Every finding on record at The Whole Person, Inc.

A complaint investigation 2793185 was completed on 03/17/2026 at the home health provider. The provider had six current patients. The complaint is substantiated. One or more of the allegations reported are verified and standard deficiencies were cited that are related to the allegations being investigated.

Document efforts to resolve problems CFR(s): 484.50(d)(5)(iv) (iv) Document the problem(s) and efforts made to resolve the problem(s), and enter this documentation into its clinical records; This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure the patient had the right to have all efforts made and documented to resolve issues that resulted in an unsupported determination of homebound status and discharge from services in one of three patient records reviewed (Record/Patient #2). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider's policy titled, "Coordination of Services with Other Providers," revised December 2025, showed in part, the case manager is responsible for coordinating services between providers, initiating communication with other organizations involved in the patient’s care, and monitoring for duplication or conflict of services. Review of the provider's policy titled, "Admission Criteria and Process," revised December 2025, showed in part, services may be provided to a patient who is homebound and requires skilled services. RECORD/PATIENT #2: Review of the clinical record showed the patient received skilled nursing services for wound care and management of lower extremity edema (swelling of the tissues). Documentation showed the patient was receiving lower extremity wraps from an outside provider three times per week. Review of communication notes dated 02/18/2026 and 02/21/2026 showed missed visits due to the patient attending church services and medical appointments. Record review showed the provider rescheduled visits and notified the physician; however, the record failed to include evidence that showed the provider identified, contacted, or coordinated care with the outside provider performing lower extremity wraps three times per week to address the impact on services. Visit documentation dated 02/24/2026 showed the patient continued to require skilled services, utilized a walker, and had ongoing clinical needs. The record further indicated the patient was leaving the home for health care appointments and church activities. Review of discharge documentation showed the patient was discharged from home health services on 02/26/2026 due to no longer meeting homebound criteria. The clinical record failed to include evidence that the provider promoted the patient's rights by attempting to coordinate care with the outside provider that performed lower extremity wraps, exploring whether services could be provided in the home, or adjusting the plan of care or visit schedule to support the patient’s needs. During an interview, beginning at 03/03/2026 at 10:17 AM, the patient stated: - Home health told him/her that going to the church and doctor were acceptable; - He/she used Oates transportation; - He/she was receiving wound care by home health twice a week to the area on his/her tailbone and he/she was unable to do the dressing changes independently; - He/she had attended the lymphedema clinic three times a week for lower extremity compression wraps and home health did not offer to provide the wraps in the home; and - He/she added she did not drive his/her car because his/her kids took his/her keys away. During an interview on 03/17/2026 at 10:13 AM, the clinical manager stated that: - The patient was receiving lower extremity wraps three times per week, but he/she was unsure who or what provider was performing the service and had not attempted to identify or contact the provider; - The patient still received wound care and used a walker upon discharge; and - The clinical manager further stated that there was no additional assessment completed to support the determination that the patient was no longer homebound other than documentation of church and physician visits.

The Emergency Preparedness regulations were reviewed as part of the Medicare recertification survey completed on 07/09/2025. During the survey it was determined the home health provider is in compliance with the requirements of 42 CFR 484.102 Condition of Participation: Emergency Preparedness for Home Health Providers.

An extended survey for Medicare recertification for the home health provider was completed on 07/09/2025. The provider had 25 current patients. Five condition-level deficiencies were identified during this survey: - §484.45 Condition of Participation: Reporting OASIS information; - §484.55 Condition of Participation: Comprehensive assessment of patients; - §484.60 Condition of Participation: Care planning, coordination of services, and quality of care; - §484.65 Condition of Participation: Quality assessment and performance improvement (QAPI); and - §484.105 Condition of Participation: Organization and administration of services. A home health provider that is found out of compliance with any Condition of Participation evaluated as part of a standard survey may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. A deficiency has been cited at §484.80(f)(3) – see Tag G0782.

Reporting OASIS information CFR(s): 484.45 Condition of participation: HHAs must electronically report all OASIS data collected in accordance with §484.55. This CONDITION is not met as evidenced by: Based on review of the internet Quality Improvement and Evaluation System (iQIES; a cloud-based application developed by the Centers for Medicare and Medicaid Services (CMS) for managing provider and patient information, and ensuring quality healthcare, specifically for Medicare and Medicaid beneficiaries) website, policy review, and interview, the home health provider failed to ensure that the Outcome and Assessment Information Set (OASIS; a standardized data collection tool. The data from the OASIS is used for quality improvement and determining reimbursement under Medicare) had been electronically transmitted and submitted since 12/30/2024 to the CMS system for any patients on service (G0372). The cumulative effect of this deficient practice has the potential to affect the quality of care for all the patients on service.

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on review of the internet Quality Improvement and Evaluation System (iQIES; a cloud-based application developed by the Centers for Medicare and Medicaid Services (CMS) for managing provider and patient information, and ensuring quality healthcare, specifically for Medicare and Medicaid beneficiaries) website, policy review, and interview, the home health provider failed to ensure that the Outcome and Assessment Information Set (OASIS; a standardized data collection tool. The data from the OASIS is used for quality improvement and determining reimbursement under Medicare) had been electronically transmitted and submitted since 12/30/2024 to the CMS system for any patients on service. This deficient practice has the potential to affect the provider’s financial health as well as the potential to affect the quality of care for all the patients on service. Findings included: Review of the iQIES website on 07/09/2025 at 12:00 PM, showed the provider had failed to electronically transmit or submit any OASIS since 12/30/2024. Review of the provider’s undated policy titled, “OASIS Data Entry & Transmission,” showed in part the following: - OASIS data will be transmitted in accordance with current CMS transmission policy, which currently requires the provider to transmit data using electronic communication software that complies with the Federal Information Processing Standard; - The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than five calendar days after the start of care; - The provider will encode and transmit (export) OASIS data within 30 days of completing an OASIS data set using software from CMS or software that conforms to the CMS standard electronic record layout; and - Data entry audits will be conducted to assure that the OASIS entered from paper forms is accurate and complete and will be reported to the Quality Assessment Performance Improvement (QAPI) committee. An OASIS Data Entry/Transmission Error Report log will be completed on a monthly basis to monitor any encoding/transmission errors. During an interview on 07/09/2025 at 12:30 PM, the administrator stated that he/she thought that the provider’s electronic medical record (EMR) company had been electronically transmitting and submitting the OASIS. He/she also denied running the home health agency (HHA) error summary report (This report compiles OASIS submission errors to iQIES).

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on policy review, home visit observation, and interview, the home health provider failed to ensure staff provided the patient and/or caregiver with contact information for the administrator, in order to receive complaints, in one of three home visit observations conducted (Record/Patient #2). This deficient practice has the potential to adversely affect the knowledge of self-care and provider expectations in all the patients served by the provider. Findings included: Review of the providers undated policy titled, “Agency Grievance Policy/Process,” showed, in part: - To ensure that our services meet your needs, we encourage you to make us aware of any complaints or concerns; - Complaints should be addressed to the administrator who will promptly review the problem; and - If you have information about unethical behavior, criminal activities, or other concerns regarding your services, please call the director at your office. Observation on 07/08/2025, beginning at 12:30 PM, showed: - The home health folder contained the name and contact information of the precious administrator; and - The licensed practical nurse (LPN) A stated that the folder needed to be updated because he/she didn’t even know who the names (previous staff) were. During an interview on 07/09/2025, beginning at 4:55 PM, the administrator stated that the home folder should be updated with the correct information.

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 policy review, record review, home visit observation, and interview, the provider failed to ensure: - An initial assessment visit was completed within 48 hours of the referral, or within 48 hours of the patient’s return home (G0514); - A comprehensive assessment that accurately reflected the patient’s current health status (G0528); and - An accurate medication review and/or update of the patient medications (G0536). The cumulative effect of these deficient practices has the potential to affect all the patients served by the provider.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to complete the initial assessment of the patient within 48 hours of the referral to home care, or 48 hours after the patient's return home, or on the physician ordered start of care date in four (Patients/Records #1, #3, #4, and #5) of five records reviewed. This deficient practice has the potential to affect the immediate needs of all the provider’s patients. RECORD/PATIENT #3: Review of the clinical record showed: - A fax cover sheet dated “6/6/25”, titled new home health (HH) referral; - The OASIS SOC assessment, and the first skilled nursing (SN) visit to the patient, was dated 06/11/2025 with an inpatient discharge date of 06/06/2025 (five days after discharge); and - Further review of the clinical record failed to show physician orders for a late SOC. RECORD/PATIENT #4: Review of the clinical record showed: - A fax cover sheet dated 05/06/2025 with the comment: New HH for SN/wound care; - A communication note date 05/09/2025 that showed the patient was home and stated they had overslept the previous day. Will have nurse reach out to set a time for SOC, patient has a doctor appointment on Monday (05/12/2025); - The OASIS SOC assessment, and the first skilled nursing (SN) visit to the patient, was dated 05/13/2025 with an inpatient discharge date of 05/07/2025 (four days after the provider had made contact with patient to set up SOC); and - Further review of the clinical record failed to show physician orders for a late SOC. During an interview on 07/06/2025 at 4:55 PM, the home health administrator stated that he/she would expect the SOC within 24-48 (twenty-four to forty-eight) hours from hospital discharge or by physician SOC order. Findings included: Review of the provider’s undated policy titled, 12.5.7 “Assessment - Comprehensive,” showed in part: - A registered nurse, or qualifying clinician, must conduct an initial assessment within 48 hours of referral or patient’s return to home, or on the physician ordered start of care date. RECORD/PATIENT #1: Review of the clinical record showed: - The provider’s home health initial intake screening form dated 05/29/2025 showed an accepted for care date of 05/29/2025 with skilled nursing (SN), physical therapy (PT) and occupational therapy (OT); - The OASIS (Outcome and Assessment Information Set; a standardized data collection tool) start of care assessment (SOC), and the first SN visit to the patient, was dated 06/04/2025. Further review of the clinical record failed to show physician orders for a late SOC; and - The OT assessment was not conducted until 06/11/2025 (seven days after the SOC). During an interview on 07/09/2025 at 5:44 PM, the administrator stated that there should be an order for when the OT can go and if it’s not in the five days then they should let the referral know the provider cannot see the patient on time. RECORD/PATIENT #5: Review of the clinical record showed: - The hospital discharge summary showed a discharge date of 06/05/2025 with patient discharging home with home health services to start 06/2025; - The OASIS start of care assessment, and the first SN visit to the patient, was dated 06/12/2025 with an inpatient discharge date of 06/04/2025 (eight days prior to SOC), and referral date of 06/05/2025. Further review of the clinical record failed to show physician orders for a late SOC; and - The PT assessment was not completed until 06/13/2025 (nine days after discharge); and - The OT assessment was not completed until 06/13/2025 (nine days after discharge). During an interview on 07/09/2025 at 12:07 PM, the director of home care services stated that the hospital discharge summary showed home health would start from 06/2025.

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 policy review, record review, and interview, the home health provider failed to ensure the comprehensive assessment accurately reflected the patient’s current health status in, two of five full records reviewed (Records/Patients #2 and #4). This deficient practice has the potential to affect all the patients served by the provider. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services with a primary diagnosis of a stage three (3) pressure ulcer of the right buttock. Review of the initial comprehensive assessment dated 05/13/2025 showed: - Nephrostomy tubes (a thin flexible tube (catheter) inserted through the skin to drain urine when the normal flow is blocked), last changed 04/20/2025; - Patient has wound of right posterior thigh currently with excessive drainage and needs to be cleaned; - The documentation failed to show the size of the catheters or an assessment of the insertion sites; and - The documentation failed to show measurements of the right posterior thigh wound. During an interview on 07/09/2025, beginning at 4:55 PM, the administrator stated that he/she would expect documentation of nephrostomy tube insertion site assessments. Findings included: Review of the provider’s undated policy titled, “Assessment- Comprehensive,” showed, in part, each patient will receive a patient specific, comprehensive assessment that accurately reflect the patient’s current health status and includes information that may be used to demonstrate the patient’s progress toward achievement of desired outcomes. Review of the provider’s undated policy titled, “Assessment- Initial,” showed, in part: - The agency will identify the patient’s physical, cognitive, behavioral, emotional and psychosocial status; - This assessment identifies the following, but is not limited to; symptoms that might be associated with a disease, condition, or treatment; - The initial history/social/physical include, in part: * Pain assessment * Endocrine assessment * Medications (prescribed and over the counter) * Integumentary status; * Cardiovascular status * Gastrointestinal status * Acuity status - The clinician will evaluate information gathered at the time of the initial assessment; - A plan of care will be developed collaboratively with the physician and patient/family; and - Ongoing assessment will occur with each visit and necessary revisions will be made to the plan of care. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (an injury with full-thickness skin loss caused by unrelieved pressure) of the right buttock. The patient lived at home with his/her significant other. Review of the recertification comprehensive assessment, dated 05/13/2025, showed, in part: - The patient sits in his/her recliner all day and in his/her feces for hours, resulting in pressure injury/wound; - The patient had a stage 3 pressure injury to the right buttock; - The patient and caregiver were educated to cleanse off fecal material daily and as needed, then apply A&D (brand name of an ointment that contains vitamins A and D and is used to treat or prevent dry, rough, scaly, itchy skin and minor irritations) ointment to buttock; and - The documentation failed to include wound measurements. During an interview on 07/09/2025, beginning at 4:55 PM, the administrator stated that he/she would expect that wounds be measured during the comprehensive assessment and weekly.

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, record review, home visit observation, and interview, the home health provider failed to ensure an accurate medication review and/or update of the patient medications was completed, in three of five full records reviewed (Records/Patients #1, #2, and #3). This deficient practice has the potential to affect all the patients served by the provider. Findings included: Review of the provider’s undated policy titled, “Medication-Regimen Review Comprehensive,” showed in part: - The registered nurse will be responsible for monitoring the patient's medication regimen through a collaborative effort with the multidisciplinary team and physician involved in the patients care; - All required comprehensive assessments will include 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, more significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy; - At the time of admission an accurate, current and complete list of all prescription and over the counter medications, as well as herbal medications, taken by the patient will be maintained on the medication profile; - The clinician will compare the medication list to those on the referral or other documents provided to the provider. Any discrepancies will be reconciled with the physician and documented in the clinical records; - Every effort will be made to reconcile any discrepancies with the physician or designee the next calendar day of the assessment; the clinician will document this contact, and any difficulties experienced in obtaining physician response; - The clinician will notify the director of patient services/ clinical manager if there is no response from the physician on medication reconciliation; - The medication profile will be placed in a highly visible place and include essential information about the dosages, drug schedules, immunizations, and drug allergies; - Nursing staff will assess on an ongoing basis the patient’s response to the medication and the patient/ caregiver’s compliance with medication regime regimen; - Changes in the medication regimen will be documented in the clinical record as well as communicated to the patient and or caregiver; - Review of medications will be ongoing, but done a minimum of every 60 days; and - An updated version of the medication list will be provided in a timely manner to the patient following any changes and prior to discharge from named provider. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 06/11/2025 with a primary diagnosis of type II diabetes mellitus with diabetic chronic kidney disease (a chronic disease that affects how the body uses sugar for energy with resulting damage to the kidneys). The patient lived at home alone. Review of the provider's current medication list showed in part: - Melatonin 3mg one tablet at bedtime for insomnia; - Echinacea 350mg one capsule twice daily (used for the immune system); - Cyclobenzaprine HCL 5mg, one tablet three times daily (muscle relaxer); - Ascorbic acid 500mg one tablet daily (vitamin C supplement); - It failed to list: lidocaine patches (used for pain relief), diclofenac 1% gel (used to relieve arthritis pain), super B vitamin, potassium, calcium/magnesium/zinc (vitamin with mineral), Folate (B vitamin) or albuterol/atrovent (combination medication used to treat and prevent bronchospasm (airway narrowing)) solution per nebulizer (a small machine that turns liquid into a mist that can be easily inhaled). Review of a skilled nurse (SN) visit noted dated 06/24/2025 showed “using lidocaine patches a major decrease in pain shoulders and ankles”. Observation on 07/08/2025 at 8:24 AM, the following medication discrepancies were noted when a medication reconciliation was performed with the patient: - The patient was taking melatonin 5 mg one tablet at bedtime; and - The patient denied taking echinacea and stated that “it had been a long time” since taking that medication; - Cyclobenzaprine HCL 5 mg one tablet two to three times a day, the patient stated that “it makes him/her sleepy so he/she was not taking it three times a day”; and - The patient was taking ascorbic acid 500 mg two tablets daily. Per interview conducted with the patient during observation the patient stated that he/she also took the following which failed to be on the provider’s current medication list: - Lidocaine patch 5% to forearm/upper arm for 12 (twelve) hours a day (on at 8 PM off at 8 AM); - Diclofenac 1% gel to shoulder as needed; - Super B vitamin one tablet daily; - Potassium 99mg one every evening; - Calcium/magnesium/zinc one tablet daily (unable to identify strength as patient had put the medication in a different bottle); - Folate 666 mg one tablet at noon daily; and - Albuterol/Atrovent per nebulizer four times daily as needed for shortness of breath. During an interview on 07/09/2025 at 4:55 PM the administrator stated that he/she would expect the medications to match (what the patient was taking/the current provider’s medication profile). RECORD/PATIENT #1: Review of the clinical record, showed, in part: The patient was admitted to home health services on 06/04/2025 with primary diagnosis of hemiplegia (paralysis on one side of the body) following cerebral infarction (occurs as a result of disrupted blood flow to the brain due to problems with blood vessels that supply it) affecting the right side, type II diabetes mellitus (a group of diseases that results in too much sugar in the blood) with hyperglycemia, venous insufficiency (a condition where veins, usually in the legs, have difficulty returning blood to the heart), long term use of aspirin (can cause serious bleeding). The patient resided at home with adult children as caregivers. On 07/07/2025 at 4:40 PM, during the home visit observation with OT (occupational therapist) A, showed: - The patient’s medication list had Flonase (allergy relief nasal spray) one spray to each nostril twice a day. The patient stated that he/she hasn’t used since discharged from the hospital (06/03/2025); - The patient’s medication list had Miralax (laxative) 17 grams every day. The patient stated that he/she hasn’t used since discharged from the hospital (06/03/2025); - The patient’s medication list had Brilinta (blood thinner) 90 milligrams (mg) twice a day. The patient stated that he/she hasn’t used since discharged from the hospital (06/03/2025); - The patient’s medication list failed to include cilostazol (blood thinner) 100 mg twice a day. The patient stated that he/she took it like the medication bottle showed; - The patient’s medication list failed to include Gabapentin (treat neuropathic pain) 100 mg twice a day. The patient stated that he/she took it like the medication bottle showed; - The patient’s medication list failed to include Vitamin C (supplement) 500 mg every day. The patient stated that he/she took one tablet daily; - The patient’s medication list failed to include Co Q10 (supplement) 200 mg every day. The patient stated that he/she took one tablet daily; - The patient’s medication list failed to include Mucinex (expectorant) 600 mg every day. The patient stated that he/she took one tablet daily; and - The patient’s medication list failed to include lisinopril (high blood pressure) 10 mg every day. The patient stated that he/she took one tablet daily. During an interview on 07/09/2025 at 5:48 PM, the Administrator stated that: - The medication list should match what the patient is taking; and - The nurse is to reconcile the medications at every visit, update the medication list as needed, and check at least every 30 days. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (an injury with full-thickness skin loss caused by unrelieved pressure) of the right buttock. The patient lived at home with his/her significant other. Review of a physician order, dated 06/03/2025, showed: - Super beta prostate advanced two (2) capsules (cap) by mouth (PO) daily over-the-counter (OTC); - “Pt (patient) is taking this supplement, may we put it on (his/her) med (medication) list?;” and - The physician signed the bottom of the order on 06/11/2025 but did not specify if the patient could take the supplement (The clinical record failed to show an updated medication profile with the supplement listed). Observation on 07/08/2025, beginning at 12:30 PM showed: - The patient was taking Aspirin 81mg (milligram) chewable tablets, 1 tablet by mouth daily and the super beta prostate supplement; and - The medication profile failed to include aspirin and the prostate supplement. During an interview on 07/09/2025, beginning at 4:55 PM, the administrator stated that he/she would expect the medication profile to be current.

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 policy review, record review, home visit observation, and interview, the home health provider failed to: - Ensure an individualized plan of care (POC) included relevant physicians who were providing home health orders (G0574); - Ensure drugs, services, and treatments were administered only as ordered by a physician or allowed practitioner (G0580); - 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 (G0590); - Ensure that each patient and his/her caregiver(s) where applicable, received education and training regarding the care and services identified in the plan of care (G0610); - Provide the patient and/or caregiver with a copy of written instructions outlining the patient’s medication schedule/instructions (G0616); and - Provide the patient with the name and contact information of the provider’s clinical manager (G0622). The cumulative effect of these deficient practices has the potential to affect all the patients on service.

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 policy review, record review, and interview, the home health provider failed to develop a complete and individualized plan of care (POC) in, five of five full records reviewed (Records/Patients #1, #2, #3, #4, and #5). This deficient practice has the potential to affect all the patients served by the provider. RECORD/PATIENT #1: Review of the clinical record, showed, in part: The patient was admitted to home health services on 06/04/2025 with primary diagnosis of hemiplegia (paralysis on one side of the body) following cerebral infarction (occurs as a result of disrupted blood flow to the brain due to problems with blood vessels that supply it) affecting the right side, type II diabetes mellitus (a group of diseases that results in too much sugar in the blood) with hyperglycemia, venous insufficiency (a condition where veins, usually in the legs, have difficulty returning blood to the heart), long term use of aspirin (can cause serious bleeding). The patient resided at home with adult children as caregivers. Review of the POC dated 06/04/2025 to 08/02/2025 showed: - Skilled nurse (SN) to instruct patient on measures to detect and alleviate edema; - SN to instruct patient on daily weight self-monitoring program where the patient utilizes the same scales on a hard, flat surface each morning prior to breakfast and after urination; - Skilled nurse to assess patient’s weight log every visit; and - The POC failed to include the frequency for how often the SN was to visit the patient. Review of the SN visit dated 06/20/2025, showed, in part: - The SN documented right and left lower extremities had 2+ edema; - The SN failed to document any instructions to detect and alleviate edema; - The SN failed to document any instructions on daily weight self-monitoring program; and - The SN failed to document assessing the patient’s weight log. During an interview on 07/09/2025 that began at 5:51 PM, the administrator stated that the SN is to follow the POC and there should be a frequency for SN visits. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 06/11/2025 with a primary diagnosis of type II diabetes mellitus with diabetic chronic kidney disease (a chronic disease that affects how the body uses sugar for energy with resulting damage to the kidneys). The patient lived at home alone. Review of the initial comprehensive assessment, dated 06/112025, showed, in part: - The patient had a diagnosis of hypertensive chronic kidney disease, and type 2 diabetes mellitus (adult onset of a chronic disease that affects how the body uses sugar for energy); - The patient was insulin dependent (dependent on the use of insulin injections (a hormone produced by the pancreas that regulates blood sugar levels); and - The patient utilized a bipap (a type of non-invasive ventilation device used to help people with breathing difficulties); and - The patient had a glucometer (a small portable machine that is used to measure how much glucose (sugar) is in the blood). Observation on 07/08/2025 at 8:24 AM showed: - The patient stated “the aide” would be here the next day; and - The nurse came once a week and filled the patient’s medication planner. Review of the POC dated 06/11/2025 to 08/09/2025, showed in part: - The patient’s primary diagnosis was type II diabetes mellitus with diabetic chronic kidney disease; - The SN visit frequency of 1w9 (one time a week for nine weeks); - Interventions included SN assessment of patient with patient with hypertensive chronic kidney disease and type 2 diabetes mellitus; - The POC showed notify physician of “weight greater than (>) 5 (five) lbs (pounds) or less ( - The patient had a Dexacom G7 receiver (a continuous glucose (sugar) monitoring system that helps individuals with diabetes track their glucose levels in real time). Review of the POC dated 06/11/2025 to 08/09/2025, failed to show: - The patient’s medication planner was to be filled weekly by SN; - An aide from an outside source was coming, the frequency of their visits, and what duties they were providing; - A frequency to obtain the patient’s weight; - Specific orders for the use of the bipap; and - The management/care of the Dexacom and who was providing it. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services with a primary diagnosis of a stage three (3) pressure ulcer of the right buttock. Review of the initial comprehensive assessment, dated 05/13/2025, showed, in part: - Under the integumentary (skin) section, the patient had a stage two (partial thickness skin loss, affecting the epidermis and dermis that presents as a shallow, open ulcer or blister, either intact or ruptured, with a red or pink wound bed) pressure ulcer of the right ischium, and the patient has a wound of the right posterior thigh currently with excessive drainage and needs to be cleaned; - Under the diagnosis section diagnosis of a stage three (3) pressure ulcer of the right buttock; - The patient had nephrostomy tubes (a thin flexible tube (catheter) inserted through the skin to drain urine when the normal flow is blocked), last changed 04/20/2025, and recurrent UTI’s (urinary tract infections); and - The patient was insulin dependent and had a random blood sugar (a blood sugar measurement done at any time during the day) of 184. Review of the POC dated 05/12/2025 to 07/10/2025, showed in part: - Patient admitted to home health services on 05/12/2025; - Diagnoses included, but not limited to, a stage three (3) pressure ulcer of the right buttock; - SN “5x2” (five times a week for two weeks), then “3w7” (three times a week for seven weeks for assessment of patient with a stage three (3) pressure ulcer of the right buttock, SN to assess/evaluate wound (s) at each dressing change and prn (as needed); and - SN to instruct the patient and caregiver on wound care as follows: “posterior thigh and stump SN to cleanse open areas well with wound cleanser or equivalent place aquacel ag (a fibrous dressing with silver used for wounds at risk of, or show signs of infection) or equivalent on wound bed directly and place absorbent dressing over entire surface of posterior thigh and stump (the remaining portion of a limb or other body part after an amputation) area taping in place with “medifix” (a non-woven retention tape that conforms to body contours) or equivalent tape for at least 10 days then three times a week. Wound care treatment for “posterior thigh and stump”. Review of a missed visit order dated 05/15/2025, showed the patient had a wound care clinic appointment. Review of a wound care outpatient progress note dated 06/27/2025 showed updated orders/progress notes from “Named wound care/vascular clinic” APRN (advanced practice registered nurse) Review of the POC dated 05/12/2025 to 07/10/2025 failed to show: - Clear and specific wound care orders, including when the patient was responsible and when the SN was responsible for the dressing change; - The physician/or allowed practitioner that would have been managing the wounds; - Nephrostomy tube site assessment/care; and - Frequency of blood sugar levels and if patient or SN was to have done them; During an interview on 07/09/2025 at 4:55 PM, the administrator stated that he/she would expect: - The provider that was responsible for the wound care orders to have been listed on the POC; - The blood sugar frequency be on the POC. He/she was told it was before meals and at bedtime; - That all wound care orders and accurate wound locations to have been on the POC; and - Care and assessment of the nephrostomy tube site on the POC. Findings included: Review of the provider’s undated policy titled, “Plan of Care,” showed, in part: - An individualized plan of care is developed utilizing the comprehensive and initial assessment, as well as, information provided by member of the interdisciplinary team and the physician that identifies patient specific measurable outcomes and goals; - The initial plan of care must include, at a minimum, these patient specific items, in part: * Types of services, supplies, and equipment required * All treatments * The frequency and duration of visits to be made by all disciplines * Problems/needs of the patient and caregiver(s) * Interventions and education; and - The plan of care will serve as physician’s orders for patient care and all staff providing services will be in compliance with the orders. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (an injury with full-thickness skin loss caused by unrelieved pressure) of the right buttock. The patient lived at home with his/her significant other. Review of the recertification comprehensive assessment, dated 05/13/2025, showed, in part: - The patient sits in his/her recliner all day and in his/her feces for hours, resulting in pressure injury/wound; - The patient had a stage 3 pressure injury to the right buttock; - The patient and caregiver were educated to cleanse off fecal material daily and as needed, then apply A&D (brand name of an ointment that contains vitamins A and D and is used to treat or prevent dry, rough, scaly, itchy skin and minor irritations) ointment to buttock; - Wound care completed to stage 3 pressure sore on rt (right) buttock; and - Patient admitted to home health services for treatment and assessment of stage 3 pressure sore. Review of the plan of care (POC) dated 05/17/2025 to 07/15/2025, showed in part: - The patient’s primary diagnosis was a pressure ulcer of the right buttock, stage 3; - Skilled nurse (SN) visit frequency of 2w9 (two times a week for nine weeks); - Interventions included SN assessment of patient with stage 3 pressure ulcer of right buttock, dementia (decline in mental capacity), psychophysiological insomnia (a type of insomnia characterized by a cycle of anxiety about sleep leading to difficulty falling asleep and staying asleep, which in turn increases anxiety about sleep), nonalcoholic steatohepatitis (NASH, a buildup of fat in the liver), alcoholic cirrhosis (chronic liver damage from a variety of causes leading to scarring and liver failure) of the liver without ascites (fluid build up in abdomen), alcohol dependence, and polyneuropathy (a general term for peripheral nervous system disorders that impact nerve function in multiple areas of the body); and - The POC failed to include any other SN interventions and/or orders for wound care of the stage 3 pressure injury. During an interview on 07/09/2025, beginning at 4:55 PM, the administrator stated that he/she would expect SN interventions for wound care to be on the POC. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 06/11/2025 with a primary diagnosis of type II diabetes mellitus with diabetic chronic kidney disease (a chronic disease that affects how the body uses sugar for energy with resulting damage to the kidneys). The patient lived at home alone. Review of the initial comprehensive assessment, dated 06/112025, showed, in part: - The patient had a diagnosis of hypertensive chronic kidney disease, and type 2 diabetes mellitus (adult onset of a chronic disease that affects how the body uses sugar for energy); - The patient was insulin dependent (dependent on the use of insulin injections (a hormone produced by the pancreas that regulates blood sugar levels); and - The patient utilized a bipap (a type of non-invasive ventilation device used to help people with breathing difficulties); and - The patient had a glucometer (a small portable machine that is used to measure how much glucose (sugar) is in the blood). Observation on 07/08/2025 at 8:24 AM showed: - The patient stated “the aide” would be here the next day; and - The nurse came once a week and filled the patient’s medication planner. Review of the POC dated 06/11/2025 to 08/09/2025, showed in part: - The patient’s primary diagnosis was type II diabetes mellitus with diabetic chronic kidney disease; - The SN visit frequency of 1w9 (one time a week for nine weeks); - Interventions included SN assessment of patient with patient with hypertensive chronic kidney disease and type 2 diabetes mellitus; - The POC showed notify physician of “weight greater than (>) 5 (five) lbs (pounds) or less ( - The patient had a Dexacom G7 receiver (a continuous glucose (sugar) monitoring system that helps individuals with diabetes track their glucose levels in real time). Review of the POC dated 06/11/2025 to 08/09/2025, failed to show: - The patient’s medication planner was to be filled weekly by SN; - An aide from an outside source was coming, the frequency of their visits, and what duties they were providing; - A frequency to obtain the patient’s weight; - Specific orders for the use of the bipap; and - The management/care of the Dexacom and who was providing it. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services with a primary diagnosis of a stage three (3) pressure ulcer of the right buttock. Review of the initial comprehensive assessment, dated 05/13/2025, showed, in part: - Under the integumentary (skin) section, the patient had a stage two (partial thickness skin loss, affecting the epidermis and dermis that presents as a shallow, open ulcer or blister, either intact or ruptured, with a red or pink wound bed) pressure ulcer of the right ischium, and the patient has a wound of the right posterior thigh currently with excessive drainage and needs to be cleaned; - Under the diagnosis section diagnosis of a stage three (3) pressure ulcer of the right buttock; - The patient had nephrostomy tubes (a thin flexible tube (catheter) inserted through the skin to drain urine when the normal flow is blocked), last changed 04/20/2025, and recurrent UTI’s (urinary tract infections); and - The patient was insulin dependent and had a random blood sugar (a blood sugar measurement done at any time during the day) of 184. Review of the POC dated 05/12/2025 to 07/10/2025, showed in part: - Patient admitted to home health services on 05/12/2025; - Diagnoses included, but not limited to, a stage three (3) pressure ulcer of the right buttock; - SN “5x2” (five times a week for two weeks), then “3w7” (three times a week for seven weeks for assessment of patient with a stage three (3) pressure ulcer of the right buttock, SN to assess/evaluate wound (s) at each dressing change and prn (as needed); and - SN to instruct the patient and caregiver on wound care as follows: “posterior thigh and stump SN to cleanse open areas well with wound cleanser or equivalent place aquacel ag (a fibrous dressing with silver used for wounds at risk of, or show signs of infection) or equivalent on wound bed directly and place absorbent dressing over entire surface of posterior thigh and stump (the remaining portion of a limb or other body part after an amputation) area taping in place with “medifix” (a non-woven retention tape that conforms to body contours) or equivalent tape for at least 10 days then three times a week. Wound care treatment for “posterior thigh and stump”. Review of a missed visit order dated 05/15/2025, showed the patient had a wound care clinic appointment. Review of a wound care outpatient progress note dated 06/27/2025 showed updated orders/progress notes from “Named wound care/vascular clinic” APRN (advanced practice registered nurse) Review of the POC dated 05/12/2025 to 07/10/2025 failed to show: - Clear and specific wound care orders, including when the patient was responsible and when the SN was responsible for the dressing change; - The physician/or allowed practitioner that would have been managing the wounds; - Nephrostomy tube site assessment/care; and - Frequency of blood sugar levels and if patient or SN was to have done them; During an interview on 07/09/2025 at 4:55 PM, the administrator stated that he/she would expect: - The provider that was responsible for the wound care orders to have been listed on the POC; - The blood sugar frequency be on the POC. He/she was told it was before meals and at bedtime; - That all wound care orders and accurate wound locations to have been on the POC; and - Care and assessment of the nephrostomy tube site on the POC. RECORD/PATIENT #1: Review of the clinical record, showed, in part: The patient was admitted to home health services on 06/04/2025 with primary diagnosis of hemiplegia (paralysis on one side of the body) following cerebral infarction (occurs as a result of disrupted blood flow to the brain due to problems with blood vessels that supply it) affecting the right side, type II diabetes mellitus (a group of diseases that results in too much sugar in the blood) with hyperglycemia, venous insufficiency (a condition where veins, usually in the legs, have difficulty returning blood to the heart), long term use of aspirin (can cause serious bleeding). The patient resided at home with adult children as caregivers. Review of the POC dated 06/04/2025 to 08/02/2025 showed: - Skilled nurse (SN) to instruct patient on measures to detect and alleviate edema; - SN to instruct patient on daily weight self-monitoring program where the patient utilizes the same scales on a hard, flat surface each morning prior to breakfast and after urination; - Skilled nurse to assess patient’s weight log every visit; and - The POC failed to include the frequency for how often the SN was to visit the patient. Review of the SN visit dated 06/20/2025, showed, in part: - The SN documented right and left lower extremities had 2+ edema; - The SN failed to document any instructions to detect and alleviate edema; - The SN failed to document any instructions on daily weight self-monitoring program; and - The SN failed to document assessing the patient’s weight log. During an interview on 07/09/2025 that began at 5:51 PM, the administrator stated that the SN is to follow the POC and there should be a frequency for SN visits. Findings included: Review of the provider’s undated policy titled, “Plan of Care,” showed, in part: - An individualized plan of care is developed utilizing the comprehensive and initial assessment, as well as, information provided by member of the interdisciplinary team and the physician that identifies patient specific measurable outcomes and goals; - The initial plan of care must include, at a minimum, these patient specific items, in part: * Types of services, supplies, and equipment required * All treatments * The frequency and duration of visits to be made by all disciplines * Problems/needs of the patient and caregiver(s) * Interventions and education; and - The plan of care will serve as physician’s orders for patient care and all staff providing services will be in compliance with the orders. RECORD/PATIENT #1: Review of the clinical record, showed, in part: The patient was admitted to home health services on 06/04/2025 with primary diagnosis of hemiplegia (paralysis on one side of the body) following cerebral infarction (occurs as a result of disrupted blood flow to the brain due to problems with blood vessels that supply it) affecting the right side, type II diabetes mellitus (a group of diseases that results in too much sugar in the blood) with hyperglycemia, venous insufficiency (a condition where veins, usually in the legs, have difficulty returning blood to the heart), long term use of aspirin (can cause serious bleeding). The patient resided at home with adult children as caregivers. Review of the POC dated 06/04/2025 to 08/02/2025 showed: - Skilled nurse (SN) to instruct patient on measures to detect and alleviate edema; - SN to instruct patient on daily weight self-monitoring program where the patient utilized the same scales on a hard, flat surface each morning prior to breakfast and after urination; - Skilled nurse to assess patient’s weight log every visit; and - The POC failed to include the frequency for how often the SN was to visit the patient. Review of the SN visit dated 06/20/2025, showed, in part: - The SN documented the right and left lower extremities had 2+ edema (a grading system that measured the swelling of tissues); - The SN failed to document any instructions to detect and alleviate edema; - The SN failed to document any instructions on daily weight self-monitoring program; and - The SN failed to document that the patient’s weight log was assessed. During an interview on 07/09/2025 that began at 5:51 PM, the administrator stated that the SN was to follow the POC and there should have been a frequency for SN visits. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (an injury with full-thickness skin loss caused by unrelieved pressure) of the right buttock. The patient lived at home with his/her significant other. Review of the recertification comprehensive assessment, dated 05/13/2025, showed, in part: - The patient sat in his/her recliner all day and in his/her feces for hours, resulting in pressure injury/wound; - The patient had a stage 3 pressure injury to the right buttock; - The patient and caregiver were educated to cleanse off fecal material daily and as needed, then apply A&D (brand name of an ointment that contains vitamins A and D and is used to treat or prevent dry, rough, scaly, itchy skin and minor irritations) ointment to buttock; - Wound care completed to stage 3 pressure sore on rt (right) buttock; and - Patient admitted to home health services for treatment and assessment of stage 3 pressure sore. Review of the plan of care (POC) dated 05/17/2025 to 07/15/2025, showed in part: - The patient’s primary diagnosis was a pressure ulcer of the right buttock, stage 3; - SN visit frequency of 2w9 (two times a week for nine weeks); - Interventions included SN assessment of patient with stage 3 pressure ulcer of right buttock, dementia (decline in mental capacity), psychophysiological insomnia (a type of insomnia characterized by a cycle of anxiety about sleep leading to difficulty falling asleep and staying asleep, which in turn increases anxiety about sleep), nonalcoholic steatohepatitis (NASH, a buildup of fat in the liver), alcoholic cirrhosis (chronic liver damage from a variety of causes leading to scarring and liver failure) of the liver without ascites (fluid build up in abdomen), alcohol dependence, and polyneuropathy (a general term for peripheral nervous system disorders that impact nerve function in multiple areas of the body); and - The POC failed to include any other SN interventions and/or orders for wound care of the stage 3 pressure injury. During an interview on 07/09/2025, beginning at 4:55 PM, the administrator stated that he/she would expect SN interventions for wound care to be on the POC. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 06/11/2025 with a primary diagnosis of type II diabetes mellitus with diabetic chronic kidney disease (damage to the kidneys caused by diabetes). The patient lived at home alone. Review of the initial comprehensive assessment, dated 06/112025, showed, in part: - The patient had a diagnosis of hypertensive chronic kidney disease, and type 2 diabetes mellitus (adult onset of a chronic disease that affects how the body uses sugar for energy); - The patient was insulin dependent (dependent on the use of insulin injections (a hormone produced by the pancreas that regulates blood sugar levels); - The patient utilized a bipap (a type of non-invasive ventilation device used to help people with breathing difficulties); and - The patient had a glucometer (a small portable machine that is used to measure how much glucose (sugar) is in the blood). Review of the POC dated 06/11/2025 to 08/09/2025, showed in part: - The patient’s primary diagnosis was type II diabetes mellitus with diabetic chronic kidney disease; - The SN visit frequency of 1w9 (one time a week for nine weeks); - Interventions included SN assessment of patient with patient with hypertensive chronic kidney disease and type 2 diabetes mellitus; - The POC showed notify physician of “weight greater than (>) 5 (five) lbs (pounds) or less ( - The patient had a Dexacom G7 receiver (a continuous glucose (sugar) monitoring system that helped individuals with diabetes track their glucose levels in real time). Observation and interview on 07/08/2025 at 8:24 AM showed: - The patient stated “the aide” would be here the next day; and - The nurse came once a week and filled the patient’s medication planner. The POC failed to include: - The patient’s medication planner was to be filled weekly by SN; - An aide from an outside source was coming, the frequency of their visits, and what duties they were to provide; - A frequency to obtain the patient’s weight; - Specific orders for the use of the bipap; and - The management/care of the Dexacom and who was providing it. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services with a primary diagnosis of a stage 3 pressure ulcer of the right buttock. Review of the initial comprehensive assessment, dated 05/13/2025, showed, in part: - Under the integumentary (skin) section, the patient had a stage two (partial thickness loss of skin) pressure ulcer of the right ischium (the lower and back part of the hip bone), and the patient had a wound of the right posterior thigh with excessive drainage that needed to be cleaned; - Under the diagnosis section diagnosis of a stage 3 pressure ulcer of the right buttock; - The patient had nephrostomy tubes (a thin flexible tube (catheter) inserted through the skin to drain urine when the normal flow is blocked), last changed 04/20/2025, and recurrent UTI’s (urinary tract infections); and - The patient was insulin dependent and had a random blood sugar (a blood sugar measurement done at any time during the day) of 184. Review of the POC dated 05/12/2025 to 07/10/2025, showed in part: - Patient admitted to home health services on 05/12/2025; - Diagnoses included, but were not limited to, a stage three 3 pressure ulcer of the right buttock; - SN “5x2” (five times a week for two weeks), then “3w7” (three times a week for seven weeks for assessment of patient with a stage three (3) pressure ulcer of the right buttock, SN to assess/evaluate wound (s) at each dressing change and prn (as needed); and - SN to instruct the patient and caregiver on wound care as follows: “posterior thigh and stump SN to cleanse open areas well with wound cleanser or equivalent place aquacel ag (a fibrous dressing with silver used for wounds at risk of, or show signs of infection) or equivalent on wound bed directly and place absorbent dressing over entire surface of posterior thigh and stump (the remaining portion of a limb or other body part after an amputation) area taping in place with “medifix” (a non-woven retention tape that conforms to body contours) or equivalent tape for at least 10 days then three times a week. Wound care treatment for “posterior thigh and stump”. Review of a missed visit order dated 05/15/2025, showed the patient had a wound care clinic appointment. Review of a wound care outpatient progress note dated 06/27/2025 showed updated orders/progress notes from “Named wound care/vascular clinic” APRN (advanced practice registered nurse) The POC failed to include: - Clear and specific wound care orders, that included when the patient was responsible and when the SN was responsible for the dressing change; - The physician/or allowed practitioner that managed the wounds; - Nephrostomy tube site assessment/care; and - Frequency to check blood sugar levels and who was responsible for doing them; During an interview on 07/09/2025 at 4:55 PM, the administrator stated that he/she would expect the POC to have included: - The provider that was responsible for the wound care orders; - The blood sugar frequency (he/she was told it was before meals and at bedtime; - That all wound care orders and accurate wound locations to have been on the POC; and - Care and assessment of the nephrostomy tube site on the POC.

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 policy review, record review, home visit observation, and interview, the home health provider failed to ensure that treatments were provided only as ordered by the physician, in three of five full records reviewed (Records/Patients #1, #2 and #4). This deficient practice has the potential to affect all the patients served by the provider. RECORD/PATIENT #1: Review of the clinical record, showed, in part: The patient was admitted to home health services on 06/04/2025 with primary diagnosis of hemiplegia (paralysis on one side of the body) following cerebral infarction (occurs as a result of disrupted blood flow to the brain due to problems with blood vessels that supply it) affecting the right side, type II diabetes mellitus (a group of diseases that results in too much sugar in the blood) with hyperglycemia, venous insufficiency (a condition where veins, usually in the legs, have difficulty returning blood to the heart), long term use of aspirin (can cause serious bleeding). The patient resided at home with adult children as caregivers. Review of the plan of care (POC), dated 06/04/2025 to 08/02/2025 failed to show a visit frequency for a SN. Review of a skilled nurse visit note, dated 06/20/2025, showed that the SN (skilled nurse) visited the patient and performed an assessment. Review of a missed visit form, dated 07/02/2025, showed that the SN visit was missed and there was no answer at patient’s phone. During an interview on 07/09/2025 at 5:51 PM, the administrator stated that there should be a SN frequency on the POC. Findings included: Review of the provider’s undated policy titled, “Physician Plan of Care (POC)/ Physician’s Orders,” showed in part: - Physician orders are to be obtained prior to the initiation of any care, including all support services related to client/patient care, and any services requiring the administration of medication, prescribed treatment(s), or other activities governed by state law; - Services are provided under an individualized plan of care that is established by the primary care physician, the home health provider staff, and the patient; and - The POC is written by the appropriate staff member in collaboration with the multidisciplinary team, the physician, and the patient, and is based on the initial assessment of the patient's problems and needs at the start of care. It is then reviewed and revised as frequently as the patient's condition or needs require, but no less than every 60 days from the start of care; and - The plan of care will serve as physician orders for patient care and all staff providing services will be in compliance with the orders. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services with a primary diagnosis of a stage three (3) pressure ulcer of the right buttock. Review of the POC dated 05/12/2025 to 07/10/2025, showed in part: - Patient admitted to home health services on 05/12/2025; - Diagnoses included, but not limited to, a stage three (3) pressure ulcer of the right buttock; - SN “5x2” (five times a week for two weeks), then “3w7” (three times a week for seven weeks for assessment of patient with a stage three (3) pressure ulcer of the right buttock, SN to assess/evaluate wound (s) at each dressing change and prn (as needed); - SN to instruct the patient and caregiver on wound care as follows: “posterior thigh and stump SN to cleanse open areas well with wound cleanser or equivalent place aquacel ag (a fibrous dressing with silver used for wounds at risk of, or show signs of infection) or equivalent on wound bed directly and place absorbent dressing over entire surface of posterior thigh and stump (the remaining portion of a limb or other body part after an amputation) area taping in place with metafix (a non-woven retention tape that conforms to body contours) or equivalent tape for at least 10 days then three times a week. It failed to indicate how often the patient and caregiver were going to change the dressing and how often the SN would. Review of a SN visit note dated 05/16/2025 showed, under the wound section: - Wound two: location- abdomen, treatment- cleansed areas well with wound cleanser and cover with aquacel ag and place abd (abdominal gauze pad used to absorb heavy drainage) and medifix tape on open area. The POC failed to show an order for an abdominal wound treatment; and - Wound three: location- left stump posterior, treatment- cleansed area well and cover with aquacel ag and place abd on top and tape in place, but spray with wound skin prep (used to create a protective barrier on the skin before applying adhesives, tapes, or dressings) after cleaning the wound bed. The POC failed to show an order for use of skin prep. Review of a SN visit note dated 05/23/2025 showed, under the wound section: - Wound two: location- right stump area, treatment- cleansed well and sprayed with wskin prep to strengthen skin and covered with fibrous dressing and placed abdominal dressing and taped in place. The POC failed to show an order for use of a fibrous dressing without silver or the use of skin prep. During an interview on 07/09/2025 at 4:55 PM the administrator stated that he/she would expect wound care orders to be followed Findings included: Review of the provider’s undated policy titled, “Physician Plan of Care (POC)/ Physician’s Orders,” showed in part: - Physician orders are to be obtained prior to the initiation of any care, including all support services related to client/patient care, and any services requiring the administration of medication, prescribed treatment(s), or other activities governed by state law; - Services are provided under an individualized plan of care that is established by the primary care physician, the home health provider staff, and the patient; and - The POC is written by the appropriate staff member in collaboration with the multidisciplinary team, the physician, and the patient, and is based on the initial assessment of the patient's problems and needs at the start of care. It is then reviewed and revised as frequently as the patient's condition or needs require, but no less than every 60 days from the start of care; and - The plan of care will serve as physician orders for patient care and all staff providing services will be in compliance with the orders. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (an injury with full-thickness skin loss caused by unrelieved pressure) of the right buttock. The patient lived at home with his/her significant other. Review of the plan of care (POC) dated 05/17/2025 to 07/15/2025, showed in part: - The patient’s primary diagnosis was a pressure ulcer of the right buttock, stage 3; - Skilled nurse (SN) visit frequency of 2w9 (two times a week for nine weeks); - Interventions included SN assessment of patient with stage 3 pressure ulcer of right buttock, dementia (decline in mental capacity), psychophysiological insomnia (a type of insomnia characterized by a cycle of anxiety about sleep leading to difficulty falling asleep and staying asleep, which in turn increases anxiety about sleep), nonalcoholic steatohepatitis (NASH, a buildup of fat in the liver), alcoholic cirrhosis (chronic liver damage from a variety of causes leading to scarring and liver failure) of the liver without ascites (fluid build up in abdomen), alcohol dependence, and polyneuropathy (a general term for peripheral nervous system disorders that impact nerve function in multiple areas of the body); and - The POC failed to include any other SN interventions and/or orders for wound care of the stage 3 pressure injury. Observation on 07/08/2025, beginning at 12:30 PM showed: - The SN applied A&D (brand name of an ointment that contains vitamins A and D and is used to treat or prevent dry, rough, scaly, itchy skin and minor irritations) ointment to the patient’s buttocks and Voltaren gel (a topical nonsteroidal anti-inflammatory medication that treats joint pain) to the patient’s back and bilateral lower extremities (BLE); and - The clinician completed interventions that were not listed on the POC and the clinical record failed to show orders for the treatments RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services with a primary diagnosis of a stage three (3) pressure ulcer of the right buttock. Review of the POC dated 05/12/2025 to 07/10/2025, showed in part: - Patient admitted to home health services on 05/12/2025; - Diagnoses included, but not limited to, a stage three (3) pressure ulcer of the right buttock; - SN “5x2” (five times a week for two weeks), then “3w7” (three times a week for seven weeks for assessment of patient with a stage three (3) pressure ulcer of the right buttock, SN to assess/evaluate wound (s) at each dressing change and prn (as needed); - SN to instruct the patient and caregiver on wound care as follows: “posterior thigh and stump SN to cleanse open areas well with wound cleanser or equivalent place aquacel ag (a fibrous dressing with silver used for wounds at risk of, or show signs of infection) or equivalent on wound bed directly and place absorbent dressing over entire surface of posterior thigh and stump (the remaining portion of a limb or other body part after an amputation) area taping in place with metafix (a non-woven retention tape that conforms to body contours) or equivalent tape for at least 10 days then three times a week. It failed to indicate how often the patient and caregiver were going to change the dressing and how often the SN would. Review of a SN visit note dated 05/16/2025 showed, under the wound section: - Wound two: location- abdomen, treatment- cleansed areas well with wound cleanser and cover with aquacel ag and place abd (abdominal gauze pad used to absorb heavy drainage) and medifix tape on open area. The POC failed to show an order for an abdominal wound treatment; and - Wound three: location- left stump posterior, treatment- cleansed area well and cover with aquacel ag and place abd on top and tape in place, but spray with wound skin prep (used to create a protective barrier on the skin before applying adhesives, tapes, or dressings) after cleaning the wound bed. The POC failed to show an order for use of skin prep. Review of a SN visit note dated 05/23/2025 showed, under the wound section: - Wound two: location- right stump area, treatment- cleansed well and sprayed with wskin prep to strengthen skin and covered with fibrous dressing and placed abdominal dressing and taped in place. The POC failed to show an order for use of a fibrous dressing without silver or the use of skin prep. During an interview on 07/09/2025 at 4:55 PM the administrator stated that he/she would expect wound care orders to be followed RECORD/PATIENT #1: Review of the clinical record, showed, in part: The patient was admitted to home health services on 06/04/2025 with primary diagnosis of hemiplegia (paralysis on one side of the body) following cerebral infarction (occurs as a result of disrupted blood flow to the brain due to problems with blood vessels that supply it) affecting the right side, type II diabetes mellitus (a group of diseases that results in too much sugar in the blood) with hyperglycemia, venous insufficiency (a condition where veins, usually in the legs, have difficulty returning blood to the heart), long term use of aspirin (can cause serious bleeding). The patient resided at home with adult children as caregivers. Review of the plan of care (POC), dated 06/04/2025 to 08/02/2025 failed to show a visit frequency for a SN. Review of a skilled nurse visit note, dated 06/20/2025, showed that the SN (skilled nurse) visited the patient and performed an assessment. Review of a missed visit form, dated 07/02/2025, showed that the SN visit was missed and there was no answer at patient’s phone. During an interview on 07/09/2025 at 5:51 PM, the administrator stated that there should be a SN frequency on the POC.

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 policy review, record review, and interview, the home health provider failed to promptly alert the physician when the patient had a change in condition, in four of five full records reviewed (Record/Patient #1, #2, #3, and #4). This deficient practice has the potential to affect all the patients served by the provider. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 06/11/2025 with a primary diagnosis of type II diabetes mellitus with diabetic chronic kidney disease (a chronic disease that affects how the body uses sugar for energy with resulting damage to the kidneys). The patient lived at home alone. Review of the clinical record showed: - A SN visit note dated 06/24/2025 showed the patient was utilizing a lidocaine patch (patch used to treat pain); and - Review of the current medication list supplied to the state agent failed to have lidocaine patches listed. Observation on 07/08/2025 at 8:24 AM, showed the patient voiced he/she: - Had fallen two weeks ago while at church; and - Had utilized lidocaine patches that were helping with the pain. Review of the physical therapist visit noted date 07/08/2025 failed to show any communication with the physician or home health provider regarding the patient’s fall. Further review of the clinical record failed to show any documentation of physician notification of the patient’s fall or use of lidocaine patches. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services with a primary diagnosis of a stage three (3) pressure ulcer of the right buttock. Review of the plan of care dated 05/12/2025 to 07/10/2025 showed: - A diagnosis of type I diabetes mellitus with ketoacidosis with coma (a life long condition where the pancreas makes little tor no insulin, which leads to high blood sugar levels, leading to a buildup of acids (ketones) in the blood and causing a loss of consciousness); - It failed to contain an order for a frequency to check the patient’s blood sugar. Review of a skilled nurse noted dated 05/26/2025 showed: -A comment under the blood sugar section- “Not taking blood sugar as prescribed”; and - Under the coordination plan section, physician contact failed to have any documentation. It was left blank. Review of a skilled nurse note dated 06/25/2025 showed in comments under the pain assessment section- “06/25/2025 Client have developed pus filled pockets under wound on back of right and on her abdominal. Client have wound care appt on Friday 06/27/2025; - Under the coordination plan section, physician contact failed to have any documentation. It was left blank. During an interview on 07/09/2025 at 4:55 PM the administrator stated that: - He/she would expect the lidocaine patch came from the pharmacy. The nurse should have written it down and gotten an order; - It is expected that the clinician should notify the physician of a fall and if there are injuries; - He/she would assume the frequency the patient was to have checked their blood sugar to have been on the plan of care and would expect the physician to be notified if the patient was not following the frequency it was to be checked; - He/she was told the frequency was before meals and at bedtime. Findings included: Review of the provider’s undated policy titled, 12.5.44 “Physician Plan of Care/Physician’s Orders,” showed in part: - The relevant physician(s) must be notified of any changes in the patient condition or needs that suggest that outcomes are not being met and/or the plan of care should be revised. RECORD/PATIENT #1: Review of the clinical record, showed, in part: The patient was admitted to home health services on 06/04/2025 with primary diagnosis of hemiplegia (paralysis on one side of the body) following cerebral infarction (occurs as a result of disrupted blood flow to the brain due to problems with blood vessels that supply it) affecting the right side, type II diabetes mellitus (a group of diseases that results in too much sugar in the blood) with hyperglycemia, venous insufficiency (a condition where veins, usually in the legs, have difficulty returning blood to the heart), long term use of aspirin (can cause serious bleeding). The patient resided at home with adult children as caregivers. Review of the skilled nurse visit note, on 06/20/2025, showed, in part: - Skin, comment – discoloration bilateral lower extremities; - Edema - left and right lower extremities 2 plus edema; and - The clinical record failed to show that the physician was notified of the discoloration in the bilateral lower extremities and edema. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (an injury with full-thickness skin loss caused by unrelieved pressure) of the right buttock. The patient lived at home with his/her significant other. Review of the recertification comprehensive assessment, dated 05/13/2025, showed, in part: - The patient had pitting edema to the bilateral feet and ankles; - A goal for the patient to verbalize and demonstrate edema relieving measures by elevating bilateral lower extremities (BLE) and wearing light pressure stockings with a target date of 07/15/2025 for the goal to be met; - The wound worksheet section showed the patient had a stage 3 opened pressure injury to right buttock, open, present on admission, length not applicable (N/A), width N/A, depth N/A, cleanse and apply A&D (brand name of an ointment that contains vitamins A and D and is used to treat or prevent dry, rough, scaly, itchy skin and minor irritations) ointment to buttock, and the patient and caregiver were educated to cleanse off fecal material daily and as needed and then apply A&D ointment to buttock; and - Interventions performed showed, SN to assess and evaluate wound(s) at each dressing change and as needed (PRN) for signs and symptoms of infection, instruct the spouse on signs and symptoms of wound infection to report to physician, and teach spouse to perform wound care daily and as needed. Review of the plan of care (POC) dated 05/17/2025 to 07/15/2025, showed in part: - The patient’s primary diagnosis was a pressure ulcer of the right buttock, stage 3; - Skilled nurse (SN) visit frequency of 2w9 (two times a week for nine weeks); - Interventions included SN assessment of patient with stage 3 pressure ulcer of right buttock, dementia (decline in mental capacity), psychophysiological insomnia (a type of insomnia characterized by a cycle of anxiety about sleep leading to difficulty falling asleep and staying asleep, which in turn increases anxiety about sleep), nonalcoholic steatohepatitis (NASH, a buildup of fat in the liver), alcoholic cirrhosis (chronic liver damage from a variety of causes leading to scarring and liver failure) of the liver without ascites (fluid build up in abdomen), alcohol dependence, and polyneuropathy (a general term for peripheral nervous system disorders that impact nerve function in multiple areas of the body); and - The POC failed to include a diagnosis of edema and any SN interventions for edema and wound care. Review of the skilled nurse (SN) visit note, dated 06/03/2025, showed in part: - The patient had edema to BLE and was educated to elevated feet frequently due to edema; - A patient was taking super beta prostate advance (supplement for the prostate) two (2) capsules (caps) daily, the patient did not want to bother the primary care provider (PCP) but wanted to take the supplement, and a medication request was sent to the PCP; and - The documentation failed to show the physician was notified of the patient’s edema and taking a prostate supplement without an order. Review of a physician order, dated 06/03/2025, showed: - Super beta prostate advanced 2 cap by mouth (PO) daily over-the-counter (OTC); - “Pt (patient) is taking this supplement, may we put it on (his/her) med (medication) list?;” - The physician signed the bottom of the order on 06/11/2025 but did not specify if the patient could take the supplement; and - The clinical record failed to show the physician was notified for clarification regarding the medication order. Review of the SN visit note, dated 06/10/2025, showed: - The wound worksheet section showed “handwritten note from (named) PCP in home to try solosite (a gel that is used to create a moist wound environment that aides in healing) and mupirocin (a topical antibiotic ointment primarily used to treat bacterial skin infections) for wound care;” - Solosite with mupirocin was applied to the wound; and - The documentation failed to show that the physician was notified regarding the handwritten note for wound care and the clinical record failed to show orders for the wound care. Review of the SN visit note, dated 06/20/2025, showed in part: - “Pt states (he/she) was taking ASA (aspirin- nonsteroidal anti-inflammatory medication) 61mg (milligrams) every day, even though the dr (doctor) did not order it, but has not taken it in 5 days d/t (due to) slight bruising on arm. Educated pt that dr did not order ASA and should not take meds without dr red ring (ordering) them; and - The documentation failed to show the physician was notified that the patient was taking aspirin and the clinical record failed to show orders for the aspirin. Findings included: Review of the provider’s undated policy titled, "12.5.44 Physician Plan of Care/Physician’s Orders,” showed in part the relevant physician(s) must be notified of any changes in the patient condition or needs that suggest that outcomes are not being met and/or the plan of care should be revised. RECORD/PATIENT #1: Review of the clinical record, showed, in part: The patient was admitted to home health services on 06/04/2025 with primary diagnosis of hemiplegia (paralysis on one side of the body) following cerebral infarction (occurs as a result of disrupted blood flow to the brain due to problems with blood vessels that supply it) affecting the right side, type II diabetes mellitus (a group of diseases that results in too much sugar in the blood) with hyperglycemia, venous insufficiency (a condition where veins, usually in the legs, have difficulty returning blood to the heart), long term use of aspirin (can cause serious bleeding). The patient resided at home with adult children as caregivers. Review of the skilled nurse (SN) visit note, dated 06/20/2025, showed, in part: - Skin, comment – discoloration bilateral lower extremities; - Edema (swelling of the tissues) - left and right lower extremities 2 plus (a grading system used to measure edema) edema; and - The clinical record failed to show that the physician was notified of the discoloration in the bilateral lower extremities (BLE) and edema. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (an injury with full-thickness skin loss caused by unrelieved pressure) of the right buttock. The patient lived at home with his/her significant other. Review of the recertification comprehensive assessment, dated 05/13/2025, showed, in part: - The patient had pitting edema to the bilateral feet and ankles; - A goal for the patient to verbalize and demonstrate edema relieving measures by elevating BLE and wearing light pressure stockings with a target date of 07/15/2025 for the goal to be met; - The wound worksheet section showed the patient had a stage 3 opened pressure injury to right buttock, open, present on admission, length not applicable (N/A), width N/A, depth N/A, cleanse and apply A&D (brand name of an ointment that contains vitamins A and D and is used to treat or prevent dry, rough, scaly, itchy skin and minor irritations) ointment to buttock, and the patient and caregiver were educated to cleanse off fecal material daily and as needed and then apply A&D ointment to buttock; and - Interventions performed showed, SN to assess and evaluate wound(s) at each dressing change and as needed (PRN) for signs and symptoms of infection, instruct the spouse on signs and symptoms of wound infection to report to physician, and teach spouse to perform wound care daily and as needed. Review of the plan of care (POC) dated 05/17/2025 to 07/15/2025, showed in part: - The patient’s primary diagnosis was a pressure ulcer of the right buttock, stage 3; - Skilled nurse (SN) visit frequency of 2w9 (two times a week for nine weeks); - Interventions included SN assessment of patient with stage 3 pressure ulcer of right buttock; and - The POC failed to include SN interventions for edema and wound care. Review of the SN visit note, dated 06/03/2025, showed in part: - The patient had edema to BLE and was educated to elevated feet frequently due to edema; - A patient was taking super beta prostate advance (supplement for the prostate) two (2) capsules (caps) daily, the patient did not want to bother the primary care provider (PCP) but wanted to take the supplement, and a medication request was sent to the PCP; and - The documentation failed to show the physician was notified of the patient’s edema and that the patient took a prostate supplement without an order. Review of a physician order, dated 06/03/2025, showed: - Super beta prostate advanced 2 cap by mouth (PO) daily over-the-counter (OTC); - “Pt (patient) is taking this supplement, may we put it on (his/her) med (medication) list?;” - The physician signed the bottom of the order on 06/11/2025 but did not specify if the patient could take the supplement; and - The clinical record failed to show the physician was notified for clarification regarding the medication order. Review of the SN visit note, dated 06/10/2025, showed: - The wound worksheet section showed “handwritten note from (named) PCP in home to try Solosite (a gel that is used to create a moist wound environment that aides in healing) and mupirocin (a topical antibiotic ointment primarily used to treat bacterial skin infections) for wound care;” - Solosite with mupirocin was applied to the wound; and - The documentation failed to show that the physician was notified regarding the handwritten note for wound care and the clinical record failed to show orders for the wound care. Review of the SN visit note, dated 06/20/2025, showed in part: - “Pt states (he/she) was taking ASA (aspirin- nonsteroidal anti-inflammatory medication) 61mg (milligrams) every day, even though the dr (doctor) did not order it, but has not taken it in 5 (five) days d/t (due to) slight bruising on arm. Educated pt that dr did not order ASA and should not take meds without dr red ring (ordering) them; and - The documentation failed to show the physician was notified that the patient was taking aspirin and the clinical record failed to show orders for the aspirin. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 06/11/2025 with a primary diagnosis of type II diabetes mellitus with diabetic chronic kidney disease (damage to the kidneys caused by diabetes). The patient lived at home alone. Review of the clinical record showed: - A SN visit note dated 06/24/2025 showed the patient was utilizing a lidocaine patch (patch used to treat pain); and - Review of the current medication list supplied to the state agent failed to include lidocaine patches. Observation and interview on 07/08/2025 at 8:24 AM, showed the patient had lidocaine patches in the home and the patient stated that he/she: - Had fallen two weeks ago while at church; and - Had utilized lidocaine patches that were helping with the pain. Review of the physical therapist visit noted dated 07/08/2025, failed to show any communication with the physician or home health provider regarding the patient’s fall. Further review of the clinical record failed to show any documentation of physician notification of the patient’s fall or use of lidocaine patches. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services with a primary diagnosis of a stage 3 pressure ulcer of the right buttock. Review of the POC, dated 05/12/2025 to 07/10/2025 showed: - A diagnosis of type I diabetes mellitus with ketoacidosis with coma (a life long condition where the pancreas makes little tor no insulin, which leads to high blood sugar levels, leading to a buildup of acids (ketones) in the blood and causing a loss of consciousness); - It failed to show an order for a frequency to check the patient’s blood sugar. Review of a SN noted dated 05/26/2025 showed: -A comment under the blood sugar section- “Not taking blood sugar as prescribed”; and - coordination plan section, physician contact failed to have any documentation. It was left blank. Review of a skilled nurse note dated 06/25/2025 showed in comments under the pain assessment section- “06/25/2025 Client have (has) developed pus filled pockets under wound on back of right and on her abdominal. Client have (has) wound care appt on Friday 06/27/2025; and - Under the coordination plan section, physician contact failed to have any documentation. It was left blank. During an interview on 07/09/2025 at 4:55 PM the administrator stated that: - He/she would expect the lidocaine patch came from the pharmacy. The nurse should have written it down and gotten an order; - It is expected that the clinician should notify the physician of a fall and if there are injuries; - He/she would assume the frequency the patient was to have checked their blood sugar to have been on the plan of care and would expect the physician to be notified if the patient was not following the frequency it was to be checked; - He/she was told the frequency was before meals and at bedtime.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure that each patient and his or her caregiver(s), received education regarding the physician order to instruct the patient on measures to detect and alleviate edema and instruct on a daily weight self-monitoring program, in one of five full records reviewed (Record/Patient #1). This deficient practice has the potential to affect all the patients served by the provider. Findings included: Review of the provider’s undated policy titled, “Plan of Care,” showed, in part: - The initial plan of care (POC) must include interventions and education; and - The POC will serve as physician’s orders for patient care and all staff providing services will be in compliance with the orders. RECORD/PATIENT #1: Review of the clinical record, showed, in part: The patient was admitted to home health services on 06/04/2025 with primary diagnosis of hemiplegia (paralysis on one side of the body) following cerebral infarction (occurs as a result of disrupted blood flow to the brain due to problems with blood vessels that supply it) affecting the right side, type II diabetes mellitus (a group of diseases that results in too much sugar in the blood) with hyperglycemia, venous insufficiency (a condition where veins, usually in the legs, have difficulty returning blood to the heart), long term use of aspirin (can cause serious bleeding). The patient resided at home with adult children as caregivers. Review of the POC, dated 06/04/2025 to 08/02/2025, showed: - Skilled nurse (SN) to instruct patient on measures to detect and alleviate edema; and - SN to instruct patient on daily weight self-monitoring program where the patient utilized the same scales on a hard, flat surface each morning prior to breakfast and after urination. Review of the SN visit dated 06/20/2025, showed, in part: - The SN documented right and left lower extremities had 2+ edema (a grading system to measure swelling of the tissues); - The SN failed to document any instructions to detect and alleviate edema; and - The SN failed to document any instructions on daily weight self-monitoring program. During an interview on 07/09/2025 that began at 5:51 PM, the administrator stated that the SN was to follow the POC and document education given to the patient and if goals were met.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on policy review, record review, home visit observation, and interview, the home health provider failed to ensure each patient received complete/accurate written instructions related to their medication schedule/instruction in two of three home visit observations (Records/Patients #2 and #3). This deficient practice has the potential to affect all the patients served by the provider. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (full-thickness skin loss, where the wound extends into the fatty layer but does not expose bone, tendon, or muscle) of the right buttock. The patient lived at home with his/her significant other. Observation on 07/08/2025 at 12:30 PM with registered nurse (RN) A and licensed practical nurse (LPN) A, showed that the home folder failed to contain a written medication schedule/instructions. During an interview on 07/09/2025, beginning at 4:55 PM, the administrator stated that the patient’s medication list should be in the home. Findings included: Review of the home health provider’s undated policy titled, “Medication - Regimen Review Comprehensive,” showed in part: - At the time of admission an accurate, current, and complete list of all prescription and over the counter medications, as well as herbal medications taken by the patient will be maintained on the medication profile; - The medication profile will be placed in a highly visible place and include essential information about dosages, drug schedules, immunizations, and drug allergies; - Review of the medications will be ongoing, but done a minimum of every 60 days; and - An updated version of the medication list will be provided in a timely manner to the patient following any changes and prior to discharge from “named provider”. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 06/11/2025 with a primary diagnosis of type II diabetes mellitus with diabetic chronic kidney disease (a chronic disease that affects how the body uses sugar for energy with resulting damage to the kidneys). The patient lived at home alone. Observation on 07/08/2025 at 8:24 AM with physical therapist (PT) A, showed that the home folder was missing and there failed to be written medication schedule/instructions in the home. Per interview conducted during observation, the patient stated that the nurse comes weekly and sets up his/her medication planner and brings a medication list with them. Findings included: Review of the home health provider’s undated policy titled, “Medication - Regimen Review Comprehensive,” showed in part: - At the time of admission an accurate, current, and complete list of all prescription and over the counter medications, as well as herbal medications taken by the patient will be maintained on the medication profile; - The medication profile will be placed in a highly visible place and include essential information about dosages, drug schedules, immunizations, and drug allergies; - Review of the medications will be ongoing, but done a minimum of every 60 days; and - An updated version of the medication list will be provided in a timely manner to the patient following any changes and prior to discharge from “named provider”. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (an injury with full-thickness skin loss caused by unrelieved pressure) of the right buttock. The patient lived at home with his/her significant other. Observation on 07/08/2025 at 12:30 PM, showed that the home folder (given to patients on admission) failed to contain a written medication schedule/instructions. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 06/11/2025 with a primary diagnosis of type II diabetes mellitus with diabetic chronic kidney disease (a chronic disease that affects how the body uses sugar for energy with resulting damage to the kidneys). The patient lived at home alone. Observation on 07/08/2025 at 8:24 AM with physical therapist (PT) A, showed that the home folder was missing and there failed to be written medication schedule/instructions in the home. Per interview conducted during observation, the patient stated that the nurse comes weekly and set up his/her medication planner and brought a medication list with them. During an interview on 07/09/2025, beginning at 4:55 PM, the administrator stated that the patient’s medication list should have been in the home.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on policy review, record review, home visit observation and interview, the home health provider failed to ensure staff provided the patient and/or caregiver with the name contact information for the provider’s clinical manager in, one of three home visit observations conducted (Record/Patient #2). This deficient practice has the potential to adversely affect the knowledge of self-care and provider expectations in all the patients served by the provider. Findings included: Review of the providers undated policy titled, “Agency Grievance Policy/Process,” showed: - If you have any concerns at all, please tell us verbally, or in writing, the administrator or clinical manager or any staff member you are comfortable with; and - They will ensure the concern is presented to the administrator or clinical manager. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (an injury with full-thickness skin loss caused by unrelieved pressure) of the right buttock. The patient lived at home with his/her significant other. Observation on 07/08/2025, beginning at 12:30 PM, showed: - The home health folder (given to patients on admission) contained a business card with the name and contact information of the previous administrator; - Three names were handwritten on the front of the folder (none matched the current clinical manager); and - The licensed practical nurse (LPN) A stated that the folder needed to be updated because he/she didn’t even know who the names (previous staff) were. During an interview on 07/09/2025, beginning at 4:55 PM, the administrator stated that the home folder should have been updated with the correct information.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on review of the internet quality improvement and evaluation system (iQIES; a cloud-based application developed by the Centers for Medicare and Medicaid Services (CMS) for managing provider and patient information, and ensuring quality healthcare, specifically for Medicare and Medicaid beneficiaries) website, policy review, review of the governing body meeting minutes, and interview, the home health provider failed to: - Ensure the quality assessment performance improvement (QAPI) program included quality indicator data, derived from the outcome and assessment information set (OASIS; a standardized data collection tool) reports (G0644); and - Provide evidence that the governing body was responsible for ensuring an ongoing program for quality improvement and patient safety (G0660). The cumulative effect of these deficient practices has the potential to affect the quality of care and safety for all the patients on service.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on review of the internet quality improvement and evaluation system (iQIES; a cloud-based application developed by the Centers for Medicare and Medicaid Services (CMS) for managing provider and patient information, and ensuring quality healthcare, specifically for Medicare and Medicaid beneficiaries) website, policy review, review of the governing body meeting minutes, and interview, the home health provider failed to ensure the quality assessment performance improvement (QAPI) program included quality indicator data, derived from the outcome and assessment information set (OASIS; a standardized data collection tool) reports. This deficient practice has the potential to affect the quality of care for all the patients on service. Findings included: Review of the iQIES website on 07/09/2025 at 12:00 PM, showed the provider had failed to electronically transmit or submit any OASIS since 12/30/2024, therefore there failed to be any OASIS reports for the previous two quarters (01/01/2025 through 06/30/2025). Review of the provider’s policy titled, “QAPI Program,” dated 10/2018, showed in part the following: - The agency (provider) will develop, implement, maintain and document effective, ongoing agency-wide, data-driven quality assessment and performance improvement program; - The program will use quality indicator data, including measures derived from OASIS reports, home health compare, infection prevention and control data, patient satisfaction, and other relevant data, in the design of its program; - The agency will use the data collected to monitor the effectiveness and safety of services and quality of care as well as identify opportunities and priorities for improvement; - Activities will be monitored and acted upon by the QAPI committee, designated by the governing body, ensuring that the agency implements its established QAPI program; - The QAPI committee consists of selected disciplines, along with clinical and/or administrative management; - The QAPI committee will meet to; * Advise the agency to ensure quality and appropriateness of patient care and service delivery * Identify QAPI quality indicators * Review of OASIS outcome reports to identify low patient outcomes necessitating quality indicators and/or education - The following reports/databases will be used by the agency in determining quality indicators to include in the agency QAPI program; and * Outcome reports based upon OASIS data submitted by the organization (Agency patient related characteristics, risk adjusted outcome report, potentially avoidable events, and process-based quality improvement) - The QAPI monitoring, and evaluation activities will address all home care services provided by the agency with the goal to improve patient care and agency operations. Review of the provider’s policy titled, “OASIS Data Measurements,” dated 10/2018, showed in part the following: - Data driven systems, such as OASIS data collection and outcome measurement, depend on the accuracy of source data describing patient health status. Minimizing data errors that could affect accuracy of clinical data or outcome analysis are a necessary function; - By CMS having a data driven system for the benchmarking of outcomes from OASIS data collection, the agency is able to assess where they rank in relation to home health agencies in the nation, and on home health compare, to the state; - The agency will incorporate review of the outcomes in the OASIS reports as part of the agency-wide QAPI program. The agency, with input/oversight of the agency’s governing body, will determine quality indicators to include in the QAPI program review for the review period (quarter/annual) which are of chief concern to the agency’s patient population; - The agency may utilize the quality indicators included in the OASIS, as well as other industry accepted measures; and - A summary of findings and any actions to take for improvement will be reported to the QAPI committee, agency administrator, and to the governing body. Review of the governing body meeting minutes, dated 12/29/2024, showed the administrator was the QAPI/infection control coordinator for 2025. During an interview on 07/09/2025 at 12:30 PM, the administrator stated that he/she thought that the provider’s electronic medical record (EMR) company had been electronically transmitting and submitting the OASIS to iQIES. On 07/09/2025 at 3:45 PM, the state agent (SA) requested the administrator run/print the OASIS reports for QAPI for the last two quarters (01/01/2025 through 06/30/2025). During an interview on 07/09/2025 at 4:00 PM, the administrator stated that: - He/she ran the reports, but that the report showed no data available; - There was no data available because no OASIS had been electronically transmitted or submitted; - He/she did not realize that they were to run the OASIS reports as part of the QAPI program (per the agency policy); - He/she was part of the QAPI committee and was also on the governing body; and - He/she could not show the SA any QAPI information as the clinical manager had that on his/her computer and the clinical manager was in the hospital.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on policy review, review of the governing body meeting minutes, and interview, the home health provider failed to provide evidence that the governing body was responsible for ensuring an ongoing program for quality improvement and patient safety. This deficient practice has the potential to affect the quality of care and safety for all the patients on service. Findings included: Review of the provider’s undated policy titled, “Governing Body,” showed in part the following: - The governing body carries out responsibilities specific to the organization including; * Assume responsibility for the agency’s (provider’s) Quality Assessment Performance Improvement (QAPI) program * Evaluating organizational performance - The governing body complies with organizational policies, regulations, and/or other organizational legal documents; and -The governing body meets to review the operation of the agency and documents all meetings by minutes. The minutes of all official meetings of the governing body are retained for a minimum of five years. At a minimum, the minutes of the governing body will include: Review of the QAPI reports, trends, and actions taken, as appropriate. Review of the governing body meeting minutes, dated 03/12/2025 and 06/02/2025, failed to show evidence of oversight/review of the QAPI program. During an interview on 07/09/2025 at 4:00 PM, the administrator stated that: - He/she was part of the governing body; - QAPI was discussed during the governing body meetings; and - He/she had no evidence that the QAPI program was discussed during the governing body meeting.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on policy review, review of governing body minutes, and interview, the home health provider failed to provide evidence the infection control program was included in the quality assessment performance improvement (QAPI) program. This deficient practice has the potential to affect the quality of care and safety for all the patients on service. Findings included: Review of the provider’s policy titled, “QAPI Program,” dated 10/2018, showed in part the following: - The provider will develop, implement, maintain and document effective, ongoing agency-wide, data-driven QAPI program. The QAPI activities will include performance improvement projects; - The provider’s governing body will ensure that the program: Addresses priorities for improved quality of care, infection prevention and patient safety, and that all improvement actions are evaluated for effectiveness and sustainability; - The program will use quality indicator data, including measures derived from outcome and assessment information set (OASIS; a standardized data collection tool) reports, home health compare, infection prevention and control data, patient satisfaction, and other relevant data, in the design of its program; - The provider’s QAPI activities will track incidents, complaints, infections, medication errors, and other adverse patient events and analyze their causes, and implement preventative actions; - Written minutes will document dates of meetings, signatures of attendees with their titles, agendas, written summary of clinical record review findings and recommendations suggested by QAPI members; and - The QAPI committee shall submit the written findings of the meeting to the governing body. Review of the provider’s undated policy titled, “Governing Body,” showed in part the following: - The governing body meets to review the operation of the agency and documents all meetings by minutes; and - At a minimum, the minutes of the governing body will include, a review of the QAPI reports, trends, and actions taken, as appropriate. Review of the governing body minutes dated 03/12/2025 and 06/02/2025, failed to show QAPI or infection control was discussed. During an interview on 07/09/2025 at 4:00 PM, the administrator stated that: - He/she was part of the QAPI committee and was also on the governing body; - Infection control was discussed during QAPI; - QAPI was discussed during the governing body meetings; - He/she had no evidence that the QAPI program was discussed during the governing body meeting; and - He/she could not show the state agent any QAPI information as the clinical manager had that on his/her computer and the clinical manager was in the hospital.

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on policy review, clinical record review, and interview, the home health provider failed to maintain professional standards when wound measurements were not obtained/documented according to the provider's policy in, two of two records with wounds (Records/Patients #2 and #4). This deficient practice has the potential to affect all the patients with wounds served by the provider. Findings included: Review of the home health provider’s undated policy titled, "Wound Measurement Policy- Weekly Assessment," showed in part: - All licensed nursing staff registered nurse (RN) or licensed practical nurse (LPN) are responsible for performing wound measurements weekly or more frequently if there is significant change in the wounds condition; and - Measurements must be recorded accurately in the patient's clinical record using standardized methods and terminology. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services with a primary diagnosis of a stage three (3) pressure ulcer of the right buttock. Review of the POC dated 05/12/2025 to 07/10/2025, showed in part: - Patient admitted to home health services on 05/12/2025; - Diagnoses included, but not limited to, a stage three (3) pressure ulcer of the right buttock; - SN “5x2” (five times a week for two weeks), then “3w7” (three times a week for seven weeks for assessment of patient with a stage three (3) pressure ulcer of the right buttock, SN to assess/evaluate wound (s) at each dressing change and prn (as needed); - SN to instruct the patient and caregiver on wound care as follows: “posterior thigh and stump SN to cleanse open areas well with wound cleanser or equivalent place aquacel AG or equivalent on wound bed directly and place absorbent dressing over entire surface of posterior thigh and stump (the remaining portion of a limb or other body part after an amputation) area taping in place with metafix or equivalent tape for at least 10 days then three times a week. It failed to indicate how often the patient and caregiver were going to change the dressing and how often the SN would. Review of the SN SOC visit note dated 05/13/2025, showed in part, under the wound care worksheet portion: - Wound one: location- right posterior ischium (lower part of your pelvis bone), onset date- 05/12/2025, type- pressure injury, Stage 2 (partial thickness skin loss, affecting the epidermis and dermis that presents as a shallow, open ulcer or blister, either intact or ruptured, with a red or pink wound bed), size- length 13cm (centimeters)/width 14cm/depth 1cm, wound bed- red, wound edges- non attached, drainage- serosanguineous (a thin, red discharge composed of serum and blood), amount- large, odor- musty, surrounding tissue- erythema (redness of the skin), excoriated (injury/irritation to the skin such as scratching, an abrasion, or a burn), additional information- “PATIENT HAS WOUND OF RIGHT POSTERIOR THIGH CURRENTLY WITH EXCESSIVE DRAINAGE AND NEEDS TO BE CLEANED”; and - There failed to be any measurements of the right posterior thigh wound. Review of every SN visit note dated from 05/26/2025 up to and including 06/30/2025 failed to show any wound measurements documented. Review of the OASIS (Outcome and Assessment Information Set; a standardized data collection tool) recertification SN visit note dated 07/07/2025 showed: - Wound one: location- right posterior “ISHIUM”, onset date- 05/12/2025, status- closed, onset date- 05/12/2025, type- pressure injury, Stage 2, size- length 13cm width 14cm/depth 1cm, wound bed-left blank, drainage- serosanguineous, amount- large, odor- musty; - Wound two: location- right stump area, status- open, present on admission, type- traumatic, wound bed-left blank, drainage- serosanguineous, amount- moderate, odor- left blank; and - Wound three: location- abdominal, status- open, present on admission, type- pressure injury, stage- two, wound bed-left blank, drainage- serosanguineous, amount- moderate, odor- left blank; and - There failed to be measurements documented of wounds two and three. Further review of the clinical record failed to show orders to discontinue any wound care/dressings or addition of any new wound care orders. During an interview on 07/09/2025 at 4:55 PM, the administrator stated that weekly wound measurements were expected to be documented per the agency’s (provider’s) policy. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (an injury with full-thickness skin loss caused by unrelieved pressure) of the right buttock. The patient lived at home with his/her significant other. Review of the plan of care (POC) dated 05/17/2025 to 07/15/2025, showed in part: - The patient’s primary diagnosis was a pressure ulcer of the right buttock, stage 3; - Skilled nurse (SN) visit frequency of 2w9 (two times a week for nine weeks); - Interventions included SN assessment of patient with stage 3 pressure ulcer of right buttock, dementia (decline in mental capacity), psychophysiological insomnia (a type of insomnia characterized by a cycle of anxiety about sleep leading to difficulty falling asleep and staying asleep, which in turn increases anxiety about sleep), nonalcoholic steatohepatitis (NASH, a buildup of fat in the liver), alcoholic cirrhosis (chronic liver damage from a variety of causes leading to scarring and liver failure) of the liver without ascites (fluid build up in abdomen), alcohol dependence, and polyneuropathy (a general term for peripheral nervous system disorders that impact nerve function in multiple areas of the body). Review of clinical record failed to show documentation of any wound measurements from 05/17/2025 to 07/08/2025. During an interview on 07/09/2025, beginning at 4:55 PM, the administrator stated that he/she would expect that wounds be measured during the comprehensive assessment and weekly. Findings included: Review of the home health provider’s undated policy titled, "Wound Measurement Policy- Weekly Assessment," showed in part: - All licensed nursing staff registered nurse (RN) or licensed practical nurse (LPN) are responsible for performing wound measurements weekly or more frequently if there is significant change in the wounds condition; and - Measurements must be recorded accurately in the patient's clinical record using standardized methods and terminology. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (an injury with full-thickness skin loss caused by unrelieved pressure) of the right buttock. The patient lived at home with his/her significant other. Review of the plan of care (POC) dated 05/17/2025 to 07/15/2025, showed in part: - The patient’s primary diagnosis was a pressure ulcer of the right buttock, stage 3; - Skilled nurse (SN) visit frequency of 2w9 (two times a week for nine weeks); and - Interventions included SN assessment of patient with stage 3 pressure ulcer of right buttock. Review of clinical record showed the skilled nurses failed to measure the patient's wound from 05/17/2025 to 07/08/2025. During an interview on 07/09/2025, beginning at 4:55 PM, the administrator stated that he/she would expect that wounds were measured during the comprehensive assessment and weekly. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services with a primary diagnosis of a stage three (3) pressure ulcer of the right buttock. Review of the POC dated 05/12/2025 to 07/10/2025, showed in part: - Patient admitted to home health services on 05/12/2025; - Diagnoses included, but were not limited to, a stage 3 pressure ulcer of the right buttock; - SN “5x2” (five times a week for two weeks), then “3w7” (three times a week for seven weeks for assessment of patient with a stage three (3) pressure ulcer of the right buttock, SN to assess/evaluate wound (s) at each dressing change and prn (as needed); and - SN to instruct the patient and caregiver on wound care as follows: “posterior thigh and stump SN to cleanse open areas well with wound cleanser or equivalent place aquacel AG or equivalent on wound bed directly and place absorbent dressing over entire surface of posterior thigh and stump (the remaining portion of a limb or other body part after an amputation) area taping in place with metafix or equivalent tape for at least 10 days then three times a week. It failed to indicate how often the patient and caregiver were going to change the dressing and how often the SN would. Review of the initial comprehensive assessment, dated 05/13/2025, showed in part, under the wound care worksheet portion: - Wound one: location- right posterior ischium (lower part of your pelvis bone), onset date- 05/12/2025, type- pressure injury, Stage 2 (partial thickness skin loss, affecting the epidermis and dermis that presents as a shallow, open ulcer or blister, either intact or ruptured, with a red or pink wound bed), size- length 13cm (centimeters)/width 14cm/depth 1cm, wound bed- red, wound edges- non attached, drainage- serosanguineous (a thin, red discharge composed of serum and blood), amount- large, odor- musty, surrounding tissue- erythema (redness of the skin), excoriated (injury/irritation to the skin such as scratching, an abrasion, or a burn), additional information- “PATIENT HAS WOUND OF RIGHT POSTERIOR THIGH CURRENTLY WITH EXCESSIVE DRAINAGE AND NEEDS TO BE CLEANED”; and - The nurse failed to measure the right posterior thigh wound. Review of every SN visit note dated from 05/26/2025 up to and including 06/30/2025 failed to show any wound measurements documented. Review of the SN visit notes dated 06/03/2025, 06/09/2025, 06/11/2025, and 06/13/2025, 06/16/2025, 06/18/2025, 06/23/2025, and 06/30/2025 showed LPN A failed to document wound assessments and wound care as ordered in the POC. Review of the OASIS (Outcome and Assessment Information Set; a standardized data collection tool) recertification SN visit note dated 07/07/2025 showed: - Wound one: location- right posterior “ISHIUM”, onset date- 05/12/2025, status- closed, onset date- 05/12/2025, type- pressure injury, Stage 2, size- length 13cm width 14cm/depth 1cm, wound bed-left blank, drainage- serosanguineous, amount- large, odor- musty; - Wound two: location- right stump area, status- open, present on admission, type- traumatic, wound bed-left blank, drainage- serosanguineous, amount- moderate, odor- left blank; - Wound three: location- abdominal, status- open, present on admission, type- pressure injury, stage- two, wound bed-left blank, drainage- serosanguineous, amount- moderate, odor- left blank; and - There failed to be measurements documented of wounds two and three. Further review of the clinical record failed to show orders to discontinue any wound care/dressings or addition of any new wound care orders. During an interview on 07/09/2025 at 4:55 PM, the administrator stated that weekly wound measurements were expected to be documented per the agency’s (provider’s) policy.

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 policy review, clinical record review, and interview, the home health provider failed to ensure the registered nurse (RN) adequately supervised the licensed practical nurse (LPN) in two of five records of patients who received LPN visits (Records/Patients #2, and #4). This deficient practice has the potential to affect all the patients receiving care from LPNs. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services with a primary diagnosis of a stage three (3) pressure ulcer of the right buttock. Review of the POC dated 05/12/2025 to 07/10/2025, showed in part: - Patient admitted to home health services on 05/12/2025; - Diagnoses included, but not limited to, a stage three (3) pressure ulcer of the right buttock; - SN “5x2” (five times a week for two weeks), then “3w7” (three times a week for seven weeks for assessment of patient with a stage three (3) pressure ulcer of the right buttock, SN to assess/evaluate wound (s) at each dressing change and prn (as needed); and - SN to instruct the patient and caregiver on wound care as follows: “posterior thigh and stump SN to cleanse open areas well with wound cleanser or equivalent, place aquacel ag (a fibrous dressing with silver used for wounds at risk of, or showing signs of infection) or equivalent on wound bed directly and place absorbent dressing over entire surface of posterior thigh and stump (the remaining portion of a limb or other body part after an amputation) area taping in place with “medifix” tape (a non-woven retention tape that conforms to body contours) or equivalent tape for at least 10 days then three times a week. The POC failed to indicate how often the patient and caregiver were going to change the dressing and how often the SN would. Review of the skilled nurse visit notes, dated 06/03/2025, 06/09/2025, 06/11/2025, 06/13/2025, 06/16/2025, 06/18/2025, 06/23/2025, 06/25/2025, and 06/30/2025 showed LPN A failed to document wound assessments, or wound care according to the POC. The LPN also failed to document weekly wound measurements per the home health provider’s policy. Further review of the clinical record showed the LPN also failed to document weekly wound measurements per the home health provider’s policy. Review of the LVN/LPN supervisory note dated 06/13/2025/2025 showed: - Follows client plan of care as instructed: excellent; - Documents appropriately: satisfactory; and - Adheres to organizational policies and procedures: satisfactory. Review of the LVN/LPN supervisory note dated 07/07/2025 showed: - Follows client plan of care as instructed: satisfactory; - Documents appropriately: satisfactory; and - Adheres to organizational policies and procedures: satisfactory. During an interview on 07/09/2025 at 4:55 PM the administrator stated that: - He/she would have expected the RN to make sure the LPN was documenting what was on the POC; and - Weekly wound measurements were expected to be documented per the agency’s (provider’s) policy. Findings included: Review of the providers undated policy titled, “Description of Services Policy- Skilled Nursing,” showed: - (The home health provider) provides skilled nursing services under the supervision of a registered nurse and in compliance with the plan of care (POC); - The qualified registered nurse will: * Supervise the LPN/licensed vocational nurse (LVN) through instruction on initial POC as established by the qualified RN * Perform LPN/LVN supervisory visits by making a patient on-site visit without the LPN/LVN, and by communicating with the LPN/LVN and reviewing documentation * When indicated, the RN will make on-site visits with the LPN/LVN; and - The LPN/LVN provides patient services as assigned and is directly supervised by the RN. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (an injury with full-thickness skin loss caused by unrelieved pressure) of the right buttock. The patient lived at home with his/her significant other. Review of the plan of care (POC) dated 05/17/2025 to 07/15/2025, showed in part: - The patient’s primary diagnosis was a pressure ulcer of the right buttock, stage 3; - Skilled nurse (SN) visit frequency of 2w9 (two times a week for nine weeks); - Interventions included SN assessment of patient with stage 3 pressure ulcer of right buttock, dementia (decline in mental capacity), psychophysiological insomnia (a type of insomnia characterized by a cycle of anxiety about sleep leading to difficulty falling asleep and staying asleep, which in turn increases anxiety about sleep), nonalcoholic steatohepatitis (NASH, a buildup of fat in the liver), alcoholic cirrhosis (chronic liver damage from a variety of causes leading to scarring and liver failure) of the liver without ascites (fluid build up in abdomen), alcohol dependence, and polyneuropathy (a general term for peripheral nervous system disorders that impact nerve function in multiple areas of the body); and - The POC failed to include any other SN interventions and/or orders for wound care of the stage 3 pressure injury. Review of the supervisory visit note, dated 07/08/2025, showed, in part: - Satisfactory was answered for the LPN following the client plan of care as instructed; - Excellent was answered for the LPN documenting appropriately; and - Satisfactory was answered for the LPN adhering to organizational policies and procedures. Observation on 07/08/2025, beginning at 12:30 PM showed: - RN A was conducting an on-site supervisory visit of LPN A during the SN visit; - The SN applied A&D (brand name of an ointment that contains vitamins A and D and is used to treat or prevent dry, rough, scaly, itchy skin and minor irritations) ointment to the patient’s buttocks and Voltaran gel (a topical nonsteroidal anti-inflammatory medication that treats joint pain) to the patient’s back and bilateral lower extremities (BLE); - The POC failed to show interventions for Voltaren gel to be applied to the patients back and BLE and wound care to be performed during SN visits; - The LPN failed to assess all medications that the patient was taking; - Medication discrepancies were identified during the visit as the patient was taking a prostate supplement and aspirin that were not listed on the medication profile.

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 five Conditions of Participation: Reporting OASIS information, Patient rights, Care planning, coordination of services, and quality of care, Quality assessment and performance improvement (QAPI), and Organization and administration of 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 07/09/2027.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on current survey findings, policy review, review of the governing body minutes, and interview, the home health provider failed to ensure: - The governing body assumed responsibility for the overall clinical and financial operations and the quality assessment performance improvement (QAPI) program (G0942); and - That the administrator and governing body authorized in writing a pre-designated administrator for when the administrator is not available (G0954). The cumulative effect of these deficient practices has the potential to affect the quality of care and safety of all the patients on service.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on current survey findings, policy review, review of the governing body minutes, and interview, the home health provider failed to ensure the governing body assumed responsibility for the overall clinical and financial operations and the quality assessment performance improvement (QAPI) program. This deficient practice has the potential to affect all the patients on service. Findings included: Review of current survey findings showed the provider failed to meet compliance for: - Five Conditions of Participation: * §484.45 Reporting OASIS information (G0370; affects payment); * §484.55 Comprehensive assessment of patients (G0510); * §484.60 Care planning, coordination of services, and quality of care (G0570); * §484.65 QAPI (G0640); * §484.105 Organization and administrations of services; and - Level 1 (one) standard deficiencies, including: * G0414: Contact information for the home health administrator; * G0514: Registered nurse must conduct initial assessment within 48 hours of referral, or return home, or on ordered start of care date; * G0528: Comprehensive assessment must accurately reflect the patient’s status and include at a minimum current health, psychosocial, functional, and cognitive status; * G0536: A review of all current medications; * G0574: Plan of care must be individualized; * G0580: Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner; * G0590: Promptly alert 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; * G0610: Ensure that education and training are provided; * G0616: Provide a copy of the patient’s medication schedule/instructions to the patient; * G0622: Provide the name and contact information of the home health clinical manager to the patient; * G0710: Provide services that are ordered by the physician or allowed practitioner as indicated in the plan of care; * G0726: Nursing services are provided under the supervision of a registered nurse; and * G1024: All clinical record entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Review of the provider’s undated policy titled, “Governing Body,” showed in part the following: -The governing body assumes full legal authority and responsibility for the operation of the agency (provider), including: * Management of operations; * Provision of all home health services; * Fiscal operations; * Review of budget; * Operational plans; * QAPI program; - The governing body carries out responsibilities specific to the organization including: * Selecting and evaluating the administrator; * Assume responsibility for the provider’s QAPI program; * Evaluating organizational performance; - The governing body complies with organizational policies, regulations, and or other organizational legal documents; - The governing body meets to review the operation of the agency and documents all meetings by minutes; and - At a minimum, the minutes of the governing body will include: * Appointment of the administrator; and * Review QAPI reports, trends, and actions taken, as appropriate. Review of the governing body minutes, dated 12/29/2024, showed in part the following: - The current administrator appointed as the administrator for 2025; - The current administrator was the QAPI/infection control coordinator for 2025; and - QAPI and infection control manuals reviewed, discussed, and approved. Review of the governing body minutes, dated 03/12/2025, showed in part the following: - The current administrator in attendance; and - Failed to show the QAPI program or infection control were discussed or reviewed. Review of the governing body minutes, dated 06/02/2025, showed in part the following: - The current administrator in attendance; and - Failed to show the QAPI program or infection control were discussed or reviewed. During an interview on 07/09/2025 at 4:00 PM, the administrator stated that: - He/she was part of the governing body; - QAPI and infection control were discussed and reviewed during the governing body meetings; and - He/she had no evidence that the QAPI program or infection control were discussed or reviewed during the governing body meeting.

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on policy review, review of the governing body minutes, and interview, the home health provider failed to ensure that the administrator and governing body authorized in writing a pre-designated administrator for when the administrator is not available. This deficient practice has the potential to affect all the patients on service. Findings included: Review of the provider’s undated policy titled, “Governing Body,” showed in part the following: - The governing body assumes full legal authority and responsibility for the operation of the agency (provider), including: Management and operations; - Governing body members are oriented to the organization and are knowledgeable and responsive to key issues affecting the organization; - The governing body complies with organizational policies, regulations, and or other organizational legal documents; - The governing body meets to review the operation of the agency and document all meetings by minutes; and - At a minimum, the minutes of the governing body will include: Appointment of the administrator. Review of the governing body minutes, dated 12/29/2024, showed in part the following: - The current administrator appointed as the administrator for 2025; and - A previous employee as the designee in the absence of the administrator for 2025. Review of the governing body minutes, dated 06/02/2025, showed in part the following: - The previous employee that was named as the designee for 2025, removed from the governing body; and - The minutes failed to show anyone else named as a designee for the administrator. During the entrance interview on 07/07/2025 at 10:55 AM, the administrator stated that the new clinical manager was the pre-designated back-up administrator. During an interview on 07/09/2025 at 5:00 PM, the administrator stated that he/she was unable to find in writing where he/she and the governing body had appointed and approved of the pre-designated back-up administrator.

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 were accurate and complete, in two of five full records reviewed (Records/Patients #2 and #4). This deficient practice has the potential to affect all the patients served by the provider. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services with a primary diagnosis of a stage three pressure ulcer of the right buttock. Review of the POC dated 05/12/2025 to 07/10/2025 showed: - A stage three pressure ulcer on the right buttock; and - Wound care treatment for wounds on the “posterior thigh and stump; The POC failed to: - Include wound care and treatment orders for the right buttock pressure ulcer; and - Specify whether the posterior thigh and stump wounds were on the right or left leg. Review of the initial comprehensive assessment dated 05/13/2025 (one day after the POC effective date), included an entry on the wound care worksheet portion that showed, wound one: location- right posterior ischium (lower part of your pelvis bone), onset date- 05/12/2025, additional information- “PATIENT HAS WOUND OF RIGHT POSTERIOR THIGH CURRENTLY WITH EXCESSIVE DRAINAGE AND NEEDS TO BE CLEANED”. The documentation failed to specify whether the “posterior thigh” wound was a separate wound or whether the intent was to refer to the wound on the right posterior ischium. Review of the SN visit note dated 05/16/2025, showed: - Wound one: location- left posterior “ISHIUM” (ischium) (the lower and back part of the hip bone) the onset date was 05/12/2025. The initial comprehensive assessment showed the wound was on the right ischium),; - Wound two: location- abdominal, status- closed, present on admission; (the abdominal wound was not identified on the 05/13/2025 initial comprehensive assessment); and - Wound three: location- left posterior stump (the remaining portion of a limb or other body part after an amputation), status- open, present on admission. Review of a SN visit noted dated 05/19/2025, included an entry in the discharge planning section that showed: written notice of discharge provided to patient. Discharge scheduled for: 04/28/2025 (15 days prior to admission). Review of the SN visit note dated 06/25/2025, included a narrative note that showed “06/25/2025 Client have (has) developed pus filled pockets under wound on back of right and on her abdominal. Client have (has) wound care appt (appointment) on Friday 06/27/2025”. Review of a skilled nurse visit note dated 06/30/2025 included a narrative note in the pain assessment section- “06/25/2025 Client have (has) developed pus filled pockets under wound on back of right and on her abdominal. Client have (has) wound care appt (appointment) on Friday 06/27/2025” (the entry was identical to the narrative note in the 06/25/2025 SN note and the wound care appointment would have occurred three days prior to this visit). During an interview on 07/09/2025 at 4:55 PM, the administrator stated that: - The POC date of 05/12/2025 should have matched the date of the initial comprehensive assessment (05/13/2025); - He/she spoke with the nurse about the contradicting locations of the wounds; and - He/she would expect the documentation to be accurate, not just copied and pasted. Findings included: Review of the provider’s undated policy titled, “Clinical Record- Authorization/ Authentication of Entries,” showed in part, all entries will be legible, cleat, and complete. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 11/18/2024 with a primary diagnosis of stage three (3) pressure ulcer (an injury with full-thickness skin loss caused by unrelieved pressure) of the right buttock. The patient lived at home with his/her significant other. Review of the plan of care (POC) dated 05/17/2025 to 07/15/2025, showed in part: - The patient’s primary diagnosis was a pressure ulcer of the right buttock, stage 3; - Skilled nurse (SN) visit frequency of 2w9 (two times a week for nine weeks); - Interventions included SN assessment of patient with stage 3 pressure ulcer of right buttock, dementia (decline in mental capacity), psychophysiological insomnia (a type of insomnia characterized by a cycle of anxiety about sleep leading to difficulty falling asleep and staying asleep, which in turn increases anxiety about sleep), nonalcoholic steatohepatitis (NASH, a buildup of fat in the liver), alcoholic cirrhosis (chronic liver damage from a variety of causes leading to scarring and liver failure) of the liver without ascites (fluid build up in abdomen), alcohol dependence, and polyneuropathy (a general term for peripheral nervous system disorders that impact nerve function in multiple areas of the body); and - The POC failed to include any other SN interventions and/or orders for wound care of the stage 3 pressure injury. Review of the skilled nurse (SN) visit note, dated 06/03/2025, showed in part: - The patient demonstrated medication compliance; - Medication compliance as per evidence of pill bottles; - Medication request sent to the doctor for super beta prostate advance 2 capsules (caps) daily (The SN documented compliance with medications but the patient was taking a prostate supplement that was not ordered by the physician); - The patient stated that he/she wanted to take it for the prostate but did not want to bother the primary care provider (PCP); - Within normal limits (WNL) was documented for the skin assessment (The patient had a pressure injury to the right buttock); - The comments section had treatment done to buttocks per order (The POC failed to show an order for wound care); - The wound assessment section had stage 3 opened pressure injury to right buttock, open, present on admission, length not applicable (N/A), width N/A, depth N/A, and wound remains the same (The wound measurements had N/A and the documentation failed to specify how the wound remained the same); and - Interventions performed showed, SN to instruct spouse on wound care as follows: buttocks, cleanse with wound cleanser and use A&D (brand name of an ointment that contains vitamins A and D and is used to treat or prevent dry, rough, scaly, itchy skin and minor irritations) ointment, cover with foam dressing as needed to prevent fecal contamination of wound, frequent position changes while in bed, daily and PRN to help in wound healing and prevent infection. SN to teach spouse to perform wound care daily and as needed 05/16/2025 (More than two weeks prior to this SN visit). Review of a physician order, dated 06/03/2025, showed: - Super beta prostate advanced 2 cap by mouth (PO) daily over-the-counter (OTC); - “Pt (patient) is taking this supplement, may we put it on (his/her) med (medication) list?;” and - The physician signed the bottom of the order on 06/11/2025 but did not specify if the patient could take the supplement (The clinical record failed to show an updated medication profile with the supplement listed). Review of the skilled nurse (SN) visit note, dated 06/06/2025, showed in part: - The skin assessment showed WNL and treatment done to buttocks per order; - The comments section had treatment done to buttocks per order (The POC failed to show an order for wound care); and - The wound assessment section had stage 3 opened pressure injury to right buttock, open, present on admission, length N/A, width N/A, depth N/A, A&D ointment applies per order, and wound is improving (The documentation failed to show how the wound was improving). Review of the SN visit note, dated 06/10/2025, showed: - The skin assessment section showed WNL and treatment done to buttocks per order (The clinical record failed to show treatment orders and the wound treatment performed this visit were different than the previous visits); - The wound section had additional information with “handwritten note from (named) PCP in home to try solosite (a gel that is used to create a moist wound environment that aides in healing) and mupirocin (a topical antibiotic ointment primarily used to treat bacterial skin infections) for wound care;” and - Solosite with mupirocin was applied to the wound (The clinical record failed to include this order). Review of the SN visit note, dated 06/13/2025, showed: - The skin assessment showed WNL and treatment done to buttocks per order; and - The wound assessment section had stage 3 opened pressure injury to right buttock, open, present on admission, length N/A, width N/A, depth N/A, solosite and mupirocin ointment applied to wound, skin barrier applied to surrounding area, and caregiver educated to cleanse and apply barrier cream daily. Review of the SN visit note, dated 06/20/2025, showed in part: - The patient demonstrated medication compliance; - Medication compliance as per evidence of pill bottles; - “Pt states (he/she) was taking ASA (aspirin- nonsteroidal anti-inflammatory medication) 61mg (milligrams) every day, even though the dr (doctor) did not order it, but has not taken it in 5 days d/t (due to) slight bruising on arm. Educated pt that dr did not order ASA and should not take meds without dr red ring (ordering) them” (The SN documented compliance with medications and the patient was taking aspirin without a physician order); - The patient’s skin assessment had WNL and treatment done to buttocks per order (There was no documentation to show what treatment was performed); - The comments section showed the patient and caregiver were educated to use moisture barrier frequently on coccyx sore (This is different than the solosite and mupirocin ointment that was applied the previous two SN visits); and - There was not a wound assessment section this visit (Previous SN visit notes had a wound assessment section). Review of the SN visit note, dated 06/24/2025, showed in part: - The patient demonstrated medication compliance; - Medication compliance as per evidence of pill bottles; - “Pt states (he/she) was taking ASA 61mg every day, even though the dr did not order it, but has not taken it in 5 days d/t slight bruising on arm. Educated pt that dr did not order ASA and should not take meds without dr red ring (ordering) them” (This documentation is the exact same documentation from the previous SN visit four days prior); - The patient’s skin assessment had WNL and treatment done to buttocks per order (This is the same documentation from the previous SN visit notes); - There was no wound assessment section this visit; and - The comment section showed the patient and caregiver were educated to use moisture barrier frequently on coccyx sore (The treatments to the buttock wound were inconsistent between SN visits and the clinical record failed to include orders for any of the treatments that were being provided). Observation on 07/08/2025, beginning at 12:30 PM showed: - The patient was taking Aspirin 81mg (milligram) chewable tablets, 1 tablet by mouth daily; - The medication profile failed to include aspirin and the prostate supplement; - The SN applied A&D ointment to the patient’s buttocks and Voltaren gel (a topical nonsteroidal anti-inflammatory medication that treats joint pain) to the patient’s back and bilateral lower extremities (BLE); and - The clinical record failed to show documentation that Voltaren gel is applied to the patients back and BLE during SN visits.

A partial extended survey for Medicare certification for the home health provider was completed on 10/05/2022. The agency had 51 current patients. The Emergency Preparedness regulations were reviewed as part of the Medicare certification survey completed on 10/05/2022. One (1) standard level deficiency was identified.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on the agency’s policy review, record review, and interview, the agency failed to ensure staff were provided annual Emergency Preparedness (EP) training, in two (Employees #2 and #5) of five employee files reviewed. This deficient practice has the potential to adversely affect the care and safety of all patients served by the agency during an emergency. Findings included: Review of the agency's policy, titled, "Emergency Preparedness Plan-Training & Testing Program," dated 10/2018, showed: - Emergency preparedness training is provided to personnel; - Training is documented, including the dates, participants, and the content cover; - The training program will consist of initial training in emergency preparedness policies and procedures to all new and existing agency staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles; - The agency will provide annual emergency preparedness training and additional training will be provided as indicated for all agency staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles; and - All training will be documented and kept on file at the agency. EMPLOYEE #2 (E2): - Date of hire: 10/12/2020; - Position: PTA (physical therapy assistant); and - No evidence of EP training on orientation. EMPLOYEE #5 (E5): - Date of hire: 06/18/2020; - Position: Contract PT (physical therapist); and - No evidence of EP training on orientation and every two years. During an interview on 10/04/2022 at 2:35 PM, the clinical manager stated that: - He/she reviewed all of the employee files; and - No records of EP training was found.

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on the agency’s policy review, home visit observation, and interview, the agency failed to provide the patient with contact information for the HHA (home health agency) administrator, in one (Record/Patient #2) of three home visit observations. This deficient practice has the potential to affect the rights of all the agency patients. Findings included: Review of the agency’s policy, titled, “Home Health Condition of Participation: Patient Rights,” dated, 01/13/2018, showed: - The HHA must provide the patient and the patient’s representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: * Written notice of the patient’s rights and responsibilities; and * Contact information for the HHA, including the administrator’s name, business address, and business phone number in order to receive complaints. RECORD/PATIENT #2: Observation on 10/04/2022, beginning at 12:40 PM, during the patient's home visit, showed: - Admission folder was reviewed; and - The previous administrator’s name and contact information was listed. During an interview on 10/04/2022 at 4:00 PM, the clinical manager stated that; - Staff keep admission folders in their cars; - The patient must have been provided with an old admission folder; and - All of the admission folders at the office were updated with the correct information.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on the agency’s policy review, home visit observation, and interview, the agency failed to ensure that the patients be advised, orally and in writing, of the extent to which payment for HHA (home health agency) services may be expected, in one (Record/Patient #2) of three home visit observations. This deficient practice has the potential to affect the rights of all the agency patients. Findings included: Review of the agency’s policy, titled, “Home Health Condition of Participation: Patient Rights,” dated, 01/13/2018, showed: - The patient has the right to be informed of: * The extent to which payment for HHA services may be expected from Medicare, Medicaid or any other federally funded or federal aid program known to the HHA; * The charges for services that may not be covered by Medicare, Medicaid, or any other federally funded or federal aid program known to the HHA; * The charges the individual may have to pay before care is initiated; and * To receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the services may be non-covered, or in advance of the HHA reducing or terminating on-going care. Review of the agency’s undated policy, titled, “Assessment-Initial,” showed: - During this assessment, the qualified clinician will determine the reason for admission, patient needs, type of care/services, and the need for further assessment; - The primary staff member will complete and/or review with the patient and/or representative, if any, and family/caregiver the following on the initial visit: * Description of services, including disciplines and their respective frequencies; and * Consent/authorization for services, including patient financial liability including charges for services, projected insurance coverage and patient co-pay/cost. RECORD/PATIENT #2: Observation on 10/04/2022, beginning at 12:40 PM, during the patient's home visit, showed: - Admission folder was reviewed; and - The financial liability form inside of the folder was not filled out and/or signed by the patient (all sections left blank). During an interview on 10/04/2022 at 4:00 PM, the clinical manager stated that, he/she would expect the financial liability form to be filled out.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on the agency's policy review, record review and interview, the agency failed to conduct the initial assessment visit to determine the immediate care and support needs of the patient within 48 (forty eight) hours of the referral, in three (Records/Patients #1, #2, and #4) of five full records reviewed. This deficient practice has the potential to adversely affect the health and safety of late assessed patients with immediate care needs. RECORD/PATIENT #2: Review of the clinical record showed, in part: - Referral orders for home health services with a date of 08/12/2022 at 11:05 AM; - Skilled nurse SOC (start of care) visit was dated 08/15/2022 at 1:15 PM; - OASIS (The Outcome and Assessment Information Set- patient specific, standardized assessment used in home health care to; plan care, determine reimbursement, and measure quality) (M0102) physician ordered start of care date question, was selected with a date of 08/15/2022; and - No orders received for physician ordered start of care date indicating a specific SOC date. During an interview on 10/05/2022 at 9:15 AM, the clinical manager stated that he/she was unable to find documentation for why the SOC was late. Findings included: Review of the agency’s undated policy titled, “12.5.8 ASSESSMENT-INITIAL”, showed: - An initial assessment will be completed within 48 hours of referral/hospital discharge or on physician ordered start of care date, by appropriate “Named Agency” staff. - An initial history/social/physical assessment will be completed on the initial visit to identify patient needs and assess the patient’s residence as a basis for planning individualized, outcome-oriented care; - “Named agency” will coordinate care, treatment, or services within a time frame that meets the patient’s needs and physician orders; and - The initial visit will be completed by a registered nurse, unless it is a therapy only case (in which case a therapist may be assigned to do the admission), within 48 (forty eight) hours after referral/hospital discharge, unless otherwise ordered by the physician. Review of the agency’s undated policy titled, “12.5.7 ASSESSMENT-COMPREHENSIVE”, showed: - Each patient will receive a patient specific, comprehensive assessment that accurately reflects the patient’s current health status and includes information that may be used to demonstrate the patient’s progress toward achievement of desired outcomes; and - A registered nurse, or qualifying clinician, must conduct an initial assessment within 48 hours of referral or patient’s return home, or on the physician ordered start of care date. RECORD/PATIENT #1 Review of the clinical record showed: - A referral with a fax cover sheet from a local hospital dated 8-26-22 with an order requisition, dated 08/25/2022 for Home Health Consult request; - An order dated 08/29/2022 (three days later) showed: Referral received on Friday 08/26/2022, plan for HH (home health) SOC (start of care) for 08/30/22 per patient/family request; - A Start of Care OASIS (Outcome and Assessment Information Set- a standardized evaluation) with a visit date of 08/30/2022 documented and digitally signed by the RN 08/30/2022; and - A Plan of Care (POC) dated 08/30/2022 to 10/28/2022, showed orders for SN 2w9 (2 times a week for 9 weeks), and PT (Physical Therapy) and OT (Occupational Therapy) to evaluate and treat.

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 the agency's policy review, record review, observation, and interview, the agency failed to ensure an accurate and complete review of all medications was completed upon admission/SOC (start of care) and/or update of the patient’s medications was completed, in two (Records #2 and #3) of five full records reviewed. This deficient practice has the potential to adversely affect the agency’s ability to ensure safe and effective use of medication for all patients served by the agency. RECORD/PATIENT #2: Review of the clinical record showed, in part: - Patient admitted to home health services on 08/15/2022 for evaluation and treatment for increased back pain; - Patient hospitalized on 09/13/2022 for acute blood loss resulting in need for blood transfusion; - Hospital resumption of care referral orders, dated, 09/16/2022, at 9:23 AM, failed to show melatonin (supplement to help with sleep) listed on medication order; - Plan of care (POC) dated 08/15/2022 to 10/13/2022 showed, melatonin oral 3 mg [milligram] 1 tab(s) [tablet/s] at hs [hour of sleep]; - POC not updated with ROC comprehensive assessment on 09/20/2022; - Patient medication record, dated 09/17/2022, showed, “melatonin oral 200 mg #1 at hs (pre-sleep),” with a start date of 09/17/2022; and - No documentation of physician order for melatonin. Observation on 10/04/2022, beginning at 12:40 PM, during the patient’s home visit showed: - The PTA did not review the medications with the patient; - Patient was provided with the POC (plan of care) that included medications as the list to use for his/her medication list; - Surveyor reviewed patient medications after PTA confirmed completion of visit and found the following: * Patient was provided with a copy of the POC dated, 08/15/2022 to 10/13/2022, to use for medication list; * Melatonin (supplement to help with sleep) Oral 3 mg 1 tab [tablet] at hs [hour of sleep] was listed on the POC with a line marked though it in ink; * At the bottom of the POC medication list, “Restart Melatonin Oral 200mg 1 tab PO at hs” was handwritten in ink; * No clarification for medication changes and/or instructions noted on medication list; and * Review of the medications showed, the Melatonin bottle contained 200 mg tablets and patient taking 1 tablet at bedtime. During an interview on 10/04/2022 at 2:50 PM, the clinical manager stated that: - The ROC does not generate an updated POC; - Goals and interventions are updated within the ROC documentation and should include SN interventions and patient/caregiver education on enoxaparin injection but the physician does not sign it; - The nurse creates an order for the physician to sign; - A copy of the updated medication list is sent with the orders but the physician does not always sign the copy of the medication list when signing the orders; - Melatonin was not listed on the resumption of care order that was created by the nurse and sent to the physician; and - Unable to locate physician order for melatonin 200mg. Findings included: Review of the agency’s undated policy titled “12.5.41 Medication-Regimen Review Comprehensive,” showed: - All required comprehensive assessments will include 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; - “Named agency” may assign a registered nurse to perform the review when the OASIS (Outcome and Assessment Information Set- a standardized evaluation) is completed by a qualified therapist; - At the time of admission an accurate, current and complete list of all prescription and over-the-counter (OTC) medications, as well as herbal medications, taken by the patient will be maintained on the medication profile; - The medication list must include medication name, dose, route and frequency; - The clinician will compare the medication list to those on the referral or other documents provided to the agency. Ay discrepancies will be reconciled with the physician and documented in the clinical record; - Every effort will be made to reconcile any discrepancies with the physician or designee the next calendar day of the assessment; - The clinician will document this contact and ay difficulties experienced in obtaining physician’s response; - The clinician will ask the patient to describe or confirm any prescription medications, over the counter medications, vitamins, herbs or other supplements, as well as their perceptions about any side effects, and efficacy; - The medication profile will be placed in a highly visible place and include essential information about dosages, drug schedules, immunizations, and drug allergies; - This medication profile will also include medication action/classification, dosage, administration schedule, route, initial order and discontinuation dates, where applicable and if drug is new (N) or changed (C); - Nursing staff will assess on an ongoing basis the patient’s response to the medication and the patient/caregiver’s compliance with the medication regimen. This will include, but not be limited to: gathering the patient’s own perceptions about side effects and, when appropriate perceived efficacy, and referring to information from the patient’s record; and - Changes in the medication regimen will be documented in the clinical record as well as communicated to the patient and/or caregiver. RECORD/PATIENT #3 Review of the referral Clinical summary medication list, dated 9/14/2022 showed: - Dexamethasone (a medication used to reduce inflammation) 0.5mg (milligram) oral tablet two times a day with food once in the morning and once at night on 9/16; - Your next dose is due: 1mg two times a day with food on 9/15 once in the morning and once at night; - Your next scheduled dose is due 2mg oral at bedtime with food take 2 mg at 2100 (9 PM) on 9/14; and - Prilosec (a medication used to treat heartburn or stomach ulcers) OTC 20mg oral delayed release tablet two times daily. Review of the Initial plan of care dated 09/15/2022 to 11/12/2022 showed: - Dexamethasone 0.5mg 1 tablet by mouth two times daily with food; and - Prilosec OTC oral 20mg 1 tablet by mouth daily. Review of the Start of Care OASIS (Outcome and Assessment Information Set- a standardized evaluation), dated with a visit date of 09/16/2022 showed Item M2001 Drug regimen review: Did a complete drug regimen review identify potentially clinically significant medication issues? Marked No- No issues found during review. Further review of the clinical record failed to show documentation of communication with the physician and/or physician orders regarding the discrepancies of the dexamethasone and Prilosec. Observation on 10/04/2022 at 12:40 PM, during the patient’s home visit, review of the current medication profile in the home showed it failed to show dexamethasone listed and listed the Prilosec as 20mg 1 tablet daily by mouth. Per interview conducted during observation, the patient stated that: - The dexamethasone was only for three days after getting home; and - He/she is taking the Prilosec once daily as on the medication profile.

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on the agency’s policy review, record review, and interview, the agency failed to ensure a comprehensive assessment was completed within 48 (forty-eight) hours of the patient’s return home from a hospital admission, in one (Record/Patient # 1) of five full records reviewed. This deficient practice has the potential to adversely affect all patients served by the agency. Findings included: Review of the agency’s undated policy, titled, “Assessment-Comprehensive,” showed, in part: - A registered nurse, or qualifying clinician, must conduct an initial assessment within 48 hours of referral or patient’s return to home, or on the physician ordered start of care date; - The comprehensive assessment must be updated and revised as warranted due to patient decline or improvement in health status, but not less frequently than; * Discharge and return to the same home health agency during the 60 (sixty) day episode; and * Within 48 hours of return to home from a hospital admission of 24 (twenty-four) hours or more for any reason other than diagnostic tests, or on physician ordered resumption date. RECORD/PATIENT #2: Review of the clinical record showed, in part: - Patient admitted to home health services on 08/15/2022; - Patient hospitalized on 09/13/2022 for acute (sudden onset) blood loss resulting in need for blood transfusion; - Hospital referral orders for patient to discharge home with home health was dated 09/16/2022 at 9:23 AM; - Resumption of care visit was made on 09/20/2022 at 1:00 PM; - No specific SOC (start of care) date ordered by physician; - A communication note, dated 09/19/2022, showed, in part, the agency received a call from the primary care provider’s nurse reporting that the physician was requesting home health be resumed on the patient; and - No documentation of why the patient did not receive a resumption of care visit within 48 hours of return home. During an interview on 10/04/2022 at 4:05 PM, the clinical manager stated that: -He/she was unsure why the patient did not have a ROC visit within 48 hours of return home from the hospital; and - He/she would review the clinical record for documentation of why ROC was late and provide the record if available. During an interview on 10/05/2022 at 9:15 AM, the clinical manager stated that: - He/she found two communication notes regarding hospitalization and ROC; - A communication note regarding the discovery of patient being hospitalized and the other communication note was regarding the phone call from the physician’s nurse requesting home health to resume; and - No other documentation was found.

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 the agency's policy review, record review, and interview, the agency failed to obtain orders to provide services and treatments only as ordered by a physician or allowed practitioner, in two (Records/Patients #1 and #2) of five full records reviewed. This deficient practice has the potential to adversely affect physician driven care of all patients served by the agency. Review of the agency’s undated policy titled “12.5.45 Plan of Care”, showed: - An individualized plan of care is developed utilizing the comprehensive and initial assessment, as well as, information provided by members of the interdisciplinary team and the physician that identify patient specific measurable outcomes and goals and is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his/her state license, certification or registration; - Upon completion of the initial assessment, by a RN (registered nurse) or qualifying therapist (Physical Therapist or Speech Language Pathologist), and determination that the patient meets admission criteria, the patient is officially accepted for care and the POC (plan of care) developed; - The initial POC must include, at a minimum, types of services, all treatments, interventions and education; - 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 “named agency” and patient in the POC; - Verbal orders may be accepted by authorized staff, in accordance with state laws. The order must be documented in the medical record by the staff receiving the order, indicated by staff signature, credentials, and the date and time that the order was received; - Services are provided under an individualized POC that is established by the primary care physician, the agency staff, and the patient; - The POC is written by the appropriate staff member in collaboration with the multi-disciplinary team, the physician, and the patient and is based on the initial assessment of the patient’s problems and needs at the start of care; - It is then reviewed and revised as frequently as the patient’s condition or needs require, but no less than every 60 (sixty) days from the start of care; - The POC will serve as physician’s orders for patient care and all staff providing services will be in compliance with the orders; and - Authorized clinicians staff members may only administer medications or treatments as ordered by the physician. Findings included: RECORD/PATIENT #1: Review of the initial POC dated 08/30/2022 to 10/28/2022 showed: - The patient was admitted 08/30/2022 with a primary diagnosis of cellulitis of right lower limb (bacterial skin infection of the right lower leg) and, but not limited to, secondary diagnoses of cellulitis of the left lower limb, chronic venous insufficiency (occurs when your leg veins don’t allow blood to flow back up to your heart, often leading to open sores and swelling) and peripheral vascular disease (a circulatory condition in which narrowed blood vessels reduce blood flow to the legs.); - Bactroban (an antibiotic ointment) external 2% thin layer apply topically to affected area (s) from cellulitis to lower right extremity with SN (skilled nurse) to apply with dressing change and then cover with Triact AG (an antimicrobial wound contact dressing containing silver sulfate), lightly wrap with Kerlix (a brand of bandage roll-kling), secure with netting with dressing change at SOC (start of care) and as needed for soiling until otherwise instructed after wound clinic visit; and - Normal Saline (NS) 0.9% for removing old dressing to right lower extremity and then to cleanse wound before applying ordered wound care treatments with each dressing change until otherwise instructed. Review of a physician order dated 09/28/2022 showed: - Implement wound care treatment to right lower extremity as follows: remove prior dressing and cleanse wound site with NS/wound cleanser and pat dry; - apply Triact (no longer Triact AG) or adaptic (a non-adhering non medicated dressing) to wound site; - Cover with ABD dressing (a non-woven thick absorbent dressing); and - And secure with Kerlix, tape and tubigrips (elasticated bandage that provides compression to improve circulation (if patient will allow) 2 times weekly and as needed. Observation on 10/04/2022 at 11:03 AM, during the patient’s home visit observation, the RN, after cleaning right lower leg wound with normal saline applied a goldish/brown weaved like dressing that had previously been cut to fit the wound. This surveyor was unable to see the package this dressing came from. Per interview conducted during observation, the RN stated that: - He/she was unable to find the original package; and - It (the dressing) was Triact AG. During an interview on 10/04/2022 at 3:21 PM the clinical manager stated that he/she would expect wound care orders to be followed. RECORD/PATIENT #2: Review of the clinical record, showed, in part: - SN (skilled nurse) visit note on 09/27/2022, showed, “set up med [medication] planner x [times] 1 week and reviewed Lovenox [blood thinner to prevent clots] 40 mg [milligram] injection at hs (hour of sleep] (technique),” in the comments section; - Review of the POC (plan of care), dated 08/15/2022 to 10/13/2022, showed: * SN to determine if the patient/caregiver is able to identify the correct dose, route, and frequency of each medication; * SN to instruct the patient/caregiver on precautions for high risk medications, such as, hypoglycemic, anticoagulants/antiplatelets, sedative hypnotics, antiarrhythmics, antineoplastics, skeletal muscle relaxants; * SN to instruct the patient/caregiver on medication regimen dose, indications, side effects, and interactions; * Lovenox was not listed on the POC; and * POC failed to include interventions for SN to fill medication planner. During an interview on 10/04/2022 at 3:30 PM, the clinical manager stated that, when the nurse fills the medication planner, it should be on the POC.

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 the agency's policy review, record review, and interview, the agency failed to alert the physician to a change in the patient’s condition, in two (Records/Patients #1 and #2) of five full records reviewed. This deficient practice has the potential to adversely affect all patients on service with the agency. RECORD/PATIENT #2: Review of a clinical record showed, in part: - The patient was admitted to home health services on 08/15/2022 with a primary diagnosis of chronic pain; - POC (plan of care), dated 08/15/2022 to 10/13/2022, showed, in part: * Urinary incontinence [loss of bladder control, varying from a slight loss of urine to complete inability to control urine] listed as one of the secondary diagnosis; * SN (skilled nurse) to instruct patient/caregiver on signs/symptoms of UTI [urinary tract infection- an infection in any part of the urinary system, the kidneys, bladder, or urethra] to report to MD [medical doctor]/SN; * SN may obtain urinalysis and urine culture and sensitivity (c&s) test as needed for signs/symptoms of UTI, to include pain, foul odor, cloudy or blood-tinged urine and fever; - SN visit note on 09/13/2022, at 1:00 PM, showed: * GU (genitourinary- the organs of the reproductive and the urinary system) assessment included, incontinence, frequency, and urgency, and “assessed pt [patient] for UTI and pt denies and s/sx [signs/symptoms] of UTI at this time” noted in comments section; * Psychosocial (having to do with the mental, emotional, social, and spiritual health) assessment included, impaired decision making, irritability, and “Pts [patients] back hurts and SN instructed her dtr [daughter] to give her pain med [medication] (Lortab) as ordered” noted in comments section; * Pain assessment included, “I went to have my labs drawn like [named physician] saidand now I am a mess with my back hurting,” and “SN instructed pt to let SN know if [he/she] knows of lab work due and [named physician] will be contacted to see if it can be done in the home by SN,” noted in comments section; * SN “contacted [named physician] office regarding SN available for lab draws and assessments etc,” noted in narrative section; * Assessment findings of patient with irritability and urinary urgency are a change in condition from the previous nursing visit on 09/09/2022 (no documentation of physician being notified of new assessment findings for urgency, irritability, and increased back pain); - Transfer OASIS had a completion date of 09/13/2022, and reason for hospitalization included, dehydration (loss of body fluids) and malnutrition (lack of proper nutrition); - A transfer summary showed, completion date of 09/16/2022, transfer date of 09/13/2022, and reason for hospitalization with, “low blood counts, blood transfusion,” typed in the comments section; - ROC (resumption of care) on 09/20/2022, “SN resuming pt to home health for (diabetes/severe stenosis of back/ recent anemia with low blood counts needing blood transfusions/ recurrent UTI’s, weakness) and dementia,” noted in narrative section; - Physician order, dated, 09/20/2022, showed: * VO (verbal order): Okay to resume home health skilled nursing services for continuation of observation, assessment, education, co-morbid conditions with nursing focus on anemia, current UTI (urinary tract infection), medication changes of Lovenox (brand name for Enoxaparin), and numerous other diagnosis, infection control, and safety; * SN (skilled nurse) ROC (resumption of care) frequency “2w thru recertification period” (2 times weekly the remainder of the certification period); * PT (physical therapy) “eval and tx” (evaluate and treat) and evaluate need for OT (occupational therapy) services; - Medication record, electronically signed by the RN (registered nurse) on 09/20/2022, showed, Cipro [ciprofloxacin- is an antibiotic used to treat bacterial infections] Oral 500 MG (milligram) 1 Tab [tablet], take 1 pill 2x [2 times] daily x 3 [times 3] days for UTI, start on 09/20/2022 and discontinue on 09/23/2022; - No documentation of infection incident report in clinical record for UTI; and - No documentation of physician communication regarding change in condition on 09/13/2022. During an interview on 10/04/2022 at 3:20 PM, the clinical manager stated that, he/she would expect the physician to be notified when there’s a change in condition. Findings included: Review of the agency’s undated policy titled “12.5.45 Plan of Care”, showed that the relevant physician must be notified of any changes in the patient condition or needs that suggest that outcomes are not being met and/or the plan of care should be revised. RECORD/PATIENT # 1: Review of the initial POC dated 08/30/2022 to 10/28/2022 showed the patient was admitted 08/30/2022 with a primary diagnosis of cellulitis of right lower limb (bacterial skin infection of the right lower leg) and, but not limited to, secondary diagnoses of cellulitis of the left lower limb, chronic venous insufficiency (occurs when your leg veins don’t allow blood to flow back up to your heart, often leading to open sores and swelling) and peripheral vascular disease (a circulatory condition in which narrowed blood vessels reduce blood flow to the legs.). Review of the Start of Care OASIS (Outcome and Assessment Information Set- a standardized evaluation), dated 08/30/2022 showed under the Neuro/Emotional/Behavioral Status section with: - Oriented to person, place and time marked under Neurological; - WNL (within normal limits) marked under Psychosocial (irritability was left unmarked); and - Under comments it showed the patient was pleasant and cooperative during this visit, noted orders for hydroxyzine for anxiety as needed, patient denies any issues with anxiety. Review of the skilled observation note dated 09/02/2022 showed oriented to person place and time marked under neurological and WNL marked under psychosocial. Review of the skilled observation note dated 09/06/2022 showed oriented to person place and time marked under neurological as well as forgetful and WNL marked under psychosocial. Review of the skilled observation note dated 09/09/2022 showed oriented to person place and time marked under neurological as well as forgetful and WNL marked under psychosocial. Review of the skilled observation note dated 09/13/2022 showed oriented to person place and time, forgetful and lethargic marked under neurological and impaired decision making marked under psychosocial. Review of the skilled observation note dated 09/16/2022 showed oriented to person place and time, forgetful and lethargic marked under neurological and impaired decision making marked under psychosocial. Review of the skilled observation note dated 09/20/2022 showed oriented to person place and time, forgetful and lethargic marked under neurological and impaired decision making and irritable marked under psychosocial. Further review of the clinical record failed to show any communication with the physician regarding the change in the patient’s condition when the patient became lethargic or irritable. During an interview on10/04/2022 at 3:21 PM the clinical manager stated that if there was no prior documentation of irritability he/she would expect the physician to be notified.

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 the agency’s policy review, record review, and interview, the agency failed to ensure a revised plan of care accurately reflected information from the patient’s updated comprehensive assessment, in one (Record/Patient # 1) of five full records reviewed. This deficient practice has the potential to adversely affect all patients served by the agency. Findings included: Review of the agency’s undated policy, titled, “Plan of Care,” showed, in part: - 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 agency and patient; - The plan of care will serve as physician’s orders for patient care and all staff providing services will be in compliance with the orders; - The clinical record will document that the change in the plan of care is based on reassessment date; and - Changes are noted on the plan of care and/or in the progress notes based on client/patient requests, client/patient’s condition, client/patient’s response to therapy, and when physician orders indicate changes. RECORD/PATIENT #2: Review of the clinical record showed, in part: - Patient admitted to home health services on 08/15/2022; - Patient hospitalized on 09/13/2022 for acute (sudden onset) blood loss resulting in need for blood transfusion; - Hospital ROC (resumption of care) referral orders for patient to discharge home with home health, dated, 09/16/2022, at 9:23 AM, showed; * New medication order for, Enoxaparin (blood thinner to prevent clots) 40 mg (milligrams)/0.4 ml (milliliters) injectable solution, inject subcutaneous (under the skin) at bedtime; * Discontinued Xarelto (blood thinner) 20mg oral tablet daily (replaced with Enoxaparin injection); - Plan of care (POC), dated, 08/15/2022 to 10/13/2022, showed; * Xarelto oral 20 mg 1 tablet daily; * No updated POC with new medication of Enoxaparin injection and/or the discontinuation of xarelto; - Review of physician order, dated, 09/20/2022, showed: * VO (verbal order): Okay to resume home health skilled nursing services for continuation of observation, assessment, education, co-morbid conditions with nursing focus on anemia, current UTI (urinary tract infection), medication changes of Lovenox (brand name for Enoxaparin), and numerous other diagnosis, infection control, and safety; * SN (skilled nurse) ROC frequency “2w thru recertification period” (2 times weekly the remainder of the certification period); * PT (physical therapy) “eval and tx” (evaluate and treat) and evaluate need for OT (occupational therapy) services; - Verbal order failed to include medication dose, frequency, route, orders, and/or SN interventions for patient/caregiver education on administration of Enoxaparin injection; and - The POC was not updated with ROC comprehensive assessment on 09/20/2022. During an interview on 10/04/2022 at 2:50 PM, the clinical manager stated that: - The ROC does not generate an updated POC; - Goals and interventions are updated within the ROC documentation and should include SN interventions and patient/caregiver education on enoxaparin injection but the physician does not sign it; - The nurse creates an order for the physician to sign; and - A copy of the updated medication list is sent with the orders but the physician does not always sign the copy of the medication list when signing the orders.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on the agency’s policy review, home visit observation, and interview, the agency failed to ensure that accepted standards of practice to prevent the transmissions of infections and communicable diseases were followed in one (Record/Patient #3) of three home visits conducted. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's undated policy, titled, "Bag Technique," showed: - When the supply bag is required to be taken into the home, the following procedures will be followed: - Upon entering the home, the supply bag should not be placed on any floor surface, but on a clean surface, utilizing a barrier if a clean surface is not available or hung on a doorknob; - Wash hands thoroughly; - Remove all other bag items which will be needed for the visit. Place them on a barrier which has been placed near the supply bag; - Clean any items from the supply bag which have become soiled during patient care. Place them on a barrier or clean paper towel; and - Wash hands and return equipment to supply bag. Close supply bag. Review of the agency's undated policy, titled, "Cleaning of Equipment, Supply Bag, & Other Supplies," showed: - Interior and outer surfaces of the supply bag should be cleaned following the bag manufacturer’s recommendation or, if not available, with soap and water or a spray or 70% isopropyl alcohol solution or other agency approved antimicrobial wipe disinfectant that meets the CDC [Centers for Disease Control and Prevention] guidelines with visibly soiled; - Washable equipment may be cleaned with soap and water, rinsed and dried or wiped thoroughly with 70% isopropyl alcohol solution or other agency approved antimicrobial wipe if contamination occurs during use; - Blood pressure cuffs shall be cleansed when visibly soiled in accordance with manufacturer’s recommendation or if not available, with soap and water or a spray or 70% isopropyl alcohol solution or other agency approved antimicrobial wipe disinfectant that meets the CDC guidelines; - Wipe stethoscope diaphragm with 70% isopropyl alcohol solution or another agency approved antimicrobial wipe between each patient use; - Pulse oximeters shall be cleaned with a mild detergent solution or 70% isopropyl alcohol solution or another agency approved antimicrobial wipe; and - Thermometers: If a thermometer is taken from home to home, it shall be covered with plastic sheath for taking the temperature. After taking the temperature, the sheath is removed and the thermometer is cleaned with alcohol and replaced in its plastic case. RECORD/PATIENT #2: Observation on 10/04/2022, beginning at 12:40 PM, during the patient's home visit, showed: - Upon entering the home, the PTA (physical therapy assistant) placed his/her supply bag on dining room table without cleansing the surface and/or having a barrier down; - Equipment for vital signs retrieved from bag one at a time, as the PTA needed them; - He/she sprayed equipment with a bottle of spray labeled “hand sanitizer” after use and immediately placed back into bag prior to obtaining next equipment needed for vital signs; - He/she placed electronic tablet on the dining room table without cleansing surface or placing a barrier down; and - Electronic tablet not cleansed after home visit. During an interview on 10/04/2022 at 2:40 PM, the clinical manager stated that; - A barrier should be used to place equipment on during the visit; and - Hand sanitizer spray is not an acceptable for properly cleansing equipment after use.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on the agency’s policy review, record review, review of infection control logs/reports, and interview, the agency failed to maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases specific to care and services provided, in two (Records/Patients #1 and #2) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Review of the agency’s undated policy titled “12.7.9 Infection Control Program,” showed, in part: - “Named agency” will maintain a coordinated agency-wide program for the surveillance, identification, prevention, control and investigation of infectious and communicable diseases; - The organization identifies infection risks based on the following: its geographic location, community, the population served and the treatment, or services it provides; - “Named agency” will develop plans for agency-wide infection prevention and control activities, including surveillance, to minimize, reduce, or eliminate the risk of infection; - The infection surveillance report is completed by the involved staff person for each observation of patient related infections, any noted staff related infections, and other categories of infection; and - Each report is promptly submitted to the Director of Patient Services/Clinical Manager whereby all reports are aggregated and trended at a minimum quarterly and reported through the Agency’s QAPI (quality assurance and performance improvement- a data driven and proactive approach to quality improvement) program, keeping in mind the emergence and/or reemergence of pathogens in the community. RECORD/PATIENT #1 Review of the initial POC dated 08/30/2022 to 10/28/2022 showed: - The patient was admitted 08/30/2022 with a primary diagnosis of cellulitis of right lower limb (bacterial skin infection of the right lower leg) and, but not limited to, secondary diagnoses of cellulitis of the left lower limb, chronic venous insufficiency (occurs when your leg veins don’t allow blood to flow back up to your heart, often leading to open sores and swelling) and peripheral vascular disease (a circulatory condition in which narrowed blood vessels reduce blood flow to the legs), methicillin susceptible staphylococcus infection (an infection caused by a type of bacteria commonly found on the skin) and enterococcus (a bacteria which causes difficult to treat infections I the hospital setting); - Bactroban (topical antibiotic used to treat skin infections) external 2% thin layer apply topically to affected areas from cellulitis to lower right extremity; - Vancomycin HCL (an antibiotic used to treat infections) oral 125mg (milligram) 1 capsule by mouth daily for 21 (twenty one) days; and - Keflex (an antibiotic used to treat infections) oral 500mg 1 capsule every 12 (twelve) hours by mouth for 14 (fourteen) days. Review of the infection control logs/reports failed to show patient #1 with the Bactroban, Vancomycin or Keflex listed. During an interview on 10/04/2022 at 2:40PM the clinical manager stated that: - An infection report should be completed for patients on antibiotics for new diagnosis; and - Patient #1 and #2 are not on the list so they were not completed. Review of the agency's policy, titled, "Infection Control- Reporting & Tracking," dated 10/2018, showed: - The agency will have an agency-wide infection control program designed to track, report, and prioritize those at risk for infections in order to identify patterns of infections, and implement proactive measures to mitigate prevention of infection; - Infections among patients, staff, volunteers, and students will be reported and analyzed to identify patterns of infection occurrence(s); - Each infection control incident and/or surveillance report will be submitted to the Director of Patient Services/Clinical Manager or designee nursing supervisor, who will determine if it meets the established criteria for home care nosocomial infection and classify the infection; - After the Clinical Manager or designee reviews the report, the report will be logged onto the infection control log, identifying the patient’s name and ID (identification), diagnosis, probable cause of infection, symptomology, and resolution; - The infection incident/surveillance forms and log will be reviewed by the Director of Patient Services/Clinical Manager or designee to determine if any trends are present; - All identified trends, supportive data, and actions taken to reduce the risk of infections in patients of the agency will be reviewed; and - At each Quality Assessment Performance Improvement meeting, trends of data will be reviewed with a purposeful discussion of the agency’s strategies to minimize, reduce, or eliminate the prioritized risks. RECORD/PATIENT #2: Review of the clinical record showed: - ROC (resumption of care) OASIS (The Outcome and Assessment Information Set- patient specific, standardized assessment used in home health care to; plan care, determine reimbursement, and measure quality), dated 09/20/2022, showed, in part: * OASIS (M1005) inpatient discharge date question, answered with 09/16/2022 and the reason for inpatient stay had “anemia [lack of red blood cells], blood transfusions needed, UTI [urinary tract infection-infection in part of the urinary system], low hgb [hemoglobin which is a protein in the red blood cells that carries oxygen throughout the body] (5.9)” noted; * OASIS (M1600) question, asking if patient has been treated for a urinary tract infection in the past 14 days, was marked with “Yes;” - Plan of care (POC) dated 08/15/2022 to 10/13/2022, failed to show new diagnosis and/or treatment for UTI; - Review of physician order, dated, 09/20/2022, showed: * VO (verbal order): Okay to resume home health skilled nursing services for continuation of observation, assessment, education, co-morbid conditions with nursing focus on anemia, current UTI, medication changes of Lovenox (brand name for Enoxaparin), and numerous other diagnosis, infection control, and safety; * SN (skilled nurse) ROC (resumption of care) frequency “2w thru recertification period” (2 times weekly the remainder of the certification period); * PT (physical therapy) “eval and tx” (evaluate and treat) and evaluate need for OT (occupational therapy) services; - Review of the patient medication record, electronically signed by the RN (registered nurse) on 09/20/2022 showed, in part: * Cipro [ciprofloxacin- is an antibiotic used to treat bacterial infections] Oral 500 MG (milligram) 1 Tab [tablet], take 1 pill 2x [2 times] daily x 3 [times 3] days for UTI, start on 09/20/2022 and discontinue on 09/23/2022; * Lovenox (blood thinner to prevent clots) Injection 40mg/0.4 ml (milliliters), 1 at hs (hour of sleep), with a start date of 09/20/2022; - Hospital referral orders for patient to discharge home with home health, dated, 09/16/2022, at 9:23 AM, failed to show any medications used to treat UTI; and - No documentation of infection incident report in clinical record; and - No documentation/record of the patient in the infection control log for UTI. During an interview on 10/04/2022 at 2:00 PM, the clinical manager stated that; - The SN (skilled nurse) should complete an infection report for patients on antibiotics for a new diagnosis; and - The patient is not on the list so his/hers was not completed.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on the agency’s policy review, record review, and interview, the agency failed to ensure ongoing interdisciplinary assessment of patient, in three (Records/Patients #1, #2, and #4) of five full records reviewed. This deficient practice has the potential to affect the coordination of care and services for all patients on service with the agency. RECORD/PATIENT #1 Review of the clinical record showed: - A referral with a fax cover sheet from a local hospital dated 8-26-22 with an order requisition from the hospital, dated 08/25/2022 for Home Health Consult Request; - An order dated 08/29/2022 (three days later) showed: Referral received on Friday 08/26/2022, plan for HH (home health) SOC (start of care) for 08/30/22 per patient/family request; - An order dated 08/30/2022 showed, in part, PT/OT to eval (evaluate) and treat; - A Plan of Care (POC) dated 08/30/2022 to 10/28/2022, showed orders for SN 2w9 (2 times a week for 9 weeks), and PT (Physical Therapy) and OT (Occupational Therapy) to evaluate and treat; and - A PT evaluation visit note dated 09/06/2022 (eight days later). Findings included: Review of the agency’s undated policy, titled, “Referral Process,” showed, in part: - The Director of Patient services/Clinical Manager or designee will assign the clinician responsible for the evaluating visit and the dare of the case opening will be agreed upon based on orders and clinical need; - Additional services (SN [skilled nurse] Physical Therapy [PT], Occupational Therapy [OT], Speech Therapy, Medical Social Work, and Home Health Aide Services) will be asses as the patient’s need dictate and will be indicated by the physician’s orders; and - Additionally, ordered disciplines will evaluate the patient within 5 (five) days of referral/order, unless otherwise indicated by physician’s orders. RECORD/PATIENT #2: Review of the clinical record showed: - Home health referral orders, dated 08/12/2022 at 11:05 AM, showed, skilled nursing and physical therapy to evaluate and treat for increased back pain; - SN SOC (start of care) visit was on 08/15/2022 at 1:15 PM; - Plan of care (POC) dated 08/15/2022 to 10/13/2022, showed, orders for SN 2xwx9 [2 times a week times 9 weeks], and PT to eval [evaluate] and tx [treat]; - PT evaluation visit was made on 08/23/2022 at 10:55 AM; and - No documentation and/or physician’s order for late PT evaluation. RECORD/PATIENT #4: Review of the clinical record showed: - Home health referral orders, dated 08/02/2022 at 2:00 PM, showed, home health PT/OT/Nursing to eval and treat; - SN SOC visit was on 08/12/2022 at 1:10 PM; - POC dated 08/12/2022 to 10/10/2022, showed, orders for SN 1w1 [1 time a week for 1 week], 2w2 [2 times a week for 2 weeks], 1w5 [1 time a week for 5 weeks], PT to eval and tx, and OT to eval and tx; - PT evaluation visit was made on 09/02/2022 at 10:30 AM; and - No documentation and/or physician’s order for late PT evaluation. During an interview on 10/04/2022 at 2:00 PM, the clinical manager stated that: - The PT is provided under arrangement; - The PTA (physical therapy assistant) is the agency’s full-time therapy employee; - He/she sends referrals to the contract company for PT evaluations; and - He/she is having issues with PT completing evaluations timely due to “staffing issues” at the contract agency.

Rehab services supervised by PT, OT CFR(s): 484.75(c)(2) Rehabilitative therapy services are provided under the supervision of an occupational therapist or physical therapist that meets the requirements of §484.115(f) or (h), respectively. This ELEMENT is not met as evidenced by: Based on the agency’s policy review, record review, and interview, the agency failed to ensure that physical therapy assistant (PTA) services were provided under the supervision of the physical therapist (PT), in one (Record/Patient #2) of five full records reviewed. This deficient practice has the potential to affect all patients receiving therapy services from the agency. Findings included: Review of the agency’s undated policy titled, “Description of Services-Occupational Therapist, Physical Therapist & Speech Therapist,” showed: - Physical Therapy will be provided by a licensed Physical Therapist or a licensed Physical Therapy Assistant, under the supervision of a licensed Physical Therapist, in compliance with the Plan of Care (POC); - Qualified supervisory personnel will supervise staff; - Supervise the Physical Therapy Assistant through: * Instruction on initial care plan as established by PT; * On-site visits and through review of documentation and communication; and * Provide timely documentation of supervision of the LPTA (licensed physical therapy assistant) services. RECORD/PATIENT #2: Review of the clinical record showed, in part: - Initial PT evaluation visit was made on 08/23/2022 at 10:55 AM; - PT frequency and duration, 2w4 (2 times a week for 4 weeks), 1w1 (1 time a week for 1 week), effective 08/23/2022; - PT evaluation visit was made on 09/27/2022 at 1:05 PM; - PTA completed all of the therapy visits between the PT evaluation visits on 08/23/2022 and 09/27/2022; and - No documentation of PTA supervisory visits being made by PT. During an interview, on 10/04/2022, at 3:05 PM, the clinical manager stated that he/she would expect the PT to do a supervisory visit.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on review of Section 192.2490.12 RSMo and Section 192.2495.6 and 7 RSMo, agency policy review, employee file review, record review, and interview, the agency failed to: 1) Ensure all staff had the Employee Disqualification List (EDL) checked prior to hire (E1, E2, E3, and E4), and had the Family Care Safety Registry (FCSR) checked prior to patient contact (E1, E2, E3, and E4); and 2) Ensure services were provided in accordance with their established policy regarding weekly wound measurements in one (Record/Patient #1) of five full records reviewed. These deficient practices have the potential to adversely affect the care and safety of all patients served by the agency. Findings included: Review of Section 192.2490.12 RSMo showed “No person, corporation, organization, or association who received the employee disqualification list under subdivisions (1) to (7) of subsection 11 of this section shall knowingly employ any person who is on the employee disqualification list.” Review of Section 192.2495 RSMo showed it requires employees of licensed home health agencies under contract with the Missouri Department of Health and Senior Services, to register with the Family Care Safety Registry regardless of hire date. This section also requires home health agencies to conduct criminal background screenings by checking the Family Care Safety Registry. Review of Section 192.2495.6, RSMo showed "A provider is guilty of a class A misdemeanor if the provider knowingly hires or retains a person to have contact with patients or residents and the person has been found guilty in this state or any other state or has been found guilty of a crime, which if committed in Missouri would be a class A or B felony violation of chapter 565, 566 or 569, or any violation of subsection 3 of section 198.070 or section 568.020." Review of Section 192.2495.7, RSMo (effective August 28, 2018): "Any in-home services provider agency or home health agency shall be guilty of a class A misdemeanor if such agency knowingly employs a person to provide in-home services or home health services to any in-home services client or home health patient and such person either refuses to register with the family care safety registry or if such person: (1) Has any of the disqualifying factors listed in subsection 6 of this section; (2) Has been found guilty of or pleaded guilty or nolo contendere to any felony offense under chapter 195 or 579; (3) Has been found guilty of or pleaded guilty or nolo contendere to any felony offense under section 568.045, 568.050, 568.060, 568.175, 570.023, 570.025, 570.030, 570.040 as it existed prior to January 1, 2017, 570.090, 570.145, 570.223, 575.230, or 576.080; (4) Has been found guilty of or pleaded guilty or nolo contendere to a violation of section 577.010 or 577.012 and who is alleged and found by the court to be an aggravated or chronic offender under section 577.023; (5) Has been found guilty of or pleaded guilty or nolo contendere to any offense requiring registration under section 589.400; (6) Is listed on the department of health and senior services employee disqualification list under section 192.2490; (7) Is listed on the department of mental health employee disqualification registry under section 630.170; or (8) Has a finding on the child abuse and neglect registry under sections 210.109 to 210.183." EMPLOYEE #1 (E1): Review of E1's personnel file showed: - Date of hire 06/10/2022; - Date of first patient contact 06/14/2022; - A FCSR dated 06/27/2022 (after 1st patient contact); and - An EDL dated 07/01/2022 (after date of hire). EMPLOYEE #2 (E2): Review of E2's personnel file showed: - Date of hire 10/12/2020; - Date of first patient contact 10/14/2020; - A FCSR dated 05/18/2021 (after 1st patient contact); and - An EDL dated 10/12/2021 (after date of hire). EMPLOYEE #3 (E3): Review of E3's personnel file showed: - Date of hire 02/02/2021; - Date of first patient contact 02/22/2021; - The agency failed to request and obtain results of findings of the FCSR prior to patient contact; and - An EDL dated 02/10/2021 (after date of hire). EMPLOYEE #4 (E4): Review of E4's personnel file showed: - Date of hire 06/10/2022; - Date of first patient contact 06/15/2022; - A FCSR dated 06/27/2022 (after 1st patient contact); and - An EDL dated 07/01/2022 (after date of hire). Review of the agency’s undated policy titled “12.11.218 V.A.C (Vacuum Assisted Closure) for Wound” showed weekly wound measurements will be performed for comparison of wound healing progress. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted 08/30/2022 with a primary diagnosis of cellulitis of right lower limb (bacterial skin infection of the right lower leg) and, but not limited to, secondary diagnoses of cellulitis of the left lower limb, chronic venous insufficiency (occurs when your leg veins don’t allow blood to flow back up to your heart, often leading to open sores and swelling) and peripheral vascular disease (a circulatory condition in which narrowed blood vessels reduce blood flow to the legs.) for SN (skilled nursing) 2 times weekly to provide and instruct on wound care to right lower extremity wound (s). Review of the Start of Care OASIS (Outcome and Assessment Information Set- a standardized evaluation), dated 08/30/2022: - Showed wounds addressed on this visit- Wound 1- location: right lower leg. Status: open, present on admission. Type: chronic cellulitis/staph infection. Wound Bed: scabby, pink, yellow. Drainage: bloody, some yellow. Amount: small. Odor: none. Surrounding tissue: dry, scaly. (Failed to provide measurements); and - Showed wounds addressed on this visit- Wound 2 - location: left outer lower leg. Status: closed, present on admission. Type: chronic cellulitis. Wound Bed: red. Eschar: 100%. Wound edges: attached. Surrounding tissue: intact. (Failed to provide measurements). Review of the SN (skilled nursing) notes showed no measurements of wound 1 until the SN visit 09/20/2022 at which time the wound measured: length- 2.3cm (centimeter), width- 0.1cm, and depth- 0.1cm. (21 days later). Review of a SN visit noted dated 09/02/2022 showed wound 2 status as open and failed to contain any measurements. Further review of the SN visit notes failed to show any measurements of wound 2. During an interview on 10/04/2022 at 2:35 PM the clinical manager stated that he/she was unable to find any other record of EDLs or FCSRs for employees 1, 2, 3 and 4. During an interview on 10/04/2022 at 3:21 PM the clinical manager stated that he/she would expect wound measurements weekly if it (the wound) was open. During an interview on 10/05/2022 at 9:20 AM the clinical manager stated: -“This is the wound vac policy”; - “It shows where we do weekly wound measurements”; and - “I can’t find anything else (wound documentation policy) at this time.”

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 agency failed to complete or send a transfer summary to the receiving institution within two business days of becoming aware of becoming aware of an unplanned transfer in two (Records/Patients #2 and #5) of five full records reviewed; and the agency failed to send a discharge summary to the primary care practitioner or other healthcare professional within five business days of the discharge in one (Record/Patient #5) of six applicable records reviewed. These deficient practices have the potential for unmet care needs for all patients transferred or discharged from the agency. RECORD/PATIENT #2: Review of the clinical record showed: - Patient admitted to home health services on 08/15/2022 for back pain; - On 09/14/2022 a communication note was submitted by the PTA regarding the patient being hospitalized on 09/13/2022 per family; - Transfer OASIS (The Outcome and Assessment Information Set- patient specific, standardized assessment used in home health care to; plan care, determine reimbursement, and measure quality), was completed on 09/13/2022 by the RN; - Transfer Summary, completed and electronically signed by the RN (registered nurse) on 09/16/2022 with “copy of transfer summary sent to physician upon request” noted (No documentation of transfer summary being sent to the physician); and - No documentation of transfer summary being provided to the receiving facility. During an interview on 10/04/2022 at 3:45 PM, the clinical manager stated that the transfer summary should be sent to the physician, as well as, the receiving facility. Findings included: Review of the agency’s undated policy titled “12.5.23 Discharge/Transfer – Patient” showed: - “Named agency” will discharge and/or transfer patients in a timely, coordinated manner when the agency meets the agency discharge/transfer criteria; - “Named agency will arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the agency’s capabilities; - “Named agency” may discharge a patient if the physician who is responsible for the home health plan of care agree that “Named Agency” the measurable outcomes and goals set forth in the plan of care have been achieved and that the patient no longer needs “Named Agency” services; - A completed discharge summary will be sent to the primary care practitioner or other healthcare professional who will be responsible for providing care and services to the patient after discharge from the HHA (home health agency) (if any) within five business days of the patient’s discharge; - A completed transfer summary is sent within two business days of a planned transfer or within two business days of becoming aware of an unplanned transfer, if the patient’s care will be/still is receiving care in a healthcare facility; and - The discharge summary will be placed in the patient’s clinical record. RECORD/PATIENT #5: Review of the clinical record showed: - The patient was admitted to the agency 08/02/2022 with orders for SN two times a week for five weeks then one time a week for four weeks; - An order dated 09/08/2022 showed discharge patient from skilled nursing due to nursing goals met; - A completed SN (skilled nurse) discharge summary dated; - An order dated 09/26/2022 showed hold home health due to hospitalization; - A completed transferred summary dated 09/26/2022; and - No evidence of the discharge or transfer summaries being sent anywhere. During an interview on 10/04/2022 at 3:40 PM with the referral coordinator while reviewing the electronic medical record, he/she stated that: - Neither the discharge summary nor the transfer summary had been sent; - They are both in QA (for review to be sent); - The transfer should go to the Doctor and wherever the patient is transferred; and - I usually do this but I was on vacation.

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 the agency's policy review, record review, and interview, the agency failed to ensure clinical record documentation was complete and/or accurate in, two (Records/Patients #3 and #4) of five full records reviewed. This deficient practice has the potential to adversely affect the care of all patients served by the agency. RECORD/PATIENT #4: Review of the clinical record, showed: - OT (occupational therapy) visit on 09/14/2022, showed, time in (start time for the visit) at 2:45 PM, time out (time visit was completed) was left blank, and visit documentation was not signed and dated by the clinician; - OT visit on 09/19/2022, showed, time in at 2:30 PM, time out was left blank, and visit documentation was not signed and dated by the clinician; - OT visit on 09/26/2022, showed, time in at 4:15 PM, time out at 5:00 PM, and visit documentation was not signed and dated by the clinician; - The electronic medical record showed, OT tasks, showed, visit status listed as, “saved,” on all of the incomplete visits; and - Status of “not started” was listed for OT visits on 09/23/2022 and 09/28/2022. During an interview on 10/04/2022 at 3:15 PM, the clinical manager stated that; - He/she not sure why old visits have “not started” listed for status; - OT visits should be completed with signature and date; and - He/she expects documentation to be completed at least weekly. Findings included: Review of the agency’s undated policy titled “12.6.7 OASIS Data Entry & Transmission” showed: - Personnel completing OASIS forms, paper or computerized, will enter accurate and complete information which reflects the patient’s status at the time of assessment; - Data entry audits will be conducted to assure that OASIS from paper forms is accurate and complete and will be reported to the QAPI committee; - An OASIS Data Entry/Transmission Error Report log will be completed on a monthly basis to monitor any encoding/transmission errors; and - With certain OASIS data entry errors, it may be necessary for authorized personnel to unlock the record, make the correction, and re-lock the record, and submit the correction to the state. RECORD/PATIENT #3 Review of the Start of Care OASIS (Outcome and Assessment Information Set- a standardized evaluation) showed: - A visit date of 09/16/2022 documented; - Item M0030 Start of Care date documented as 09/15/2022 (a day prior to the visit date); and - Item M0090 Date assessment completed documented as 09/16/2022. Review of the plan of care showed: - A start of care date of 09/15/2022; and - Certification period from 09/15/2022 to 11/13/2022. Review of a physician order dated 09/15/2022 showed: - Verbal report given to, and orders received from doctor’s representative regarding patient’s admission to Home Health for skilled nursing for observation and instruction on meningioma (a usually noncancerous tumor that arises from the membranes surrounding the brain and spinal cord), increased weakness, medication management, instruction on safety of mobility, and infection precautions; and - Nursing frequency will be 1w1w (one time a week for one week), 2w8w (two times a week for eight weeks), PT/OT eval (evaluate) and treat. Further review of the clinical record failed to show any other discipline had seen the patient until 09/16/2022. During an interview on 10/04/2022 at 3:20 PM, after reviewing the date discrepancy of the SOC and visit date, the clinical manager stated that he/she would look for more information to clarify the discrepancy. During an interview on 10/05/2022 at 9:20 AM the clinical manager handed the surveyor a policy that had been requested the prior day and stated that he/she didn’t find any information about the discrepancy of dates.