Pike County Health Dept/Home Health & Hospice

“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 policy review, record review, and interview, the provider failed to meet the requirements for the Condition of Participation: Skilled Professional Services, when the provider failed to ensure skilled nursing services were planned, coordinated, and provided in accordance with the patient’s changing condition and physician-ordered care. The provider was aware the patient had undergone a major procedure and had patient information in the clinical record and the provider failed to ensure skilled nursing staff were directed on required monitoring, assessment, and follow-up. This failure resulted in skilled services being provided without an updated and comprehensive plan. (G0708). This failure resulted in plans of care that did not reflect current patient needs and posed the potential for harm to all the patients served by the provider.”

“Eligible training/competency evaluation orgs. CFR(s): 484.80(f) A home health aide training program and competency evaluation program may be offered by any organization except by an HHA that, within the previous 2 years: (1) Was out of compliance with the requirements of paragraphs (b), (c), (d), or (e) of this section; or (2) Permitted an individual who does not meet the definition of a “qualified home health aide” as specified in paragraph (a) of this section to furnish home health aide services (with the exception of licensed health professionals and volunteers); or (3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or (4) Was assessed a civil monetary penalty of $5,000 or more as an intermediate sanction; or (5) Was found to have compliance deficiencies that endangered the health and safety of the HHA’s patients, and had temporary management appointed to oversee the management of the HHA; or (6) Had all or part of its Medicare payments suspended; or (7) Was found under any federal or state law to have: (i) Had its participation in the Medicare program terminated; or (ii) Been assessed a penalty of $5,000 or more for deficiencies in federal or state standards for HHAs; or (iii) Been subjected to a suspension of Medicare payments to which it otherwise would have been entitled; or (iv) Operated under temporary management that was appointed to oversee the operation of the HHA and to ensure the health and safety of the HHA’s patients; or (v) Been closed, or had its patients transferred by the state; or (vi) Been excluded from participating in federal health care programs or debarred from participating in any government program. This Standard is not met as evidenced by: Based on the results of this extended level survey, resulting in noncompliance with one Condition of Participation: Skilled Professional Services, the home health provider may not train, or competency evaluate their home health aides for a period of two (2) years following the date of this survey. This restriction ends 12/19/2027.”

“Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This Element is not met as evidenced by: Based on review of provider’s policy, record review, and interview, the home health provider failed to ensure the patient’s individualized plan of care (POC) was updated and communicated to reflect changes in the patient’s condition and physician-ordered care, including a known high-risk cardiac device implantation, in one of three records reviewed (Record/Patient #1). This deficient practice failed to ensure coordination of care and timely revision of the individualized POC based on changes in the patient’s condition and physician-ordered services. This deficient practice has the potential to affect care and services for all the patients served by the provider. Findings included: Review of the provider’s policy titled, “Promptly Alert the Physician to Changes in Condition,” dated 07/02/2024, showed in part: - In the event of a change in condition or needs suggest outcomes are not being achieved and/or the patient’s POC should be altered, the home health agency (HHA) will notify both the responsible physician and the physician(s) associated with the relevant aspect of care in the event of change in condition or needs that suggest outcomes are not being achieved and/or that the patient’s POC should be altered; and - The skilled clinician who becomes aware that the patient has a change in condition or that the patient has needs that suggest outcomes are not being achieved and/or that the patient’s POC should be altered, will notify both the responsible physician and the physician(s) associated with the relevant aspect of care as soon as possible but no later than 24 hours. Review of the provider’s policy titled, “Plan of Care,” dated 04/12/2024, showed in part: - The patient’s physician or allowed practitioner orders are the foundation of the plan of care; - The policy required the HHA to promptly alert the physician to changes in the patient’s condition or needs that suggest outcomes are not being achieved and/or the POC should be altered; and - The policy further required the POC to be updated as needed to reflect current information from the patient’s assessment, patient progress toward measurable outcomes, and changes in patient status, and that changes in the patient’s condition are consistently communicated. Review of the provider’s policy titled, “Plan of Care Components,” dated 04/12/2024, showed in part, the individualized plan of care must include all medications and treatments, patient-specific interventions, education, and measurable outcomes identified through comprehensive assessment. RECORD/PATIENT #1: Review of the medical record showed the patient was admitted to the home health provider on 01/11/2025 with a primary diagnosis of hypertensive heart disease with heart failure (long-term high blood pressure has damaged the heart) and resided at home with his/her spouse. Review of cardiologist pre- and post-device implant instructions dated 10/07/2025, showed in part, the patient was scheduled to undergo ICD (implanted cardiac device, designed to detect and treat dangerous heart rhythms) implantation and required post-procedure monitoring, activity restrictions, wound care, and immediate reporting of complications including worsening pain, swelling, fever, chest pain, shortness of breath, and changes in condition. The provider failed to timely revise the patient’s individualized POC to incorporate physician ordered post-ICD implantation monitoring requirements, nursing assessments, and interventions. Review of the skilled nursing notes dated 10/07/2025 at 10:55 AM and 10/14/2025 at 10:30 AM, showed the provider’s staff were aware the patient was scheduled for an ICD implantation on 10/17/2025. The patient’s POC was not revised to reflect the planned implantation, associated risks, or required post-procedure nursing interventions. Review of a signed cardiology consultation report dated 10/17/2025, showed the patient underwent implantation and included physician orders for post-procedure care, including activity restrictions, monitoring, antibiotic administration, vital signs per protocol, maintenance of a pressure dressing for 72 hours, enrollment in remote device monitoring, and follow-up wound evaluation in two weeks. The POC was updated to include the dressing removal. The POC was not revised to reflect the patient’s ICD implantation, required post procedure monitoring, parameters for nursing assessment, or interventions to address the reported change in condition. Review of an activity note dated 10/20/2025 at 9:44 AM, showed the registered nurse (RN) received a call from the patient’s caregiver requesting an immediate nursing visit due to weakness following the ICD implantation. The RN instructed the caregiver to call an ambulance, stating the agency did not have physician orders. The RN did not contact the implanting physician, obtain post procedure orders, revise the POC, or arrange a skilled nursing visit that day. Review of the skilled nursing note dated 10/21/2025 at 1:30 PM, showed the RN completed a home visit four days after the ICD implantation, at which time the patient was noted to have elevated blood pressure, elevated pulse, and severe pain at the ICD site. The RN assisted the spouse to get the patient into the car to go to the emergency department (ED). The documentation failed to include any follow up regarding the ED. The failure to revise the POC and implement post-implant and implement post-implant monitoring contributed to a lack of coordinated follow-up when the patient required emergency care. During an interview on 12/17/2025 at 9:30 AM, the registered nurse case manager (RNCM) stated that the POC did not include post-ICD implantation interventions or monitoring parameters. During an interview on 12/17/2025 at 4:00 PM, the administrator stated that the RN should have contacted the implanting physician, revised the POC and followed up with the patient the day the patient returned home following ICD implantation.”

“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 policy review, record review, and interview, the home health provider failed to ensure all documented entries included appropriate authentication and completion in a timely manner in three of five full records reviewed (Records/Patients #1, #2, and #3). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s policy titled, “Authentication-Timely Documentation”, dated 02/03/2022, showed in part: - 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; and - All clinical documentation both written and electronic will be completed within five (5) days of the patient visit/activity. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services on 08/29/2024 with a diagnosis of Parkinson’s (a neurological disorder that causes unintended or uncontrolled movements or stiffness) disease without dyskinesia (abnormal involuntary movement of the body) for physical therapy (PT) to work on balance and gait. Further review of the clinical record showed: - The routine PT visit note, dated 09/03/2024 showed the service note status completed on 09/15/2024 (12 days later); - The routine PT visit note, dated 09/05/2024 showed the service note status completed on 09/16/2024 (11 days later); and - The routine PT visit note, dated 09/09/2024 showed the service note status completed on 09/16/2024 (7 days later). RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 05/03/2024 with a primary diagnosis of venous insufficiency (a wound that occurs due to poor blood flow) for skilled nursing (SN) to complete wound care. Further review of the clinical record showed: - The routine SN visit note, dated 08/13/2024 showed the service note status completed on 09/03/2024 (21 days later); - The routine SN visit note, dated 08/23/2024 showed the service note status completed on 09/03/2024 (11 days later); - The routine SN visit note, dated 09/03/2024 showed the service note status completed on 09/16/2024 (13 days later); and - The routine SN visit note, dated 09/10/2024 showed the service note status was incomplete when state agent (SA) entered on 09/16/2024 (6 days later). RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 08/01/2024 with a diagnosis of encounter for change or removal of a surgical wound dressing (patient had a history of colon cancer requiring an ileostomy (a surgical opening in the abdomen bringing the end or loop of the small intestine to the surface of the skin to allow passage of waste (bowel movement.) This opening had been reversed to restore the bowel to its normal position and was requiring daily wound care by skilled nursing (SN). Further review of the clinical record showed: - The routine SN visit note, dated 08/02/2024 showed the service note status completed on 08/12/2024 (10 days later); - The routine SN visit note, dated 08/19/2024 showed the service note status completed on 08/29/2024 (10 days later); - The routine SN visit note, dated 08/24/2024 showed the service note status completed on 09/06/2024 (13 days later); and - The routine SN visit note, dated 08/25/2024 showed the service note status was incomplete when SA entered on 09/16/2024 (22 days later). During an interview on 09/17/2024 at 10:50 AM, the administrator stated that their policy was 5 days for documentation completion.”

“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 policy review, clinical record review, home visit observation, and interview, the home health provider failed to ensure a complete and accurate medication list was maintained in, one of three home visit observations (Record/Patient #2). This deficient practice has the potential to affect the provider’s ability to ensure safe and effective use of medications for all patient’s served by the provider. Findings included: Review of the provider’s policy titled, “Medication Regimen Review,” revision date June 2005, showed in part: - Medications will be reviewed on the initial visit and on each subsequent visit to ensure an ongoing accurate reflection of the patient’s medication regimen; - The medication record in the electronic medical record (EMR) will match the patient’s medication at all times; - The patient’s clinical record will identify all medications that the patient is taking, both prescription and non-prescription; - At each subsequent visit the clinician will reconcile the medication record; - Each medication entered in the EMR will be reviewed with the patient to ensure the patient’s medication regimen has not changed; and - If the medication record in the EMR does not match the patients verbalized medication regimen the clinician will then enter the current medication regimen as verbalized by the patient, in the EMR under “Patient Medications”. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 05/03/2024 with a primary diagnosis of venous insufficiency (a wound that occurs due to poor blood flow), non-pressure chronic ulcer, severe morbid obesity, anxiety and depression. Observation and interview on 09/17/2024 at 1:25 PM, during the patient’s home visit, showed the following discrepancies: - The medication profile showed the patient took albuterol solution (opens airways to make breathing easier) 2.5 milligrams (mg)/3 milliliters (mL) one vial twice a day as needed for shortness of breath. The patient stated he/she used it four times a day or more; - The medication profile showed the patient took Diazepam (treats anxiety) 5 mg one tablet three times a day as needed for anxiety. The patient stated he/she took it three times a day just like the bottle directions; and - Lisinopril (treats hypertension and heart failure) 40 mg one daily. The patient stated he/she took one daily. The medication bottle was dated 11/07/2023. The medication was not on the patient’s medication profile. Per interview conducted during the observation, LPN A stated that he/she would notify the physician and get the discrepancies clarified. During an interview on 09/18/2024 starting at 1:54 PM, the administrator stated that he/she: - Would have expected the medications to be looked at during every visit; and - Expected all medications the patient was taking to be on the medication profile and how they were taking the medication.”

“Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This Element is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure the plan of care (POC) was revised/updated to address the patient’s needs for one of five full records reviewed (Record/Patient #3). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s policy titled, “Creation and Review of the Plan of Care,” revised February 25, 2019, showed in part, the following: -Each patient must receive an individualized written POC, including any revisions or additions; - The individualized plan of care must specify the care and services necessary to meet the patient’s specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the home health agency anticipates will occur as a result of implementing and coordinating the POC; and - The individualized plan of care must also specify patient and caregiver education and training. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 08/01/2024 with a diagnosis of encounter for change or removal of a surgical wound dressing (patient had a history of colon cancer requiring an ileostomy (a surgical opening in the abdomen bringing the end or loop of the small intestine to the surface of the skin to allow passage of waste (bowel movement.) This opening had been reversed to restore the bowel to its normal position and was requiring daily wound care by skilled nursing (SN), under the care of physician-A. Review of the SN (skilled nurse) visit notes dated 08/02/2024, 08/03/2024, 08/04/2024, 08/05/2024, 08/06/2024, 08/09/2024, 08/11/2024, 08/12/2024, 08/13/2024, 08/14/2024, 08/16/2024, 08/17/2024, 08/18/2024, 08/19/2024, 08/20/2024, 08/22/2024, 08/23/2024, 08/24/2024, 08/25/2024, 08/27/2024, 08/28/2024, 08/30/2024, 08/31/2024, and 09/01/2024 showed the patient complained of diarrhea and the SN provided the patient specific intervention education regarding the diarrhea. Review of the SN visit notes dated 08/02/2024, 08/06/2024, and 08/12/2024, showed communication with physician-A regarding the diarrhea. Review of the SN visit note dated 08/28/2024 showed physician-B notified regarding the diarrhea and a physician order obtained on 08/29/2024 from physician-B to obtain lab work. Review of the SN visit note dated 08/30/2024 showed the patient reported a lymph node was inflamed detected on a CT (computed tomography) scan (a medical imaging technique that uses X-rays and a computer to create detailed pictures of the inside of the body) completed on 08/27/2024 and was now scheduled 09/03/2024 for a PET (positron emission tomography) scan (an imaging test that uses a radioactive tracer to create detailed pictures of the bodies metabolic processes, blood flow, and chemical composition.) Review of the SN visit note dated 09/04/2024 showed the patient stated they had found out the cancer had returned and a tumor was on the left femur (thigh bone) below the hip joint as well as several lymph nodes that “light up” (meaning it could be a sign of active cancer cells) and the patient is to meet with the radiation oncologist tomorrow. Review of the SN visit note dated 09/13/2024 showed the patient stated the radiation would begin next Wednesday, 09/18/2024. Review of the plan of care failed to show: - Patient specific interventions regarding the diarrhea; - Reoccurrence of cancer with patient specific interventions; - Patient specific interventions regarding initiation of radiation; and - Inclusion of the oncologist and radiologist as coordinating physicians in the patient’s care. During an interview on 09/17/2024 at 2:05 PM, the clinical manager stated that he/she couldn’t find any updates to the plan of care and would expect the plan of care to be updated.”

“Communication with all physicians CFR(s): 484.60(d)(1) Standard: Coordination of Care. The HHA must: (1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This Element is not met as evidenced by: Based on policy review, record review, and interview the home health provider failed to ensure communication with all physicians involved in the plan of care (POC) in one of five full records reviewed (Record/Patient #3). This deficient practice has the potential to affect the coordination of care and services for all patients on service with the provider. Findings included: Review of the provider’s policy titled, “Coordination of Care,” dated April 29, 2020, showed, in part: - It is the policy of this agency to assure communication with all physicians involved in the plan of care; - The physician who initiated home health care will be responsible for the ongoing plan of care; - In order to assure the development and implementation of a coordinated plan of care, the home health agency will communicate with all physicians involved in the patients care when necessary. “Physicians involved in the plan of care” means those physicians who give orders that are directly related to home health skilled services; and - The clinical manager or other staff assigned will be responsible for integrating all orders from all relevant physicians involved into the home health agency plan of care and ensuring the orders are approved by the responsible physician. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 08/01/2024 with a diagnosis of encounter for change or removal of a surgical wound dressing (patient had a history of colon cancer requiring an ileostomy (a surgical opening in the abdomen bringing the end or loop of the small intestine to the surface of the skin to allow passage of waste (bowel movement) under the care of physician-A. This opening had been reversed to restore the bowel to its normal position and was requiring daily wound care by skilled nursing (SN). Review of the SN routine visit note dated 08/28/2024 showed physician-B was contacted to obtain lab orders. Review of a physician’s order dated 08/29/2024, received from physician-B, showed to obtain labs at next scheduled visit 08/29/2024. Further review of the clinical record failed to show physician-B listed on the POC or approval received from the responsible physician (physician-A) to accept orders from physician-B. Coordination of care between physician-A and physician-B failed to be documented. During an interview on 09/17/2024 at 11:00 AM, the clinical manager stated that: - They (provider) did not normally put other physicians on the POC; - The physician on the POC was the patient’s GI (gastrointestinal) physician (physician-A) and he/she wouldn’t order labs. He/she only dealt with the GI stuff; - The lab results were only sent to the oncologist (physician-B); and - They normally just send the results to the ordering physician.”

“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 policy review, record review, and interview, the home health provider failed to provide a discharge summary that included all necessary components was sent to the primary care physician after discharge within five business days of the patient’s discharge in one of two discharge records reviewed (Record/Patient #6). This deficient practice has the potential to adversely affect the post discharge care of all patients served by the provider. Findings included: Review of the provider’s policy titled, “Discharge/Transfer of Care Summary,” most recently updated June 25,2024, showed in part, the following: -All patients who are discharged or transferred from the home health agency will have a completed discharge/ transfer summary completed in the EMR (electronic medical record) and faxed to the primary care practitioner or other healthcare professional who will be responsible for providing the care and services to the patient after discharge/ transfer from the home health agency; and - The discharge summary will be completed and faxed within five (5) business days of the patient’s discharge. RECORD/PATIENT #6: Review of the clinical record showed that the patient was admitted to the provider on 02/07/2024 with a diagnosis of pneumonitis (pneumonia), with orders for skilled nursing and physical therapy. Review of the discharge OASIS (Outcome and Assessment Information Set; a standardized data collection tool) showed Item M0906- Discharge/Transfer/Death Date: 03/01/2024. Review of the discharge summary showed it was completed by the physical therapist and electronically signed by them on 03/13/2024 (eight (8) business days after discharge). There failed to be a fax status report to show when the summary was sent to the physician. During an interview on 09/17/2024 at 11:51 AM, the clinical manager stated the date the physical therapist sent it to the physician was the date that it was signed (03/13/2024, 8 business days after discharge). During an interview on 09/17/2024 at 2:27 PM the clinical manager stated that he/she would expect the discharge summary to be sent within 5 business days to the physician.”