Every finding on record at Inspire Home Health LLC

The Emergency Preparedness regulations were reviewed as part of the Medicare recertification survey completed on 03/18/2026. 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.

A partial extended survey for Medicare recertification for the home health provider was completed on 03/18/2026. The provider had 154 current patients.

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on review of the Internet Quality Improvement and Evaluation System's (iQIES; a cloud-based application developed by the Centers for Medicare and Medicaid Services (CMS) for managing provider and patient information, and ensuring quality healthcare, specifically for Medicare and Medicaid beneficiaries) home health agency (HHA) error summary by agency report, policy review, and interview, the home health provider failed to ensure that the Outcome and Assessment Information Set (OASIS; a standardized data collection tool) was electronically transmitted to the CMS system within the required timeframe in 222 of 2442 (9.09%) of the assessments submitted. This deficient practice has the potential to affect all the patients served by the provider. Findings included: Review of the iQIES report titled, “Home Health Agency (HHA) Error Summary by Agency,” for the reporting period of 02/01/2025 through 02/01/2026 showed the provider failed to ensure that the OASIS assessment was submitted to the CMS system within 30 days of completing the beneficiary’s assessment for 222 of 2442 (9.09%) assessments submitted. Review of the provider’s policy titled, “OASIS Data Transmission,” revised 4/2023, showed that all completed OASIS assessments will be electronically transmitted to the CMS system within 30 days of completing the assessment of the beneficiary. During an interview on 03/17/2026 at 2:00 PM, the home health administrator stated that there was a process error with face to face and coding issues and they were working on a new process to decrease the late OASIS submissions.

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, observation, and interview, the home health provider failed to ensure an accurate medication review and/or update of the patient medications was completed, in two of five full records reviewed (Records/Patients #1 and #2). This deficient practice has the potential to affect all the patients served by the provider. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 02/02/2026 with a primary diagnosis of discitis (a rare, severe inflammation or infection of the intervertebral disc space, often causing intense back pain, stiffness, and fever). The patient lived at home with a family caregiver. Observation on 03/17/2026 at 8:00 AM, showed: -The provider's medication profile showed the patient took chlorthalidone (reduces the amount of water in the body by increasing the flow of urine, which helps to lower blood pressure) 25 mg tablets, take one tablet daily. The patient did not have this medication in the home; -The provider's medication profile showed that patient took metronidazole (used to treat bacterial infections in different areas of the body) 500 mg tablet, take one tablet twice daily. The patient did not have this medication in the home; -The provider's medication profile showed that the patient took pantoprazole (used to treat certain conditions in which there is too much acid in the stomach) 40 mg tablet, take one tablet daily. The patient did not have this medication in the home; -The provider's medication profile showed that the patient took rosuvastatin (used to treat cholesterol) 20 mg tablet, take one tablet daily. The patient did not have this medication in the home; -The provider's medication profile showed that the patient took quetiapine (a second-generation antipsychotic medication primarily used to treat schizophrenia, bipolar disorder, and major depressive disorder) 25 mg, take one tablet daily. The patient took one tablet twice daily; and -The patient had ondansetron (used to prevent nausea and vomiting) 4 mg tablets, take one tablet every six hours as needed. The provider's medication profile failed to contain this medication. During interview on 03/18/2026, beginning at 10:55 AM, the administrator stated all clinicians should ask every visit if there are any medication changes, obtain those orders for medication changes (if needed) and those clinicians would then notify the clinical managers of changes. The clinicians should make sure to update the patient’s medication list in the home. She would expect the patient’s medications and medication profiles to match. Findings included: Review of the provider’s policy titled, “Medication Profile, Reconciliation, and Review Policy and Procedure,” last reviewed on 03/17/2026, showed in part the following: -Medication reconciliation will be done at admission, when updates to the comprehensive assessments are performed, when care is resumed after a patient has been placed on hold, and with the addition of a new medication; -Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications; -Compare the medication information the patient is currently taking with the medications ordered for the patient to identify and resolve discrepancies; and -Through observation during home visit and record review, a qualified clinician will confirm the medications the patient is taking against medical record documentation to verify all medications were identified, both prescription and non-prescription. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services on 10/23/2025 and recertified on 02/20/2026 with a primary diagnosis of aftercare following joint replacement surgery and pressure ulcer (skin injury caused by unrelieved pressure) of unspecified site. The patient lived with his/her adult child. Observation and interview on 03/18/2026 at 08:47 AM, showed: -The provider’s medication profile had alprazolam (used to treat anxiety) 1 milligram (mg) two to four tablets by mouth daily. The patient stated he/she takes one tablet every six hours; -The provider’s medication profile had amlodipine (used to treat high blood pressure) 5 mg by mouth daily. The patient’s medication profile in the home failed to include amlodipine; - The provider’s medication profile had lamotrigine (used to stabilize mood and treat depression) 150 mg by mouth twice daily. The patient’s medication profile in the home failed to include lamotrigine; - The provider’s medication profile had lisinopril (used to treat high blood pressure) 20 mg by mouth daily. The patient’s medication profile in the home failed to include lisinopril; - The provider’s medication profile had tamsulosin (used to treat urinary retention) 0.4 mg by mouth daily. The patient’s medication profile in the home failed to include tamsulosin; -The patient’s medication profile had topiramate (used to treat epilepsy) 50 mg four tablets by mouth in the morning and at bedtime. The provider’s medication profile failed to include topiramate; - The patient’s medication profile had prochlorperazine (used to treat nausea) 10 mg by mouth every six hours as needed. The provider’s medication profile failed to include prochlorperazine; -The patient’s medication profile had ibuprofen (anti-inflammatory) 200 mg four tablets by mouth every eight hours as needed. The provider’s medication profile failed to include ibuprofen; -The provider’s medication profile had amoxicillin 875mg-Potassium Clavulanate 125mg (antibiotic) one tablet by mouth twice daily. The patient stated he/she no longer takes this medication; -The provider’s medication profile had doxycycline hyclate (antibiotic) 100mg one tablet by mouth twice daily. The patient stated he/she no longer takes this medication; -The provider’s medication profile had Lantus U-100 insulin (long acting insulin, (injectable medication used to lower blood sugar) subcutaneous (SQ) as directed. The patient stated he/she no longer takes this medication; and -The provider’s medication profile had Tresiba flextouch U-100 (prefilled long acting insulin pen) insulin 15 units SQ at bedtime. The patient stated he/she no longer takes this medication. During an interview on 03/18/2026, beginning at 10:55 AM, the administrator stated all clinicians should ask every visit if there are any medication changes, obtain those orders for medication changes (if needed) and those clinicians would then notify the clinical managers of changes. The clinicians should make sure to update the patient’s medication list in the home. She would expect the patient’s medications and medication list to match.

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, observation, and interview, the home health provider failed to ensure the plan of care (POC) included only pertinent diagnosis, interventions to address patient needs, and safety measures in two of five full records reviewed (Records/Patients #2, and #3). This deficient practice has the potential to affect the provision of care for all the patients served by the provider. Findings included: Review of the provider's policy titled, "Care Planning Policy and Procedure," revised 04/2023, showed that an individualized POC shall be developed for each patient and is documented by the registered nurse (RN), or licensed therapist, if a therapy only admission, in coordination with the patient/family and must include: - A list of dates of onset of problems/needs based upon assessment data and physician orders; - All pertinent diagnoses; - Interventions to address the identified patient needs, including teaching and training guidelines as appropriate to the scope of practice of the individual developing and/or updating the POC consistent with relevant clinical practice guidelines; - Medications and treatments; and - Safety measures to protect against injury. RECORD/PATIENT #3: Review of the hospital admission history and physical (H & P) note, dated 02/16/2026 through 02/20/2026, showed the patient was admitted to the hospital on 02/16/2026 with a primary diagnosis of left subcapsular hematoma of the left kidney (an accumulation of blood beneath the renal capsule (a tough, fibrous connective tissue layer surrounding the kidney), often causing compression (applied pressure) of the kidney) and hemorrhage in left perirenal space (bleeding around the kidney). The H & P note contained the following additional diagnoses: - Hypoxia (an absence of enough oxygen in the tissues to sustain bodily functions); - Hypertension (HTN; elevated blood pressure)/congestive health failure (CHF; decrease in the ability of the heart to pump blood); - Hyperlipidemia (HLD; abnormally high levels of fats, specifically cholesterol and triglycerides, in the blood); - Diabetes Mellitus (DM; a chronic disease that affects how the body uses sugar for energy); - Benign Prostatic Hyperplasia (BPH; enlarged prostate gland); - Chronic Obstructive Pulmonary Disease (COPD; a group of lung diseases that block airflow and make it difficult to breathe); - Chronic Kidney Disease (CKD; a long-term condition where kidneys are damaged and cannot filter blood properly); - Gastroesophageal Reflux Disease (GERD; when stomach acid flows back up into the esophagus and causes a burning sensation in the chest); - Pulmonary embolism one year ago (PE; when a blood clot gets stuck in an artery in the lung); - Depression; - Hyperparathyroidism (condition caused by overactive parathyroid glands); and - DVT prophylaxis (preventative measures to stop deep vein thrombosis (clots in deep veins) and pulmonary embolism); and - Review of the care management note, on the H & P, showed the patient would receive therapies (physical and occupational therapy-PT/OT) at home when discharged and the anticipated date for discharge was 02/21/2026. Review of the clinical record showed the patient was admitted to home health services on 03/02/2026 with a primary diagnosis of acute kidney failure (sudden and often reversible loss of kidney function). The patient lived at home with a family caregiver. Review of the POC, dated 03/02/2026, showed: - The POC was created by the PT; - The diagnoses section contained the diagnoses listed on the H & P, including DM, and included several additional diagnoses, all had exacerbation dates (a sudden worsening or flare-up of a chronic disease’s symptoms, making them more severe than usual) of 02/24/2026, including but not limited to: -- Other instability, left knee; -- Coronavirus infection, unspecified; -- Abrasion of right forearm, initial encounter; -- Non-displaced fracture of head of right radius; -- Other fatigue; -- Hypotension; -- Precordial pain; -- Encounter for screening for malignant neoplasm of colon; -- Conductive hearing loss, bilateral; -- Aneurysm of iliac artery; -- Pneumonia, unspecified organism; -- Allergic rhinitis; -- Infrarenal abdominal aortic aneurysm without rupture; -- Rheumatic mitral valve disease; and -- Nonrheumatic tricuspid valve disease; - The section for treatment orders failed to include interventions related to assessment or monitoring of the patient’s DM; and - The section for durable medical equipment (DME) and supplies failed to include if the patient had a glucometer in the home. Observation and interview on 03/17/2026 at 11:30 AM showed the patient was able to move all extremities without pain, had no abrasion to the right forearm, and the patient stated that he/she was independent with diabetic management, and checked his/her blood sugar two times daily and recorded the results on a log. During an interview on 03/18/2026 at 11:15 AM, the home health administrator stated that: - There should be something on the plan of care about DM management, and the glucometer should be listed under DME/supply list; and - The diagnoses for patient #3 were not all exacerbated on 02/24/2026 and they will review these to correct this problem. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 02/02/2026 with a primary diagnosis of discitis (a rare, severe inflammation or infection of the intervertebral disc space, often causing intense back pain, stiffness, and fever). The patient lived at home with a family caregiver. Review of the clinical record showed the patient was prescribed clopidogrel (an antiplatelet) on 05/01/2025. Review of the plan of care, dated 02/02/2026-04/02/2026, failed to show a safety measure for bleeding precautions. During an interview on 03/18/2026 at 10:30 AM, the home health administrator stated that he/she would expect bleeding precautions to be included on the plan of care of patients who are prescribed antiplatelets.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on policy review, record review, observation, and interview, the home health provider failed to ensure the accuracy of documentation 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 of the provider's policy titled, "Clinical Record Data Collection," dated 04/2023, showed the following: -Documentation in the clinical record will be completed accurately, timely, and reflective of the care and services provided; and -Entries into the clinical record will be clear, concise, and contain specific statements of fact. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 02/02/2026 with a primary diagnosis of discitis (a rare, severe inflammation or infection of the intervertebral disc space, often causing intense back pain, stiffness, and fever). The patient lived at home with a family caregiver. Review of the plan of care dated 02/02/2026-04/02/2026 showed the following: -Diagnoses of: *Discitis, unspecified, lumbosacral region (a rare, severe inflammation or infection of the intervertebral disc space, often causing intense back pain, stiffness, and fever); *Essential (primary) hypertension (a chronic condition where blood forces against artery walls too strongly); *Retention of urine, unspecified; *Other retention of urine; *Atherosclerotic heart disease of native coronary artery without angina pectoris (a condition where plaque—fat, cholesterol, and calcium—builds up inside artery walls, restricting blood flow and oxygen to the heart); *Hyperlipidemia, unspecified (a common condition characterized by high levels of lipids (cholesterol/triglycerides) in the blood); *Other myocardial infarction type (decreased or complete cessation of blood flow to a portion of the myocardium); *Other low back pain; *Spondylosis without myelopathy or radiculopathy, lumbar region (a common age-related degeneration of the spinal discs and joints (arthritis of the spine) occurring in the neck or back); and -The patient had an expressed goal "to be able to walk with [his/her] walker again". Review of the clinician visit notes showed: -On 02/02/2026, the registered nurse (RN) documented an abnormal neurological finding of paralysis. The patient never had a diagnosis of paralysis; -On 02/05/2026, the occupational therapist (OT) documented an abnormal neurological finding of paralysis. The patient never had a diagnosis of paralysis; -On 02/19/2026, the OT documented an abnormal neurological finding of paralysis. The patient never had a diagnosis of paralysis; -On 02/23/2026, the OT documented an abnormal neurological finding of paralysis. The patient never had a diagnosis of paralysis; -On 02/24/2026, the physical therapist (PT) documented an abnormal neurological finding of paralysis. The patient never had a diagnosis of paralysis; -On 02/26/2026, the PT documented an abnormal neurological finding of paralysis. The patient never had a diagnosis of paralysis; -On 02/26/2026, the RN documented an abnormal neurological finding of paralysis. The patient never had a diagnosis of paralysis; -On 03/02/2026, the RN documented an abnormal neurological finding of paralysis. The patient never had a diagnosis of paralysis; -On 03/04/2026, the OT documented an abnormal neurological finding of paralysis. The patient never had a diagnosis of paralysis; -On 03/05/2026, the PT documented an abnormal neurological finding of paralysis. The patient never had a diagnosis of paralysis; -On 03/06/2026, the RN documented an abnormal neurological finding of paralysis. The patient never had a diagnosis of paralysis; -On 03/11/2026, the OT documented an abnormal neurological finding of paralysis. The patient never had a diagnosis of paralysis; and -On 03/12/2026, the PT documented an abnormal neurological finding of paralysis. The patient never had a diagnosis of paralysis. Observation on 03/17/2026, beginning at 8:00 AM, showed the patient working with the PT doing sit to stand exercises and lower extremity range of motion exercises. During an interview on 03/17/2026, at 8:45 AM, the patient stated that he/she had increased lower extremity weakness caused by back pain from a surgical site that became infected. He/she stated that, prior to the surgery, he/she was walking with a walker and he/she wished to be able to do that again with therapy. During an interview on 03/18/2026, at 10:30 AM, the home health clinical manager stated that the patient had never been diagnosed with paralysis. He/she also stated that the electronic medical record (EMR) had the option of "no abnormal findings" directly below the finding of "paralysis" in the neurological assessment section. He/she stated that it was a documentation error and that clinicians would be educated on ensuring the correct findings were documented in the EMR.

An extended survey for Medicare recertification for the home health provider was completed on 03/08/2023. The agency had 141 current patients. Five condition-level deficiencies were identified during this survey. A condition-level deficiency is identified at: - §484.50 Condition of Participation: Patient Rights; - §484.60 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care; - §484.70 Condition of Participation: Infection Prevention and Control; - §484.75 Condition of Participation: Skilled Professional Services; and - §484.105 Condition of Participation: Organization and Administration of Services. A home health agency 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 G788. The COVID-19 Health Care Staff Vaccination regulation was reviewed as part of the Medicare recertification survey. One standard level deficiency was identified. The Emergency Preparedness regulations were reviewed as part of the Medicare recertification survey completed on 03/08/2023. Two standard level deficiencies were identified.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on review of the agency’s personnel files and interview, the agency failed to provide initial training in emergency preparedness policies and procedures to all new and existing staff, and individuals providing services under arrangement and maintain documentation of the training in two (Employees #1 and #4) of four personnel files reviewed. This deficient practice has the potential to affect the safety of all patients served by the agency. Findings included: EMPLOYEE #1: Review of Employee #1’s personnel file showed: - Employee #1 is a registered nurse; - A hire date of 10/10/2022; and - The file failed to contain evidence that the employee received training in emergency preparedness policies and procedures upon hire. EMPLOYEE #4: Review of Employee #4’s personnel file showed: - Employee #4 is a contracted physical therapist; - A hire date of 08/23/2022; and - The file failed to contain evidence that the employee received training in emergency preparedness policies and procedures upon hire. During an interview on 03/08/2023 at 11:45 AM, the administrator stated that the nursing supervisor (a licensed practical nurse) had kept the training and personnel records to be “state ready” and was putting everything in a binder. That was his/her big project, to be state ready, and we do not have anything. The nursing supervisor quit approximately two weeks ago and they have not been able to find the records.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on policy review, emergency plan review, and interview the agency failed to document a follow-up analysis/evaluation when the agency activated their emergency plan in three of three emergency plan exercises reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's undated policy titled, "Emergency Preparedness Plan," showed in part the agency will review/analyze, at least yearly and as needed, its disaster plan responses after every drill, tabletop exercise and emergency event that occurs through its QAPI (quality assessment and performance improvement) committee. The agency discusses the plan and the procedures for communicating with staff. Review of the agency's emergency plan showed they activated their emergency plan in 2020, 2021, and 2022 due to inclement weather. There was no follow-up analysis/evaluation documented after the activation of the emergency plan. During an interview on 03/06/2023, at 2:55 PM, the office manager stated that he/she did not have a follow-up analysis when the agency activated their emergency plan. No further information was provided.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on policy review, admission packet review, clinical record review and interview, the agency failed to provide care and services that met the requirements for the Condition of Participation: Patient Rights. The agency failed to: - Ensure the written notice of the patient's rights and responsibilities provided are understandable to persons who have limited English proficiency and accessible to individuals with disabilities (G412); - Provide written notice of the patient's rights and responsibilities to a patient-selected representative within four business days of the initial evaluation visit (G422); - Ensure the patient has the right to receive all services outlined in the plan of care (G436); - Advise patients of the state toll free home health telephone hot line, its contact information, its hours of operation, and that the purpose is to receive complaints or questions about local home health agencies (G444); - Advise patients of the names, addresses, and telephone numbers of the Federally-funded and state-funded entities that serve the area where the patient resides (G446); - Inform patients of the right to access auxiliary aids and language services and how to access these services (G450); and - Ensure information is provided to patients in plain language and in a manner that is accessible and timely to persons with disabilities including accessible web sites and the provision of auxiliary aids and services at no cost to the individual and to persons with limited English proficiency through the provision of language services at no cost to the individual, including oral interpretation and written translations (G490). The effect of the singular deficient practice, failure to ensure the patient has the right to receive all services outlined in the plan of care (G436), has elevated the deficiencies under the Condition of Participation: Patient Rights to the condition level. .

Written notice of patient's rights CFR(s): 484.50(a)(1)(i) (i) 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. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This ELEMENT is not met as evidenced by: Based on admission packet review, review of the agency’s current patient’s rights information, and interview, the agency failed to ensure that written notice of the patient’s rights and responsibilities and the agency transfer and discharge policies is understandable to persons who have limited English proficiency and accessible to individuals with disabilities. The effect of this deficient practice has the potential to affect all patients served by the agency. Findings included: The agency's office manager provided an admission packet for review on 03/06/2023. The agency's notice of patient rights and other information given to a patient during the initial visit failed to contain information that the rights and responsibilities must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities. During an interview on 03/07/2023 at 11:30 AM, the administrator stated that he/she also looked for the information missing from the agency’s patient rights booklet and was unable to find the missing items.

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 admission packet review, 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 patient’s right to have 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 all patients served by the agency. Findings included: Review of the admission folder, provided by the agency’s office manager on 03/06/2023, showed 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 have 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 03/07/2023 at 11:30AM, the administrator stated that he/she also looked for the information missing from the agency’s patient rights booklet and was unable to find the missing items.

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on policy review, clinical record, and interview, the provider failed to ensure the patient has the right to receive all services outlined in the plan of care in one (Record/Patient #4) of five full records reviewed. This deficient practice has the potential to affect the right to individualized physician ordered care for all patients served by the agency. Findings included: Review of the current patient's rights information and other documents provided to patients on admission, showed the patient has the right to the following: - Receive and access services consistently and in a timely manner; - Appropriate and professional care relating to physician orders; and - To be admitted for service only if the agency has the ability to provide safe professional care at the level of intensity needed and to be in formed of the agency's limitations. Review of the agency’s undated policy titled, “Care Plan,” showed in part: - In order to ensure that a patient’s needs are being met adequately and appropriately, a care plan is essential; - Each patient will have an individualized plan of care that specified the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline, and the measurable outcomes that the agency anticipates will occur; - A care plan is started upon initiation of service by the RN (registered nurse), based upon the plan of treatment and an assessment of the patient’s needs, resources, family and environment; - Home health services from members of the agency staff, as well as those under contractual arrangements, shall be provided in accordance with the plan of treatment and the patient care plan; and - The patient care plan shall be written by appropriate members of the home health services team based upon the plan of treatment and an assessment of the patient’s needs, resources, family, and environment. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to the agency with a principal diagnosis of acute respiratory failure with hypercapnia (a sudden failure of the respiratory system due to the inability of the lungs to remove carbon dioxide from the bloodstream) and additional diagnoses of acute systolic congestive heart failure (a condition in which the heart does not pump blood as well as it should), chronic obstructive pulmonary disease with exacerbation (a flare up of an inflammatory lung disease that can block air flow and make it harder for the patient to breathe), and Type 2 diabetes mellitus with hyperglycemia. The patient lives in his/her own home and has an ex-spouse who comes in to prepare meals, set up medication and help with care throughout the week. Review of the POC, dated 02/06/2023 to 04/06/2023, showed orders for the skilled nurse (SN) to see the patient once a week for nine weeks. Review of SN notes showed the following: - A start of care visit was performed on 02/06/2023; - A missed visit note on 02/17/2023 stated that the patient was called several times with no answer and no visit was made; - No documented visit for the week of 02/19/2023 through 02/25/2023 and no documented missed visit note or note that an attempt was made to reschedule a missed visit; - A missed visit note on 03/03/2023 stated that no answer to calls or at door and no documented attempt to reschedule the missed visit; and - The SN notes failed to contain documentation that the patient’s physician was notified of the missed visits (no visit since the admission on 02/06/2023). During an interview on 03/07/2023 at 2:00 PM, the administrator stated that they do not usually notify the physician of a missed visit unless that visit is one that would affect the patient’s care, such as a lab draw being due. He/she wasn’t sure if the agency had a policy to direct how many ordered visits may be missed before the physician is notified. He/she stated that he/she would have assumed the nurses would have notified the physician by now, after a couple weeks of missed visits.

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 admission packet review, review of the agency’s current patient rights information, and interview, the agency failed to provide patients with the correct hours of operation for the state toll free home health hotline telephone number. This deficient practice has the potential to affect the exercise of patient rights for all agency patients. Findings included: Review of the admission folder, provided by the agency’s office manager on 03/06/2023, showed the patient rights information, and other information provided to patients on admission, contained an undated document titled, “Client Bill of Rights, Patient Rights and Responsibilities” that listed patient rights numerically. Item number 33 stated that the toll-free Missouri home health hotline number is operated from 8:00 AM to 5:00 PM daily (the correct hours of operation are 7:00 AM to 8:00 PM, seven days a week.) The patient rights information also contained an undated document titled, “Patient/Client Grievance” that showed the toll-free Missouri home health hotline number hours of operation as 7:00 AM to 12:00 AM 365 days per year. During an interview on 03/06/2023 at 11:50 AM, the administrator stated that he/she must have missed the notification when the hotline hours were changed.

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 admission packet review, review of the agency’s current patient rights information and interview, the agency failed to ensure the patient was advised of the name, address, and telephone number of the Federally-funded and state-funded entities that serve the area where the patient resides. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency’s current patient admission packet showed a document titled, “Community Resources,” in which the name and phone number of the area agency on aging was listed. The document failed to contain the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area: - Center for Independent Living; - Protection and Advocacy Agency; - Aging and Disability Resource Center; and -Quality Improvement Organization. The above findings were reviewed with the administrator on 03/07/2023 at 11:30 AM. Per an interview conducted during the review, the administrator stated that he/she was not aware these agencies were required to be listed in the patient’s rights information.

Access to auxiliary aids and language service CFR(s): 484.50(c)(12) Be informed of the right to access auxiliary aids and language services as described in paragraph (f) of this section, and how to access these services. This ELEMENT is not met as evidenced by: Based on admission packet review, review of the agency’s current patient rights information, and interview, the agency failed to ensure the patient was informed of the right to access auxiliary aids and language services and how to access these services. This deficient practice has the potential to affect the knowledge and comprehension of rights for all patients served by the agency. Findings included: Review of the agency’s current admission packet showed the patient’s rights information, provided to the patient on admission, failed to include that the patient had the right to be informed of their right to access auxiliary aids and language services and how to access these services. During an interview on 03/07/2023 at 11:30AM, the administrator stated that he/she also looked for the information missing from the agency’s patient rights booklet and was unable to find the missing items.

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 ensure the written notice of patient’s rights included that information must be provided to patients in plain language and in a manner that is accessible and timely to persons with disabilities, including accessible web sites and the provision of auxiliary aids and services at no cost to the individual and must be provided to persons with limited English proficiency through the provision of language services 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 rights for all patients served by the agency. Findings included: Review of the agency’s current admission packet showed the notice of patient rights, and other information given to a patient during the initial visit, contained no written information regarding the patient’s right to be informed that information must be provided to patients in plain language and in a manner that is accessible and timely to persons with disabilities, including accessible web sites 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 costs to the individual including oral interpretation and written translations. During an interview on 03/07/2023 at 11:30 AM, the administrator stated that he/she also looked for the information missing from the agency’s patient rights booklet and was unable to find the missing items

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, observation, and interview the agency failed to maintain an accurate/updated medication profile in three (Records/Patients #1, #2, and #3) of three home visit observations and failed to document a medication review by a nurse in one (Record/Patient #6) of one record reviewed that received therapy services only. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency’s undated policy titled, “Medication Profile,” showed in part: - The comprehensive assessment includes a review of all medications the patient is currently using, both prescription and non-prescription; - In therapy only cases, the therapist submits a list of the medications, which he/she will collect during the comprehensive assessment, to the registered nurse (RN) to review; - The drug regimen review occurs as an ongoing part of the care to the patient; - The medication profile must contain all current patient medications; - Medication profiles must be updated every 60 days and whenever there is a change in the medication regime; - The nurse performs ongoing medication monitoring to determine their action, indications, special precautions, patient response to therapy, side effects, allergies and contraindications, and to ensure appropriateness and continuity of care and includes the information necessary for creating an accurate medication history and a complete medication profile; - A medication profile will be filled out upon initial evaluation of each patient. A copy is kept in the patient’s home and updated as personnel are made aware of any changes; - The copy that is placed I the patient’s chart will be updated, as appropriate, but no less than every recertification period; - Medications will be reviewed at the start of care (SOC), two weeks, four weeks, six weeks, and eight weeks after the SOC, then a minimum of monthly thereafter; and - Medications will also be reviewed with resumption of care (after hospitalization), follow up Oasis (outcome assessment information set, a federally mandated assessment that occurs at certain time frames), and recertification Oasis. RECORD/PATIENT #3: Observation and interview on 03/07/2023 beginning at 1:10 PM, during the patient's home visit, showed the following medication discrepancies with the agency's medication profile: - The patient took acetaminophen (Tylenol) 650 milligrams (mg) as needed. The medication profile showed acetaminophen 500 mg two tablets every four hours as needed. The patient stated that he/she took the 650 mg two to three times a day; - The patient took gabapentin (used to treat nerve pain) 300 mg one capsule three times a day. The medication profile showed gabapentin 100 mg three times a day for 14 days; - The medication profile showed vitamin D 25 micrograms (mcg) daily. The patient’s spouse stated that he/she only took a multivitamin. He/she did not take a separate vitamin D tablet; and - The patient took pregabalin (used to treat nerve pain) 100 mg one capsule at bedtime. The patient’s spouse stated that he/she has taken this “forever”. This was not included on the medication profile. During an interview on 03/07/2023 beginning at 3:20 PM, the administrator stated that from the start of care, if any discrepancies are noted the physician is notified. The policy was to review/update the medications every two weeks for eight weeks then monthly thereafter. RECORD/PATIENT #6: Review of the physical therapist (PT) start of care assessment dated 12/15/2022, showed the PT documented a drug regimen review was completed. There was no documentation that the medication list was submitted to a nurse for review. Review of the medication profile showed the section for dates reviewed and by whom were blank. During an interview on 03/08/2023 beginning at 10:45 AM, the administrator stated that in therapy only cases, the therapist enters the medications in the computer then lets the office know so a nurse can review them. During an interview on 03/08/2023, at 1:40 PM, the administrator stated that he/she could not find a report where a nurse reviewed the medications. RECORD/PATIENT #1: Observation and interview on 03/06/2023 beginning at 2:00 PM, during the patient’s home visit, showed the following medication discrepancies with the agency’s medication profile: - The medication profile showed an order for aspirin (used to thin the blood) 325 milligrams (mg) one tablet twice daily (BID). The patient stated that they are no longer taking it; - The medication profile showed duplicate orders for rosuvastatin (used to treat high cholesterol and triglyceride levels) 5 mg one tablet every evening and rosuvastatin 5 mg one tablet daily. The patient stated that he/she is only supposed to take one 5 mg tablet in the evening and does not take the 5 mg daily; - The nurse asked the patient if he/she was still taking his/her insulin; - The patient stated that he/she is still taking Lantus (a long acting insulin used to treat diabetes) 16 units by subcutaneous (SQ) injection (an injection into the fatty tissue under the layers of the skin) every evening at bedtime; and - The Lantus insulin was not on the agency’s medication profile. During an interview on 03/06/2023 at 3:35 PM, the administrator stated that the agency recently initiated new medication reconciliation forms that the nurse fills out during the initial visit. If the nurse finds any medication issues, they are to call the physician for clarification. The expectation is for the clinician to review the patient’s medication bottles against the agency’s medication profile every two weeks for a full certification period (60 days) and then monthly, thereafter. The nurses are encouraged to ask the patient if any medications have changed at each home visit. RECORD/PATIENT #2: Review of the document titled, “Order Summary Report,” dated 02/03/2023, showed the long term care facility referral contained the following medications: - Aspirin 325 mg one tablet by mouth (PO) one time a day; - Atorvastatin calcium (used to treat high cholesterol and triglyceride levels) 40 mg tablet PO at bedtime; - Insulin glargine (Lantus) solution, inject 15 units SQ at bedtime; - Insulin Lispro (Humalog, a short acting insulin used to treat diabetes) solution, inject SQ per sliding scale, if blood sugar is 151 – 175 give 1 unit, if blood sugar is 176 – 200 give 2 units, if blood sugar is 201 – 225 give 3 units, if blood sugar is 226 – 250 give 4 units, if blood sugar is 251 to 275 give 5 units, if blood sugar is 276 – 300 give 6 units, if blood sugar is greater than 300 give 7 units; - Losartan potassium (used to treat high blood pressure) give 100 mg PO one time a day; and - Metformin hydrochloride extended release (ER) (an oral medication used to treat diabetes) 1000 mg PO one time daily. Observation and interview on 03/06/2023 beginning at 12:35 PM, during the patient’s home visit, showed the following medication discrepancies with the agency’s medication profile: - The agency’s profile included clopidogrel bisulfate (used to prevent the blood from clotting) 75 mg one tab daily. The patient stated that he/she is no longer taking this; - The agency’s profile showed Humalog KwikPen 100 units/milliliter U/ml, three units SQ three times daily (TID). The patient stated that he/she does not take three units but follows the sliding scale orders he/she received on discharge from the long term care facility; - The agency’s profile failed to contain the order for losartan potassium and metformin hydrochloride ER; and - The patient stated that he/she is taking his/her medications as instructed per the long term care facility on discharge. During an interview on 03/06/2023 at 3:35 PM, the administrator stated that the agency recently initiated new medication reconciliation forms that the nurse fills out during the initial visit. If the nurse finds any medication issues, they are to call the physician for clarification. The expectation is for the clinician to review the patient’s medication bottles against the agency’s medication profile every two weeks for a full certification period (60 days) and then monthly, thereafter. The nurses are encouraged to ask the patient if any medications have changed at each home 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, observation, and interview the agency failed to provide care and services that met the requirements for the Condition of Participation: Care Planning, coordination, and quality of care. The agency failed to: - Ensure patients received services that are written in the individualized plan of care (G572) - Develop a complete, individualized plan of care (G574); - Promptly alert the physician of changes in patient condition (G590); and - Coordinate care between all disciplines (G606). The cumulative effect of these deficient practices has the potential to affect the care and services provided to all the agency's patients. .

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on policy review, clinical record review, and interview the provider failed to ensure that patient’s received the home health services that are written in their individualized plan of care in, but not limited to, two (Records/Patients #2 and #4) 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 undated policy titled, “Physician’s Plan of Treatment,” showed in part: - A physician prepares a plan of treatment and it is made available to the agency; and - The physician’s plan of treatment must be signed by the physician and include specific orders and frequency of visits. Review of the agency’s undated policy titled, “Care Plan,” showed in part: - In order to ensure that a patient’s needs are being met adequately and appropriately, a care plan is essential; - Each patient will have an individualized plan of care that specified the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline, and the measurable outcomes that the agency anticipates will occur; - A care plan is started upon initiation of service by the RN (registered nurse), based upon the plan of treatment and an assessment of the patient’s needs, resources, family and environment; - Home health services from members of the agency staff, as well as those under contractual arrangements, shall be provided in accordance with the plan of treatment and the patient care plan; and - The patient care plan shall be written by appropriate members of the home health services team based upon the plan of treatment and an assessment of the patient’s needs, resources, family, and environment. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to the agency with a principal diagnosis of type 2 diabetes mellitus with hyperglycemia (elevated blood sugar) and monoplegia (paralysis that affects one side of the body or limb) following cerebral infarction (a stroke) affecting the left non-dominant side. The patient lives in his/her own home with his/her spouse and adult child and they help monitor the patient’s blood sugar and administer their insulin. Review of the plan of care (POC), dated 02/07/2023 to 04/07/2023, showed in part: - Skilled nurse (SN) was to see the patient twice a week for the week of 02/07/2023 through 02/11/2023); and - SN to see the patient once a week for eight weeks (02/12/2023 through 04/07/2023). Review of SN notes, dated 02/09/2023 through 02/28/2023, showed the following: - A missed visit note dated 02/17/2023; - The SN notes failed to contain documentation that an attempt was made to reschedule the missed visit; and - The SN notes failed to contain documentation that the patient’s physician was notified of the missed visit. During an interview on 03/07/2023 at 2:00 PM, the administrator stated that they do not usually notify the physician of a missed visit unless that visit is one that would affect the patient’s care, such as a lab draw being due. He/she wasn’t sure if the agency had a policy to direct how many ordered visits may be missed before the physician is notified. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to the agency with a principal diagnosis of acute respiratory failure with hypercapnia (a sudden failure of the respiratory system due to the inability of the lungs to remove carbon dioxide from the bloodstream) and additional diagnoses of acute systolic congestive heart failure (a condition in which the heart does not pump blood as well as it should), chronic obstructive pulmonary disease with exacerbation (a flare up of an inflammatory lung disease that can block air flow and make it harder for the patient to breathe), and Type 2 diabetes mellitus with hyperglycemia. The patient lives in his/her own home and has an ex-spouse who comes in to prepare meals, set up medication and help with care throughout the week. Review of the POC, dated 02/06/2023 to 04/06/2023, showed the SN was to see the patient once a week for nine weeks. Review of SN notes showed the following: - A start of care visit was performed on 02/06/2023; - A missed visit note on 02/17/2023 stated that the patient was called several times with no answer and no visit was made; - No documented visit for the week of 02/19/2023 through 02/25/2023 and no documented missed visit note or note that an attempt was made to reschedule a missed visit; - A missed visit note on 03/03/2023 stated that no answer to calls or at door and no documented attempt to reschedule the missed visit; and - The SN notes failed to contain documentation that the patient’s physician was notified of the missed visits (no visit since the admission on 02/06/2023). During an interview on 03/07/2023 at 2:00 PM, the administrator stated that they do not usually notify the physician of a missed visit unless that visit is one that would affect the patient’s care, such as a lab draw being due. He/she wasn’t sure if the agency had a policy to direct how many ordered visits may be missed before the physician is notified. He/she stated that he/she would have assumed the nurses would have notified the physician by now, after a couple weeks of missed visits.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview the agency failed to develop a complete, individualized plan of care (POC) for three (Records/Patients #1, #2, and #5) 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 undated policy titled, "Care Plan," showed in part: - In order to ensure that a patient needs are being met adequately and appropriately, and services are adapted and adjusted within an individual patient situation as needed, a care plan is essential; - Each patient will have an individualized POC that specifies 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 agency anticipates will occur; and - A care plan is started upon initiation of service by the RN, based upon the plan of treatment and an assessment of the patient's needs, resources, family, and environment. RECORD/PATIENT #5: Review of the registered nurse (RN) comprehensive assessment dated 11/23/2022, showed in part: - Resided in an assisted living facility; - On Coumadin (anticoagulant, blood thinning medication) therapy; and - Skilled nurse (SN) to perform INR (a blood test to determine how long it takes your blood to clot) checks as ordered. Review of the POC dated 11/23/2022 showed in part: - SN to obtain INR weekly and as needed; - A goal that the patient/caregiver will verbalize understanding of coumadin therapy and all aspects of associated care, but no specific interventions related to this goal such as education/monitoring related to assessment for signs of bleeding or bleeding precautions; and - The section for safety measures failed to include anticoagulant/bleeding precautions. During an interview on 03/08/2023 beginning at 10:45 AM, the administrator stated that he/she would expect bleeding precautions to be included on the POC. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to the agency with a principal diagnosis of a pressure ulcer of the left heel, stage 3 (a sore caused by pressure in which the sore has gone through all layers of the skin into the fat tissue) and additional diagnoses of type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar), and a partial amputation (surgical removal) of a portion of the left foot. The patient goes to a wound center for wound treatment and management and they provide the agency with orders for wound care. Review of the plan of care (POC), dated 01/16/2023 to 03/16/2023, showed, in part: - Wound care will be performed by skilled nurse (SN); - The POC failed to contain orders for the frequency of SN visits; and - The POC failed to contain the information that the patient is being treated by the wound center or how often the patient is seen by the wound center. During an interview on 03/07/2023 at 11:30 AM, the administrator stated that the patient visit frequency is usually determined in the start of care or recertification assessment then it is put on the POC for physician signature but it must have been missed and not caught by the quality assurance reviewer who reviews the outcome and assessment information set (OASIS) assessments. During an interview on 03/08/2023 at 10:55 AM, the administrator stated that he/she would expect the POC to include information that the patient is being treated by the wound center and their frequency of visits so that all of the agency’s clinicians are aware. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to the agency with a principal diagnosis of type 2 diabetes mellitus with hyperglycemia (elevated blood sugar) and monoplegia (paralysis that affects one side of the body or limb) following cerebral infarction (a stroke) affecting the left non-dominant side. The patient lives in his/her own home with his/her spouse and adult child and they help monitor the patient’s blood sugar and administer their insulin. Review of the POC, dated 02/07/2023 to 04/07/2023, showed the POC failed to contain any interventions to monitor for signs of hypoglycemia (abnormally low blood sugar) or hyperglycemia (abnormally high blood sugar) or any information regarding the frequency of the patient’s blood sugar checks. Findings were reviewed with the administrator on 03/08/2023 at 4:00 PM and he/she stated that the POC should have included an assessment for signs and symptoms of hypoglycemia and hyperglycemia and should have included the frequency of blood sugar checks.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on policy review, clinical record review, and interview the agency failed to promptly alert the physician or allowed practitioner to changes in the patient’s condition in one (Record/Patient #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 undated policy titled, “Physician’s Plan of Treatment,” showed the physician is immediately notified when: - An adverse drug reaction is experienced by the patient; - The patient experiences a fall, even if no injury is apparent; and - Any significant adverse change in the patient’s condition. RECORD/PATIENT #1: Review of the skilled nursing (SN) note, dated 01/26/2023, showed: - The licensed practical nurse (LPN) documented a visit summary which stated that the patient possibly has the start of new wound; - No interventions had been started yet by wound clinic according to the patient (note does not say if the wound clinic was notified by the patient of the existence of the new wound); - A 2x2 mepilex (a two inch square dressing) was applied over the lateral left foot for protection; - Under the heading titled, “Concerns,” the LPN documented “Potential for new wound to worsen. Pt. (patient) going to wound care in 1 week;” and - The LPN failed to document that the physician was notified of the presence of the new wound. During an interview on 03/08/2023 at 10:55 AM, the administrator stated that he/she would expect the LPN to notify the physician of the presence of a new wound and document it in the clinical record. He/she would also expect the LPN to do a thorough assessment of the wound, to notify the registered nurse of the presence of a new wound and document the assessment and the notification in the clinical record.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview the agency failed to coordinate care regarding patient needs in 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. Findings included: Review of the agency’s undated policy titled, “Coordination of Services,” showed in part: - The primary functions of the agency are to be responsible for the professional coordination of services under the direction of the patient's physician; - Be responsible for the professional coordination of these services under the direction of the patient's physician; - Perform all activities according to acceptable professional standards and policies; and - The staff professional nurse is responsible for the professional coordination of all home care services, ensuring that the established plan of care is carried out, the ongoing evaluation and assessment of the patient's home care needs, maintaining channels of communication between/among all active caregivers and documents same on patient record. RECORD/PATIENT #3: Review of the RN (registered nurse) skilled nursing recertification visit dated 02/02/2023 showed the patient had pain to the back and buttock at a level of four that was sharp and relieved with rest and medication. History of pain management was Tylenol and Norco (narcotic pain medication). The pain assessment failed to address the patient’s history of pain levels, how often he/she took pain medication, and the level of relief achieved after taking the pain medication. The patient had a stage 2 (partial thickness loss of skin layers that presents clinically as an abrasion, blister, or shallow crater) pressure ulcer to the right buttock that measured 1.3 x 0.5 x 0.1 cm (wounds are measured length by width by depth), wound bed red in color, with no drainage or odor. (this was the first measurement and description of the wound since before 01/20/2023). Wound care consisted of cleansing with Vashe, apply collagen to wound bed, apply skin prep and Calmo (skin protectant) to the periwound (surrounding skin) and cover with optifoam (foam dressing). Review of the POC for the certification period 02/04/2023 through 04/04/2023 showed: - Start of care 06/09/2022; - Diagnoses included stage 2 pressure ulcer of the right buttock; - Monitor the patient’s pain at each visit and report any breakthrough pain greater than eight (pain is rated on a scale of 0 to 10 with 0 meaning no pain and 10 meaning the worst pain) to the physician for intervention; and - Pain medications included acetaminophen (Tylenol) 500 mg two tablets every four hours as needed, gabapentin 100 mg three times a day for 14 days, and hydrocodone-acetaminophen (narcotic pain medication) 5-325 mg one tablet every six hours as needed for pain. Review of the LPN (licensed practical nurse) skilled nurse visit notes showed: - On 02/07/2023 the patient had sharp pain to his/her bottom all of the time at a level of five. The section for pain precipitated by, relieved by, history of pain management, effectiveness showed “none”. The narrative portion showed the patient stated pain to the bottom was 5/10 constantly hurting all the time. The nurse failed to address what the patient took for pain and how often he/she took pain medication. The patient’s wound was cleansed with wound cleanser and patted dry. Applied Calmo to the area and left open. The patient declined a bandage saying they just get wet and come off. The nurse failed to document why the bandage was getting wet. The assessment failed to include a description and/or measurements of the wound. No documentation the RN or physician was notified regarding the patient having pain all of the time, or that the patient declined having a bandage applied; and - On 02/09/2023 the pain assessment portion showed sharp, dull pain all of the time in the lower back at a level of six out of ten. Pain precipitated by, relieved by, history of pain management, current pain management and effectiveness, patients pain goal, and progress toward pain goal all showed “none”. The narrative portion showed the pain a level of six to the bottom constantly “hurting all the time” and throbbing this visit. The assessment failed to address what the patient took for pain, how often, and what level of relief was achieved after taking pain medication. The patient’s wound was cleansed with wound cleanser, patted dry, applied calmo to the area and left open. The patient declined a bandage saying they just get wet and have to come off. No documentation as to why the bandage was getting wet. The patient tolerated well. No documentation the RN or physician was notified regarding the patient having pain all of the time, or that the patient declined having a bandage applied. Review of an RN skilled nurse visit report dated 02/21/2023 showed the patient had pain to the sacrum that does not interfere with activity or movement at a level of six. The section for pain precipitated by, relieved by, description, history of pain management, current pain management and effectiveness, patient’s pain goal and progress toward pain goal showed “not assessed”. The narrative portion showed no further information regarding the patient’s history of pain levels, what he/she took for pain, how often he/she took pain medication, and the level of relief achieved after taking the pain medication. The wound assessment section showed the patient had a stage 2 pressure ulcer to the coccyx. The measurement section showed “not assessed”. The wound bed color was pink and wound bed tissue was eschar (dead tissue which is usually black in color, this would represent a decline in the condition of the wound, unclear regarding this documentation since the wound bed color was pink) with no drainage or odor. No further documentation to explain this assessment or discussion with previous nurses that saw the patient. During an interview on 03/07/2023, beginning at 3:20 PM, the administrator stated that the nurses should document a complete pain assessment each visit including a rating, location, what they have taken for pain, how often and its effect. If the patient rated pain a level of seven or higher they should report to the RN. The RN should be notified of any new issues. He/she thought at one time the physician did not want to give the patient more pain medication. The nurses should document in the integumentary (skin) section and/or narrative what wound care they provided and how they tolerated the wound care, a good description of the wound, if drainage or odor is present and measurements weekly. When asked about the documentation of eschar to the wound, he/she stated that he/she needed to do education on wound assessments. He/she was not sure if that was documented by mistake. Review of the agency’s undated policy titled, “Clinical Record Contents,” showed: - In order to assure that the highest quality of coordinated home health care is provided to all patients through direct communication of all involved disciplines, we have established effective interchange, reporting, and coordinated patient evaluation through patient case conferences; - Patient case conferences are conducted every 60 days and as needed; - An interdisciplinary case conference can be requested by any member of the staff who identifies a need for in-depth interdisciplinary intervention in order to successfully provide the care that the patient requires; and - Subjects include, but are not limited to, patient assessment of physical status or changes in condition. RECORD/PATIENT #1: Review of the skilled nursing (SN) note, dated 01/26/2023, showed: - The licensed practical nurse (LPN) documented a visit summary which stated that the patient possibly has the start of new wound; - No interventions had been started yet by wound clinic according to the patient (note does not say if the wound clinic was notified by the patient of the existence of the new wound); - A 2x2 mepilex (a two inch square dressing) was applied over the lateral left foot for protection; - Under the heading titled, “Concerns,” the LPN documented “Potential for new wound to worsen. Pt. (patient) going to wound care in 1 week;” and - The LPN failed to document that a supervising registered nurse (RN) was notified of the presence of the new wound. During an interview on 03/08/2023 at 10:55 AM, the administrator stated that he/she would expect to LPN to notify the RN of the presence of a new wound and document it in the clinical record.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on policy review, personnel record review, home visit observation, and interview the agency failed to provide care and services that met the requirements for the Condition of Participation: Infection Prevention and Control. The agency failed to: - Follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases (G682); - Maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases as a part of the agency’s quality assessment and performance improvement (QAPI) program (G684); - Provide infection control education to staff, patients, and caregivers (G686); and - Develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19 including: * A process for tracking and securely documenting the COVID-19 vaccination status of all staff; and * A process for tracking and securely documenting information provided by those staff who have requested, and for whom the agency has granted, an exemption from the staff COVID-19 vaccination requirements (G687). The cumulative effect of these systemic deficient practices has the potential to affect the health and safety of all patients served by the agency. .

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on policy review, home visit observation, and interview the agency failed to ensure staff followed acceptable standards of practice for infection control in three (Records/Patients #1, #2, and #3) of three home visit observations. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's undated policy titled, "Nursing Bag Technique," showed in part the bag will be placed on a clean, hard surface in the home and a barrier will be placed under the bag. The bag is never placed on the floor unless it is a rolling bag. Remove any items needed to provide care, including any personal protective equipment. Wash hands again if you need to access the bag to obtain supplies during patient care. When the visit is completed, reusable equipment will be cleaned using alcohol and/or soap and water as appropriate. Wash your hands, then repack and close the healthcare bag. Review of the agency's undated policy titled, "Hand Hygiene and Wound Care," showed in part that the old dressing is removed and discarded immediately. Dirty gloves are removed and discarded. Hand hygiene performed properly before accessing clean supplies. Clean gloves applied. RECORD/PATIENT #3: Observation on 03/07/2023, beginning at 1:10 PM, during the patient's home visit, showed: - The nurse placed his/her nursing bag on the floor without a barrier; - Placed his/her computer on the patient's coffee table without a barrier; - Placed a blood pressure cuff, pulse oximeter (a machine used to measure the oxygen content in the blood), and thermometer on a table without a barrier; - Removed a stethoscope from a plastic container inside the nursing bag and placed it around his/her neck; - After using the equipment on the patient, placed the equipment back in the nursing bag without cleaning the equipment or using hand sanitizer, placed the stethoscope back in the plastic container without cleaning and then placed the plastic container in the nursing bag; - Proceeded to perform wound care. Removed the old bandage, then without changing his/her gloves or using hand sanitizer cleaned the wound, then removed gloves, but failed to use hand sanitizer before he/she applied clean gloves then performed the rest of the wound care; and - After the patient signed on the computer, the nurse placed the computer back in the nursing bag without cleaning. Per interview conducted during observation, the nurse stated that he/she usually cleaned his/her equipment when he/she got to his/her car. During an interview on 03/07/2023, beginning at 3:20 PM, the administrator stated that staff should use barriers and clean their equipment before placing it back in their bags. Staff should use hand sanitizer when they changed their gloves and change gloves and use hand sanitizer after removing an old dressing. RECORD/PATIENT #1: Observation on 03/06/2023 at 2:00 PM, during the patient’s home visit, showed the licensed practical nurse (LPN): - Placed a barrier on the patient’s floor and set his/her nursing bag on it; - Reached into the nursing bag and removed a zipped case containing equipment for taking vital signs and placed it on the patient’s fabric covered chair without using a barrier; - Placed the agency’s tablet (used for documentation of nursing visits) on the patient’s fabric covered chair without using a barrier; - Obtained vital signs, placed equipment back into the zippered case, removed case from the chair and placed it back into the nursing bag; and - Used the tablet to document and then placed it onto the patient’s side table without using a barrier. During an interview on 03/06/2023 at 3:35 PM, the administrator stated that his/her expectation is for the agency’s clinicians to use a barrier under their nursing bag, tablet, and any other equipment when being taken into the home. He/she would not expect the clinician to lay their tablets and equipment on the patient’s furniture without using a barrier. RECORD/PATIENT #2: Observation on 03/06/2023 at 12:35 PM, during a home visit, showed the physical therapy assistant (PTA): - Brought his/her tablet and fiberboard clipboard into the patient’s home; - Laid his/her clipboard on the patient’s floor without using a barrier; and - Laid his/her tablet on top of the clipboard. During an interview on 03/06/2023 at 3:35 PM, the administrator stated that his/her expectation is for the agency’s clinicians to use a barrier under their nursing bag, tablet, and any other equipment when being taken into the home. He/she would not expect the clinician to lay their tablets and equipment on the patient’s furniture or floor without using a barrier.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on policy review, review of the agency’s infection control program, review of the agency’s quality assurance performance improvement (QAPI) meeting notes, and interview the agency failed to maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases as an integral part of the agency QAPI program. This deficient practice has the potential to affect the health and safety of all patients served by the agency. Findings included: Review of the agency’s undated policy titled, “Risk Management,” showed, in part: - Risk management is designed to identify areas of agency operations which pose a potential risk to the agency, its employees, and patients; - Management systems are in place to support, coordinate, and implement risk management and infection control functions; - The steps to evaluate a risk include: * Identification; * Investigation of the causal factors, review of company policies, procedures, operating practices, and professional standards of practice; * Development and implementation of corrective actions; * Evaluation and monitoring the response and effect of corrective action; and - Areas of potential risk include, but are not limited to, infection control including breaks in techniques (i.e., bag technique, hand washing). During review of the agency’s infection control program, the office manager provided a COVID-19 tracking book which included: - Hand-written logs of staff who had tested positive for COVID-19; - The date the staff tested positive; - Whether the positive staff had utilized time off under the Family and Medical Leave Act (FMLA); - If the positive staff had provided direct patient care, an entry was made that stated that all patients were contacted; and - The agency failed to document any additional follow up surveillance for the exposed patients. The administrator produced a three ring binder that was titled “Patient Incident Reports / Patient Hospitalization Logs / Patient Infection Control Logs,” that contained blank forms titled, “Patient Adverse Event / Incident / Occurrence Log.” The binder failed to contain any documentation that showed an infection control program has been implemented by the provider. Review of the agency’s QAPI meeting minutes dated 02/08/2022, 04/12/2022, and 10/11/2022 showed: - The names of the attendees at the meeting; - The start time of the meeting; - The identified topics were authorization and work flow, discharge summaries, and staff communication; - An entry in the 10/11/2022 minutes stated that “patients were discussed”; and - The meeting minutes failed to address infection prevention and control. During an interview on 03/07/2023 at 1:00 PM, the administrator stated that the follow up for patients exposed to Covid by positive staff was to call them and offer a Covid test and instruct them to report any signs and symptoms of COVID-19. The nursing supervisor (a licensed practical nurse) was supposed to do this, but he/she quit without notice approximately two weeks ago. No documentation was provided that showed the patients were contacted. He/she stated that the nursing supervisor was in charge of the infection control program but, seeing that it is empty, it did not look like he/she did anything with it.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on review of the agency’s personnel files and interview the agency failed to maintain a coordinated agency-wide infection control program that included infection control education upon hire for a contracted staff in one (Employee #4) of four personnel files reviewed. This deficient practice has the potential to affect the health and safety of all patients served by the agency. Findings included: EMPLOYEE #4: Review of Employee #4’s personnel file showed: - Employee #4 is a contracted physical therapist; - The date of hire was 08/23/2022; and - No documentation was found verifying infection control training was completed upon hire. During an interview on 03/08/2023 at 11:45 AM, the administrator stated that the nursing supervisor (a licensed practical nurse) had kept the training and personnel records to be “state ready” and was putting everything in a binder. That was his/her big project, to be state ready, and we do not have anything. The nursing supervisor quit approximately two weeks ago and they have not been able to find the records.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on policy review, review of employee COVID-19 vaccination information, and interview the agency failed to ensure one (Employee #1) of nine employees reviewed had an approved exemption from the COVID-19 vaccination. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled, "COVID-19 Vaccination Policy," revised/reviewed 02/14/2022, showed in part: - The corporation will engage in an interactive process to determine if a reasonable accommodation can be provided that does not create a undue hardship hardship on the corporation or pose a direct threat to the health or safety of others in the workplace and/or to the employee. To request an accommodation, notify the human resources department. The corporation will engage in an interactive process to identify possible accommodations; - An employee request for reasonable accommodation religious exemption from COVID-19 vaccination showed that when requested by the employee, the corporation will provide an exemption/reasonable accommodation for any employees whose religious beliefs and practices prohibit them from receiving the vaccine; and - To request an exemption/accommodation the employee will complete the form and return it to human resources. EMPLOYEE #1: Review of staff vaccination information showed no proof of vaccination or exemption for the employee. During an interview on 03/07/2023, at 9:35 AM, the administrator stated that he/she was waiting on proof of exemption for the employee. During an interview on 03/08/2023 beginning at 10:45 AM, the administrator stated that getting the exemption was an oversight and they were getting it now. The administrator provided an exemption form signed by the employee and dated 03/08/2023.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on policy review, record review, observation, and interview the agency failed to provide care and services that met the requirements for the Condition of Participation: Skilled Professional Services. The agency failed to: - Follow the agency's policies and procedures (G702); - Document complete pain and wound assessments (G706); - Follow the physician ordered plan of care (G710); - Document accurate information (G716); and - Provide agency inservice training for all employees (G722). The cumulative effect of these deficient practices has the potential to affect the services provided by skilled professional staff to all the agency's patients. .

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on policy review, record review, and interview the agency failed to ensure staff followed their policy and procedure for wound and pain assessments in 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. Findings included: Review of the agency’s undated policy titled, “Pain Assessment,” showed in part: - When the patient has complaints of pain assess the location, what increases and decreases the pain, quality of pain, symptoms caused by the pain, the pain rating, how the pain affects physical and social functioning, any history of prior pain medication and its effectiveness in controlling the pain, psychosocial implications for chronic pain, identify the treatment or medication currently used to control pain, evaluate the effectiveness of treatment or medication currently used to control pain, continue to assess pain at regular intervals after starting the treatment plan, with each new report of pain, at a suitable interval after each non pharmacologic or pharmacologic intervention (for example one hour after oral administration); and - Document the location of pain, factors that increase and decrease the pain, quality of the patient’s pain, patient’s rating of pain, any treatment used to control the pain, patient’s response to pain therapy, physician notification if applicable; and other pertinent findings. Review of the agency’s undated policy titled, “Wound Assessment and Documentation,” showed in part: - Assess the wound location and size, measure the length, width, and depth, color of the wound bed, drainage, odor, stage, surrounding skin, response to treatment, and consult with the physician and revise the plan of care (POC) as needed if the wound is not healing satisfactorily; and - Documentation guidelines included to document on the visit report the treatment and condition of the wound each visit, appearance of the wound bed, wound measurements (at least weekly), depth and location of undermining (an opening under the edge of a wound) in centimeters (cm), inflammation or redness of the skin around the wound, color, odor, and estimated amount of drainage, stage the wound weekly and compare the progress with the goals of therapy, any patient/caregiver instructions on wound care and response to teaching, physician notification if applicable, and other pertinent findings. Review of the agency’s undated policy titled, “Coordination of Services,” showed in part: - The primary functions of the agency are to be responsible for the professional coordination of these services under the direction of the patient's physician; - Be responsible for the professional coordination of these services under the direction of the patient's physician; and - Perform all activities according to acceptable professional standards and policies. RECORD/PATIENT #3: Review of the skilled nurse (SN) visits from 01/20/2023 through 02/17/2023 the SN failed to document complete wound and/or pain assessments. During an interview on 03/07/2023, beginning at 3:20 PM, the administrator stated that the nurses should document a complete pain assessment each visit including a rating, location, what they have taken for pain, how often and its effect. If the patient rated pain a level of seven or higher they should report to the RN. The nurses should document in the integumentary (skin) section a good description of the wound, if drainage or odor is present and measurements weekly. RECORD/PATIENT #1: Review of the skilled nursing (SN) recertification, dated 01/13/2023, showed the patient had a wound identified as a stage 3 (full-thickness skin loss) left calf/heel pressure ulcer. Length is recorded as a “6” (no unit of measurement was recorded) by width of “7” (no unit of measurement was recorded) and depth is “0.5” (no unit of measurement was recorded). The patient also had a skin tear to the left anterior lower leg below the knee that has a documented length of “2” (no unit of measurement was recorded) by a width of “2” (no unit of measurement was recorded). Review of SN notes with dates ranging from 01/24/2023 through 03/06/2023 showed the following: - On 01/24/2023, the SN failed to document an assessment or obtain measurements of the patient’s wounds; - On 01/26/2023, the SN failed to document an assessment or obtain measurements of the patient’s wounds and a new wound was discovered on the left lateral foot with no documentation of an assessment or measurements; - On 02/01/2023 and 02/03/2023, the SN failed to document an assessment or obtain measurements of the patient’s left calf wound. The status of the skin tear on the left lower leg and the wound on the left lateral foot (discovered on 01/26/2023) was not addressed; - On 02/09/2023, a supervisory visit was made by the registered nurse with no assessment or measurements of the patient’s wounds; - On 02/10/2023, the SN failed to obtain measurements of the patient’s left calf wound. The status of the skin tear on the left lower leg and the wound on the left lateral foot (discovered on 01/26/2023) was not addressed; - On 02/14/2023, the SN performed an assessment of the left calf wound and obtained measurements of length “1.5” (no unit of measurement was recorded) and width “1.2” (no unit of measurement was recorded). The status of the skin tear on the left lower leg and the left lateral foot was not addressed; - On 02/17/2023, the SN note failed to address the status of the skin tear on the left lower leg and the wound on the left lateral foot; - On 02/21/2023, 02/28/2023 and 03/02/2023, the SN failed to obtain measurements of the left calf wound. The status of the skin tear on the left lower leg and the left lateral foot was not addressed; and - 03/06/2023, the SN failed to perform and assessment or obtain measurements of the left calf wound. The status of the skin tear on the left lower leg and the left lateral foot was not addressed. During an interview on 03/07/2023 at 3:36 PM, the administrator stated that he/she would expect the nurses to perform a thorough wound assessment at every visit and document the assessment in the clinical record.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on policy review, record review, observation, and interview the agency failed to ensure staff documented complete pain assessments and wound assessments in 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. Findings included: Review of the agency’s undated policy titled, “Pain Assessment,” showed in part: - When the patient has complaints of pain assess the location, what increases and decreases the pain, quality of pain, symptoms caused by the pain, the pain rating, how the pain affects physical and social functioning, any history of prior pain medication and its effectiveness in controlling the pain, psychosocial implications for chronic pain, identify the treatment or medication currently used to control pain, evaluate the effectiveness of treatment or medication currently used to control pain, continue to assess pain at regular intervals after starting the treatment plan, with each new report of pain, at a suitable interval after each non pharmacologic or pharmacologic intervention (for example one hour after oral administration), - Perceptions of pain in the elderly may be diminished. Disorders such as dementia or stroke may interfere with the patient’s ability to report the chronology and character of the pain. Use questions that are very specific and related to activities, such as “what happens to the pain when you lean forward to stand up”?; and - Document the location of pain, factors that increase and decrease the pain, quality of the patient’s pain, patient’s rating of pain, any treatment used to control the pain, patient’s response to pain therapy, physician notification if applicable; and other pertinent findings. Review of the agency’s undated policy titled, “Wound Assessment and Documentation,” showed in part: - Assess the wound location and size, measure the length, width, and depth, color of the wound bed, drainage, odor, stage, surrounding skin, response to treatment, and consult with the physician and revise the plan of care (POC) as needed if the wound is not healing satisfactorily; and - Documentation guidelines included to document on the visit report the treatment and condition of the wound each visit, appearance of the wound bed, wound measurements (at least weekly), depth and location of undermining (an opening under the edge of a wound) in centimeters (cm), inflammation or redness of the skin around the wound, color, odor, and estimated amount of drainage, stage the wound weekly and compare the progress with the goals of therapy, any patient/caregiver instructions on wound care and response to teaching, physician notification if applicable, and other pertinent findings. RECORD/PATIENT #3: - Review of the POC for the certification period 12/06/2022 through 02/03/2023 showed: - Start of care 06/09/2022; - Diagnoses included unstageable (full thickness tissue loss in which the wound bed is covered by slough/eschar (dead tissue) pressure ulcer of the sacral region; - Skilled nurse to assess skin integrity of the coccyx (tailbone) each visit and perform wound care as follows. Cleanse with Vashe (a wound cleanser for cleansing, irrigating, moistening, debriding (removal of dead tissue), and removing foreign material), skin prep (helps dressings to adhere to the skin) then Calmoseptine (skin protectant) to the periwound (surrounding skin), apply Prisma (an antimicrobial collagen wound dressing) to the wound bed, and over with a sacrum (lower part of the spine) shaped bordered foam dressing two times a week; - Monitor the patient’s pain at each visit and report any breakthrough pain greater than eight (pain is rated on a scale of 0 to 10 with 0 meaning no pain and 10 meaning the worst pain) to the physician for intervention; and - Pain medications included acetaminophen (Tylenol) 500 mg two tablets every four hours as needed, gabapentin 100 mg three times a day for 14 days, and hydrocodone-acetaminophen (narcotic pain medication) 5-325 mg one tablet every six hours as needed for pain. Review of the LPN (licensed practical nurse) skilled nurse visit notes showed: - On 01/20/2023 the patient had pain to the lower back that was daily but not constant and described as an ache at a level of six. Pain relieved by pain medication and current pain management effective. The section for pain precipitated by, history of pain management, patient’s pain goal and progress toward pain goal was “none”. The narrative portion showed no further information regarding the patient’s history of pain levels, what he/she took for pain, how often he/she took pain medication, and the level of relief achieved after taking the pain medication. The section to assess skin integrity to the coccyx was marked yes but failed to include a description and/or measurements of the wound; - On 01/22/2023 the patient had pain described as sharp, dull, ache to the lower back at a level of five. The frequency of pain was blank. Relieved by pain medication, current pain management effective The section for pain precipitated by, history of pain management, patient’s pain goal and progress toward pain goal was “none”. The narrative portion showed no further information regarding the patient’s history of pain levels, what he/she took for pain, how often he/she took pain medication and the level of relief achieved after taking the pain medication. The section to assess skin integrity to the coccyx was marked yes but failed to include a description and/or measurements of the wound; - On 01/23/2023 the patient had pain to the lower back that was daily but not constant and described as sharp, dull, ache to the lower back at a level of five. Relieved by pain medication, current pain management effective. The section for pain precipitated by, history of pain management, patient’s pain goal and progress toward pain goal was “none”. The narrative portion showed no further information regarding the patient’s history of pain, how often he/she took pain medication, and the level of relief achieved after taking the pain medication. The section to assess skin integrity to the coccyx was marked yes. Wound care completed. Patient tolerated well without complaints. No signs of infection noted. The wound has greatly improved but no description or measurements of the wound. Will obtain measurements at next visit; and - On 01/26/2023 the patient had pain to the lower back that was daily but not constant and described as sharp and dull at a level of seven. The patient had not taken pain medication. The section for pain precipitated by, relieved by, history of pain management, current pain management and effectiveness, patient’s pain goal and progress toward goal was marked “none”. The narrative portion showed no further information regarding the patient’s history of pain, how often he/she took pain medication, and the level of relief achieved after taking the pain medication. The narrative portion showed the patient’s bottom was cleansed with wound cleanser, patted dry and applied Calmo to area, rubbed skin prep to area where bandaged adhesives would be for better adhesion and applied a 4 x 4 island dressing to the area. The assessment failed to include a description and/or measurements of the wound. Review of the RN (registered nurse) skilled nursing recertification visit dated 02/02/2023 showed the patient had pain to the back and buttock at a level of four that was sharp and relieved with rest and medication. History of pain management was Tylenol and Norco (narcotic pain medication). The pain assessment failed to address the patient’s history of pain levels, how often he/she took pain medication, and the level of relief achieved after taking the pain medication. The patient had a stage 2 (partial thickness loss of skin layers that presents clinically as an abrasion, blister, or shallow crater) pressure ulcer to the right buttock that measured 1.3 x 0.5 x 0.1 cm (wounds are measured length by width by depth), wound bed red in color, with no drainage or odor. (this was the first measurement and description of the wound since before 01/20/2023). Wound care consisted of cleansing with Vashe, apply collagen to wound bed, apply skin prep and Calmo to the periwound and cover with optifoam (foam dressing). Review of the POC for the certification period 02/04/2023 through 04/04/2023 showed: - Start of care 06/09/2022; - Diagnoses included stage 2 pressure ulcer of the right buttock; - Skilled nurse to assess skin integrity of the coccyx each visit and perform wound care as follows. Cleanse with Vashe, apply skin prep then Calmoseptine to the periwound, apply Prisma to the wound bed, and cover with a sacrum (lower part of the spine) shaped bordered foam dressing two times a week; - Monitor the patient’s pain at each visit and report any breakthrough pain greater than eight (pain is rated on a scale of 0 to 10 with 0 meaning no pain and 10 meaning the worst pain) to the physician for intervention; and - Pain medications included acetaminophen (Tylenol) 500 mg two tablets every four hours as needed, gabapentin 100 mg three times a day for 14 days, and hydrocodone-acetaminophen (narcotic pain medication) 5-325 mg one tablet every six hours as needed for pain. Review of the LPN skilled nurse visit notes showed: - On 02/07/2023 the patient had sharp pain to his/her bottom all of the time at a level of five. The section for pain precipitated by, relieved by, history of pain management, effectiveness showed “none”. The narrative portion showed the patient stated pain to the bottom was 5/10 constantly hurting all the time. The assessment failed to address what the patient took for pain and how often he/she took pain medication. The patient’s wound was cleansed with wound cleanser and patted dry. Applied Calmo to the area and left open. The patient declined a bandage saying they just get wet and come off. The nurse failed to document why the bandage was getting wet. The assessment failed to include a description and/or measurements of the wound; - On 02/09/2023 the pain assessment portion showed sharp, dull pain all of the time in the lower back at a level of six out of ten. Pain precipitated by, relieved by, history of pain management, current pain management and effectiveness, patients pain goal, and progress toward pain goal all showed “none”. The narrative portion showed the pain a level of six to the bottom constantly “hurting all the time” and throbbing this visit. The assessment failed to address what the patient took for pain, how often, and what level of relief was achieved after taking pain medication. The patient’s wound was cleansed with wound cleanser, patted dry, applied calmo to the area and left open. The patient declined a bandage saying they just get wet and have to come off. No documentation as to why the bandage was getting wet. The patient tolerated well; - On 02/14/2023 the patient had sharp, dull pain to the lower back daily but not constantly at a level of four. Pain precipitated by, relieved by, history of pain management, current pain management and effectiveness, patient’s pain goal and progress toward pain goal showed “none”. The narrative portion showed no further information regarding the patient’s history of pain levels, what he/she took for pain, how often he/she took pain medication, and the level of relief achieved after taking the pain medication. The section to assess skin integrity to the coccyx was marked yes. Wound care completed. Patient tolerated well without complaints. No signs of infection noted. The assessment failed to include a description/measurements of the wound; and - On 02/17/2023 the patient had sharp pain to the lower back daily but not constantly at a level of four. Pain precipitated by, relieved by, history of pain management, current pain management and effectiveness, and patient’s pain goal showed “none”. The narrative portion showed no further information regarding the patient’s history of pain levels, what he/she took for pain, how often he/she took pain medication, and the level of relief achieved after taking the pain medication. Wound care completed. Patient tolerated without complaints. No signs of infection noted. The assessment failed to include a description/measurements of the wound. Review of an RN skilled nurse visit report dated 02/21/2023 showed the patient had pain to the sacrum that does not interfere with activity or movement at a level of six. The section for pain precipitated by, relieved by, description, history of pain management, current pain management and effectiveness, patient’s pain goal and progress toward pain goal showed “not assessed”. The narrative portion showed no further information regarding the patient’s history of pain levels, what he/she took for pain, how often he/she took pain medication, and the level of relief achieved after taking the pain medication. The wound assessment section showed the patient had a stage 2 pressure ulcer to the coccyx. The measurement section showed “not assessed”. The wound bed color was pink and wound bed tissue was eschar (dead tissue which is usually black in color, this would represent a decline in the condition of the wound, unclear regarding this documentation since the wound bed color was pink) with no drainage or odor. No further documentation to explain this assessment or conference with previous nurses that saw the patient. Observation and interview on 03/07/2023 beginning at 1:10 PM, during the patient's home visit, showed the LPN asked the patient about pain. The patient stated that he/she always had back pain. The LPN asked if it was tolerable and about a three or four. The patient shook his/her head yes. After the LPN finished his/her visit the surveyor asked the patient what he/she took for pain and how often he/she took pain medication. The patient stated that he/she took Tylenol about two to three times a day and hydrocodone a couple of times a day and at night. When asked about his/her pain levels, the patient stated that the pain medication just did not help. The LPN provided wound care for the patient. The LPN stated that the area was about the same and always looked like a callused area. The wound to the coccyx area showed a raised whitish looking callused area with no drainage or odor. During an interview on 03/07/2023, beginning at 3:20 PM, the administrator stated that the nurses should document a complete pain assessment each visit including a rating, location, what they have taken for pain, how often and its effect. If the patient rated pain a level of seven or higher they should report to the RN. The RN should be notified of any new issues. The nurses should document in the integumentary (skin) section and/or narrative what wound care they provided and how they tolerated the wound care, a good description of the wound, if drainage or odor is present and measurements weekly. When asked about the documentation of eschar to the wound, he/she stated that he/she needed to do education on wound assessments. He/she was not sure if that was documented by mistake. When he/she had seen the patient, the wound had flaky white skin to the area. RECORD/PATIENT #1: Review of the skilled nursing (SN) recertification, dated 01/13/2023, showed the patient had a wound identified as a stage 3 (full-thickness skin loss) left calf/heel pressure ulcer. Length is recorded as a “6” (no unit of measurement was recorded) by width of “7” (no unit of measurement was recorded) and depth is “0.5” (no unit of measurement was recorded). The patient also had a skin tear to the left anterior lower leg below the knee that has a documented length of “2” (no unit of measurement was recorded) by a width of “2” (no unit of measurement was recorded). Review of SN notes with dates ranging from 01/24/2023 through 03/06/2023 showed the following: - On 01/24/2023, the SN failed to assess the patient’s wounds; - On 01/26/2023, the SN failed to assess the patient’s wounds and a new wound was discovered on the left lateral foot. The nurse failed to assess the new wound; - On 02/01/2023 and 02/03/2023, the SN failed to assess the patient’s left calf wound. The status of the skin tear on the left lower leg and the wound on the left lateral foot (discovered on 01/26/2023) was not addressed; - 03/06/2023, the SN failed to assess the left calf wound. The status of the skin tear on the left lower leg and the left lateral foot was not addressed.

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, observation, and interview the agency failed to follow the physician ordered plan of care (POC) in 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 POC for the certification period 02/04/2023 through 04/04/2023 showed in part an order for the skilled nurse (SN) to cleanse the wound with Vashe (a wound cleanser for cleansing, irrigating, moistening, debriding (removal of dead tissue), and removing foreign material). Observation and interview on 03/07/2023, beginning at 1:10 PM, during the patient’s home visit, the SN cleansed the wound with skin integrity wound cleanser. When questioned if they used Vashe to cleanse the wound, the SN stated that they used to, but he/she thought the patient ran out and this was the cleanser the patient had to use. During an interview on 03/07/2023 beginning at 3:20 PM, the administrator stated that he/she would expect staff to follow the wound care orders. If the wound care changed, he/she would expect them to get a new physician order. RECORD/PATIENT #1: Review of the physician orders for wound care, dated 02/23/2023, showed: - Clean with Vashe wound cleanser (for cleansing, irrigating, moistening, debridement (removal of dead tissue) of wounds, contains hypochlorous acid); and - Apply pink foam dressing daily. Observation on 03/06/2023 at 2:35 PM, during a home visit, showed the patient had a large box of various dressing supplies on the kitchen table. The licensed practical nurse (LPN) explained the following steps as he/she performed wound care: - Cleansed the wound with CarraKlenz (a wound cleanser that does not contain hypochlorous acid); - Applied pink foam dressing; and - Applied Mepilex foam dressing over pink foam. During an interview on 03/08/2023 at 10:55 AM, the administrator stated that he/she would expect the nurses to follow the current physician’s orders and use the Vashe wound cleanser.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview the agency failed to ensure staff documented accurate information in 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 skilled nurse (SN) visit notes on 01/20/2023, 01/22/2023, 01/23/2023, 02/14/2023, and 02/17/2023 the SN documented the same verbiage on the narrative portion of the notes. During an interview on 03/07/2023 beginning at 3:20 PM, the administrator stated that he/she did not know about the same verbiage on the assessments but would look at it. No further information was provided. RECORD/PATIENT #1: Review of the physician orders for wound care, dated 02/23/2023, showed: - Clean with Vashe wound cleanser (for cleansing, irrigating, moistening, debridement (removal of dead tissue) of wounds, contains hypochlorous acid); and - Apply pink foam dressing daily. Review of the skilled nursing (SN) notes, dated 02/28/2023, 03/02/2023, and 03/06/2023, showed under the heading “Wound Interventions,” the nurse documented completion of the following wound care, “Left heel – Clean with Vashe wound cleanser. Apply barrier cream to periwound (the skin surrounding the wound), Santyl (an ointment that removes dead tissue from the wound bed) nickel thick to wound bed, cover w/pink foam dressing daily.” The clinical notes failed to include the current order for wound care. During an interview on 03/08/2023 at 10:55 AM, the administrator stated that the incorrect wound care was probably the order that was current when the recertification assessment was completed. As the wound center physician’s changed the orders, they were not updated in the computer so the outdated orders continued to carry over into the nurse’s notes. He/she would expect the documentation and the nurse’s notes to be accurate and reflect the current orders from the physician for wound care.

Participate in HHA-sponsored in-service CFR(s): 484.75(b)(9) Participation in HHA-sponsored in-service training. This ELEMENT is not met as evidenced by: Based on review of the agency’s personnel files and interview the agency failed to ensure staff were provided with annual agency in-service training in one (Employee #1) of four personnel files reviewed. This deficient practice has the potential to affect all patients served by the agency Findings included: EMPLOYEE #1: Review of Employee #1’s personnel file showed: - Employee #1 is a registered nurse; - A hire date of 10/10/2022; and - The personnel file failed to show annual agency in-service training. During an interview on 03/08/2023 at 11:45 AM, the administrator stated that the nursing supervisor (a licensed practical nurse) had kept the training and personnel records to be “state ready” and was putting everything in a binder. That was his/her big project, to be state ready, and we do not have anything. The nursing supervisor quit approximately two weeks ago and they have not been able to find the records.

Org. had partial/extended survey CFR(s): 484.80(f)(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 This ELEMENT is not met as evidenced by: Based on the results of this extended level survey, resulting in noncompliance with four Conditions of Participation: Care planning, coordination of services, and quality care; Skilled professional services; Infection control and prevention, and Organization and administration of services, the agency may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. The restriction ends 03/08/2025.

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 policy review, review of governing body meeting minutes, and interview the agency failed to organize, manage, and administer its resources in a manner that met the requirements for the Condition of Participation: Organization and Administration of Services. The agency failed to ensure: - The governing body assumed full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services and its quality assessment and performance improvement program (G942); - The administrator is responsible for all day-to-day operations of the home health agency (G948); and - All home health agency services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice (G984). The cumulative effect of these systemic deficient practices has the potential to result in the inability of the agency to provide effective ongoing management of all clinical services and to ensure the patient’s care needs would be met. .

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on policy review, review of the agency’s governing body minutes, and interview the agency failed to ensure the governing body assumed full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, its operational plans, and its quality assessment and performance improvement (QAPI) program. This deficient practice has the potential to affect the care and safety of all patient’s served by the agency. Findings included: Review of the agency’s undated policy titled, “Annual Program Evaluation,” showed the agency, through the governing body, and agency staff, shall annually evaluate the extent to which the agency’s program is appropriate, adequate, effective and efficient. The scope of the review shall encompass the following patient care information including: - Policies and procedures; - Organizational structure and system; - Measurable patient outcomes; - Programs, including utilization and quality of services and products, appropriateness and adequacy; - Human resources; - Safety practices; - Risk management; - Performance improvement findings; - Clinical record review and quality improvement findings; - Review of personnel records; - Review of conformance with personnel policies; - Personnel qualifications; and -Participation in both in-service and continuing education programs. The review committee will prepare recommendations and submit them to the governing body. The governing body will take action on all recommendations. The administrator will be responsible for implementing recommendations of the governing body and shall periodically report to the governing body regarding this process. Review of the agency’s undated policy titled, “Quality Assurance and Performance Improvement Policy,” showed the governing body and the facility leadership are responsible for the development and leadership of the facility QAPI program. The governing body will take a proactive role in working with facility leadership to gather input from facility staff, residents, and families; the governing body is responsible for oversight and direction of the QAPI program. The governing body will be responsible for establishing and approving policies to sustain the facility’s QAPI program and will set expectation around resident safety, rights, and choice and respect. The leadership of the building will ensure appropriate and adequate resources are available for facility staff to carry out the QAPI plan. Upon surveyor entrance to the agency on 03/06/2023 at 09:50 AM, a list of needed items for surveyor review was provided to the administrator. The list of items needed for the survey included the governing body minutes for the current and the past year including information pertinent to the agency and its QAPI program. On 03/08/2023 the administrator provided two documents. The documents were titled, “Weekly Sr. (Senior) Mgt (Management) Meeting,” and were dated 10/17/2022 at 9:30 AM and 10/31/2022 at 9:30 AM and showed, in part: - The administrator was a participant in the meetings; - Topics presented by the administrator at the 10/17/2023 meeting included; * Patient census; * Recruitment of staff; * A marketing plan; - Topics presented by the administrator at the 10/31/2023 meeting included; * The number of weekly and pending admissions; * Current patient census; * An employee get together was being planned; - The meeting minutes failed to include; * Notes regarding the provision of home health services; * Operational plans for the agency; and * The agency’s QAPI program. During an interview on 03/08/2023 at 10:50 AM, the administrator stated that these were the governing body minutes as requested on the first day of the survey.

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, policy review, observation and interview it cannot be assured the administrator has effectively assumed responsibility for the overall administration, supervisory functions, and day-to day operations of the home health agency. This deficient practice has the potential to affect the provision of care to all patients served by the agency. Findings included: Review of the agency’s undated policy titled, “Annual Program Evaluation,” showed the administrator shall be responsible for implementing the patient care, administrative, and financial recommendations of the governing body and shall periodically report to the governing body regarding the implementation process. Observation throughout the survey showed: - The administrator was not aware of the location of results of the Family Care Safety Registry (FCSR) checks, Employee Disqualification List (EDL) checks, infection control training, annual agency in-service training, Alzheimer’s training, and emergency preparedness training missing from the agency’s personnel files; - The administrator was not aware the agency did not have a system for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases (the administrator became aware when he/she opened the infection control binder and it was empty); - The administrator was not aware a patient admitted to the agency (Patient #4) had not been seen by the agency since he/she was admitted, a month prior, with no notification to the patient’s physician; - The administrator did not know whether the agency had policies and procedures in place or agency protocols about missed visits and when to notify the physician; and - Five condition-level deficiencies were identified for the recertification survey with the exit date of 03/08/2023. This indicates the administrator was ineffective in managing the day to day operations of the home health provider. During an interview on 03/07/2023 at 11:30 AM, the administrator stated that he/she has been doing both the administrator and clinical manager jobs and it has been difficult to manage with 141 patients. During an interview on 03/08/2023 at 11:20 AM, the administrator stated that he/she has not had a registered nurse clinical manager for about a year and a half. A decision was made by her supervisor for him/her to be the administrator and the clinical manager. He/she is currently acting as the agency director, the administrator, and the clinical manager and has told his/her supervisors that he/she needs help. A nurse consultant was brought in and told him/her they would get him/her some help.

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 the agency’s personnel files and interview the agency failed to provide services in accordance with current clinical practice guidelines and accepted professional standards of practice when it failed to verify results of the Family Care Safety Registry (FCSR) for two (Employees #1 and #2) of four employee files reviewed, the Employee Disqualification List (EDL) for three (Employees #1, #2, and #3) of four employee files reviewed, and provide Alzheimer’s training for two (Employees #1 and #4) of four employee files reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: EMPLOYEE #1: Review of Employee #1’s personnel file showed: - The employee is a registered nurse; - The hire date was 10/10/2022; - The file failed to contain results of the FCSR check; - The file failed to contain results of the EDL check; and - The file failed to contain evidence that Alzheimer’s training was provided upon orientation. EMPLOYEE #2: Review of Employee #2’s personnel file showed: - The employee is a licensed practical nurse (LPN); - The hire date was 10/04/2021; - The file failed to contain results of the FCSR check; and - The file failed to contain results of the EDL check. EMPLOYEE #3: Review of Employee #3’s personnel file showed: - The employee is a contracted physical therapist; - The hire date was 09/26/2022; and - The file failed to contain results of the EDL check. EMPLOYEE #4: Review of Employee #4’s personnel file showed: - The employee is a contracted physical therapist; - The hire date was 08/23/2022; and - The file failed to contain evidence that Alzheimer’s training was provided upon orientation. During an interview on 03/08/2023 at 11:45 AM, the administrator stated that the education, FCSR, and EDL checks had been completed but he/she gave the printed verification to his/her nursing supervisor (a licensed practical nurse) because they wanted to get everything together in a binder so they would be state ready. The nursing supervisor quit without notice approximately two weeks ago and now they cannot find them, and do not have anything to prove that anything was done. He/she called the contact person for their onboarding software and was told there was no way to show proof after the process is complete.