Every finding on record at Lutheran Senior Services

The Emergency Preparedness regulations were reviewed as part of the Medicare recertification survey completed on 02/13/2025. During the survey it was determined the home health provider is in compliance with the requirements of 42 CFR 484.102 Condition of Participation: Emergency Preparedness for Home Health Providers.

An extended survey for Medicare recertification for the home health was completed on 02/13/2025. The provider had 70 current patients. Two condition-level deficiencies were identified during this survey: - §484.60 Condition of Participation: Care planning, coordination of services, and quality of care; and - §484.105 Condition of Participation: Organization and administration of services. A home health provider that is found out of compliance with any Condition of Participation evaluated as part of a standard survey may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. A deficiency has been cited at §484.80(f)(3) – see Tag G782.

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on review of the home health provider’s HHA (Home Health Agency) Error Summary by Agency report, policy review, and interview, the provider failed to encode and electronically transmit each completed Outcome and Assessment Information Set (OASIS; standardized data collection tool) within 30 days of completing the assessment. This deficient practice has the potential to affect all of the Medicare/Medicaid patients served by the provider. Findings included: Review of the documents titled, “HHA Error Summary by Agency,” showed a progressive increase in OASIS submissions greater than 30 days after the M0090 date for the past three years. The OASIS Error rates were as follows: - 01/01/2025 to survey exit of 02/13/2025 showed an error rate of 49.7%; - 01/01/2024 to 12/31/2024 showed an error rate of 39.68%; - 01/01/2023 to 12/31/2023 showed an error rate of 38.8%; - 01/01/2022 to 12/31/2022 showed an error rate of 19.37; and - The provider failed to show an improvement in a known quality issue over a three-year span. Review of the policy titled, “OASIS Data Entry and Transmission,” revised 10/2014, showed in part that the provider would encode and transmit (export) OASIS data within 30 days of completing an OASIS data set using software from CMS (Centers for Medicare and Medicaid Services) or software that conforms to the CMS standard electronic record layout. During an interview on 02/13/2025 at 12:17 PM, the administrator stated that: - They were aware of their increased number of late OASIS submissions; - They had issues with the electronic health record (EHR) providing incorrect billing codes based off of the OASIS assessments; - They have had multiple meetings with their information systems employees and EHR provider; - They meet every one to two weeks to make sure the items remained a high priority as they have caused problems with regulatory compliance; and - They have documentation where they had notified the EHR provider and were told that fixing the issue would not be an “easy fix.”

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 Centers for Medicare & Medicaid Services (CMS) Outcome and Assessment Information Set (OASIS; standardized data collection tool) manual, policy review, record review and interview, the home health provider failed to ensure the accuracy of the OASIS data in one of five full records reviewed (Record/Patient #2). This deficient practice has the potential to affect all Medicare/Medicaid patients served by the provider. Findings included: Review of the CMS OASIS-E manual, effective 01/01/2023, showed in part: - A valid referral is considered received when the provider has received adequate information about a patient to initiate patient assessment and confirmed that the referring physician/allowed practitioner or another physician/allowed practitioner, will provide the plan of care and ongoing orders; and - The provider will note the date the alternate or attending physician/allowed practitioner agreed to follow the patient as the referral date (M0104) unless referral details are later updated or revised. Review of the provider’s policy titled, “OASIS Data Entry and Transmission,” revised 08/2017, showed personnel completing OASIS forms will enter accurate and complete information that reflects the patient’s status at the time of the assessment. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 01/21/2025 with a diagnosis of a closed left hip fracture with routine healing. He/she had additional diagnoses of type two diabetes mellitus (a group of diseases that results in too much sugar in the blood) and atherosclerotic heart disease (ASHD, thickening of the arterial wall that results in decreased supply of blood flow). The patient had a brief stay in a long-term care facility (LTCF) prior to returning home to live with his/her spouse. Review of the physician order, dated 01/20/2025, showed the physician agreed to sign orders and follow home health for disciplines of skilled nursing (SN), physical therapy (PT) evaluation, occupational therapy (OT) evaluation, and home health aide. Review of the initial assessment, dated 01/21/2025, showed in part: - The inpatient discharge date (OASIS item M1005) was 01/16/2025; and - The date of referral (OASIS item M0104) was 01/16/2025 (the provider did not have a physician to accept the patient until 01/20/2025). During an interview on 02/13/2025 at 9:00 AM, the administrator stated that there was a system problem, and they were aware the referral date was incorrect and should have used the date the physician accepted the patient.

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on review of the provider’s patient handbook, policy review, interview, and home visit observation, the provider failed to provide their patients with the address for the QIO (Quality Improvement Organization) that served the area where the patient resided in, but not limited to, one of three home visit observations (Record/Patient #3). This deficient practice has the potential to affect the quality of care for all of the provider’s patients. Findings included: Review of page five of the undated document titled, “Home Health Patient Handbook,” provided to all patients on the initial comprehensive assessment, showed in part, the document failed to contain the address for the provider’s QIO. Review of the provider’s policy titled, “Patient Bill of Rights and Responsibilities,” revised 07/2022, showed in part, that the patient had a right to be advised of the names, addresses, and telephone numbers of federally and state funded entities that served the area where the patient resided including the QIO. During an interview on 02/09/2025 at 1:30 PM, the administrator stated that: - They were aware that providing the QIO address was required; and - Their patient handbook failed to contain the address of their QIO; and - They had corrected the patient handbook to include the QIO’s address prior to survey exit. RECORD/PATIENT #3: Observation on 02/10/2025 at 2:24 PM, showed the provider's patient handbook in the patient's home failed to contain the address of the provider’s QIO.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on policy review, complaint/grievance log review, after-hours call log review, and interview, the home health provider failed to ensure systems were in place to document the existence and the resolution of patient complaints. This deficient practice has the potential to affect all the patients served by the provider. Findings included: Review of the provider’s policy titled, “Complaint and Grievance Process – Customer,” revised 08/2017, showed in part: - Customers have the right to voice grievances regarding treatment or care that is (or fails to be) furnished; - The provider will investigate all complaints made by a patient/family/caregiver or representative and will document both the existence of the complaint and the resolution of the complaint; - All complaints will be investigated by the administrator/clinical manager, who will provide follow-up with the patient/family or representative in a timely manner; - All patient complaints/grievances will be documented on the complaint log; and - Documentation must include the resolution of the complaint. Review of the complaint/grievance log showed: - On 01/22/2025, an entry stated that the family did not feel like the physical therapist was working the patient “hard enough” and the resolution was a different physical therapist was paired with the client; - A printed page entry that showed “There were no complaints during the following quarter: Q4FY2024 (quarter four fiscal year 2024)”; - A printed page entry that showed “There were no complaints during the following quarter: Q3FY2024 (quarter three fiscal year 2024); - A printed page entry that showed “There were no complaints during the following quarter: Q2FY2024 (quarter two fiscal year 2024); and - A printed page entry that showed “There were no complaints during the following quarter: Q1FY2024 (quarter one fiscal year 2024). Review of the after-hours call log showed in part: - On 01/28/2025 at 12:40 PM, a family member called to complain they still had issues with care. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 01/27/2025 at 06:21 PM, a family member called to complain they were given conflicting information regarding the scheduled visit. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 01/22/2025 at 1:47 PM, a family member called to complain that the provider was supposed to call him/her every time someone went to their mother’s house because their mother would not answer. The staff was supposed to call them if they needed to reschedule any visits, and they had requested no visits on Thursdays. This was the third time they had to tell the provider this. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 01/05/2025 at 10:21 AM, a patient called to complain they had been out of their medication for over a week. The medication was supposed to be taken for a week and then labs were supposed to be drawn. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 12/18/2024 at 5:04 PM, the patient called to complain they had not seen the wound nurse in “quite a while”, the nurse used to come out three times a week and they did not know what was going on. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 12/10/2024 at 1:29 PM, a patient called to ask when they would be getting physical therapy again. He/she had only had one visit so far and had not heard from anyone since last week. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 12/03/2024 at 3:46 PM, a patient called to complain that (named staff) was supposed to be there at 2:00 PM and no one had shown up. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 11/29/2024 at 10:20 AM, a patient called and wanted to know if anyone would be replacing the aide who called out sick. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 11/28/2024 at 9:26 PM, the patient called to complain that no one had called him/her to set up the next day’s appointment with (named staff). The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 11/18/2024 at 4:40 PM, a patient called to complain he/she was supposed to be released that week. His/her family had been helping him/her out for six weeks. He/she needed to know when the provider would be out to release them because he/she had things to do. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; and - On 11/10/2024 at 8:30 PM, a patient complained they were expecting a call from a nurse about his/her wound care the next day but had not heard from anyone. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint. During an interview on 02/13/2025 at 9:00 AM, the administrator stated that they had a nurse on-call who returned the patient calls, and the on-call nurse was supposed to let them know when there was an issue. He/she also thought the intake team needed to better communicate with them when there was a patient/family issue. When the intake team did notify them, the administrator asked them what they did to resolve the complaint and documented the issue in the complaint log. He/she was aware they were required to keep a documented record of complaints and their resolution.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on policy review, record review, home visit observation, and interview, the home health provider failed to maintain an accurate/updated medication profile in three of three home visit observations conducted (Records/Patients #1, #2, and #3). This deficient practice has the potential to affect all the patients served by the provider. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 12/06/2024 with a primary diagnosis of aftercare following surgery on the circulatory system. The patient had undergone peripheral vascular angioplasty (a minimally invasive medical procedure used to open narrowed or blocked arteries in the limbs, typically the legs). The patient had secondary diagnoses of pressure ulcer (wound) of the left heel, laceration (cut) of the left forearm, atrial fibrillation (abnormal heart rhythm characterized by rapid and irregular heartbeat) , chronic obstructive pulmonary disease (COPD; a group of lung diseases that block airflow and make it difficult to breathe). The patient resided in their own home with the assistance of their adult child. Observation and interview on 02/10/2025 beginning at 2:20 PM, during the patient’s home visit, Registered Nurse (RN) A asked the patient if he/she had any medication changes. The patient stated “no”. After RN A finished his/her visit, the surveyor asked RN A and the patient to look at his/her medications. A review of the agency’s current medication record compared to the medications in the patient’s home showed the provider’s medication record failed to contain orders for: - Pantoprazole (a medication used to reduce the amount of acid the stomach makes) 40 milligram (mg) daily; - Sodium chloride (a medication used to make mucus in the airways easier to cough out) 0.7 percent (%) via nebulizer two times per day; - Oxycodone (a semi-synthetic narcotic pain medication) 5 mg every night as needed for severe pain; and - Potassium chloride 20 milliequivalents (mEq) daily. During an interview on 02/13/2025 at 10:00 AM, the administrator stated that medications were reconciled a minimum of every 30 days, at resumption of care, at discharge, and with changes reported by the patient. Findings included: Review of the provider’s policy titled, “Medication, Regimen Review Comprehensive,” revised 08/2017, showed in part: - At the time of admission an accurate, current and complete list of all prescription and over the counter (OTC) medications, as well as herbal medications, taken by the patient will be maintained on the medication profile; - All required comprehensive assessments will include a review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions; - Changes in the medication regimen will be documented in the clinical record as well as communicated to the patient and/or caregiver; and - Review of medications will be on-going but done a minimum of every 60 days. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health on 01/27/2025, with a diagnosis of surgical aftercare following an aortic valve replacement (surgical replacement of a heart valve) and an ascending aortic aneurysm repair (repair of a ballooning in the wall of the ascending aorta). The patient had additional diagnoses of atherosclerotic heart disease (ASHD; thickening of the arterial wall that results in decreased supply of blood flow) and type two diabetes mellitus (a group of diseases that results in too much sugar in the blood). He/she lived at home with his/her spouse. Observation on 02/10/2025 at 3:00 PM showed the following medication discrepancies: - The provider’s medication profile showed the patient took vitamin C (a supplement) 500 milligrams (mg) one tablet two times daily. The patient had a bottle of vitamin C 500 mg that also contained vitamin D3 25mg, vitamin A 450 micrograms (mcg), and zinc 11 mg; - The provider’s medication profile showed bupropion hydrochloride extended release (an antidepressant) 150 mg, one tablet daily. The patients spouse stated the patient took 300 mg daily; - The provider’s medication profile showed metoprolol tartrate (used to lower blood pressure and heart rate) 12.5 mg two times a day. The patient took 25 mg two times a day; - The patient took potassium citrate (a supplement) 10 milliequivalents (mEq), four tablets daily. The provider’s profile failed to include this medication; - The patient took coenzyme Q10 (CoQ10 – a supplement) 200 mg daily. The provider’s profile failed to include this medication; and - The patient took fish oil (a supplement) 1200 mg with omega three 360 mg, one capsule daily. The provider’s profile failed to include this medication. During an interview on 02/13/2025 at 9:00 AM, the administrator stated that the physical therapist should have looked at the patient’s medication bottles and compared them to the list on file. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 01/21/2025 with a diagnosis of a closed left hip fracture with routine healing. He/she had additional diagnoses of type two diabetes mellitus (a group of diseases that results in too much sugar in the blood) and atherosclerotic heart disease (ASHD, thickening of the arterial wall that results in decreased supply of blood flow). The patient had a brief stay in a long-term care facility (LTCF) prior to returning home to live with his/her spouse. Observation on 02/10/2025 at 10:30 AM showed the following medication discrepancies: - The provider’s medication profile showed Robitussin DM (brand) 5 mg -100 mg / 5 milliliter (mL) cough syrup, take 10 mL as needed for cough/congestion. The patient stated that he/she does not take this medication; - The provider’s medication profile showed tamsulosin (for enlarged prostate) 0.4 mg one daily. The patient stated that he/she does not take this medication; - The provider’s medication profile showed polyethylene glycol (a laxative) 17-gram powder, take 17 grams as needed. The patient stated that he/she does not take this medication. - The provider’s medication profile showed aspirin 81 mg, one daily. The patient stated that he/she does not take this medication; - The provider’s medication profile showed melatonin 3 mg tablet, take one tablet at bedtime for sleep. The patient stated that he/she does not take this medication; - The provider’s medication profile showed vitamin D2 (a supplement) 1250 mcg capsule, take one capsule daily. The patient stated that he/she does not take this medication; - The provider’s medication profile showed glipizide (used to lower blood sugar) 2.5 mg tablet, take one daily. The patient stated that he/she does not take this medication. During an interview on 02/13/2025 at 9:00 AM, the administrator stated that he/she would expect every clinician to review medications, look at the medication bottles, and update the medication list each skilled visit.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on policy review, record review, home visit observation, and interview, the home health provider failed to: - Ensure an individualized plan of care (POC) that included all pertinent diagnoses and treatments (G574); - Provide written instructions outlining the visit schedule (G614); and - Provide written instructions outlining physician ordered treatments (G618). The cumulative effect of these deficient practices has the potential to affect all the patients on service with the provider.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on policy review, record review, home visit observation, and interview, the home health provider failed to ensure an individualized plan of care (POC) that included all pertinent diagnoses and treatments, in three of five full records reviewed (Records/Patients #2, #3, and #4). This deficient practice has the potential to affect the coordination of care and services for all the patients on service with the provider. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 01/21/2025 with a diagnosis of a closed left hip fracture with routine healing. He/she had additional diagnoses of type two diabetes mellitus (a group of diseases that results in too much sugar in the blood) and atherosclerotic heart disease (ASHD, thickening of the arterial wall that results in decreased supply of blood flow). The patient had a brief stay in a long-term care facility (LTCF) prior to returning home to live with his/her spouse. Review of the LTCF referral document titled, “Physician Order Report: 12/13/2024 – 01/13/2025”, showed the following: - The patient had a left heel deep tissue injury (DTI, skin injury caused by unrelieved pressure) identified on 01/02/2025; and - The wound care for the DTI was to apply skin prep (a fast-drying liquid skin protectant that creates a barrier to prevent further skin breakdown and promote healing) and let dry then apply a foam dressing daily. Review of the initial assessment, dated 01/21/2025, showed that the patient: - Discharged from the LTCF on 01/16/2025; - Scored a three on the nutrition screening (a score of six to eight indicated a high nutritional risk that required further intervention); - Was incontinent of urine; - Had no skin ulcers or wounds but was at risk for pressure ulcers; and - Did not use any pressure relieving devices. Review of the POC, dated 01/21/2025, showed the following integumentary goals and interventions: - Goal - Patient will not have any new evidence of skin breakdown by discharge; - Assess/instruct patient/caregiver in measures to prevent skin breakdown; pressure relief, incontinence care, nutrition, and hydration; - The POC failed to include interventions for the skilled nurse (SN) to assess the patient’s skin for breakdown; and - The POC failed to include individualized interventions to prevent skin breakdown. Findings included: Review of the policy titled, “Plan of Care,” revised 08/2017 showed in part: - An individualized plan of care is developed utilizing the comprehensive and initial assessment, information provided by members of the interdisciplinary team, and the physician; - The plan of care must include at a minimum the types of services, supplies, and equipment required for the patient, nutritional requirements, and all treatments and interventions. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 12/06/2024 with a primary diagnosis of aftercare following surgery on the circulatory system. The patient had undergone peripheral vascular angioplasty (a minimally invasive medical procedure used to open narrowed or blocked arteries in the limbs, typically the legs). The patient had secondary diagnoses of pressure ulcer (wound) of the left heel, laceration (cut) of the left forearm, atrial fibrillation (abnormal heart rhythm characterized by rapid and irregular heartbeat) , chronic obstructive pulmonary disease (COPD; a group of lung diseases that block airflow and make it difficult to breathe). The patient resided in their own home with the assistance of their adult child. Review of the document titled, “OASIS (Outcome assessment information set) Nursing Services SOC/ROC (Start of Care/Resumption of Care),” dated 12/06/2024 showed in part that the patient had: - Oxygen in the home, at 2 (two) liters per minute per nasal cannula continuously; - Air boots in the home to be worn while the patient was in bed; and - The patient was not at a high nutritional risk and had a nutritional screening score of 3; Review of the document titled, “Plan of Care,” with certification dates of 12/06/2024 to 02/03/2025 showed the document: - Contained interventions for oxygen precautions and a nutritional supplement; and - Failed to contain orders for supplies and interventions including: * Durable medical equipment listing oxygen supplies; * Identification of the amount, delivery method, and rate of the patient’s oxygen use; * Medical supplies listing the air boots to be worn while the patient was in bed; and * Identification of the type and amount of nutritional supplementation ordered for the patient. During a home visit observation on 02/10/2025 starting at 2:20 PM, the nurse stated, “I’m going to take your blood pressure in your right arm because I know we don’t use your left arm.” The patient then stated that he/she had undergone a left mastectomy (removal of the left breast) in the past. Review of the documents titled, “Plan of Care,” with certification dates of 12/06/2024 to 02/03/2025 and 02/04/2025 to 04/04/2025 showed the documents failed to contain instructions to only use the patient’s right arm to monitor a blood pressure. During an interview on 02/13/2025 at 9:40 AM, the administrator stated they would expect all equipment, supplies, and interventions to be on the patient’s plan of care. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services on 01/09/2025 with a primary diagnosis of type 2 (two) diabetes (a group of diseases that results in too much sugar in the blood) with a foot ulcer (wound). The patient had secondary diagnoses of osteomyelitis (an infection of the bone) of the right foot and ankle, cellulitis (a bacterial infection of the skin) of the left lower limb, hypertension, diabetic polyneuropathy (the malfunction of many outlying nerves throughout the body), Crohn’s disease (a chronic inflammatory bowel disease), obstructive sleep apnea (sleep disorder that affects the breathing during sleep), and dependence on other enabling machines and devices. The patient resided in his/her own home with occasional short-term assistance. Review of the document titled, “OASIS Nursing Services SOC/ROC,” dated 01/09/2025 showed in part the patient was at a high fall and nutritional risk. Review of the document titled, “Plan of Care,” with certification dates of 01/09/2025 to 03/09/2025 showed in part the document: - Contained: * A diagnosis of dependence on other enabling machines and devices; * An order for Neosporin (antibiotic ointment) to the skin crack on the right foot twice per day; * A pain goal that the patient/caregiver would verbalize/demonstrate measures to manage pain: medication management/alternative pain relief measures, behavior modification to avoid factors that increase pain/use of pain scale to identify intensity and determine comfort goal; * Fall precautions; and * Nutritional orders for a regular diet; and - Failed to contain: * Identification of the enabling machines and devices on which the patient was dependent; * Interventions for the clinician to assess, perform, instruct on care to the skin crack on the right foot; * A measurable element to identify the patient’s pain comfort goal; * Individualized interventions to address the patient’s high risk for falls; * Interventions to address the patient’s high nutritional risk; and * Interventions to assess the patient’s diabetic status including, but not limited to, assessment of the patient’s blood sugar levels. During an interview on 02/13/2025 at 10:00 AM, the administrator and clinical manager stated that they would expect clinicians to monitor the patient’s blood sugars, per the patient’s report, as part of a diabetic assessment. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 01/21/2025 with a diagnosis of a closed left hip fracture with routine healing. He/she had additional diagnoses of type two diabetes mellitus (a group of diseases that results in too much sugar in the blood) and atherosclerotic heart disease (ASHD, thickening of the arterial wall that results in decreased supply of blood flow). The patient had a brief stay in a long-term care facility (LTCF) prior to returning home to live with his/her spouse. Review of the LTCF referral document titled, “Physician Order Report: 12/13/2024 – 01/13/2025”, showed the following: - The patient had a left heel deep tissue injury (DTI, skin injury caused by unrelieved pressure) identified on 01/02/2025; and - The wound care for the DTI was to apply skin prep (a fast-drying liquid skin protectant that creates a barrier to prevent further skin breakdown and promote healing) and let dry then apply a foam dressing daily. Review of the initial assessment, dated 01/21/2025, showed that the patient: - Discharged from the LTCF on 01/16/2025; - Scored a three on the nutrition screening (a score of six to eight indicated a high nutritional risk that required further intervention); - Was incontinent of urine; - Had no skin ulcers or wounds but was at risk for pressure ulcers; and - Did not use any pressure relieving devices. Review of the POC, dated 01/21/2025, showed the following integumentary goals and interventions: - Goal - Patient will not have any new evidence of skin breakdown by discharge; - Assess/instruct patient/caregiver in measures to prevent skin breakdown; pressure relief, incontinence care, nutrition, and hydration; - The POC failed to include interventions for the skilled nurse (SN) to assess the patient’s skin for breakdown; and - The POC failed to include individualized interventions to prevent skin breakdown. Findings included: Review of the policy titled, “Plan of Care,” revised 08/2017, showed in part: - An individualized plan of care is developed utilizing the comprehensive and initial assessment, information provided by members of the interdisciplinary team, and the physician; - The plan of care must include at a minimum the types of services, supplies, and equipment required for the patient, nutritional requirements, and all treatments and interventions. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 12/06/2024 with a primary diagnosis of aftercare following surgery on the circulatory system. The patient had undergone peripheral vascular angioplasty (a minimally invasive medical procedure used to open narrowed or blocked arteries in the limbs, typically the legs). The patient had secondary diagnoses of pressure ulcer (wound) of the left heel, laceration (cut) of the left forearm, atrial fibrillation (abnormal heart rhythm characterized by rapid and irregular heartbeat), chronic obstructive pulmonary disease (COPD; a group of lung diseases that block airflow and make it difficult to breathe). The patient resided in their own home with the assistance of their adult child. Review of the document titled, “OASIS (Outcome assessment information set) Nursing Services SOC/ROC (Start of Care/Resumption of Care),” dated 12/06/2024 showed in part that the patient had: - Oxygen in the home, at 2 (two) liters per minute per nasal cannula continuously; - Air boots in the home to be worn while the patient was in bed; and - The patient was not at a high nutritional risk and had a nutritional screening score of three. Review of the document titled, “Plan of Care,” with certification dates of 12/06/2024 to 02/03/2025 showed the document: - Contained interventions for oxygen precautions and a nutritional supplement; and - Failed to contain orders for supplies and interventions including: * Durable medical equipment listing oxygen supplies; * Identification of the amount, delivery method, and rate of the patient’s oxygen use; * Medical supplies listing the air boots to be worn while the patient was in bed; and * Identification of the type and amount of nutritional supplementation ordered for the patient. Observation on 02/10/2025 starting at 2:20 PM, the nurse stated, “I’m going to take your blood pressure in your right arm because I know we don’t use your left arm.” The patient then stated that he/she had undergone a left mastectomy (removal of the left breast) in the past. Review of the documents titled, “Plan of Care,” with certification dates of 12/06/2024 to 02/03/2025 and 02/04/2025 to 04/04/2025, showed the documents failed to contain instructions to only use the patient’s right arm to monitor a blood pressure. During an interview on 02/13/2025 at 9:40 AM, the administrator stated they would expect all equipment, supplies, and interventions to be on the patient’s plan of care. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services on 01/09/2025 with a primary diagnosis of type two diabetes with a foot ulcer (wound). The patient had secondary diagnoses of osteomyelitis (an infection of the bone) of the right foot and ankle, cellulitis (a bacterial infection of the skin) of the left lower limb, hypertension, diabetic polyneuropathy (the malfunction of many outlying nerves throughout the body), Crohn’s disease (a chronic inflammatory bowel disease), obstructive sleep apnea (sleep disorder that affects the breathing during sleep), and dependence on other enabling machines and devices. The patient resided in his/her own home with occasional short-term assistance. Review of the document titled, “OASIS Nursing Services SOC/ROC,” dated 01/09/2025, showed in part the patient was at a high fall and nutritional risk. Review of the document titled, “Plan of Care,” with certification dates of 01/09/2025 to 03/09/2025 showed in part the document: - Contained: * A diagnosis of dependence on other enabling machines and devices; * An order for Neosporin (antibiotic ointment) to the skin crack on the right foot twice per day; * A pain goal that the patient/caregiver would verbalize/demonstrate measures to manage pain: medication management/alternative pain relief measures, behavior modification to avoid factors that increase pain/use of pain scale to identify intensity and determine comfort goal; * Fall precautions; and * Nutritional orders for a regular diet; and - Failed to contain: * Identification of the enabling machines and devices on which the patient was dependent; * Interventions for the clinician to assess, perform, instruct on care to the skin crack on the right foot; * A measurable element to identify the patient’s pain comfort goal; * Individualized interventions to address the patient’s high risk for falls; * Interventions to address the patient’s high nutritional risk; and * Interventions to assess the patient’s diabetic status including, but not limited to, assessment of the patient’s blood sugar levels. During an interview on 02/13/2025 at 10:00 AM, the administrator and clinical manager stated that they would expect clinicians to monitor the patient’s blood sugars, per the patient’s report, as part of a diabetic assessment.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on policy review, record review, home visit observation, and interview, the provider failed to ensure that a written visit schedule that included frequency of visits by home health personnel was provided to patients and caregivers in three of three home visit observations conducted (Records/Patients #1, #2, and #3). This deficient practice has the potential to affect all the patients served by the provider. Findings included: Review of the provider’s policy titled, “Coordination of Care,” revised 08/2017, showed the patient and caregiver must be provided with a copy of written instructions outlining the visit schedule, including frequency of visits by home health staff and personnel acting on behalf of the provider. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health on 01/27/2025, with a diagnosis of surgical aftercare following an aortic valve replacement (surgical replacement of a heart valve) and an ascending aortic aneurysm repair (repair of a ballooning in the wall of the ascending aorta). The patient had additional diagnoses of atherosclerotic heart disease (ASHD; thickening of the arterial wall that results in decreased supply of blood flow) and type two diabetes mellitus (a group of diseases that results in too much sugar in the blood). He/she lived at home with his/her spouse. Review of the plan of care (POC) dated 01/27/2025, showed in part: - Physical therapy (PT) visits two times a week for one week beginning 02/03/2025, then for one time a week for one week starting 02/09/2025; - Occupational therapy (OT) visits one time a week for one week starting 02/04/2025; and - Skilled Nursing (SN) visits two times a week for one week starting 01/27/2025, then two times a week for one week starting 02/02/2025, then one time a week for one week starting 02/09/2025. Observation on 02/10/2025 at 3:00 PM, during the patient’s home visit, showed the folder left in the patient’s home on admission failed to contain a written schedule of the disciplines seeing the patient and the frequency of the visits. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 01/21/2025 with a diagnosis of a closed left hip fracture with routine healing. He/she had additional diagnoses of type two diabetes mellitus (a group of diseases that results in too much sugar in the blood) and atherosclerotic heart disease (ASHD, thickening of the arterial wall that results in decreased supply of blood flow). The patient had a brief stay in a long-term care facility (LTCF) prior to returning home to live with his/her spouse. Review of the POC dated 01/21/2025, showed in part: - SN visits one time a week for one week starting 01/21/2025, then one time a week for two weeks starting 01/26/2025, then two times a week for one week starting 02/11/2025, then one time a week for one week starting 02/18/2025; - PT visits one time a week for one week starting 01/23/2025, then two times a week for three weeks starting 01/26/2025, then one time a week for one week starting 02/16/2025; - OT visits one time a week for four weeks starting 01/27/2025; and - Home health aide visits (HHA) two times a week for four weeks beginning 01/21/2025. Observation on 02/10/2025 at 10:30 AM, during the patient’s home visit, showed the folder left in the patient’s home on admission failed to contain a written schedule of the disciplines seeing the patient and the frequency of the visits. During an interview 02/13/2025 at 9:00 AM, the administrator stated that the visit calendar in the admission booklet should have been filled out and each discipline should have added their frequency to the calendar. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 12/06/2024 with a primary diagnosis of aftercare following surgery on the circulatory system. The patient had undergone peripheral vascular angioplasty (a minimally invasive medical procedure used to open narrowed or blocked arteries in the limbs, typically the legs). The patient had secondary diagnoses of pressure ulcer (wound) of the left heel, laceration (cut) of the left forearm, atrial fibrillation (abnormal heart rhythm characterized by rapid and irregular heartbeat), chronic obstructive pulmonary disease (COPD; a group of lung diseases that block airflow and make it difficult to breathe). The patient resided in their own home with the assistance of their adult child. Review of the POC dated 02/04/2025 showed in part: - SN visits one time a week for one week starting 02/23/2025, then three times a week for two weeks starting 02/09/2025, then two times a week for one week starting 02/04/2025; and - HHA two times a week for four weeks beginning 02/09/2025. Observation on 02/10/2025 at 2:20 PM, during the patient’s home visit, showed the folder left in the patient’s home on at recertification failed to contain a written schedule of the disciplines seeing the patient and the frequency of the visits. Findings included: Review of the provider’s policy titled, “Coordination of Care,” revised 08/2017, showed the patient and caregiver must be provided with a copy of written instructions outlining the visit schedule, including frequency of visits by home health staff and personnel acting on behalf of the provider. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health on 01/27/2025, with a diagnosis of surgical aftercare following an aortic valve replacement (surgical replacement of a heart valve) and an ascending aortic aneurysm repair (repair of a ballooning in the wall of the ascending aorta). The patient had additional diagnoses of atherosclerotic heart disease (ASHD; thickening of the arterial wall that results in decreased supply of blood flow) and type two diabetes mellitus (a group of diseases that results in too much sugar in the blood). He/she lived at home with his/her spouse. Review of the plan of care (POC) dated 01/27/2025, showed in part: - Physical therapy (PT) visits two times a week for one week beginning 02/03/2025, then for one time a week for one week starting 02/09/2025; - Occupational therapy (OT) visits one time a week for one week starting 02/04/2025; and - Skilled Nursing (SN) visits two times a week for one week starting 01/27/2025, then two times a week for one week starting 02/02/2025, then one time a week for one week starting 02/09/2025. Observation on 02/10/2025 at 3:00 PM, showed the folder left in the patient’s home on admission failed to contain a written schedule of the disciplines seeing the patient and the frequency of the visits. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 01/21/2025 with a diagnosis of a closed left hip fracture with routine healing. He/she had additional diagnoses of type two diabetes mellitus and ASHD. The patient had a brief stay in a long-term care facility (LTCF) prior to returning home to live with his/her spouse. Review of the POC dated 01/21/2025, showed in part: - SN visits one time a week for one week starting 01/21/2025, then one time a week for two weeks starting 01/26/2025, then two times a week for one week starting 02/11/2025, then one time a week for one week starting 02/18/2025; - PT visits one time a week for one week starting 01/23/2025, then two times a week for three weeks starting 01/26/2025, then one time a week for one week starting 02/16/2025; - OT visits one time a week for four weeks starting 01/27/2025; and - Home health aide visits (HHA) two times a week for four weeks beginning 01/21/2025. Observation on 02/10/2025 at 10:30 AM, showed the folder left in the patient’s home on admission failed to contain a written schedule of the disciplines seeing the patient and the frequency of the visits. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 12/06/2024 with a primary diagnosis of aftercare following surgery on the circulatory system. The patient had undergone peripheral vascular angioplasty (a minimally invasive medical procedure used to open narrowed or blocked arteries in the limbs, typically the legs). The patient had secondary diagnoses of pressure ulcer (skin injury caused by unrelieved pressure) of the left heel, laceration (cut) of the left forearm, atrial fibrillation (abnormal heart rhythm characterized by rapid and irregular heartbeat), chronic obstructive pulmonary disease (COPD; a group of lung diseases that block airflow and make it difficult to breathe). The patient resided in their own home with the assistance of their adult child. Review of the POC dated 02/04/2025, showed in part: - SN visits one time a week for one week starting 02/23/2025, then three times a week for two weeks starting 02/09/2025, then two times a week for one week starting 02/04/2025; and - HHA two times a week for four weeks beginning 02/09/2025. Observation on 02/10/2025 at 2:20 PM, during the patient’s home visit, showed the folder left in the patient’s home on at recertification failed to contain a written schedule of the disciplines seeing the patient and the frequency of the visits. During an interview 02/13/2025 at 9:00 AM, the administrator stated that the visit calendar in the admission booklet should have been filled out and each discipline should have added their frequency to the calendar.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on policy review, record review, home visit observation, and interview, the home health provider failed to ensure the patient and caregiver were given written instructions outlining treatments to be administered by their personnel in one of three home visit observations conducted (Record/Patient #2). This deficient practice has the potential to affect all the patients served by the provider. Findings included: Review of the provider’s policy titled, “Coordination of Care,” revised 08/2017, showed the patient and caregiver must be provided with written instructions outlining any treatments to be administered by home health personnel and personnel acting on behalf of the provider. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 01/21/2025 with a diagnosis of a closed left hip fracture with routine healing. He/she had additional diagnoses of type two diabetes mellitus (a group of diseases that results in too much sugar in the blood) and atherosclerotic heart disease (ASHD, thickening of the arterial wall that results in decreased supply of blood flow). The patient had a brief stay in a long-term care facility (LTCF) prior to returning home to live with his/her spouse. Review of the skilled nurse (SN) visit note, dated 02/06/2025, showed in part: - The patient had an unstageable pressure ulcer (skin injury caused by unrelieved pressure) on the left heel; - Wound care included wash with soap and water, pat dry, paint with betadine, let dry, perform twice daily; and - Patient/caregiver to perform wound care once competency demonstrated. Observation on 02/10/2025 at 10:30 AM, during the patient’s home visit, showed the folder and booklet left in the patient’s home on admission failed to contain written instructions on the wound care being provided by the SN. During an interview on 02/13/2025 at 9:00 AM, the administrator stated that any treatments being provided should be written in the booklet given to the patient on admission.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on policy review, HHA (Home Health Agency) Error Summary reports, the provider's complaint/grievance log, Quality Assurance Process Improvement (QAPI) documentation, review of the provider's answering service logs, and interview, the home health provider failed to ensure the QAPI program measured, analyzed and tracked quality indicators, and other aspects of performance to assess processes of care. This deficient practice has the potential to affect the overall quality of care for all of the provider’s patients. Findings included: Review of the document titled, “Quality Assessment Performance Improvement, Outcome and Assessment Information Set (OASIS; a standardized data collection tool) Data Measurements,” revised 08/2017, showed in part: - The policy that data driven systems, such as OASIS data collection and outcome measurement, depend on the accuracy of source data describing patient health status. Minimizing data errors that could affect accuracy of clinical data or outcome analysis are a necessary function; - The program activities would include tracking of incidents, complaints, infections, medication errors, and other adverse patient events and analyze their causes, and implement preventative actions and mechanisms; and - The QAPI program will be comprehensive and assess, identify, monitor, and improve the quality of services and care provided. Review of the provider’s policy titled, “Complaint and Grievance Process – Customer,” revised 08/2017, showed in part: - Customers have the right to voice grievances regarding treatment or care that is (or fails to be) furnished; - The provider will investigate all complaints made by a patient/family/caregiver or representative and will document both the existence of the complaint and the resolution of the complaint; - All complaints will be investigated by the administrator/clinical manager, who will provide follow-up with the patient/family or representative in a timely manner; - All patient complaints/grievances will be documented on the complaint log; and - Documentation must include the resolution of the complaint. Review of the document titled, “QAPI Meeting,” dated 01/21/2025, showed that during the meeting the provider failed to address late OASIS submissions and client complaints. Review of the documents titled, “HHA Error Summary by Agency,” showed a progressive increase in OASIS submissions greater than 30 days after the M0090 date for the past three years. The OASIS Error rates were as follows: - 01/01/2025 to survey exit of 02/13/2025 showed an error rate of 49.7% (percent); - 01/01/2024 to 12/31/2024 showed an error rate of 39.68%; - 01/01/2023 to 12/31/2023 showed an error rate of 38.8%; - 01/01/2022 to 12/31/2022 showed an error rate of 19.37; and - The provider failed to show an improvement in a known quality issue over a three-year span. Review of the complaint/grievance log showed: - On 01/22/2025, an entry stated that the family did not feel like the physical therapist was working the patient “hard enough” and the resolution was a different physical therapist was paired with the client; - A printed page entry that showed “There were no complaints during the following quarter: Q4FY2024 (quarter four fiscal year 2024);" - A printed page entry that showed “There were no complaints during the following quarter: Q3FY2024 (quarter three fiscal year 2024);" - A printed page entry that showed “There were no complaints during the following quarter: Q2FY2024 (quarter two fiscal year 2024);" and - A printed page entry that showed “There were no complaints during the following quarter: Q1FY2024 (quarter one fiscal year 2024)." Review of the after-hours call log showed in part: - On 01/28/2025 at 12:40 PM, a family member called to complain they still had issues with care. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 01/27/2025 at 06:21 PM, a family member called to complain they were given conflicting information regarding the scheduled visit. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 01/22/2025 at 1:47 PM, a family member called to complain that the provider was supposed to call him/her every time someone went to their mother’s house because their mother would not answer. The staff was supposed to call them if they needed to reschedule any visits, and they had requested no visits on Thursdays. This was the third time they had to tell the provider this. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 01/05/2025 at 10:21 AM, a patient called to complain they had been out of their medication for over a week. The medication was supposed to be taken for a week and then labs were supposed to be drawn. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 12/18/2024 at 5:04 PM, the patient called to complain they had not seen the wound nurse in “quite a while”, the nurse used to come out three times a week and they did not know what was going on. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 12/10/2024 at 1:29 PM, a patient called to ask when they would be getting physical therapy again. He/she had only had one visit so far and had not heard from anyone since last week. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 12/03/2024 at 3:46 PM, a patient called to complain that (named staff) was supposed to be there at 2:00 PM and no one had shown up. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 11/29/2024 at 10:20 AM, a patient called and wanted to know if anyone would be replacing the aide who called out sick. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 11/28/2024 at 9:26 PM, the patient called to complain that no one had called him/her to set up the next day’s appointment with (named staff). The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; - On 11/18/2024 at 4:40 PM, a patient called to complain he/she was supposed to be released this week. His/her family had been helping him/her out for six weeks. He/she needed to know when the provider would be out to release them because he/she had things to do. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint; and - On 11/10/2024 at 8:30 PM, a patient complained they were expecting a call from a nurse about his/her wound care the next day but had not heard from anyone. The provider failed to enter this complaint into the complaint log and failed to document the resolution of the complaint. During an interview on 02/13/2025 at 9:00 AM, the administrator stated that: - They had a nurse on-call who returned the patient calls, and the on-call nurse was supposed to let them know when there was an issue; - He/she also thought the intake team needed to better communicate with them when there was a patient/family issue; - When the intake team did notify them, the administrator asked them what they did to resolve the complaint and documented the issue in the complaint log; and - He/she was aware they were required to keep a documented record of complaints and their resolution. During an interview on 02/13/2025 at 10:00 AM, the administrator stated that: - They were having problems with their electronic health record generating incorrect billing codes; - They were aware of the regulatory requirement to submit OASIS within 30 days of the M0090 date; and - They had multiple tickets, meetings, and evidence of addressing the issue of late submission.

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 policy review, record review, and interview, the registered nurse (RN) failed to provide an individualized, patient specific home health aide plan of care in one of three records reviewed (Record/Patient #3). This deficient practice has the potential to affect all the patients served by the provider. Findings included: Review of the document titled, “Physician/Extender Orders,” dated 11/21/2024, showed in part, that orders for services to be furnished “as needed” or “PRN” must be accompanied by a description of the client’s medical signs and symptoms that would occasion a visit and a specific limit on the number of those visits to be made under the order before an additional order would have to be obtained. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 12/06/2024 with a primary diagnosis of aftercare following surgery on the circulatory system. The patient had undergone peripheral vascular angioplasty (a minimally invasive medical procedure used to open narrowed or blocked arteries in the limbs, typically the legs). The patient had secondary diagnoses of pressure ulcer (skin injury caused by unrelieved pressure) of the left heel, laceration (cut) of the left forearm, atrial fibrillation (abnormal heart rhythm characterized by rapid and irregular heartbeat), chronic obstructive pulmonary disease (COPD; a group of lung diseases that block airflow and make it difficult to breathe). The patient resided in their own home with the assistance of their adult child. Review of the document titled, “HHA (Home Health Aide) Plan of Care,” dated 12/07/2024, showed in part, that the aide should perform oral care, skin care, hair care, shampoo, assistance with dressing, and shaving with an electric razor PRN (as needed). During an interview on 02/13/2025 at 10:00 AM, the administrator stated that: - They would expect PRN orders to have a reason for use; - On an aide assignment sheet, if the patient was without cognitive impairment, then the patient could decide if the PRN task was to be completed by the aide at that visit; and - The aide assignment sheet for Record/Patient #3 did contain interventions to be performed on a PRN basis and failed to specify a reason for performance of the assigned task.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure the skilled nurse (SN) obtained physician orders before providing wound care in one of five full records reviewed (Record/Patient #2). This deficient practice has the potential to affect all the patients served by the provider. Findings included: Review or the provider’s policy titled, “Provision of Care, Treatment and Services,” dated 11/21/2024, showed in part: - Care and services provided will be provided according to physician orders; - Drug, services, and treatments are administered by staff only as ordered by the physician; - Verbal orders are put in writing, signed, timed, and dated with the date of receipt by a registered nurse (RN) or therapist responsible for furnishing or supervising ordered services; and - It is the RN’s or therapist’s responsibility to make any necessary revisions to the plan of care (POC) based on that order. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 01/21/2025 with a diagnosis of a closed left hip fracture with routine healing. He/she had additional diagnoses of type two diabetes mellitus (a group of diseases that results in too much sugar in the blood) and atherosclerotic heart disease (ASHD, thickening of the arterial wall that results in decreased supply of blood flow). The patient had a brief stay in a long-term care facility (LTCF) prior to returning home to live with his/her spouse. Review of the skilled nurse (SN) visit note, dated 02/06/2025, showed in part: - The patient had an unstageable pressure ulcer (skin injury caused by unrelieved pressure) on the left heel; and - Wound care performed by the SN included wash with soap and water, pat dry, paint with betadine, let dry, perform twice daily; and - The wound care interventions documented in the note showed an effective date of 02/10/2025 (four days after the wound care was performed) Review of the physician order for the left heel wound care showed: - A date of 02/06/2025 in the upper right-hand corner; - Wound care to left heel two times daily, cleanse with soap and water, pat dry, paint with betadine, let dry. Patient/caregiver to perform wound care once competence demonstrated. Start/effective date 02/10/2025. Assess wound status start/effective 02/10/2025 (four days after wound care was performed); and - The date the order was signed by the RN was 02/10/2025 at 11:53 AM (approximately two hours after the survey started). During an interview on 02/13/2025 at 9:00 AM, the administrator stated that the RN should have obtained and signed the wound care orders on the day he/she discovered the wound, and he/she should not have performed wound care without an order.

Eligible training/competency evaluation orgs. CFR(s): 484.80(f) A home health aide training program and competency evaluation program may be offered by any organization except by an HHA that, within the previous 2 years: (1) Was out of compliance with the requirements of paragraphs (b), (c), (d), or (e) of this section; or (2) Permitted an individual who does not meet the definition of a "qualified home health aide" as specified in paragraph (a) of this section to furnish home health aide services (with the exception of licensed health professionals and volunteers); or (3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or (4) Was assessed a civil monetary penalty of $5,000 or more as an intermediate sanction; or (5) Was found to have compliance deficiencies that endangered the health and safety of the HHA's patients, and had temporary management appointed to oversee the management of the HHA; or (6) Had all or part of its Medicare payments suspended; or (7) Was found under any federal or state law to have: (i) Had its participation in the Medicare program terminated; or (ii) Been assessed a penalty of $5,000 or more for deficiencies in federal or state standards for HHAs; or (iii) Been subjected to a suspension of Medicare payments to which it otherwise would have been entitled; or (iv) Operated under temporary management that was appointed to oversee the operation of the HHA and to ensure the health and safety of the HHA's patients; or (v) Been closed, or had its patients transferred by the state; or (vi) Been excluded from participating in federal health care programs or debarred from participating in any government program. This STANDARD is not met as evidenced by: Based on the results of this extended level survey, resulting in noncompliance with two Conditions of Participation: 484.60-Care planning, Coordination of Services, and Quality of Care and 484.105-Organization and Administration of Services, the home health provider may not train, or competency evaluate their home health aides for a period of two (2) years following the date of this survey. This restriction ends 02/13/2027.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on current survey findings, administrator job description review, clinical manager job description, and interview, the home health provider failed to ensure: - The administrator was responsible for the day-to-day operations of the provider (G0948); and - The clinical manager provided oversight assuring the development, implementation, and updating of the individualized plan of care (G0968). The cumulative effect of these systemic practices resulted in the provider’s inability to ensure the patient’s care needs were met.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on current survey findings, administrator job description review, and interview, the home health provider failed to ensure the administrator was responsible for day-to-day operations and that regulatory compliance was achieved. This deficient practice has the potential to affect the administrative oversight for care for all the patients on service with the provider. Findings included: Review of current survey findings showed the provider failed to meet compliance for: - Two Conditions of Participation: * §484.60 Condition of Participation: Care planning, coordination of services, and quality of care; and * §484.105 Condition of Participation: Organization and administrations of services; and - Level 1 (one) standard deficiencies, including: * G0484: Document complaint and resolution; * G0536: A review of all current medication; * G0574: Plan of care must include- all pertinent diagnoses and all medications and treatments; * G0614: Visit schedule- the home health provider must provide the patient and caregiver with a copy of written instructions outlining the visit schedule; * G0618: Any treatments- the home health provider must provide the patient and caregiver with a copy of written instructions outlining the treatments to be administered; * G0708: Development and evaluation of the plan of care- skilled professionals must assume responsibility for, but not be restricted to the development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); and * G0710: Provide services in the plan of care- skilled professionals must assume responsibility for, but not be restricted to providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care. Review of the document titled, “Position Title: Director of Home Health/Home Health Administrator,” dated 09/2023, showed in part, the administrator’s responsibilities included, but were not limited to: - Ensuring high quality of care and excellent customer service is provided, and all regulatory laws are met; and - Assures compliance with all state, federal, and local laws regarding licensure and certification; assures adherence to agency procedures and policies by all staff. During an interview on 02/13/2025 at 10:00 AM, the administrator stated that her/his job duties included, but were not limited to: - The provision of oversight of the entire operation of the provider; and - Assuring regulatory compliance.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on current survey findings, clinical manager job description review, and interview the home health provider failed to ensure the clinical manager provided oversight in the development, implementation, and updating of the individualized plan of care (POC). This deficient practice has the potential to affect the clinical management of care for all the patients on service with the provider. Findings included: Review of current survey findings showed the provider failed to meet compliance for: - Two Conditions of Participation: * §484.60 Condition of Participation: Care planning, coordination of services, and quality of care; and * §484.105 Condition of Participation: Organization and administrations of services; and - Level 1 (one) standard deficiencies, including: * G0484: Document complaint and resolution; * G0536: A review of all current medication; * G0574: Plan of care must include- all pertinent diagnoses and all medications and treatments; * G0614: Visit schedule- the home health provider must provide the patient and caregiver with a copy of written instructions outlining the visit schedule; * G0618: Any treatments- the home health provider must provide the patient and caregiver with a copy of written instructions outlining the treatments to be administered; * G0708: Development and evaluation of the plan of care- skilled professionals must assume responsibility for, but not be restricted to the development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); and * G0710: Provide services in the plan of care- skilled professionals must assume responsibility for, but not be restricted to providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care. Review of the document titled, “Position Title: Director of Nursing, Home Health/Clinical Manager,” dated 04/2024 showed in part the clinical manager’s responsibilities included, but were not limited to: - Ensuring regulatory compliance and resolves deficiencies when needed; - Ensuring appropriate reporting to outside agencies, including timely submission of OASIS data to Center for Medicare and Medicaid Services (CMS); - Oversees intake and quality improvement (QI) processes; supervises the maintenance and accuracy of patient care and medical records; - Assuring patient needs were continually assessed; and - Participates in the development and monitoring of Quality Assurance and Performance Improvement (QAPI). During an interview on 02/13/2025 at 10:00 AM, the administrator stated that the role of the clinical manger was to: - Oversee all of the clinical operations of the provider; - Manage the regulatory aspects of care; - Assure policies and procedures are followed; and - Direct supervision of all nursing staff.

A partial extended survey for Medicare certification for Lutheran Senior Services Home Health was completed on 03/02/2022. The agency had 54 current patients. The Emergency Preparedness regulations were also reviewed as part of the Medicare certification survey completed on 03/02/2022. One standard level deficiency was identified.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on review of the agency's Emergency Preparedness (EP) binder and interview, the agency failed to ensure contact information was included and updated for federal emergency preparedness staff. This deficient practice has the potential to adversely affect the care and safety of all patients served by the agency during an emergency. Findings included: Review of the agency's EP binder showed no contact information for federal EP staff. Findings were reviewed with the administrator on 03/02/2022 at 11:50 AM, and she stated that there was no federal emergency management agency (FEMA) contact information in the EP binder.

OASIS privacy notice CFR(s): 484.50(a)(1)(iii) (iii) An OASIS privacy notice to all patients for whom the OASIS data is collected. This ELEMENT is not met as evidenced by: Based on review of the agency’s policy and review of the home health folder in the patient’s (Record/Patient #2) home, the agency failed to ensure the OASIS privacy notice was provided to the patient on admission. This deficient practice has the potential to adversely affect the care and safety of all patients served by the agency. Findings included: Review of the agency’s policy titled "Patient Rights and Responsibilities", last revised August 2017, showed that an outcome and assessment information set (OASIS) privacy notice will be provided during the initial evaluation visit and in advance of furnishing care to the patient. The agency administrator provided an admission packet for review on 02/28/2022. The patient rights written information was reviewed, including an OASIS privacy notice to all patients for whom the OASIS data is collected. RECORD/PATIENT #2: Observation on 03/01/2022 at 11:30 AM, during the patient's home visit, showed the OASIS privacy notice information was missing from the patient’s admission packet. On 03/02/2022 at 11:50 AM, the findings were reviewed with the agency administrator and no additional information was provided by survey exit.

Written notice within 4 business days CFR(s): 484.50(a)(4) Provide written notice of the patient's rights and responsibilities under this rule and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section to a patient-selected representative within 4 business days of the initial evaluation visit. This ELEMENT is not met as evidenced by: Based on review of the agency’s current patient rights information, and interview, the agency failed to provide the written notice of patient rights, that included the right to receive a copy of the patient’s rights and responsibilities, and the agency’s transfer and discharge policies, provided to a patient-selected representative within four business days of the initial evaluation visit. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all patients served by the agency. Findings included: Review of the admission folder, provided by the administrator on 02/28/2022, showed that the notice of patient rights and other information given to a patient during the initial visit, failed to contain information regarding the patient’s right to receive a copy of the patient’s rights and responsibilities, and the agency’s transfer and discharge policies provided to a patient-selected representative, within four business days of the initial evaluation visit. During an interview on 03/02/2022 at 1130 AM, the administrator stated that the agency was in the process of changing their patient rights packet and would get the information updated.

State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This ELEMENT is not met as evidenced by: Based on policy review, observation, home folder review, and interview, the agency failed to update the written notice of the state toll-free hotline hours of operation (7:00 AM to 8:00 PM) in the admission folders of three (Patients #1, #2, and #3) of three home visit observations. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. PATIENT/RECORD #2: Review of clinical record showed the patient was admitted to home health on 02/13/2022. During a home visit on 03/01/2022 at 11:30 AM, the elder abuse and neglect hotline hours in the patient’s home folder/packet showed the state toll-free hotline hours were 7:00 AM to midnight. During the home visit observation, the clinician added new papers to the folder to include the correct hotline hours. The agency failed to provide the correct hotline hours of operation at the time of admission. PATIENT/RECORD #3: Review of clinical record showed the patient was admitted to home health on 02/21/2022. During a home visit on 03/01/2022 at 1:00 PM, observation showed the elder abuse and neglect hotline hours in the patient’s home folder/packet showed the state toll-free hotline hours were 7:00 AM to midnight on one paper and 7:00 AM to 8:00 PM on another paper. Per interview conducted in home visit, the RN stated he/she added the new papers the day before because the hotline hours had changed recently. The agency failed to provide the correct hotline hours of operation at the time of admission. Findings included: Review of the agency’s policy titled, “Patient Rights, Patient Bill of Rights and Responsibilities, Home Health Hotline,” dated/revised 08/2017, showed the elder abuse and neglect toll free hotline hours are 7:00 AM to 8:00 PM. PATIENT/RECORD #1: Review of the clinical record showed the patient was admitted to home health services on 02/07/2022. During a home visit on 03/01/2022 at 9:35 am, the elder abuse and neglect hotline hours in the patient’s home folder/packet showed the state toll-free hotline hours were 7:00 AM to midnight. The agency failed to provide the correct hotline hours of operation on admission. During an interview on 02/28/2022 at 11:30 AM, the administrator stated that the agency recently had their hospice survey and they were cited for incorrect hotline hours. He/she stated that they realized their home health packets also had the incorrect hours and they had updated their admission packets and were updating them in the patient’s home folders.

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on policy review, observation, and interview, the agency failed to update the written notice of patient rights to include that the patient and representative (if any) be advised of the name, addresses, and telephone number of the Federally funded and state funded entities that serve the area where the patient resides, to include the current Quality Improvement Organization (QIO), in two (Records/Patients #2 and #3) of five records reviewed. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: Review of the agency’s policy, titled “Patient Rights, Advance Beneficiary Notices – Home Health,” revised 08/2017, showed the Home Health Agencies are required to provide a Notice of Medicare Non-Coverage (NOMNC) to beneficiaries when their Medicare covered service(s) are ending. The NOMNC informs beneficiaries of how to request an expedited determination from their Quality Improvement Organization (QIO) and gives beneficiaries the opportunity to request an expedited determination from a QIO. A Detailed Explanation of Non-Coverage (DENC) is given only if a beneficiary requests an expedited determination. The DENC explains the specific reasons for the end of services. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health on 02/13/2022. Observation on 03/01/2022 at 11:30 AM, during the patient's home visit, showed the home folder listed KEPRO for the QIO, rather than the current QIO of LIVANTA. The agency failed to provide the current QIO contact information. RECORD/PATIENT #3: Review of clinical record showed the patient was admitted to home health on 02/21/2022. Observation on 03/01/2022 at 01:00 PM, during the patient's home visit, showed the home folder listed KEPRO for the QIO, rather than the current QIO of LIVANTA. The agency failed to provide the current QIO contact information. On 03/02/2022 at 11:50 AM, the findings were reviewed with the agency administrator. No additional information was provided by survey exit.

Accessibility CFR(s): 484.50(f)(1,2) Standard: Accessibility. Information must be provided to patients in plain language and in a manner that is accessible and timely to- (1) Persons with disabilities, including accessible web sites and the provision of auxiliary aids and services at no cost to the individual in accordance with the Americans with Disabilities Act and Section 504 of the Rehabilitation Act. (2) Persons with limited English proficiency through the provision of language services at no cost to the individual, including oral interpretation and written translations.Standard: Accessibility Information must be provided to patients in plain language and in a manner that is accessible and timely to- This STANDARD is not met as evidenced by: Based on review of the agency’s current patient rights information, and interview, the agency failed to update the written notice of patient rights, to include that information must be provided to patients in a language and in a manner that is accessible and timely to persons with disabilities, including accessible websites, and the provision of auxiliary aids services, at no cost to the individual, and must be provided to persons with limited English proficiency, at no cost to the individual, including oral interpretation and written translations. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The administrator provided an admission packet for review on 02/28/2022. The agency’s patient rights information titled’ “Patient Bill of Rights and Responsibilities,” and other packet information given to a patient during the initial visit, failed to contain that written information must be provided to patients in plain language and in a manner that is accessible and timely to persons with disabilities, including accessible websites, and the provision of auxiliary aids and services, at no cost to the individual in accordance with the Americans with Disabilities Act and Section 504 of the Rehabilitation Act, and that persons with limited English proficiency through the provision of language services, at no cost to the individual, including oral interpretation and written translations. During an interview on 02/28/2022 at 11:30 AM, the findings were reviewed with the administrator. The administrator stated that they recently updated their patient rights information. He/she reviewed the agency’s patient bill of rights and admission packet contents and could not find the required information.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on policy review, clinical record review, and interview, the agency failed to ensure the patient’s current health status was assessed and documented in one (Patient/Record #1) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency’s policy titled, “Assessment, Comprehensive,” dated 08/2017, showed: - Each patient will receive a patient specific, comprehensive assessment that accurately reflects the patient’s current health status and includes information that may be used to demonstrate the patient’s progress toward achievement of desired outcomes; and - The comprehensive assessment must include medical, nursing, rehabilitative, social, and discharge planning needs. Review of the agency’s policy titled, “Description of Services Policy, Skilled Nursing,” dated 08/2017, showed the duties of the registered nurse include the following: - Evaluate the patient’s needs; - Coordinate services, informing the physician and other interdisciplinary team members of changes in the patient’s condition and needs; and - Keep current and adequate documentation showing assessment of the patient’s current status, response to treatment, and the treatments provided. RECORD/PATIENT #1: Review of the start of care assessment, dated 02/07/2022, showed: - Surgical wound #1 on superior (upper) left hip with seven staples; - Surgical wound #2 on left middle hip with eight staples; and - Surgical wound #3 on left inferior (lower) hip with six staples. Review of the skilled nursing notes, dated 02/11/2022, showed; - Wound #1, #2, and #3 are closed/resurfaced; and - A narrative entry stating “skin intact, wounds healed properly.” The agency failed to document in the clinical record when the patient’s staples were removed and who removed them. During an interview on 03/02/2022 at 11:20 AM, the administrator stated that the medical record should have included an assessment and documentation by the clinician of when the staples were removed and who removed them.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on policy review, record review, home visit observation, and interview, the agency failed to ensure that a complete/accurate medication review and/or update of the patient’s medications was completed in, but not limited to, two (Records/Patients #1 and #3) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #3: Review of the patient's medication profile, showed the following: - On 02/21/2021 calcitriol (vitamin D3) 0.25 mg capsule one capsule daily; - On 02/21/2022 Miralax (treats constipation) 17 gram (gm) powder packet one packet daily as needed; and - On 02/22/2022 Klor-Con (potassium) 10 milliequivalents (mEq) tablet, extended release, two tablets every day. During a home visit observation on 03/01/2022 beginning at 01:00 PM showed the following medication discrepancies with the patient’s medication list in his/her home and the current medication profile and plan of care (POC): - The patient’s medication list showed calcitriol 0.25 mg capsule one capsule twice a day; - The patient’s medication list did not show Miralax 17 gm powder packet one packet daily as needed; and - The patient’s medication list showed Klor-Con ER two tablets daily. The agency failed to clarify the patient was taking calcitriol twice a day, Miralax as needed and the dosage of Klor-Con on the patient’s medication list. Findings included: Review of the agency’s policy titled, “Medication, Regimen Review Comprehensive,” dated 08/2017, showed the following: - At the time of admission, an accurate, current and complete list of all prescription and over-the counter (OTC) medications, as well as herbal medications, taken by the patient will be maintained on the medication profile; - At the time of admission, the clinician will ask the patient to describe or confirm any prescription medications, over the counter medications, vitamins, herbs or other supplements; - Adverse patient response, lack of patient response, and/or compliance concerns will be communicated to the physician as well as documented in the clinical record; - Changes in the medication regimen will be documented in the clinical record as well as communicated to the patient and/or caregiver; - Review of medications will be on-going; and - The clinician will communicate a complete list of the patient’s medications to the next service provider when the patient is referred or transferred to another setting service, practitioner or level of care within or outside the organization. The communication is documented in the clinical record. RECORD/PATIENT #1: Review of the plan of care, dated 02/07/2022, and the agency medication profile showed: - Acetaminophen 325 milligrams (mg) two tablets every six hours as needed (PRN) (pro re nata); - Vitamin C 500 mg one time a day; - Vitamin D3 25 micrograms (mcg) one capsule daily; - Levothyroxine 75 mcg one tablet daily; - Ropinirole 0.5 mg one tablet daily; and - PreserVision Lutein 226 mg-200 unit-5 mg-0.8 mg capsule one capsule two times daily. Review of the clinical record showed nursing discharged the patient on 02/23/2022. A home visit observation on 03/01/2022 at 9:35 AM, showed: - The patient stopped taking Vitamin C 500 mg; - The patient was taking Melatonin 5 mg every day at bedtime; and - The physical therapist did not review the medications during the home visit. The agency failed to reconcile the plan of care and the medication profile to show that the patient is no longer taking Vitamin C 500 mg daily and is taking Melatonin 5 mg daily at bedtime. An interview with the physical therapist was conducted during the home visit on 03/01/2022 at 10:20 AM. The physical therapist stated that, if it is a therapy only case, therapy will reconcile the medications but the patient was just discharged from nursing services last week. He/she stated that since nursing had just discharged the patient, he/she didn’t check the medications. During an interview on 03/02/2022 at 11:20 AM, findings were reviewed with the administrator. The administrator stated that the medications should have been reconciled when the clinician went into 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 policy review, record review, home visit observation, and interview, the agency failed to include all the elements of an individualized plan of care in, but not limited to, four (Patients/Records #1, #2, #3, and #4) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #2: Review of the start of care assessment, dated 02/13/2022, showed: - A diagnosis of acute respiratory failure with hypoxia (absence of enough oxygen in the tissues to sustain bodily functions); - A diagnosis of dysphagia (difficulty swallowing); - Advance directives: patient/caregiver reports has advance directive/living will, copy requested for home health chart; and - Patient aware of advance directives The plan of care failed to include any further information regarding the advance directive’s contents, the patient’s wishes or if the patient refused to provide a copy. Review of the plan of care, dated 02/07/2022, showed: - Acute respiratory failure with hypoxia; - Dysphagia; - Aspiration precautions; - Regular diet; and - The patient / caregiver reports has advance directive / living will, copy requested for home health chart. - The plan of care failed to include the aspiration precautions, and any further information regarding the advance directive’s contents, the patient’s wishes or if the patient refused to provide a copy. During an interview on 03/02/2022 at 11:02 AM, findings were reviewed with the administrator. The administrator stated that they have a copy of the advance directive and it should have been included on the POC. No further information was provided. RECORD/PATIENT #3: Review of the start of care assessment, dated 02/21/2022, showed: - A diagnosis of Hypertensive heart and chronic kidney disease without heart failure and stage 1-4 / unspecified chronic kidney disease (high blood pressure causing heart to pump harder and kidneys not functioning properly); - Type 2 diabetes mellitus (impairment in the way the body regulates and uses sugar (glucose) as a fuel) with diabetic chronic kidney disease (high levels of sugar in the blood damage the millions of tiny filtering units within each kidney and this eventually leads to kidney failure); - Long term use of insulin; - Patient is able to take medication(s) at the correct times if given reminders by another person based on the frequency of the injection; - Patient does not currently have an Advanced Directive or Living Will. Skilled nurse to facilitate patient / caregiver instruction on the benefits of an Advance Care Plan as well as provide verbal and written information and instruction on obtaining the necessary forms to complete the process on start of care (SOC) visit; - Patient aware of advance directives; - Diabetic precautions. Review of the plan of care, dated 02/21/2022, showed: - A diagnosis of Hypertensive heart and chronic kidney disease without heart failure and stage 1-4 / unspecified chronic kidney disease; - Type 2 diabetes mellitus with diabetic chronic kidney disease; - Lantus Solostar (insulin to manage blood sugars) U-100 Insulin 100 unit/milliliter (ml) (3 ml) subcutaneous (injection into the tissue layer between the skin and the muscle) pen, subcutaneous 15 units every day; - Diabetic precautions; - Venipuncture goal: Client will have therapeutic blood levels per medical doctor orders; and - The patient does not currently have an Advanced Directive or Living Will. Skilled nurse to facilitate patient / caregiver instruction on the benefits of an Advance Care Plan as well as provide verbal and written information and instruction on obtaining the necessary forms to complete the process on start of care (SOC) visit. The plan of care failed to include the diabetic precautions, who is responsible for obtaining blood sugar, how often patient to complete blood sugars aspiration precautions, and any further information regarding the advance directive’s contents, the patient’s wishes or if the patient refused to provide a copy. Review of the Skilled Nurse Visit Note, dated 02/23/2022 showed: - Blood sugar – blank; - Patient / caregiver self-monitoring – blank; - Blood glucose range per patient / caregiver – blank; - Blood glucose monitoring performed by – patient or other left blank; - No documentation the skilled nurse facilitated the patient / caregiver on the benefits of an Advance Care Plan as well as provide verbal and written information and instruction on obtaining the necessary forms to complete the process on SOC visit. During an interview on 03/02/2022 at 11:02 AM, findings were reviewed with the administrator. The administrator stated the agency does not have an advance directive for the patient. No further information was provided. Findings included: Review of the agency’s policy titled, “Assessment, Comprehensive,” dated 08/2017, showed each patient will receive a patient specific, comprehensive assessment that accurately reflects the patient’s current health status and includes information that may be used to demonstrate the patient’s progress toward achievement of desired outcomes. Review of the agency’s policy titled, “Assessment, Initial,” dated 08/2017, showed an ongoing assessment will occur with each visit and necessary revisions will be made to the plan of care. Review of the agency’s policy titled, “Plan of Care,” dated/revised 08/2017, showed: - An individualized plan of care is developed utilizing the comprehensive and initial assessment; - The plan of care is written by the appropriate staff in collaboration with the multi-disciplinary team, the physician, the patient and is based on the initial assessment of the patient’s problems and needs at the start of care; - The plan of care is reviewed and revised as frequently as the patient’s problems or needs require; - The plan of care must include the following; * All pertinent diagnoses; * The types of services, supplies, and equipment required; *All medications; *All treatments; *Safety measures to protect against injury; *Advance directive status and information; *Problems/needs of patient and caregiver(s); and *Interventions and education. Review of the agency’s undated policy titled, “Advance Directive and Resuscitation,” showed: - The agency will keep copies of the patient’s advance directives in the patient’s clinical record; - If the patient refuses to provide Lutheran Senior Services with a copy, this will be documented in the patient’s clinical record; - The director of home health or designee will contact the physician regarding the patient’s advance directives; - Staff will discuss the types of care and service that the patient wants and does not want. Staff will document the discussion of the patient’s wishes in the clinical record; and - The patient’s advance directive status will be communicated to all staff involved in the patient’s care by verbal and written communication (patient initial assessment, patient case conferences, copy of patient’s clinical record or patient report). RECORD/PATIENT #1: Review of the start of care assessment, dated 02/07/2022, showed: - A diagnosis of macular degeneration (an eye disease that causes loss in the center of the field of vision); - Memory deficits (forgetfulness) with the inability to recall events of the past twenty-four hours; - A skin lesion to the right shin that measured 2 centimeters (cm) long by 2 cm wide; - The integumentary portion of the assessment contained a section titled, “Wound care provided,” which showed a check mark beside the box titled, “See Interventions section”; and - The section titled, “Interventions/education provided,” showed the registered nurse failed to address wound care interventions. A home visit observation on 03/01/2022 at 9:35 AM, showed: - The patient has a wound on his/her right shin, covered by a large adhesive bandage; - The patient told clinician he/she just noticed his/her right foot was bleeding but he/she didn’t remember hitting it on anything; - Small round areas of blood smears (approximately the size of a nickel) on the patient’s floor from the patient's bedroom to the bathroom; and - The patient’s right foot had an adhesive bandage in place. Per an interview conducted during the home visit, the physical therapist (PT) stated that he/she will notify the patient’s daughter that there was a new wound on the patient’s right foot because she was going to take him/her to the doctor that day. The PT stated that the wound on the right shin is chronic and the clinicians believe that the patient is getting skin tears, which he/she keeps scratching or bumping on objects in the home. The PT stated that he/she would make sure the clinical manager was aware of the new wound on the patient’s right foot. Review of the plan of care, dated 02/07/2022, showed: - The agency failed to include any interventions for assessment of the right shin wound; - The agency failed to include any safety education regarding skin tears; - The patient has an advance directive and a copy was requested; and - The plan of care failed to include any further information regarding the advance directive’s contents, the patient’s wishes or if the patient refused to provide a copy. During an interview on 03/02/2022 at 11:30 AM, findings were reviewed with the administrator. The administrator stated that the concern of chronic skin tears should have been included in the plan of care because it was an ongoing issue for this patient. He/she also stated that the agency did not have a copy of the patient’s advance directive. No further information was provided. RECORD/PATIENT #4: Review of the infectious diseases consultation, dated 02/09/2022, showed: - The patient has an ulcer on the left second toe with suspected osteomyelitis (inflammation of the bone caused by infection); - 02/08/2022, the left toe ulcer culture showed results were positive for methicillin-resistant staphylococcus aureus (MRSA) (a type of bacteria that is resistant to many common antibiotics making the infection more difficult to treat). Review of the hospital’s discharge summary, dated 2/12/2022, showed: - The patient's cultures grew MRSA; - The patient was diuresed (the use of medication to increase the body’s production of urine, used to remove excess fluid from the body) aggressively for chronic (persisting for a long time) congestive heart failure (CHF) (a condition in which the heart doesn’t pump blood adequately, resulting in shortness of breath, swelling in the legs, fatigue and a rapid heartbeat); - The patient has a repeating pattern of fluid overload (a condition in which the liquid portion of the blood is too high) and edema (swelling); and - The patient is on warfarin (a blood thinner used to treat and prevent blood clots and requires laboratory monitoring to ensure correct dosage) Review of the plan of care dated 02/13/2022 through 04/13/2022 showed: - The agency failed to include the diagnosis of MRSA; - The agency failed to include contact infection control precautions (methods intended to prevent transmission of infectious agents which are spread by direct contact or indirect contact with the patient or the patient's environment) for the MRSA infection; - The agency failed to include patient/caregiver education on MRSA infection and contact precautions; - The agency failed to include interventions and patient caregiver education on management of edema; - The patient has a diagnosis of type 2 diabetes mellitus. The agency failed to include patient specific information on how he/she manages his/her blood sugar; and - The agency failed to include patient specific information regarding how the patient’s warfarin dosing and PT/INR (prothrombin time/ international normalized ratio) is managed.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on review of the agency’s admission folder, home folder review, and interview, the agency failed to provide the name and contact information of the current clinical manager in the admission folders of three (Patients #1, #2 and #3) of three home visit observations. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #2: During a home visit on 03/01/2022 at 11:30 AM, a review of the patient’s home folder showed the agency failed to provide the name and contact information of the current clinical manager. RECORD/PATIENT #3: During a home visit on 03/01/2022 at 01:00 PM, a review of the patient’s home folder showed the agency failed to provide the name and contact information of the current clinical manager. Findings included: Review of the agency’s admission packet showed the name and contact information of the current clinical manager. RECORD/PATIENT #1: During a home visit on 03/01/2022 at 9:35 am, a review of the patient’s home folder showed the agency failed to provide the name and contact information of the current clinical manager. During an interview on 03/02/2022 at 11:20 AM, the administrator stated that the patient’s home packets should have been corrected to show the name and contact information of the current clinical manager.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on policy review, clinical record review, and interview, the agency failed to ensure staff provided services as ordered by the physician in one (Record/Patient #2) of five full clinical records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled "Plan of Care," revised August, 2017 showed: - The relevant physician(s) must be notified of any changes in the patient condition or needs that suggest that outcomes are not being met and/or the Plan of Care should be revised; - The nurse or therapist will document communication to the physician or other authorized parties; and - The Plan of Care for each discipline will be updated and/or revised, to include such areas as problems, interventions, goals, psychosocial status, home environment, response to care, changes in diagnoses, treatments, equipment, precautions and limitations which might indicate the need to alter the Plan of Care or for terminating the services. Review of the agency's undated policy titled "Description of Services, Occupational Therapist, Physical Therapist and Speech," showed: - All therapy services will be provided under the supervision of a qualified therapist and in compliance with the Plan of Care; - Physical Therapy will be provided by a licensed Physical Therapist or a licensed Physical Therapist Assistant, under the supervision of a licensed Physical Therapist, in compliance with the Plan of Care; - Physical Therapist duties will include: * Evaluate the patient’s needs, including medical, psychosocial and environmental needs; and * Develop and implement, with physician and patient, an individualized Plan of physical, medical, psychosocial and environmental needs, and make appropriate revisions as the patient’s condition changes. RECORD/PATIENT #2: Review of the outcome and assessment information set (OASIS) nursing services start of (SOC), dated 02/13/2022 showed: - Frequency of Pain interfering with patient’s activity or movement – daily, but not constantly; - Pain: * Pain rating - four (moderate pain) on a scale of zero (no pain) to ten (worst possible pain); * Location – back; * Cause of pain – chronic; * What relieves pain – medications; and * How often is breakthrough medication needed – more than three times a day. Review of the Plan of Care (POC) dated 02/13/2022 through 04/13/2022, showed: - Diagnosis of fibromyalgia (chronic widespread pain, fatigue, waking unrefreshed, cognitive symptoms, lower abdominal pain or cramps, and depression); - Tylenol Extra Strength 500 milligram tablets take two tablets as needed for pain; and - Pain interventions –Interdisciplinary team to notify medical doctor (MD) if pain greater than seven on three consecutive days while taking medications for pain, on a scale one to ten. Review of the Skilled Nurse Visit Note, dated 02/17/2022 (Thursday) showed: - Pain: * Pain rating – five (moderate pain) on a scale of zero to ten; * Location – back; * What relieves pain – medications; * How often is breakthrough medication needed – two to three times a day; * Tylenol relieves pain some “takes the edge off;” and - Care coordination with – blank. Review of the Physical Therapy Visit Note, dated 02/18/2022 (Friday) showed: - Pain: * Pain rating – eight on a scale of zero to ten; * Location – generalized muscle aches and on all joints; * Cause – fibromyalgia; *Description – aching; * What relieves pain – rest and relaxation; * Comments – Patient states current pain medication / management acceptable; - Interventions/education provided – Patient required two minute rest breaks. Patient declined further gait training secondary to fibromyalgia acting up; - Patient response – Patient required extended rest break this session due to patient’s fibromyalgia acting up, but was able to participate in majority of interventions today; - Care coordination with – patient, patient’s representative and caregiver; and - Coordination details –POC, scheduling. Review of the Physical Therapy Visit Note, dated 02/21/2022 (Monday) showed: - Pain: * Pain rating – seven on a scale of zero to ten; * Location – low back lumbar (L) L4/L5 region and left posterior hip; * Cause – osteoarthritis; * Description – tingling, aching; * What makes it worse – movement; * What relieves pain – medication, rest and relaxation; * Frequency of pain and impact on activities – standing and walking; * How often is breakthrough medications needed – current pain control medications adequate; * Comments – Patient took Tylenol for pain medication/management. Patient reports current pain management/medication is not enough to make a change in his/her pain level; - Interventions/education provided – Patient instructed to contact primary care provider (PCP) regarding symptoms and signs for low back and schedule appointment soon; - Care coordination with – patient, patient’s representative and caregiver; physician, and clinical manager; and - Coordination details –POC, scheduling. Review of the Physical Therapy Visit Note, dated 02/25/2022 (Friday) showed: - Pain: * Pain rating – seven on a scale of zero to ten; * Location – low back to left lower leg; * Description – tingling; * What makes it worse – movement; * What relieves pain – medication, rest and relaxation; * Frequency of pain and impact on activities – affects his/her standing activities and walking; * How often is breakthrough medications needed – current pain control medications adequate; * Comments – Patient reports that current pain medications/management is unacceptable; - Ongoing skilled need – Patient is making minimal progress towards discharge goals this visit, secondary to flare up in low back pain. - Care Planning/Coordination with – patient, patient’s representative and caregiver; and - Coordination details –POC, scheduling. Review of the clinical record showed the agency failed to notify the physician to get a new order to treat the patent’s pain when current treatment was not working. During an interview on 03/02/2022 at 11:00 AM, the administrator stated that the staff should have contacted the patient’s physician.

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 Missouri State Code of Regulations, employee record review, and interview, the agency failed to provide dementia specific training about Alzheimer’s disease to one (Employee #3) of six employee records reviewed. This deficient practice has the potential to affect the safety of all patients served by the agency. Findings included: Review of 19 CSR 30-26.010 (1) (B) required: "Licensed home health agencies shall provide dementia-specific training about Alzheimer's disease and related dementias to their employees and those persons working as independent contractors, who provide direct care to or may have daily contact with residents, patients, clients or consumers with Alzheimer's disease or related dementias. 1. The training for persons providing direct care shall address the following areas, at a minimum: (A) An overview of Alzheimer's disease and related dementias; (B) Communicating with persons with dementia; (C) Behavior management; (D) Promoting independence in activities of daily living; and (E) Understanding and dealing with family issues. 2. Employees or independent contractors who do not provide direct care for, but may have daily contact with, persons with Alzheimer's disease or related dementias shall receive dementia-specific training that includes, at a minimum: (A) An overview of Alzheimer's disease and related dementias; and (B) Communicating with persons with dementia. 3. Dementia-specific training about Alzheimer's disease and related dementias shall be incorporated into orientation for new employees with direct patient contact and independent contractors with direct patient contact. The training shall be presented by an instructor who is qualified by education, experience, and knowledge in the current standards of practice regarding individuals with Alzheimer's disease and other related dementias. The training shall be provided annually and updated as needed. Review of employee files showed Employee #3 is providing occupational therapy services under arrangement. The agency’s file failed to contain records that showed the employee received dementia specific training about Alzheimer’s disease on orientation and annually. During an interview on 03/01/2022 at 2:00 PM, the administrator stated that the contracted employees do not complete the agency’s training, but receive training via their contracted healthcare staffing agency. The administrator stated that the onboarding and annual training provided by the contracted staffing agency was reviewed by their agency and approved, because it followed along with the agency’s training requirements. He/she provided a copy of the staffing agency’s dementia training. The dementia training provided failed to address the elements required in the Missouri state code of regulations.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on policy review, clinical record review, and interview, the agency failed to ensure a completed discharge summary was sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the home health agency, within 5 business days of the patient’s discharge in one (Record/Patient #6) of two discharge records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency’s policy titled, “Discharge/Transfer, Patient,” dated 08/2017, showed a discharge summary will be completed by the discharging discipline, and upon physician request, forwarded with a copy of the last visit note to the physician for review. PATIENT/RECORD #6: Review of the discharge summary, dated 02/17/2022, showed: - The patient is going to a skilled nursing/rehab facility to stay while his/her spouse is there receiving care; and - The agency failed to include the patient’s diagnosis/reason for admission to the home health agency. During an interview on 03/02/2022 at 10:00 AM, the administrator stated that the discharge summary should include the patient’s diagnosis/reason for admission to the home health.