete patients’ care plans. The DPCS stated that a list is sent to the subcontractors of the patients that require plans of care. The DPCS stated the HHA sends to the subcontractors. The DPCS stated that the “office” reviews, corrects, and finalize the plans of care received from the subcontractors. The DPCS stated that after finalizing the care plans, he (DPCS) asks the nurses to sign it. The plans of care are drafts because they are not complete. Plans of care are completed once the nurse reviews and signs it. During an interview on 2/2/2026 at 1:20 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated that a patient’s plan of care was a guide for nurses to follow. The DPCS stated patient’s services to be provided are outlined in their plan of care. The DPCS stated a doctor’s signature in the patients plans of care, signifies the doctor is aware and approved the patients’ care. The DPCS stated that if a patient’s plan of care is not signed by a doctor, the patient can receive the wrong care. The DPCS stated that the HHA will not know the direction to take with a patient that does not have a signed plan of care. The DPCS stated that without a physician signature on the plan of care, the HHA does not have orders to see or treat the patient. During an interview on 2/4/2026 at 2:47 p.m. with Registered Nurse 4 (RN4), RN4 stated that she (RN4) has been employed by the HHA for 7-8 years. RN4 stated that she (RN4) assesses and admits 3-4 patients per day for the HHA. RN4 stated that she (RN4) documents her assessments within 48 hours of the visit. RN4 stated that she (RN4) was not responsible to formulate patients’ plans of care. During an interview on 2/4/2026 at 3:38 p.m. with Subcontractor 1 (S1), S1 stated that she (S1) was a registered nurse and has been contracted by the HHA since 2023 to assist with coding and developing patients’ plans of care. S1 stated Office Manager 1 (OM1) emails her (S1) a list of the patients that require plans of care to be drafted. S1 stated she logs into the HHAs electronic medical record (EMR) patients comprehensive nursing assessments and drafts a care plan with the information that is documented there. S1 stated she (S1) submits the plan of care (POC) draft into the HHA’s EMR, then “someone in the office” reviews and edits the POC if needed. S1 stated that she (S1) does not sign the POC because she (S1) does not assess the patients. During an interview on 2/4/2026 at 3:45 p.m. with S1, S1 stated that she (S1) does not document or edit patients initial or recertification comprehensive nursing assessments because she (S1) was told not to and she (S1) did not feel comfortable editing them. S1 stated that the documentation of the patients’ comprehensive assessments was the admitting nurses’ responsibility because the admitting nurse saw and assessed patients. During an interview on 2/4/2026 at 3:53 p.m. with S1, S1 was made aware of patients document history function in the HHAs’ EMR. S1 stated that she (S1) has not shared her (S1) EMR log in information with anyone. S1 stated that the HHA never asked her (S1) to change any documentation. S1 stated that she (S1) does not remember if she (S1) decided to change patients comprehensive nursing assessments. S1 stated that if the EMR’s document history indicated that she (S1) changed patients’ comprehensive assessments, she (S1) does not remember. S1 stated, “If the system says that I changed it, then what can I say.” During an interview on 2/5/2026 at 12:35 p.m. with the DPCS, the DPCS stated that the Subcontractor 1 (S1) was a registered nurse hired as a contractor to complete patients plans of care and coding. The DPCS stated that S1 was not allowed to make changes to comprehensive nursing assessments. During an interview on 2/5/2026 at 1:37 p.m. with the DPCS, the DPCS stated patients nursing assessment are to be signed by the visiting nurse to confirm the visiting nurse documented findings. The DPCS stated an author’s signature indicates it was documented by the author. The DPCS stated that if a document does not have the author’s signature, that document is not valid. 1. During a record review of Patient 6’s medical record form titled “Patient Information” undated, indicated a start of care date (SOC) of 10/23/2025 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During a record review on 2/4/2026 at 3:27 p.m. of Patient 6’s medical record form titled “Start of Care (SOC) Assessment” dated 10/23/2025, indicated Registered Nurse 3 (RN3) had Patient 6’s SOC assessment in progress on 10/24/2025. The form also indicated the Subcontractor 1 (S1) had Patient 6’s SOC assessment in progress from 10/30/2025 till 11/4/2025. Patient 6’s SOC assessment was submitted by RN3 on 11/17/2025. Patient 6’s SOC assessment was approved by the Director of Patient Care Services (DPCS) on 11/17/2025. During a record review on 2/4/2026 at 3:17 p.m. of Patient 6’s medical record form titled “Document History – Start of Care Assessment” dated 10/23/2025, indicated there were changes made to Patient 6’s SOC assessment by S1. RN3’s last entry made on 10/24/2025 was compared to the last entry made by S1 on 11/4/2025. The form Document History indicated that S1 made changes to the documented findings of RN3 SOC Assessment of Patient 6. These are some of the changes made by S1: Grooming from 1 to 2Ability to dress upper body safely from 1 to 2Ability to dress lower body safely from 1 to 2Bathing from 1 to 3Toileting from 1 to 2Transferring from 1 to 2Ambulating from 1 to 2Mobility from 5 to 4Primary diagnosis with severity from blank to 3Risk for hospitalization from 0 to 1 – describe risk multiple medications check boxRisk for hospitalization from 0 to 1 – describe risk other check box from 0 to 1Risk for hospitalization from blank to “presence of open wound, breast cancerDiscipline and frequency from blank to SN (skilled nurse), duration 2, duration period week(s), frequency 1, and frequency period week(s)Pain comments from blank to no pain during this visitPain medication from 0 to 1Pain reducing method from 0 to 1Verbalizes understanding from 0 to 1Pain Regimen: frequency used from blank to take one tablet by mouth every 6 hoursPain med from blank to acetaminophen (pain medication) 500 milligrams (unit dose measurement) oral tabletActivities permitted – permitted care from 1 to 0Permitted exercise from 0 to 1Place holder for medication profile from blank to “acetaminophen…. Ibuprofen…. Metoprolol…. Tramadol…Vitamin D3…. Whole Mega Fish oil…”Nutritional status prescribed diet from blank to Low salt and low fatSN interventions Performed: S1 added Patient 6’s wound treatment order which was not documented by RN3 During a record review of Patient 6’s medical record form titled “Home Health Certification and Plan of Care” dated from 10/23/2025 to 12/21/2025, indicated it was electronically signed by Rn3 on 10/23/2025. The form also indicated it had a wet signature under “attending physician signature” but it did not indicate the date the attending physician signed the form. During a record review of Patient 6’s medical record form titled “Recertification Assessment” dated 12/21/2025, indicated the form was not complete and the authors name or signature were not documented. The form also indicated under section “Diagnosis and Symptom Control”, Patient 6’s primary diagnosis was malignant neoplasm of unspecified site of right female breast (right breast cancer). During a record review of Patients 6’s medical record form titled “Document History – Recertification Assessment” dated 12/21/2025, indicated Registered Nurse 3 (RN3) was assigned and schedule to assess Patient 6 on 12/21/2025. The form also indicated that the Director of Patient Care Services (DPCS) was the only clinician that documented Patient 6’s form on 12/31/2025. During a record review of Patient 6’s medical record form titled “Home Health Certification and Plan of Care” dated from 12/22/2025 to 2/19/2026, indicated the form was a “Draft”. The form was incomplete and was not signed by a registered nurse or a physician. During a concurrent interview and record review on 2/2/2026 at 2:30 p.m. with the Director of Patient Care Services (DPCS) of Patient 6’s medical record, the DPCS stated that Patient 6’s plan of care dated 10/23/2025 to 12/21/2025 was signed by a physician but it was not noted when the physician signed the form. The DPCS stated he (DPCS) did not know when the form was signed. During a concurrent interview and record review on 2/2/2026 at 2:35 p.m. with the DPCS of Patient 6’s medical record, the DPCS stated that Patient 6’s plan of care dated 12/22/2025 to 2/19/2026 was to be completed by 12/28/2025. The DPCS also stated that Patient 6’s recertification nursing assessment dated 12/21/2025 was still in progress and did not contain the author’s signature. The DPCS stated that Patient 6’s recertification nursing assessment should have been completed by 12/31/2025. 2. During a record review of Patient 7’s medical record form titled “Patient Information” undated, indicated a start of care date (SOC) of 11/18/2024 with a primary diagnosis of type 2 diabetes mellitus (high blood sugar resulting from the body’s inability to produce and/or properly use insulin) with foot ulcer (an open sore or wound on the foot that fails to heal). During a record review of Patient 7’s medical record form titled “Physician Certification of Face-to-Face Encounter” dated from 11/18/2024 to 1/16/2025, indicated the form was blank and had the Medical Doctor 2 (MD2) signature dated on 3/24/2025. The form also indicated Patient 7’s primary physician’s (MD1) name was listed but it was crossed out. During a record review of Patient 7’s medical record form titled “Doctor’s Order” dated 11/18/2024, indicated MD1 under “Physicians Name. The form also indicated under notes “referral to home health services”. The form also did not indicate a specific wound care order, it stated “skilled nurse for wound care/management”. Lastly, the form was not signed by a physician. During a record review of Patient 7’s medical record form titled “Chart Navigation” undated, indicated that during Patient 7’s episode period from 11/13/2025 to 1/11/2026, there were no assessments documented. During a record review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 11/18/2024 to 1/16/2025, indicated it was not completed or signed by a physician. During a record review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 1/17/2024 to 3/17/2025 and 3/18/2025 to 5/16/2025, indicated it both forms were signed by a physician on 5/19/2025. During a record review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 9/14/2025 to 11/12/2025, indicated it was not completed or signed by a physician or a nurse. The form also indicated it was a draft. During a record review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 11/13/2025 to 1/11/2026, indicated it was not completed or signed by a physician or a nurse. The form also indicated it was a draft. During a record review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 1/12/2026 to 3/12/2026, indicated it was not completed or signed by a physician or a nurse. The form did not identify orders for treatments, education, or recertification. The form also listed Meropenem (antibiotic) IV (intravenous) was under the current medications. The form also indicated it was a draft. During a record review of Patient 7’s medical record form titled “Recertification Assessment” dated 1/13/2026, indicated Patient 7 date of assessment was on 1/13/2026. During a record review of Patient 7’s medical record form titled “Document History – Recertification Assessment” dated 1/11/2026, indicated that on 2/2/2026 the Office Manager 1 (OM1) logged into Patient 7’s medical record and changed the assessment date from 1/13/2026 to 1/11/2026. During a concurrent interview and record review on 2/4/2026 at 1:45 p.m. with OM1 of Patient 7’s medical record, OM1 stated that she (OM1) logged into Patient 7’s medical record and changed the assessment date from 1/13/2026 to 1/11/2026, due to payroll reasons. OM1 stated that it would not be a problem to log back in and change it back once payroll is completed. During a concurrent interview and record review on 2/2/2026 at 1:10 p.m. with the DPCS of Patient 7’s medical record, the DPCS stated that there were two doctors signed plans of care for Patient 7 dated 11/18/2024 to 1/16/2025 and 3/18/2025 to 5/16/2025. The DPCS stated the two plans of care were Patient 7’s recertification orders. The DPCS stated that Patient 7 did not have recertification orders after 5/16/2025. Lastly, the DPCS stated that Patient 7’s plans of care dated 9/14/2025 to 11/12/2025, 11/13/2025 to 1/11/2026, and 1/12/2026 to 3/12/2026 are not completed. The DPCS stated, “I don’t know what happened here.” During a concurrent interview and record review on 2/2/2026 at 1:20 p.m. with the DPCS of Patient 7’s medical record, the DPCS stated that Patient 7’s comprehensive nursing recertification assessment for certification period 11/13/2025 to 1/11/2026, was not completed. The DPCS stated the recertification assessment should have been completed by 11/18/2025. The DPCS stated it was important to have the comprehensive nursing recertification assessment completed to demonstrate the patients updated condition. The DPCS stated that since it was not done, Patient 7 had the risk of receiving improper care due to not being assessed. 3. During a record review of Patient 8’s medical record form titled “Patient Information” undated, indicated a start of care date (SOC) of 5/17/2025 and an end of care date of 1/24/2026 with a primary diagnosis of cellulitis (acute, spreading inflammation, presenting as swollen, red, tender, and warm skin) of left lower limb. During a record review of HHA’s form titled “Patient Census Report” dated 2/2/2026, indicated Patient 8’s name was listed as a current patient, status admitted. During a record review of Patient 8’s medical record form titled “Home Health Certification and Plan of Care” dated 7/16/2025 to 9/13/2025, indicated it was not completed or signed by a physician or a nurse. The form also indicated it was a draft. During a record review of Patient 8’s medical record form titled “Recertification Assessment” date 9/13/2025, indicated Patient 8’s primary diagnosis was type 2 diabetes with peripheral angiopathy without gangrene. The form did not indicate who the author was. During a record review of Patient 8’s medical record form titled “Home Health Certification and Plan of Care” dated 9/14/2025 to 11/12/2025, indicated it was not completed or signed by a physician or a nurse. The form also indicated it was a draft. During a record review of Patient 8’s medical record form titled “Home Health Certification and Plan of Care” dated 11/13/2025 to 1/11/2026, indicated it was not completed or signed by a physician or a nurse. The form also indicated it was a draft. During a record review of Patient 8’s medical record form titled “Chart Navigation” undated, did not indicate there was an assessment for Patient 8 for episode 11/13/2025 to 1/11/2026. During a record review of Patient 8’s medical record form titled “Recertification Assessment” dated 1/11/2026, indicated it was not completed. The form did not indicate the author’s name or signature. During a record review on 2/5/2026 at 11:04 a.m. of Patient 8’s medical record title “Document History” undated, indicated Patient 8’s Recertification Assessment dated 1/11/2026 was in progress on 2/4/2026 by RN3. During a record review on 2/5/2026 at 11:26 a.m. of Patient 8’s medical record title “Document History” undated, indicated Patient 8’s Recertification Assessment dated 1/11/2026 was submitted on 2/4/2026 by RN3. During a record review of Patient 8’s medical record form titled “Home Health Certification and Plan of Care” dated 1/12/2026 to 3/12/2026, indicated it was not completed or signed by a physician or a nurse. The form also indicated it was a draft. During a record review on 2/5/2026 at 11:01 a.m. of Patient 8’s medical record title “Document History” dated 1/24/2026, indicated Patient 8’s Discharge Assessment was created on 2/3/2026 by the Case Manager 1 (CM1) and submitted on 2/5/2026 by Registered Nurse 3 (RN3). During a record review on 2/5/2026 at 11:38 a.m. of Patient 8’s medical record title “Document History” dated 1/24/2026, indicated Patient 8’s Discharge Summary was created and submitted on 2/5/2026 by RN3. During a concurrent interview and record review on 2/2/2026 at 3 p.m. with the DPCS of Patient 8’s medical record, the DPCS stated that Patient 8’s current comprehensive nursing recertification assessment dated 1/11/2026 and plan of care were in process. The DPCS stated that Patient 8’s medical record did not contain comprehensive nursing recertification assessments or plans of care for certification periods 9/14/2025 to 11/12/2025 and 11/13/2025 to 1/11/2026. During a concurrent interview and record review on 2/5/2026 at 10:40 a.m. with the DPCS of Patient 8’s medial record, the DPCS stated that Patient 8 was discharged on 2/2/2026. The DPCS stated that he (DPCS) did not know why Patient 8’s name was on the current HHA census. Further review, the DPCS stated that Patient 8 was discharged on 1/24/2026 and not 2/2/2026. During an interview on 2/5/2026 at 10:40 a.m. with Patient 8, Patient 8 stated that he (Patient 8) was being seen by the HHA once a week, with last visit being last Monday 2/2/2026. Patient 8 stated that the HHA nurse cleans and bandages his wounds on the buttocks and back. 4. During a record review of Patient 9’s medical record form titled “Patient Information” undated, indicated a start of care date (SOC) of 11/14/2024 and an end of care date of 1/12/2025 with a primary diagnosis of hyperglycemia (high blood sugar) unspecified. During a record review of Patient 9’s medical record form titled “H&P Notes” dated 10/29/2024, indicated Patient 9 was referred for home health services to perform the following wound treatment, right hallux, iodoform packing, betadine wet to dry gauze, kerlix, tape, three times per week. During a record review of Patient 9’s medical record form titled “Physician Order” dated 11/14/2024, indicated it was a start of care physician order written by RN3. The form also indicated Patient 9’s wound treatment included a wound vacuum three times per week. The form did not indicate it was signed by a physician. During a record review on 2/5/2026 at 11:44 a.m. of Patient 9’s medical record form titled “Document History – physician order” dated 11/14/2024, indicated RN3 created and submitted the physician order on 4/30/2025. During a record review of Patient 9’s medical record form titled “Order Note” dated 11/20/2024, indicated Patient 9’s wound treatment included a wound vacuum three times per week. The form was electronically signed by Medical Doctor 4 (MD4). During a record review of Patient 9’s medical record form titled “Start of Care (SOC) Assessment” dated 11/14/2024, indicated Patient 9’s primary diagnosis was type 2 diabetes mellitus with foot ulcer. The form did not indicate the author’s name. During a record review on 2/5/2026 at 11:53 a.m. of Patient 9’s medical record form titled “Document History – Start of Care Assessment” dated 11/14/2024, indicated RN3 created the document on 11/15/2024 and submitted on 11/29/2024. The form also indicated that the Subcontractor (S1) accessed Patient 9’s Start of Care Assessment form from 12/11/2024 to 12/31/2024. Lastly, the form indicated the Clinical Supervisor/Intake Review (CS1) accessed Patient 9’s Start of Care Assessment form on 2/3/2026. During a record review on 2/5/2026 at 11:57 a.m. of Patient 9’s medical record form titled “Document History”, indicated there were changes made to Patient 9’s SOC assessment by S1. RN3’s last entry made on 11/29/2024 was compared to the last entry made by S1 on 12/31/2024. The form Document History indicated that S1 made changes to the documented findings of RN3 SOC Assessment for Patient 9. These are some of the changes made by S1: Ambulating from 1 to 2Primary diagnosis with severity from blank to 3Describe risk multiple medications check box from 0 to 1Describe risk significant infection from 0 to 1Diabetes management FSBS (fasting blood sugar) from 0 to 1Diabetes management FSBS Memo from blank to “110-250 mg/dl”Diabetes management Glucometer from 0 to 1Diabetes management knowledge deficit from 0 to 1Diabetes management knowledge deficit Memo “disease process”Diabetes management Manifestations from 0 to 1Diabetes management Manifestations Type Other from 0 to 1Diabetes management Manifestations Type Other Memo from blank to “Diabetic foot ulcer”Discipline and frequency from blank to SN (skilled nurse), duration 1, duration period week(s), frequency 1, and frequency period week(s)Patient Category Risk Disaster from “low risk or Low priority” to Medium Risk or Medium priorityPrognosis from good to fair During a record review of Patient 9’s medical record form titled “Home Health Certification and Plan of Care” dated from 11/14/2024 to 1/12/2025, indicated it was not signed by a physician. During a record review of Patient 9’s medical record form titled “Chart Navigation” indicated Patient 9 was discharged due on 1/12/2025 due to “lack of funds”. During a record review of Patient 9’s medical record form titled “SN (skilled nurse) DC (discharge) Summary” dated 1/12/2025, indicated Patient 9 was discharge from the HHA on 1/12/2025 due to “no further authorized visits”. During a record review of Patient 9’s medical record form titled “Discharge Assessment” dated 1/12/2025, indicated the form was not complete. The Discharge Assessment had no vital signs or wound assessments documented. The Discharge Assessment also indicated Patient 9 had clear lung sounds, regular heart sounds, strong peripheral and pedal pulses, good skin turgor, and dry/warm skin. Patient 9’s Discharge Assessment indicated Patient 9 was informed on DC (discharge) plans, patient rights and responsibilities, medication schedule, emergency plan, state or county hotline. Patient 9’s Discharge Assessment indicated Patient 9’s wound is healing and caregiver able to manage wound care. Patient 9’s Discharge Assessment indicated Patient 9 was provided with discharge instructions. Lastly, Patient 9’s Discharge Assessment indicated it was electronically signed by RN3. During a record review on 2/5/2026 at 11:49 a.m. of Patient 9’s medical record form titled “Document History – Discharge Assessment” dated 1/12/2025, indicated Clinical Supervisor/Intake Review (CS1) created the document on 2/3/2026. During a concurrent interview and record review on 2/5/2026 at 1:37 p.m. with the DPCS of Patient 9’s medical record, the DPCS stated that S1 made changes to RN3’s documentation on Patient 9’s Start of Care Assessment. The DPCS stated that S1 did not visit or assess Patient 9, therefore, she (S1) should not be making any changes to the document. During a concurrent interview and record review on 2/5/2026 at 1:45 p.m. with the DPCS of Patient 9’s medical record, the DPCS stated that Patients 9’s Physician Order dated 11/14/2024 was created on 4/30/2025 by RN3. The DPCS stated that Patient 9 was discharged from the HHA on 1/12/2025. The DPCS stated that RN3 documentation of the physician order, was created after Patient 9 was discharged and that that was not the standard of practice. The DPCS stated that he (DPCS) had no idea what occurred. During a concurrent interview and record review on 2/5/2026 at 1:50 p.m. with the DPCS of Patient 9’s medical record, the DPCS stated that Patients 9’s plan of care dated 11/18/2024 to 1/12/2025 was created on 1/20/2025, after Patient 9 was discharged. The DPCS stated that he (DPCS) did not know what the visiting nurses were using to care for Patient 9. The DPCS stated that Patient 9 was at risk of receiving improper treatment, which can affect the patient’s condition, for example the wound getting worse. The DPCS stated Patient 9 needed a plan of care to be taken care of properly. During a concurrent interview and record review on 2/5/2026 at 2:44 p.m. with the CS1 of Patient 9’s medical record, CS1 stated that she (CS1) was not a Licensed Vocational Nurse or a Registered Nurse. CS1 stated that she (CS1) created Patient 9’s DC Summary on 2/3/2026. CS1 stated that she (CS1) completed the DC summary based on nurses’ documentation. CS1 stated she (CS1) asked RN3 to review the DC summary then sign it. CS1 stated that she (CS1) documented Patient 9’s DC Summary because she (CS1) followed instructions. 5. During a record review of Patient 10’s medical record form titled “Patient Information” undated, indicated a start of care date (SOC) of 8/29/2025 and an end of care date of 10/23/2025 with a primary diagnosis of hemothorax (accumulation of blood in the space between the chest wall and the lung). During a record review of Patient 10’s medical record form titled “Start of Care (SOC) Assessment” dated 8/29/2025, indicated it was electronically signed by the DPCS. During a record review of Patient 10’s medical record form titled “Document History – Start of Care Assessment” dated 8/29/2025, indicated it was created and submitted by RN1 on 10/3/2025. The form also indicated that S1 access Patient 10’s SOC Assessment from 10/10/2025 to 11/3/2025. Lastly, the form was resubmitted and approved on 2/3/2026 by the DPCS. During a record review on 2/5/2026 at 12:31 p.m. of Patient 10’s medical record form titled “Document History - Start of Care Assessment” dated 8/29/2025, indicated there were changes made to Patient 10’s SOC assessment by S1. RN1’s last entry made on 10/3/2025 was compared to the last entry made by S1 on 11/3/2025. The form Document History indicated that S1 made changes to the documented findings of RN1’s SOC Assessment for Patient 10. These are some of the changes made by S1: Mobility from 6 to 4Height from blank to 70Describe risk other memo from blank to “Traumatic pneumothorax, anxiety disorder, multiple fracture sitesDiscipline and frequency from blank to SN (skilled nurse), duration 9, duration period week(s), frequency 1, and frequency period week(s)Patient input into care goals from blank to “Pt verbalizes that he wants to get well soon”Patient input into care outcomes from blank to “Patient will have good response to all medications and have no exacerbation of disease processesPOC overall summary from blank to “Skilled assessment done….Prognosis from blank to “fair”Genitourinary amount and color from blank to "adequate and clearNew SN interventions performed from blank to “SN arrive at patients’ home…. During a record review of Patient 10’s medical record form titled “Discharge Assessment” dated 10/23/2025, indicated Patients 10 identification was verified by “response to name”. The form indicated Patient 10’s was verbally provided with a current medication list. The form assessed Patient 10’s mental status by having him (Patient 10) verbalize the current date and year and repeat spoken words. The form also indicated Patient 10 had limited range of motion to his (Patient 10) left arm. The form indicated Patient 10 had bowel sounds in four abdominal quadrants, capillary refill was less than 3 seconds, heart sounds were regular, pedal and peripheral pulses were strong, and visiting nurse utilized personal protective equipment during visit. Lastly, the form was electronically signed by Registered Nurse 1 (RN1). During a record review on 2/5/2026 at 1:17 p.m. of Patient 10’s medical record form titled “Document History – Discharge Assessment” dated 10/23/2025, indicated the form was created by the DPCS and submitted by RN1 on 2/3/2026. During a record review of Patient 10’s medical record form titled “Home Health Certification and Plan of Care” dated from 8/29/2025 to 10/27/2025, indicated it was not signed by a physician. During a concurrent interview and record review on 2/5/2026 at 1:03 p.m. with the DPCS of Patient 10’s medical record, the DPCS stated that he (DPCS) created and submitted Patient 10’s Discharge Assessment dated 10/23/2025 on 2/3/2026 based on Patient 10’s SOC Assessment dated 8/29/2025. The DPCS stated that he (DPCS) was aware that S1 changed RN1’s documentation of Patient 10’s SOC Assessment. During a concurrent interview and record review on 2/5/2026 at 1:05 p.m. with the DPCS of Patient 10’s medical record, the DPCS stated that RN1 was no longer working for the HHA. The DPCS stated that he (DPCS) used RN1’s electronic log in information to log into Patient 10’s medical record to be able to document Patient 10’s Discharge Assessment. The DPCS stated that he (DPCS) “usually ask the RNs for their log in information, to be able to sign when a signature is required. The DPCS stated that he (DPCS) was asked to complete patients’ documentation when he began his (DPCS) DPCS role. The DPCS stated that he (DPCS) should not have signed or completed patients notes because he (DPCS) did not visit the patients. The DPCS stated he (DPCS) did not know if Patient 10 was “ok” for discharge because he did not visit the patient. The DPCS stated that his (DPCS) signature indicated he approved Patient 10’s assessment. The DPCS stated that he was unaware that S1 was changing the nurse’s documentation. The DPCS stated that During a concurrent interview and record review on 2/5/2026 at 1:15 p.m. with the DPCS of Patient 10’s medical record, the DPCS stated that Patient 10’s Discharge Assessment was not valid because he (Patient 10) was not visited by HHA staff on 10/23/2025. The DPCS stated that the HHA had no choice but to discharge Patient 10 because Patient 10 did not answer his (Patient 10) phone. The DPCS stated that the proper thing to have done was to document a communication note stating that Patient 10 did not answer his (Patient 10) phone. During a record review of the HHA’s form titled, “Rights/Responsibilities” revised 11/2017, indicated “The completion of all assessments and care to be furnished, based on the comprehensive assessment. The organization shall ensure that the patient receives all services outlined in the plan of care.” During a record review of the HHA’s form titled, “Care Planning Process” revised 11/2017, indicated “A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days… At the time of the initial assessment, the clinician, along with the physician and other involved disciplines, will develop the patient plan of care based upon the patients’ identified needs and will review it with the patient and family/caregiver”. During a record review of the HHA’s form titled, “Physician Participation in Plan of Care” revised 11/2017, indicated “A physician will direct the care of every home health patient admitted for service…The attending physician will participate in the care planning process by reviewing and revising the plan of care (therapeutic and diagnostic orders). The care will be provided in compliance with his/her therapeutic and diagnostic orders and accepted standards and practice.” During a record review of the HHA’s form titled, “Reassessment/Recertification” revised 11/2017, indicated “The total plan of care must be renewed at least every 60 days, or more often as warranted by the condition of the patient.” During a record review of the HHA’s form titled, “Initial and Comprehensive Assessment” revised 11/2017, indicated “A comprehensive patient assessment will be completed within five (5) calendar days of the patient's start of care.” During a record review of the HHA’s form titled, “Verification of Physician Orders” revised 1/2006, indicated “Orders will be obtained from a licensed physician for care and services to be provided to home health patients. A qualified individual will review each order or prescription before care is provided. The original order will be delivered to the physician for his/her signature. Signed orders will be placed in the clinical record within 30 days of initiation of the order…” During a record review of the HHA’s form titled, “Discharge Planning” revised 11/2017, indicated “Patients will not be discharged without appropriate preparation. The patient's continuing care needs will be assessed on an ongoing basis, as well as at discharge. Information will be provided to assist the patient in planning his/her discharge, including referral and transfer.” During a record review of the HHA’s form titled, “Discharge Criteria and Process” revised 11/2017, indicated “An update to the comprehensive assessment, including required OASIS data elements, will be completed, as required by regulation. All discharge paperwork will be due in the office within 72 hours of the discharge date. This will include the discharge order, discharge summary, plan of care, medication profile, and OASIS.” During a record review of the HHA’s form titled, “Discharge Summary” revised 11/2017, indicated “Each patient discharged from a service and from the organization will have a written discharge summary filed in the clinical record. The discharge summary and other relevant clinical record documents will be completed and submitted within 72 hours of discharge from service. A copy of the discharge summary will be provided to the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the organization within five (5) business days of the patient's discharge. The organization will complete all necessary audits to determine completeness of the patient's clinical record within 30 days of the last home visit and discharge date. The, discharge record will be organized according to policy for clinical records contents and removed from the active file.” During a record review of the HHA’s form titled, “Entries into the Clinical Record” revised 11/2017, indicated “Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided. During a record review of the HHA’s form titled, “Safeguarding/Retrieval of Clinical Records” revised 11/2017, indicated “If electronic medical record computers/devices are utilized, access to information procedures should be followed. Safeguard procedures should be followed but not limited to: C. Passwords will not be shared with other persons.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on interview and record review, the (HHA – an organization that provides skilled nursing, therapeutic services and aide services directly to patients in their homes) failed to ensure patient care records were safeguarded against unauthorized use for four of ten sampled patients (Patient 6, Patient 7, Patient 9, and Patient 10). This failure resulted in records being modified by people not involved in the patients’ care. During an interview on 2/2/2026 at 1:10 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated the HHA uses subcontractors to complete patients’ care plans. The DPCS stated that a list is sent to the subcontractors of the patients that require plans of care. The DPCS stated that the “office” reviews, corrects, and finalize the plans of care received from the subcontractors. The DPCS stated that after finalizing the care plans, he (DPCS) asks the nurses to sign it. Plans of care are completed once the nurse reviews and signs it. During an interview on 2/4/2026 at 3:38 p.m. with Subcontractor 1 (S1), S1 stated that she (S1) was a registered nurse and has been contracted by the HHA since 2023 to assist with coding and developing patients’ plans of care. S1 stated Office Manager 1 (OM1) emails her (S1) a list of the patients that require plans of care to be drafted. S1 stated she logs into the HHAs electronic medical record (EMR) patients comprehensive nursing assessments and drafts a care plan with the information that is documented there. S1 stated that she (S1) does not sign the POC because she (S1) does not assess the patients. During an interview on 2/4/2026 at 3:45 p.m. with S1, S1 stated that she (S1) does not document or edit patients initial or recertification comprehensive nursing assessments because she (S1) was told not to and she (S1) did not feel comfortable editing them. S1 stated that the documentation of the patients’ comprehensive assessments was the admitting nurses’ responsibility because the admitting nurse saw and assessed patients. During an interview on 2/4/2026 at 3:53 p.m. with S1, S1 was made aware of patients document history function in the HHAs’ EMR. S1 stated that she (S1) has not shared her (S1) EMR log in information with anyone. S1 stated that the HHA never asked her (S1) to change any documentation. S1 stated that she (S1) does not remember if she (S1) decided to change patients comprehensive nursing assessments. S1 stated that if the EMR’s document history indicated that she (S1) changed patients’ comprehensive assessments, she (S1) does not remember. S1 stated, “If the system says that I changed it, then what can I say.” During an interview on 2/5/2026 at 12:35 p.m. with the DPCS, the DPCS stated that the Subcontractor 1 (S1) was a registered nurse hired as a contractor to complete patients plans of care and coding. The DPCS stated that S1 was not allowed to make changes to comprehensive nursing assessments. 1. During a record review of Patient 6’s medical record form titled “Patient Information” undated, indicated a start of care date (SOC) of 10/23/2025 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During a record review on 2/4/2026 at 3:27 p.m. of Patient 6’s medical record form titled “Start of Care (SOC) Assessment” dated 10/23/2025, indicated Registered Nurse 3 (RN3) had Patient 6’s SOC assessment in progress on 10/24/2025. The form also indicated the Subcontractor 1 (S1) had Patient 6’s SOC assessment in progress from 10/30/2025 till 11/4/2025. Patient 6’s SOC assessment was submitted by RN3 on 11/17/2025. Patient 6’s SOC assessment was approved by the Director of Patient Care Services (DPCS) on 11/17/2025. During a record review on 2/4/2026 at 3:17 p.m. of Patient 6’s medical record form titled “Document History – Start of Care Assessment” dated 10/23/2025, the record indicated there were changes made to Patient 6’s SOC assessment by S1. RN3’s last entry made on 10/24/2025 was compared to the last entry made by S1 on 11/4/2025. The form Document History indicated that S1 made changes to the documented findings of RN3 SOC Assessment of Patient 6. These are some of the changes made by S1: Grooming from 1 to 2. Ability to dress upper body safely from 1 to 2. Ability to dress lower body safely from 1 to 2. Bathing from 1 to 3. Toileting from 1 to 2. Transferring from 1 to 2. Ambulating from 1 to 2. Mobility from 5 to 4. Primary diagnosis with severity from blank to 3. Risk for hospitalization from 0 to 1 – describe risk multiple medications check box. Risk for hospitalization from 0 to 1 – describe risk other check box from 0 to 1. Risk for hospitalization from blank to “presence of open wound, breast cancer. Discipline and frequency from blank to SN (skilled nurse), duration 2, duration period week(s), frequency 1, and frequency period week(s). Pain comments from blank to no pain during this visit. Pain medication from 0 to 1. Pain reducing method from 0 to 1. Verbalizes understanding from 0 to 1. Pain Regimen: frequency used from blank to take one tablet by mouth every 6 hours. Pain med from blank to acetaminophen (pain medication) 500 milligrams (unit dose measurement) oral tablet. Activities permitted – permitted care from 1 to 0. Permitted exercise from 0 to 1. Place holder for medication profile from blank to “acetaminophen…. Ibuprofen…. Metoprolol…. Tramadol…Vitamin D3…. Whole Mega Fish oil…” Nutritional status prescribed diet from blank to Low salt and low fat. SN interventions Performed: S1 added Patient 6’s wound treatment order which was not documented by RN3. During a record review of Patient 6’s medical record form titled “Recertification Assessment” dated 12/21/2025, the record indicated the form was not complete and the authors name or signature were not documented. During a record review of Patients 6’s medical record form titled “Document History – Recertification Assessment” dated 12/21/2025, the record indicated Registered Nurse 3 (RN3) was assigned and schedule to assess Patient 6 on 12/21/2025. The form also indicated that the Director of Patient Care Services (DPCS) was the only clinician that documented Patient 6’s form on 12/31/2025. 2. During a record review of Patient 7’s medical record form titled “Patient Information” undated, indicated a start of care date (SOC) of 11/18/2024 with a primary diagnosis of type 2 diabetes mellitus (high blood sugar resulting from the body’s inability to produce and/or properly use insulin) with foot ulcer (an open sore or wound on the foot that fails to heal). During a record review of Patient 7’s medical record form titled “Recertification Assessment” dated 1/13/2026, the record indicated Patient 7's date of assessment was on 1/13/2026. A record review of Patient 7’s medical record form titled “Document History – Recertification Assessment” dated 1/11/2026, indicated that on 2/2/2026 the Office Manager 1 (OM1) logged into Patient 7’s medical record and changed the assessment date from 1/13/2026 to 1/11/2026. During a concurrent interview and record review on 2/4/2026 at 1:45 p.m. with OM1 of Patient 7’s medical record, OM1 stated that she (OM1) logged into Patient 7’s medical record and changed the assessment date from 1/13/2026 to 1/11/2026, due to payroll reasons. OM1 stated that it would not be a problem to log back in and change it back once payroll is completed. During a record review of Patient 7’s medical record form titled “Physician Certification of Face-to-Face Encounter” dated from 11/18/2024 to 1/16/2025, the record indicated the form was blank and had the Medical Doctor 2 (MD2) signature dated on 3/24/2025. The form also indicated Patient 7’s primary physician’s (MD1) name was listed but it was crossed out. During a concurrent interview and record review on 2/6/2026 at 12:25 p.m. with the DPCS of Patient 7’s medical record, the DPCS stated that there was a face-to-face report dated from 11/18/2024 to 1/16/2025, that was signed by a physician, but the form was left blank. The DPCS stated he (DPCS) did not know why the form was blank. The DPCS stated that the physician who signed the form should have filled it out before signing it. The DPCS stated that anyone can document anything on the form. 3. During a record review of Patient 9’s undated “Patient Information” record, the record indicated a start of care date (SOC) of 11/14/2024 and an end of care date of 1/12/2025 with a primary diagnosis of hyperglycemia (high blood sugar) unspecified. During a record review of Patient 9’s medical record form titled “Start of Care (SOC) Assessment” dated 11/14/2024, the record indicated Patient 9’s primary diagnosis was type 2 diabetes mellitus with foot ulcer. The form did not indicate the author’s name. During a record review on 2/5/2026 at 11:53 a.m. of Patient 9’s medical record form titled “Document History – Start of Care Assessment” dated 11/14/2024, the record indicated RN3 created the document on 11/15/2024 and submitted on 11/29/2024. The form also indicated that the Subcontractor (S1) accessed Patient 9’s Start of Care Assessment form from 12/11/2024 to 12/31/2024. Lastly, the form indicated the Clinical Supervisor/Intake Review (CS1) accessed Patient 9’s Start of Care Assessment form on 2/3/2026. During a record review on 2/5/2026 at 11:57 a.m. of Patient 9’s medical record form titled “Document History”, indicated there were changes made to Patient 9’s SOC assessment by S1. RN3’s last entry made on 11/29/2024 was compared to the last entry made by S1 on 12/31/2024. The form Document History indicated that S1 made changes to the documented findings of RN3 SOC Assessment for Patient 9. These are some of the changes made by S1: Ambulating from 1 to 2. Primary diagnosis with severity from blank to 3. Describe risk multiple medications check box from 0 to 1. Describe risk significant infection from 0 to 1. Diabetes management FSBS (fasting blood sugar) from 0 to 1. Diabetes management FSBS Memo from blank to “110-250 mg/dl.” Diabetes management Glucometer from 0 to 1. Diabetes management knowledge deficit from 0 to 1. Diabetes management knowledge deficit Memo “disease process.” Diabetes management Manifestations from 0 to 1. Diabetes management Manifestations Type Other from 0 to 1. Diabetes management Manifestations Type Other Memo from blank to “Diabetic foot ulcer.” Discipline and frequency from blank to SN (skilled nurse), duration 1, duration period week(s), frequency 1, and frequency period week(s). Patient Category Risk Disaster from “low risk or Low priority” to Medium Risk or Medium priority. Prognosis from good to fair. During a concurrent interview and record review on 2/5/2026 at 1:37 p.m. with the DPCS of Patient 9’s medical record, the DPCS stated that S1 made changes to RN3’s documentation on Patient 9’s Start of Care Assessment. The DPCS stated that S1 did not visit or assess Patient 9, therefore, she (S1) should not be making any changes to the document. During a record review of Patient 9’s medical record form titled “SN (skilled nurse) DC (discharge) Summary” dated 1/12/2025, the record indicated Patient 9 was discharged from the HHA on 1/12/2025 due to “no further authorized visits”. During a record review of Patient 9’s medical record form titled “Discharge Assessment” dated 1/12/2025, the assessment indicated the form was not complete. The Discharge Assessment had no vital signs or wound assessments documented. The Discharge Assessment also indicated Patient 9 had clear lung sounds, regular heart sounds, strong peripheral and pedal pulses, good skin turgor, and dry/warm skin. Patient 9’s Discharge Assessment indicated Patient 9 was informed on DC (discharge) plans, patient rights and responsibilities, medication schedule, emergency plan, state or county hotline. Patient 9’s Discharge Assessment indicated Patient 9’s wound is healing and caregiver able to manage wound care. Patient 9’s Discharge Assessment indicated Patient 9 was provided with discharge instructions. Lastly, Patient 9’s Discharge Assessment indicated it was electronically signed by RN3. During a record review on 2/5/2026 at 11:49 a.m. of Patient 9’s medical record form titled “Document History – Discharge Assessment” dated 1/12/2025, the record indicated Clinical Supervisor/Intake Review (CS1) created the document on 2/3/2026. During a concurrent interview and record review on 2/5/2026 at 2:44 p.m. with the CS1 of Patient 9’s medical record, CS1 stated that she (CS1) was not a Licensed Vocational Nurse or a Registered Nurse. CS1 stated that she (CS1) created Patient 9’s DC assessment and summary on 2/3/2026. CS1 stated that she (CS1) completed the DC assessment and summary based on nurses’ documentation. CS1 stated she (CS1) asked RN3 to review the DC assessment and summary then sign it. CS1 stated that she (CS1) documented Patient 9’s DC assessment and summary because she (CS1) followed instructions. 4. During a record review of Patient 10’s medical record form titled “Patient Information” undated, indicated a start of care date (SOC) of 8/29/2025 and an end of care date of 10/23/2025 with a primary diagnosis of hemothorax (accumulation of blood in the space between the chest wall and the lung). During a record review of Patient 10’s medical record form titled “Start of Care (SOC) Assessment” dated 8/29/2025, the record indicated it was electronically signed by the DPCS. During a record review of Patient 10’s medical record form titled “Document History – Start of Care Assessment” dated 8/29/2025, the record indicated it was created and submitted by RN1 on 10/3/2025. The form also indicated that S1 access Patient 10’s SOC Assessment from 10/10/2025 to 11/3/2025. Lastly, the form was resubmitted and approved on 2/3/2026 by the DPCS. During a record review on 2/5/2026 at 12:31 p.m. of Patient 10’s medical record form titled “Document History - Start of Care Assessment” dated 8/29/2025, the record indicated there were changes made to Patient 10’s SOC assessment by S1. RN1’s last entry made on 10/3/2025 was compared to the last entry made by S1 on 11/3/2025. The form Document History indicated that S1 made changes to the documented findings of RN1’s SOC Assessment for Patient 10. These are some of the changes made by S1: Mobility from 6 to 4. Height from blank to 70. Describe risk other memo from blank to “Traumatic pneumothorax, anxiety disorder, multiple fracture sites. Discipline and frequency from blank to SN (skilled nurse), duration 9, duration period week(s), frequency 1, and frequency period week(s). Patient input into care goals from blank to “Pt verbalizes that he wants to get well soon.” Patient input into care outcomes from blank to “Patient will have good response to all medications and have no exacerbation of disease processes. POC overall summary from blank to “Skilled assessment done... Prognosis from blank to “fair.” Genitourinary amount and color from blank to "adequate and clear . New SN interventions performed from blank to “SN arrive at patients’ home… During a record review of Patient 10’s medical record form titled “Discharge Assessment” dated 10/23/2025, the assessment indicated Patient 10's identification was verified by “response to name.” The form indicated Patient 10’s was verbally provided with a current medication list. The form assessed Patient 10’s mental status by having him (Patient 10) verbalize the current date and year and repeat spoken words. The form also indicated Patient 10 had limited range of motion to his (Patient 10) left arm. The form indicated Patient 10 had bowel sounds in four abdominal quadrants, capillary refill was less than 3 seconds, heart sounds were regular, pedal and peripheral pulses were strong, and visiting nurse utilized personal protective equipment during visit. Lastly, the form was electronically signed by Registered Nurse 1 (RN1). During a record review on 2/5/2026 at 1:17 p.m. of Patient 10’s medical record form titled “Document History – Discharge Assessment” dated 10/23/2025, the record indicated the form was created by the DPCS and submitted by RN1 on 2/3/2026. During a concurrent interview and record review on 2/5/2026 at 1:03 p.m. with the DPCS of Patient 10’s medical record, the DPCS stated that he (DPCS) created and submitted Patient 10’s Discharge Assessment dated 10/23/2025 on 2/3/2026 based on Patient 10’s SOC Assessment dated 8/29/2025. The DPCS stated that he (DPCS) was aware that S1 changed RN1’s documentation of Patient 10’s SOC Assessment. During a concurrent interview and record review on 2/5/2026 at 1:05 p.m. with the DPCS of Patient 10’s medical record, the DPCS stated that RN1 was no longer working for the HHA. The DPCS stated that he (DPCS) used RN1’s electronic log in information to log into Patient 10’s medical record to be able to document Patient 10’s Discharge Assessment. The DPCS stated that he (DPCS) “usually ask the RNs for their log in information, to be able to sign when a signature is required. The DPCS stated that he (DPCS) was asked to complete patients’ documentation when he began his DPCS role. The DPCS stated that he should not have signed or completed patients notes because he did not visit the patients. The DPCS stated he (DPCS) did not know if Patient 10 was “ok” for discharge because he did not visit the patient. The DPCS stated that his (DPCS) signature indicated he approved Patient 10’s assessment. The DPCS stated that he was unaware that S1 was changing the nurse’s documentation. During a concurrent interview and record review on 2/5/2026 at 1:15 p.m. with the DPCS of Patient 10’s medical record, the DPCS stated that Patient 10’s Discharge Assessment was not valid because he (Patient 10) was not visited by HHA staff on 10/23/2025. The DPCS stated that the HHA had no choice but to discharge Patient 10 because Patient 10 did not answer his (Patient 10) phone. The DPCS stated that the proper thing to have done was to document a communication note stating that Patient 10 did not answer his (Patient 10) phone. During an interview on 2/6/2026 at 1:15 p.m. with the Administrator (ADM), the ADM stated that RN1 has not been assigned to any patients since 8/2025. A record review of the HHA’s policy titled, “Entries into the Clinical Record” revised 11/2017, indicated “Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided. During a record review of the HHA’s policy titled, “Safeguarding/Retrieval of Clinical Records” revised 11/2017, indicated “If electronic medical record computers/devices are utilized, access to information procedures should be followed. Safeguard procedures should be followed but not limited to: C. Passwords will not be shared with other persons.”

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey. Representing the California Department of Public Health: Surveyor ID: 44802, Health Facilities Evaluator, Nurse Surveyor ID: 36459, Health Facilities Evaluator, Nurse Unduplicated Admissions: 778 Active Patients: 158 Sample Size: 4 Home Visits: 2 The following Conditions of Participation (COPs) were not met: - 484.55 Comprehensive Assessment of Patients 484.60 Care Planning, Coordination, Quality of Care

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to ensure the Condition of Participation for Comprehensive Patient Assessment was met as follows: The Home Health Agency (HHA) failed to conduct an accurate comprehensive assessment that reflected the patient’s current health status. For Patient 1, the HHA did not conduct an assessment of the patient's the nutritional requirements to identify accurate diet. For Patient 2, the Registered Nurse 1 (RN 1) did not assess the actual location of the wound, that the Plan of Care (POC) indicated the patient wound was on the sacrum, the actual wound was on the left buttocks. This deficiency had the potential to result in lack of care and treatment, complication and hospitalization. (Refer to G526). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal regulations for Comprehensive Assessments of the Patients to ensure the highest quality of care. .

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to: 1) Ensure the nutrition requirements was assessed accurately to reflect the current diet required for one of four sampled patients (Patient 1). The deficient practice placed the patient at risk of not meeting the patient's nutritional needs. 2) Ensure the pressure ulcer (injuries to the skin due to prolong pressure on the skin) to the sacrum were assessed accurately to reflect current wound status for one of four sampled patients (Patient 2). This deficient practice placed the patient at risk for delayed wound healing on the wound sites resulting in severe complication and hospitalization. Findings: a. A review of Patient 1's Patient Information Sheet indicated a Start of Care (SOC) on 12/3/2023, with primary diagnosis of perforation (a hole that develops through the wall of a body organ) of intestine (nontraumatic) and other diagnoses of unspecified open wound of abdominal wall, unspecified quadrant without penetration into peritoneal cavity, and accidental discharge from unspecified firearms or gun. The Patient Information Sheet indicated in the Notes section, per hospital case manager, “No wound vac (Vacuum assisted closure, a negative-pressure wound therapy, is a therapeutic technique using a suction pump, tubing, and a dressing to remove excess exudate and promote healing in acute or chronic wounds and second- and third-degree burn frequency order but no change in wound vac dressing for the next seven to ten days once the patient discharges per physician order. A review of Patient 1’s General Acute Community Hospital (GACH 1) notes dated 12/1/2022 indicated Patient 1 was tolerating a liquid diet (a full liquid diet is made up only of fluids and foods that are normally liquid and foods that turn to liquid when they are at room temperature, like ice cream) and to stop total parenteral nutrition (the feeding of nutritional products to a person intravenously, bypassing the usual process of eating and digestion) once current bag is completed. The GACH note indicated plan for Patient 1 to be discharged on 12/2/2022 with home health nurse for wound care/wound vac and to discuss with wound are specialist regarding wound care instructions. A review of Patient 1’s Comprehensive Adult Nursing Assessment for Start of Care (SOC)/OASIS (Outcome and Assessment Information Set, a patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality), dated 12/3/2022, indicated the primary reason for home health admission was for abdominal surgery with wound vac and required RN for wound Vac management and for strength training due to generalized weakness. The assessment indicated that Patient 1 had no problem with nutritional status and that nutritional approaches (parenteral/IV feeding, feeding tube, mechanically altered diet) as not applicable. The assessment was signed by Licensed Vocational Nurse (LVN 2). A review of Patient 1's Plan of Care (POC)/485 for certification periods from 12/3/2022 to 1/31/2023 and from 2/1/2023 to 4/1/2023 included an order for the Skilled Nurse (SN) to visit once a week for the first week (of certification period). The POC indicated a regular diet and for the SN to teach regarding diet and medication regimen. A review of Patient 1’s OASIS Recertification, dated 1/31/2023, indicated in Section K-Nutritional status assessment was blank. A review of the GACH 1 notes, dated 2/13/2023, indicated Patient 1 was admitted with enterocutaneous fistula (enterocutaneous [EC] fistula is referred to as a channel between the gut and the skin) with high output (fecal matter, urine, or mucous of an EC fistula of more than 500 ml per day). A review of Patient 1's Physician order, dated 2/18/2023, indicated the patient was discharged and transferred to another HHA per patient's request. During an interview on 5/23/2023 at 1:30 pm, Medical Doctor (MD 1) stated he was the primary physician for Patient 1 and that Patient 1 was on a wound care program. MD 1 stated that the wound vac was changed by MD 3 (Patient 1’s surgeon) and the plan was for discharge from GAHC 1 with a liquid diet and follow up in ten days to determine if Patient 1’s abdominal wound can be closed with surgery or to wait and see if it will close on its own. MD 1 stated he was not aware of the wound care orders and that the HHA was to follow up with MD 3 for the wound care orders. MD 1 stated that if the HHA sends me a plan of care to sign, I will sign it. During an interview on 5/23/2023 at 1:25 pm, Registered Nurse (RN 2) stated that she performed the SOC assessment for Patient 1 and remembered the patient because he had a gunshot wound to the abdomen. RN 2 stated she receives a text or email message that she has a SOC and that the HHA provides her variety of paperwork, specific orders regarding the wound vac and the history and physical of the patient. RN 2 stated she always read the history and physical before she visits the patient for SOC. RN 2 stated, she could not remember the diet order for Patient 1 had. During an interview and record review with the Director of Patient Care Services (DPCS) on 5/23/2023 at 3:02 pm, GACH 1 notes were reviewed. The GACH 1 notes indicated for a liquid diet. When asked what kind of diet a patient with a perforated intestine should be given, the DPCS stated that his diet should be full liquid as it is in the history and physical. b. A review of Patient 2's Patient Information Sheet indicated a Start of Care (SOC) on 3/15/2023. A review of Patient 2’s GACH 2 notes, dated 11/29/2022, indicated that Patient 1 had an ongoing problem of a decubitus ulcer (bedsore) of the sacral region. A review of Patient 2’s Comprehensive Adult Nursing Assessment for Start of Care (SOC)/OASIS dated 3/16/2023, indicated that Patient 2’s Integumentary (skin) Status was no problem, and that Patient 2 did not have at least one unhealed pressure ulcer/injury at Stage 2 (pressure ulcer characterized by partial thickness loss of dermis presenting as a shallow open ulcer with a red-pink wound bed, without slough [dead tissue separating from living tissue]) or higher. The wound care indicated “not appliable”, that wound care was not during the visit and that the location of wound site was “left buttock known wound.” The assessment further indicated “left buttock with wound vac in place for change every three days.” The assessment of the wound indicated location as left buttock and type as other: non removable dressing. The assessment indicated that the primary diagnosis for admission was cerebral infarction and Type 2 DM. On 5/23/2023 at 10:00am, a home visit was conducted with License Vocation Nurse (LVN 2) at Patient 2’s home residence. Caregiver (CG 1) was present during the visit. Patient 2 was lying in a low air loss (LAL) bed (a mattress that helps keep the skin dry and wicks away any moisture), arms and legs contracted, and clean. CG 1 stated Patient 2 had a stroke in 1999. Patient 2 was nonverbal and made eye contact and was able to hold the rail of the bed when turned for wound care to the sacrum. LVN 2 performed wound care to Patient 2’s sacrum. LVN 2 bridged the dressing from the sacral wound and to the side of Patient 2’s left buttock and attached the wound vac. LVN 2 stated, the patient's POC indicated the wound was on Patient 2’s left buttock. LVN 2 stated that the Registered Nurse (RN) did the admission and the LVNs followed up treatment and the nurse probably checked the dressing but did not remove the dressing to check the wound. LVN 2 stated that it may have looked like it was on the left buttock because the dressing was bridged from the sacrum to the left buttock. During an interview on 5/24/2023 at 1:03 pm, RN 1 stated that the HHA sent her information about the patients to be admitted and would perform an assessment. RN 1 stated, when a patient has a wound, she would conduct wound assessment, but if the wound has a non-removal dressing, she will not touch it and just write what was observed and document it on the notes. RN 1 stated she performs her assessment and reports back to the case manager. During an interview on 5/24/2023 at 2:12 pm, the DPCS stated, if there was an order for wound care, the nurse has to perform the wound treatment during the home visit. The DPCS stated, the nurse who went to do the SOC of the patient should have checked the site to ensure the correct location. The DPCS stated, the HHA provides the RNs who perform the SOC with instructions on the face sheet and the history and physical (H & P) of the patient. The DPCS stated that RN 1 has to document the wound location as sacral as it was described in Patient 2’s H & P. A review of the HHA’s policy, “Initial Comprehensive Assessment,” dated 10/2011, indicated that during initial and comprehensive patient assessments, all baseline data to be used in measuring the patient’s progress toward goals and other relevant information will be documented in the patient’s clinical record, including at lease t the following information, if applicable….a physical assessment, including blood pressure, temperature, pulse, respiration, skin, pain status, approximate height/weight, nutritional status, and other relevant data related to pertinent physical findings.

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 observation, interview, and record review the Home Health Agency (HHA) failed to review and document all the medications changes for one of four sampled patients (Patients 3). The deficient practice had the potential to result in placing the patients at risk for drug interactions, adverse actions, and medication errors that could affect the patient's already compromised health status. Findings: A review of Patient 3's clinical record indicated a start of care date (SOC) of 03/14/2023, with diagnosis of cellulitis (bacterial skin infection that causes redness, swelling and pain in the infected area of the skin) and type two diabetes mellitus (disease in which there is a high level of sugar in the blood). A review of Patient 3's Plan of Care (POC) for the certification period of 05/13/2023 to 07/11/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient two times a week for nine weeks. On 05/23/2023, at 11:05 a.m., a joint home visit with the Licensed Vocational Nurse (LVN 1) was conducted at Patient 3’s residence. A review of Patient 3’s Medication Profile provided by the agency, did not indicated that patient was taking Tylenol for pain medication. During an interview with Patient 3 on 05/23/2023 at 11:30 a.m., he stated that he takes Tylenol 400 milligrams as needed for pain. Patient 3 further stated that he takes two tablets of Tylenol whenever he has to go visit the doctor. During an interview with the Director of Patient Care Services (DPCS) on 05/24/2023 at 2:40 p.m., she stated that every medication that a patient is taking should be on the medication profile. DPCS further stated that medication reconciliation should be done every visit. A review of the agency’s policy and procedure titled “Medication Profile,” dated 11/2017, indicated that patients receiving medications will have a current, accurate medication profile in the clinical record. The policy and procedure further indicated that medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on interview, and record review, the hospice agency failed to ensure that the Condition of Participation regarding Care Planning, coordination and quality of care was met as follows: 1) The hospice agency failed to follow the plan of care (POC) to two of four sampled patients (Patient 3 and 4). For Patient 3, the patient’s blood sugar was not checked. For Patient 4, the wound care was not performed as ordered. (Refer to G572) 2) The hospice agency failed to obtain and follow a physician order for the wound treatment for three of four sampled patients (Patient 1, 2 and 3). For Patient 1, there was no physician order to change the pressure setting of the Wound Vac (Vacuum assisted closure, a negative-pressure wound therapy, is a therapeutic technique using a suction pump, tubing, and a dressing to remove excess exudate and promote healing in acute or chronic wounds and second- and third-degree burns) from 125 mmHg to 100 mmHg and when to begin wound dressing change. For Patient 2, there was no physician order to perform wound care to the sacrum. For Patient 4, wound care treatment was not followed per doctor's order (Refer G0580). The cumulative effect of these systemic practices resulted in the agencies failure to ensure the plan of care was followed to reach patient's goals. .

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 interview and record review, the home health agency (HHA) failed to follow the plan of care (POC) for two of seven sampled patients (Patient 3 and 4). This deficient practices resulted in the patient not receiving the quality of care and services identified in the POC. a. A review of Patient 3's clinical record indicated a start of care date (SOC) of 03/14/2023, with diagnosis of cellulitis (bacterial skin infection that causes redness, swelling and pain in the infected area of the skin) and type two diabetes mellitus (disease in which there is a high level of sugar in the blood). A review of Patient 3's Plan of Care (POC) for the certification period of 03/14/2023 to 05/12/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient two times a week for eight weeks and three times a week for one week. Patient 3’s POC further indicated that SN to check blood sugar using patient’s own glucometer on each skilled nurse visit. A review of Patient 3's Plan of Care (POC) for the certification period of 05/13/2023 to 07/11/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient two times a week for nine weeks. Patient 3’s POC further indicated that SN to check blood sugar using patient’s own glucometer on each skilled nurse visit. A review of Patient 3’s Skilled Nursing Clinical Notes for the certification period of 03/14/2023 to 05/12/2023 and 05/13/2023 to 07/11/2023, indicated that there was no documentation that the blood sugar was checked during skilled nurse visits. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 05/24/2023 at 1:50 p.m., she stated that since the POC indicated that blood sugar should be checked then the nurse should have checked the blood sugar and documented on the notes. b. A review of Patient 4's clinical record indicated a start of care date (SOC) of 12/10/2022, with diagnosis of paraplegia (inability to voluntarily move the lower parts of the body) and cellulitis (bacterial skin infection that causes redness, swelling and pain in the infected area of the skin). A review of Patient 4's Plan of Care (POC) for the certification period of 04/06/2023 to 06/04/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient every other day for 60 days or until MD (Medical Doctor) further order. POC further indicated that SN to perform/demonstrate wound care to the right gluteal using aseptic technique, cleanse with normal saline, pat dry, pack with foam, then cover with transparent dressing and set wound vacuum to 125 mmHG continuously and change dressing every other day and as needed if dislodged or with malfunction. A review of Patient 3’s Skilled Nursing Clinical Notes for the certification period of 04/06/2023 to 06/04/2023, indicated that the skilled nurses documented two different wound locations, the sacral area and above the scrotum which does not reflect the location indicated in the POC for wound care. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 05/24/2023 at 1:50 p.m., she stated that wound documentation should be accurate and precise and should match the plan of care. DPCS further stated that any changes to the wound should be reported to the physician and documented. A review of the agency’s policy and procedure titled “Care Planning Process,” dated 10/2011, indicated that the purpose of the policy and procedure is to provide clinical direction to the clinicians providing direct patient care.

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 observation, interview and record review, the home health agency (HHA) failed to obtain and follow a physician's order for the wound treatment of three of four sampled patients (Patient 1, 2 and 4). This deficient practice had the potential for performing a treatment on the patients' wound without a physician’s order which could result in ineffective wound treatment and delay in wound healing. c. A review of Patient 4's clinical record indicated a start of care date (SOC) of 12/10/2022, with diagnosis of paraplegia (inability to voluntarily move the lower parts of the body) and cellulitis (bacterial skin infection that causes redness, swelling and pain in the infected area of the skin). A review of Patient 4's Plan of Care (POC) for the certification period of 12/12/2023 to 02/09/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient three times a week for nine weeks. POC further indicated that SN to perform/demonstrate wound care to the right gluteal using aseptic technique, cleanse with normal saline, pat dry, pack with foam, then cover with transparent dressing and set wound vacuum to 125 mmHG continuously and change dressing every 72 hours and as needed if dislodged or with malfunction. A review of Patient 4's Plan of Care (POC) for the certification period of 02/05/2023 to 04/05/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient every other day for 60 days or until MD (Medical Doctor) further order. POC further indicated that SN to perform/demonstrate wound care to the right gluteal using aseptic technique, cleanse with normal saline, pat dry, pack with foam, then cover with transparent dressing and set wound vacuum to 125 mmHG continuously and change dressing every other day and as needed if dislodged or with malfunction. A review of Patient 4's Plan of Care (POC) for the certification period of 04/06/2023 to 06/04/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient every other day for 60 days or until MD (Medical Doctor) further order. POC further indicated that SN to perform/demonstrate wound care to the right gluteal using aseptic technique, cleanse with normal saline, pat dry, pack with foam, then cover with transparent dressing and set wound vacuum to 125 mmHG continuously and change dressing every other day and as needed if dislodged or with malfunction. A review of Patient 4’s wound vac order from the general acute care hospital (GACH) dated 12/08/2023, indicated to cleanse with normal saline, pat dry, apply sure prep barrier to periwound and bridge area, apply adaptic oil-emulsion dressing to wound bed, fill out wound cavity with KCI black granufoam then bridge to right anterior thigh, seal with transparent drape, apply T.RA.C. pad and apply 125 mmHg low continuous suction. A review of Patient 4’s Doctor’s Order dated 12/09/2023 at 12:52 p.m., indicated an order for SN for wound vac care/management. A review of patient 4’s Doctor’s Order dated 01/21/2023, indicated an order for SN for negative pressure wound therapy to left perineum, cleanse with normal saline, pat dry with gauze, paint peri wound with cavilon skin barrier wipe, let dry, apply foam dressing and change canister every week and as needed, dislodgement or malfunction. A review of Patient 4’s V.A.C. Therapy Insurance Authorization Form dated 12/09/2023, indicated that KCI V.A.C. Therapy was prescribed for four months. The V.A.C. Therapy Insurance Authorization Form further indicated that on section 3 for supplies for delivery oil emulsion gauze adaptic was requested. A review of Patient 4’s Plan of Care (POC) for the certification period of 12/12/2023 to 02/09/2023, 02/05/2023 to 04/05/2023 and 04/06/2023 to 06/04/2023 did not include oil emulsion gauze adaptic to be used during wound care. A review of Patient 4’s Skilled Nursing Clinical Notes for the certification period of 12/12/2023 to 02/09/2023, 02/05/2023 to 04/05/2023 and 04/06/2023 to 06/04/2023 indicated that the skilled nurses did not indicate if oil emulsion gauze adaptic was used during wound care. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 05/24/2023 at 1:50 p.m., she stated that Patient 4’s wound vac order from the hospital that includes adaptic should have been what was on the plan of care during the start of care. DPCS further stated that Patient 4’s wound care should have included adaptic and that there was no other order to discontinue adaptic. DPCS further stated that the nurse should documents on the skilled nursing notes step by step on what was done during wound care and that Patient 4’s nursing notes did not indicate if adaptic was used during wound treatment. Findings: a. A review of Patient 1's Patient Information Sheet indicated a Start of Care (SOC) on 12/3/2022, with primary diagnosis of perforation (a hole that develops through the wall of a body organ) of intestine (nontraumatic) and other diagnoses of unspecified open wound of abdominal wall, unspecified quadrant without penetration into peritoneal cavity, and accidental discharge from unspecified firearms or gun. The Patient Information Sheet indicated in the Notes section, per hospital case manager, “No wound vac (Vacuum assisted closure, a negative-pressure wound therapy, is a therapeutic technique using a suction pump, tubing, and a dressing to remove excess exudate and promote healing in acute or chronic wounds and second- and third-degree burns) frequency order but no change in wound vac dressing for the next seven to ten days once the patient discharges per physician order. A review of Patient 1’s General Acute Community Hospital (GACH) notes dated 12/1/2022 indicated Patient 1 was tolerating a liquid diet (a full liquid diet is made up only of fluids and foods that are normally liquid and foods that turn to liquid when they are at room temperature, like ice cream) and to stop total parenteral nutrition (the feeding of nutritional products to a person intravenously, bypassing the usual process of eating and digestion) once current bag is completed. The GACH note indicated plan for Patient 1 to be discharged on 12/2/2022 with home health nurse for wound care/wound vac and to discuss with wound are specialist regarding wound care instructions. A review of Patient 1’s Physician order, dated 12/2/2022, indicated to monitor wound vac, not to change dressing, 125mmHg continuous (wound vac pressure) and okay to change canister. A review of Patient 1's Plan of Care (POC)/485 for certification periods from 12/3/2022 to 1/31/2023 and from 2/1/2023 to 4/1/2023 included an order for the Skilled Nurse (SN) to visit once a week for the first week (of certification period) and then twice a week to perform/demonstrate the following procedures: to Patient 1’s mid-abdominal area (surgical wound) to use aseptic technique, cleanse with normal saline, pat dry, pack with foam, then cover with transparent dressing and set wound vacuum to 100 mmHg continuously and change dressing every 72 hours and as needed if dislodged or malfunction. The POC indicated a regular diet and for the SN to teach regarding diet and medication regimen. A review of the Patient 1’s clinical record did not indicate a physician order to change the wound vac pressure from 125 mmHg to 100 mmHg or when to perform wound care on the patient. A review of Patient 1’s SN notes dated 12/13/2022 indicated that wound care was provided following physician order: cleanse wound with normal saline, pat dry and place adaptic (a non-adhering dressing that protects the wound and minimizes pain and maceration [when your skin is broken down by moisture on a cellular level and becomes prone to infection]), then foam directly on wound then cover with a clear film that seals to the skin around the wound and insert a tube into a small opening in the clear film and connect the other end to a vacuum pump at a rate of 100 millimeters (mm) of Mercury (Hg). A review of Patient 1’s SN note dated 12/17/2022, 12/20/2022, 12/23/2022 indicated that Patient 1’s surgical wound, mid abdomen with moderate bloody drainage, and no signs and symptoms of infection noted. The note indicated that wound care was provided following physician order: cleanse wound with normal saline, pat dry, protect surrounding tissue with plastic drape, then apply black foam, pack lightly, then seal with clear plastic drape, and connect to wound vac at 100 mmHg continuous. LVN 1 signed the SN notes. A review of Patient 1’s unsigned Physician Order, dated 12/26/2022 indicated for the Skilled nurse to perform/demonstrate the following procedures: Site: Mid-abdominal area (surgical wound) Wound care: Using aseptic technique, cleanse with normal saline, pat dry, protect surrounding tissue with plastic drape, then apply Adaptec and black foam, pack lightly, then seal with plastic drape, connect to wound vac 100mmHg continuously and change dressing every 72 hours and as needed if dislodged or with malfunction. May use wet or dry dressing; use sterile normal saline solution (NSS) and gauze, as needed for Vac malfunction or therapeutic pause. Change every day. Teach patient/caregiver to change wet to dry dressing. The order did not have a physician signature. A review of Patient 1’s SN notes during certification period 12/3/2022 to 1/31/2023 (12/26/2022, 1/3/2022, 1/6/2022, 1/12/2023, 1/16/2023, 1/21/2023, 1/24/2023, 1/27/2023, 1/30/2023) indicated that Patient 1’s surgical wound, mid abdomen with moderate bloody drainage, and no signs and symptoms of infection noted. The note indicated that wound care was provided following physician order: cleanse wound with normal saline, pat dry, protect surrounding tissue with plastic drape, then apply adaptic and black foam, pack lightly, then seal with clear plastic drape, and connect to wound vac at 100 mmHg continuous. A review of Patient 1’s SN notes during certification period 2/1/2023 to 4/1/2023 (2/2/2023 and 2/10/2023) indicated that Patient 1’s surgical wound, mid abdomen with moderate bloody drainage, and no signs and symptoms of infection noted. The note indicated that wound care was provided following physician order: cleanse wound with normal saline, pat dry, protect surrounding tissue with plastic drape, then apply adaptic and black foam, pack lightly, then seal with clear plastic drape, and connect to wound vac at 100 mmHg continuous. A review of Patient 1’s unsigned Physician order dated 2/2/2023, indicated for the Skilled nurse to perform/demonstrate the following procedures: Site: Mid-abdominal area (surgical wound) Wound care: Using aseptic technique, cleanse with normal saline, pat dry, protect surrounding tissue with plastic drape, then apply adaptic and black foam, pack lightly, then seal with plastic drape, connect to wound vac 100mmHg continuously and change dressing every 72 hours and as needed if dislodged or with malfunction. May use wet or dry dressing; use sterile normal saline solution (NSS) and gauze, as needed for Vac malfunction or therapeutic pause. Change every day. Teach patient/caregiver to change wet to dry dressing. The order did not have a physician signature. A review of Patient 1’s clinical records indicated there was no order clarification regarding the modification of the wound vac pressure from the start of care on 12/3/2022 to from 125 mmHg to 100 mmHg and the initial wound care treatment order performed on 12/13/2022. A review of Patient 1's SN note dated 2/13/2023, indicated that wound vac dressing was removed, mid abdomen with moderate bloody drainage and that SN noticed feces being discharged to the wound site. The SN note indicated that Patient was instructed to go to the Emergency Room (ER) for further management. SN applied wet to dry dressing to wound and secured with tape. A review of the GACH 1 notes, dated 2/13/2023, indicated Patient 1 was admitted with enterocutaneous fistula (enterocutaneous [EC] fistula is referred to as a channel between the gut and the skin) with high output (fecal matter, urine, or mucous of an EC fistula of more than 500 ml per day). A review of Patient 1's Physician order, dated 2/18/2023, indicated the patient was discharged and transferred to another HHA per patient's request. During an interview on 5/23/2023 at 1:30 pm, Medical Doctor (MD 1) stated he was the primary physician for Patient 1 and that Patient 1 was on a wound care program. MD 1 stated he was not aware of the Patient 1’s wound care orders and that the HHA was to follow up with MD 3 for the wound care orders. MD 1 stated that if the HHA sends me a plan of care to sign, I will sign it. During an interview on 5/24/2023 at 11:40 pm, Patient 1 stated that LVN 1 put the black foam directly on his wound, pulled it and it ripped his intestine. Patient 1 stated LVN 1 was doing the wound care correctly in the beginning of his care but then it changed. Patient 1 stated that LVN 1 did not put a patch on top of the wound to protect it from the black foam. Patient 1 stated that only the nurse performed his wound care and that he always waited for the nurse and never changed it by himself. Patient 1 stated LVN 1 never taught us how to do any dressing change and that MD 3 did not want him to touch the wound. During an interview on 5/24/2023 at 1:59 pm, the Director of Patient Care Services (DPCS) stated that when the wound vac order is a standard order, the wound care is performed as followed, “using aseptic technique, cleanse with normal saline, pat dry, pack with foam, then cover with transparent dressing and set wound vacuum to 125 millimeters of mercury (mmHg) continuously and change dressing every 72 hours and as needed if dislodged or malfunction.” The DPCS stated that if there was a change to the standard order, the nurse should have made an addendum to the order. During an interview on 5/24/2023 at 4:14 pm, the DPCS stated that there was no written order to decrease the wound vacuum order from 125 mmHg to 100 mmHg and no order to indicate when to start the wound dressing change. The HHA was not able to provide the Patient 1’s orders dated 12/26/2022 and 2/2/2023 signed by the physician. b. A review of Patient 2's Patient Information Sheet indicated a Start of Care (SOC) on 3/15/2023. The information sheet included the following physician orders: Referral to home health services, please admit patient to HHA, skilled nursing evaluation, skilled nurse (SN) for wound care/management, and physical therapy evaluation. A review of Patient 2's Plan of Care (POC)/485 for certification period from 3/16/2023 to 5/14/2023 indicated a primary diagnosis of aphasia (difficulty communicating) following cerebral infarction (a result of disrupted blood flow to the brain due to problems with the blood vessels that supply it which can cause parts of the brain to die off) and other diagnoses of pressure ulcer of left buttock, encounter of change or removal of non-surgical wound dressing, and type 2 diabetes mellitus (DM, a chronic condition that affects the way the body processes blood sugar) without complications and included an order for the Skilled Nurse (SN) to visit twice a week. The POC indicated for the SN to perform/demonstrate the following procedures to Patient 1’s left buttocks using aseptic technique, cleanse with normal saline, pat dry, pack with foam, then cover with transparent dressing and set wound vacuum to “blank” millimeters of mercury (mmHg) continuously and change dressing every 72 hours and as needed if dislodged or malfunction. A review of Patient 2’s GACH 2 report, dated 11/29/2022, indicated that Patient 1 had an ongoing problem of a decubitus ulcer (bedsore) of the sacral region. A review of Patient 2’s wound care order, dated 3/22/2023 indicated that the order was for a pressure ulcer to the right sacral buttocks with instruction for Negative Pressure Wound Therapy to right sacral buttocks, three times a week with one additional visit as needed, set vacuum at 125 mmHg. The order was written by Case Manager (CM 1) and faxed to Patient 1’s physician (MD 2). On 5/23/2023 at 10:00am, a home visit was conducted with License Vocation Nurse (LVN 2) at Patient 2’s home residence. Caregiver (CG 1) was present during the visit. Patient 2 was lying in a low air loss (LAL) bed (a mattress that helps keep the skin dry and wicks away any moisture), arms and legs contracted, and clean. Patient 2 had Kerlex dressing (bandage rolls that provide wicking action, aeration and absorbency) wrapped around patient big toe of right foot and on left foot. CG 1 stated Patient 2 had a stroke in 1999. Patient 2 was nonverbal and made eye contact and was able to hold the rail of the bed when turned for wound care to the sacrum. LVN 2 performed wound care to Patient 2’s sacrum. LVN 2 bridged the dressing from the sacral wound to the side of Patient 2’s left buttock and attached the wound vac. When LVN 2 was asked why the POC stated the wound was on Patient 2’s left buttock, LVN 2 stated that the Registered Nurse (RN) does the admission and that the nurse probably checked the dressing but did not remove the dressing to check the wound. LVN 2 stated that it may have looked like it was on the left buttock because the dressing was bridged from the sacrum to the side of the left buttock. LVN 2 stated that the bridging prevents the patient from lying on the tubing and causing a pressure injury to the skin. During an interview on 5/24/2023 at 2:12 pm, the DPCS stated that if there was an order for wound care, the nurse who visited the patient should perform the wound treatment. The DPCS stated the nurse who went to do the SOC of the patient should have checked the site to ensure the correct location. The DPCS stated that the HHA provides the RNs who perform the SOC with instructions on the face sheet and the history and physical (H & P) of the patient. The DPCS stated that RN 1 should have documented the wound location as sacral as it was described in Patient 2’s H & P. During an interview on 5/24/2023 at 2:42 pm, the DPCS stated that the incorrect location of the wound was documented on the OASIS, the wound order by the CM and the POC incorrectly. The DPCS stated that it was important to know the right site of the wound to ensure that the nurse is performing the right treatment to the correct site and to ensure that the wound treatment is working or not. A review of the Patient 2’s clinical record did not indicate for an order to perform wound care to Patient 2’s sacrum. A review of the HHA’s policy, “Care Planning Process,” dated 10/2011 indicated that the plan of care will be based upon the physician’s (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies, and services required to meet the patient’s needs. A review of the HHA’s policy, “Care Coordination,” dated 11/2017, indicated that timely and ongoing communication is the responsibility of each team member of the interdisciplinary group, will be appropriate to the needs and abilities of the patient, and will be relevant to the care provided. The policy indicated that the clinicians will be responsible for facilitating communications about changes in the patient’s status among the assigned personnel. Documentation of all communications will be included in the clinical record on a communication note, case conference summary, or clinical note. The policy indicated that the documentation will include: the date and time of the communication, individuals involved with the communication, information discussed, and the outcome of the communication. A review of the HHA’s policy, “Verification of Physician Orders,” dated 1/2006 indicated that signed orders will be placed in the clinical record within 30 days of initiation of the order, unless otherwise specified by applicable state law and regulation.

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 interview and record review the home health agency (HHA) failed to employ qualified personnel by failing to ensure Licensed Vocational Nurse (LVN 1 and LVN 2) had a current competency review and LVN 2 had a performance evaluation on file. These failures have the potential risk for these patients not to receive quality of care and services provided by the unqualified personnel. Findings: a. A review of LVN 1 employee records indicated a date of hire on 5/27/2020. There was no current annual competency in the file. A review of LVN 1’s Pediatrics Skills Competency Checklist for Registered Nurse (RN)/ LVN was dated 5/27/2021. b. A review of LVN 2’s employee records indicated a date of hire on 11/15/2016. There was no current annual competency or performance evaluation in the file. A review of LVN 2’s Pediatrics Skills Competency Checklist for RN/ LVN was dated 11/15/2021. During an interview on 5/22/2022 at 2 pm., the Director of Patient Care Services (DPCS) stated that she and the Clinical Supervisor (CS 1) were responsible to perform the nurse’s performance evaluations and that they were performed annually. The DPCS stated that she was responsible for performing the skills competency annually and that the competency’s for LVN 1 and LVN 2 should have been for an adult skills competency and not a pediatrics skills competency. A review of the HHA’s policy, “Personnel Record Contents,” dated 11/2017 indicated that the content of the personnel files for regular full or part-time personnel will include: -performance evaluation and competency assessment for patient care staff.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to: 1) Document Patient 1's name correctly on the Skilled Nursing (SN) Clinical Note for one of four sampled patients (Patient 1). 2) Sign the Comprehensive Adult Assessment for two of four sampled patients (Patient 2 and 3) 3) Sign the SN Clinical Notes for three of four sampled patients (Patient 1, 2 and 4). This deficient practice placed the patient at a potential risk for not receiving skilled nursing care as needed. c. A review of Patient 3's clinical record indicated a start of care date (SOC) of 03/14/2023, with diagnosis of cellulitis (bacterial skin infection that causes redness, swelling and pain in the infected area of the skin) and type two diabetes mellitus (disease in which there is a high level of sugar in the blood). A review of Patient 3's Plan of Care (POC) for the certification period of 05/13/2023 to 07/11/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient two times a week for nine weeks. A review of Patient 3’s OASIS (Outcome and Assessment Information Set – a group of standard data elements home health agencies integrate into their comprehensive assessment) dated 03/14/2023, indicated that there was no name or signature of the nurse who completed the OASIS. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 05/24/2023 at 1:50 p.m., she stated that the OASIS should have the name of the nurse who completed the assessment and that it should be signed. d. A review of Patient 4's clinical record indicated a start of care date (SOC) of 12/10/2022, with diagnosis of paraplegia (inability to voluntarily move the lower parts of the body) and cellulitis (bacterial skin infection that causes redness, swelling and pain in the infected area of the skin). A review of Patient 4's Plan of Care (POC) for the certification period of 04/06/2023 to 06/04/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient every other day for 60 days or until MD (Medical Doctor) further order. A review of Patient 4’s Skilled Nursing Clinical Notes for the certification period of 04/16/2023 to 06/04/2023, indicated that there was no signature of the skilled nurse. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 05/24/2023 at 1:50 p.m., she stated that skilled nurse notes should be signed by the nurse. Findings: a. A review of Patient 1's Patient Information Sheet indicated a Start of Care (SOC) on 12/3/2023, with primary diagnosis of perforation (a hole that develops through the wall of a body organ) of intestine (nontraumatic) and other diagnoses of unspecified open wound of abdominal wall, unspecified quadrant without penetration into peritoneal cavity, and accidental discharge from unspecified firearms or gun. The Patient Information Sheet indicated in the Notes section, per hospital case manager, “No wound vac (Vacuum assisted closure, a negative-pressure wound therapy, is a therapeutic technique using a suction pump, tubing, and a dressing to remove excess exudate and promote healing in acute or chronic wounds and second- and third-degree burn frequency order but no change in wound vac dressing for the next seven to ten days once the patient discharges per physician order. A review of Patient 1's Plan of Care (POC)/485 for certification periods from 12/3/2022 to 1/31/2023 and from 2/1/2023 to 4/1/2023 included an order for the Skilled Nurse (SN) to visit once a week for the first week (of certification period) and then twice a week to perform/demonstrate the following procedures: to Patient 1’s mid-abdominal area (surgical wound) to use aseptic technique, cleanse with normal saline, pat dry, pack with foam, then cover with transparent dressing and set wound vacuum to 100 mmHg continuously and change dressing every 72 hours and as needed if dislodged or malfunction. The POC indicated a regular diet and for the SN to teach regarding diet and medication regimen. A review of Patient 1’s Skilled Nursing (SN) note dated 12/7/2022, indicated incorrect patient's name. The note was signed by Licensed Vocational Nurse (LVN 1). A review of Patient 1’s SN note dated 12/13/2022, indicated incorrect patient's name. The note was signed by LVN 1. b. A review of Patient 2's Patient Information Sheet indicated a Start of Care (SOC) on 3/15/2023 instead of 3/16/2023. A review of Patient 2's Plan of Care (POC)/485 for certification period from 3/16/2023 to 5/14/2023 indicated a primary diagnosis of aphasia (difficulty communicating) following cerebral infarction (a result of disrupted blood flow to the brain due to problems with the blood vessels that supply it which can cause parts of the brain to die off) and other diagnoses of pressure ulcer of left buttock, encounter of change or removal of non-surgical wound dressing, and type 2 diabetes mellitus (DM, a chronic condition that affects the way the body processes blood sugar) without complications and included an order for the Skilled Nurse (SN) to visit twice a week for the first week and then twice a week for one more week for evaluation and assessment of all body systems focusing on neurological and mental status related to aphasia (a disorder that affects how you communicate) following cerebral infarction, integumentary status related to stage 2 pressure ulcer of left buttock and encounter for change or removal of nonsurgical wound dressing. The SN was to assess the severity of the wound on the left buttocks area and its response to the current treatment, and signs and symptoms of infection. A review of Patient 2’s Comprehensive Adult Nursing Assessment for Start of Care (SOC)/OASIS dated 3/16/2023, indicated that Patient 2’s Integumentary (skin) Status was no problem, and that Patient 2 did not have at least one unhealed pressure ulcer/injury at Stage 2 (pressure ulcer characterized by partial thickness loss of dermis presenting as a shallow open ulcer with a red-pink wound bed, without slough [dead tissue separating from living tissue]) or higher. The wound care indicated “not appliable”, that wound care was not during the visit and that the location of wound site was “left buttock known wound.” The assessment further indicated “left buttock with wound vac in place for change every three days.” The assessment of the wound indicated location as left buttock and type as other: non removable dressing. The assessment indicated that the primary diagnosis for admission was cerebral infarction and Type 2 DM. There was no signature from the Registered Nurse (RN 1) who performed the assessment on the form. During an interview and record review with the Director of Patient Care Services (DPCS)on 5/22/2023 at 1:06 pm, Patient 2’s SN Clinical notes for the certification period from 3/20/2023 through 5/3/2023 were reviewed. The SN Clinical notes did not have a License Vocational Nurse (LVN) signature for 13 of 17 notes. During an interview on 5/22/2023 at 1:10 pm, the Administrator (ADM) stated that the HHA was not using an electronic medical records system and were in the process of evaluating several types. The ADM stated that the nurses were using electronic forms created by their Information Technology (IT) consultant and were able to type their assessments on it. During an interview on 5/22/2023 at 1:30 pm, the Quality Assurance (QA 1) stated the nurse will send him their notes by email, postal mail or will drop the notes off in person. QA 1 stated if there is a correction that needs to be made on the notes, we inform the nurse to correct the notes, so it is documented correctly and that it matches the patient’s plan of care. The QA 1 stated that the nurse will correct the notes and will send the new notes back to me. The QA 1 stated that the original notes with the errors are given back to the nurse and the new notes are filed in the patient’s clinical chart. QA 1 stated he performs a QA check on the patients charts every two weeks and makes sure the notes are correct and have a handwritten signature. A review of the HHA’s policy, “Entries into the Clinical Record,” dated 11/2017 indicated that entries into the clinical record will be made on the day care is provided to the patient. All documentation will be turned in to the office at the end of the workday and clinical notes dictated or written will be incorporated into the patient's health record at least every seven working days. The policy indicated that the clinical note will include the signature of clinician and his/her credentials. The policy indicated that the signature authorization of clinical documentation will include the staff member's name and credentials (as specified on professional licenses and/or certification documents). The policy indicated that late entries and amendments will be documented, stating “late entry or amendment for visit of (date and time of visit)" and include: A. The date the entry is made (month, day, year) B. The date and documentation that was originally omitted or amended C. The signature and title of the staff member making the late entry or amendment The policy indicated that errors in documentation will be corrected as follows: A. Draw a line through the entry, date, and initial. B. Do not erase, use correction fluid, or deface a document.

The following reflects the findings of the California Department of Public Health (CDPH) during a Complaint Validation Survey conducted on 7/20/2021 through 7/22/2021. Representing the California Department of Public Health: Surveyors: 25997 34959 36892 Census: 49 Unduplicated Admissions: 321 Home visits with record reviews: 3 Record Reviews without home visits: 4 Sample size: 7 The following Conditions of Participation were surveyed: CFR 484.50 Patient Rights CFR 484.60 Care Planning, Coordination of Services, and Quality of Care CFR 484.65 Quality Assurance and Performance Improvement (QAPI) CFR 484.75 Skilled Professional Services CFR 484.105 Organization and Administration of Services The following complaint was investigated and substantiated during this survey: CA00741096 (Refer to G700, G710, G940 and G952) The following Conditions of Participation were not met: CFR 484.75 Skilled Professional Services CFR 484.105 Organization and Administration of Services

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: The Condition is not met as evidenced by: The HHA failed to ensure the Condition of Participation: CFR 484.75 Skilled Professional Services was met when: a. Staff 1 (an unlicensed staff) provided skilled nursing care for Patient 6 from 2/6/2017 to 2/3/2017 (approximately 2 years and 11 months). (Refer to G710) b. RN supervisory visits were not conducted. (Refer to G710) The cumulative effect of these systemic practices resulted in the failure of the HHA's inability to deliver care in compliance with the Condition of Participation: CFR 484.75 Skilled Professional Services

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 interview and record review, the HHA failed to provide services that were ordered by the physician as indicated in the plan of care for one of seven sampled patients (Patient 6). 1. Staff 1 (an unlicensed staff) provided skilled nursing care for Patient 6 from 2/6/2017 to 2/3/2017 (approximately 2 years and 11 months). 2. Registered Nurse (RN) Supervision visits were not conducted. These failures had the potential to result in adverse health outcomes for Patient 6, and all patients receiving services provided by the HHA. Findings: 1. During a review of Patient 6's Home Health Certification and Plan of Care/Physician's Orders, for the certification period from 1/28/2020 through 3/27/2020, it indicated the following: a. Start of care, 6/17/16 b. Diagnoses included cerebral palsy (a disorder of the nervous system), severe intellectual disability, seizure disorder, and difficulty digesting food. c. Gastrostomy tube (surgically inserted for liquid nutrition and medication administration). d. Skilled Nursing care 15 hours per week (60 hours per month) e. Skilled Nursing care and services included: Skilled nursing assessment of all body systems Diet and medication regimen review Maintenance of gastrostomy tube Check blood pressure and notify physician if greater than or less than set parameters. Compliance/response to and effectiveness of ordered medications Signs and symptoms of medication side effects Assess for muscle weakness Ensure family can verbalize understanding of medications f. 60-Day Summary, dated 11/29/2019 through 1/27/2020, indicated a skilled nurse (not Staff 1) provided all prescribed care, according to the plan of care. During a review of Patient 6's Extended Hour Nursing Flow Sheets, completed by Staff 1, dated 10/4/19 through 1/31/20, indicated Staff 1 conducted home visits every other day, and provided skilled nursing care. There was no documented evidence in Patient 6's medical record to show a skilled nurse provided skilled nurse visits that were ordered by the physician as indicated in the plan of care. During an interview with the Administrator on 7/22/2021 at 11:45 AM, the Administrator stated Staff 1 was not a licensed nurse. The Administrator stated Staff 1, who was not a skilled nurse, provided all skilled nursing care for Patient 6 from 2/6/2017 to 2/3/2017. 2. During a review of Patient 6's Home Health Certification and Plan of Care/Physician's Orders, for the certification period from 1/28/2020 through 3/27/2020, it indicated the following: a. HHA Start of care, 6/17/16 b. Diagnoses included cerebral palsy (a disorder of the nervous system), severe intellectual disability, seizure disorder, and difficulty digesting food. c. Gastrostomy tube (surgically inserted for liquid nutrition and medication administration). d. Registered Nurse supervision one (1) hour each month. During a review of Patient 6's medical record, it failed to show documented evidence a RN completed the RN Supervision visits that were ordered by the physician as indicated in the plan of care. During an interview with the Administrator on 7/22/2021 at 11:45 AM, Administrator 1 was unable to provide documented evidence to show Patient 6's RN Supervision visits were completed as ordered by the physician. The Administrator stated the RN supervision visits were not completed that were ordered by the physician as indicated in the plan of care. During a review of the HHA's Policy and Procedure (P&P), undated, titled, "Supervision," Policy No. 1-007-1, the P&P indicated: a. All skilled nursing... and other therapeutic services will be provided under the supervision or direction of a qualified Clinical Supervisor/Nursing Supervisor and/or designee.

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: The Condition is not met as evidenced by: The facility failed to ensure the Condition of Participation: CFR 484.105 Organization and Administration of Services was met when an unlicensed staff, Staff 1, provided skilled nursing care for approximately 2 years and 11 months. (Refer to G952) The cumulative effect of these systemic practices resulted in the failure of the HHA's inability to deliver care in compliance with the Condition of Participation: CFR 484.105 Organization and Administration of Services

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 interview and record review, the HHA failed to ensure Staff 1 was a qualified licensed nurse prior to assigning her to provide skilled nursing care for one of seven sampled patients (Patient 6) for approximately 2 years and 11 months. This failure had the potential to result in adverse outcomes for Patient 6, and all HHA patients receiving care provided by the HHA. Findings: During a review of Staff 1's Personnel File, it included the Employment Application, dated 2/6/2017. The Employment Application indicated Staff 1 applied for a Licensed Vocational Nurse (LVN) position. There was no documented evidence to show that Staff 1 was a qualified LVN. During an interview with Administrator 1 on 7/22/2021 at 11:45 AM, Administrator 1 stated Staff 1 was not a licensed nurse. Administrator 1 stated Staff 1 was assigned to provide Patient 6's skilled nursing care from 2/6/2017 to 2/3/2017. During a review of the HHA Policy and Procedure (P&P) titled, "Selection/Hiring of Personnel," (undated) Policy Number 1-004.1, the P&P indicated, the following: a. Candidates are screened to ensure they meet the job requirements, competencies, and qualifications. b. Staff providing patient care will possess a license, certification, or registration.