Spirit Home Health Care

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on observation, interview and record review, the visiting nurse failed to administer prescribed wound treatment as ordered for a Stage 3 pressure ulcer on the right lower extremity for one out of seven patients (Patient 10). This deficient practice placed the patient’s wound at risk for slow healing. During a review of Patient 10’s Patient Information sheet, the Patient Information sheet indicated a start of care date of 2/16/2024. During a review of Patient 10’s Home Health Certification (HHC) and Plan of Care (POC) form for certification period 4/16/2024 to 6/14/2024,the HHC and POC indicated a diagnosis of laceration without foreign body. The HHC and POC indicated an order for the skilled nurse (SN) to visit the patient twice a week for nine weeks, for comprehensive skilled nursing assessment (the required in-person clinical assessment of the patient’s physical, functional, mental, psychosocial, and cognitive status to identify the needs of the patient and caregiver that will be addressed by the home health agency’s services), observation and evaluation of all body systems, assessment of vital signs (measures the basic function of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level and ability to perform activities of daily living (ADL) tasks, and to evaluate therapeutic response to current/new medications and compliance to medication/diet regimen. One of the SN interventions was to assess, instruct patient/caregiver and perform wound care treatment to Stage 3 pressure ulcer at right lower extremity as follows: to cleanse with Normal Saline, pat dry, apply Xeroform dressing to wound bed and cover with dry dressing daily. During a review of Patient 10’s Wound Specialist Progress Note dated 4/16/2024, indicated Patient 10 had a Stage 3 pressure ulcer on the right posterior lower leg measuring 3.5 centimeter (cm) in length by 2.5 cm in width by o.2 cm in depth, with moderate amount of sero-sanguineous drainage and 25 percent slough. During a review of Patient 10’s Communication Note dated 4/26/2024, indicated there was a missed visit on this day, however, there was no documented evidence of a valid reason to justify why the visiting nurse failed to visit the patient. During a review of Patient 10’s SN Visit Notes indicated no documented evidence of a visit note done on 4/26/2024. During an interview with the Director of Patient Care Services) on 9/6/2024, at 12 p.m., she stated there was no visit done on 4/26/2024, and prescribed wound treatment was not provided for Patient 10 for that day. The DPCS further stated the visiting nurse did not coordinate with the agency and notify the physician regarding the missed visits. A review of the agency’s undated policy and procedure “Missed Visits”, indicated the SN should report the miss visit to their immediate supervisor.”

“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 interview and record review, the home health agency (HHA) failed to ensure the Condition of Participation (refer to the requirements that healthcare organizations must meet to participate in federal healthcare programs) regarding Patients’ Rights was met as follows: 1.The HHA failed to provide information regarding discharge planning for one of seven sampled patients (Patient 6). This deficient practice had the potential for Patient 6’s care needs not to be provided and could affect the quality of care and wellbeing of Patient 6 after discharge to the community. (Refer to G 452) 2. The HHA failed to document and thoroughly investigate an alleged complaint (reporting a problem, expressing dissatisfaction) by a caregiver to the Registered Nurse 1 (RN 1) in their grievance (complaint) log and its resolution (decision) for one of seven sampled patients (Patient 7). (Refer to G 484) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily (written rules or law) mandated compliance with Federal Regulations for Patient Rights and had the potential that grievances presented to the HHA would not be addressed and resolved.”

“Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This Condition is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to meet the Condition of Participation (conditions that healthcare organizations must meet in order to begin and continue participating in the Medicare [is federal health insurance for people 65 or older, and some people under 65 with certain disabilities or conditions] and Medicaid [a joint federal and state program that helps cover medical costs for some people with limited income and resources] programs) for Comprehensive Assessment of Patients as follows: 1. The HHA failed to ensure to conduct a comprehensive assessment (an examination of social and behavioral influences, health risks and information needs of patients and/or families/caregivers) that reflected the patient’s current health status for one of seven sampled patients (Patient 4). For Patient 4, the skilled nurse (SN) did not identify and assess Patient 4’s had a Foley catheter (a flexible plastic tube that is put through the urinary opening (urethra) and into your bladder to drain urine into a drainage bag) with a plug. This deficient practice placed Patient 4 at risk for urine retention and infection. (Refer to G526). 2. The HHA failed to review and update the “Medication Profile” (the information about the medicines a person is using and has used) with all the medications that patients were currently taking for two of seven sampled patient (Patients 4 and Patient 5). This deficient practice had the potential for medication error and side effect if the medication were not taken as prescribed. (Refer to G 536). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily (written rules or laws) mandated compliance with the Federal (government) regulations for Comprehensive Assessment of patient, to ensure the provision of quality health care to patients in a safe environment.”

“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 observation, interview and record review, the home health agency failed to meet the Condition of Participation for Care planning, coordination of services and quality of care as evidenced by: 1. Failure to implement interventions indicated in the plan of care (POC) for 2 out of 7 sampled patients (Patients 4 and 5). This deficient practice had the potential to provide poor quality care and services that will affect the care necessary to maintain the highest practicable physical and mental well-being of th patients. (Refer to G572) 2. Failure to ensure accurate primary care physicians’ name were available in the clinical record for 2 out of 7 sampled patients (Patient 4 and 5). This failure had the potential a primary care physician would not be accessible when a patient has medical need or emergencies which can affect the quality of care and services provided to the patients. (Refer to G602) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated (in a way that is decided and controlled by law) compliance with the Federal (government) Regulations for Care planning, coordination of services and quality of care, to ensure the provision of quality health care services in a safe manner. .”

“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 observation, interview and record review, the home health agency (HHA) failed to meet the Condition of Participation for Organization and Administration of services as follows. The HHA failed to ensure a Director of Nursing was employed as part of the governing body (a group of people who formulate the policy and direct the affairs of the home health agency) to assume responsibility and oversee its clinical day to day operations. This deficient practice had the potential to result in the substandard quality of care that could affect the health and safety of the patients. (Refer to G942) The HHA failed to employ a Director of Nursing (DON) or a DON Designee (a registered nurse appointed to perform certain duties on behalf of the DON) to provide oversight of all patient care services and personnel in the day-to-day operations of the home health agency. This deficient practice can result to poor nursing supervision and poor-quality patient care delivered to the home health patients. (Refer to G958) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated (in a way that is decided and controlled by law) compliance with the Federal (government) Regulations for Organization and Administration of services to ensure the provision of quality health care services in a safe manner. .”

“Transfer and discharge CFR(s): 484.50(d) Standard: Transfer and discharge. The patient and representative (if any), have a right to be informed of the HHA’s policies for transfer and discharge. The HHA may only transfer or discharge the patient from the HHA if: This Standard is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to provide information on discharge planning for one of seven sampled patients (Patient 6). This deficient practice had the potential for Patient 6’s care needs not to be provided and could affect the quality of care and wellbeing of Patient 6 after discharge. Findings: During a review of Patient 6’s Patient Information Sheet, the Patient Information Sheet indicated Patient 6 had a start of care (SOC) date of 9/6/2023 with diagnoses including sepsis (infection in the blood), acute kidney failure (a condition in which the kidneys suddenly cannot filter waste from the blood) and multiple open wounds. During a review of Patient 6’s Home health certification and Plan of Care for the certification period of 9/6/2023 to 11/4/2023, the Home health certification and Plan of Care indicated Patient 6 was admitted to the Home Health Agency for skilled nursing management of multiple unstageable deep tissue injuries (obscured full-thickness skin and skin loss). The Home health certification and Plan of Care indicated Patient 6 was bedbound with dementia (loss of memory and other mental abilities severe enough to interfere with daily life) and had a complex (complicated) urology (urinary system) history. During a review of Patient 6’s Outcome and Assessment Information Set (OASIS) for the SOC date of 9/6/2023, the OASIS indicated Patient 6 had the following unstageable deep tissue injuries: right upper leg/hip, the left and right ankles, the right heel, the coccyx (tail bone), and the left buttock. During a review of Patient 6’s Physician’s Orders sent to the HHA on 9/11/2023, the Physician’s Orders indicated to admit Patient 6 to the HHA for a consult STAT (it means that order should be prioritized first as it’s needed urgently). The Physician’s Orders indicated Patient 6’s primary physician did not do house calls. The Physician’s Orders did not indicate the HHA clarified the orders. Attached to the Physician Orders, there was a History and Physical (H&P) of Patient 6 that indicated a diagnosis of Cellulitis (is a common, potentially serious bacterial skin infection) of the left upper limb and supplies sent to the pharmacy. During a concurrent interview and record review, on 3/8/2024, at 3:30 p.m., with the Administrator (ADM) and the Licensed Vocational Nurse Care Coordinator (LVNCC), Patient 6’s document titled “OASIS -E Discharge,” was reviewed. The OASIS -E Discharge form indicated the HHA discharged Patient 6 from the care of the HHA on 9/19/2023. LVNCC stated there was no indication or documented evidence to which palliative care or hospice agency (agency providing care to terminally ill patients who have six months or less to live) Patient 6 was discharged to. LVNCC stated there was no endorsement or transfer documentation the HHA provided upon discharge. During a concurrent interview and record review, on 3/8/2024, at 3:30 p.m., with the LVNCC Patient 6’s Skilled Nurse Visit wound care notes dated 9/8/2023 and 9/16/2023, were reviewed. The LVNCC stated there was no documented evidence the visiting nurses performed wound care at the time of their home visits. During an interview on 3/8/2024, at 3:30 p.m., with the ADM, the ADM could not answer the nursing questions the surveyor asked. The ADM stated Patient 6’s discharge assessment was done administratively. During a telephone interview on 3/8/2024, at 10:52 a.m., with Patient 6’s primary Patient Care Coordinator (PCC) from Patient 6’s primary physician, the PCC stated she faxed the HHA (unidentified date). The PCC stated the HHA did not communicate with the clinic to verify Patient 6’s physician orders. The PCC stated based on her records, Patient 6’s Primary physician wanted either a home health or a hospice agency to care for Patient 6 at home immediately because he did not do house calls. PCC stated the FAM1 called their office to inform them Patient 6 passed on 10/10/2023 but had no knowledge or notification if the patient was in the care of a home health or a hospice agency. On 3/8/2024, at 11 a.m., a phone call attempt to interview Patient 6’s FAM1 was unsuccessful. No call back received. During an interview on 3/8/2024, at 3:40 p.m., with the HHA’s Chief executive Officer (CEO), the CEO stated the HHA did not have a Director of Nursing (DON) and or DON Designee (DOND) to monitor the care and oversee the day-to-day clinical operations of their patients. A review of the HHA’s document titled “ Discharge Criteria and Process” revised 11/2021 indicated when the patient’s plan of care changes and this change results in discharge from or reduction of services, the patient or his/her representative, as well as his/her primary physician ( or other authorized licensed independent practitioner), will be notified and involved in planning decisions. Discharge/Reduction of Services Criteria: Services will be terminated when the patient meets one (1) or more of the following discharge criteria: 1. There is a change in the patient’s medical or treatment program. 2. A change in the patient’s condition requires care or services other than that provided by the organization. If the patient’s acuity requires another level of care that the organization cannot provide, the organization shall arrange for a safe and appropriate transfer to another organization that can provide the needed level of care. 3. If appropriate, the physician (or other authorized licensed independent practitioner) and the organization agree that the goals of home health have been attained or are no longer attainable. 4. The patient or family/caregiver refuses, discontinues or elects transfer to another organization for care. 5. The patient or family/caregiver refuses to cooperate in attaining the objectives of home health. 6. Conditions in the home are no longer safe for the patient or organization personnel. 7. The patient and/or family display disruptive, abusive, and uncooperative behavior For a patient requiring continuing care, assistance will be given to the patient and family/caregiver in order to manage continuing care needs after the organization’s services are discontinued. Discharge instructions will be provided. Discharge planning will identify ongoing needs the patient may have. Arrangement for such services will be coordinated by the organization, when applicable. A review of the HHA’s document tiled “ Discharge Summary” revised 11/2021 indicated that a copy of the discharge summary will be provided to the patient’s primary care practitioner (or other authorized licensed independent practitioner) or other health care professional who will be responsible for providing care and services to the patient after discharge from the organization within five (5) business days of the patient’s discharge. The decision to terminate or reduce services must be documented in the clinical record, citing the circumstances and notification to the patient, the responsible family/caregiver or representative, and the patient’s physician. Efforts to resolve problems prior to discharge will also be documented in the patient’s record. The patient shall be provided contact information for other home health agencies and providers if continued care is needed. The Clinical Supervisor or designee is accountable for the decision and the required documentation.”

“Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: This Standard is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to ensure to conduct a comprehensive assessment (an examination of social and behavioral influences, health risks and information needs of patients and/or families/caregivers) that reflected the patient’s current health status for one of seven sampled patients (Patient 4). For Patient 4, the skilled nurse (SN) did not identify and assess Patient 4’s had a Foley catheter (a flexible plastic tube that is put through the urinary opening (urethra) and into your bladder to drain urine into a drainage bag) with a plug. This deficient practice placed Patient 4 at risk for urine retention and infection 1. A review of Patient 4’s Outcome and Assessment Information Set (OASIS, the patient-specific, standardized assessment used in home health care to plan care, determine reimbursement, and measure quality) dated 2/9/2024 for the certification period of 2/9/2024 to 4/8/2024 indicated that the Patient was admitted to the home health agency with the medical diagnosis of unspecified osteoarthritis (a degenerative joint disease, in which the tissues in the joint break down over time), and essential hypertension (high blood pressure). Patient 4’s OASIS indicated that the Registered Nurse (RN) who performed the admission assessment indicated on Section H- Bowel and Bladder M1610: there were three choices: 00: No incontinence, 01: Patient is incontinent, 02: Patient requires a urinary catheter (specifically: external, indwelling, intermittent, suprapubic). The OASIS indicated 01: Patient is incontinent. During an interview on 3/6/2024 at 1:00 p.m., with the Administrator (ADM) and the Chief Executive Officer (CEO), the ADM and CEO stated that they do not have a Director of Nursing (DON) and a DON Designee for the past two months to verify the documentation from OASIS. The ADM and CEO stated registered nurses who conducted the admissions and home visits worked as per diem. During a joint home visit, observation, and interview on 3/7/2024 at 10:30 a.m., with the Physical Therapist (PT) at Patient 4’s residence, PT stated that he would conduct discharge assessment because Patient 4 would be transferred to a memory care facility to continue Patient 4’s therapy. PT stated that it was the first time to conduct an assessment for Patient 4. Patient 4’s caregiver answered the door and the PT initiated the home visit without checking the patient’s vitals prior his therapy. PT was observed walked Patient 4 around the house and do range of motion exercises for 20 minutes. Patient was alert and oriented to name, person and place, able to follow instructions very well and denied pain. Patient observed used a walker to walk. During a concurrent interview and record review on 3/7/2024 at 11:00 a.m., with Patient 4’s caregiver, Patient’s Caregiver stated that Patient 4 was diagnosed 6 years ago with prostatic hyperplasia (condition in which the prostate gland [below the bladder in men and surrounds the top portion of the tube that drains urine from the bladder] becomes very enlarged and may cause problems associated with urination) and was doing self catheterization (a way to completely empty your bladder where you put a thin tube called a catheter into your bladder), for 6 years until he was diagnosed with Alzheimer’s (affects memory, thinking and behavior) that Patient 4 was unable to do self catheterization and was changed to a Foley catheter by the urologist (a doctor who specializes in diagnosing and treating diseases of the urinary system) with a plug ( used for occluding the drainage lumen on Foley catheters and prevents urine from coming out of the catheter tubing any time). Patient 4’s Caregiver stated that the Foley catheter was changed every three months at the clinic. Caregiver stated that he was seeing his PCP for the past 27 plus years and had not changed since. When asked if the home health agency knew about Patient 4’s Foley catheter, Caregiver stated “He has been on multiple home health care that does not know that he uses a catheter so I am sure this agency does not know it”. When asked how the patient urinates with this type of Foley with a plug, caregiver stated, “When he has the urge to urinate, I help him go to the bathroom, remove the plug and he is able to void in the toilet.” When asked if the patient is visited by a skilled nurse, the caregiver stated, “ No.” A phone call attempt was conducted on 3/7/2024 at 2:59 p.m. to the primary care physician listed on Patient 4’s face sheet. A patient care coordinator (PCC) answered the phone call and was able to answer inquiries for this patient. PCC stated that their clinic only saw the patient once and is not the attending physician for Patient 4 and provided the number for his primary care physician. A consecutive phone call attempt was conducted with the patients primary care physician but there was no answer and call back. A phone call attempted on 3/7/2024 at 3:54 p.m., for the admitting nurse, no answer and left her a message on voicemail and thru text message. No reply received. Requested the ADM on 3/8/2024 at 11:00 a.m., to have the admitting nurse call the agency, ADM stated hat she left a message and texted her but with no reply. During a telephone interview on 3/8/2024 at 2:08 p.m., with the Patient Care Coordinator (PCC) of the urology clinic, the PCC stated that the urology clinic did not know that Patient 4 was admitted to home health service. PCC stated that Patient 4 would go to the urology clinic every three months for Foley catheter change and the last changed was on 3/2/2024. PCC stated if the urology clinic knew Patient 4 was on home health service, the home health could change the Foley catheter every three months. During an interview with the ADM on 3/8/2024 at 12:34 p.m., ADM stated that the DON resigned from her position and started worked in the field. ADM stated that the agency were in the process of hiring a new DON and in the meantime hired a new care coordinator (CC) to monitor patients charts and coordinate with the doctors and field staff. During a joint interview with the CC and ADM on 3/8/2024 at 3:30 p.m., ADM stated that the CC and Licensed Vocational Nurse (LVN) reviewed the patients charts and made sure to be compliant and communicates with the doctors and completed and consistent, takes all the reports from all the field nurses and communicates with the doctors. CC stated that he mostly in the office received field staff reports, performed case management, coordinates with ancillary services , carrying out orders, assisted with intake and referrals, reviewed and assessed patient charts and makes sure that medication were reconciled in the electronic medical record (EMR). A review of the HHA’s document titled “ Responsibilities /Supervision of Clinical Services” revised 11/2021 indicated to ensure a process is in place for the selection of a qualified individual for overseeing all clinical care and services. Supervision of clinical care and services will be available 24 hours a day, seven (7) days a week. Supervisor-to-patient-care personnel ratios will depend on the acuity level of the patients and case-mix, and will be in compliance with applicable law or regulation. The Clinical Director will be responsible for the clinical direction and will oversee the day to day clinical operation of the organization and will take reasonable steps to ensure that: 1. Services are continuously available 2. Care and services provided by organization personnel and contracted organization personnel are coordinated and integrated 3. Policies and procedures, which guide and support the provision of care and services, are developed and implemented 4. Recommendations for required resources are made in a timely and effective manner The Clinical Director will be qualified and possess appropriate clinical training and experience, as verified by: 1. Education, training, and previous work experience 2. Current professional licensure 3. Interview assessing understanding of care and service being provided as well as population being served 4. Management experience and clinical knowledge”

“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 observation, interview, and record review, the home health agency (HHA) failed to ensure individualized plan of care (POC) were formulated and implemented for 2 out of 7 sampled patients (Patients 4 and 5). This deficient practice had the potential to provide poor quality care and services that will affect the care necessary to maintain the highest practicable physical and mental well-being of the patients. A review of Patient 1’s OASIS (Outcome and Assessment Information Set (OASIS) is the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality) dated 12/16/2023 for the certification period of 12/16/2023 to 2/3/2024 indicated that Patient 1 was admitted to the home health agency with the medical diagnoses of pressure ulcer of right/left buttocks, sacral region, right upper back, , non-pressure chronic ulcer of the skin, , and G-tube, Review of the Home Health Certification And Plan of care for the certification period of 2/14/2024- 4/13/2024, instructed the skilled nurse 9sn0 to visit the patient one time a week for 1 week and two times a week for eight week for comprehensive nursing assessment, observation and evaluation of all body systems, to assess g-tube site for any signs of infection, check stoma site for redness, drainage, and skin breakdown. During a joint home visit with the Patient 1’s caregiver (CG) and LVN on 3/7/2024 at 8:30 a.m. at Patient 1’s residence. LVN was observed providing wound treatment to all the pressure ulcer areas , however, the LVN did not check patient 1’s stoma per the plan of care. Patient 1 is is non-ambulatory and non-verbal. During an interview with the ADM on 3/8/2024 at 12:34 p.m., ADM stated that the DON resigned from her position and started working in the field. ADM stated that they are still in the process of hiring a new DON and in the meantime hired a new care coordinator (CC) to monitor their patients charts and coordinate with the doctors and field staff. 1. A review of Patient 4’s OASIS (Outcome and Assessment Information Set (OASIS) is the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality) dated 2/9/2024 for the certification period of 2/9/2024 to 4/8/2024 indicated that the Patient was admitted to the home health agency with the medical diagnosis of unsteadiness on feet, unspecified osteoarthritis ( a degenerative disease that worsens over time, often resulting in chronic pain. Joint pain and stiffness), glaucoma ( a disease that damages your eye’s optic nerve) and essential hypertension (a type of high blood pressure that has no clearly identifiable cause, but is thought to be linked to genetics, poor diet, lack of exercise and obesity). A joint home visit was conducted with the Physical Therapist (PT) on 3/7/2024 at 10:30 a.m. at Patient 4’s residence. PT stated that he is there to conduct his discharge assessment because patient is going to be transferred to a memory care facility to continue his therapy. PT also stated this is his first time to assess and see the patient Upon arrival, Patient 4’s caregiver answered the door and the PT initiated his home visit without checking the patient’s vitals prior his therapy. PT was observed to have the patient walk around the house and do range of motion exercises for 20 minutes. Patient was alert and oriented to name, person and place, able to follow instructions very well and denied pain. Patient uses a walker for assistance. During a concurrent interview and record review with Patient 4’s caregiver on 3/7/2024 at 11:00 a.m., noted that there were multiple medications for urinary management. Caregiver stated that the patient was diagnosed 6 years ago with prostatic hyperplasia (type of prostate enlargement isn’t thought to be a precursor to prostate cancer. With this condition, the urinary stream may be weak, or stop and start. In some cases, it can lead to infection, bladder stones, and reduced kidney function) and was doing self catheterization (a way to completely empty your bladder when you need to. You put a thin tube called a catheter into your bladder. This lets the urine flow out) for 6 years until he was diagnosed with Alzheimer’s (a type of dementia that affects memory, thinking and behavior) that patient was unable to do self catheterization and was changed to an indwelling foley catheter (soft, plastic or rubber tube that is inserted into the bladder to drain the urine) by the urologist (a doctor who specializes in diagnosing and treating diseases of the urinary system) with a plug ( used for occluding the drainage lumen on foley catheters. It prevents urine from coming out of the catheter tubing any time) and is changed every three months at the clinic. When asked who is his primary care physician (PCP) caregiver stated that it was not the doctor listed in the patient 4’s face sheet. Caregiver stated that he was seeing his PCP for the past 27 plus years and had not changed since. Caregiver stated that patient is seeing doctors for his memory care, urinary care and his PCP. When asked if the home health agency knew about his foley catheter and his doctors, caregiver stated “He has been on multiple home health care that does not know that he uses a catheter so I am sure this agency does not know it”. When asked how the patient urinates with this type of foley with a plug, caregiver stated, “When he has the urge to urinate, I help him go to the bathroom, remove the plug and he is able to void in the toilet.” When asked if the patient is visited by a skilled nurse, the caregiver stated, “ No.” A phone call attempt was conducted on 3/7/2024 at 2:59 p.m. to the primary care physician listed on Patient 4’s face sheet. A patient care coordinator (PCC) answered the phone call and was able to answer inquiries for this patient. PCC stated that their clinic only saw the patient once and is not the attending physician for Patient 4 and provided the number for his primary care physician. A consecutive phone call attempt was conducted with the patients primary care physician but there was no answer and call back. A phone call attempt to the admitting nurse on 3/7/2024 at 3:54 p.m., no answer and left her a message on voicemail and thru text message. No reply received. Requested the ADM on 3/8/2024 at 11:00 a.m., to have the admitting nurse call the agency for the interview. ADM stated hat she left a message and texted her but with no reply. A phone interview with the Patient Care Coordinator (PCC) of the urology clinic on 3/8/2024 at 2:08 p.m., PCC stated that the urologist is seeing patients and she will answer any inquiries for the doctor. PCC stated that they do not know that Patient 4 was admitted to home health service and further stated that the patient goes to the clinic every three months to have his foley catheter change and was last changed on 3/2/2024. PCC stated if they knew the patient was on home health service, the home health can change the foley catheter every three months. PCC also confirmed that the patient uses a size 18 French coude ( a style of intermittent catheter that has a bent tip) that has a plug at the end. During an interview with the ADM on 3/8/2024 at 12:34 p.m., ADM stated that the DON resigned from her position and started working in the field. ADM stated that they are still in the process of hiring a new DON and in the meantime hired a new care coordinator (CC) to monitor their patients charts and coordinate with the doctors and field staff. During a joint interview with the CC and ADM on 3/8/2024 at 3:30 p.m., ADM Stated that the LVNCC does the case coordinator LVN, he reviews the pts charts and makes sure we are compliant and communicates with the doctors and makes sure its completed and consistent, takes all the reports from all the field nurses and communicates with the doctors. CC stated that he is a licensed vocational nurse and is mostly in the office receiving field staff reports, performs case management, coordinates with ancillary services , carrying out orders, assist with intake and referrals, reviews and assess patient charts and makes sure that medication were reconciled in the electronic medical record (EMR). 2. A review of Patient 5’s “Home Health Certification and Plan of Care” indicated that Patient 5 was admitted on 12/15/2023 with the medical diagnoses of type 2 diabetes (a disease that occurs when your blood glucose, also called blood sugar, is too high), macular degeneration ( loss in the center of the field of vision) and malignant neoplasm of the bladder (cancer of the bladder). “Orders and Treatments” for the certification period of 2/13/2024 to 4/12/2024 indicated interventions to address underlying risk factors for ER(emergency room)/hospitalization. Teach emergency care plan. Wound care treatment orders cleanse with normal saline, pat dry, apply xeroform and abdominal pad to wound bed, wrap with rolled gauze and secure with ace wrap to be changed weekly and as needed if dressing becomes soiled. Goals: Discharge when all goals have been met. There was no written documentation of the Patient 5’s primary care physician on the face sheet. A phone interview was conducted on 3/7/2024 at 5:00 p.m., with Patient 5 who stated that she is a retired registered nurse. When asked about her PCP, Patient 5 stated that it is not her primary care doctor that is listed in the face sheet. Patient 5 stated that she has been going to her PCP for the “longest time.” Patient 5 stated that the doctor listed on the face sheet covered for her PCP at the time she went to the clinic for a wound on her right lower leg that required wound care. Patient 5 stated that this doctor diagnosed her with stasis ulcer (wounds that are slow to heal. They typically occur in people with vein issues). Patient 5 stated that she is seeing a wound care doctor once a week every Thursday and the nurse from the agency is seeing her once a week every Monday. When asked if there were other doctors that she frequently see, she stated “I also see a vascular surgeon (specialists who are highly trained to treat diseases in the veins) and her eye doctor.” Patient 5 also stated that she also was placed on warfarin ( a medication that prevents blood clots) therapy for her atrial fibrillation ( an irregular and often very rapid heart rhythm. An irregular heart rhythm is called an arrhythmia). There was no written documentation in the plan of care for patients warfarin therapy and her atrial fibrillation. A review of the HHA’s document titled “Initial and Comprehensive Assessment” revised 11/2021 indicated that An initial patient assessment will be performed and documented in the patient’s clinical record by a registered nurse, physical therapist, occupational therapist or speech therapist on all patients referred. The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of the patient’s return home, on the start of care date ordered by the physician (or other authorized licensed independent practitioner), or at the patient/family request with the approval of the physician (or other authorized licensed independent practitioner). A comprehensive patient assessment will be completed within five (5) calendar days of the patient’s start of care. Prior to completion of a comprehensive assessment by a therapist, a registered nurse or qualified clinician must conduct a Drug Regimen Review. The assessment will be patient-specific and comprehensive to include the patient’s need for home health care, rehabilitative care, social services, and discharge planning. The assessment will also include the exact use of the current versions of the Outcomes and Assessment Information Set (OASIS). This assessment will measure patient outcomes from data collected at the start of care and at the following defined intervals thereafter: Organization personnel will communicate changes in a timely manner via telephone, one­-to-one meetings, case conferences and home visits. Documentation of all communications will be included in the clinical record on a communication note, case conference summary, or clinical note. Documentation will include: the date and time of the communication, individuals involved with the communication, information discussed, and the outcome of the communication. Written evidence of care coordination may be found in the plan of care, case conference summary forms, or clinical notes in the patient’s clinical record. The transmission of patient care information will be timely, accurate, and standardized, whenever possible. A review of the HHA’s document titled “Ongoing assessments” revised 11/2021 indicated that he scope and intensity of ongoing assessments will be determined by the patient’s diagnoses, condition, desire for care, response to previous care, and the care setting. During each home visit, the clinician or other discipline will re-evaluate the patient according to the problems identified during the initial visit and subsequent visits. The comprehensive assessment shall reflect and determine: A. Patient problems/needs/strengths B. The patient’s continuing need for home health care C. The patient is eligible for payment (e.g., homebound status) D. Patient prognosis E. Patient goals F. Patient care preferences G. Plan of care, including type of services, frequency, and duration H. Any information that may be used to demonstrate the patient’s progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the organization. I. The ability of the organization to adequately meet the patient’s medical, nursing, rehabilitation, social services, and discharge planning needs. Information gathered during the initial and comprehensive assessments will be used by the physician ( or other authorized licensed independent practitioner) in developing and authorizing the plan of care. 1). A review of Patient 1’s Outcome and Assessment Information Set ([OASI]) patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality) dated 12/16/2023 for the certification period of 12/16/2023 to 2/3/2024 indicated that Patient 1 was admitted to the home health agency with the medical diagnoses of pressure ulcer of right/left buttocks, sacral region, right upper back, , non-pressure chronic ulcer of the skin, , and gastric tube ( [GT] a tube surgically inserted into the abdomen to administer nutrition and medications). A review of the Home Health Certification And Plan of care for the certification period of 2/14/2024- 4/13/2024, instructed the skilled nurse to visit patient one time a week for 1 week and two times a week for eight weeks for comprehensive nursing assessment, observation, and evaluation of all body systems, to assess GT site for any signs of infection, check stoma site for redness, drainage, and skin breakdown. During a joint home visit on 3/7/2024 at 8:30 a.m. with the Patient 1’s caregiver (CG) and Licensed Vocational Nurse (LVN) at Patient 1’s residence, LVN was observed providing wound treatment to Patient 1’s pressure ulcers. The LVN was not observed checked Patient 1’s GT stoma as indicated in the plan of care. 2). A review of Patient 4’s OASIS dated 2/9/2024 for the certification period of 2/9/2024 to 4/8/2024 indicated Patient 4 was admitted to the HHA with diagnoses of unsteadiness on feet, unspecified osteoarthritis (a degenerative disease that worsens over time, often resulting in chronic pain. Joint pain and stiffness), glaucoma (a disease that damages your eye’s optic nerve) and essential hypertension (high blood pressure). A joint home visit was conducted with the Physical Therapist (PT) on 3/7/2024 at 10:30 a.m. at Patient 4’s residence. Upon arrival, PT initiated his home visit without checking Patient 4’s vital signs prior his therapy. During a concurrent interview and record review with Patient 4’s caregiver on 3/7/2024 at 11:00 a.m., noted that there were multiple medications for urinary management. Caregiver stated Patient 4 was doing self-catheterization (process when patient inserts the catheter into the urethra to drain urine from the bladder) and was changed to an indwelling foley catheter (to drain urine). Caregiver stated Patient 4 had not been visited by a skilled nurse. 3). A review of Patient 5’s “Home Health Certification and Plan of Care” indicated that Patient 5 was admitted on 12/15/2023 with the medical diagnoses of type 2 diabetes (abnormal blood sugar), macular degeneration (loss in the center of the field of vision) and malignant neoplasm of the bladder (cancer of the bladder). The “Orders and Treatments” for the certification period 2/13/2024 to 4/12/2024 indicated interventions to address underlying risk factors for emergency room/hospitalization and teach emergency care plan. A phone interview was conducted on 3/7/2024 at 5:00 p.m., with Patient 5. Patient 5 stated that she was placed on warfarin (a medication that prevents blood clots) therapy for her atrial fibrillation ( an irregular and very rapid heart rhythm) by her primary care physician, however, Patient 5’s clinical record did not indicate a plan of care for warfarin therapy and Patient 5’s atrial fibrillation.”

“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 observation, interview, and record review, the home health agency (HHA) failed to ensure a Director of Nursing was employed as part of the governing body (a group of people who formulate the policy and direct the affairs of the home health agency) to assume responsibility and oversee its clinical day to day operations. This deficient practice had the potential to result in the substandard quality of care that could affect the health and safety of the patients. During a joint interview with the Administrator (ADM) and the Chief Executive Officer (CEO) during the complaint validation survey conducted on 3/6/2024, the ADM and CEO stated the agency have no Director of Nursing (DON) and a DON Designee that would oversee the clinical day to day operations of their agency for the past two months. A request was made to the HHA to provide their governing body (a group of people who formulate the policy and direct the affairs of an institution) minutes and the Quality Assurance and Performance Improvement ([QAPI] a data driven and proactive approach to quality improvement which combines two approaches - Quality Assurance (QA) and Performance Improvement (PI) , the agency was unable to provide evidence that a governing body meeting exists to address the functioning hospice operations and QAPI program. A review of the home health agency’s (HHA) document titled, “ Responsibilities /Supervision of Clinical Services,” revised 11/2021, supervision of clinical care and services will be available 24 hours a day, seven (7) days a week. The document indicated the Clinical Director will be responsible for the clinical direction of the organization and will take reasonable steps to ensure that services are continuously available. The document indicated; the Clinical Director will oversee the day-to-day clinical operations. A review of the HHA’s document titled “ Governing Body” revised 11/2021 indicated the Governing Body will assume full legal authority and responsibility for the operation of Spirit Home Health. The Governing Body of Spirit Home Health will serve as the governing authority for the home health program, which will function according to Spirit Home Health’s bylaws.”

“Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This Standard is not met as evidenced by: Based on observation, interview and record review, the home health agency failed to employ a Director of Nursing (DON) or a DON Designee (a registered nurse appointed to perform certain duties on behalf of the DON) to provide oversight of all patient care services and personnel in the day-to-day operations of the home health agency. This deficient practice can result to poor nursing supervision and poor-quality patient care delivered to the home health patients. During the complaint validation survey conducted on 3/6/2024 to 3/8/2024, a Licensed Vocational Nurse (LVN) was observed overseeing medication reconciliation, coordinating with physicians, receiving patient referrals and clinical documentation of field staffs. There was no DON or a DON designee in the office to oversee the agency’s clinical operations. During a joint interview with the Administrator (ADM) and the Chief Executive Officer (CEO) on 3/6/2024 at 1:00 p.m., the CEO stated that they have no Director of Nursing (DON) and DON designee that oversee the clinical day to day operations of the home health agency. The CEO stated it had been two months that they do not have a DON or a DON designee. The ADM stated their DON resigned from her position and had been employed as a Registered Nurse (RN) conducting field admissions and home visits. Both the ADM and the CEO confirmed that they did not notify the California Department of Public Health when DON and DON designee had left the position. During an interview with LVN 2 and the ADM on 3/8/2024 at 3:00 p.m., LVN 2 stated they did not have staff in-services for the past year. The ADM stated they have not conducted any in-services for all staff for last year and this year. A review of the home health agency’s (HHA) document titled, “ Responsibilities /Supervision of Clinical Services,” revised 11/2021, indicated, supervision of clinical care and services will be available 24 hours a day, seven (7) days a week. The document indicated the Clinical Director will be responsible for the clinical direction of the organization and will take reasonable steps to ensure that services are continuously available. The document indicated; the Clinical Director will oversee the day-to-day clinical operations. A review of the HHA’s document titled, “ Designation of Individual in Absence of the Executive Director/Administrator,” revised 11/2021, indicated to facilitate smooth and uninterrupted daily operations of Spirit Home Health during the absence of key administrative personnel and if the Executive Director/Administrator is absent, the Clinical Director will assume the operational duties and responsibilities at Spirit Home Health. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence. A review of the HHA’s document titled, “ Governing Body,” revised 11/2021, indicated, the Governing Body will assume full legal authority and responsibility for the operation of Spirit Home Health. The Governing Body of Spirit Home Health will serve as the governing authority for the home health program, which will function according to Spirit Home Health’s bylaws.”

“Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This Element is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to document and thoroughly investigate an alleged complaint (reporting a problem, expressing dissatisfaction) by a caregiver to the Registered Nurse 1 (RN 1) in their grievance (complaint) log and its resolution (decision) for one of seven sampled patients (Patient 7). This deficient practice placed Patient 7 at risk for her needs not to be addresses and her grievances presented to the HHA would not be resolved. Findings During a review of Patient 7’s Patient Information, the Patient Information indicated Patient 7 had a start of care (SOC) date of 12/12/2023 with diagnoses including hypertensive heart disease (heart problems that occur because of high blood pressure that is present over a long time), and chronic obstructive pulmonary disease (COPD, group of lung diseases that block airflow and make it difficult to breathe) with a certification period reviewed 12/12/2023 to 2/9/2024. During a review of Patient 7’s Outcome and Assessment Information Set (OASIS), the OASIS indicated Patient 7 was discharged to the acute care hospital on 2/5/2024 for altered level of consciousness (a change in a patient’s state of awareness), and possible stroke (damage to tissues in the brain due to a loss of oxygen to the area). The OASIS indicated upon Patient 7’s discharge from the hospital, all home health services would resume. During a review of the HHA’s document titled “Patient Status Update,” dated 2/14/2024 indicated the agency received a call at 2:15 p.m., from Patient 7’s caregiver who was verbally upset and made a complaint about pending services for the start of care evaluation. The Patient Status Update indicated Patient 7’s caregiver reported that the Registered Nurse (unidentified) assigned to Patient 7 did not communicate the pending status for the evaluation visit and a scheduling conflict occurred. The Patient Status Update indicated Patient 7’s caregiver stated the RN simply arrived at the residence and did not wait or contact an updated status. The Patient Status Update indicated the Licensed Vocational Nurse Care Coordinator (LVNCC) apologized to Patient 7’s caregiver for the inconvenience and started to provide an alternative information and advised her she (LVNCC) would contact the RN (unidentified) to investigate the complaint. During a joint interview with the ADM and Chief Executive officer (CEO) on 3/6/2024 at 1 p.m., ADM stated the HHA did not have a complaint or grievance log, but the agency had saved email communication that they can print out. During a joint interview with the Administrator (ADM) and the LVNCC on 3/8/2024, at 3:30 p.m., the ADM stated Patient 7 was discharged due to refusal of services. When asked how she dealt with Patient 7’s complaint, the ADM stated the HHA spoke to both parties involved and documented in Patient 7’s record that Patient 7’s caregiver refused for the patient to be readmitted to the service and. The ADM stated there was no incident report or any documentation that the agency conducted a thorough investigation on what led to the refusal of services. A review of the HHA’s document titled “ Complain/Grievance Process” revised 11/2021 indicated Patients can freely voice complaints regarding care, treatment or services that are (or fail to be) provided or are provided inconsistently or inappropriately. The patient also has the right to voice grievances regarding lack of respect for persons or property. The patient can recommend changes without being subject to coercion, discrimination, reprisal, or unreasonable interruption of care, treatment, and services. Any difference of opinion, dispute, or controversy between a patient or family/caregiver or patient representative and Spirit Home Health concerning any aspect of services or the application of policies or procedures will be considered a grievance. The organization will investigate complaints regarding treatment or care, mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the organization. The organization shall be responsible for asking the necessary questions to determine cause of injuries. The Executive Director/Administrator will be informed of situations that may become detrimental to good patient relations, and will be committed to maintaining a consistently high level of patient relations. This grievance procedure will be included in the Patient Bill of Rights document given to each patient upon admission. The organization personnel receiving the complaint will discuss, verbally and in writing, the grievance with the Clinical Supervisor within five (5) days of the alleged grievance. The Clinical Supervisor will investigate the grievance within five (5) days after receipt of such grievance and will make every effort to resolve the grievance to the patient’s satisfaction. Response to the patient regarding the complaint will occur within ten (10) days of receipt. If the grievance cannot be resolved to the patient’s satisfaction, the patient or his/her representative is to notify, verbally or in writing, the Executive Director/Administrator. The grievance must state the problem or action alleged and the date the Clinical Supervisor was notified. The Executive Director/Administrator or designee will then investigate the grievance and contact the patient or his/her representative regarding the grievance in an attempt to resolve the differences. The Executive Director/Administrator will respond to the patient within ten (10) days of notification of failure to resolve the complaint.”

“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 observation, interview and record review, the home health agency (HHA) failed to review and update the “Medication Profile” (the information about the medicines a person is using and has used) with all the medications that patients were currently taking for two of seven sampled patient (Patients 4 and Patient 5). This deficient practice had the potential for medication error and side effect if the medication were not taken as prescribed to maintain an accurate, and current medication profiles for 2 of 7 patients (Patients 4, and 5). 1. A review of Patient 4’s Outcome and Assessment Information Set (OASIS, is the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality) dated 2/9/2024 for the certification period of 2/9/2024 to 4/8/2024 indicated that Patient 4 was admitted to the home health agency with the diagnoses of unspecified osteoarthritis (a degenerative joint disease, in which the tissues in the joint break down over time), glaucoma ( a disease that damages your eye’s optic nerve) and essential hypertension (a type of high blood pressure). During a joint home visit, observation and interview conducted on 3/7/2024 at 10:30 a.m., with the Physical Therapist (PT) at Patient 4’s residence, PT stated that he would conduct discharge assessment because Patient 4 would be transferred to a memory care facility to continue therapy. PT stated it was the first time to assess and see Patient 4. Upon arrival, Patient 4’s caregiver answered the door and the PT initiated the home visit without checking the patient’s vitals prior to the therapy. PT was observed walked Patient 4 around the house and performed range of motion exercises for 20 minutes. Patient was alert and oriented to name, person and place, able to follow instructions very well and denied pain. Patient 4 was observed uses a walker to walk. During a review of Patient 4’s current medication on 3/7/2024 at 11:00 a.m., with Patient 4’s Caregiver, the following medications were observed at Patient 4’s home and was not documented and updated on Patient 4’s Medication Profile. Turmeric 1500 mg 1 capsule daily for pain management 2. Focus factor 1 tablet daily as memory supplement 3. Probiotic 1 tablet 2 times daily as supplement 4. Stool softener 250 mg as needed for constipation 5. Generlac 10 grams per 15 ml as needed for constipation 6. Synthroid 75 mcg daily for thyroid supplement 7. AZO 1 tablet as needed for urinary symptoms 8. Venlafaxine HCL 150 mg daily was increased to twice daily then was increased to 300mg twice daily. 2. A review of Patient 5’s “Home Health Certification and Plan of Care” indicated that Patient 5 was admitted on 12/15/2023 with the medical diagnoses of type 2 diabetes (a disease that occurs when your blood glucose, also called blood sugar, is too high), macular degeneration ( loss in the center of the field of vision) and malignant neoplasm of the bladder (cancer of the bladder). “Orders and Treatments” for the certification period of 2/13/2024 to 4/12/2024 indicated interventions to address underlying risk factors for ER (emergency room)/hospitalization. Teach emergency care plan. Wound care treatment orders cleanse with normal saline, pat dry, apply xeroform and abdominal pad to wound bed, wrap with rolled gauze and secure with ace wrap to be changed weekly and as needed if dressing becomes soiled. Goals: Discharge when all goals have been met. There was no written documentation of the Patient 5’s primary care physician on the face sheet. During a telephone interview conducted on 3/7/2024 at 5:00 p.m., with Patient 5, stated that she is a retired registered nurse, Patient 5 stated that she has been going to her PCP for the “longest time.” Patient 5 stated that the doctor listed on the face sheet covered for her PCP at the time she went to the clinic for a wound on her right lower leg that required wound care. Patient 5 stated that this doctor diagnosed her with stasis ulcer (wounds that are slow to heal. They typically occur in people with vein issues). Patient 5 stated that she is seeing a wound care doctor once a week every Thursday and the nurse from the agency was seeing her once a week every Monday. Patient 5 stated that she was placed on warfarin (a medication that prevents blood clots) therapy for her atrial fibrillation (an irregular and often very rapid heart rhythm. An irregular heart rhythm is called an arrhythmia). During the telephone interview with Patient 5 on 3/7/2024 at 5:00 p.m., Patient 5 stated she was taking the following medications and not documented and updated on Patient 5’s Medication Profile. 1. Vitamin D 1000 micrograms (mcg, unit of measurement) daily for macular degeneration 2. New order for Xeroform gauze for wound care 3. Amoxi-Clav 875mg/125 mg was finished but it was still in the medication profile 4. Cephalexin 500mg 4 times daily for 7 days was finished but it was still in the plan of care. 5. Tramadol 50 mg 1 tablet 2x daily as needed for pain , patient stated she usually takes 2-3 times a day for pain. During a joint interview on 3/8/2024 at 3:30 p.m., with the Licensed Vocational Nurse/Care Coordinator (LVNCC) and ADM, ADM stated that the LVNCC he reviewed the patients charts and make sure the agency were compliant and communicated with the doctors and makes sure its completed and consistent. The LVNCC took all the reports from all the field nurses and communicates with the doctors. LVNCC stated that he mostly in the office receiving field staff reports, performs case management, coordinates with ancillary services, carrying out orders, assist with intake and referrals, reviews and assess patient charts and makes sure that medication were reconciled in the electronic medical record (EMR). LVNCC further stated that the outcome for not reviewing medications can cause patients adverse reactions and not following the plan of care. A review of the HHA’s document titled “Monitoring patient’s Response/Reporting to Physician” revised 11/2021 indicated that To provide guidelines for monitoring the patient’s conditions, response to care and for reporting to the patient’s physician. Clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit. Progress toward goals will be measured at regular intervals. Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. During each home visit, the clinician will monitor the patient’s response to care against the established goals, including, but not limited to: A. Care interventions and treatments B. Medications. C. Teaching. During case conferences as well as the recertification process, the care will be evaluated to determine achievement of goals. The patient’s physician ( or other authorized licensed independent practitioner) will be contacted on the same day when any of the following occur: Changes in the patient’s condition, Changes in the patient’s psychosocial status, family/caregiver support, home environment, Inability to achieve goals within the specified time frame, Changes in the patient’s expected response to treatment or medications, Changes that have occurred regarding diagnoses, prognosis, or treatment (including procedures, medications, precautions, and limitations), When there is any problem implementing the plan of care. A review of the HHA’s document titled “ Responsibilities /Supervision of Clinical Services” revised 11/2021 indicated to ensure a process is in place for the selection of a qualified individual for overseeing all clinical care and services. Supervision of clinical care and services will be available 24 hours a day, seven (7) days a week. Supervisor-to-patient-care personnel ratios will depend on the acuity level of the patients and case-mix, and will be in compliance with applicable law or regulation. The Clinical Director will be responsible for the clinical direction and will oversee the day to day clinical operation of the organization and will take reasonable steps to ensure that: 1. Services are continuously available 2. Care and services provided by organization personnel and contracted organization personnel are coordinated and integrated 3. Policies and procedures, which guide and support the provision of care and services, are developed and implemented 4. Recommendations for required resources are made in a timely and effective manner The Clinical Director will be qualified and possess appropriate clinical training and experience, as verified by: 1. Education, training, and previous work experience 2. Current professional licensure 3. Interview assessing understanding of care and service being provided as well as population being served 4. Management experience and clinical knowledge A review of the HHA’s document titled “ Medication Monitoring” revised 11/2021 indicated that Ongoing patient medication monitoring will use a collaborative approach among the clinicians, physicians, pharmacists, patients, and family/caregivers. The results of medication monitoring will be used to improve the patient’s medication regime. The ongoing monitoring will occur in accordance with the established goals of therapy and be used to: Ongoing patient medication monitoring will use a collaborative approach among the clinicians, physicians, pharmacists, patients, and family/caregivers. The results of medication monitoring will be used to improve the patient’s medication regime. The ongoing monitoring will occur in accordance with the established goals of therapy and be used to: Evaluate the continued use of a medication in the current regimen, Evaluate patient adherence to the prescribed medication regime. The clinician will assess the effect of medications on the patient. The assessment will identify drug interactions, duplicative drug therapy, and noncompliance with drug therapy.”

“Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This Element is not met as evidenced by: Based on interview and record review, the home health agency failed to ensure accurate name for 2 out of 7 sampled patients’ (Patient 4 and 5) primary care physicians were available in the clinical record. This failure had the potential a primary care physician would not be accessible when a patient has medical need or emergencies which can affect the quality of care and services provided to the patients. 1). A review of Patient 4’s Outcome and Assessment Information Set [(OASIS) the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality) dated 2/9/2024 for certification period 2/9/2024 to 4/8/2024, indicated Patient 4 was admitted to the HHA with diagnoses of unsteadiness on feet, unspecified osteoarthritis ( a degenerative disease that worsens over time, often resulting in chronic pain. Joint pain and stiffness), glaucoma (a disease that damages your eye’s optic nerve) and essential hypertension (abnormal blood pressure). During a concurrent interview and record review on 3/7/2024 at 11:00 a.m., with Patient 4’s caregiver, the clinical record indicated Patient 4 was on multiple medications for urinary management. Caregiver stated Patient 4 was diagnosed 6 years ago with prostatic hyperplasia (enlarge prostate) and was doing self-catheterization (process when patient inserts the catheter into the urethra to drain urine from the bladder). Caregiver stated Patient 4 was unable to do self-catheterization and was changed to an indwelling foley catheter (catheter to drain urine) by the urologist (a doctor specialized in urinary system), with a plug (occluding the drainage lumen on foley catheter). The indwelling catheter was changed every three months at the clinic. When asked who Patient 4’s primary care physician (PCP), Caregiver stated the physician’s name listed on Patient 4’s face sheet was incorrect. Caregiver stated that Patient 4 was seeing his PCP for the past 27 years and had not changed since. When asked if the home health agency knew about the foley catheter and the PCP, the Caregiver stated, “the HHA might not know.” 2). A review of Patient 5’s “Home Health Certification and Plan of Care” indicated Patient 5 was admitted on 12/15/2023 with the medical diagnoses of type 2 diabetes (a disease that occurs when your blood glucose, also called blood sugar, is too high), macular degeneration (loss in the center of the field of vision) and malignant neoplasm of the bladder (cancer of the bladder). “Orders and Treatments” for the certification period of 2/13/2024 to 4/12/2024 indicated interventions to address underlying risk factors for emergency room/ hospitalization. Teach emergency care plan. Wound care treatment orders cleanse with normal saline, pat dry, apply xeroform and abdominal pad to wound bed, wrap with rolled gauze and secure with ace wrap to be changed weekly and as needed if dressing becomes soiled. Goals: Discharge when all goals have been met. There was no written documentation of the Patient 5’s primary care physician on the face sheet. A phone interview was conducted on 3/7/2024 at 5:00 p.m., with Patient 5. Patient 5 stated that it was not her PCP listed in the face sheet, it was the wound doctor. Patient 5 stated that she had been going to her PCP for the “longest time.” During a joint interview with the Care Coordinator (CC) and ADM on 3/8/2024 at 3:30 p.m., the ADM stated that a Licensed Vocational Nurse (LVN) does the case coordination. The LVN CC takes the reports from all the field nurses and communicates with the doctors. A review of the home health agency’s (HHA) document titled, “Monitoring patient’s Response/Reporting to Physician,” revised 11/2021, indicated that clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient… The document indicated… the patient’s physician (or other authorized licensed independent practitioner) will be contacted on the same day for changes in the patient’s condition, changes in the patient’s psychosocial status, family/caregiver support, home environment, Inability to achieve goals within the specified time frame, changes in the patient’s expected response to treatment or medications, changes that have occurred regarding diagnoses, prognosis, or treatment (including procedures, medications, precautions, and limitations), and when there is any problem implementing the plan of care.”