Ideal Care Home Health, Inc.

“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: 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 Comprehensive Assessment of Patients as follows: 1.The HHA failed to ensure the comprehensive assessment included information about the doctor who performed the surgery (surgeon) for one of seventeen sampled patients (Patient 7). This deficient practice resulted in delay of care because staff did not have the information of the surgeon, to call and report a change of condition when Patient 7 was complaining of unrelieved pain. (Refer to G534). 2. The HHA failed to review and document all the medications and treatments the patient was currently using for five of seventeen sampled patients (Patient 7, Patient 8, Patient 13, Patient 14, and Patient 16). This deficient practice placed the patients at risk of drug-to-drug interaction and harm by not knowing which medications the patients were taking. This failure resulted in patients not having an accurate and comprehensive medical list that could place the patients at risk for medication errors and adverse drug reactions. (Refer to G536). 3. The HHA failed to ensure a Registered Nurse updated the comprehensive assessment for the recertification period for two of seventeen sampled patients (Patient 13 and Patient 16). This deficient practice had the potential to result in decline in health status by not assessing the patient’s needs. (Refer to 546). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with the Federal regulations for Comprehensive Assessment of patients to ensure home health care benefits are verified for eligibility to patients provided home health services.”

“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 (HHA) failed to ensure the Condition of Participation regarding Care Planning, Coordination, Quality of Care was met as follows: 1. The Home Health agency (HHA) failed to follow the plan of care (POC, an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) for Patient 7 who had a laminectomy (a surgery to remove bone spurs and tissues associated with arthritis of the spine) and posterior (back)-lateral (side) spinal fusion (surgery to remove bony pressure on the spinal canal and spinal nerves to relieve buttock, hip, and leg pain) on 11/4/2023 by failing to implement effective pain management for Patient 7 severe pain on the right arm, right shoulder, and left leg pain, and spasms on 11/16/2023; failed to notify Patient 7’s primary care physician regarding severe pain on the right arm, right shoulder, and left leg pain and spasms on 11/16/2023 and ensure Patient 7 received physical therapy and occupational therapy as ordered by the primary care physician. (refer to G572) 2. The HHA failed to ensure Patient 10, who had the wound vacuum on the left stump, had instructions how to manage a wound vacuum (machine used as a therapy to help wound heal) on the left stump (the body part left after an amputation) and ensure Patient 13 had the diagnosis of diabetes mellitus type 2 (chronic high blood sugar levels) and POC for interventions formulated. (Refer to G574). 3. The HHA failed to ensure the physician had signed physician orders for seven of 17 patients (Patients 1, 2, 3, 4 5, 6 and 16). (Refer to G584). 4.The HHA failed to ensure POC were reviewed and signed by the physician for three of seventeen sampled patients (Patient 13, Patient 16, and Patient 17). (Refer to G588). 5. The HHA failed to ensure the POC was revised based on comprehensive assessment (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) for one of seventeen sampled patients (Refer to G592). 6. The HHA failed to ensure two of seventeen sampled patients (Patient 13 and Patient 14), received education regarding the disease process and training in the administration of insulin medication (medication to control blood sugar levels) injection. (Refer to G610). 7. The HHA failed to provide copy of the plan of care at the residence home for four of seventeen sampled patients (Patient 7, Patient 8, Patient 13 and Patient 14). (Refer to G612) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care is provided to patients assessed to receive home health services.”

“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 interview, observation, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Skilled Professional Services as follows: 1. The HHA failed to ensure two out of 17 sampled patients (Patient 2 and Patient 10) received treatments and/or services in accordance with their written plan of care. This failure resulted in delay in care and services that could lead to hospitalization and/or death. (Refer to G710). 2. The HHA failed to perform supervisory visits for their Licensed Vocational Nurse (LVN) services for six out of 17 sampled patients (Patient 6, Patient 10, Patient 11, Patient 12, Patient13, and Patient 14). This failure had the potential to result in patients being taken care of by an unqualified staff. (Refer to G726). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care is provided to patients assessed to receive home health services.”

“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, an organization that delivers skilled nursing and other therapeutics service to a patient at home), failed to ensure Condition of Participation (conditions that healthcare organizations must meet in order to begin and continue participating in the Medicare [a federal system of health insurance for people over 65 years of age and for certain younger people with disabilities]) for Organization and Administration of Services was met. The HHA failed for the Director of Patient Services (DPCS) to oversee the overall nursing care and services provided for one out of 17 sampled patients (Patient 7). The DPCS failed to provide oversight to ensure Licensed Vocational Nurses (LVN) followed the Patient 7’s Plan of Care (POC), when Patient 7 (who underwent a laminectomy and posterior lateral spinal fusion (PSF – a surgical procedure to remove bony pressure on the spinal canal and spinal nerves to relieve buttock, hip, and leg pain on 11/4/2023 ) had a change of condition of complained of right arm severe pain, right shoulder severe pain, left leg severe pain, and left leg spasms on 11/16/2023. This deficient practice resulted in Patient 7 experienced severe pain could not sleep, and was not able to move his right arm, that could result in undetected serious complications of post cervical surgery that could lead to hospitalization, paralysis, or death. (Refer to G958). The cumulative effect of this systemic practice resulted in the failure of the HHA to deliver statutorily (rules or law) mandated compliance with the Federal (government) regulations for Organization and Administration of Services to ensure the highest practicable functional capacity, including optimal care and services to to meet patients’ care goals. .”

“Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. 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 regarding Clinical Records was met as follows: 1. The HHA failed to ensure clinical records accurately reflected the care for five of 17 sampled patients (Patient 9, Patient 10, Patient 13, Patient 14, and Patient 17). This failure resulted in an incomplete clinical record. (Refer to G1012). 2. The HHA failed to send all necessary medical information to the primary care practitioner within five days of discharge for two of 17 sampled patients (Patient 11 and Patient 12). This deficient practice resulted in the primary care practitioner not receiving information regarding the services and care provided by the HHA. (Refer G1022). 3. The HHA failed to ensure four out of 17 sampled patients (Patient 7, Patient 8, Patient 9, and Patient 16) clinical records indicated the author of the note. This failure resulted in an incomplete medical record. (Refer to G1024). The cumulative effect of these systemic practices resulted in the failure of the HHA to ensure the provision of a quality health care in a safe environment.”

“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 failed to follow the plan of care (an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) for Patient 7 who had a laminectomy (a surgery to remove bone spurs and tissues associated with arthritis of the spine) and posterior (back)-lateral (side) spinal fusion (surgery to remove bony pressure on the spinal canal and spinal nerves to relieve buttock, hip, and leg pain) on 11/4/2023 by failing to: 1. Implement effective pain management for Patient 7 severe pain on the right arm, right shoulder, and left leg pain, and spasms on 11/16/2023. 2. Notify Patient 7’s primary care physician regarding severe pain on the right arm, right shoulder, and left leg pain and spasms on 11/16/2023. 3. Ensure Patient 7 received physical therapy and occupational therapy as ordered by the primary care physician. These failures resulted in Patient 7’s severe pain, inability to sleep at night, inability to move his right arm and potential for other serious complications leading to hospitalization, paralysis, or death. On 11/17/2023 at 3:47 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) in the presence of the facility’s Administrator, Director of Nursing, Case Manager, Office Manager for the facility’s failure to: 1. assess and manage Patient 7’s change of condition when Patient 7 complained of right arm severe pain, right shoulder severe pain, left leg severe pain, and left leg spasms on 11/16/23. 2. Ensure to notify Patient 7’s primary care physician (MD 1) of Patient 7’s change of condition of right arm severe pain, right shoulder severe pain, left leg severe pain, and left leg spasms on 11/16/2023. 3. Ensure Patient 7 received Physical Therapy and Occupational Therapy as ordered. The written IJ removal plan was accepted, and survey team verified the IJ removal plan onsite during a complaint validation survey, the IJ was removed on 11/20/2023 at 2:50 p.m. The IJ removal plan included: A. IMMEDIATE AGENCY ACTIONS. On November l7 PM at 5:00 pm, the Administrator (ADM), the Director of Patient Care Services (DPCS), the Office Manager (OM) and Case Managers (CM) held a meeting and discussed the HHA’s failure to oversee the Skilled Nurse (SN) assigned to care for Patient 7. The HHA Case Manager called the hospital to speak to the Surgeon who performed the surgery and was referred to the Outpatient Spine Center and spoke to the Clinic Representative on November 17, 2023 at 11:11 AM to try to have the Surgeon re-evaluate Patient 7’s complaints of pain in the right shoulder radiating to the right arm and pain in the left leg associated with spasms at a pain level of 10/10 (0-10 pain scale). The HHA Case Manager was told that the Surgeon did not have a clinic but will relay the message as soon as possible. As per the Clinic Representative, she would call Patient 7 and will refill his pain medication (Oxycodone) and that if Patient 7 continues to be concerned with the spasms or abnormal symptoms, Patient 7 would have to go to the hospital as soon as possible. B. SUBSEQUENT AGENCY ACTIONS 1. On November 19,2023 at 6:30pm, the Administrator and DPCS contacted its medical doctor consultant to conduct an immediate and mandatory in-service with the office staff, case managers, and field skilled nurses. The topic was regarding Communications and Documentation, The MD in-service presentation included the proper establishment of plan of care, proper documentation, communication, escalation of change of condition, assessments. 2. On November 20, 2023, the ADM and the DPCS will call a General Staff Meeting for all employees and clinicians in the {field, including contractors such as PT, OT, MSW, the DPCS will provide everyone present a copy of the HHA’s Policy and Procedures for creating a Plan of Care. DPCS emphasized the importance of strict compliance with the Plan of Care. The DPCS also noted that the Plans of Care were missing in the patient’s admission packets for all the patients visited. Effective immediately, the DPCS instructed all Field Staff that the patient’s Plan of Care (including the latest for Recertified patients) shall be placed in the patient’s Admission packet as soon as it is created and should be documented in the patient’s Medical Records with a Communication Note by the follow-up SN. In addition, on Monday, November 20, 2023, the consultant conducted an in-service to all staff, including contractors on the agency’s policy on Pain Management and the steps that need to be taken to address patients that are experiencing pain. One on one counseling, assessment and performance evaluation will be provided for each individual staff member, including the Administrator and DPCS. a. Designated Contacts - Specific individuals have been assigned as Primary and Secondary Contacts for Escalation, namely Primary Contact is the ADM Secondary Contact is the DPCS. b. Response Times - Upon identification of a Significant Change or Concern, the Primary Contact is expected to respond immediately and the Secondary Contact within 15 minutes. This would ensure a rapid acknowledgement and communication of the issue. c. Structured Approach - The Escalation Process will follow a structured approach to address the urgent issues promptly and obtain a resolution as soon as possible. This will include an initial assessment of the situation by the RN in conjunction with the LVN responsible for the patient. Once the assessment is completed, the clinical staff will notify the office after the visit and the immediate notification of the Case Manager (CM) responsible, and initiation of any necessary interventions outlined in the Plan of Care with oversight by the DPCS. The Primary Care Physician shall then be notified of the urgent issue and an MD order shall be created as part of the resolution. d. Documentation - Each step of the Escalation Process shall be documented in the patient’s Medical Record, through the Communication Notes, including the nature of the concern, the individuals contacted, and the actions taken. The person documenting the Communication Note shall affix his/her name on the note, sign and date the document. All medical record documentation must be updated 7 days as per agency policy. Additionally, HHA Clinical Supervisor will conduct weekly check-ins with the Field Staff and their patients to assess the patients’ progress in accordance with the patients’ Plans of Care. These check-ins shall be documented in the patients’ Medical Record to allow a comprehensive overview of the patient’s progress towards the stated goals and any necessary adjustments to be made in the Plan of Care. A review of Patient 7’s Patient Profile indicated a start of care date (SOC) of 11/8/2023 with diagnoses including spondylosis cervical region (degeneration of the bones and disks in the neck) and intervertebral disc degeneration, lumbar region (wear and tear of lower back intervertebral disc). A review of Patient 7’s medical record titled Home Health Certification and Plan of Care (POC) dated from 11/8/2023 to 1/6/2023, indicated Skilled Nurse (SN) to perform skilled assessment/evaluation of all body systems with emphasis on… musculoskeletal, pain/comfort, compliance with prescribed treatment regimen. The POC indicated SN to teach/instruct Patient/PCG disease process and its management, medication regimen… pain management… A review of Patient 7’s medical record titled Patient Medication Profile dated 11/8/2023 to 1/6/2023, indicated Oxycodone (opioid pain medication) 5 mg (milligrams) one (1) tablet orally every six (6) hours as needed for pain. The pain medication profile indicated Tylenol (pain medication) 500 mg 1 tablet orally every eight (8) hours as needed. During a home visit observation conducted on 11/16/2023, at 9:30 a.m. with Licensed Vocational Nurse 1 (LVN), Patient 7 could not lift his right arm completely and had pain. During an interview on 11/16/2023, at 9:33 a.m., Patient 7’s caregiver (CG 1) stated Patient 7 needed a refill for his Norco (pain medication) when he needed it for severe pain. CG 1 stated Tylenol (a pain reliever) does not help Patient 7 relieve his pain at night, that resulted to Patient 7’s inability to sleep. During a concurrent observation and interview during home visit on 11/16/2023, at 9:55 a.m. Patient 7’s caregiver asked Licensed Vocational Nurse (LVN) 1 how to obtain refill for Norco medicine. LVN 1 instructed Patient 7 or the caregiver to call the doctor to get a refill. LVN 1 stated she had never called the doctor to request refill for pain medicine. During a home visit interview on 11/16/2023, at 9:57 a.m., LVN 1 asked Patient 7 about his pain status. Patient 7 stated his current pain level on the right arm and left leg was 5 out of 10 (a numerical pain scale to assess the pain level- 0 no pain; one to three means mild pain; four to seven is moderate pain; eight and above is severe pain) and at night, the pain level was 11 out of 10. Patient 7 stated Tylenol did not relieve the pain. Patient 7 stated when his left leg hurt, it felt warm and had spasms (a sudden, brief, involuntary muscle contraction). Patient 7 told LVN 1 he ran out of Norco and the last time she took Norco was five (5) days ago (date unknown). LVN 1 told caregiver to call the hospital where Patient 7 had his surgery to obtain a refill. CG 1 stated Patient 7 had not slept the night prior (11/15/2023) because the pain was not relieved with Tylenol until the morning of 11/16/2023. During an interview on 11/16/2023 at 10:07 a.m., LVN 1 stated they do not call the physician for Norco refills, only to report pain assessment. During an interview on 11/17/2023, at 10:05 a.m., the Director of Nurses (DON) stated the nurse should have called the doctor who signed the plan of care and inform the patient was in pain, had ran out of medication and patient needed pain medication. The DON stated this process was important to follow because patient safety and comfort is the primary objective. The DON stated in the POC, if patient’s pain medications were inadequate, a review of the medication is warranted and the doctor needs to be notified to see if a change of pain management is needed. 2.A review of Patient 7’s medical record titled Home Health Certification and Plan of Care, dated from 11/8/2023 to 1/6/2023, indicated Skilled Nurse (SN) to perform skilled assessment/evaluation of all body systems with emphasis on… musculoskeletal, pain/comfort, compliance with prescribed treatment regimen. The plan of care also indicated to monitor for signs and symptoms of infection to surrounding area of the surgical incision to posterior neck during each visit and report any abnormal findings to the physician. During an interview on 11/17/2023, at 10:31 a.m., the DON stated Patient 7’s pain on the right arm and left leg could be a complication of the surgery and needed to be reevaluated by the surgeon. The DON stated LVN 1 should have immediately called the doctor’s office to report Patient 7’s unrelieved pain and requested a refill of the pain medication. The DON stated Patient 7’s pain on the right arm and left leg, should have been conveyed to the surgeon immediately. The DON stated LVN 1 did not notify the doctor and did not inform the office immediately when Patient 7 reported severe pain on the right arm and left leg pain on 11/16/2023. The DON stated the severe pain on the right arm and left leg could indicate complications of the surgery and should have been reported to the surgeon for safety reasons and for reevaluation. 3.A review of Patient 7’s medical record titled Home Health Certification and Plan of Care, dated 11/8/2023 to 1/6/2023, indicated Physical Therapist (PT) to assess/evaluate Patient 7…” A review of Patient 7’s medical record titled, Discharge and Consult Orders, dated 11/6/2023, indicated, Patient 7 needs home health Physical Therapy (PT) and Occupational Therapy (OT) for continued therapy until after discharged. During an interview on 11/16/2023, at 9:33 a.m., in Patient 7’s residence, Patient 7 stated a PT came to his home and informed him he could not start therapy until his neck brace was off. During the home visit observation on 11/16/2023, at 10:05 a.m., Patient 7 tried to close his right hand. The right index finger could not meet the right thumb. Patient 7 stated he could not close his hand very well due to stiffness and pain. During a concurrent interview and record review on 11/17/2023, at 11:04 a.m., of the PT evaluation, dated 11/9/2023, the DON stated the PT evaluation indicated not to perform physical therapy until the neck brace is off. The DON stated there was no doctor order to discontinue PT because the brace was on. During an interview on 11/17/2023, at 11:13 a.m., the Office Manager (OM), stated the HHA had forgotten to call OT therapy. During an interview on 11/17/2023, at 11:14 a.m., the DON stated the surgery affected Patient 7’s movements. The DON stated PT was important for Patient 7 to restore his prior level of functioning and for pain management. The DON stated there was a delay in achieving Patient 7’s rehabilitation goals because PT and OT were not provided. A review of facility’s policy and procedure (P&P) titled, “Pain Assessment and Reassessment”, revised 2014, indicated, when a patient’s pain is not relieved, the nurse or therapist will notify the patients physician, provide patient education regarding alternative pain relief measures…” A review of facility’s P&P titled, “Medication Administration,” revised 2014, indicated patients will be assessed and reassessed on an ongoing basis for medication effectiveness and actual or potential drug related problems. Staff will use information from medication monitoring to assess the medications continued administration and will communicate medication findings to patient’s physician and other appropriate staff. The P&P also indicated, any unresolved, significant concerns about medications will be discussed by the nurse with the patient’s physician and appropriate staff. A review of facility’s P&P titled, “Plan of Care,” revised 2015, indicated the agency professional staff will promptly alert the physician about any changes that suggests a need to alter the Plan of Care. The Plan of Care will be reviewed more frequently. A review of facility’s P&P titled, “Plan of Care,” revised 2015, indicated care and services provided will be provided according to physician orders. A review of facility’s P&P titled, “Patient Bill of Rights,” revised 2014, indicated the agency protects and promotes the right of each individual… the patient is informed both verbally and in writing of all rights including: to effective pain management.” A review of facility’s undated document titled, Patient Orientation for Home Health Care, indicated pain management to receive appropriate initial and ongoing assessment and management of pain. It also indicated effective pain control strategies contribute to healing, promotion of health and wellness, and the restoration of optimum functioning. Patients can expect that pain management will be a priority of their holistic care.”

“Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This Standard is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency failed to provide copy of the plan of care at the residence for four of seventeen sampled patients (Patient 7, Patient 8, Patient 13 and Patient 14). This deficient practice had the potential for the affected patients to not receive the care outlined in the plan of care. 1). A review of Patient 7’s “Patient Profile” indicated a start of care date (SOC) of 11/8/2023 with diagnoses including spondylosis cervical region (degeneration of the bones and disks in the neck) and intervertebral disc degeneration, lumbar region (wear and tear of lower back intervertebral disc). During a concurrent observation and interview on 11/16/2023, at 9:42 a.m., Licensed Vocational Nurse (LVN) 1 was providing care to Patient 7. During the interview with Patient 7, Patient 7 stated he had not received a copy of his plan of care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers). During an interview on 11/16/2023, at 10:07 a.m., LVN 1 stated there was no POC in Patient 7’s home health folder at the residence. LVN 1 stated it was important to have the POC in Patient 7’s home to know the care Patient 7 needed and to know the involvement of other discipline in the care of Patient 7. LVN 1 stated Patient 7 had the right to a copy of his POC to know the services the agency will be providing. 2). A review of Patient 8’s “Patient Profile” indicated a start of care date (SOC) of 10/17/2023 with diagnoses including paroxysmal atrial fibrillation (irregular heartbeat that normalizes within 7 days on its own or with treatment). During an observation of the home visit on 11/16/23, at 11:15 a.m., the POC was not observed in Patient 8’s home. LVN 2 provided care to Patient 8 without a POC onsite. LVN 2 stated the home health agency (HHA) told her what to do for Patient 8’s home visit. During an interview on 11/19/2023, at 11:24 a.m., the Director of Nurses (DON) stated patients should be provided with their POC as it is a way for them to know who will visit them, and how often they will be seen. 3). A review of Patient 13’s “Patient Profile” indicated a start of care date (SOC) of 6/14/2023 with diagnoses including stage II pressure ulcer (a shallow open ulcer with a red or pink wound bed) on left buttocks and pressure ulcer of other site, stage II. A review of Patient 13’s medical record titled Home Health Certification and Plan of Care, dated 10/12/2023 to 12/10/2023, indicated an order for skilled nurse (SN) to do one (1) visit for 1 week, then two visits for eight weeks (1w1, 2w8) to perform skilled assessment/evaluation of all body systems with emphasis on… integumentary (skin), endocrine (hormone levels and to teach/instruct patient/caregiver the disease process and its management, medication regiment, diet, meticulous skin care and infection control, pain management, energy conservation, fall precaution, equipment safety measures, and 911/emergency protocol.” It also indicated SN to teach/demonstrate wound care to left buttocks/left upper thigh to the patient/ caregiver. During concurrent interview and record review of Patient 13’2 plan of care on 11/16/2023 at 7:10 a.m. with LVN 1, LVN 1 was unable to locate the plan of care at the patient’s home. 4). A review of Patient 14’s “Patient Profile” indicated a start of care date (SOC) of 9/1/2022 and end of care (EOC) of 9/26/2023 with diagnoses including Diabetes Meletus II (DMII -high blood sugar) with hyperglycemia (high blood sugar). A review of Patient 14’s medical record form titled “Patient Medication Profile” undated, indicated “Lantus insulin (long lasting insulin – medication to lower blood sugar levels) solution for injection, inject 17 units (unit of measurement) subcutaneously (under the skin) once daily.” A review of Patient 14’s medical record titled “Home Health Certification and Plan of Care” dated 10/26/2023 – 12/24/2023, indicated “SN to teach/instruct patient/ patient care giver disease process and its management, medication regimen…” During a concurrent observation and interview on 11/16/2023 at 6:20 a.m. with LVN 1 during a joint home visit for Patient 14, LVN 1 administered 17 units of Lantus insulin to Patient 14’s right arm. LVN 1 was not observed providing education or instructing Patient 14 on how to administer the insulin. LVN 1 was unable to locate Patient 14’s POC in his HHA patient folder. During a concurrent interview and record review on 11/17/2023 at 1 p.m. with the Director of Nursing (DON) of Patient 14’s Electronic Medical Record (EMR), the DON stated there are several things the plan of care indicates. The DON stated patient teaching/education starts at the beginning and with every home visit. It is important to evaluate the patients and caregiver understanding of their care, medication, safety concerns. The DON stated patient or caregiver education/teaching should be done daily and the nurse must evaluate if the patient and or caregiver understood the instructions. The DON stated Patient 14 needed education/teachings how to check his blood sugar levels and insulin administration weekly. During an interview on 11/16/2023 at 7:30 a.m. with LVN 1, LVN 1 stated there were no POC in Patient 14’s HHA folders. LVN 1 stated patients plan of care is a guideline on their care. LVN 1 stated she have not seen Patient 14’s plan of care in their HHA folder. A review of facility’s policy and procedure titled “Patient Bill of Rights” revised 2014, indicated the agency protects and promotes the right of each individual… the patient is informed both verbally and in writing of all rights including to be notified in advance about the care that is to be furnished, the types (disciplines) of the caregivers who will furnish the care and the frequency of the visits that tare proposed to be furnished.””

“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 (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home), failed for the Director of Patient Services (DPCS) to oversee the overall nursing care and services provided for one out of 17 sampled patients (Patient 7). The DPCS failed to provide oversight to ensure Licensed Vocational Nurses (LVN) followed the Patient 7’s Plan of Care (POC), when Patient 7 (who underwent a laminectomy and posterior-lateral spinal fusion (PSF – a surgical procedure to remove bony pressure on the spinal canal and spinal nerves to relieve buttock, hip, and leg pain on 11/4/2023 ) had a change of condition of complained of right arm severe pain, right shoulder severe pain, left leg severe pain, and left leg spasms on 11/16/2023. This deficient practice resulted in Patient 7 experienced severe pain could not sleep, and was not able to move his right arm, that could result in undetected serious complications of post cervical surgery that could lead to hospitalization, paralysis, or death. On 11/17/2023 at 3:50 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) in the presence of the facility’s Administrator, Director of Nursing, Case Manager, Office Manager, for the HHA failure to ensure the Director of Patient Care Services provided oversight to ensure the Licensed Nurses followed Patient 7’s Plan of Care to assess and manage Patient 7’s change of condition, when Patient 7 complained of right arm severe pain, right shoulder severe pain, left leg severe pain, and left leg spasms on 11/16/2023. The HHA submitted an IJ removal plan on 11/20/2023. The written IJ removal plan was accepted, and the survey team verified the IJ removal plan onsite during a complaint validation survey. The Department removed the IJ situation on 11/20/2023 at 2:50 p.m. A review of the HHA’s IJ removal plan indicated the following; A. IMMEDIATE AGENCY ACTIONS. On November l7 PM at 5:00 pm, the Administrator (ADM), the Director of Patient Care Services (DPCS), the Office Manager (OM) and Case Managers (CM) held a meeting to discuss the Home Health Agency’s failure to oversee the Skilled Nurse (SN) assigned to care for Patient 7. On November 17, 2023 at 9:50 a.m., under the direction of the Director of Patient Care Services (DPCS), the Home Health Agency’s (HHA) Case Manager (CM) responsible for supervising the Patient 7 care called the Clinic where Patient 7 goes to for follow-up visits. The Medical Assistant from the Clinic stated that Patient 7 had to go back to the hospital to follow up for refills pain medication (Oxycodone) as the hospital was where the medication was prescribed. 1. The HHA Case Manager called the hospital to speak to the Surgeon who performed the surgery and was referred to the Outpatient Spine Center and spoke to the Clinic Representative on November 17, 2023 at 11:11 AM to try to have the Surgeon re-evaluate Patient 7’s complaints of pain in the right shoulder radiating to the right arm and pain in the left leg associated with spasms at a pain level of 10/10 (0-10 pain scale). The HHA Case Manager was told that the Surgeon did not have a clinic but will relay the message as soon as possible. As per the Clinic Representative, she would call Patient 7 and will refill his pain medication (Oxycodone) and that if Patient 7 continues to be concerned with the spasms or abnormal symptoms, Patient 7 would have to go to the hospital as soon as possible. B. SUBSEQUENT AGENCY ACTIONS- 1. On November 19,2023 at 6:30pm, the Administrator and DPCS contacted its medical doctor consultant to conduct an immediate and mandatory in-service with the office staff, case managers, and field skilled nurses. The topic was regarding Communications and Documentation, The MD in-service presentation included the proper establishment of plan of care, proper documentation, communication, escalation of change of condition, assessments. 2. On November 20, 2023, the ADM and the DPCS will call a General Staff Meeting for all employees and clinicians in the {field, including contractors such as PT, OT, MSW, the DPCS will provide everyone present a copy of the HHA’s Policy and Procedures for creating a Plan of Care. DPCS emphasized the importance of strict compliance with the Plan of Care. The DPCS also noted that the Plans of Care were missing in the patient’s admission packets for all the patients visited. Effective immediately, the DPCS instructed all Field Staff that the patient’s Plan of Care (including the latest for Recertified patients) shall be placed in the patient’s Admission packet as soon as it is created and should be documented in the patient’s Medical Records with a Communication Note by the follow-up SN. The RN conducting the LVN Supervisory Visit shall also check the presence of the Plan of Care during the Supervisory Visit in addition to performing a Medication Reconciliation. The presence of the Plan of Care (including the latest POC for Recertified patients) shall be documented in the LVN Supervisory Visit form in the Narrative Portion of the form, to be accomplished by the RN, and to be signed and dated as well. In addition, on Monday, November 20, 2023, the consultant will give an in-service to all staff, including contractors on the agency’s policy on Pain Management and the steps that need to be taken to address patients that are experiencing pain. One on one counseling, assessment and performance evaluation will be provided for each individual staff member, including the Administrator and DPCS. a. Designated Contacts - Specific individuals have been assigned as Primary and Secondary Contacts for Escalation, namely Primary Contact is the ADM Secondary Contact is the DPCS. b. Response Times - Upon identification of a Significant Change or Concern, the Primary Contact is expected to respond immediately and the Secondary Contact within 15 minutes. This would ensure a rapid acknowledgement and communication of the issue. c. Structured Approach - The Escalation Process will follow a structured approach to address the urgent issues promptly and obtain a resolution as soon as possible. This will include an initial assessment of the situation by the RN in conjunction with the LVN responsible for the patient. Once the assessment is completed, the clinical staff will notify the office after the visit and the immediate notification of the Case Manager (CM) responsible, and initiation of any necessary interventions outlined in the Plan of Care with oversight by the DPCS. The Primary Care Physician shall then be notified of the urgent issue and an MD order shall be created as part of the resolution. d. Documentation - Each step of the Escalation Process shall be documented in the patient’s Medical Record, through the Communication Notes, including the nature of the concern, the individuals contacted, and the actions taken. The person documenting the Communication Note shall affix his/her name on the note, sign and date the document. All medical record documentation must be updated 7 days as per agency policy. Additionally, HHA Clinical Supervisor will conduct weekly check-ins with the Field Staff and their patients to assess the patients’ progress in accordance with the patients’ Plans of Care. These check-ins shall be documented in the patients’ Medical Record to allow a comprehensive overview of the patient’s progress towards the stated goals and any necessary adjustments to be made in the Plan of Care. A review of Patient 7’s “Patient Profile” indicated a start of care date (SOC) of 11/8/2023 with diagnoses including spondylosis cervical region (degeneration of the bones and disks in the neck) and intervertebral disc degeneration, lumbar region (wear and tear of lower back intervertebral disc). A review of Patient 7’s “Home Health Certification and Plan of Care” dated from 11/8/2023 to 1/6/2023, indicated for Skilled Nurse (SN) to perform skilled assessment/evaluation of all body systems with emphasis on… musculoskeletal, pain/comfort, compliance with prescribed treatment regimen.” It indicated, “SN to teach/instruct Patient/PCG – disease process and its management, medication regimen… pain management…” “Surgical incision to posterior neck: Monitor for s/sx (signs and symptoms) of infection to surrounding area during each visit and report any abnormal findings.” It also indicated “Reportable Parameters: Pain >8/10…” A review of Patient 7’s “Patient Medication Profile” dated 11/8/2023 – 1/6/2023, indicated “Oxycodone (opioid pain medication) 5 milligrams (mg, unit of measurement) 1 tablet orally (by mouth) every 6 hours as needed.” Patient 7’s medication profile indicated “Tylenol (pain medication) 500 mg 1 tablet orally every 8 hours as needed. During an observation of the home visit on 11/16/2023, at 9:30 a.m., Licensed Vocational Nurse 1 (LVN 1) provided care to Patient 7. During a concurrent observation and interview of the home visit on 11/16/2023, at 9:33 a.m., Patient 7 demonstrated to LVN 1 that he could not lift his right arm completely. Patient 7 stated his right arm still hurt to lift. During an interview on 11/16/2023, at 9:33 a.m., Patient 7’s caregiver (CG 1) stated needed a refill for his pain medication (Norco-pain medication) for the severe pain. CG 1 stated Tylenol (a pain reliever) was not helping Patient 7 manage his pain at night, and as a result, Patient 7 could not sleep at night. During a concurrent observation and interview of the conversation during the home visit on 11/16/2023, at 9:55 a.m. Patient 7’s CGV asked LVN 1 how to get a refill for pain medication “Norco”. LVN 1 told CG 1 that Patient 7 or herself should call the doctor to get a refill. LVN 1 stated, “I’ve never called the doctor for a refill on pain medicine”. During an observation and interview on 11/16/2023, at 9:57 a.m., LVN 1 asked Patient 7 about his pain. Patient 7 stated his current pain level was “5/10” (based on a pain scale 0 to 10, 0 being no pain, 10 being worst pain). Patient 7 stated to LVN 1 his paint level at nighttime is “11/10”, and Tylenol did not help. Patient 7 stated to LVN 1 his nighttime pain was on his right arm and left leg. Patient 7 stated to LVN 1 he was concerned because when his left leg hurt, it felt warm and spasmed (a sudden, brief, involuntary muscle contraction). During an observation and interview on 11/16/2023, at 10:03 a.m. Patient 7’s CG 1 asked LVN 1 what to do about the pain medication refill. LVN 1 stated to CG 1 to call the hospital where Patient 7 had his surgery to get a refill. LVN 1 stated the family needed to call to get pain medication refill. CG 1 stated Tylenol worked for Patient 7 if he had a little bit of pain. CG 1 stated Patient 7 did not sleep the night prior because his pain was not relieved until the morning of 11/16/2023. LVN 1 asked Patient 7 when was the last time he took “Norco”. Patient 7 stated to LVN 1 the last time he took “Norco” was 5 days ago because that is when he ran out of the last pill. Patient 7 stated he had not had pain relief at night, because every night has been painful “11/10”. During an observation and interview of the home visit on 11/16/2023, at 10:05 a.m., Patient 7 tried to close his right hand. Patient 7 could not grip a pen: the right index finger could not meet the right thumb. Patient 7 stated he could not close his hand very well due to stiffness and pain. During an interview on 11/16/2023 at 10:07 a.m., LVN 1 stated, was asked if she was planning on calling the doctor. LVN 1 stated, “we don’t call for refills, only to report pain assessment.” During an interview on 11/17/2023, at 10:05 a.m., the Director of Nurses (DON) stated the nurse had to call the doctor who signed the plan of care, to inform the patient was in pain, had run out of medication and patient needs pain medication. The DON stated this process was important to follow because patient safety and comfort is the primary objective. Also, in the POC, there were parameters that needed to be reported. If patient pain medications are inadequate, a review of the medication is warranted, the doctor needs to be notified to see if a change of pain management is needed. During an interview on 11/17/2023, at 10:31 a.m., the DON stated Patient 7’s reported pain on the right arm and left leg could be a complication of the surgery and needed to be reevaluated by the surgeon (doctor who did the operation) who did the surgery. The DON stated he expected LVN 1, upon being aware of Patient 7’s reported symptoms, to immediately call the doctor’s office to request a refill of the pain medication and inform about patient 7’s reported symptoms. If LVN 1 was unable to reach the patient’s doctor, the office would have called the doctor on her behalf. The DON stated Patient 7’s complaints of pain on the right arm and left leg, should have been conveyed to the surgeon immediately. The DON stated LVN 1 did not notify the doctor and inform the office when learning about Patient 7’s reported symptoms on 11/16/2023. During an interview on 11/17/2023, at 10:43 a.m., the DON stated Patient 7’s reported symptoms could indicate complications of the surgery and should have been reported to the surgeon. It was important to notify the surgeon for patient safety reasons, if there was a complication due to the surgery, the surgeon needed to reevaluate the patient. During an interview on 11/17/2023, at 10:58 a.m., the administrator (ADM) was asked what his involvement was in the day to day operation of the HHA in regards to patient care. The ADM stated the HHA had a communication process as follows: the case manager was responsible in reporting patient care concerns to the ADM. The ADM stated he would communicate with the DON and address it right away. The ADM stated Patient 7’s care concerns were not reported to him on 11/16/2023 or today, 11/07/2023. During an interview on 11/17/2023, at 11:02 a.m., the DON stated he needed to revisit the HHA’s process to make sure the communication is improved. During an interview on 11/17/2023, at 11:13 a.m., the Office Manager (OM), stated the HHA had forgotten to call OT therapy. During an interview on 11/17/2023, at 11:14 a.m., the DON stated Physical Therapy was important for Patient 7’s management of pain. The surgery affected Patient 7’s movements, he needed to restore that as quickly as possible. Physical Therapy was supposed to be helpful in restoring previous level of functioning. The DON stated, as of now, we do not know if the doctor agrees to hold Physical Therapy. The DON stated Patient 7 could have a delay in restoring to his rehabilitation goals, due to not receiving Physical Therapy. During an interview on 11/17/2023, at 11:16 a.m., the DON stated it was important for Patient 7 to receive occupational therapy because it would help with activities of daily living such as dressing, bathing, picking up things from the floor, putting on socks, holding a pen, and utensils for eating. The DON stated Patient 7 could have a delay in restoring to his rehabilitation goals, due to not receiving Occupational Therapy. A review of facility’s form titled “Director of Patient Care Services” undated, indicated “Participates in developing standards which ensure safe and therapeutically effective services to patients and families. Has joint responsibility with the Administrator for seeing that standards are met. Directs implementation of approved work methods and procedures that reflect elements essential to rendering high quality care. Participates in the review, analysis, and appraisal of the effectiveness of the total Agency program. Coordinates the quarterly clinical record review program. Established methods for coordination of care by all disciplines. Establishes staffing patterns which reflect the quality and quantity of various personnel necessary to plan, provide and supervise the care rendered to clients and families. Participates in establishing the functions and qualifications for each services position; coordinates interdisciplinary team services: assures ongoing assessment of patient/family needs and implementation of interdisciplinary team plan of care. Assures physician approval of plans for continuity of medical care. Participates in establishing the functions and qualifications for each services position; coordinates interdisciplinary team services: Assures physician approval of plans for continuity of medical care. Investigates and reports and problem relating to patient care of conditions which might harm the patient and/or employee well-being. Ensures that patients’ plan of care are developed, implemented and evaluated.””

“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 interview and record review, the Home Health Agency (HHA) failed to ensure four out of 17 sampled patients (Patient 7, Patient 8, Patient 9, and Patient 16) clinical records indicated the author of the note. This failure resulted in an incomplete medical record. 1) A review of Patient 7’s “Patient Profile” indicated an SOC date of 11/8/2023 with diagnoses including spondylosis cervical region (degeneration of the bones and disks in the neck) and intervertebral disc degeneration, lumbar region (wear and tear of lower back intervertebral disc). During an interview and concurrent record review on 11/19/2023, at 11:48 a.m., the DON reviewed Patient 7’s record titled, “Start of Care - further visits planned”, dated 11/10/2023. The DON stated the record was not signed. The HHA failed to ensure Patient 7’s medical records were authenticated by the author of the note. 2) A review of Patient 8’s “Patient Profile” indicated a start of care (SOC) date of 10/17/2023 with diagnoses including paroxysmal atrial fibrillation (irregular heartbeat that normalizes within seven days on its own or with treatment). During an interview and concurrent record review on 11/19/2023 at 11:45 a.m., the Director of Nurses (DON) reviewed Patient 8’s record titled, “Start of Care - further visits planned”, dated 10/19/2023. The DON stated the record was not signed and the record was supposed to be authenticated within five days of when the assessment was done. The DON stated the purpose of authentication was due to Medicare standards, compliance with conditions of participation, to authenticate the visit was which is done by the registered nurse, and to validate if the assessment done including the patient condition. The HHA failed to ensure Patient 8’s medical records were authenticated by the author of the note. 3) A review of Patient 9’s “Patient Profile” indicated an SOC date of 11/6/2023 with diagnoses including essential primary hypertension (high blood pressure). During a concurrent interview and record review on 11/19/2023, at 11:49 a.m., the DON reviewed Patient 9’s record titled, “Start of Care - further visits planned”, dated 11/8/2023. The DON stated the record was not signed. The HHA failed to ensure Patient 7’s medical records were authenticated by the author of the note. 4) A review of Patient 16’s “Patient Profile” indicated an SOC date of 9/15/2023 with diagnoses including hypertensive (high blood pressure) heart disease and chronic kidney disease (CKD – damaged kidneys that can’t filter blood the way they should). A review of Patient 16’s medical record form titled “Home Health Certification and Plan of Care” dated 9/15/2023 to 11/13/2023, indicated “SN (skilled nurse) frequency: daily including weekends x 60 days then reassess. It also indicated “Attending Physician Signature, Date Signed (Please Sign All Pages)” was left blank. During an interview and concurrent record review on 11/17/2023 at 11:45 with the DPCS of Patient 16’s EMR, the DPCS stated Patient 16’s POC dated 9/15/2023 to 11/13/2023 was not signed by a physician. A review of Patient 16’s medical record form titled “Home Health Certification and Plan of Care” dated 11/14/2023 to 1/12/2023, indicated “Date Assessment Completed: 11/13/2023.” It also indicated sections “Self-Care Follow up Performance; Mobility Follow up Performance; Cognitive Functioning Narrative; Advance Directive” were left blank. It also indicated it was not signed or dated. During an interview and concurrent record review on 11/17/2023 at 11:45 with the DPCS of Patient 16’s EMR, the DPCS stated Patient 16’s recertification was not complete and that the nurse was still working on it. The DPCS stated, “It is important to complete, it could lead to errors in the patients’ treatments, the nurse who is following up might see the old or wrong information.” A review of Patient 16’s medical record form titled “Order/Telephone Order”, dated 9/15/2023, 9/20/2023, and 9/29/2023, indicated sections “Physician Name: (Medical Director 1 – MD1).” It also indicated “Signature:” was left blank. During an interview and concurrent record review on 11/17/2023 at 11:45 with the DPCS of Patient 16’s EMR, the DPCS stated, “Technically, before we do the final claim… our policy states that MD orders should be signed within one month.” DPCS stated that none of Patient 16’s medical orders were signed for her last recertification. During an interview and concurrent record review on 11/17/2023 at 11:45 a.m. with DPCS of Patient 16’s EMR, the DPCS stated Patient 16’s nursing visit notes dated 11/12/2023, 11/11/2023, 10/2/2023, 9/25/2023, 9/24/2023, 9/23/2023, 9/22/2023, 9/21/2023, 9/19/2023, 9/17/2023, 9/16/2023. The DPCS stated he expected nurses to document and upload by Monday following their visits. DPCS stated nurses need to sign their notes to authenticate their findings. The HHA failed to ensure Patient 16’s POC, comprehensive assessment, and medical orders were reviewed, revised and signed by HHA staff. A review of facility’s form titled “Job Description - Administrator”, revised 2014, indicated “Directs the Agency’s ongoing function. Evaluates effectiveness and efficiency of the Agency.” A review of facility’s policy and procedure titled “Timely Submission of Patient Documentation”, revised 2009, indicated “The agency will ensure the timely and proper submission of patient documentation. Itineraries, with all visit reports attached, must be submitted the next schedule workday, not exceeding ten (10) business days. All patients visit reports from contracted personnel must be submitted within ten (10) business days from the date of the visit…” A review of facility’s policy and procedure titled “Medical Record Entries: Authentication”, revised 2014, indicated “All medical record entries will be dated and authenticated. All entries in the medical records will be authenticated by staff by signing first name or initial, last name and tilted by authenticating entries in the patients records, staff is validating the correctness of the information. Signatures are legible and legal. If automated clinical record system is used, electronic signature authentication of entries will be in accordance with state law.””

“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 observation, interview, and record review the Home Health Agency (HHA) failed to provide admission records to people who have limited English proficiency and elected a preferred language in advance of furnishing care to the patient or during the initial evaluation visit before the initial treatment for five of seventeen sampled patients (Patient 2, 7, 9, 11 and Patient 16). This deficient practice resulted in patients not being able to understand/refer to HHA information. 1) A review of Patient 7’s “Patient Profile” indicated a start of care date (SOC) of 11/8/2023 with diagnoses including spondylosis cervical region (degeneration of the bones and disks in the neck) and intervertebral disc degeneration, lumbar region (wear and tear of lower back intervertebral disc). During an observation of the home visit on 11/16/2023, at 9:30 a.m., Licensed Vocational Nurse 1 (LVN 1) provided care to Patient 7. During an interview and concurrent record review with Patient 7, on 11/16/2023, at 9:38 a.m., “Patient Orientation for Home Health”, indicated English literature. Patient 7 stated he did not read English. A record review of Patient 7’s document titled, “Start of care-further visits planned”, dated 11/10/2023, indicated, …”What is your preferred language? “Spanish”. Do you need or want an interpreter to communicate with a doctor or health care staff? “Yes.” 2) A review of Patient 9’s “Patient Profile” indicated a start of care date (SOC) of 11/6/2023 with diagnoses including essential primary hypertension (high blood pressure). A record review of Patient 9’s document titled, “Start of care-further visits planned”, dated 11/8/2023, indicated, …”What is your preferred language? “Spanish”. Do you need or want an interpreter to communicate with a doctor or health care staff? “Yes.” During an interview on 11/18/2023, at 12:43 p.m., the Director of Nurses (DON) stated written information should be provided in language patients are able to understand so they are aware of the services they are receiving. If patients have questions, it is easier for them to ask because they are able to read the information. During an interview on 11/18/2023, at 12:49 p.m., the Case Manager (CM 1) stated there was no documentation in Patient 9’s record to indicate the HHA provided the information booklet and consents in Spanish. 3) A review of Patient 11’s “Patient Profile” indicated a start of care date (SOC) of 2/2/2023 with diagnoses including sepsis (infection in the blood), urinary tract infection (infection in urine), and diabetes mellitus II (high blood sugar). A record review of Patient 11’s document titled, “Start of care-further visits planned”, dated 2/4/2023, indicated, …”What is your preferred language? “Spanish”. Do you need or want an interpreter to communicate with a doctor or health care staff? “Yes.” During an interview on 11/18/2023, at 12:49 p.m., the Case Manager (CM 1) stated there was no documentation in Patient 11’s record to indicate the HHA provided the information booklet and consents in Spanish. 4) A review of Patient 16’s “Patient Profile” indicated a start of care date (SOC) of 9/15/2023 with diagnoses including hypertensive (high blood pressure) heart disease and chronic kidney disease (CKD, damaged kidneys that can’t filter blood the way they should). A review of Patient 16’s medical record form titled “Start of Care – further visit planned” dated 9/15/2023 to 11/13/2023, indicated “What is your preferred language? “Spanish”. The HHA failed to provide written information in Patients 7, Patient 9, Patient 11, and Patient 16’s preferred language, Spanish. A review of facility’s policy and procedure titled “Patient Bill of Rights” revised 2014, indicated “The agency protects and promotes the right of each individual… the patient is informed both verbally and in writing of all rights including: to effective communication.” 1). A review of Patient 2’s “Patient Profile” indicated a start of care date (SOC) of 9/29/2023 with diagnoses including acute cholecystitis (inflammation of the gallbladder, where a thick liquid called bile is stored, which is produced by the liver to help in digesting fat) and diabetes mellitus type II (high blood sugar). During a concurrent home visit with Licensed Vocational Nurse and patient 2 on 11/16/2023, at 11:00 a.m., review of patient 2’s “Patient Orientation for Home Health”, indicated English literature. During a interview with patient 2 at that time, he stated he does not read English. A review of patient 2’s documented form titled, “What is your preferred language indicated it was Spanish speaking. Patient 2 stated during the home visit he did not read English.”

“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 observation, interview and record review the Home Health Agency (HHA) failed to ensure three of seventeen sampled patients (Patient 7, Patient 13, and Patient 14) received information regarding the State toll free home health complaint telephone hotline, its contact information, its hours of operation, and its purpose. This failure resulted in a violation of patient’s rights due to not having the information necessary to make a complaint regarding the agency’s care or voice their concerns. 1). A review of Patient 7’s “Patient Profile” indicated a start of care date (SOC) of 11/8/2023 with diagnoses including spondylosis cervical region (degeneration of the bones and disks in the neck) and intervertebral disc degeneration, lumbar region (wear and tear of lower back intervertebral disc). During an observation of the home visit on 11/16/2023, at 9:30 a.m., Licensed Vocational Nurse 1 (LVN 1) provided care to Patient 7. During a concurrent interview and record review with Patient 7, on 11/16/2023, at 9:38 a.m., “Patient Orientation for Home Health”, indicated English literature. Patient 7 stated he did not read English. Patient 7 stated he did not know how to contact the California Department of Public Health to report concerns with care. 2). A review of Patient 13’s “Patient Profile” indicated a start of care date (SOC) of 6/14/2023 with diagnoses including stage II pressure ulcer (a shallow open ulcer with a red or pink wound bed), left buttocks. During a concurrent interview and record review on 11/16/2023 at 7:35 a.m. with License Vocational Nurse 1 (LVN1) of Patient 13 HHA patient folder, LVN1 was unable to locate the toll-free Department complaint number. LVN1 stated “I don’t think it is in here.” LVN1 stated that it was the patient’s right to be provided with the toll-free Department complaint number, just in case they want to make a complain about anything. During an interview on 11/16/2023 at 7:35 a.m. with Patient 13, Patient 13 stated she did not know how to file a complaint with the State. 3). A review of Patient 14’s “Patient Profile” indicated a start of care date (SOC) of 9/1/2022 and end of care (EOC) of 9/26/2023 with diagnoses including Diabetes Meletus II (high blood sugar) with hyperglycemia (high blood sugar). During a concurrent interview and record review on 11/16/2023 at 7:35 a.m. with License Vocational Nurse 1 (LVN1) of Patient 14 HHA patient folder, LVN1 was unable to locate the toll-free Department complaint number. LVN1 stated “I don’t think it is in here.” LVN1 stated that it was the patient’s right to be provided with the toll-free Department complaint number, just in case they want to make a complain about anything. During an interview on 11/16/2023 at 6:55 a.m. with Patient 14, Patient 14 stated he does not know where to call to place a complaint. The HHA failed to provide and ensure the Patient 7, 13, and 14 received the State toll free complaint phone number and information.”

“HHA can no longer meet the patient’s needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient’s welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient’s needs, based on the patient’s acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA’s capabilities; This Element is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure one of seventeen sampled patients (Patient 17) was notified of pending discharge. This failure had the potential to result in an unsafe discharge with a possibility of rehospitalization and death due to patient being unable be catheterize self on a daily. A review of Patient 17’s “Patient Profile” indicated a start of care date (SOC) of 3/3/2023 and an End of Care (EOC) date of 9/5/2023, with diagnoses including urinary tract infection (urine infection) and retention of urine (unable to empty all the urine from the bladder). A review of Patient 17’s medical record form titled “Home Health Certification and Plan of Care” dated from 8/30/2023 to 10/28/2023, indicated “SN (skilled nurse) Frequency: daily except for Sunday.” Form also indicated “SN to perform/demonstrate/instruct/supervise to patient/PCG straight catheterization (an intermittent soft hollow tube inserted into the urethra to let urine out of the bladder) 16 French (size of the catheter in diameter) daily for urine retention. There is no willing and able caregiver to perform straight catheterization at this time.” A review of Patient 17’s medical record form titled “Nursing Progress Note” dated 9/4/2023, indicated “Straight catheterization 16 French daily for urine retention. SN to hold full responsibility for care until there is a willing and able caregiver. Advised patient/PCG (patient care giver) of some important tips… drink plenty of fluids every day 8-10 glasses of water or liquid…. Straight catheter inserted using sterile technique. Clear urine immediate return… Total urine output 700 cc (cubic centimeter – unit of measure).” A review of Patient 17’s medical record form titled “Patient Medication Profile” undated, indicated “Spironolactone (medication that help the kidneys remove fluid and salt from the blood through urine) 25 mg (milligrams – unit of measure) oral tablet. Take one tablet by mouth daily.” A review of Patient 17’s medical record form titled “Communication Note” dated 8/30/2023, indicated “(LVN5) spoke with (OS2) at Medical Doctor (MD) office regarding patients request. Per (OS2) that they are short staff in the clinic and will put a request in. (LVN5) advise (OS2) that we have a SN (skilled nurse) to assist with patient requested time to visit on 8/31/2023. (OS2) advise to follow up tomorrow morning regarding assigned home health agency.” A review of Patient 17’s medical record form titled “Communication Note” dated 8/31/2023, indicated “Advise patient we have no staff to accommodate evening. Patient is ok to do early visits till she is able to change agency.” A review of Patient 17’s medical record form titled “Order/Telephone Orders” dated 9/5/2023, indicated “Patient to be discharged from home health services due to unable to accommodate patients requested time after 5pm.” It also indicated “Discharge from (HHA).” A review of Patient 17’s medical record form title “Discharge Summary” undated, indicated “MD office staff (OS1) advise she will notify MD to transfer to another home health agency to accommodate patients care. Case Manager (CM 1) spoke with the patient and advised that there is no willing staff to accommodate patients time 5:00- 8:00 pm. Advised patient that available staff 8:00-10:00 pm. Patient continues to refuse time slot. Came manager advised patient to schedule MD appointment as soon as possible (asap) for daily straight catheterization at MD office until they are able to find a home health agency able to accommodate time requested. Patient aware of discharge.” Form also indicated it was signed on 9/5/2023 by License Vocational Nurse 5 (LVN5). During a concurrent interview and record review on 11/17/2023 at 12:40 p.m. with the Director of Patient Care Services (DPCS) of Patient 17’s Electronic Medical Record (EMR), DPCS stated there was no documentation in Patient 17’s EMR that stated if she was received/admitted by another HHA. DPCS stated Patient 17 needed to be catheterized daily and had a significant amount of residual urine. DPCS stated without daily catheterization, Patient 17 had a risk of developing an infection or be hospitalized. DPCS stated they should have continued their services for Patient 17, until another HHA was found. During a concurrent interview and record review on 11/20/2023 at 10:45 a.m. with DPCS or Patient 17’s EMR, DPCS stated Patient 17 had a discharge order dated 9/5/2023. DPCS stated Patient 17’s end of care date was 9/5/2023. DPCS was unable to state if Patient 17’s was made aware of her discharge. DPCS stated, “There is no documentation the patient was notified she was going to be discharged. She was supposed to be informed of pending discharge; she has to know how to cope with daily cauterization. She is expecting the nurse to be doing on a daily basis…” DPCS stated Patient 17 had to plan out her daily catheterization. DPCS stated they needed to hand off Patient 17 to whoever was going to provide the care that she needs. The HHA failed to inform Patient 17 in advance of being discharge. A review of facility’s form titled “Job Description - Administrator” revised 2014, indicated “The Administrator ensures quality and safe delivery of home health care services; coordinates services that reflect the Agency’s philosophy and standard of care; and plans, develops, implements, and evaluates Agency services, programs, and activities. It also indicated “Directs the Agency’s ongoing function. Evaluates effectiveness and efficiency of the Agency.” A review of facility’s policy and procedure titled “Patient Admission Criteria” revised 2009, indicated “When services are to be terminated, the patient will be notified five (5) working days in advance of the date of termination stating the reason, as possible.” A review of facility’s policy and procedure titled “Discharge Criteria” revised 2009, indicated “Patients are discharged by Agency based on specifically defined criteria. The patient is informed of discharge plan in a timely manner and acknowledges understanding reason.” It also indicated “Patients are discharged by Agency based on specifically defined criteria. The patient is informed of discharge plan in a timely manner and acknowledges understanding reason.” A review of facility’s policy and procedure titled “Transfer/Referral Criteria” revised 2009, indicated “Patients are to be transferred or referred to alternative care situations when specifically defined conditions exist: the Agency becomes unable to meet the patients’ needs. The patient/family and physician will be involved in the transfer and referral decisions as appropriate.””

“Patient’s needs CFR(s): 484.55(c)(4) The patient’s medical, nursing, rehabilitative, social, and discharge planning needs; This Element is not met as evidenced by: Based on observation, interview, and record review, the HHA failed to ensure the comprehensive assessment included information about the doctor who performed the surgery (surgeon) for one of seventeen sampled patients (Patient 7). This deficient practice resulted in delay of care because staff did not have the information of the surgeon, to call and report a change of condition when Patient 7 was complaining of unrelieved pain. A review of Patient 7’s “Patient Profile” indicated a start of care date (SOC) of 11/8/2023 with diagnoses including spondylosis cervical region (degeneration of the bones and disks in the neck) and intervertebral disc degeneration, lumbar region (wear and tear of lower back intervertebral disc). A review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated from 11/8/2023 to 1/6/2024, indicated “Skilled Nurse (SN) to perform skilled assessment/evaluation of all body systems with emphasis on… musculoskeletal, pain/comfort, compliance with prescribed treatment regimen.” It also indicated “Surgical incision to posterior neck: Monitor for s/sx (signs and symptoms) of infection to surrounding area during each visit and report any abnormal findings.” During an observation of the home visit on 11/16/2023, at 9:30 a.m., Licensed Vocational Nurse 1 (LVN 1) provided care to Patient 7. During an interview on 11/16/2023, at 9:33 a.m., Patient 7’s caregiver (CG 1) stated Tylenol (a pain reliever) was not helping Patient 7 manage his pain at night, and as a result, Patient 7 could not sleep at night. During a concurrent observation and interview of the pain assessment during the home visit on 11/16/2023, at 9:57 a.m., LVN 1 asked Patient 7 about his pain. Patient 7 stated his current pain level was “5/10” (based on a pain scale 0 to 10, 0 being no pain, 10 being worst pain). Patient 7 stated to LVN 1 his paint level at nighttime is “11/10”, and Tylenol did not help. Patient 7 stated to LVN 1 his nighttime pain was on his right arm and left leg. Patient 7 stated to LVN 1 he was concerned because when his left leg hurt, it felt warm and spasmed (a sudden, brief, involuntary muscle contraction). During an interview on 11/17/2023, at 10:31 a.m., the DON stated Patient 7’s reported pain on the right arm and left leg could be a complication (problem) of the surgery and needed to be reevaluated by the surgeon (doctor who did the operation) who did the surgery. The DON stated he expected LVN 1, upon being aware of Patient 7’s reported symptoms, to immediately call the doctor’s office to inform about patient 7’s reported symptoms. If LVN 1 was unable to reach the patient’s doctor, the office would have called the doctor on her behalf. The DON stated Patient 7’s complaints of pain on the right arm and left leg, should have been conveyed to the surgeon immediately. The DON stated LVN 1 did not notify the doctor and inform the office when learning about Patient 7’s reported symptoms on 11/16/2023. During an interview on 11/17/2023, at 10:43 a.m., the DON stated Patient 7’s reported symptoms could indicate complications of the surgery and should have been reported to the surgeon. It was important to notify the surgeon for patient safety reasons, if there was a complication due to the surgery, the surgeon needed to reevaluate the patient. The DON stated Patient 7’s initial comprehensive assessment did not have the surgeon’s information and the information about the surgeon should have been included so care staff know who to call for surgical complications. A record review of the HHA’s policy and procedures titled, “Care Planning Process”, dated 2014, indicated, “Policy: In order to assure that care provided is appropriately planned to meet each patient’s specific needs and problems, the Agency will utilize data/information gathered during patient assessment in the care planning process…Procedure…All initial and ongoing assessments will utilize relevant baseline data to determine patient problems, needs, interventions and goals.” The HHA failed to ensure the initial comprehensive assessment had the information of Patient 7’s surgeon, to ensure Patient 7’s medical needs were met.”

“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 document all the medications and treatments the patient was currently using for six of seventeen sampled patients (Patient 2, Patient 7, Patient 8, Patient 13, Patient 14, and Patient 16). This deficient practice placed the patients at risk of drug-to-drug interaction and harm by not knowing which medications the patients were taking. This failure resulted in patients not having an accurate and comprehensive medical list that could place the patients at risk for medication errors and adverse drug reactions. 1). A review of Patient 7’s “Patient Profile” indicated a start of care date (SOC) of 11/8/2023 with diagnoses including spondylosis cervical region (degeneration of the bones and disks in the neck) and intervertebral disc degeneration, lumbar region (wear and tear of lower back intervertebral disc). During an observation of the home visit on 11/16/2023, at 9:30 a.m., Licensed Vocational Nurse 1 (LVN 1) provided care to Patient 7. During a concurrent observation, interview, and record review on 11/16/2023, at 10:00 a.m., LVN 1 reviewed the medications Patient 7 was using form “Patient Medication Profile”, for episode period: 11/8/2023 to 1/6/2023. LVN 1 stated the information on the medication bottle did not match the medication profile for: Docusate (a stool softener). LVN 1 stated the instructions on the label indicated to take the medication for 10 days. The medication profile did not include this information. Robaxin (muscle relaxant). LVN 1 stated the instructions on the label indicated to take the medication for 7 days. The medication profile did not include this information. During an interview on 11/17/2023, at 10:05 a.m., the Director of Nurses (DON) stated medications needed to be reviewed every visit to ensure patients are taking medications as prescribed and for the nurse to update the medication profile for any discrepancies, as this was needed to maintain patient safety. The HHA failed to ensure Patient 7’s medication profile accurately reflected the medications being taken. 2). A review of Patient 8’s “Patient Profile” indicated a start of care date (SOC) of 10/17/2023 with diagnoses including paroxysmal atrial fibrillation (irregular heartbeat that normalizes within 7 days on its own or with treatment). During a concurrent observation and interview of the home visit on 11/16/2023, at 11:20 a.m., Licensed Vocational Nurse 2 (LVN 2) reviewed the medications Patient 7 was taking. LVN 2 stated she did not have a medication profile with her because the HHA told her there was a medication profile in Patient 7’s home. LVN 2 stated she could not use the copy of the medication profile in Patient 7’s profile because it was not readable. LVN 2 used the surveyor’s copy of medication profile to review the medication Patient 7 was taking. LVN 2 stated medication “Metformin” (a medication used to control blood sugar levels) was not included in the medication profile. Medication “Levofloxacin” (a medication used to treat or prevent infection) was listed but patient was no longer taking. Medication “Carvedilol” (a medication used for high blood pressure) was listed but the instructions on how to take it were not indicated in the medication profile. During an interview on 11/19/2023, at 11:37 a.m., the DON stated the nurse needed to use a medication profile when reviewing medication to ensure the accuracy of the profile. If the medication profile was not accurate, the nurse needed to report the discrepancy to the HHA to make sure the profile is updated. The HHA failed to ensure Patient 8’s medication profile accurately reflected the medications being taken. 3). A review of Patient 13’s “Patient Profile” indicated a start of care date (SOC) of 6/14/2023 with diagnoses including stage II pressure ulcer (a shallow open ulcer with a red or pink wound bed), left buttocks. A review of Patient 13’s medical record form titled “Home Health Certification and Plan of Care” dated 10/12/2023 – 12/10/2023, indicated “SN (skilled nurse) to teach/instruct patient/pcg (patient care giver) disease process and its management, medication regimen…” A review of Patient 13’s medical record form titled “Patient Medication Profile” undated, indicated “Aspirin (fast acting medication to thin the blood, absorbed in the stomach) 81 mg (milligrams – unit of measure), take 1 tablet orally once daily; Klor-con (medication to treat or prevent low potassium in the blood) 10 mEq (milliequivalent – unit of measure) 1 tablet by mouth three times daily; Senna-lax (medication to treat constipation) 8.6 mg oral tablet, 2 tablets by mouth as needed at bedtime.” During a concurrent observation, interview, and record review on 11/16/2023 at a.m. with License Vocational Nurse 1 (LVN1) of Patient 13’s medications and HHA medication list, LVN1 stated she visits Patient 13 twice a week, to administer Ozempic (medication to lower blood sugar) every Monday. Patient 13’s HHA medication list was compared to her medication bottles, with the following findings: HHA medication list: -Aspirin 81 mg -Klor-con 10 mEq -Senna-lax 8.6 mg take 2 tablets as needed at bedtime Medication Label: -Aspirin EC 81 mg (long lasting medication to thin the blood, absorbed in the small intestine to prevent stomach ulcers) - Klor-con ER 10 mEq (long lasting medication to treat low potassium blood levels) -Senna-lax 8.6 mg take 2 tablets at bedtime, filled 10/25/2023 During a concurrent interview and record review on 11/18/2023 at 10:45 a.m. with the Director of Patient Care Services (DPCS) of Patient 13’s Electronic Medical Record (EMR), DPCS stated the patient medication list is completed when the patient is seen by a Registered Nurse and the follow up nurse. DPCS stated those medications should be updated regularly. DPCS stated Patient 13’s medication list is not updated. The HHA failed to ensure Patient 13’s current medications were reviewed and updated in their medical record. 4). A review of Patient 14’s “Patient Profile” indicated a start of care date (SOC) of 9/1/2022 and end of care (EOC) of 9/26/2023 with diagnoses including Diabetes Meletus II (high blood sugar) with hyperglycemia (high blood sugar). A review of Patient 14’s medical record form titled “Home Health Certification and Plan of Care” dated 10/26/2023 – 12/24/2023, indicated “SN (skilled nurse) to teach/instruct patient/pcg (patient care giver) disease process and its management, medication regimen…” A review of Patient 14’s medical record form titled “Patient Medication Profile” undated, indicated “Aspirin (fast acting medication to thin the blood, absorbed in the stomach) 81 mg, take 1 tablet orally once daily; Jardiance (medication to lower blood sugar) 25 mg take 1 tablet orally once daily; Metoprolol (fast acting medication to lower blood pressure, chest pain and heart attack) 25 mg, take 1 tablet orally once daily.” During a concurrent observation, interview, and record review on 11/16/2023 at 6:40 a.m. with LVN 1of Patient 14’s medications and HHA medication list, LVN1 stated she reconciles patients’ medications weekly. LVN1 stated the last time Patient 14’s medications were reconciled were Saturday, 11/11/2023. Patient 14’s HHA medication list was compared to his medication bottles, with the following findings: HHA medication list: -Aspirin 81 mg -Jardiance 25 mg take 1 tablet orally once daily -Metoprolol 25 mg Medication Label: -Aspirin EC (long lasting medication to thin the blood, absorbed in the small intestine to prevent stomach ulcers) 81 mg -Jardiance 25 mg take ½ tablet, filled on 9/26/2023 -Metoprolol XL Succinate (long lasting medication to lower blood pressure, chest pain, and heart failure) 25 mg LVN 1 stated Metoprolol and Aspirin labels are different than the HHA medication list. LVN 1 stated it needs to be identical “so patients get the correct medication/dose.” LVN 1 stated there is a reason for the Aspirin AC and not the regular aspiring. LVN 1 stated the reason is that it is enteric coated does not irritate the stomach. LVN 1 stated Patient 14’s Jardiance was filled on 9/26/2023. Patient 14’s home medications also included Fluticasone (medication to treat asthma and emphysema), filled on 11/9/2023. Fluticasone was not listed on Patient 14’s HHA medication list. During a concurrent interview and record review on 11/18/2023 at 11:30 a.m. with the Director of Patient Care Services (DPCS) of Patient 14’s Electronic Medical Record (EMR), DPCS stated the nurse should see the medication vials and look at the fill date and see if there are any changes in the profile. Especially in the assisted living, where they are consistent in the medication record. It appears as though Registered Nurse 1 (RN1) did not reconcile his medication. During an interview on 11/18/2023 at 11:35 a.m. with Case Manager 1 (CM 1), CM 1 stated that she received and uploaded Patient 14’s updated medication list from the assisted living facility he was living in, on 11/15/2023. The HHA failed to ensure Patient 14’s current medications were reviewed and updated in their medical record. 5). A review of Patient 16’s “Patient Profile” indicated a start of care date (SOC) of 9/15/2023 with diagnoses including hypertensive (high blood pressure) heart disease and chronic kidney disease (CKD – damaged kidneys that can’t filter blood the way they should). A review of Patient 16’s medical record form titled “Home Health Certification and Plan of Care” dated 9/15/2023 – 11/13/2023, indicated “Doxycycline (medication to treat bacterial infection) 100 mg oral capsule, take 1 capsule by mouth twice daily for 7 days.” A review of Patient 16’s medical record form titled “Home Health Certification and Plan of Care” dated 11/14/2023 – 1/12/2023, indicated “Doxycycline 100 mg oral cap, take 1 cap by mouth two times daily.” A review of Patient 16’s medical record form titled “Patient Medication Profile” dated from 9/15/2023 – 11/13/2023, indicated “Doxycycline 100 mg oral capsule, take 1 capsule by mouth twice daily for 7 days.” A review of Patient 16’s medical record form titled “Patient Medication Profile” dated from 11/14/2023 – 1/12/2023, indicated “Doxycycline 100 mg oral cap, take 1 cap by mouth two times daily.” It also indicated section “Classification” sections were left blank. A review of Patient 16’s medical record form titled “Start of Care – further visit planned” dated 9/15/2023 to 11/13/2023, indicated Patient 16 is taking antibiotics. During a concurrent interview and record review on 11/17/2023 at 11:45 with the DPCS of Patient 16’s EMR, DPCS stated Patient 16’s medication Doxycycline should have been discontinued and that the nurse auto populated (form automatically fills if prompted to) Patient 16’s medication list. DPCS stated “Sometimes when you click recert, the orders auto populate.” DPCS stated the nurse should have completed a medication reconciliation during her recertification visit completed on 11/13/2023, to identify if Patient 16 was still taking the Doxycycline. DPCS stated that this oversight could result in “overdosage and adverse reactions, the patient should not have been taking it.” DPCS stated the medication classifications should ideally be listed on the patient’s medication list. DPCS stated “so that they are aware of what they are taking to prevent adverse reaction and they need to know the indications.” The HHA failed to identify if Patient 16’s was still taking Doxycycline by not reconciliating the medication list. It also failed to list the medication classifications. During an interview on 11/16/2023 at 7:30 a.m. with LVN1, LVN 1 stated if medication list and medication labels do not match patient can have an overdose. LVN 1 stated “It’s not being given as ordered, you won’t get the right outcome, the expected outcome.” During an interview on 11/16/2023 at 10 a.m. with DPCS, DPCS stated it is the nurses’ job is to ask the patient if they have seen a physician or if they were prescribed new medications then the nurse needs to instruct the patient and care giver about the new medications. DPCS stated “The RNs places documents in the medication profile, the LVN will compare that list with the medication vials. This is supposed to be done every visit.” DPCS stated if there are any discrepancies the visiting LVN will notify the RN in charge of the case and the HHA case manager, to make the appropriate changes. DPCS stated the case manager calls the physician if the nurse is unable to, to inform of the medication changes. DPCS stated “It is important to review the medications because sometimes patients may be taking the wrong dose.” DPCS stated safety is the number one issue. A review of facility’s policy and procedure titled “Medication Administration” revised 2014, indicated “Patients will be assessed and reassessed on an ongoing basis for medication effectiveness and actual or potential drug related problems. Staff will use information from medication monitoring to assess the medications continued administration and will communicate medication findings to patient’s physician and other appropriate staff.” A review of facility’s policy and procedure titled “Medication Administration” revised 2014, indicated “Agency staff will check all patient medicines to identify possible ineffective drug therapy or adverse reactions, significant side effects, drug allergies and contraindicated medication and report any problems to the physician.” A review of facility’s policy and procedure titled “Medication Labels” revised 2014, indicated “Agency staff will review patients’ medication at time of admission and on an ongoing basis.” A review of facility’s policy and procedure titled “Medication Reconciliation” revised 2014, indicated “At time of admission, the admitting RN (Registered Nurse), PT (Physical Therapist), or SLP (Speech Language Therapist) will create and document a complete list of medications that patient is taking at home, including dose, route, and frequency. Medication ordered while the patient is receiving will be compared to the medication list/profile. The medication list/profile will be updated with each new or changed medication.” A review of facility’s policy and procedure titled “Medication Labels” revised 2014, indicated “Each medication should be labeled with medication name, strength, amount, frequency, and expiration date.” A review of facility’s form titled “Job Description - Administrator” revised 2014, indicated “The Administrator ensures quality and safe delivery of home health care services; coordinates services that reflect the Agency’s philosophy and standard of care; and plans, develops, implements and evaluates Agency services, programs and activities.” A review of facility’s policy and procedure titled “Medication Orders” revised 2014, indicated “Each patients record will reflect a diagnosis, condition or indication for use for each medication ordered.” It also indicated “Agency staff will verify with the physician any incomplete, illegible or unclear medication orders prior to administering the medication and/or providing patient education about the medication.” 1). A review of Patient 2’s “Patient Profile” indicated a start of care date (SOC) of 9/29/2023, with diagnoses including acute cholecystitis (inflammation of the gallbladder, where a thick liquid called bile is stored, which is produced by the liver to help in digesting fat) and diabetes mellitus type II (high blood sugar). During a concurrent home visit with License Vocational Nurse (LVN) and patient 2 in his residence, the discrepancy with patient 2’s medication profile revealed the following: Review of patient 2’s medication profile given to the surveyor dated 9/25/2023, indicated Hydralazine 50 mg /oral /take one tab twice a day. Review of patient 2’s medication bottle in his residence, with a fill date of 10/27/2023, indicated Hydralizine 25 mg. ( a unit of measure) take 2 tablets twice a day. Review of patient 2’s medication profile indicated for patient 2 to take Sevelamer HCL 800 mg. ( a unit of measure) tablets /oral/take 4 tablets 3 times daily. Review of Patient 2’s medication bottle with refill date of 10/27/2023, in the home with patient 2 and LVN , indicated Sevelamer Hydrochloride tablet 800 mg. ( a unit dose) 4 tablets, 4 times a day. Medication not listed on Patient 2’s medication profile with a fill date of 19/27/2023, was Lanthanum Carbonate 500mg. (a unit measure) chewable take three times a day.”

“Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure a Registered Nurse updated the comprehensive assessment for the recertification period for two of seventeen sampled patients (Patient 13 and Patient 16). This deficient resulted in Patient 13 blood sugar levels not being monitored. It also had the potential to result in a decline in health status by not assessing and providing the needed interventions to Patient 13 and Patient 16. 1). A review of Patient 13’s “Patient Profile” indicated a start of care date (SOC) of 6/14/2023 with diagnoses including stage II pressure ulcer (a shallow open ulcer with a red or pink wound bed), left buttocks and pressure ulcer of other site, stage II. A review of Patient 13’s medical record form titled “Patient Medication Profile” undated, indicated “Ozempic (medication to sugar levels in the blood) 0.25 mg (milligrams – unit of measure) inject 0.25 mg subcutaneous (under the skin) once a week.” A review of Patient 13’s medical record form titled “Recertification (follow up) assessment” dated 10/12/2023 – 12/10/2023, indicated “Date Assessment Completed: 10/10/2023. Diagnoses (sequencing of diagnoses should reflect the seriousness of each condition and support the disciplines and services provided) Primary Diagnosis Pressure ulcer of left buttocks, stage 2. Other Diagnosis: Pressure ulcer of other site, stage II; hemiplegia (one side of body weakness) and hemiparesis following cerebral infarction affecting right dominant; essential (primary) hypertension (high blood pressure); other seizures (uncontrolled body movement); hyperlipidemia (high fat content in blood) unspecified; and constipation unspecified. A review of Patient 13’s medical record form titled “Home Health Certification and Plan of Care” dated 8/13/2023 – 10/11/2023, indicated “SN (skilled nurse) Frequency: 1w1 (one time once a week), 2w8 (twice a week for eight weeks). SN to perform skilled assessment/evaluation of all body systems with emphasis on… Integumentary (skin), endocrine (hormone levels) … SN to teach/instruct patient/pcg (patient care giver) … meticulous skin care, infection control… It also indicated “SN to teach/demonstrate WOUND CARE to left buttocks/left upper thigh to be done as follows… A review of Patient 13’s medical record form titled “Home Health Certification and Plan of Care” dated 10/12/2023 – 12/10/2023, indicated “SN (skilled nurse) Frequency: 1w1 (one time once a week), 2w8 (twice a week for eight weeks). SN to perform skilled assessment/evaluation of all body systems with emphasis on… Integumentary (skin), endocrine (hormone levels) … SN to teach/instruct patient/pcg… meticulous skin care, infection control… It also indicated “SN to teach/demonstrate WOUND CARE to left buttocks/left upper thigh to be done as follows… During a concurrent observation, interview, and record review on 11/16/2023 at 7:10 a.m. with LVN 1 of Patient 13, LVN 1 stated Patient 13’s wounds have been healed since July 2023. Patient 13 stated that she did have a wound on the left upper back of her thigh. Patient 13 was reminded by Care Giver 2 (CG2) and LVN 1 that her wounds have been healed since July. LVN 1 stated that she does not know why Patient 13’s plan of care included a wound treatment ordered. LVN 1 stated that she reviewed Patient 13’s plan of care on Monday. LVN 1 stated, “I must have missed it.” During a concurrent interview and record review on 11/18/2023 at 10:45 a.m. with the Director of Patient Care Services (DPCS) of Patient 13’s Electronic Medical Record (EMR), DPCS was unable to state if Patient 13 had Diabetes Meletus type 2 (DMII). DPCS stated Patient 13’s doctors medical records stated that she had diet-controlled diabetes but was unable to locate any documentation in Patient 13’s HHA medical records indicating a DMII diagnosis. DPCS stated the registered nurse responsibility is to complete a head-to-toe assessment and patients’ history. DPCS stated all of Patient 13’s registered nurse assessments are incomplete. DPCS stated “Part of the plan of care is to assess patients’ blood sugar control and to be able to know if the blood sugar is unstable so we can call the doctor. DPCS stated Patient 13’s blood sugars readings are not being monitored. DPCS stated “Diabetes has multi organ complications, it can affect multiple organs increasing her risk for mortality.” During a concurrent interview and record review on 11/18/2023 at 10:45 a.m. with the DPCS of Patient 13’s EMR, DPCS stated according to Patient 13’s most current assessment completed on 10/10/2023 by Registered Nurse 1 (RN1), Patient 13 does have wounds. DPCS stated “It is not accurate; our expectations are that they should complete a full body assessment that is part of their job description.” DPCS stated “She does have a wound, according to the nursing notes dated 10/13/2023. The nurse documented stage II. I am not aware if the patient has a wound. LVN 1 should have completed a full body assessment, that is part of the patients care and it is because it is specified in her POC (plan of care – guidelines for individual care planned for patient) SN (skilled nurse) to perform skilled assessment to all body systems including integumentary.” The HHA failed to ensure Patient 13 had an accurate comprehensive nursing assessment to reflect her DMII diagnosis and wound status. 2). A review of Patient 16’s “Patient Profile” indicated a start of care date (SOC) of 9/15/2023 with diagnoses including hypertensive (high blood pressure) heart disease and chronic kidney disease (CKD – damaged kidneys that can’t filter blood the way they should). A review of Patient 16’s medical record form titled “Home Health Certification and Plan of Care” dated 11/14/2023 – 1/12/2023, indicated “Date Assessment Completed: 11/13/2023.” It also indicated sections “Self-Care Follow up Performance; Mobility Follow up Performance; Cognitive Functioning Narrative; Advance Directive” were left blank. It also indicated it was not signed or dated. During a concurrent interview and record review on 11/17/2023 at 11:45 with the DPCS of Patient 16’s EMR, DPCS stated Patient 16’s recertification was not complete and that the nurse was still working on it. DPCS stated “It is important to complete it could lead to errors in the patients’ treatments, the nurse who is following up might see the old or wrong information.” The HHA failed to update Patient 16’s comprehensive assessment five days before her recertification period. A review of facility’s policy and procedure titled “Care Planning Process” revised 2014, indicated “The Nursing Care Plan Update from will be utilized to update the care plan between certification and recertification to document modifications. Will reflect new problems, interventions, goals, and goal evaluation/goal resolution.” A review of facility’s policy and procedure titled “Reassessments/Update of the Comprehensive Assessment” revised 2014, indicated “Each patient will have appropriate reassessments performed and documented.” It also indicated “Staff will additionally reassess each patient with each home visit on an ongoing basis to evaluate current problems and needs as well as to adjust the care provided. Such reassessment will be documented on discipline-specific visit notes. Staff will analyze the data from assessments and reassessments. Such analysis of data will assist staff in identifying and prioritizing patient needs and problems to direct care and services.” A review of facility’s policy and procedure titled “Medical Record Entries: Authentication” revised 2014, indicated “All medical record entries will be dated and authenticated. All entries in the medical records will be authenticated by staff by signing first name or initial, last name and tilted By authenticating entries in the patients records, staff is validating the correctness of the information. Signatures are legible and legal. If automated clinical record system is used, electronic signature authentication of entries will be in accordance with state law.” A review of facility’s form titled “Job Description - Administrator” revised 2014, indicated “The Administrator ensures quality and safe delivery of home health care services; coordinates services that reflect the Agency’s philosophy and standard of care; and plans, develops, implements and evaluates Agency services, programs and activities.””

“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 interview and record review, for two of seventeen sampled patients (Patient 10 and Patient 13), the home health agency failed to: 1. Ensure Patient 10, who had the wound vacuum on the left stump, had instructions in the plan of care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) how to manage a wound vacuum (machine used as a therapy to help wound heal) on the left stump (the body part left after an amputation. 2. Ensure Patient 13 had the diagnosis of Diabetes Mellitus type 2 (chronic high blood sugar levels) and a POC for interventions formulated. This failure had the potential for Patient 10 and the caregiver will not have the knowledge on how to ensure the wound vacuum will operate effectively and can delay the healing process of the stump, which could lead to serious complications, hospitalization and/or death. This failure resulted in Patient 13 not having her blood sugar monitored which could result to more serious health complications including hospitalizations and death. 1. A review of Patient 10’s “Patient Profile” indicated a start of care date (SOC) of 9/20/2023 with diagnoses including infection of left lower extremity (an end part of a limb of the body) amputation (surgically cutting off a limb) stump (body part left after amputation). During a concurrent interview and record review on 11/19/2023, at 12:50 p.m., the Patient 10’s record titled, Home Health Certification and Plan of Care” for certification period 9/20/2023 to 11/18/2023 were reviewed with the Director of Nurses (DON). The record indicated physician’s order for skilled nurse (SN) to provide negative pressure wound therapy to left stump every three days and as needed for wound complications or wound vacuum malfunction (failure). The DON stated the POC did not indicate instructions how to manage the wound vacuum. The DON stated the wound vacuum must have the proper settings and proper set-up and it was important for the nurses to know the proper settings and set up to make sure the vacuum was working as intended. 2. A review of Patient 13’s “Patient Profile” indicated a start of care date (SOC) of 6/14/2023 with diagnoses including stage II pressure ulcer (a shallow open ulcer with a red or pink wound bed), left buttocks and pressure ulcer of other site, stage II. A review of Patient 13’s medical record titled recertification assessment dated 10/12/2023 – 12/10/2023, indicated assessment was completed on 10/10/2023 with primary diagnosis of pressure ulcer of left buttocks, stage 2 (skin that breaks open, wears away, or forms an ulcer, which is usually tender and painful), hemiplegia (weakness one side of the body) and hemiparesis (inability to move on one side of the body), essential hypertension (high blood pressure), seizures (uncontrolled body movement), hyperlipidemia (high fat content in blood) and constipation. A review of Patient 13’s medical record titled Patient Medication Profile undated, indicated, ozempic (medication for persons with abnormal blood sugar levels), inject 0.25 mg subcutaneous (under the skin) once a week. A review of Patient 13’s medical record titled Home Health Certification and Plan of Care, dated 10/12/2023 to 12/10/2023, indicated an order for skilled nurse (SN) visits. Frequency: 1w1, 2w8. During an observation on 11/16/2023 at 7 a.m., Licensed Vocational Nurse (LVN) 1 did not perform Patient 13’s integumentary (skin) or endocrine (glands or organs) assessment and did not provide teachings to Patient 13 regarding the disease process. During an interview and concurrent record review on 11/18/2023 at 10:45 a.m. of Patient 13’s Electronic Medical Record (EMR), the DON was unable to locate any documentation indicating Patient 13 diagnosis of diabetes mellitus type 11 (chronic high blood sugar). The DON stated the registered nurse (RN) responsibility was to complete a head-to-toe assessment and patients’ history. The DON stated all of Patient 13’s RN assessments were incomplete. The DON stated part of the plan of care was to assess patients’ blood sugar control and know if the blood sugar was unstable and report to the doctor. The DON stated Patient 13’s blood sugars readings were not being monitored. The DON stated diabetes can affect multi organ and increase complications and risk for mortality. The DON stated LVN 1 should have completed a full body assessment because it was specified in the POC for SN to perform skilled assessment to all body systems including integumentary.” A review of facility’s document titled, “Job Description - Administrator” revised 2014, indicated, the Administrator ensures quality and safe delivery of home health care service, coordinates services that reflect the agency’s philosophy and standard of care, and plans, develops, implements and evaluates agency services, programs and activities. It also indicated evaluates effectiveness and efficiency of the agency. A review of facility’s policy and procedure (P&P), titled, “Plan of Care – Physician Orders”, revised 2011, indicated the plan of care includes: diagnosis (relevant and secondary.)” A review, of facility’s form titled “Patient Orientation for Home Health Care” undated, indicated “The plan of care is reviewed and updated as needed, based on your changing needs.” A review of facility’s P&P titled, “Plan of Care”, revised 2015, indicated the agency professional staff will promptly alert the physician to any changes that suggests a need to alter the plan of care. The Plan of Care will be reviewed more frequently. A review of facility’s P&P titled, “Reassessments/Update of the Comprehensive Assessment”, revised 2014, indicated staff will additionally reassess each patient with each home visit on an ongoing basis to evaluate current problems and needs as well as to adjust the care provided. Such reassessment will be documented on discipline-specific visit notes. Staff will analyze the data from assessments and reassessments. Such analysis of data will assist staff in identifying and prioritizing patient needs and problems to direct care and services.” A review of facility’s P&P titled, “Care Planning Process”, revised 2014, indicated the Nursing Care Plan Update form will be utilized to update the care plan between certification and recertification to document modifications.”

“Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies. (4) When services are provided on the basis of a physician or allowed practitioner’s verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA’s policies, must document the orders in the patient’s clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies. This Element is not met as evidenced by: Based on interview and record review the Home Health Agency failed to ensure the physician orders for seven of 17 patients (Patients 1, 2, 3, 4 5, 6 and 16) were signed by the physician. This failure had the potential for medication errors. A review of Patient 16’s “Patient Profile” indicated a start of care date (SOC) of 9/15/2023 with diagnoses including hypertensive (high blood pressure) heart disease and chronic kidney disease (CKD – damaged kidneys that can’t filter blood the way they should). A review of Patient 16’s medical record form titled “Order/Telephone Order” dated 9/15/2023, 9/20/2023, and 9/29/2023, indicated sections “Physician Name: (Medical Director 1 – MD1).” It also indicated “Signature:” was left blank. During a concurrent interview and record review on 11/17/2023 at 11:45 with the DPCS of Patient 16’s EMR, DPCS stated “Technically, before we do the final claim… our policy states that MD orders should be signed within one month.” DPCS stated that none of Patient 16’s medical orders were signed for her last recertification. The HHA failed to ensure Patient 16’s medical orders were signed in a timely manner. A review of facility’s form titled “Job Description - Administrator” revised 2014, indicated “The Administrator ensures quality and safe delivery of home health care services; coordinates services that reflect the Agency’s philosophy and standard of care; and plans, develops, implements and evaluates Agency services, programs and activities.” A review of facility’s policy and procedure titled “Plan of Care” revised 2015, indicated “Care and services provided will be provided according to physician orders. Orders are current and updated.” It also indicated “Orders are verified when: there are questions or discrepancies with orders.” A review of facility’s policy and procedure titled “Medication Orders” revised 2014, indicated “Agency staff will verify with the physician any incomplete, illegible or unclear medication orders prior to administering the medication and/or providing patient education about the medication.” A review of facility’s policy and procedure titled “Physician Orders – Verbal Orders” revised 2014, indicated “All verbal orders must be subsequently signed by the physician.” It also indicated “The original order is submitted to the Agency within three (3) business days after receipts(s).” A review of facility’s policy and procedure titled “Physician Orders and Tracking System” revised 2014, indicated “Physician orders are signed and returned to the Agency for placement in the patients’ medical record within 30 – 60 days of the day there are written.” It also indicated “when following up on a late order, document the action taken including the name of the person following up the date and to whom spoken.” 1), A review of Patient 1’s “Patient Profile” indicated a start of care date (SOC) of 6/30/2022 with diagnoses including human immunodeficiency virus (HIV – an infection that attacks the body’s immune system). A review of Patient 1’s medical record form titled “ Home Health Certification And Plan Of Care Order” dated from the start of care date/certification period of 6/30/2022 to current certification period date of ,10/24/2023-12-21-2023, indicated sections “ Attending Physician “Signature ,Date signed :” was left blank. During a concurrent interview and record review on 11/17/2023 at 11:45 with the DPCS of Patient 1’s EMR, DPCS stated “Technically, before we do the final claim… our policy states that MD orders should be signed within one month.” DPCS stated that none of Patient 1’s medical orders were signed. The HHA failed to ensure Patient 1’s medical orders were signed in a timely manner. 2). A review of Patient 2’s “Patient Profile” indicated a start of care date (SOC) of 9/29/2023 with diagnoses including acute cholecystitis (inflammation of the gallbladder, where a thick liquid called bile is stored, which is produced by the liver to help in digesting fat) and diabetes mellitus type II (high blood sugar). A review of Patient 2’s medical record form titled “ Home Health Certification And Plan Of Care Order” for the certification period of 9/29/2023 to 11/27/2023 , indicated sections “ Attending Physician “Signature ,Date signed :” was left blank. During a concurrent interview and record review on 11/17/2023 at 11:45 with the DPCS of Patient 2’s EMR, DPCS stated “Technically, before we do the final claim… our policy states that MD orders should be signed within one month.” DPCS stated that none of Patient 1’s medical orders were signed.. The HHA failed to ensure Patient 2’s medical orders were signed in a timely manner. 3). A review of Patient 3’s “Patient Profile” indicated a start of care date (SOC) of 10/21/2023 with diagnoses including diabetes mellitus type II (high blood sugar) and foot ulcer (open sores or lesions that will not heal or that return over a long period of time.) A review of Patient 3’s medical record form titled “Order/Telephone Order” dated 9/15/2023, 9/20/2023, and 9/29/2023, indicated sections “Physician Name: (Medical Director 1 – MD1).” It also indicated “Signature:” was left blank. During a concurrent interview and record review on 11/17/2023 at 11:45 with the DPCS of Patient 3’s EMR, DPCS stated “Technically, before we do the final claim… our policy states that MD orders should be signed within one month.” DPCS stated that none of Patient 3’s medical orders were signed . The HHA failed to ensure Patient 3’s medical orders were signed in a timely manner. A review of Patient 4’s “Patient Profile” indicated a start of care date (SOC) of 8/18/2023 with diagnoses including chronic obstructive pyelonephritis (inflammation and scarring induced by persistent or recurrent kidney infection or other causes of urinary tract obstruction). A review of Patient 4’s medical record form titled “Order/Telephone Order” dated 9/15/2023, 9/20/2023, and 9/29/2023, indicated sections “Physician Name: (Medical Director 1 – MD1).” It also indicated “Signature:” was left blank. During a concurrent interview and record review on 11/17/2023 at 11:45 with the DPCS of Patient 4’s EMR, DPCS stated “Technically, before we do the final claim… our policy states that MD orders should be signed within one month.” DPCS stated that none of Patient 16’s medical orders were signed The HHA failed to ensure Patient 4’s medical orders were signed in a timely manner. A review of Patient 5’s “Patient Profile” indicated a start of care date (SOC) of 3/1/23, with diagnoses including Neoplasm of Rectum (a disease in which cancer cells form in the tissues of the rectum). A review of Patient 5’s medical record form titled “Order/Telephone Order” dated 9/15/2023, 9/20/2023, and 9/29/2023, indicated sections “Physician Name: (Medical Director 1 – MD1).” It also indicated “Signature:” was left blank. During a concurrent interview and record review on 11/17/2023 at 11:45 with the DPCS of Patient 5.s EMR, DPCS stated “Technically, before we do the final claim… our policy states that MD orders should be signed within one month.” DPCS stated that none of Patient 16’s medical orders were signed. The HHA failed to ensure Patient 5’s medical orders were signed in a timely manner. A review of Patient 6’s “Patient Profile” indicated a start of care date (SOC) of 8/2/23, with diagnoses including cutaneous abscess of back (a buildup of pus in or on the skin). A review of Patient 6’s medical record form titled “Order/Telephone Order” dated 9/15/2023, 9/20/2023, and 9/29/2023, indicated sections “Physician Name: (Medical Director 1 – MD1).” It also indicated “Signature:” was left blank. During a concurrent interview and record review on 11/17/2023 at 11:45 with the DPCS of Patient 6’s EMR, DPCS stated “Technically, before we do the final claim… our policy states that MD orders should be signed within one month.” DPCS stated that none of Patient 6’s medical orders were signed. The HHA failed to ensure Patient 6’s medical orders were signed in a timely manner.”

“Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This Element is not met as evidenced by: Based on interview and record review the Home Health Agency failed to ensure the plan of care (the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) was reviewed and revised by the attending physician. This failure had the potential for the necessary care and services needed will not be addressed and provided to the patients and could result to more complications including hospitalization. A review of Patient 13’s “Patient Profile” indicated a start of care date (SOC) of 6/14/2023 with diagnoses including stage II pressure ulcer (a shallow open ulcer with a red or pink wound bed) on left buttocks and pressure ulcer of other site, stage II. A review of Patient 13’s medical record titled Home Health Certification and Plan of Care, dated 8/13/2023 – 10/11/2023, indicated a primary diagnosis of pressure ulcer of left buttocks, stage 2, pressure ulcer of other site, stage II, hemiplegia (weakness one side of body) and right hemiparesis (weakness or the inability to move on right side of the body) after a cerebral infarction (stroke), hypertension (high blood pressure), seizures (uncontrolled body movement), hyperlipidemia (high fat content in blood) and constipation. The home health certification and plan of care document also indicated the attending physician signature, was left blank. A review of Patient 13’s medical record titled Recertification assessment” dated 10/12/2023 – 12/10/2023, indicated diagnosis including pressure ulcer of left buttocks, stage 2, pressure ulcer of other site, stage II, hemiplegia, and hemiparesis following cerebral infarction, hypertension, seizures, hyperlipidemia and constipation. A review of Patient 13’s undated medical record titled “Patient Medication Profile”, indicated Ozempic (medication to sugar levels in the blood) 0.25 mg (milligrams – unit of measure) inject 0.25 mg subcutaneous (under the skin) once a week.” During an interview and concurrent record review on 11/18/2023 at 10:45 a.m. of Patient 13’s Electronic Medical Record (EMR), the Director of Patient Care Services (DPCS) was unable to state if Patient 13 had Diabetes Meletus type 2 (DM II, chronic high blood sugar levels) and the EMR did not indicate if Patient 13’s blood sugar levels were monitored. The DPCS stated Licensed Vocational Nurse (LVN) 1 should have completed the full body assessment as indicated in the plan of care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers). The DPCS stated if the POC was incorrect, we must notify the physician and make the corrections in the care plan.” A review of Patient 16’s “Patient Profile” indicated a start of care date (SOC) of 9/15/2023 with diagnoses including hypertensive (high blood pressure) heart disease and chronic kidney disease (kidney failure). A review of Patient 16’s medical record titled, “Home Health Certification and Plan of Care” dated 9/15/2023 – 11/13/2023, indicated Skilled Nurse visit daily including weekends for 60 days then reassess. The home health certification and plan of care document did not indicate the attending physician signed. The document was left blank. During a concurrent interview and record review on 11/17/2023 at 11:45 a.m. on Patient 16’s EMR Home Health Certification and Plan of Care, the DPCS stated Patient 16’s POC dated 9/15/2023 – 11/13/2023 was not signed by a physician. A review of Patient 17’s “Patient Profile” indicated a start of care date (SOC) of 3/3/2023 and an End of Care (EOC) date of 9/5/2023, with diagnoses including urinary tract infection and retention of urine (retaining of urine in the bladder). A review of Patient 17’s medical record titled, “Home Health Certification and Plan of Care” dated 8/30/2023 – 10/28/2023, indicated SN visit daily except Sunday. It also indicated the Home Health Certification and Plan of Care was not signed by the physician. The document was left blank. A review of facility’s policy and procedure (P&P) titled, “Plan of Care” revised 2015, indicated the total plan of care will be reviewed and signed by the attending physician and agency personnel involved in the patients care as often as the severity of the patient’s condition requires, but at least once every sixty (60) days. A review of facility’s P&P titled, “Plan of Care – Physician Orders”, revised 2011, indicated each plan of care must be signed and dated by the physician. It also indicated consultation with the physician on any modification in the plan of care will be documented and the physicians signature obtained within 30 – 60 days, or according to state law. Orders are current and updated.”

“Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This Element is not met as evidenced by: Based on observation, interview, and record review, the home health agency failed to ensure the plan of care (process of identifying patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) was revised to reflect current information from the updated comprehensive assessment (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) for one of seventeen sampled patients (Patient 7). This failure resulted in Patient 7 to suffer severe pain on the right arm and left leg when the pain interventions were not effective. A review of Patient 7’s “Patient Profile” indicated a start of care date (SOC) of 11/8/2023 with diagnoses including spondylosis cervical region (degeneration of the bones and disks in the neck) and intervertebral disc degeneration, lumbar region (wear and tear of lower back intervertebral disc). A review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated from 11/8/2023 to 1/6/2023, indicated “SN to perform skilled assessment/evaluation of all body systems with emphasis on… musculoskeletal, pain/comfort, compliance with prescribed treatment regimen.” It also indicated “Surgical incision to posterior neck: Monitor for s/sx (signs and symptoms) of infection to surrounding area during each visit and report any abnormal findings.” During an observation of the home visit on 11/16/2023, at 9:30 a.m., Licensed Vocational Nurse 1 (LVN 1) provided care to Patient 7. During an interview on 11/16/2023, at 9:33 a.m., Patient 7’s caregiver (CG 1) stated Tylenol (a pain reliever) was not helping Patient 7 manage his pain at night, and as a result, Patient 7 could not sleep at night. During a concurrent observation and interview of the pain assessment during the home visit on 11/16/2023, at 9:57 a.m., LVN 1 asked Patient 7 about his pain. Patient 7 stated his current pain level was “5/10” (based on a pain scale 0 to 10, 0 being no pain, 10 being worst pain). Patient 7 stated to LVN 1 his paint level at nighttime is “11/10”, and Tylenol did not help. Patient 7 stated to LVN 1 his nighttime pain was on his right arm and left leg. Patient 7 stated to LVN 1 he was concerned because when his left leg hurt, it felt warm and spasmed (a sudden, brief, involuntary muscle contraction). During an interview on 11/17/2023, at 10:31 a.m., the DON stated Patient 7’s reported pain on the right arm and left leg could be a complication of the surgery and needed to be reevaluated by the surgeon (doctor who did the operation) who did the surgery. The DON stated he expected LVN 1, upon being aware of Patient 7’s reported symptoms, to immediately call the doctor’s office to inform about patient 7’s reported symptoms. If LVN 1 was unable to reach the patient’s doctor, the office would have called the doctor on her behalf. The DON stated Patient 7’s complaints of pain on the right arm and left leg, should have been conveyed to the surgeon immediately. The DON stated LVN 1 did not notify the doctor and inform the office when learning about Patient 7’s reported symptoms on 11/16/2023. During an interview on 11/17/2023, at 10:43 a.m., the DON stated Patient 7’s reported symptoms could indicate complications of the surgery and should have been reported to the surgeon. It was important to notify the surgeon for patient safety reasons, if there was a complication due to the surgery, the surgeon needed to reevaluate the patient. The DON stated Patient 7’s plan of care did not have the surgeon’s information and the information about the surgeon should have been included so care staff know who to call for surgical complications. A record review of the HHA’s policy and procedures titled, “Care Planning Process”, dated 2014, indicated, “Policy: In order to assure that care provided is appropriately planned to meet each patient’s specific needs and problems, the Agency will utilize data/information gathered during patient assessment in the care planning process…Procedure…All initial and ongoing assessments will utilize relevant baseline data to determine patient problems, needs, interventions and goals.” The HHA failed to ensure the POC had the information of Patient 7’s surgeon, to ensure Patient 7’s medical needs were met. A review of Patient 2’s “Patient Profile” indicated a start of care date (SOC) of 9/29/2023 with diagnoses including acute cholecystitis (inflammation of the gallbladder, where a thick liquid called bile is stored, which is produced by the liver to help in digesting fat) and diabetes mellitus type II (high blood sugar). A review of Patient 2’s medical record form titled “Home Health Certification Plan of Care (POC) , for the certification period of 9/29/2-23 – 11/27/2023, instructed the skilled nurse (SN) to visit once a week for one week (1W!), and two times a week for 8 weeks (2W8) to assess/evaluate all body systems, check central Cath on right chest for infection, numbness/tingling in the area, and pain due to patient 2’s ongoing dialysis every Monday-Wednesday-Friday. During a home visit with LVN 4 on 11/16/2023, at 11:a.m, in patient 2’s residence, LVN4 stated that patient 2 had been on peritoneal dialysis (a type of dialysis that uses the peritoneum in a person’s abdomen as the membrane through which fluid and dissolved substances are exchanged with the blood. It is used to remove excess fluid, correct electrolyte problems, and remove toxins in those with kidney failure.) which his does himself in his home. During a telephone interview translated on 11/17/2023, at 12.pm., Patient 2 stated he was on hemodialysis when he first started with the HHA , however he has been doing peritoneal dialysis for the last 3 weeks. During a concurrent record review of Patient 2’s EMR and interview with the DPCS on 11/17/23,the EMR indicated patient 2 was receiving hemo-dialysis ( is a procedure where a dialysis machine and a special filter called an artificial kidney, or a dialyzer, are used to clean your blood.) however, there was no documentation when patient 2 started peritoneal dialysis . The DPCS was unable to find any documentation that patient 2 was on peritoneal dialysis. The DPCS stated the plan of care should have been updated to reflect patient 2’s current condition.”

“Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This Element is not met as evidenced by: Based on observation and interview, the Home Health Agency failed to ensure two of seventeen sampled patients (Patient 13 and Patient 14), received education regarding the disease process and training in the administration of insulin (medication to control blood sugar levels) injection. This failure had the potential to result in patient not receiving the knowledge on how to manage his disease. A review of Patient 13’s “Patient Profile” indicated a start of care date (SOC) of 6/14/2023 with diagnoses including stage II pressure ulcer (a shallow open ulcer with a red or pink wound bed) on left buttocks and pressure ulcer of other site, stage II. A review of Patient 13’s medical record titled Patient Medication Profile undated, indicated, ozempic (medication for persons with abnormal blood sugar levels), inject 0.25 mg subcutaneous (under the skin) once a week. A review of Patient 13’s medical record titled Home Health Certification and Plan of Care, dated 10/12/2023 to 12/10/2023, indicated an order for skilled nurse (SN) to do one (1) visit for 1 week, then two visits for eight weeks (1w1, 2w8) to perform skilled assessment/evaluation of all body systems with emphasis on… integumentary (skin), endocrine (hormone levels and to teach/instruct patient/caregiver the disease process and its management, medication regiment, diet, meticulous skin care and infection control, pain management, energy conservation, fall precaution, equipment safety measures, and 911/emergency protocol.” During a concurrent observation and interview on 11/16/2023 at 7 a.m., Licensed Vocational Nurse (LVN) 1 did not perform Patient 13’s integumentary (skin) or endocrine (glands or organs) assessment and did not provide teachings to Patient 13 regarding the disease process, diet, skin care and insulin administration. LVN 1 stated ozempic (injectable medication to lower blood sugar) had been administered to Patient 13 every Mondays. During a concurrent interview and record review on 11/18/2023 at 10:45 a.m. of Patient 13’s electronic medical record (EMR), the Director of Nursing (DON) stated LVN 1 must document instructions provided to the patient and clinical conditions the nurse needed to report to the physician. The DON stated the plan of care (POC, the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) is basically our guide to services provided to the patient in coordination with the doctor to provide the specific care indicated in the care plan. A review of Patient 14’s “Patient Profile” indicated a start of care date (SOC) of 9/1/2022 and end of care (EOC) of 9/26/2023 with diagnoses including diabetes mellitus II (chronic high blood sugar) with hyperglycemia (high blood sugar). A review of Patient 14’s medical record titled “Patient Medication Profile” undated, indicated lantus insulin (long lasting insulin – medication to lower blood sugar levels) solution, to inject 17 units (unit of measurement) subcutaneously (under the skin) once daily. A review of Patient 14’s medical record titled “Home Health Certification and Plan of Care”, dated 10/26/2023 – 12/24/2023, indicated skilled nurse (SN) to teach/instruct patient/ patient care giver (pcg) the disease process and its management, medication regimen. During a joint home visit observation on 11/16/2023 at 6:20 a.m. and concurrent interview for Patient 14 with LVN 1, LVN 1 administered 17 units of Lantus insulin to Patient 14’s right arm. LVN 1 did not provide education and did not provide instruction to Patient 14 how to administer the insulin and did not provide education diet management for DM. During an interview on 11/17/2023 at 1 p.m. with the DON, the DON stated the POC indicated patient and CG teaching/education should have been started at the beginning and with every home visit basing on Patient 14’s diagnosis. It was important for LVN 1 to evaluate the patient and CG understanding of their care, medication, safety concerns. The nurse must evaluate if the patient and or CG were receptive to instructions. The DON stated one of Patient 14’s education/teachings included how to check his blood sugar levels and insulin administration weekly. The DON stated education/teaching should have been done daily. During an interview on 11/16/2023 at 7:30 a.m. with LVN 1, LVN 1 stated patient’s plan of care are guidelines for Patient 14’s care. LVN 1 stated Patient 14’s POC stated the patients’ goals, limitations, medication list, diet, physical limitations, and infection control. LVN 1 stated she have not seen Patient 14’s POC in the home health agency’s folder at home. A review of facility’s policy and procedure (P&P) titled “Patient Education” revised 2010, indicated agency staff will provide initial and ongoing education to meet each individual patient’s needs. The P&P also indicated the patient education will be presented in a manner that the patient understands.”

“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 interview, observation, and record review, the Home Health Agency (HHA) failed to ensure two out of seventeen sampled patients (Patient 2 and Patient 10) received treatments and/or services in accordance with their written plan of care. This failure resulted in a delay in healing that could lead to hospitalization and/or death. 2) A review of Patient 10’s “Patient Profile” indicated a start of care date (SOC) of 9/20/2023 with diagnoses including infection of left lower extremity (an end part of a limb of the body) amputation (surgically cutting off a limb) stump (the bit that is left beyond a health joint). A record review of Patient 10’s document titled, “Home Health Certification and Plan of Care”, for certification period 9/20/2023 to 11/18/2023, indicated the skilled nurse was to visit the patient twice a week, perform skilled assessment/evaluation of all body systems, provide negative pressure wound therapy to left stump every three days and as needed for wound complication and to teach/demonstrate wound care. A record review of Patient 10’s document titled, “Order/Telephone Orders”, dated 10/10/2023, indicated the skilled nurse was to monitor for proper wound healing process and infection control for further prevention of hospitalization and to notify the doctor for significant findings. During an interview and concurrent record review on 11/19/2023, at 12:14 p.m., the Director of Nurse (DON) reviewed Patient 10’s electronic medical record to review the nursing notes. The DON stated a wound assessment which included documentation on wound locations, characteristics, drainage, size, appearance, surrounding skin, and staging if appropriate, were supposed to be done on a weekly basis. The DON stated pictures were supposed to be taken if the wound was getting better or worse. The DON stated there were no weekly wound assessments between 9/24/2023 to 10/17/2023. The DON stated there were no pictures of the wound. During an interview and concurrent record review on 11/19/2023, at 12:14 p.m., the DON reviewed Patient 10’s record titled, “Nursing Progress Note”, dated 9/20/2023 and “Wound Care Worksheet”, dated 9/23/2023. The DON stated based on the nursing note of 9/20/2023 and 9/23/2023 the wound status remained the same. The “Wound Care Worksheet”, dated 9/23/2023 indicated the wound on the left stump measured 9x9 centimeter (cm, a unit of measurement). During an interview and concurrent record review on 11/19/2023, at 12:27 p.m., the DON reviewed Patient 10’s record titled, “Nursing Progress Note”, dated 10/18/2023. The record indicated the wound on the left stump measured 15.5x9x0.2 cm (the most commonly used wound measurements are length, width, and depth). The DON stated the wound became worse and did not know what happened in between 9/24/2023 to 10/17/2023 because there were no nursing notes. The DON stated there was no documentation in Patient 10’s medical record to indicate interventions were taken and if the doctor had been notified. During a interview and concurrent record review on 11/19/2023, at 12:37 p.m., the DON reviewed Patient 10’s record titled, “Nursing Progress Note” and “Wound Care Worksheet, dated 10/20/2023. The record did not indicate if the wound was improving or worsening. The DON stated, based on the measurement, the status of the wound was the same. During an interview and concurrent record review on 11/19/2023, at 12:37 p.m., the DON reviewed Patient 10’s record titled, “Nursing Progress Note” and “Wound Care Worksheet, dated 10/27/2023. The record did not indicate if the wound was improving or worsening. The DON stated, based on the measurement, the status of the wound was the same. During an interview and concurrent record review on 11/19/2023, at 12:40 p.m., the DON reviewed Patient 10’s record titled, “Nursing Progress Note” and “Wound Care Worksheet, dated 10/31/2023. The record did not indicate if the wound was improving or worsening. The record indicated the wound measurement to be 13.5x7.5x0.2 cm. The DON stated, based on the measurement the status was improving because it was decreasing in size. The DON stated the nurses should document the status of the wound: improving, worsening, or the same. During an interview and concurrent record review on 11/19/2023, at 12:40 p.m., the DON reviewed Patient 10’s record titled, “Nursing Progress Note” and “Wound Care Worksheet, dated 11/3/2023. The record indicated the wound measurement to be 13.5x7.5 cm. The DON stated the record did not indicate if the wound was improving, the same or worsening. The DON stated he did not know what the current status of Patient 10’s wound was because there were no subsequent nursing visit notes after 11/3/2023. The DON stated he did not know if the nurse is following the POC, because there were no notes about the wound assessment. The DON stated by not following the POC, Patient 10 was at high risk for wound deterioration because he was diabetic. Patient 10 should have been referred to the doctor. During an interview on 11/19/2023 at 1:48 p.m., the Case Manager (CM 1) stated Patient 10’s medical record did not indicate the doctor was notified of the worsening wound on 10/18/2023. During an interview on 11/19/2023, at 1:49 p.m., the DON stated the nurse should have notified Patient 10’s doctor on 10/18/2023, as his wound measurement indicated a significant change of condition because the wound worsened significantly. The DON stated the doctor needed to be notified because a plan of care could have changed on 10/18/2023. The doctor could have provided new orders for the patient. The DON stated the outcome was delay in healing. During an interview on 11/19/2023, at 1:54 p.m., the CM 1 stated Patient 10’s medical record did not indicate the doctor had been made aware of the wound changes. A record review of the HHA’s policy and procedure titled, “Residual Limb (Stump) Care”, dated August 2002, indicated, “Documentation Guidelines. 1. Document in the clinical record: a…condition of stump and skin.” A review of facility’s policy and procedure titled “Plan of Care”, revised 2015, indicated “The agency professional staff will promptly alert the physician to any changes that suggests a need to alter the Plan of Care. The Plan of Care will be reviewed more frequently: a significant change in condition occurs, resulting in a change in case-mix assignment.” A review of facility’s policy and procedure titled “Plan of Care”, revised 2015, indicated “Care and services provided will be provided according to physician orders.” A review of facility’s form titled “Job Description - Administrator”, revised 2014, indicated “The Administrator ensures quality and safe delivery of home health care services; coordinates services that reflect the Agency’s philosophy and standard of care; and plans, develops, implements and evaluates Agency services, programs and activities.” It also indicated “Directs the Agency’s ongoing function. Evaluates effectiveness and efficiency of the Agency.” The HHA failed to ensure Patient 10 received services according to the POC by not assessing the wound weekly and notifying the doctor when there was evidence the wound worsened. 1) A review of Patient 2’s “Patient Profile” indicated a start of care date (SOC) of 9/29/2023 with diagnoses including acute cholecystitis (inflammation of the gallbladder, where a thick liquid called bile is stored, which is produced by the liver to help in digesting fat) and Diabetes mellitus type II (high blood sugar). A review of Patient 2’s medical record form titled “Home Health Certification Plan of Care (POC), for the certification period of 9/29/2023 to 11/27/2023, instructed the skilled nurse (SN) to visit once a week for one week (1W), and two times a week for eight weeks (2W8) to assess/evaluate all body systems, check central Catheter (a long, flexible tube provider inserts into a vein in the neck, chest, arm, or groin) on right chest for infection, numbness/tingling in the area, and pain due to Patient 2’s ongoing dialysis (a type of treatment that helps to remove extra fluids and waste products from the body when kidneys are not able to) every Monday-Wednesday-Friday and to report to Medical Doctor (MD): Blood pressure more than 160/90 mmHg (a unit of measurement to measure pressure in the blood vessel). During a home visit with LVN 4 on 11/16/2023, at 11:00 a.m., in Patient 2’s residence, LVN4 stated that patient 2 has a history of unstable blood pressure when she comes to visit. LVN 4 stated but pressure is always high. During the home visit Patient 2’s blood pressure was documented at 178/88 (120/80 mmHg considered normal blood pressure, 140/90 mmHg considered high blood pressure). During an interview and concurrent record review with the Director of Patient Services (DPCS) of Patient 2’s electronic medical record, on 11/17/2023 at 12:00 p.m., skilled Nursing Progress notes dated 10/28/2023, indicated Patient 2’s blood pressure was 166/101 mmHg, then it was rechecked and the blood pressure was 157/88 mmHg. The DPCS stated patient 2’s high blood pressure readings should have been reported to the Medical Doctor. A review of the skilled Nursing Progress Notes dated 10/31/2023 indicated that Patient 2’s blood pressure was 193/75 mmHg, then it was rechecked and the blood pressure was 172/8p mmHg. A review of the skilled Nursing Progress notes dated 11/16/2023 indicated patient 2’s blood pressure was 169/99 mmHg. There was no documented evidence that the medical doctor was informed about the patients high blood pressure. The HHA failed to ensure Patient 2 received services according to the POC and the doctor was notified of elevated blood pressure.”

“Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to perform supervisory visits for their Licensed Vocational Nurse (LVN) services for six out of 17 sampled patients (Patient 6, Patient 10, Patient 11, Patient 12, Patient 13, and Patient 14). This failure resulted in delay of wound healing for Patient 10. This failure also had the potential to result in patients being taken care of by an unqualified staff. 2) A review of Patient 10’s “Patient Profile” indicated a start of care date (SOC) of 9/20/2023 with diagnoses including infection of left lower extremity (an end part of a limb of the body) amputation (surgically cutting off a limb) stump (the bit that is left beyond a health joint). A record review of Patient 10’s document titled, “Home Health Certification and Plan of Care”, for certification period 9/20/2023 to 11/18/2023, indicated the skilled nurse was to visit the patient twice a week, perform skilled assessment/evaluation of all body systems, provide negative pressure wound therapy to left stump every three days and as needed for wound complication and to teach/demonstrate wound care. A record review of Patient 10’s document titled, “Order/Telephone Orders”, dated 10/10/2023, indicated the skilled nurse was to monitor for proper wound healing process and infection control for further prevention of hospitalization and to notify the doctor for significant findings. During an interview on 11/18/2023, at 12:12 p.m., the Director of Nurses (DON) stated supervisory visits were supposed to be done every 30 days by the registered nurse. During an interview on 11/19/2023, at 12:06 p.m., the DON stated there wasn’t any supervisory visits done for Patient 10. The DON stated there should have been two supervisory visits to ensure the Licensed Vocational Nurse followed the plan of care and to evaluate if there were any unmet needs. During an interview and concurrent record review on 11/19/2023, at 12:14 p.m., the DON reviewed Patient 10’s electronic medical record to review the nursing notes. The DON stated a wound assessments were supposed to be done on a weekly basis. The DON stated pictures were supposed to be taken if the wound was getting better or worse. The DON stated there were no weekly wound assessments between 9/24/2023 to 10/17/2023. The DON stated there were no pictures of the wound. During an interview and concurrent record review on 11/19/2023, at 12:27 p.m., the DON reviewed Patient 10’s record titled, “Nursing Progress Note”, dated 10/18/2023. The record indicated the wound on the left stump measured 15.5x9x0.2 cm. The DON stated the wound became worse and did not know what happened in between 9/24/2023 to 10/17/2023 because there were no nursing notes. The DON stated there was no documentation in Patient 10’s medical record to indicate interventions were taken and if the doctor had been notified. During an interview and concurrent record review on 11/19/2023, at 12:40 p.m., the DON reviewed Patient 10’s record titled, “Nursing Progress Note” and “Wound Care Worksheet, dated 11/3/2023. The record indicated the wound measurement to be 13.5x7.5 cm. The DON stated the record did not indicate if the wound was improving, the same or worsening. The DON stated he did not know what the current status of Patient 10’s wound was because there were no subsequent nursing visit notes after 11/3/2023. The DON stated he did not know if the nurse was following the POC, because there were no notes about the wound assessment. During an interview on 11/19/2023 at 1:54 p.m., the CM 1 stated Patient 10’s medical record did not indicate the doctor had been made aware of the wound changes. During an interview on 11/19/2023, at 1:49 p.m., the DON stated the nurse should have notified Patient 10’s doctor on 10/18/2023, as his wound measurement indicated a significant change of condition because the wound worsened significantly. The DON stated the doctor needed to be notified because a plan of care could have changed on 10/18/2023. The doctor could have provided new orders for the patient. The DON stated the outcome was delay in healing. The HHA failed to supervise the Licensed Vocational Nurse every 30 days to ensure the plan of care was followed. 3) A review of Patient 11’s “Patient Profile” indicated an SOC date of 2/2/2023 with diagnoses including sepsis (infection in the blood), urinary tract infection (infection in urine), and Diabetes Mellitus Type II (high blood sugar). During an interview on 11/19/2023, at 12:02 p.m., the DON stated Patient 11 was missing a second LVN supervisory visit. The DON stated it was important for the registered nurse to supervise the LVN to make sure the POC was being followed, based on the doctor’s orders. The purpose of the supervisory visit was to check with Patient 11 to make sure she was happy with the service and to see if there were any unmet needs. The HHA failed to supervise the Licensed Vocational Nurse every 30 days to ensure the plan of care was followed. 4) A review of Patient 12’s “Patient Profile” indicated an SOC date of 1/4/2023 with diagnoses including Diabetes Mellitus Type II (high blood sugar) and hypertension (high blood pressure). During an interview on 11/19/2023, at 12:06 p.m., the DON stated there was no supervisory visits for Patient 12. The DON stated the HHA did not know if the patient was happy with the services and if the LVN followed the POC. The HHA failed to supervise the Licensed Vocational Nurse every 30 days to ensure the plan of care was followed. 5) A review of Patient 13’s “Patient Profile” indicated an SOC date of 6/14/2023 with diagnoses including stage II pressure ulcer (a shallow open ulcer with a red or pink wound bed), left buttocks. A review of Patient 13’s medical record form titled “Home Health Certification and Plan of Care”, dated 10/12/2023 to 12/10/2023, indicated “SN (skilled nurse) frequency: 1w1 (one time for one week), 2w8 (twice a week for eight weeks).” During an interview and concurrent record review on 11/18/2023 at 10:45 a.m. with the Director of Patient Care Services (DPCS), of Patient 13’s Electronic Medical Record (EMR), DPCS stated he was unable to locate any LVN supervisory visit notes. The HHA failed to conduct an LVN supervisory visit for Patient 13 every 30 days. 6) A review of Patient 14’s “Patient Profile” indicated an SOC date of 9/1/2022 and end of care (EOC) date of 9/26/2023 with diagnoses including Diabetes Meletus Type II (high blood sugar) with hyperglycemia (high blood sugar). A review of Patient 14’s medical record form titled “Home Health Certification and Plan of Care” dated 10/26/2023 to 12/24/2023, indicated “SN Frequency: Daily for 60 days then reassess.” During an interview and concurrent record review on 11/17/2023 at 1:12 p.m. with the DPCS, of Patient 14’s EMR, the DPCS stated, “LVN supervisory visits should be done every 30 days, to double check the LVN is compliant with the patients POC. We also use this as a way to check the patient’s medication profile to do medication reconciliation. We also try to ask the patient if they are satisfied with the services and if their goals are on track.” The DPCS stated the last time Patient 14 had an LVN supervisory visit was on 7/27/2023, but there was no signature on the form, therefore, not valid. The DPCS stated, “I cannot say that he had an LVN supervisory note.” The HHA failed to conduct an LVN supervisory visit for Patient 14 every 30 days. During an interview on 11/18/2023 at 10:45 a.m. with the DPCS, the DPCS stated, “The visits are important to check that the LVN is following the POC and to supervise whether or not the patient is receiving the care based on the POC. We also ask the patient to see if they are satisfied with the services. Also, to review the patient’s medications to make sure they are accurate, second set of eyes.” A review of facility’s form titled “Job Description - Administrator”, revised 2014, indicated “Responsibilities: employs qualified personnel and ensures adequate staff education and evaluation. Assesses employees on an ongoing basis to ascertain their understanding of policies and procedures.” It also indicated “Directs the Agency’s ongoing function. Evaluates effectiveness and efficiency of the Agency.” A review of facility’s undated form titled “Director of Patient Care Services”, indicated “Establishes methods for coordination of care by all disciplines. Establishes staffing patterns which reflect the quality and quantity of various personnel necessary to plan, provide, and supervise the care rendered to clients and families.” A review of facility’s form titled “Job Description – Registered Nurse (RN)”, revised 2009, indicated “Supervises and teaches other nursing personnel.” It also indicated “Workers Supervised: License Practical Nurse…” A review of facility’s form titled “Job Description – Licensed Practical/Vocational Nurse (LPN/LVN)”, revised 2015, indicated “Supervised by: Director of Clinical Services/Nursing Supervisor/RNs.” A review of facility’s undated form, titled “Job Description for Case Manager”, indicated “Assigns field Registered Nurse for 30-day supervisory visits…” A review of facility’s form titled “Job Description – Licensed Practical/Vocational Nurse (LPN/LVN)”, revised 2015, indicated “A qualified Licensed Practical/Vocational Nurse administers skilled nursing care to patients on an intermittent basis in their plan of residence. This is performed in accordance with physician orders and plan of care under the direction and supervision of the Registered Nurse. Services are furnished in accordance with Agency policies.” A review of facility’s undated policy and procedure titled “Supervision of Staff”, indicated “All staff providing home care services will be supervised as outlined by federal and state regulations. To ensure staff competency in the area of communication, anticipation of client needs, ability to respond to the client’s needs, and the ability to perform procedures/techniques properly. When skilled nursing services are being provided to a cline in addition to personal care, the Registered Nurse will make a supervisory on-site visit to the patients home every two (2) weeks.” A review of facility’s policy and procedure titled “Admission Information”, revised 2009, indicated “The provision of home health services are supervised by a person with one of the following qualifications: a physician; a registered nurse…” 1) A review of Patient 6’s “Patient Profile” indicated a start of care date (SOC) of 8/2/2023, with diagnoses including cutaneous abscess of back (a buildup of pus in or on the skin). A record review of Patient 6’s document titled, “Home Health Certification and Plan of Care”, for certification period 8/2/2023 to 9/30/2023, indicated the skilled nurse was to visit the patient daily for 60 days, perform skilled assessment/evaluation of all body systems, teach/demonstrate wound care to back and perform wound care when patient caregiver is not available. A record review of Patient 6’s document titled, “Order/Telephone Orders”, dated 8/2/2023, indicated the skilled nurse was to teach/demonstrate wound care to back, provide wound care when caregiver is not available, to monitor/instruct/demonstrate to caregiver until good return demonstration regarding blood glucose check via fingerstick, and every visit observe proper aseptic technique with insulin preparation/administration, site rotation, and sharps precaution. A review of Patient 6’ LVNs supervisory notes dated 9/6/2023, was not signed in the EMR. During an interview on 11/18/2023, at 12:12 p.m., the Director of Nurses (DON) stated supervisory visits were supposed to be done every 30 days by the registered nurse.”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure clinical records accurately reflected the care for five out of 17 sampled patients (Patient 9, Patient 10, Patient 13, Patient 14, and Patient 17). This failure resulted in an incomplete clinical record. 1) A review of Patient 9’s “Patient Profile” indicated a start of care (SOC) date of 11/6/2023 with diagnoses including essential primary hypertension (high blood pressure). A record review of Patient 9’s record titled, “Home Health Certification and Plan of Care”, for certification period 11/6/2023 to 1/4/2024, indicated a skilled nurse was to visit the patient twice a week for four weeks, the once a week for five weeks. During an interview and concurrent record review on 11/19/2023, at 11:39 a.m., the Director of Nurses (DON) reviewed Patient 9’s medical record to locate nursing notes. The DON stated there were no nursing notes documented. The DON stated the purpose of the nursing note was to document the patients current status at the time of the visit, to see if the nursing staff followed the plan of care, and to see if there was any significant findings the nurse had to report. The HHA failed to ensure Patient 9’s medical records reflected nursing visits were provided according to the plan of care. 2) A review of Patient 10’s “Patient Profile” indicated an SOC date of 9/20/2023 with diagnoses including infection of left lower extremity (an end part of a limb of the body) amputation (surgically cutting off a limb) stump (the bit that is left beyond a health joint). A record review of Patient 10’s document titled, “Home Health Certification and Plan of Care”, for certification period 9/20/2023 to 11/18/2023, indicated the skilled nurse was to visit the patient twice a week, perform skilled assessment/evaluation of all body systems, provide negative pressure wound therapy to left stump every three days and as needed for wound complication and to teach/demonstrate wound care. A record review of Patient 10’s document titled, “Order/Telephone Orders”, dated 10/10/2023, indicated the skilled nurse was to monitor for proper wound healing process and infection control for further prevention of hospitalization and to notify the doctor for significant findings. During an interview and concurrent record review on 11/19/2023, at 12:14 p.m., the Director of Nurse (DON) reviewed Patient 10’s electronic medical record to review the nursing notes. The DON stated a wound assessment which included documentation on wound locations, characteristics, drainage, size, appearance, surrounding skin, and staging if appropriate, were supposed to be done on a weekly basis. The DON stated pictures were supposed to be taken if the wound was getting better or worse. The DON stated there was no weekly wound assessments between 9/24/2023 to 10/17/2023. The DON stated there were no pictures of the wound. During an interview and concurrent record review on 11/19/2023, at 12:40 p.m., the DON reviewed Patient 10’s record titled, “Nursing Progress Note” and “Wound Care Worksheet, dated 11/3/2023. The record indicated the wound measurement to be 13.5x7.5 cm. The DON stated the record did not indicate if the wound was improving, the same or worsening. The DON stated he did not know what the current status of Patient 10’s wound was because there were no subsequent nursing visit notes after 11/3/2023. The DON stated he did not know if the nurse is following the POC, because there were no notes about the wound assessment. The HHA failed to ensure Patient 10’s medical records reflected nursing visits were provided according to the plan of care. 3) A review of Patient 13’s “Patient Profile” indicated an SOC date of 6/14/2023 with diagnoses including stage II pressure ulcer (a shallow open ulcer with a red or pink wound bed), left buttocks. A review of Patient 13’s medical record form titled “Home Health Certification and Plan of Care” dated 10/12/2023 to 12/10/2023, indicated “SN (skilled nurse) frequency: 1w1 (one time for one week), 2w8 (twice a week for eight weeks).” During an interview and concurrent record review on 11/18/2023 at 10:45 a.m. with the Director of Patient Care Services (DPCS) of Patient 13’s Electronic Medical Record (EMR), the DPCS stated the last nursing visit note was documented on 10/13/2023. The DPCS stated the nurse was late in documenting her notes and that she was told she needed to follow the HHA’s policies and procedure. The HHA failed to ensure Patient 13’s medical record reflected her current condition. 4) A review of Patient 14’s “Patient Profile” indicated an SOC date of 9/1/2022 and end of care (EOC) date of 9/26/2023 with diagnoses including Diabetes Meletus II (high blood sugar) with hyperglycemia (high blood sugar). A review of Patient 14’s medical record form titled “Home Health Certification and Plan of Care”, dated 10/26/2023 to 12/24/2023, indicated “SN Frequency: Daily for 60 days then reassess.” During an interview and concurrent record review on 11/17/2023 at 1:12 p.m. with the DPCS of Patient 14’s EMR, the DPCS stated the last nursing visit note was documented on 10/31/2023. The DPCS stated there should be nursing documentation for the month of November to be able to know what the nurses’ task were. The DPCS stated, “We do not know how the patient is doing. We are supposed to know because it is our responsibility to know that his BS (blood sugar) is stable and to know if there are any reportable parameters so that his POC (plan of care, an individualize care planned for a patient) can be reviewed and revised as needed.” The HHA failed to ensure Patient 14’s medical record reflected his current condition. 5) A review of Patient 17’s “Patient Profile” indicated an SOC date of 3/3/2023 and an End of Care (EOC) date of 9/5/2023, with diagnoses including urinary tract infection and retention of urine (unable to empty all the urine from the bladder). A review of Patient 17’s medical record form titled “Home Health Certification and Plan of Care”, dated 8/30/2023 to 10/28/2023, indicated “SN Frequency: Daily except for Sunday.” During an interview and concurrent record review on 11/17/2023 at 1:12 p.m. with the DPCS of Patient 13’s EMR, the DPCS stated there was no documentation in Patient 17’s EMR to indicate she was made aware of her pending discharge. The HHA failed to ensure Patient 17’s medical record reflected her current condition and knowledge of the date and reason for her discharge. During an interview on 11/16/2023 at 10:18 a.m. with the DPCS, the DPCS stated patients’ documentation of visits should be completed no later than the following Monday after their visit. The DPCS stated the visiting nurse need to contact the case manager to report any changes in a patient’s condition. The DPCS stated, “It is important to document and monitor any significant clinical findings. The 485 (POC) have parameters and goals, the nurse should contact the CM (case manager) if there are any changes.” A review of facility’s form titled “Job Description - Administrator”, revised 2014, indicated “The Administrator ensures quality and safe delivery of home health care services; coordinates services that reflect the Agency’s philosophy and standard of care; and plans, develops, implements, and evaluates Agency services, programs, and activities. “It also indicated “Directs the Agency’s ongoing function. Evaluates effectiveness and efficiency of the Agency.” A review of facility’s policy and procedure titled “Plan of Care”, revised 2015, indicated “The agency professional staff will promptly alert the physician to any changes that suggests a need to alter the Plan of Care. The Plan of Care will be reviewed more frequently: a significant change in condition occurs, resulting in a change in case-mix assignment.” A review of facility’s policy and procedure titled “Timely Submission of Patient Documentation”, revised 2009, indicated “The agency will ensure the timely and proper submission of patient documentation. Itineraries, with all visit reports attached, must be submitted the next schedule workday, not exceeding ten (10) business days. All patients visit reports from contracted personnel must be submitted within ten (10) business days from the date of the visit…” A review of facility’s policy and procedure titled “Medical Record Entries: Authentication”, revised 2014, indicated “All medical record entries will be dated and authenticated. All entries in the medical records will be authenticated by staff by signing first name or initial, last name and tilted by authenticating entries in the patients records, staff is validating the correctness of the information. Signatures are legible and legal. If automated clinical record system is used, electronic signature authentication of entries will be in accordance with state law.” A review of facility’s policy and procedure titled “Care Planning Process”, revised 2014, indicated “In order to assure that care provided is appropriately planned to meet each patients’ specific needs and problems, the Agency will utilize data/information gathered during patient assessments in the care planning process.””

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to send all necessary medical information to the primary care practitioner within five days of discharge for two out of 17 sampled patients (Patient 11 and Patient 12). This deficient practice resulted in the primary care practitioner not receiving information regarding the services and care provided by the HHA. 1) A review of Patient 11’s “Patient Profile” indicated a start of care (SOC) date of 2/2/2023 and end of care date of 3/31/2023 with diagnoses including sepsis (infection in the blood), urinary tract infection (infection in urine), and Diabetes Mellitus II (high blood sugar). During an interview on 11/19/2023, at 12:12 p.m., the Director of Nursing (DON) stated there was no discharge summary documentation for Patient 11. 2) A review of Patient 12’s “Patient Profile” indicated an SOC date of 1/4/2023 and end of care date of 2/24/2023 with diagnoses including Diabetes Mellitus II (high blood sugar) and hypertension (high blood pressure). During an interview on 11/19/2023, at 12:11 p.m., the DON stated the discharge summary was filled out, but not authenticated and could not be considered a complete document. The DON stated the discharge summary was not sent to the doctor. The HHA was supposed to send it within five days of the discharge so the doctor knew what services were provided and if the goals were met. A review of facility’s form titled “Job Description - Administrator”, revised 2014, indicated “Directs the Agency’s ongoing function. Evaluates effectiveness and efficiency of the Agency.” A review of facility’s form titled “Timely Submission of Patient Documentation”, revised 2009, indicated, “Agency will comply with state/federal laws and regulations related to timely submission of all patient documentation”. The HHA failed to ensure Patient 11 and Patient 12’s doctors received a discharge summary within five days of discharge.”