Every finding on record at Schofield Residence, Inc.

The following statement of deficiencies represents the results of a partially extended re-certification survey of Schofield Certified Home Care on 08/12/2025 to 08/18/2025. A standard re-certification survey was initiated on 08/12/2025. Deficient practices were identified at Level 1 standards G-716 (Preparing Clinical Notes) resulting in a partial extended survey. The survey consisted of a review of seven (7) clinical records including two (2) discharged records, five (5) personnel records, and three (3) observational home visits. The survey included a review of pertinent policies and procedures, Quality Improvement Meeting Minutes for the past twelve (12) months, agency’s Admission packet, two (2) contracts, infection control policies and procedures, the Emergency Preparedness Plan, and Complaint Log. The current patient census is ninety-seven (97). Pre-survey activities consisted of review on 08/11/2025 of the agency’s Health Commerce System (HCS), Potentially Avoidable Event Patient Listing Report for 06/03/2024 to 05/30/2025 and the Home Health Error Summary Report for 08/11/2024 to 08/11/2025. The Administrator, Director of Patient Services (DPS), Quality Assurance RN (Registered Nurse), and various professional staff were interviewed. Findings were reviewed at the exit conference on 08/18/2025. The following deficiencies are identified as a result of the survey: G-374, G-520, G-536, G-574, G-580, G-716, G-1024, J-508, J-1156, J-1424, and J-1520.

The following statement of deficiencies represents the results of a partially extended re-certification survey of Schofield Certified Home Care on 08/12/2025 to 08/18/2025. A standard re-certification survey was initiated on 08/12/2025. Deficient practices were identified at Level 1 standards G-716 (Preparing Clinical Notes) resulting in a partial extended survey. The survey consisted of a review of seven (7) clinical records including two (2) discharged records, five (5) personnel records, and three (3) observational home visits. The survey included a review of pertinent policies and procedures, Quality Improvement Meeting Minutes for the past twelve (12) months, agency’s Admission packet, two (2) contracts, infection control policies and procedures, the Emergency Preparedness Plan, and Complaint Log. The current patient census is ninety-seven (97). Pre-survey activities consisted of review on 08/11/2025 of the agency’s Health Commerce System (HCS), Potentially Avoidable Event Patient Listing Report for 06/03/2024 to 05/30/2025 and the Home Health Error Summary Report for 08/11/2024 to 08/11/2025. The Administrator, Director of Patient Services (DPS), Quality Assurance RN (Registered Nurse), and various professional staff were interviewed. Findings were reviewed at the exit conference on 08/18/2025. The following deficiencies are identified as a result of the survey: G-374, G-520, G-536, G-574, G-580, G-716, G-1024, J-508, J-1156, J-1424, and J-1520.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on review of the agency's Outcome Assessment Information Set (OASIS) submissions, clinical records and interviews with agency staff for one (1) of seven (7) patients (Patient #6), the agency failed to ensure OASIS data accurately reflects the patient's status at the time of the assessment. Failure to ensure accurate documentation of OASIS data has the potential for negative outcomes. Findings are: Patient #6- This 100-year-old patient with diagnoses that include generalized primary osteoarthritis, essential primary hypertension, and atherosclerotic heart disease of native coronary artery without angina pectoris was admitted to the home health agency on 03/27/2025. This record was chosen as a potentially avoidable event: Development of Urinary Tract Infection. Review of the Registered Nurse (RN) OASIS Admission note dated 3/27/20125 revealed the Registered Nurse documented the patient's urinary status as follows: - Has this patient been treated for a Urinary Tract Infection in the past 14 days? No, - Urinary Incontinence or Urinary Catheter Presence: 1- patient is incontinent -Frequent infections: No Review of the Physical Therapy Oasis Discharge from agency note dated 04/28/2025 revealed the Physical Therapist documented the patient's urinary status as follows: - Has this patient been treated for a Urinary Tract Infection in the past 14 days? Yes, -Frequent infections: other: patient took antibiotics for fifteen (15) days that ended on 4/27/2025. Review of the Physical Therapy (PT) Initial visit note dated 4/3/2025 revealed the Physical Therapist documented the following: General systems review\Bowel and Bladder: Frequent infections: Patient finished antibiotics on 4/2/2025 for Urinary Tract Infection (UTI). The agency failed to ensure the RN Admission OASIS Data Collection Only accurately reflects the patient's status at the time of assessment. During an interview on 8/18/2025 at 12:37 PM, the Registered Nurse stated that they were not aware of the patient’s frequent urinary tract infections or antibiotic use at the time of admission and was not able to complete a complete medication reconciliation at the time of admission as patient was going to review medication changes from rehabilitation center at upcoming primary care appointment.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policy and procedure, and interviews with staff for two (2) of seven (7) patients (Patient #s: 5 and 6) the agency failed to ensure a complete and accurate comprehensive assessment consistent with the patient's immediate needs was completed within five (5) days of the start of care. Failure to ensure that a comprehensive assessment is complete and accurate has the potential for unmet needs and possible negative outcomes. Patient #5 – This 82-year-old patient with the diagnoses of fall on same level, unspecified, chronic kidney disease, and unspecified diastolic congestive heart failure was admitted to the home care agency on 7/14/2025. A. Review of the referral orders on the Skilled Nursing Facility discharge instructions dated 7/10/2025 revealed the following: Discharge services requested: Nursing, OT (occupational therapy) evaluation, PT (physical therapy) evaluation. Review of the Home Health Certification and Plan of Care for 7/14/2025 to 9/11/2025 revealed an order for Physical Therapy evaluation effective week of 7/21/2025 for strength and endurance, safety. Review of the clinical record revealed the Physical Therapist provided an initial visit for evaluation on 7/23/2025, 9 (nine) days after the start of care. During interview on 8/18/2025 at 11:27 AM the Director of Patient Services confirmed that Physical Therapy Services were requested at time of referral prior to start of care and is unaware of why an order was placed for the evaluation to occur the following week. The Director of Patient Services further confirmed that the expectation is that all requested services complete a comprehensive assessment within five (5) days of the start of care date. B. Review of the referral orders on the Skilled Nursing Facility discharge instructions dated 7/10/2025 revealed the following: Discharge services requested: Nursing, OT (occupational therapy) evaluation, PT (physical therapy) evaluation. Review of the Home Health Certification and Plan of Care for 7/14/2025 to 9/11/2025 revealed an order for Occupational Therapy evaluation effective week of 7/21/2025 for ADL’s (activities of daily living) and safety. Review of the clinical record revealed the Occupational Therapist provided an initial visit for evaluation on 7/22/2025, 8 (eight) days after the start of care. During interview on 8/18/2025 at 11:27 AM the Director of Patient Services confirmed that Occupational Therapy Services were requested at time of referral prior to start of care and is unaware of why an order was placed for the evaluation to occur the following week. The Director of Patient Services further confirmed that the expectation is that all requested services complete a comprehensive assessment within five (5) days of the start of care date. Patient #6- This 100-year-old patient with diagnoses that include generalized primary osteoarthritis, essential primary hypertension, and atherosclerotic heart disease of native coronary artery without angina pectoris was admitted to the home health agency on 03/27/2025. This record was chosen as a potentially avoidable event: Development of Urinary Tract Infection. A. Review of the referral orders on the Skilled Nursing Facility discharge instructions dated 3/24/2025 revealed the following: Discharge services requested: Nursing, OT (occupational therapy) evaluation, PT (physical therapy) evaluation. Review of the Home Health Certification and Plan of Care for 3/27/2025 to 5/25/2025 revealed an order for Physical Therapy evaluation for strength and endurance effective the week of 3/31/2025. Review of the clinical record revealed the Physical Therapist provided an initial visit for evaluation on 4/3/2025, 7 (seven) days after the start of care. During interview on 8/18/2025 at 12:16 PM the Director of Patient Services confirmed that Physical Therapy Services were requested at time of referral prior to start of care and was unaware the agency could not request an updated order from the physician for a later start date for services to begin outside of the 5 (five) day comprehensive assessment requirement. B. Review of the referral orders on the Skilled Nursing Facility discharge instructions dated 3/24/2025 revealed the following: Discharge services requested: Nursing, OT (occupational therapy) evaluation, PT (physical therapy) evaluation. Review of the Home Health Certification and Plan of Care for 3/27/2025 to 5/25/2025 revealed an order for Occupational Therapy evaluation for ADL (activities of daily living) training and safety in the home effective week of 3/31/2025. Review of the clinical record revealed the Occupational Therapist provided an initial visit for evaluation on 4/3/2025, 7 (seven) days after the start of care. During interview on 8/18/2025 at 12:16 PM the Director of Patient Services confirmed that Occupational Therapy Services were requested at time of referral prior to start of care and was unaware the agency could not request an updated order from the physician for a later start date for services to begin outside of the 5 (five) day comprehensive assessment requirement.

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 review of agency policy and procedure, clinical records and interviews with agency staff, for three (3) of seven (7) patients (Patient #s: 2, 6, and 7), the clinical record lacked documented evidence of a complete review of all medications the patient is currently using to identify any potential adverse effects and drug reactions or concerns. Failure to conduct a complete medication review has the potential for the patient to experience medication side effects or to receive incorrect medication dosages. Findings are: Review of the agency’s policy and procedure entitled “Nurse Medication Reconciliation” dated October 2022 revealed the following: "Medication reconciliation is a formal process in which health care professionals ensure accurate and complete medication information. Medication Reconciliation is the process of identifying the most accurate list of all medications that the patient is taking, including the name, dosage, frequency, and route, by comparing the medical record to the external list of medications obtained from a hospital or facility discharge or medical office visit. The nurse will perform medication reconciliations. Developing a list of medications: 1) Compare initial 485, Resumption of Care, or recertification orders to the patient’s current medications in the home. 2) A patient’s medication list will include all medications the patient is taking including over the counter (OTC) meds and herbal preparations. 3) Compare medications on discharge instructions from the hospital or facility. 4) Help and instruct patient to discard any expired medications. Current medications: 1) Check for any missing medications or any unfilled prescriptions. 2) Check for duplicate medications. 3) Check for any medications that may adversely interact with other meds or are contraindicated (call pharmacy if needed). 4) Transcribe all medications including OTC (over-the-counter) into Medication section of Allscripts. 5) Do Not use abbreviations on Medication List. 6) Medications without MD (Medical Doctor) order: a) Call MD to confirm or discontinue medication. b) Submit the interim or verbal order for the MD signature." Patient #7 – This 84-year-old patient with diagnoses that include chronic atrial fibrillation, unspecified, hypertensive heart disease with heart failure, and congestive heart failure was admitted to the home health agency on 07/23/2024. This record was chosen as a Potentially Avoidable: This record was chosen as a Potentially Avoidable: Discharge to the Community Needing Wound Care or Medication Assistance. Review of the Skilled Nursing Facility Medication Report dated 07/18/2024 and faxed to the agency on 07/18/2024 at 17:00 (05:00 PM) revealed the following medications: - Acetaminophen Tablet 325 mg (milligrams) give two (2) tablets by mouth every four (4) hours for pain not to exceed three (3) grams in twenty-four (24) hours. - Acetaminophen tablet 325 mg give two (2) tablets by mouth every four (4) hours as needed for temperature 100F or above. - Bisacodyl Suppository 10 mg insert one (1) suppository rectally every twenty-four (24) hours as needed for bowel management daily if no results from MOM (milk of magnesia). - Eliquis Oral tablet (Apixaban) give 2.5 mg by mouth two (2) times a day for atrial fibrillation. - Fleet Enema Enema 7-19 GM (grams)/118 ml (milliliters) (Sodium Phosphates) insert one (1) application rectally every twenty-four (24) hours as needed for constipation. Fleet enema per rectal when no results from Dulcolax suppository and prn (as needed). - Furosemide tablet 20 mg – give one (1) tablet by mouth one (1) time a day for edema. - Levothyroxine Sodium tablet 112 mcg (micrograms) give one (1) tablet by mouth one (1) time a day for low thyroid hormone. - Metoprolol tartrate tablet – give 12.5 mg by mouth two (2) times a day for HTN (hypertension). - Milk of Magnesia oral suspension 400mg/5ml (magnesium hydroxide) give thirty (30) ml by mouth every twenty-four (24) hours as needed for bowel management. - Oxycodone HCL oral tablet five (5) mg (oxycodone HCL) give one (1) tablet by mouth every four (4) hours as needed for pain not relieved by Tylenol/Naprosyn. - Potassium Chloride ER (Extended Release) 10 MEQ (Milliequivalent) – give one (1) tablet by mouth one (1) time a day for Lasix therapy. - Vitamin D3 Ultra Potency oral tablet 1250 mcg (Cholecalciferol) give one (1) tablet by mouth one (1) time a day every Wednesday for supplement. Review of the Home Health Certification and Plan of Care for certification period 07/23/2024 to 09/20/2024 revealed the following: - Allegra Allergy by mouth tablet sixty (60) mg one (1) tablet daily PO PRN (as needed) allergies. - Allopurinol by mouth tablet 300 mg one (1) tablet daily PO Gout. - Eliquis by mouth tablet 2.5 mg one (1) tablet twice daily PO CHF (Congestive Heart Failure). - Levothyroxine Sodium by mouth capsule 112 mcg 1 cap (capsule) daily Po hypothyroidism. - Metoprolol Tartrate by mouth tablet 25 mg 0.5 tablet twice a day PO hypertension. - Oxycodone HCL by mouth tablet five (5) mg one (1) tablet every four (4) hours as needed PO pain. - Potassium Chloride Crys ER by mouth tablet extended release ten (10) MEQ one (1) tablet daily PO hypokalemia. - Vitamin D3 by mouth capsule (fifty) 50 mcg one (1) capsule daily PO supplement. Review of the Charts/Clinical Noters dated 07/23/2024 revealed the Registered Nurse documented the following:" patient did not have oxycodone, states that the patient does not take acetaminophen, is taking vitamin D3 50 mcg daily. In addition to discharge list of medications patient is also taking Allopurinol 300mg QD (every day), Allegra D QD as needed. Mediations checked for drug interactions and no major interactions noted. Called placed to doctor’s office, agreeable to physical therapy, occupational therapy, MSW referrals, nursing visit frequency, and medications reconciled." There is a lack of documented evidence that the patient should be taking the following or evidence that the following medications have been discontinued: - Bisacodyl Suppository 10 mg insert one (1) suppository rectally every twenty-four (24) hours as needed for bowel management daily if no results from MOM (milk of magnesia). - Fleet Enema 7-19 GM (grams)/118 ml (milliliters) (Sodium Phosphates) insert one (1) application rectally every twenty-four (24) hours as needed for constipation. Fleet enema per rectal when no results from Dulcolax suppository and prn (as needed). - Milk of Magnesia oral suspension 400mg/5ml (magnesium hydroxide) give thirty (30) ml by mouth every twenty-four (24) hours as needed for bowel management. During an interview on 08/18/2025 at 10:36 AM, the Registered Nurse (RN) stated that maybe the RN had looked at the discharge summary that was in the home. The Registered Nurse continued to state Bisacodyl, Fleets Enema, and Milk of Magnesia would have been medications on the patient’s MAR (Medication Administration Record) while at subacute rehab in the skilled nursing facility and that the patient would not be continuing those medications. Patient #2- This 72-year-old patient with diagnoses that include type 2 diabetes, non-pressure chronic ulcer of other part of right lower leg limited to breakdown of skin, and , non-pressure chronic ulcer of other part of left lower leg limited to breakdown of skin was admitted to the agency on 7/25/2025. A. Review of the History of Present Illness office visit and referral dated 06/25/2025 revealed the following medication order: - Saline Nasal 0.65% spray aerosol one squirt in each nostril every 4 (four) hours as needed for dryness Review of the Home Health Certification and Plan of Care for certification period 7/25/2025 to 9/22/2025 lacks an order for Saline Nasal Spray. Review of the Registered Nurse OASIS Start of Care lacked documentation that the Registered Nurse discussed the need to add Saline Nasal Spray to the patient's medication regime. During interview on 8/18/2025 at 1:37 PM the Registered Nurse stated that they do not recall whether the medication was on the referral medication list and confirmed that there is no documented reason why the medication was not ordered at start of care. B. Review of the History of Present Illness office visit and referral dated 06/25/2025 revealed the following medication order: - Diclofenac 1% topical gel apply 2 (two) grams by topical route 2 (two) times every day to both knees. Review of the Home Health Certification and Plan of Care for certification period 7/25/2025 to 9/22/2025 lacks an order for Diclofenac topical gel. Review of the Registered Nurse OASIS Start of Care lacked documentation that the Registered Nurse discussed the need to add Diclofenac topical gel to the patient's medication regime. During interview on 8/18/2025 at 1:37 PM the Registered Nurse stated that they do not recall whether the medication was on the referral medication list and confirmed that there is no documented reason why the medication was not ordered at start of care. C. Review of the History of Present Illness office visit and referral dated 06/25/2025 revealed the following medication order: - Carboxymethylcell 0.5% eye drops instill 1 (one) drop into both eyes twice daily for dry eyes Review of the Home Health Certification and Plan of Care for certification period 7/25/2025 to 9/22/2025 lacks an order for Carboxymethylcell eye drops. Review of the Registered Nurse OASIS Start of Care lacked documentation that the Registered Nurse discussed the need to add Carboxymethylcell eye drops to the patient's medication regime. During interview on 8/18/2025 at 1:37 PM the Registered Nurse stated that they do not recall whether the medication was on the referral medication list and confirmed that there is no documented reason why the medication was not ordered at start of care. D. Review of the History of Present Illness office visit and referral dated 06/25/2025 revealed the following medication order: - Polyethylene Glycol 3350 17 gram per dose oral powder. Take 17 grams by oral route every day for constipation, mixed with 8 ounces of water. Review of the Home Health Certification and Plan of Care for certification period 7/25/2025 to 9/22/2025 lacks an order for Polyethylene Glycol. Review of the Registered Nurse OASIS Start of Care lacked documentation that the Registered Nurse discussed the need to add Polyethylene Glycol to the patient's medication regime. During interview on 8/18/2025 at 1:37 PM the Registered Nurse stated that they do not recall whether the medication was on the referral medication list and confirmed that there is no documented reason why the medication was not ordered at start of care. Patient #6- This 100-year-old patient with diagnoses that include generalized primary osteoarthritis, essential primary hypertension, and atherosclerotic heart disease of native coronary artery without angina pectoris was admitted to the home health agency on 03/27/2025. Review of the RN OASIS Start of Care visit dated 3/27/2025 revealed the Registered Nurse documented that a review of medications were reconciled without issue, no changes made, patient compliance with medications, and the drug regimen review identified no potentially clinically significant medication issues. Review of the Skilled Nursing Clinical Note dated 3/27/2025 revealed the following: “Medications reconciled via discharge medication list and medications in the home. Primary Care office representative confirmed medication list. No major drug-to-drug interactions identified. Patient’s daughter has scheduled primary care physician follow-up for 3/31/2025.” A. Review of the Discharge Summary dated 03/24/2025 revealed the order for: Cozaar oral tablet 100mg (milligrams) 1 capsule by mouth 1 (one) time a day Review of the Home Health Certification and Plan of Care for certification period 3/27/2025 to 5/25/2025 lacks an order for Cozaar. Review of the Registered Nurse OASIS Start of Care lacked documentation that the Registered Nurse discussed the need to add Cozaar to the patient's medication regime. B. Review of the Discharge Summary dated 03/24/2025 revealed the order for: Fish Oil Capsule 1,000mg (milligrams) 1 (one) capsule by mouth 1 (one) time a day Review of the Home Health Certification and Plan of Care for certification period 3/27/2025 to 5/25/2025 lacks an order for Fish Oil. Review of the Registered Nurse OASIS Start of Care lacked documentation that the Registered Nurse discussed the need to add Fish Oil to the patient's medication regime. C. Review of the Discharge Summary dated 03/24/2025 revealed the order for: Meloxicam tablet 15mg (milligrams) 1 (one) tablet by mouth 1 (one) time a day Review of the Home Health Certification and Plan of Care for certification period 3/27/2025 to 5/25/2025 lacks an order for Meloxicam. Review of the Registered Nurse OASIS Start of Care lacked documentation that the Registered Nurse discussed the need to add Meloxicam to the patient's medication regime. D. Review of the Discharge Summary dated 03/24/2025 revealed the order for: Cholecalciferol tablet 1,000 units 1 (one) tablet my mouth 1 (one) time a day Review of the Home Health Certification and Plan of Care for certification period 3/27/2025 to 5/25/2025 lacks an order for Cholecalciferol. Review of the Registered Nurse OASIS Start of Care lacked documentation that the Registered Nurse discussed the need to add Cholecalciferol to the patient's medication regime. E. Review of the Discharge Summary dated 03/24/2025 revealed the order for: Amlodipine Besylate tablet 5mg (milligrams) 1 (one) tablet my mouth 1 (one) time a day Review of the Home Health Certification and Plan of Care for certification period 3/27/2025 to 5/25/2025 lacks an order for Amlodipine Besylate. Review of the Registered Nurse OASIS Start of Care lacked documentation that the Registered Nurse discussed the need to add Amlodipine Besylate to the patient's medication regime. F. Review of the Discharge Summary dated 03/24/2025 revealed the order for: Cyanocobalamin Tablet 1000mcg (micrograms) 1 (one) tablet my mouth 1 (one) time a day Review of the Home Health Certification and Plan of Care for certification period 3/27/2025 to 5/25/2025 lacks an order for Cyanocobalamin. Review of the Registered Nurse OASIS Start of Care lacked documentation that the Registered Nurse discussed the need to add Cyanocobalamin to the patient's medication regime. G. Review of the Discharge Summary dated 03/24/2025 revealed the order for: Metoprolol Tartrate Tablet 25mg (milligrams) 1 (one) tablet my mouth 2 (two) times a day Review of the Home Health Certification and Plan of Care for certification period 3/27/2025 to 5/25/2025 lacks an order for Metoprolol Tartrate. Review of the Registered Nurse OASIS Start of Care lacked documentation that the Registered Nurse discussed the need to add Metoprolol Tartrate to the patient's medication regime. During interview on 8/18/2025 at 9:38 AM, the Registered Nurse stated that the patient had been in skilled nursing rehabilitation prior to admission to the agency and started on several new medications. The daughter had scheduled a follow up to review discharge from rehab and all changes with primary care physician on 3/31/2025, so the medication list from the patient’s discharge summary were not reconciled at visit. H. Review of the Home Health Certification and Plan of Care for certification period 3/27/2025 to 5/25/2025 revealed an order for Tramadol Hydrochloride by mouth tablet 50mg (milligrams) 1-2 (one to two) tablets 3 (three) times a day as needed by mouth for pain. Review of the Discharge Summary dated 3/24/2025 lacked orders for Tramadol Hydrochloride. I. Review of the Home Health Certification and Plan of Care for certification period 3/27/2025 to 5/25/2025 revealed an order for Daily Multiple Vitamins by mouth tablet one tablet daily for supplement Review of the Discharge Summary dated 3/24/2025 lacked orders for Daily Multiple Vitamins. J. Review of the Home Health Certification and Plan of Care for certification period 3/27/2025 to 5/25/2025 revealed an order for Hydromorphone Hydrochloride by mouth tablet 2mg (milligrams) 1 (one) tablet 3 (three) times a day as needed for pain. Review of the Discharge Summary dated 3/24/2025 lacked orders for Hydromorphone Hydrochloride. K. Review of the Home Health Certification and Plan of Care for certification period 3/27/2025 to 5/25/2025 revealed an order Celebrex 200mg (milligrams) 1-2 (one to two) capsules by mouth daily as needed for osteoarthritis. Review of the Discharge Summary dated 3/24/2025 lacked orders for Celebrex. During interview on 8/18/2025 at 9:40 AM, the Registered Nurse stated that the patient had been in skilled nursing rehabilitation prior to admission to the agency and started on several new medications. The daughter had scheduled a follow up to review the discharge instructions from the rehabilitation facility and all changes with primary care physician on 3/31/2025. Additionally, the medications listed in the Plan of Care were present in the home.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policies and procedures, and staff interviews for five (5) of seven (7) patients (Patient #s: 1, 2, 4, 5 and 6) the agency failed to develop individualized plans of care (POC) that are complete and accurate and address the total needs of the patients. The issues are: - The POC lacked orders for PERS (personal emergency response system) - The POC lacked documentation of a primary diagnosis - The POC lacked diabetic safety precautions - The POC lacked order for knee sleeve - The POC lacked order for topical medicated cream -The POC contained inaccurate diet order Failure to ensure that a comprehensive individualized plan of care is developed has the potential for unmet patient needs. Patient #4 – This 72-year-old patient with diagnoses that include chronic obstructive pulmonary disease, type II diabetes with diabetic polyneuropathy was admitted to the home health agency on 01/18/2024. A. Review of the Home Health Certification and Plan of Care for certification period 01/18/2024 to 03/17/2024 revealed the following: - Type 2 Diabetes Mellitus with diabetic polyneuropathy. - Perform blood glucose monitoring Q (every) Visit. - Durable Medical Equipment and Supplies: Glucometer supplies. - Call MD (Medical Doctor) if BS (Blood Sugar) Parameters (greater than) 240 for two consecutive tests. - Metformin HCL ER (MOD) by mouth tablet Extended Release 24-hour 500 mg (milligram) 2 tab (tablet) daily PO DMII (type II diabetes mellitus). - Patient is a type 2 diabetic managed by medications; no insulin prescribed. Last blood sugar taken on 01/11/2024 by skilled nurse was 128. There is a lack of documented evidence of diabetic precautions on the plan of care. During an interview on 08/18/2025 at 10:45 AM, the Director of Patient Services stated there were no diabetic precautions but there should be diabetic precautions listed on the plan of care under safety measures. B. Review of the Home Health Certification and Plan of Care for certification period 07/11/2025 to 09/08/2025 revealed the following: - Type 2 Diabetes Mellitus with diabetic polyneuropathy. - Perform blood glucose monitoring Q (every) Visit. - Durable Medical Equipment and Supplies: Glucometer supplies. - Call MD (Medical Doctor) if BS (Blood Sugar) Parameters (greater than) 240 for two consecutive tests. - Metformin HCL ER (MOD) by mouth tablet Extended Release 24-hour 500 mg (milligram) 2 tab (tablet) daily PO DMII (type II diabetes mellitus). - Patient has history of long-term use of oral hypoglycemic drugs…. Random BG (Blood glucose) 134, patient reports he finished lunch just ½ hour prior to this visit. There is a lack of documented evidence of diabetic precautions. During an interview on 08/18/2025 at 09:33 AM, the Quality Assurance (QA) Nurse stated that there are no diabetic precautions but there should be diabetic precautions listed on the plan of care under safety measures. Patient #2- This 72-year-old patient with diagnoses that include type 2 diabetes, non-pressure chronic ulcer of other part of right lower leg limited to breakdown of skin, and non-pressure chronic ulcer of other part of left lower leg limited to breakdown of skin was admitted to the agency on 7/25/2025. A.) Review of the Home Health Certification and Plan of Care for certification period 7/25/2025 to 9/22/2025 revealed the following diagnosis: Type 2 diabetes mellitus with diabetic neuropathy, unspecified. Review of the Home Health Certification and Plan of Care for certification period 7/25/2025 to 9/22/2025 revealed the following safety measures: universal precautions, falls precautions, oxygen precautions, and bleeding precautions. The agency failed to include diabetic precautions as a safety measure in the Plan of Care for a patient with an active diagnosis of diabetes. During interview on 8/18/2025 at 1:41 PM, the Registered Nurse stated that diabetic precautions should be listed as a safety measure but is not. B.) Review of the Home Health Certification and Plan of Care for certification period 7/25/2025 to 9/22/2025 revealed the following: nutritional requirement – Regular. Review of the Skilled Nursing Star of Care visit dated 7/25/2025 revealed the Registered Nurse documented the following: Nutrition education: Instructed on: Prescribed diet: Low Sodium During interview on 8/18/2025 at 1:46 PM, the Registered Nurse stated that the Regular diet ordered on the Plan of Care was incorrect; the patient is on a low sodium diet due to Edema. Patient #6- This 100-year-old patient with diagnoses that include generalized primary osteoarthritis, essential primary hypertension, and atherosclerotic heart disease of native coronary artery without angina pectoris was admitted to the home health agency on 03/27/2025. This record was chosen as a potentially avoidable event: Development of Urinary Tract Infection. A.) Review of the Physical Therapy Progress Note dated 4/10/2025 revealed the Physical Therapist documented the following: Patient has an OTC (over the counter) off-brand topical cream and was applied to L (left) knee to help alleviate pain. Review of the Physical Therapy with Treatment Visit Note dated 4/16/2025 revealed the Physical Therapist documented the following: Lower extremity pain: Location: R (right) Knee Type: Other, chronic Character: intermittent Exacerbated by: walking, prolonged standing Relieved by: Rest, other: Bengay and knee sleeve application Review of the Home Health Certification and Plan of Care for 3/27/2025 to 5/25/2025 lacks an order for a topical analgesic cream. During interview on 8/18/2025 at 12:31 PM, the Physical Therapist confirmed that the patient was using a medicated topical cream for knee pain and was unaware that the medication needed to be added to the plan of care. B.) Review of the Physical Therapy with Treatment Visit Note dated 4/16/2025 revealed the Physical Therapist documented the following: Lower extremity pain: Location: R (right) Knee Type: Other, chronic Character: intermittent Exacerbated by: walking, prolonged standing Relieved by: Rest, other: Bengay and knee sleeve application Review of the Home Health Certification and Plan of Care for certification period 3/27/2025 to 5/25/2025 lacks orders for application of knee sleeve During interview on 8/18/2025 at 12:33 PM, the Physical Therapist confirmed that the patient was using a knee sleeve in the home to assist with knee pain and was unaware that the plan of care needed to be updated to include the medical equipment. Patient #5 – This 82-year-old patient with the diagnoses of fall on same level, unspecified, chronic kidney disease, and unspecified diastolic congestive heart failure was admitted to the home care agency on 7/14/2025. Review of the Skilled Nursing Clinical Notes dated 7/14/2025 revealed the Registered Nurse documented the following: RN (Registered Nurse) reviewed fall prevention, home safety, use of 4 wheeled walker (4ww), use of PERS (personal emergency response system) and emergency plan. Review of the Home Health Certification and Plan of Care for certification period 7/14/2025 to 9/11/2025 reveals the following DME (durable medical equipment) and supplies: Hospital bed, rollator walker, shower bench, toilet seat. The Agency failed to ensure the plan of care included the patient’s personal emergency response system. During interview on 8/18/2025 at 11:37 AM the Director of Patient Services confirmed that the PERS system should be listed in the plan of care under DME/supplies, but it does not. Patient #1- This 64-year-old patient with diagnoses that include type 2 diabetes mellitus, diabetic chronic kidney disease, and unspecified diastolic congestive heart failure was admitted to the agency on 5/1/2025. Review of the Home Health Certification and Plan of Care for certification period 6/30/2025 to 8/28/2025 revealed the following: Principal Diagnosis: N/A Other Pertinent Diagnosis: Type 2 diabetes mellitus with diabetic chronic kidney disease, hypertensive and chronic kidney disease with heart failure and stage 1 through 4 chronic kidney disease, unspecified diastolic heart failure, chronic kidney disease, chronic obstructive pulmonary disease, pulmonary hypertension, acquired immunodeficiency syndrome, chronic respiratory failure with hypoxia, seizure disorder, obstructive sleep apnea. The Agency failed to ensure the plan of care included a principal diagnosis. During interview on 8/18/2025 at 9:43 AM the Director of Patient Services stated that the patient’s previous principal diagnosis in past certifications was discontinued when the patient no longer has leg wound. A new principal diagnosis was never entered but should have been updated.

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 review of clinical records and interviews with agency staff for one (1) of seven (7) patients (Patient #1), the agency failed to provide services in accordance with physician orders and the Plan of Care. Failure to ensure patient care is provided in accordance with physician orders and the Plan of Care has the potential for patients to receive poor care and for health care needs to go unmet. The agency failed to ensure services were provided in accordance with physician orders and the Plan of Care as evidenced by: Patient #1- This 64-year-old patient with diagnoses that include type 2 diabetes mellitus, diabetic chronic kidney disease, and unspecified diastolic congestive heart failure was admitted to the agency on 5/1/2025. Review of the Home Health Certification and Plan of Care for certification period 6/30/2025 to 8/28/2025 revealed the following order: “Skilled Nursing to fill oral medications weekly and 2 (two) extra days for patient” Review of the Skilled Nursing Clinical Note Nurse dated 7/11/2025 revealed the following: “Two missing medications that are not in pill box. Discroll (vitamin d) and Lasix 40mg (milligrams). Patient states the medications are delivered to patient and patient expects a delivery this date. Will follow up with patient next business day. Will make PRN (as needed) visit to finish the fill as needed.” Review of the clinical record lacked documented evidence of a follow up visit to ensure all ordered medications were placed in the placed in the mediset. During interview on 8/18/2025 at 1204 PM, the Director of Patient Services (DPS) stated the clinician was unavailable for interview and confirmed that there is nothing documented in the clinical record that the Registered Nurse ever followed up on medication needs or complete medication fill as ordered by the physician and specified within the plan of care.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with staff, for five (5) of seven (7) patients (Patient #s: 1, 2, 4, 6, and 7), the agency failed to document complete and accurate clinical notes. Failure to document complete and accurate clinical and progress notes has a potential for unmet patient needs. Patient #7 – This 84-year-old patient with diagnoses that include chronic atrial fibrillation, unspecified, hypertensive heart disease with heart failure, and congestive heart failure was admitted to the home health agency on 07/23/2024. This record was chosen as a Potentially Avoidable: Discharge to the Community Needing Wound Care or Medication Assistance. Review of the Home Health Certification and Plan of Care for certification period 07/23/2024 to 09/20/2024 revealed the following: Other Pertinent Diagnoses: Acquired absence of right leg below knee SN (Skilled Nursing) SOC (Start of Care) Note: Patient returns home after being hospitalized 7/28-08/04/2023 with a diagnosis of septic shock, secondary to right lower necrotizing infection, and underwent a right BKA (Below Knee Amputation) and subsequently went to rehab for a year. Review of the Occupational Therapy (OASIS E) Routine Visit notes dated 08/01/2024, 08/02/2024, 08/20/2024, 08/27/2024, 08/28/2024, 09/04/2024, and 09/05/2024 revealed the Occupational Therapist documented the following: General Systems/Review/Skin/Amputation Amputation: Assess amputation site and/or prothesis: lower extremity. Lower Extremity – Leg Amputation: Right – above knee. Review of the Occupational Therapy (OASIS E) Initial Visit dated 08/14/2024 revealed the Occupational Therapist documented the following: General - Medical History: … acquired absence of right leg below knee… General Systems Review/Skin/Amputation – Amputation: lower extremity – leg amputation: right above the knee. Review of the Charts/Clinical Notes dated 08/14/2024 revealed the Occupational Therapist documented the following: Patient has a R (Right) AKA (Above the Knee Amputation) with prothesis and is independent with donning in the am (morning) and doffing at bedtime. The Occupational Therapist failed to ensure documentation is consistent. During an interview on 08/14/2025 at 04:03 PM, the Occupational Therapist stated that the patient has a below the knee amputation and that the OT documented incorrectly. Patient #4 – This 72-year-old patient with diagnoses that include chronic obstructive pulmonary disease, type II diabetes with diabetic polyneuropathy was admitted to the home health agency on 01/18/2024. Review of the Occupational Therapy (OASIS E) Routine Visit note dated 07/15/2025 revealed the Occupational Therapist documented the following under General Systems Review/Bladder and Bowel - Bowel: Other: Last BM (Bowel Movement): 07/20/2025. Documentation is inaccurate and does not accurately reflect the date of the patient’s last bowel movement. During an interview on 08/18/2025 at 12:38 PM, the Occupational Therapist stated that the documentation of the patient’s last bowel movement of 07/20/2025 was an error. Patient #1- This 64-year-old patient with diagnoses that include type 2 diabetes mellitus, diabetic chronic kidney disease, and unspecified diastolic congestive heart failure was admitted to the agency on 5/1/2025. Review of the Home Health Certification and Plan of Care for certification period 6/30/2025 to 8/28/2025 revealed the following order: Home Health Aide (HHA) services to continue 3 (three) times a week to assist with personal care, activities of daily living (ADL’s), meal prep. Review of the Skilled Nursing Routine Visit Note dated 7/11/2025 revealed the Registered Nurse documented following: Home Health Aide Supervision: No Home Health Aide Services. Skilled Nursing Clinical Note dated 7/11/2025 revealed the Registered Nurse documented the following: Home visit for skilled assessment and MPF. Patient ambulated to door when writer arrived. PCA present. She receives PCA services three times/week. During interview on 8/18/2025 at 12:02 PM, the Director of Patient Care Services (DPS) stated that the clinician is unavailable for interview but based on review of documentation and the clinical record, the Registered Nurse’s documentation is unclear, and confirmed the patient receives Home Health Aide Services. Patient #2- This 72-year-old patient with diagnoses that include type 2 diabetes, non-pressure chronic ulcer of other part of right lower leg limited to breakdown of skin, and non-pressure chronic ulcer of other part of left lower leg limited to breakdown of skin was admitted to the agency on 7/25/2025. Review of the Home Health Certification and Plan of Care for certification period 7/25/2025 to 9/22/2025 reveals the following short-term goals: absence of skin breakdown, preservation of skin integrity. Review of the Skilled Nurse Visit Note dated 8/1/2025 revealed the Registered Nurse documented the following: "Vital signs within parameters, afebrile. Patient states she has a blister left calf that opened during the night making a wet area on bedding. Left calf has superficial open area, pink, moist. Cleansed with wound cleanser, pat dry, triple antibiotic ointment, allevyn.” Review of the Visit Record dated 8/1/2025 revealed that the Registered Nurse documented the following: - ST (short-term): absence of skin breakdown + progressing as anticipated - ST (short-term): preservation of skin integrity + progressing as anticipated During interview on 8/18/2025 at 1:44 PM the Registered Nurse stated that documenting the goals as progressing is inaccurate and contradicts the clinical note findings. The Director of Patient Services further stated that there is an EMR (electronic medical record) limitation in which goals can only be documented as the following options: Progressing slowly, progressing as anticipated, rapidly progressing, and met. Patient #6- This 100-year-old patient with diagnoses that include generalized primary osteoarthritis, essential primary hypertension, and atherosclerotic heart disease of native coronary artery without angina pectoris was admitted to the home health agency on 03/27/2025. This record was chosen as a potentially avoidable event: Development of Urinary Tract Infection. Review of the Physical Therapy Routine Visit Note dated 4/24/2025 revealed the Physical Therapist documented following vital sign: 12:17 PM Pulse Oximetry 68.0% (at rest) Oxygen (no) During interview on 8/18/2025 at 12:36 PM, the Physical Therapist stated that the documented pulse oximetry of 68% was a typographical error, and there were no concerns with pulse oximetry reading at time of visit but does not recall what the actual reading was.

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 review of clinical records and interviews with staff, for three (3) of seven (7) patients (Patient #s: 4, 5, and 7), the agency failed to ensure all documentation by professional staff is appropriately authenticated in accordance with accepted standards of practice. Failure to authenticate documentation with professional credentials has the potential for patient to received care from unlicensed staff. The Certified Home Health Agency (CHHA) failed to ensure documentation by professional staff is appropriately authenticated as evidenced by the following: Patient #7 – This 84-year-old patient with diagnoses that include chronic atrial fibrillation, unspecified, hypertensive heart disease with heart failure, and congestive heart failure was admitted to the home health agency on 07/23/2024. This record was chosen as a Potentially Avoidable: Discharge to the Community Needing Wound Care or Medication Assistance. A.) Review of the SN – Nursing (OASIS E) Routine Visit note, Visit Record note, and Charts/Clinical Notes dated 08/02/2024 revealed the notes were electronically signed by Employee M but lacked documented evidence of the employee’s professional credentials. During an interview on 08/18/2025 at 11:08 AM, the Director of Patient Services stated that the employee is a registered nurse and that there are no credentials by the employee’s electronic signature but that there should be. B.) Review of the SN – Nursing (OASIS E) Routine Visit note, Visit Record note, and Charts/Clinical Notes dated 08/21/2024 revealed the notes were signed electronically by Employee N but lacked documented evidence of the employee’s professional credentials. During an interview on 08/18/2025 at 11:18 AM, the Director of Patient Services stated that the employee is a Licensed Practical Nurse and that there are no credentials by the employee’s electronic signature but that there should be. Patient #4 – This 72-year-old patient with diagnoses that include chronic obstructive pulmonary disease, type II diabetes with diabetic polyneuropathy was admitted to the home health agency on 01/18/2024. A.) Review of the PT (Physical Therapy) with Treatment (OASIS E1) Visit note, Visit Record note, and Charts/Clinical Notes dated 07/16/2025, 07/23/2025, and 07/30/2025 revealed the notes were electronically signed by Employee L but lacked documented evidence of the employee’s credentials. During an interview on 08/18/2025 at 10:56 AM, the Quality Assurance Nurse stated that the employee is a Physical Therapist Assistant (PTA) and that there are no credentials by the employee’s electronic signature but that there should be. B.) Review of the SN – Nursing (OASIS E1) Route Visit note, Visit Record note, and Charts/Clinical Notes dated 07/18/2025 and 08/08/2025 revealed the notes were electronically signed by Employee K but lacked documented evidence of the employee’s credentials. During an interview on 08/18/2025 at 10:58 AM, the Quality Assurance Nurse stated that the employee is a Licensed Practical Nurse (LPN) and that there are no credentials by the employee’s electronic signature but that there should be. Patient #5 – This 82-year-old patient with the diagnoses of fall on same level, unspecified, chronic kidney disease, and unspecified diastolic congestive heart failure was admitted to the home care agency on 7/14/2025. A. Review of the Skilled Nursing Routine Visits dated 7/21/2025, 7/31/2025 and 8/9/2025 lacked documented evidence of the professional’s credentials. Review of the Skilled Nursing Clinical Notes dates 7/21/2025, 7/31/2025, and 8/9/2025 lacked documented evidence of the professional’s credentials. During interview on 8/18/2025 at 11:37 AM, the Administrator stated that the lack of credentials is a system issue and is unsure why the clinician’s credentials are not included. During interview on 8/18/2025 11:37 AM, the Administrator verified that employee K is a Licensed Practical Nurse. B. Review of the Occupational Therapy Routine Visit dated 8/12/2025 lacked documented evidence of the paraprofessional’s credentials. Review of the Occupational Therapy Clinical Notes dates 7/28/2025, 7/30/2025, and 8/9/2025, and 8/12/2025 lacked documented evidence of the professional’s credentials. During interview on 8/18/2025 at 11:37 AM, the Administrator stated that the lack of credentials is a system issue and is unsure why the clinician’s credentials are not included. During interview on 8/18/2025 11:37 AM, the Administrator verified that employee O is a Certified Occupational Therapy Assistant (COTA).

This Statement of Deficiencies is the result of complaint investigation 101628 conducted 07/12/2023 through 09/19/2023. Onsite visits were conducted on 08/23/2023 and 09/19/2023 to determine compliance with the Plan of Correction submitted following the recertification survey completed on 09/22/2022. The onsite visits dated 08/23/2023 and 09/19/2023 consisted of a review of six (6) clinical records, one (1) personnel record and pertinent policies and procedures. The active patient census on 09/19/2023 was 50. Deficient practice was identified with G- 708, Development and Evaluation of the Plan of Care Interviews were conducted with the Director of Patient Services (DPS) and clinical staff.

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on a review of clinical records and interview with agency staff, for one (1) of three (3) patients (Patient #3), the agency failed to ensure staff develop, evaluate and update the plan of care (POC) based on the patient’s needs. Failure to ensure development and evaluation of the POC has the potential for unmet patient needs and negative outcomes. This 61-year-old patient with diagnoses that include peripheral vascular disease, acquired absence of left leg below knee and unspecified osteoarthritis was admitted to the home health agency on 08/29/2023. A.) Review of the Home Health Certification and Plan of Care for certification period 08/29/2023 to 10/27/2023 revealed the following: Physical Therapy (PT) once weekly for one week, twice weekly for four weeks- PT evaluation and treatment, therapeutic exercises, transfer training, establish home exercise program, gait training, prosthetic training, muscle re-education, active exercise, functional and stability exercises, stair training, assess pain, assess skin integrity, assess for depression and perform vital signs every visit and as needed; and Medical Social Services beginning week of 09/04/2023 once weekly for one week and three as needed visits for long term planning and assist with linkage to safe housing and community resources. PT start of care note on POC- “Patient has no PCG (primary caregiver) and reports that he gets aide services from Luna Care but he hasn’t had anyone come out in a month due to having no cell phone. Patient denies life alert and in writers opinion does require supervision and assistance with ADL’s (activities of daily living), med management and housekeeping but has nobody to assist.” Review of the Physical Therapy (PT) Start of Care Further Visits Planned Visit dated 08/29/2023 revealed the PT documented the following: the patient lives alone, has five (5) stairs to climb to access apartment, has occasional short term assistance from family and paid help (has not been in contact with patient for one month), has no telephone, refuses a personal emergency response system, is a fall risk, the left lower extremity below knee prosthetic is too small for the patient to properly use resulting in the patient being chair bound, requires assistance to transfer and perform activities of daily living, is unable to refill medications due to not having a telephone, refuses Occupational Therapy referral and will be referred to Social Work to evaluate for housing needs. Review of the clinical record lacks documentation of follow-up and confirmation of what additional supports are providing care to the patient to include: amount of care provided, level of care and duties performed to determine if the patient’s needs are safely being met. Review of the clinical record lacks documentation of Home Health Aide (HHA) services being offered and implemented by the agency to meet the patient’s immediate identified needs. The agency failed to develop, evaluate and update the POC based on the patient’s needs and ensure care was being provided safely and adequately. During interview on 09/19/2023 at 10:25 AM, the Physical Therapist (PT) acknowledged not following up to ensure additional outside care was being provided to the patient. The PT stated he did not offer to set up HHA services as the patient anticipated obtaining a telephone in the next few days and would follow-up at that time regarding restarting aide services, but failed to document this. B.) Review of the Physical Therapy Start of Care Further Visits Planned Visit dated 08/29/2023 revealed the PT documented the following: right knee extension within functional limits and right dorsiflexion (raising the foot upwards) and plantarflexion (pointing the foot) within functional limits. Review of the Home Health Certification and Plan of Care for certification period 08/29/2023 to 10/27/2023 revealed the patient had the following diagnoses: peripheral vascular disease, acquired absence of left leg below knee, unspecified osteoarthritis, chronic obstructive pulmonary disease, acquired absence of right leg above knee and personal history of nicotine dependence. The diagnosis of an acquired absence of the right leg above the knee is inaccurate. The agency failed to develop and evaluate the POC based on the patient’s needs. During interview on 09/19/2023 at 10:30 AM the PT stated the patient’s right lower extremity is intact and he developed the POC with an incorrect diagnosis.

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 review of clinical records and interview with agency staff for one (1) of six (6) patients (Patient #3), the agency failed to ensure patients are informed, before care is initiated, of their potential financial liability for services provided. Failure to ensure patients are informed of their potential financial liability for services has the potential to result in the patient's inability to exercise their rights. Patient #3 – This 83-year-old patient with diagnoses of weakness, hypertensive heart and chronic kidney disease with heart failure and stage five kidney disease was admitted to the home care agency on 03/17/2023. Review of the Home Health Certification and Plan of Care for certification period 03/17/2023 to 05/15/2023 revealed orders for Physical Therapy (PT) beginning 03/17/2023- 1 x week x 1 week (one time a week for one week) and as of 03/19/2023 2 x week x 4 weeks (twice weekly for four weeks). Review of the Patient Agreement dated 03/17/2023 revealed the agency notified the patient regarding the provision of PT services but failed to notify the patient of the potential financial liability for services. The agency failed to inform the patient of the potential financial liability for services. During interview on 06/27/2023 at 11:40 AM, the PT stated failing to complete the form correctly and omitted the potential patient cost for service, which was zero.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interview for two (2) of six (6) patients (Patient #'s 3 and 6), the agency failed to ensure the clinician conducted an initial assessment of the patient within forty-eight (48) hours of referral, the patient's return home, or on the physician-ordered start of care date. Failure to conduct the initial assessment within the required time frame has the potential to result in unmet patient needs and negative patient outcomes. Patient #3 – This 83-year-old patient with diagnoses of weakness, hypertensive heart and chronic kidney disease with heart failure and stage five kidney disease was admitted to the home care agency on 03/17/2023. Review of the physician office referral dated 03/14/2023 revealed the patient was referred to the agency for Physical Therapy (PT) on 03/14/2023. Review of the Physical Therapy With Treatment Start of Care Visit Note dated 03/17/2023 revealed the patient was assessed and admitted by the PT on 03/17/2023 (seventy-two) hours after the patient was referred to the agency for services. Review of the clinical record lacks documentation of a physician or patient request to delay the start of care until 03/17/2023. The agency failed to ensure clinicians perform initial assessments within required time frames. During interview on 06/27/2023 at 11:40 AM, the Director of Patient Services (DPS) stated she would look for additional documentation for the cause of the delay. No further information was provided. Patient #6 – This 79-year-old patient with diagnoses that include coronary artery disease (CAD), frequent falls and Parkinson’s disease was admitted to the home care agency on 04/28/2023. Review of the physician office referral information note dated 01/26/2023 revealed the patient was referred to the agency on 01/26/2023. Review of the SN (Skilled Nurse) OASIS (Outcome and Assessment Information Set) Admission Visit note dated 02/01/2023 revealed the initial assessment was completed on 02/01/2023, six (6) days after the patient was referred to the agency for services. Review of the clinical record lacks documented evidence of a physician order to delay the start of care until 02/01/2023. The agency failed to ensure clinicians perform initial assessments within required time frames. During interview on 07/05/2023 at 12:11 PM, the DPS stated that the patient was seen on 02/01/2023 due to the daughter’s request but failed to document this.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on clinical record review, agency policy and procedure and staff interview for one (1) of one (1) patients (Patient #3) requiring a recertification assessment, the recertification comprehensive assessment was not of sufficient scope to identify the current patient needs. Failure to ensure that comprehensive assessments contain complete and accurate information has the potential for unmet patient needs. Patient #3 – This 83-year-old patient with diagnoses of weakness, hypertensive heart and chronic kidney disease with heart failure and stage five kidney disease was admitted to the home care agency on 03/17/2023. Review of the Home Health Certification and Plan of Care for certification period 03/17/2023 to 05/15/2023 revealed the patient undergoes peritoneal dialysis every night for 9 (nine) hours with assistance from his wife. Review of the SN (Skilled Nurse) Nursing Initial Visit dated 04/04/2023 revealed the Graduate Nurse (GN) documented the patient has a “peritoneal catheter” in place in the left abdomen for home dialysis and the catheter has a dressing in place that is intact and changed nightly. Review of the Physical Therapy (PT) With Treatment Recertification Reassessment dated 05/12/2023 lacks an assessment of the patient’s peritoneal dialysis treatment and abdominal catheter the dialysis is administered through. The PT failed to ensure the updated comprehensive assessment was complete, accurate and included information regarding the patient’s peritoneal dialysis. During interview on 06/27/2023 at 01:00 PM, the PT stated the patient was continuing to receive peritoneal dialysis at the time of the recertification assessment. The PT stated the spouse was caring for the abdominal catheter and administering the peritoneal dialysis independently but she failed to assess the patient’s abdominal catheter and document regarding the patient’s peritoneal dialysis.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on clinical record reviews and interviews with the Director of Patient Services, Administrator and agency staff, it was determined this condition was not met as evidenced by: Failure to provide skilled nursing services in accordance with federal laws, rules and regulations for two of six patients. See G 702 Failure to provide ongoing interdisciplinary involvement of all staff involved in the plan of care for one of six patients. See G 706 Failure to develop, evaluate and update the plan of care for one of six patients. See G 708 Failure to provide all services outlined in the plan of care for two of six patients. See G 710 Failure to prepare clinical notes that are complete and consistent for two of six patients. See G 716 Failure to communicate with all health care practitioners related to the plan of care for one of six patients. See G 718 The cumulative effect of these systemic issues related to ensuring skilled professional services are maintained, resulted in negative outcomes for Patient #’s 1, 5 and 6 and the potential for negative outcomes for the agency’s patient population. Please refer to citations G- 0702, G- 0706, G- 0708, G- 0710, G- 0716 and G- 0718 for the findings under this condition.

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 review of clinical records and interviews with agency staff, for one (1) of six (6) records (Patient #3), the agency failed to ensure ongoing interdisciplinary involvement of all staff involved in the patient’s plan of care (POC). Failure to ensure there is ongoing interdisciplinary involvement has the potential for negative patient outcomes. Patient #3 – This 83-year-old patient with diagnoses of weakness, hypertensive heart and chronic kidney disease with heart failure and stage five kidney disease was admitted to the home care agency on 03/17/2023. Review of the Home Health Certification and Plan of Care for certification period 03/17/2023 to 05/15/2023 revealed orders for: - Physical Therapy (PT) one (1) visit for one (1) week and then two (2) visits weekly for four (4) weeks for therapeutic exercises, transfer training and developing a home exercise program; and - Skilled Nursing (SN) beginning on 04/04/2023 for three (3) visits weekly for six (6) weeks for wound care and three (3) as needed visits for fall or condition changes. A.) Review of the SN Nursing Initial Visit Notes dated 04/04/2023 revealed the Graduate Nurse (GN) assessed the patient and identified four (4) new skin tears to the right lateral forearm, right elbow, left upper arm and right calf requiring wound care three (3) times per week. Review of the clinical record lacks documentation the GN reported to the PT regarding the new wounds identified on the 04/04/2023 nursing visit. Review of the SN Nursing Routine Visit dated 04/18/2023 revealed the GN documented that the patient’s left upper arm and right elbow skin tears are healed and the right calf and right forearm wound care will be changed to both wounds receiving Xeroform (petrolatum dressing) dressing changes three (3) times weekly. Review of the clinical record lacks documentation the GN reported to the PT regarding changes in the wounds status and dressing changes identified in the 04/18/2023 nursing visit. The GN failed to ensure interdisciplinary communication occurred with PT as changes to the POC were identified. During interview on 06/27/2023 at 10:12 AM, the Director of Patient Services (DPS) acknowledged there was no documentation indicating the GN updated the PT regarding the identified changes. B.) Review of the SN Nursing Routine Visit dated 05/02/2023 revealed the SN documented the patient has a new non- surgical wound to the right foot “bunion area” that is scabbed, open to air and measures 1.5 cm (centimeters) by 1.3 cm. The SN documented the area is not reddened and the spouse reports the scab may have been caused by wearing sneakers and is covering it with a band-aid. Review of the clinical record lacks documentation the SN reported to the PT regarding the new non-surgical wound identified in the 05/02/2023 SN visit. The SN failed to ensure interdisciplinary communication occurred with PT regarding the newly identified wound. During interview on 06/27/2023 at 10:30 AM, the Registered Nurse (RN) stated the PT was not updated regarding the new right foot scab being identified. C.) Review of the Home Health Certification and Plan of Care for certification period 05/16/2023 to 07/14/2023 revealed the following orders: - PT 2 x week (two times weekly) x 4 (four) weeks to provide therapeutic exercises, transfer training, gait training and establish or upgrade home exercise program; and - SN to assess and evaluate nutritional status, compliance to medication regime and emergent care needs; - perform skilled assessment; - provide wound care to all skin tears to include cleansing with wound cleanser or soap and water, applying Xeroform gauze followed by bordered foam dressing 2 x wk until healed; - Measure wounds for depth, width and length weekly; - Assess wound exudate, odor, pain, tissue color and redness; - Assess for s/s (signs and symptoms) of secondary wound infection; - Assess wound for changes every visit until healed; - Instruct in precipitating factors to skin breakdown; and - Instruct in waste disposal. Review of the clinical record from 05/16/2023 to 06/04/2023 (date patient was hospitalized) revealed the PT made visits on the following dates: 05/17/2023, 05/19/2023, 05/24/2023, 05/26/2023, 05/31/2023 and 06/02/2023. Review of the PT visit notes dated 05/17/2023, 05/19/2023, 05/24/2023, 05/26/2023, 05/31/2023 and 06/02/2023 revealed the PT documented the patient had a non-surgical wound to the right lateral forearm skin tear, however it was not assessed in any of the identified visits. Additionally, the visit notes lack documentation the PT communicated with the SN regarding the status/ monitoring plan of the identified wound. The PT failed to ensure interdisciplinary communication occurred with SN regarding the status of the identified wound. During interview on 06/27/2023 at 12:45 PM, the PT acknowledged she did not communicate with SN to ensure the identified wound was being assessed. Additionally, the PT stated no one from the agency was observing the right forearm wound but the spouse reported the wound looked OK.

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on a review of clinical records and interview with agency staff, for one (1) of six (6) patients (Patient #3), the agency failed to ensure staff develop and evaluate the plan of care (POC) based on the patient’s needs. Failure to ensure development and evaluation of the POC has the potential for unmet patient needs and negative outcomes. Patient #3 – This 83-year-old patient with diagnoses of weakness, hypertensive heart and chronic kidney disease with heart failure and stage five kidney disease was admitted to the home care agency on 03/17/2023. Review of the Home Health Certification and Plan of Care for certification period 03/17/2023 to 05/15/2023 revealed the following SN order dated 05/04/2023: “Order correction for all skin tears- cleanse with wound cleanser or soap and water, apply Xeroform (petrolatum dressing) gauze followed by bordered foam dressing twice weekly until healed.” Review of the SN (Skilled Nursing) Routine Visit Note dated 05/02/2023 revealed the RN (Registered Nurse) documented the patient has a new non-surgical wound to the right foot “bunion area” that measures 1.5 centimeters (cm) by 1.3 cm and is scabbed. Spouse states it was caused by the patient wearing sneakers. Review of SN Nursing Routine Visit Note dated 05/05/2023 revealed the RN documented the following wound beds were healed: Right upper extremity, right elbow, left upper arm and right calf. Additionally, the RN documented the right lateral forearm is “nearly healed, wound dry and patient’s spouse will keep clean and dry, cover with band-aid as necessary.” The SN discharged nursing services at the 05/05/2023 visit. The documentation lacks an assessment of the right foot wound identified on 05/02/2023. Review of the Physical Therapy (PT) with Treatment Recertification Reassessment dated 05/12/2023 revealed the PT documented “the patient would benefit from continued therapy to improve functional mobility of transfers, ambulation and bed mobility with an extended frequency of twice weekly for four weeks.” Review of the Home Health Certification and Plan of Care for certification period 05/16/2023 to 07/04/2023 revealed orders for: - PT 2 x week (two times weekly) x 4 (four) weeks to provide therapeutic exercises, transfer training, gait training and establish or upgrade home exercise program; and - SN to assess and evaluate nutritional status, compliance to medication regime and emergent care needs; - perform skilled assessment; - provide wound care to all skin tears to include cleansing with wound cleanser or soap and water, applying Xeroform gauze followed by bordered foam dressing 2 x week (twice weekly) until healed; - Measure wounds for depth, width and length weekly; - Assess wound exudate, odor, pain, tissue color and redness; - Assess for s/s (signs and symptoms) of secondary wound infection; - Assess wound for changes every visit until healed; - Instruct in precipitating factors to skin breakdown; and - Instruct in waste disposal. The Home Health Certification and Plan of Care for certification period 05/16/2023 to 07/14/2023 lacks interventions for the recently identified right foot wound and bilateral foot assessments. Review of the clinical record from 05/16/2023 to 06/26/2023 lacks documented evidence SN services were provided. Review of the PT visit notes dated 05/17/2023, 05/19/2023, 05/24/2023, 05/26/2023, 05/31/2023 and 06/02/2023 revealed the PT documented the patient had a non-surgical wound to the right lateral forearm skin tear and it was not addressed in any of the identified visits. The identified assessments lack documentation the patient’s feet were assessed. Review of the clinical record from 05/17/2023 to 06/04/2023 lacks documented evidence the PT evaluated and updated the POC or discontinued the wound care and SN orders identified in the POC. The agency failed to develop, evaluate and update the POC based on the patient’s needs. During interview on 06/27/2023 at 10:25 AM, the RN stated the “bunion area” is at the base of the right great toe. The RN stated the scab was dry and recommended to leave it open to air. Additionally, the RN stated the right lateral forearm was healed at the time of the nursing discharge visit on 05/05/2023. During interview on 06/27/2023 at 12:40 PM, the DPS (Director of Patient Services) stated there should not have been SN orders on the POC for the recertification period 05/16/2023 to 06/26/2023. The DPS stated the RN that discharged the patient on 05/05/2023 failed to discontinue all wound care on the care plan, and as a result it mistakenly carried over to the new certification period care plan. Additionally, the DPS stated the PT should have reviewed and updated the POC when the patient was recertified and made changes to the POC as indicated.

The following statement of deficiencies represents the results of a partial extended re-certification survey of Schofield Certified Home Health Agency conducted on 09/19/2022 through 09/22/2022 and a COVID-19 vaccination survey. A standard re-certification survey was initiated on 09/19/2022. Deficient practices were identified within Level 1 standards in 484.60 Condition resulting in a partial extended survey. The survey consisted of a review of seven (7) clinical records, two (2) discharged records, nine (9) personnel records for professional personnel, two (2) contracts, and three (3) observational home visits. The survey included a review of pertinent policies and procedures, Quality Improvement Meeting minutes for the past twelve (12) months, agency's Admission Packet, the Emergency Preparedness Plan, and Complaint Log. The patient census is 72 and the agency reports they have no COVID-19 positive patients. Pre-survey activities consisted of review on 09/12/2022 of the agency's Health Commerce System account, Potentially Avoidable Reports for the period 07/2021 - 06/2022, and the agency's compliance with submission of statistical reports and emergency drills. The Director of Patient Services, Personnel Supervisor, Interim Administrator of Services, and clinical staff were interviewed. Findings were reviewed at the exit conference on 09/22/2022. The following deficiencies are identified because of the survey: G-0374, G-0526, G-0536, G-0574, G-0576, G-0578, G-0586, G-0590, G-0610, G-0716, G-0718, G-0984, J-0404, J-1168, J-1260, J-1301, J-1420, L-0001 and R-0510.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on clinical record reviews and interview with agency staff, for one (1) of seven (7) patients (Patient #6), the agency failed to ensure Outcome Assessment Information Set (OASIS) data accurately reflects the patient’s status at the time of the discharge assessment. Failure to ensure accurate documentation of OASIS data has the potential for negative patient outcomes. Patient #6 – This 79-year-old patient with diagnoses that include an unspecified open wound of right great toe, unspecified dementia and seizures was admitted to the home care agency on 11/05/2021. This patient is listed on the agency's Potentially Avoidable Event Patient Listing Report dated 11/05/2021 to 12/17/2021 for discharge to the community with a urinary tract infection (UTI) and increase in the number of pressure ulcers. Review of the SN (Skilled Nursing) OASIS Start of Care dated 11/05/2021 revealed the Registered Nurse (RN) documented the patient’s right great toe wound was not a pressure ulcer, stasis ulcer or surgical wound. Additionally, the RN documented the type of wound to the right great toe was unknown. Review of the SN OASIS Routine Visit dated 11/10/2021 revealed the RN documented the following regarding three (3) new wounds to the left lower extremity: - Site location: Left anterior lower leg Type: Unknown; - Site location: Left lower leg medial Type: Unknown; and - Site location: Left lower leg posterior Type: Unknown. Review of the SN- OASIS Routine Visit dated 11/30/2021 revealed the RN documented the following wound assessment to include a new intergluteal cleft wound: - Site location: Right lateral foot Type: Unknown; - Site location: Left anterior lower leg Type: Unknown; - Site location: Left lower leg medial Type: Unknown; - Site location: Left lower leg posterior Type: Unknown; and - Site location: Intergluteal cleft Type: Skin tear. Review of the clinical record lacks documented evidence of clarification of the wound type for the right great toe, left anterior lower leg, left lower leg medial and left lower leg posterior. Review of the OASIS Only Discharge From Agency dated 12/17/2021 revealed the RN documented the following: - Does this patient have at least one unhealed pressure ulcer/ injury at stage 2 or higher or designated as unstageable: Yes; - Stage of most problematic unhealed pressure ulcer/ injury that is stageable: Stage 2; - Current number of unhealed pressure ulcers/ injuries at stage 2: 1 (One); - Current number of unhealed pressure ulcers/ injuries of these stage 2 pressure ulcers that were present at most recent SOC (start of care)/ ROC (resumption of care): 0 (zero). Review of the clinical record lacks documented evidence of clarification that the patient’s wounds include a stage 2 pressure ulcer. The agency failed to ensure the OASIS data accurately reflected the patient's status at the time of the discharge assessment. During interview on 09/21/2022 at 02:20 PM, the Director of Patient Services (DPS) stated the RN was unavailable for interview. The DPS stated the Discharge OASIS was completed incorrectly as there was no documentation that specified the patient had a stage 2 pressure ulcer.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on review of clinical records and interview with agency staff for three (3) of seven (7) patients (Patient #’s: 2, 4 and 6), the agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient's status and needs. Failure to ensure comprehensive assessments accurately reflect the patient status and needs has the potential for unmet patient needs and the potential for negative patient outcomes. Patient #2 – This 36-year-old therapy only patient with diagnoses that include cardiomyopathy, diabetes mellitus type I, and hypertension was admitted to the home care agency on 09/06/2022. Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed the patient checks blood glucoses before each meal. Review of the Physical Therapy with Treatment OASIS (Outcome and Assessment Information Set) dated 09/06/2022 lacks documented evidence the Physical Therapist (PT) assessed the patient’s baseline blood glucoses. The agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient's status and needs. During interview on 09/21/2022 at 11:05 AM, the PT stated the patient’s boyfriend obtained the blood glucose that morning, but he was not home to give her a baseline blood glucose. She added she did not think to access the patient’s blood glucose machine to obtain the patient’s recent blood glucoses. Patient #4- This 75-year-old therapy only patient with diagnoses that include hypertension, diabetes mellitus type II, and pressure ulcer of right buttock, stage 2 was admitted to the home care agency on 09/09/2022. Review of the Home Health Certification and Plan of Care for certification period 09/09/2022 to 11/07/2022 revealed the patient checks blood glucoses four (4) times a day. Review of the Physical Therapy with Treatment OASIS dated 09/09/2022 lacks documented evidence the PT assessed the patient’s baseline blood glucoses. The agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient's status and needs. During interview on 09/21/2022 at 12:22 PM, the PT stated she did not document a baseline blood glucose for this patient. Patient #6 – This 79-year-old patient with diagnoses that include an unspecified open wound of right great toe, unspecified dementia and seizures was admitted to the home care agency on 11/05/2021. Review of the facility discharge instructions dated 11/03/2021 revealed the patient was to receive PT (Physical Therapy), OT (Occupational Therapy), ST (Speech Therapy) Dietary, Nursing and HHA (Home Health Aide) services from the home health agency. Review of the SN (Skilled Nursing) OASIS (Outcome and Assessment Information Set) Start of Care dated 11/05/2021 revealed the Registered Nurse (RN) documented the patient lives with spouse and is totally dependent with bathing, grooming, toileting, dressing, transfers, food preparation and use of telephone. The visit documentation lacks an assessment or patient/ caregiver refusal for Home Health Aide services. Review of the clinical record lacks an assessment or refusal from the patient/ caregiver for Home Health Aide services. The agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient's status and needs. During interview on 09/21/2022 at 11:25 AM, the Director of Patient Services (DPS) stated the RN was unavailable for interview. The DPS stated there should have been an assessment for a Home Health Aide, but this did not occur.

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 clinical record review, agency policy and procedure, and interview with agency staff, for three (3) of seven (7) clinical records (Patient #'s: 2, 5 and 6) lack documented evidence of a complete review of all medications the patient currently uses to identify any potential adverse effects, drug reactions, or concerns. Failure to conduct a complete medication review and to ensure the medication regime is appropriate has the potential for the patient harm. Review of the agency’s policy entitled “Medication Reconciliation” dated 01/2021 revealed the following: “1) Compare initial 485, Resumption of Care, or recertification orders to the patient’s current medications in the home. 2) A patient’s medication list will include all medications the patient is taking including over the counter (OTC) meds and herbal preparations. 3) Compare medications on discharge instructions from the hospital or facility.... 2) Check for duplicate medications…. 6) Medications without MD (medical doctor) order: a) Call MD to confirm or discontinue medication. b) Submit the interim or verbal order for the MD signature.” Patient #2 – This 36-year-old therapy only patient with diagnoses that include cardiomyopathy, diabetes mellitus type I, and hypertension was admitted to the home care agency on 09/06/2022. Review of the Referral for Services dated 08/18/2022 revealed the following orders: - Metronidazole 0.75% gel apply topically two times a day - Nystatin ointment apply topically two times a day Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 lacks orders for the identified medications. Review of the clinical record lacks documented evidence of clarification of the medication discrepancies. The Physical Therapist (PT) and Registered Nurse (RN) failed to identify and reconcile all medication discrepancies identified in the referral for services and the plan of care (POC). During interview on 09/19/2022 at 01:15 PM, the Director of Patient Services (DPS) stated the PT does the medication reconciliation using the medications that are in the home and the facility/hospital discharge summary or referral medication list. Once that information is entered in the patient’s record, the RN reviews the medications for discrepancies and interactions. During interview on 09/21/2022 at 11:06 AM, the PT stated the patient did not have the identified medications in the home and she overlooked them on the referral, so they were not added to the POC. The DPS stated she did not know why those medications were missed when the nursing portion of the medication reconciliation was done. Review of the agency’s policy entitled “Medication Reconciliation” dated 01/2021 revealed the following: “1) Compare initial 485, Resumption of Care, or recertification orders to the patient’s current medications in the home. 2) A patient’s medication list will include all medications the patient is taking including over the counter (OTC) meds and herbal preparations. 3) Compare medications on discharge instructions from the hospital or facility.... 2) Check for duplicate medications…. 6) Medications without MD (medical doctor) order: a) Call MD to confirm or discontinue medication. b) Submit the interim or verbal order for the MD signature.” Patient #5 – This 80-year-old therapy only patient with diagnoses that include vascular dementia, multiple sclerosis and muscle weakness was admitted to the home care agency on 08/19/2022. A.) Review of the Physician Referral for Services dated 08/18/2022 revealed the following orders: - Avonex Pen 30 mcg (microgram)/ 0.5 ml (milliliter); and - Trazodone HCL 100 mg (milligram). Review of the Home Health Certification and Plan of Care for certification period 08/19/2022 to 10/17/2022 lacks orders for the identified medications. Review of the clinical record lacks documented evidence of clarification of the medication discrepancies. The Physical Therapist (PT) and Registered Nurse (RN) failed to identify and reconcile all medication discrepancies identified in the referral for services and the plan of care (POC). During interview on 09/19/2022 at 01:15 PM, the Director of Patient Services (DPS) stated the PT does the medication reconciliation using the medications that are in the home and the facility/hospital discharge summary or referral medication list. Once that information is entered in the patient’s record, the RN reviews the medications for discrepancies and interactions. During interview on 09/21/2022 at 12:15 PM, the PT stated she reconciled the medications with the medications in the home and did not use the referral provided. B.) Review of the Home Health Certification and Plan of Care for certification period 08/19/2022 to 10/17/2022 revealed the following medication orders: - Dailyvite Vitamin D 5000 by mouth capsule 125 mcg daily PO (by mouth) supplement; - Solifenacin Succinate by mouth tablet 5 mg daily PO incontinence; - Crestor by mouth tablet 5 mg daily PO high cholesterol; - Risedronate Sodium by mouth tablet 150 mg every month PO preventative for osteoporosis; - Amlodipine Besylate by mouth tablet 5 mg daily PO HTN (hypertension); - Acidophilus Probiotic by mouth tablet 1 (one) tab daily PO supplement; and - Azelastine HCL Nose Solution 0.1 % (percent) 137 mcg/ ml two sprays in each nostril twice daily. Review of the Physician Referral for Services dated 08/18/2022 lacks orders for the identified medications. Review of the clinical record lacks documented evidence of clarification of the medication discrepancies. The PT and RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 09/21/2022 at 12:17 PM, the PT stated she did not reconcile the medications using the physician referral and was unaware of the medication discrepancies. C.) Review of the Physician Referral for Services dated 08/18/2022 revealed the patient has allergies to Topotecan and Morphine. Review of the Home Health Certification and Plan of Care for certification period 08/19/2022 to 10/17/2022 revealed the patient has allergies to: Codeine, Lidocaine, Mepivacaine, Morphine, Oxycodone, Phenyltoloxamine, Benadryl and Sulfa Antibiotics. Review of the clinical record lacks documented evidence of clarification of the allergy discrepancies. The PT and RN failed to identify and reconcile all allergy discrepancies identified in the referral for services and the POC. During interview on 09/21/2022 at 12:21 PM, the PT stated she did not use the physician referral to perform medication/ allergy reconciliation and was unaware of the identified discrepancies. D.) Review of the Physical Therapy with Treatment OASIS (Outcome and Assessment Information Set) Start of Care dated 08/19/2022 revealed the PT documented completing a drug regimen review and found no issues during the review. Review of the clinical record lacks documented evidence of the RN review of the patient’s medications. The RN failed to perform a review of the patient’s medications after the PT opened the patient to services. During interview on 09/19/2022 at 01:15 PM, the Director of Patient Services (DPS) stated the PT does the medication reconciliation using the medications that are in the home and the facility/hospital discharge summary or referral medication list. Once that information is entered in the patient’s record, the RN reviews the medications for discrepancies and interactions. During interview on 09/21/2022 at 12:19 PM, the DPS stated she did not review the medication list after the PT opened the patient but cannot recall the reason this did not occur. The DPS stated the agency does not have a policy and procedure for the medication reconciliation process when therapy opens the patient to services. Patient #6 – This 79-year-old patient with diagnoses that include an unspecified open wound of right great toe, unspecified dementia and seizures was admitted to the home care agency on 11/05/2021. Review of the Home Health Certification and Plan of Care for certification period 11/05/2021 to 01/03/2022 revealed the medication order: Keppra by mouth tablet 500 mg 1 tab twice a day PO seizures. Review of the Facility Discharge Instructions dated 11/03/2021 lack an order for Keppra. Review of the clinical record lacks documented evidence of clarification of the medication discrepancy. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 09/21/2022 at 11:18 AM, the DPS stated the RN was unavailable for interview. The DPS stated the RN should have clarified the discrepancy with the Physician.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interviews for three (3) of seven (7) patients (Patient #’s: 2, 4 and 6) the agency failed to develop individualized plans of care (POCs) that are complete and accurate and address the total needs of the patients. Failure to ensure that a comprehensive individualized plan of care is developed has the potential for unmet patient needs. Patient #2 – This 36-year-old therapy only patient with diagnoses that include cardiomyopathy, diabetes mellitus type I, and hypertension was admitted to the home care agency on 09/06/2022. A.) Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed the following: - Mental status: left blank The agency failed to develop individualized POCs that are complete and accurate and address the total needs of the patients. During interview on 09/21/2022 at 11:05 AM, the Physical Therapist (PT) stated the patient was alert and oriented but failed to document that on the POC. B.) Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed the order Humalog KwikPen Subcutaneous Solution Pen-Injector 100 unit/mL (milliliters) 1 application three times a day sub-q (subcutaneous). The medication order lacks a dose. The agency failed to develop individualized POCs that are complete and accurate and address the total needs of the patients. During interview on 09/21/2022 at 11:04 AM, the PT stated the dose should be 15 mL but that dose was not included on the order. C.) Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed the order for Lantus SoloStar Subcutaneous Solution Pen-Injector 100 unit/mL (milliliters) 17 units daily sub-q (subcutaneous). Review of the Referral for Services dated 08/18/2022 revealed the order for Lantus SoloStar U-100 Insulin 100 unit/mL injection inject 15 units every evening at bedtime. During interview on 09/21/2022 at 11:06 AM, the PT stated the patient is taking 15 units and the order is written incorrectly. The agency failed to develop individualized POCs that are complete and accurate and address the total needs of the patients. Patient #4- This 75-year-old therapy only patient with diagnoses that include hypertension, diabetes mellitus type II, and pressure ulcer of right buttock, stage 2 was admitted to the home care agency on 09/09/2022. A.) Review of the Home Health Certification and Plan of Care for certification period 09/09/2022 to 11/07/2022 revealed the order for Novolog FlexPen ReliOn Subcutaneous Solution Pen Injector 100 unit/mL 12 units as needed sub-q, sliding scale. The order lacks a sliding scale. The agency failed to develop individualized POCs that are complete and accurate and address the total needs of the patients. During interview on 09/21/2022 at 12:25 PM, the PT stated she did not have the instructions for the sliding scale so did not include it on the orders and did not call the physician to follow-up. B.) Review of the Home Health Certification and Plan of Care for certification period 09/09/2022 to 11/07/2022 revealed the following: - The patient is a type II diabetic - The patient takes Novolog FlexPen ReliOn Subcutaneous Solution Pen Injector 100 unit/mL 12 units as needed sub-q, sliding scale, Metformin HCL (hydrochloride) by mouth tablet 500 mg (milligrams) 1 tab daily PO (by mouth), and Basaglar KwikPen Subcutaneous Solution Pen Injector 100 unit/mL 25 unit at bedtime sub-q for diabetes type II. - The patient is ordered a regular diet. Review of the SN (Skilled Nurse) Nursing Routine Visit Note dated 09/13/2022 revealed the patient was instructed on the prescribed diabetic diet. The agency failed to develop individualized POCs that are complete and accurate and address the total needs of the patients. During interview on 09/21/2022 at 12:26 PM, the PT stated the patient follows a diabetic diet and she ordered the incorrect diet on the POC. Patient #6 – This 79-year-old patient with diagnoses that include an unspecified open wound of right great toe, unspecified dementia and seizures was admitted to the home care agency on 11/05/2021. A.) Review of the Home Health Certification and Plan of Care for certification period 11/05/2021 to 01/03/2022 revealed the following: - Mental status: left blank; and - Activities permitted: left blank. The agency failed to develop individualized POCs that are complete and accurate and address the total needs of the patients. During interview on 09/21/2022 at 11:22 AM, the Director of Patient Services (DPS) stated the Registered Nurse (RN) was unavailable for interview. The DPS acknowledged that the POC is incomplete and lacks the identified items. B.) Review of the Home Health Certification and Plan of Care for certification period 11/05/2021 to 01/03/2022 revealed the following orders: - Keppra by mouth tablet 500 mg (milligram) 1 (one) tab twice a day PO (by mouth) seizures; and - Levetiracetam (Keppra) by mouth tablet 500 mg 1 (one) tab twice a day PO seizures. (The medication orders are duplicated on the POC). The agency failed to develop individualized POCs that are complete and accurate and address the total needs of the patients. During interview on 09/20/2022 at 09:45 AM, the DPS stated the identified medication orders are duplicate and written incorrectly on the POC. C.) Review of the Home Health Certification and Plan of Care for certification period 11/05/2021 to 01/03/2022 revealed an order for: Dorzolamide HCL- Timolol Mal PF Opthalmic Solution 2-0.5 % (percent) 1 (one) gtt (drop) twice a day OP (Operating Procedure) Glaucoma. The order fails to specify the location to apply the eye drop. The agency failed to develop individualized POCs that are complete and accurate and address the total needs of the patients. During interview on 09/21/2022 at 11:15 AM, the DPS stated the RN is unavailable for interview. The DPS stated the order lacks the location to apply the eye drop and believes the RN used the incorrect abbreviation (OP).

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interviews for two (2) of seven (7) patients (Patient #’s 1 and 6), lack evidence orders were obtained to update the Plan of Care (POC) to reflect the patient's status. Failure to obtain an order to update the POC has the potential for agency staff to act on inaccurate and incomplete information, and places patient health and welfare at risk. Patient #6 – This 79-year-old patient with diagnoses that include an unspecified open wound of right great toe, unspecified dementia and seizures was admitted to the home care agency on 11/05/2021. Review of the Chart/ Clinical Note dated 11/10/2021 revealed the Registered Nurse (RN) documented the following: “Wife states (patient’s) buttocks are reddened, no open areas noted. Patient refused to be moved via hoyer lift back to his bed for visual assessment by writer. Wife educated to keep areas clean and dry, apply Zinc barrier cream two to three times per day, turn and position every two hours to offload pressure, wife verbalizes understanding.” Review of the clinical record lacks documented evidence of an order for Zinc barrier cream application. The agency failed to obtain an order to update the POC to reflect the patient's status. During interview on 09/21/2022 at 11:35 AM, the Director of Patient Services stated the RN is no longer employed by the agency. The DPS stated an order for the Zinc barrier cream was not obtained. Patient #1- This 87-year-old therapy only patient with diagnoses that include peripheral vascular disease, chronic obstructive pulmonary disease (COPD), and hypertensive chronic kidney disease stage 4 was admitted to the home care agency on 07/15/2022. Review of the Physical Therapy (PT) with Treatment Start of Care Note on 07/15/22 revealed the PT documented the patient is using compression stockings. Review of the clinical record from 09/19/2022 to 09/22/2022 lacks documented evidence of an order for compression stockings. The agency failed to obtain an order to update the POC to reflect the patient's status. During interview on 09/21/202 at 12:324 PM, the PT stated the patient does use compression stockings, but there is no order for them in the clinical record.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on review of clinical records and interviews with agency staff for one (1) of seven (7) patients (Patient #6), the agency failed to provide services in accordance with physician orders and the Plan of Care (POC). Failure to ensure patient care is provided in accordance with physician orders has the potential for patients to receive poor quality care and for health care needs to go unmet. Patient #6 – This 79-year-old patient with diagnoses that include an unspecified open wound of right great toe, unspecified dementia and seizures was admitted to the home care agency on 11/05/2021. A.) Review of the Home Health Certification and Plan of Care for certification period 11/05/2021 to 01/03/2022 revealed: - SN (Skilled Nurse) 11/05/2021 2 x week (two times a week) x 2 (for two) weeks; and - SN 11/14/2021 1 x week (one time per week) x 7 (for seven) weeks. Review of the clinical record revealed the patient received one (1) visit the week of 11/05/2021 which occurred on 11/05/2021. The agency failed to provide services in accordance with physician orders. During interview on 09/21/2022 at 11:30 AM, the Director of Patient Services (DPS) stated the medicare week began on 10/31/2021 and the patient only received one nursing visit during the identified week. B.) Review of the Home Health Certification and Plan of Care for certification period 11/05/2021 to 01/03/2022 revealed the following SN orders: - Notify MD (Physician) if BP (blood pressure) is > (greater than) 160/90 or - Notify MD if temp (temperature) is 101 F; - Resp (respiratory) rate parameter 28; and - Pulse parameters 110. Review of the SN- Nursing Routine Visit dated 11/17/2021 lacks documented evidence the SN obtained vital signs during the assessment visit. The agency failed to provide services in accordance with physician orders. During interview on 09/21/2022 at 01:10 PM, the Licensed Practical Nurse (LPN) stated she made an error and did not save the vital signs obtained during the identified visit. C.) Review of the Home Health Certification and Plan of Care for certification period 11/05/2021 to 01/03/2022 revealed the following SN order: Measure wounds for depth, width and length weekly. Review of the clinical record revealed the patient received one (1) SN visit the week of 12/05/2021 occurring on 12/08/2021. Review of the SN- Nursing Routine Visit dated 12/08/2021 revealed the LPN documented the following: - Site location: Left Anterior lower leg; - Type: Unknown; and - Wound measurement: Measure weekly, length in centimeters: 0.1. The visit note lacks a measurement of the width and depth of the identified wound. The agency failed to provide services in accordance with physician orders. During interview on 09/21/2022 at 02:35 PM, the LPN stated it was an oversight that the width and depth of the identified wound were not measured. D.) Review of the Home Health Certification and Plan of Care for certification period 11/05/2021 to 01/03/2022 revealed the following SN order: Measure wounds for depth, width and length weekly. Review of the clinical record revealed the patient received one (1) SN visit for the week of 12/12/2021 occurring on 12/15/2021. Review of the SN- Nursing Routine Visit dated 12/15/2021 revealed the Registered Nurse (RN) documented the patient has five (5) incision/ wound sites that wound care was performed during the visit to include: right lateral foot, left anterior lower leg, left lower leg medial, left lower leg posterior and intergluteal cleft. The visit note lacks measurements of the five (5) identified wounds. The agency failed to provide services in accordance with physician orders. During interview on 09/21/2022 at 02:13 PM, the DPS stated the RN was unavailable for interview. The DPS stated the wounds should have been measured at the identified visit but there is no documentation of the measurements. E.) Review of the Chart/ Clinical Note dated 12/07/2021 revealed the Speech Therapist documented the following order confirmation (OC): “Patient seen for swallow eval (evaluation). Pt (patient) to remain on mech (mechanical) soft/ nectar thick diet. Therapy recommended 1W4 (one time weekly for four weeks) including eval to educate patient and spouse on safe swallow strategies.” Review of the clinical record lacks documented evidence the patient received or declined a Speech Therapy visit the week of 12/12/2021. The agency failed to provide services in accordance with physician orders. During interview on 09/22/2022 at 09:05 AM, the DPS stated the Speech Therapist is no longer employed by the contractual agency. The DPS stated the Speech Therapist should have attempted a visit the identified week but there is no documentation that this occurred.

Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This STANDARD is not met as evidenced by: Based on review of clinical records and interviews with agency staff for two (2) of seven (7) patients (Patient #'s: 1 and 6), the agency failed to ensure the Plan of Care (POC) is reviewed and revised to reflect the patient's current status. Failure to ensure the POC is updated and revised has the potential to result in negative patient outcomes. Patient #6 – This 79-year-old patient with diagnoses that include an unspecified open wound of right great toe, unspecified dementia and seizures was admitted to the home care agency on 11/05/2021. This patient is listed on the agency's Potentially Avoidable Event Patient Listing Report dated 11/05/2021 to 12/17/2021 for discharge to the community with a urinary tract infection (UTI) and increase in the number of pressure ulcers. Review of the Chart/ Clinical Note dated 11/19/2021 revealed the Registered Nurse (RN) documented the following: “Spouse showed SN (Skilled Nurse) bottles of new medications: Ferusol, Cephalexin and Constulose.” Review of the Medication List updated 11/19/2021 revealed an order for Cephalexin by mouth capsule 500 mg (milligram) twice a day PO (by mouth) for infection. (The order lacks the duration the antibiotic is to be administered). The agency failed to ensure the Plan of Care (POC) is reviewed and revised to reflect the patient's current status. During interview on 09/21/2022 at 11:55 AM, the Director of Patient Services (DPS) stated the RN is unavailable for interview. The DPS stated the medication order was confirmed by the new prescription in the home and transcribed to the Medication List. The DPS stated the RN failed to include the duration the antibiotic was to be taken. Patient #1- This 87-year-old therapy only patient with diagnoses that include peripheral vascular disease, chronic obstructive pulmonary disease (COPD), and hypertensive chronic kidney disease stage 4 was admitted to the home care agency on 07/15/2022. Review of the agency policy entitled "Initial and Subsequent’’ revised 09/2015 revealed at Recertification Assessment “all medical equipment in use or needed in the home must be addressed and updated.” Review of the Physical Therapy (PT) with Treatment Start of Care Note on 07/15/2022 revealed the PT documented the patient is using compression stockings. Review of the PT Recertification Follow-up Reassessment dated 09/12/2022 lacks an assessment of the patient using compression stockings. Review of the Home Health Certification and Plan of Care for certification period 09/13/2022 to 11/11/2022, lacks an order for compression stockings. The agency failed to ensure the Plan of Care (POC) is reviewed and revised to reflect the patient's current status. During interview on 09/22/2022 at 09:24 AM, the Director of Patient Services (DPS) stated that the patient was ordered to wear compression stockings at the time of the recertification but the PT failed to document this in the this assessment and updated 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 review of clinical records and interview with agency staff for two (2) of seven (7) patients (Patient #'s 1 and 6), the agency staff failed to promptly alert the physician to any changes in the patient's condition that suggests the need to alter the plan of care (POC). Failure to promptly notify the physician to any changes in the patient's condition that suggests the plan of care should be altered has the potential to result in unmet patient needs and negative patient outcomes. Patient #6 – This 79-year-old patient with diagnoses that include an unspecified open wound of right great toe, unspecified dementia and seizures was admitted to the home care agency on 11/05/2021. Review of the SN (Skilled Nurse)- Nursing Routine Visit dated 11/24/2021 revealed the Registered Nurse (RN) documented the client had not had a bowel movement since 11/19/2021 (five days prior), after recently starting a new medication for constipation. Review of the Chart/ Clinical Note dated 11/24/2021 revealed the RN documented the spouse reports the patient continues to experience nightmares that are waking the spouse up. Review of the clinical record lacks documented evidence of notification to the physician of the identified issues. The RN failed to notify the physician regarding the changes in the patient's condition. During interview on 09/21/2022 at 02:00 PM, the Director of Patient Services (DPS) stated the RN is unavailable for interview. The DPS stated the RN should have updated the physician with the identified issues and did not. Patient #1- This 87-year-old therapy only patient with diagnoses that include peripheral vascular disease, chronic obstructive pulmonary disease (COPD), and hypertensive chronic kidney disease stage 4 was admitted to the home care agency on 07/15/2022. Review of the Physical Therapy (PT) Clinical Visit Note dated 07/25/2022 revealed the PT documented the patient complained of sinus congestion. Review of the clinical record from 07/25/2022 to 09/22/2022, lacked documented evidence the PT notified the physician regarding the patient's sinus congestion. The PT failed to notify the physician regarding the changes in the patient's condition. During interview on 09/21/2022 at 12:30 PM, the PT stated she should have notified the physician.

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 review of clinical records and staff interview for one (1) of seven (7) patients (Patient #6), the agency failed to ensure the Registered Nurse (RN) provided the patient/caregiver with appropriate education regarding the care and services identified in the plan of care (POC). Failure to provide appropriate education has the potential to result in the patient receiving inadequate care and could result in patient harm. Patient #6 – This 79-year-old patient with diagnoses that include an unspecified open wound of right great toe, unspecified dementia and seizures was admitted to the home care agency on 11/05/2021. Review of the Chart/ Clinical Note dated 12/01/2021 revealed the RN documented the patient has a new wound identified to the intergluteal cleft and a new treatment order to the area to include: cleanse with Normal Saline, pat dry, apply extra light hydrocolloid dressing (used to manage light wound drainage) every three (3) to five (5) days or if soiled/ displaced, to be performed by SN (Skilled Nurse) or spouse. Review of the SN- Nursing Routine Visit dated 12/01/2021 lacks documentation of education and re-demonstration of the new wound care to the patient’s spouse. Review of the clinical record revealed the next SN visit after the 12/01/2021 visit occurred on 12/08/2021 (seven days after the intergluteal cleft dressing was changed by the SN). The agency failed to ensure the RN provided the caregiver with appropriate education regarding the care and services identified in the plan of care. During interview on 09/21/2022 at 02:08 PM, the Director of Patient Services (DPS) stated the RN was unavailable for interview. The DPS stated the expectation is education and training occur for all care the caregiver is to provide. The DPS stated there is no documentation that the spouse was instructed and demonstrated the new wound care.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with agency staff, for one (1) of seven (7) patients (Patient #6), the agency failed to ensure clinicians prepare and document complete and accurate clinical and progress notes. Failure to prepare or document complete clinical and progress notes has the potential for unmet patient needs. Patient #6 – This 79-year-old patient with diagnoses that include an unspecified open wound of right great toe, unspecified dementia and seizures was admitted to the home care agency on 11/05/2021. A.) Review of the Home Health Certification and Plan of Care for certification period 11/05/2021 to 01/03/2022 revealed the following wound care orders to the right great toe: Cleanse with soap and water, pat dry, apply antibiotic ointment and dry clean dressing completed by SN (Skilled Nurse) or family (wound care frequency not specified). Review of the SN- Nursing Routine Visit dated 11/10/2021 revealed the Registered Nurse (RN) documented the following regarding the right lateral foot wound (right great toe): - Type: Unknown; - Healing: Healing by secondary intent; - Wound measurement: Measure weekly, Length in centimeters: 0.7, Width in centimeters: 0/7 (0.7), Depth in centimeters: - Incision/wound tissue observed: Scab 100% (percent); - Drainage: None; and - Dressing changed this visit: Yes, per orders, see care plan. Review of the Chart/ Clinical Note dated 11/10/2021 revealed the RN documented “Wound to right great toe is healed.” The documentation is inconsistent. The status of the right great toe wound is unclear. During interview on 09/21/2022 at 11:43 AM, the Director of Patient Services (DPS) stated the RN no longer works for the agency. The DPS acknowledged the documentation regarding the right great toe wound status is unclear. B.) Review of the SN- Nursing Routine Visit dated 11/17/2021 revealed the Licensed Practical Nurse (LPN) documented the patient’s last bowel movement occurred on 11/15/2021. Review of the Chart/ Clinical Note dated 11/17/2021 revealed the Physical Therapist (PT) made a home visit on 11/17/2021 and documented the patient’s last bowel movement occurred on 11/11/2021. The documentation is inconsistent. It is unclear what date the patient’s last bowel movement occurred on. During interview on 09/21/2021 at 01:13 PM, the DPS stated the identified documentation is a discrepancy. C.) Review of the Addendum to Plan of Care for the certification period 11/05/2021 to 01/03/2022 dated 11/10/2021 revealed the following left lower leg wound care: Cleanse with soap and water, pat dry, apply TAO (Triple Antibiotic Ointment) to wound, cover with adhesive bandage daily. Caregiver is independent when SN not in home. Review of the SN- Nursing Routine Visit dated 11/24/2021 revealed the RN documented the left lower leg posterior wound as healed. Review of the clinical record revealed the next SN visit after 11/24/2021 occurred on 11/30/2021. Review of the SN- Nursing Routine Visit dated 11/30/2021 revealed the RN documented the following regarding the left lower leg posterior wound: - Type: Unknown; - Healing: Healing by secondary intent; - Wound measurement: Measure weekly, Length in centimeters: 2.0, Width in centimeters: 2.0, Depth in centimeters: 0.1; - Incision/ wound tissue observed: Pink; - Drainage: None; - Dressing changed this visit: Yes, per orders, see care plan. The documentation is inconsistent. The status of the left lower leg posterior wound is unclear. During interview on 09/21/2022 at 02:05 PM, the DPS stated the RN was unavailable for interview. The DPS stated it was unclear if the identified wound healed and then re-opened or had never healed.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on clinical record review and staff interview for one (1) of seven (7) clinical records (Patient #6), the agency failed to ensure agency staff communicated with the patient's physician. Failure to communicate with the physician involved in the patient's care has the potential for unmet patient needs and negative outcomes. Patient #6 – This 79-year-old patient with diagnoses that include an unspecified open wound of right great toe, unspecified dementia and seizures was admitted to the home care agency on 11/05/2021. This patient is listed on the agency's Potentially Avoidable Event Patient Listing Report dated 11/05/2021 to 12/17/2021 for discharge to the community with a urinary tract infection (UTI) and increase in the number of pressure ulcers. A.) Review of the SN (Skilled Nurse)- Nursing OASIS (Outcome and Assessment Information Set) Start of Care- Further Visits Planned Note dated 11/05/2021 revealed the Registered Nurse (RN) documented the patient did not have a pressure ulcer, stasis ulcer or surgical wound. Additionally, the patient had a right great toe wound and the type of wound was “unknown.” Review of the clinical record lacks documented evidence of communication with the physician to clarify the type of wound the patient has on the right great toe. B.) Review of the SN- Nursing Routine Visit dated 11/10/2021 revealed the RN documented the following regarding three (3) new wounds to the left lower extremity: - Location: Left anterior lower leg; - Type: Unknown; - Location: Left lower leg medial; - Type: Unknown; - Location: Left lower leg posterior; and - Type: Unknown. Review of the clinical record lacks documented evidence of communication with the physician to clarify the type of wounds the patient has on the left lower extremity. The agency failed to ensure agency staff communicated with the patient's physician regarding clarification of the types of wounds the patient has. During interview on 09/21/2022 at 11:40 AM, the Director of Patient Services (DPS) stated the clinicians should have clarified the wound types with the physician, but this did not occur. C.) Review of the SN- Nursing Routine Visit dated 11/19/2021 revealed the patient was started on a new medication, Cephlexin, for infection treatment. Review of the Verbal Order dated 12/08/2021 revealed an order for the agency to obtain a urine sample on 12/08/2021 and deliver it to the laboratory for processing. Review of the Chart/ Clinical Note dated 12/08/2021 revealed the Licensed Practical Nurse (LPN) documented the urine specimen was obtained and delivered to the laboratory for processing on 12/08/2021. Review of the clinical record from 12/09/2021 to 12/17/2021 (date of discharge to Hospice) lacks documented evidence of communication with the physician regarding the urine sample results and status of the urinary tract infection diagnosed on 11/19/2021. The agency failed to ensure agency staff communicated with the patient's physician regarding follow-up results on the obtained urine sample and infection status. During interview on 09/21/2022 at 02:15 PM, the DPS stated staff should have followed-up with the physician’s office regarding the urine sample results, but there is no documentation of this.

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 clinical records, agency policy and procedure and staff interview for two (2) of seven (7) patients (Patient #'s: 4 and 6), the agency failed to follow current clinical practice guidelines, and agency policy and procedure. Failure to ensure compliance with current clinical practice guidelines and agency policy has the potential to result in unmet patient needs and inadequate care. Review of the agency’s policy entitled “Medication Reconciliation” dated 01/2021 revealed the following: “1) Compare initial 485, Resumption of Care, or recertification orders to the patient’s current medications in the home. 2) A patient’s medication list will include all medications the patient is taking including over the counter (OTC) meds and herbal preparations. 3) Compare medications on discharge instructions from the hospital or facility.” Patient #4- This 75-year-old therapy only patient with diagnoses that include hypertension, diabetes mellitus type II, and pressure ulcer of right buttock, stage 2 was admitted to the home care agency on 09/09/2022. Review of the discharge summary dated 08/17/2022 lacks documented evidence of the patient’s medication list. During interview on 09/21/2022 at 12:22 PM, the Physical Therapist (PT) stated she used the medications that were in the patient’s home to do the medication reconciliation. The Director of Patient Services (DPS) stated the expectation is that if a discharge summary comes to the agency without a medication list, the agency staff must follow-up and request one. The agency failed to follow agency policy and procedure. Patient #6 – This 79-year-old patient with diagnoses that include an unspecified open wound of right great toe, unspecified dementia and seizures was admitted to the home care agency on 11/05/2021. Review of the agency policy entitled “Pressure Ulcer And Wound Assessment” dated 05/2014 revealed “Only RN’s (Registered Nurses) will assess wounds.” Review of the Home Health Certification and Plan of Care for certification period 11/05/2021 to 01/03/2022 revealed an order to measure wounds for depth, width and length weekly. Review of the clinical record revealed the patient had one (1) SN (Skilled Nurse) visit the week of 12/05/2021 occurring on 12/08/2021. Review of the SN- Nursing Routine Visit dated 12/08/2021 revealed the Licensed Practical Nurse (LPN) documented the following: - Site location: Right lateral foot; Type: Unknown; - Healing: Healing by secondary intent; - Wound Measurement: Measure weekly, Length in centimeters: 0.3, Width in centimeters: 0.3, Depth in centimeters: - Drainage: None; - Dressing changed this visit: Yes, per orders, see care plan; - Site location: Left anterior lower leg; - Type: Unknown; - Healing: Healing by secondary intent; - Wound measurement: Measure weekly, Length in centimeters: 0.1; - Drainage: None; - Dressing changed this visit: Yes, per orders, see care plan; - Site location: Left lower leg medial; - Type: Unknown; - Healing: Healing by secondary intent; - Wound measurement: Measure weekly, Length in centimeters: 0.1, Width in centimeters: 0.1, Depth in centimeters: - Drainage: None; - Dressing changed this visit: Yes, per orders, see care plan; - Site location: Left lower leg posterior; - Type: Unknown; - Healing: Healing by secondary intent; - Wound measurement: Measure weekly, Length in centimeters 0.1, Width in centimeters: 0.1, Depth in centimeters: - Drainage: None; - Dressing changed this visit: Yes, per orders, see care plan; - Site location: Intergluteal cleft - Type: Skin tear; - Healing: Not healing; - Wound measurement: Measure weekly, Length in centimeters 3, Width in centimeters: 2, Depth in centimeters: - Drainage: None; and - Dressing changed this visit: Yes, per orders, see care plan. The agency failed to ensure the wound assessment was performed by a RN in accordance with agency policy. During interview on 09/21/2022 at 02:37 PM, the LPN stated she was unaware of the content of the agency wound policy. During interview on 09/21/2022 at 02:40 PM, the Director of Patient Services (DPS) stated she was unaware of the identified policy specification.