Every finding on record at Highlight Home Health

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey conducted at 14412 Friar street, suite 204, Van Nuys, CA 91401. Complaint Number: 106813 Representing the California Department of Public Health: Surveyor #22303, Health Facilities Evaluator Nurse Surveyor #44186, Health Facilities Evaluator Nurse Surveyor #42334, Health Facilities Evaluator Nurse Surveyor #49359, Health Facilities Evaluator Nurse Surveyor #19096, Health Facilities Evaluator Nurse Active Patients: 421 Unduplicated Admissions: 911 Sample Size - 22 Home Visits - 7 On 6/14/2024, at 5:20 p.m., the first 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) was called in the presence of the agency’s Administrator (ADM) and Director of Patient Care Services Designee (DPCSD) related to the HHA's failure to ensure the insulin was administered as ordered by the primary care physician (PCP) for Patient 1 and Patient 2 who had a diagnosis of diabetes mellitus that caused Patient 1 and Patient 2 to receive the incorrect insulin doses and placed Patient 1 and Patient 2 at risk for harm. On 6/14/2024, at 5:21 p.m., the second Immediate Jeopardy (IJ) was called in the presence of the agency’s Administrator (ADM) and the Director of Patient Care Services Designee (DPCSD) related to the HHA failure to ensure to maintain complete clinical records for eight sampled patients, Patient 6, Patient 7, Patient 8, and Patient 9, Patient 10, Patient 11, Patient 12, Patient 13. As a result, the non-compliance resulted in incomplete clinical records that does not reflect patients' current condition and needs which likely to cause unidentified needs, serious injury, harm, impairment, or death to a patient. On 6/15/2024, at 12:25 p.m., the HHA submitted an IJ Removal Plan (the facility’s plan of action to correct the deficient practices) for the second IJ. The survey team reviewed the IJ Removal Plan and on 6/15/2024, at 4:25 p.m., the survey team notified the ADM and DPCSD that the IJ Removal Plan was not accepted. On 6/15/2024, at 4:30 p.m., the survey team completed the survey tasks and conducted an exit conference, with the IJ situation not removed. Update 7/18/2024: On 7/9/2024, the HHA submitted an IJ removal plan number six for IJ #1 reviewed and accepted on 7/10/2024. The IJ removal plan as follows: For IJ #1 G580 Situation: • Home Health Agency failed to ensure the insulin medication were administered as ordered by the physician by failing to ensure Patient 1 received insulin Novolog Flex pen to inject 2 units subcutaneously (SQ) once a day before lunch as ordered by the attending physician. The Medical Director wrote an order in the plan of care (POC) to inject Novolog 8 units subcutaneously daily. Family Member 1 administered 8 to 10 units of Novolog insulin if blood sugar reading was greater than 200 mg/dl and 2 units if blood sugar reading was less than 200 mg/dl before lunch daily from 7/5/2023 to 6/11/2024. Patient 1 did not receive correct prescribed insulin unit dose daily. • Home Health Agency failed to ensure RN 1 performed medication reconciliation for Patient 1 during home visit and checked all prescribed medications to ensure the patient was getting correct insulin unit dose as prescribed. • Home Health Agency failed to ensure the medical director and agency staff coordinated with the attending physician to provide the patient the accurate insulin dose on hand. Corrective and Preventative Action Plan: For Patient 1 On Saturday 06/15/24 at 12:51PM, RN 1 contacted patient's pharmacy, Hye Pharmacy, and confirmed patients standing orders for insulin as: Novolog Flex pen 100unit/mL, 2 units subcutaneously once daily before lunch. In the meantime, RN 1 instructed Patient 1 Family Member 1 to continue with standing insulin Novolog orders and continue to monitor patient blood sugar levels and symptoms. RN 1 instructed family member to inform of all glucose readings, until verification of appropriate order. On 06/17/2024 at 2:45 PM, RN 1 spoke with Patient 1 attending physician’s office employee, Liana, to confirm standing orders for insulin Novolog 100unit/mL, 2 units subcutaneously once daily before lunch. On 06/17/2024 at 3:15 PM, RN 1 spoke with Medical Director about the error of insulin dosage. Upon his knowledge of the new findings, MD agreed that attending physician’s standing order for insulin Novolog 100unit/mL, 2 units subcutaneously once daily before lunch, is appropriate for now, until requested new lab orders for fasting blood sugar, electrolytes, and HbA1c received. On 06/18/2024, MD prescribed lab orders for fasting blood sugar, electrolytes, and HbA1C. On 06/17/2024, at 5:00 PM, RN 1 visited Patient 1 in the home to discuss diabetic management and provided education regarding the importance of following physician orders for insulin administration and the dangers of hyper- and hypoglycemia. The patient’s son verbalized understanding of the information provided by the nurse and stated that he will continue to administer insulin Novolog as prescribed. On 06/17/2024, RN validated that Patient 1 and Family Member 1 are competent in diabetic management, insulin administration, and glucometer calibration. On 06/17/2024, RN 1 provided medication reconciliation for Patient 1 during home visit regarding medication adherence and precautions such as taking medications on time, checking expiration dates on medications, disposing of expired medications, taking all medications exactly as prescribed, and reporting any reactions to medical director or nurse. For Patient 2 On Saturday 06/15/24 at 12:45 PM, RN 1 contacted patient's pharmacy, Liberty Rx Pharmacy, to confirm patient insulin Lantus orders, to inject 0.2 unit/kg subcutaneously twice daily. Pharmacy confirmed this is the order they have on file. In the meantime, RN 1 instructed Patient 2 to continue with standing insulin Lantus orders and continue to monitor patient blood sugar levels and symptoms. RN 1 instructed family member to inform of all glucose readings, until verification of appropriate order. On 06/17/2024 at 2:59 PM, RN 1 spoke with Medical Director about the error of insulin dosage. Upon his knowledge of the new findings, MD agreed that attending physician’s standing order for insulin Lantus 100unit/mL, 0.2 units/kg subcutaneously twice daily, is appropriate for now, until requested new lab orders for fasting blood sugar, electrolytes, and HbA1c received. On 06/18/2024, MD prescribed lab orders for fasting blood sugar, electrolytes, and HbA1c. On 06/17/2024 at 4:44 PM, RN 1 spoke with Patient 2 attending physician, to confirm standing orders for insulin Lantus 100unit/mL, 0.2 units/kg subcutaneously twice daily. Dr. Marina Gold stated that she will review Patient 2 medication profile and get back to me the following day. On 06/17/2024, at 6:15 PM, RN 1 visited Patient 2 in the home to discuss diabetic management and provided education regarding the importance of following physician orders for insulin administration and the dangers of hyper- and hypoglycemia. On 06/17/2024, RN validated that Patient 2 is competent in diabetic management and glucometer calibration. On 06/17/2024, RN 1 provided medication reconciliation for Patient 2 during home visit regarding medication adherence and precautions such as taking medications on time, checking expiration dates on medications, disposing of expired medications, taking all medications exactly as prescribed, and reporting any reactions to medical director or nurse. On 06/18/2024 at 1:00 PM, MD, contacted primary physician and stated that he is willing to adjust Patient 2 insulin Lantus dose per her consent. Dr. Gold stated that she is with a patient currently and will get back to him or RN 1 within the next hour. On 06/18/2024 at 1:23 PM, Patient2’s physician called RN 1 back after reviewing Patient 2 medication profile. RN 1 got a verbal order from primary physician to change patients’ insulin orders. New orders state: insulin Lantus 100unit/mL, to inject 20 units subcutaneously once daily in the morning; and insulin Novolin R 100 unit/mL, inject subcutaneously per sliding scale 1-3 times a day as needed for blood sugar greater than 180 mg/dl. Sliding scale orders: 180-200 mg/dl = 4 units, 201-250 mg/dl = 6 units, 251-300 mg/dl = 10 units, 351-400 mg/dl = 12 units, 400+ report to primary physician or medical director. Hold Novolin R injection if blood sugar reading is less than 180 mg/dl. On 7/12/2024 the survey team conducted an onsite visit to verify the implementation of the IJ removal plan. The IJ #1 and IJ #2 was removed on 7/12/2024 at 3:30 pm in the presence of the Administrator/CEO and the RN supervisor. On 06/17/2024, The DON/DPCS of the home health agency conducted in-service training for all agency staff on diabetic management for all current active patients, policies and procedures. The training emphasized the significance of adhering to physician orders, effective care planning, safe administration of medications, maintaining accurate medication profiles, and performing medication reconciliation during each nursing visit. This was done to ensure the diabetic patient receives safe and effective care. On 06/17/2024, the home health agency developed a supervision visit audit form to uphold the corrective action plan and prevent future instances of noncompliance. To ensure ongoing adherence to this plan, a supervisory RN will conduct audits every 14 days for the upcoming quarter. These audits will be documented on a compliance sheet, and a quarterly compliance rate will be calculated. The compliance rate will be determined by dividing the number of supervisory visits with accurate medication profiles and evidence of following physician orders by the total number of supervisory visits, aiming for a 100% compliance goal. Update to IJ Plan of Correction: 7/5/2024 —The agency reviewed all active patients to identify which were diabetic. Of all active patients, 135 were identified as diabetic. Of the 135 diabetic patients, 30 were insulin-dependent or had injectable insulin. For the 30 patients who had insulin injections, the agency sent out a supervisory RN visit to conduct medication reconciliation to ensure that the patient followed the physician’s orders and approved care plan and that the agency had a correct and current medication profile. Of the 30 supervisory visits, the agency identified two patients who was not following the physician’s ordered plan of care for insulin administration. Of the 192 active patient’s reviewed, 135 patients are diabetic, and 30 patients are insulin dependent. All active diabetic patient’s medications have been reviewed and updated during last noted SN visit. Please see attached insulin/non-insulin diabetic patient tracker. Over the next three months, the agency will undergo monthly in-service training sessions emphasizing the significance of thorough care planning, adhering to each patient's personalized care plan, ensuring safe practices for diabetic patients, conducting medication reconciliation, administering medications safely, maintaining accurate medication profiles, and adhering to physician orders. For IJ #2 G1012 Clinical Records The HHA submitted an IJ removal plan number five for IJ #2 on 7/11/2024 and was reviewed and accepted as follow: Situation: • Home Health Agency failed to ensure the clinical records of eight sampled patients (Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, Patient 13) included routine visit clinical notes that reflected the patients’ current health status. Corrective and Preventative Action Plan: The agency updated its Note submission policy to mandate the submission of clinical notes into the medical record within 72 hours of the visit. The agency aims to achieve 100% compliance within the next two weeks. At the time of survey, 421 active patients’ records were reviewed. At the current time, the agency has 192 active patients who were affected by deficient practice of note submission. The agency is no longer admitting any more patients. At the current time, 100 patients have current and up-to-date notes uploaded into the medical record (please see attached document for specific patients completed). Therefore, the current compliance rate is 52%. As of 07/05/24 all clinical notes for Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, Patient 13 have been uploaded. Note submission is 100%. The home health agency will conduct a review every week for 3 months to assess compliance with the new policy and evaluate any remaining backlog of skilled nursing notes. The home health agency will review the effectiveness of the corrective actions and preventative measures implemented during the next quarterly quality assurance meeting. The home health agency will continuously monitor, and update policies and procedures based on ongoing audits and feedback to ensure sustained compliance and adherence in clinical note documentation practices. The agency DON/DPCS designee will track all the patients with incomplete notes and follow up by visiting SN’s daily. DON/DPCS designee will continue the follow ups and update the tracker until all the notes are complete. Within the last 10 days, the agency DON/DPCS designee have been reviewing the uploaded notes and verifying completion. To ensure full implementation of the plan of correction, the agency created a system of consequences for failure to submit notes in a timely manner. First, staff education was provided to ensure a proper understanding of the change in policy to submit notes within seven days of the visit. Two sets of HR interventions were implemented to prevent future noncompliance: the first time a nurse was noncompliant with the note submission requirement, he or she would get a verbal warning. The second time, a written warning will be issued; the third time, the nurse will be suspended from patient visits until all notes are current. All nurses expressed understanding of this process to ensure complete compliance with ensuring the agency maintains up-to-date clinical records. By implementing this Corrective and Preventative Action Plan, the home health agency aims to improve the efficiency and compliance of note uploading into the EMR, thereby enhancing patient care through timely access to comprehensive medical records. On 7/12/2024 the survey team conducted an onsite verification of the IJ removal plan implementation. The IJ was removed on 7/12/2024 at 3:30 pm in the presence of the agency’s Administrator/CEO and the RN supervisor. The following Conditions of Participation was not met: 484.50 Patient rights. 484.55 Comprehensive Assessment of Patients 484.60 Care planning, coordination, quality of care 484.75 Skilled professional services 484.110 Clinical records

Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, agency providing care to home bound patients [patients with difficulty leaving the house]) failed to ensure the Conditions of Participations regarding Patient Rights was met as followed: a. The Home Health Agency (HHA) failed to ensure two of 22 sampled patients (Patient 6 and Patient 8) received consent and information regarding their rights as home health patient in a language that would be understood and preferred by the patients. (Refer to G412) b. The HHA failed to inform one of 22 sampled patients (Patient 8 and) what home health services are to make informed consent when furnishing care and services. (Refer to G434) This deficient practice resulted in the patients not being informed and having a lack of understanding of the HHA’s care and services available for the patients and their families. This deficient practice resulted patients not being able to exercise their right to receive or decline home health services.

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 ensure two of 22 sampled patients (Patient 6 and Patient 8) received consent and information regarding their rights as home health patient in a language that would be understood and preferred by the patients. This deficient practice resulted in the patients not being informed and having a lack of understanding of the HHA’s care and services available for the patients and their families. This deficient practice resulted patients not being able to exercise their rights to receive or decline the home health services. a. A review of Patient 6’s Patient Profile indicated a Start of Care (SOC) date of 5/3/2024, with a primary diagnosis of Type 2 Diabetes Mellitus without diabetic kidney complications (a chronic condition that affects the way the body processes blood sugar) and secondary diagnosis of unilateral primary osteoarthritis (one side degenerative (declining) changes to the cartilage and joint that occur without a known cause) of the left knee. The record indicated English as Patient 6's primary language. During a joint home visit on 6/12/2024 at 1:00 p.m., at Patient 6’s residence with Registered Nurse 1 (RN 1), Patient 6 was observed sitting in the chair, was awake, alert, and oriented to person, place, and time. During a joint home visit on 6/12/2024 at 1:00 p.m., at Patient 6’s residence with RN 1, observed RN 1 was using Patient 6’s caregiver to translate all communication needs to Patient 6 from English to Spanish. During a concurrent observation and interview on 6/12/2024 at 1:00 p.m. with Patient 6, Patient 6 stated his primary language that he speaks and reads is Spanish, he does not speak, understand, or read in English, and at every skilled nurse (SN) visit he needs translator. Patient 6 stated the caregiver or a family member is there to help translate. Patient 6 was observed speaking in Spanish during home visit with RN 1, with the help from his caregiver translating for him. During an observation on 6/12/2024 at 1:20 p.m., of Patient 6’s HHA binder, it indicated all forms including Client Consent/recertification and Patients’ Bill of Right and Responsibilities were in English. During a concurrent interview and record review on 6/15/2024 at 10:40 a.m. with Director of Patient Care Services Designee (DPCSD), Patient 6’s consents and patient’s bill of right and responsibilities were reviewed. DPCSD stated the consents and patient’s bill of rights and responsibilities are all in English. The DPCSD stated she does home visits for Start of Care (SOC) assessments and if a patient does not speak English, she will use a family member or call a staff from the agency to translate. DPCSD stated the HHA only has consent in English and Armenian, not in other languages. DPCSD further stated negative outcome of not having consents in other languages that serve their patient population is that the patients will not be able to read and understand what they are signing. b. A review of Patient 8’s Patient Profile indicated an SOC date of 5/30/2024, with a primary diagnosis of Type 2 Diabetes Mellitus with diabetic polyneuropathy (a type of nerve damage caused by long-term high blood sugar levels) and a secondary diagnosis of primary generalized osteoarthritis (cartilage that lines the joints is worn down over time and bones rub against each other when affected joints were used). The record indicated Spanish as Patient 8’s primary language. A review of Patient 8’s signed “Client’s Consent/ Certification” and “Patient Bill of Rights, Patient Responsibilities” forms were in English. During an interview on 6/13/2024 at 12:33 p.m. with Patient 8, Patient 8 stated her primary language to speak and read is Spanish, and minimally understands some English, but does not speak or read it. Patient 8 stated a lady came to see her in her home sometime in May, was unsure of her title, and had signed forms with her but no copies of the forms were left for the patient. Patient 8 further stated she did not remember what forms she signed and if the forms were about patient rights/responsibilities or consents. During a an interview on 6/15/2024 at 10:40 a.m. with the DPCSD, the DPCSD stated she does home visits for Start of Care (SOC) assessments and if a patient does not speak English, she will use a family member or call a staff from the agency to translate. DPCSD stated the HHA only has consent in English and Armenian, not in other languages. The DPCSD further stated negative outcome of not having consents in other languages that serve their patient population is that the patients will not be able to read and understand what they are signing. A review of the facility’s policy and procedure titled, “Patient Bill of Rights”, with a revised date of November 2022, indicated, “U. The organization shall provide verbal and written notice of the patient’s rights and responsibilities in the patient’s primary or preferred language and in a manner the individual understands”. A review of the facility’s policy and procedure titled, “Informed Consent/Refusal of Treatment”, with a revised date of November 2022, indicated, “Upon admission and throughout the course of care/service, the patient and family/caregiver will be: 1. Given information, in an understandable language, to make informed decisions regarding the care/service being provided.”

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to inform one of 22 sampled patients (Patient 8) what home health services are to make informed consent when furnishing care and services. This failure resulted in the patient not being informed and having a lack of understanding of the HHA’s care and services available for the patients and their families. This deficient practice resulted patients not being able to exercise their rights to receive or decline the home health services. A review of Patient 8’s Patient Profile indicated a Start of Care (SOC) date of 5/30/2024, with a primary diagnosis of Type 2 Diabetes Mellitus with diabetic polyneuropathy (a type of nerve damage caused by long-term high blood sugar levels) and a secondary diagnosis of primary generalized osteoarthritis (cartilage that lines joints is worn down over time and bones rub against each other when affected joints were used). During an interview on 6/13/2024 at 12:33 p.m. with Patient 8, Patient 8 stated she was not aware of being under home health services and did not know what home health was about. Patient 8 stated she had been contacted and visited by a lady who offered to provide Patient 8 with diapers, milk, and creams. Patient 8 stated that the lady came to see her in her home sometime in May, was unsure of her title, and had signed forms with her, but no copies of the forms were left for the patient. Patient 8 further stated that she did not remember what forms she signed, if they were about patient rights or responsibilities, and since that day she has not received what she was promised, and no other staff have called or visited her. Patient 8 stated that the lady did not offer any nursing or therapy services and was not aware that the lady was from a home health agency. Patient 8 further stated that this was the second time she was contacted and offered to be provided goods and did not receive them. Patient 8 stated that she was unaware of who the Medical Director (MD) was and stated her Primary Care Physician (PCP) was not the PCP that was indicated on her patient profile. During a concurrent interview and record review on 6/15/2024 at 10:40 a.m. with Director of Patient Care Services Designee (DPCSD), the DPCSD stated she does home visits for Start of Care (SOC) assessments and if a patient does not speak English, she will use a family member or call a staff from the agency to translate. The DPCSD further stated the consents and patient’s bill of rights and responsibilities are all in English. DPCSD stated the HHA only has consent in English and Armenian, not in other languages. DPCSD further stated negative outcome of not having consents in patient's primary language is that the patients will not be able to read and understand what they are signing. A review of the facility’s policy and procedure titled, “Patient Bill of Rights”, with a revised date of November 2022, indicated, “1. The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care of their rights. 2. The Patient Bill of Rights statement defines the right of the patient to: A. Exercise and understand his or her rights and responsibilities as a patient and not to be subject to discrimination or reprisal for exercising these rights.” A review of the facility’s policy and procedure titled, “Informed Consent/Refusal of Treatment”, with a revised date of November 2022, indicated, “Upon admission and throughout the course of care/service, the patient and family/caregiver will be: 1. Given information, in an understandable language, to make informed decisions regarding the care/service being provided.”

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Comprehensive Assessment of Patients as follows: 1. The HHA failed to assess the patient’s continuing need for home care services for four of 22 sampled patients (Patient 19, Patient 20, Patient 21, and Patient 22). This deficient practice resulted in the provision of an unnecessary home health services to the patients who did not need skilled nursing services. (Refer to G532) 2. The HHA failed to review and document all medication changes and update the medication profile with currently used medications for two of 22 sampled patients (Patient 11 and Patient 19). This deficient practice had the potential to put the patient at risk for medication errors and adverse drug reactions. (Refer to G536) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment. 11

Continuing need for home care CFR(s): 484.55(c)(3) The patient's continuing need for home care; This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA) failed to assess the patient's continuing need for home care services for four of 22 sampled patients (Patient 19, Patient 20, Patient 21, and Patient 22). This deficient practice resulted in the provision of an unnecessary home health services to the patients who did not need skilled nursing services. Findings: a. During a review of Patient 19’s Patient Information sheet indicated a start of care (SOC) of 3/22/2024, with diagnoses including type 2 diabetes mellitus (a condition that results in too much sugar circulating in the bloodstream), hypertensive heart disease (high blood pressure), and hyperlipidemia (a condition in which there are high levels of fat particles [lipids] in the blood). During a review of Patient 19's Home Health Certification and Plan of Care for the certification period starting from 3/22/2024 to 5/20/2024, included an order for the skilled nurse (SN) frequency of visits of once a week for one week and then twice a week for eight weeks, for comprehensive skilled nursing assessment, observation and evaluation of all body systems, perform every visits vital signs (measures the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain assessment, and evaluate therapeutic response to current/new medications and compliance to medication/diet regimen. The goal included patient will be free from signs and symptoms of hypoglycemia (low blood sugar)/hyperglycemia (high blood sugar), will verbalize independence with care, and will be free of any falls, injuries, and hospitalizations. Discharge planning indicated to discharge patient to care of patient caregiver (PCG) or family when goals met with MD (physician) follow up and supervision, and when maximum functional potential have been reached. On 6/13/2024, at 12:05 p.m., a joint home visit was conducted at Patient 19’s residence with a registered nurse (RN 3). Patient 19 was observed awake, alert, oriented (to person, place, and time), and ambulatory using a cane. On 6/13/2023 at 12:18 p.m., during an interview with Patient 19, she stated she takes her medications daily as scheduled, checked her blood sugar every morning and have been controlled with diet and medications, have no wounds, no falls, and no hospitalization for the past year. Patient 19 further stated she was independent with her care and visit her physician regularly. During review of Patient 19's SN Visit notes for the month of May 2024, indicated Patient 19’s blood sugar was within normal parameters, and there were no admissions to the hospital, no episodes of falls, no wound care performed, nor any evidence of the need for skilled nursing services to continue. However, Patient 19 was re-certified for another 60 days of continuous skilled nursing services. During a concurrent interview and record review, on 6/14/2024 at 1:45 p.m., with the agency’s Director of Patient Care Services (DPCS), the DPCS stated Patient 19 had no recent hospitalization, no falls, no wound care, and have no rehabilitation services performed. DPCS stated that based on the patient assessment and visit notes, her goals have been met, and should have been discharged. b. During a review of Patient 20’s Patient Information sheet indicated a start of care date of 3/22/2024, with diagnoses including intervertebral disc degeneration lumbar region (the wear and tear of the lower region of the spinal column [backbone]), hypertensive heart disease, and hyperlipidemia. During a review of Patient 20's Home Health Certification and Plan of Care for the certification period starting from 3/22/2024 to 5/20/2024, included an order for the skilled nurse (SN) frequency of visits of once a week for one week and then two times a week for 8 weeks, for comprehensive skilled nursing assessment, observation and evaluation of all body systems, perform every visits vital signs, pain assessment, and evaluate therapeutic response to current/new medications and compliance to medication/diet regimen. The goal included patient’s skin integrity will remain intact, will demonstrate competence in following medical regimen, and will be free of any falls, injuries, and hospitalizations. Discharge planning indicated to discharge patient when medical condition stabilizes and when maximum functional potential is reached. During a telephone interview, on 6/13/2024 at 9:58 a.m. with Patient 20, he stated he was independent with his care, goes visit his physician regularly, had no falls, no wounds, and no hospitalization. During a review of Patient 20's clinical record indicated there was no documented evidence Patient 20 had any wounds, had any falls or hospitalization, undergoing rehabilitation treatment, nor any evidence of the need for skilled nursing services to continue. However, Patient 20 was re-certified for another 60 days of continuous skilled nursing services. During a concurrent interview and record review, on 6/14/2024 at 1:45 p.m., with the DPCS, she stated Patient 20 had no recent hospitalization, no falls, no wound care, and have no rehabilitation services performed. DPCS stated that based on the patient assessment and visit notes, his goals have been met, and should have been discharged. c. During a review of Patient 21’s Patient Information sheet indicated a start of care date of 3/22/2024, with diagnoses including primary generalized osteoarthritis (a degenerative joint disease, in which the tissues in the joint break down over time), intervertebral disc degeneration lumbar region, and unspecified abnormalities of gait and mobility. During a review of Patient 21's Home Health Certification and Plan of Care for the certification period starting from 3/22/2024 to 5/20/2024, included an order for the skilled nurse (SN) frequency of visits of once a week for one week and then two times a week for 8 weeks, for comprehensive skilled nursing assessment, observation and evaluation of all body systems, perform every visits vital signs, pain assessment, and evaluate therapeutic response to current/new medications and compliance to medication/diet regimen. The goal included patient’s skin integrity will remain intact, patient/PCG will demonstrate competence in following medical regimen, and will be free of any falls, injuries, and hospitalizations. Discharge planning indicated to discharge patient when medical condition stablilizes and when maximum functional potential is reached. During an interview, on 6/13/2024 at 12:40 p.m. with the registered nurse (RN 3), she stated Patient 21 had no wounds, no falls, no hospitalization, have good family support, and family drives him to visit his physician regularly. During a review of Patient 21's clinical record indicated there was no documented evidence Patient 21 had any wounds, had any falls or hospitalization, undergoing rehabilitation treatment, nor any evidence of the need for skilled nursing services to continue. However, Patient 21 was re-certified for another 60 days of continuous skilled nursing services. During a concurrent interview and record review, on 6/14/2024 at 1:45 p.m., with the DPCS, she stated Patient 21 had no recent hospitalization, no falls, no wound care, and have no rehabilitation services performed. DPCS stated that based on the patient assessment and visit notes, his goals have been met, and should have been discharged. d. During a review of Patient 22’s Patient Information sheet indicated a start of care date of 3/22/2024, with diagnoses including spondylosis lumbosacral region (an age-related degeneration of the vertebrae and disks of the lower back) and primary generalized osteoarthritis. During a review of Patient 22's Home Health Certification and Plan of Care for the certification period starting from 3/22/2024 to 5/20/2024, included an order for the skilled nurse frequency of visits of once a week for one week and then two times a week for 8 weeks, for comprehensive skilled nursing assessment, observation and evaluation of all body systems, perform every visits vital signs, pain assessment, and evaluate therapeutic response to current/new medications and compliance to medication/diet regimen. The goal included patient’s skin integrity will remain intact, patient/PCG will demonstrate competence in following medical regimen, and will be free of any falls, injuries, and hospitalizations. Discharge planning indicated to discharge patient when medical condition stablilizes and when maximum functional potential is reached. During a review of Patient 22's clinical record indicated there was no documented evidence Patient 22 had any wounds, had any falls or hospitalization, undergoing rehabilitation treatment, nor any evidence of the need for skilled nursing services to continue. However, Patient 22 was re-certified for another 60 days of continuous skilled nursing services. During a concurrent interview and record review, on 6/14/2024 at 1:45 p.m., with the DPCS, she stated Patient 22 had no recent hospitalization, no falls, no wound care, have no rehabilitation services performed and should have been discharged. During a review of the agency’s policy and procedure titled, "Discharge Criteria and Process", revised November 2022, indicated the purpose of the policy is to outline the process for discharging a patient from service. Services will be terminated when the patient meets one of the following discharge criteria: if appropriate, the physician (or other authorized licensed independent practitioner) and the organization agree that the goals of home care have been attained or are no longer attainable.

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 medication changes and update the medication profile with currently used medications for four of 22 sampled patients (Patients 1, 2, 11 and 19). This deficient practice had the potential to put the patient at risk for medication errors and adverse drug reactions. b. During a review of Patient 19’s Patient Information sheet indicated a start of care (SOC) of 3/22/2024, with diagnoses including type 2 diabetes mellitus (a condition that results in too much sugar circulating in the bloodstream), hypertensive heart disease (high blood pressure), and hyperlipidemia (a condition in which there are high levels of fat particles [lipids] in the blood). During a review of Patient 19's Home Health Certification and Plan of Care for the certification period starting from 5/21/2024 to 7/19/2024, included an order for the skilled nurse (SN) frequency of visits of twice a week for one week and then once a week for 8 weeks, for comprehensive skilled nursing assessment, observation and evaluation of all body systems, perform every visits vital signs (measures the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), assessment of pain, and evaluate therapeutic response to current/new medications and compliance to medication/diet regimen. On 6/13/2024, at 12:05 p.m., a joint home visit was conducted at Patient 19’s residence with a registered nurse (RN 3). Patient 19 was observed awake, alert, oriented (to person, place, and time), and ambulatory using a cane. On 6/13/2024, at 12:25 p.m., during a review of Patient 19’s current medication, the bottle for docusate sodium (used to treat occasional constipation) 100 milligrams 1 tablet orally 2 times a day, and naproxen (can treat fever and pain) 500 milligrams orally 2 times daily could not be found. However, Patient 19’s current medication record provided by the HHA indicated Patient 19 was taking the medication. During a concurrent interview with Patient 19, she stated her physician discontinue these 2 medications about a month ago. There was a bottle of vascepa (reduced fats in adults) 1 gram 2 capsule oral twice a day, filled date 4/26/2024, gabapentin (treat seizures and nerve pain) 100 milligram 1 capsule oral three times a day, filled date 4/26/2024, hydroxyzine (treat nervousness and tension that may occur with certain mental/mood disorders) 25 milligram 1 capsule oral twice a day as needed for anxiety, filled date 5/21/2024, and diclofenac (treat pain, migraines, and arthritis) 25 milligram 1 tablet oral twice a day, filled date 5/22/2024. However, the current medication record provided by the HHA did not have these medications listed. During an interview on 6/14/2024, at 1:45 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated nursing staff need to review patient’s current medication on every nurse visit and update the medication profile in the patient’s clinical record. During a review of Patient 11’s Home Health Certification (HHC) and Plan of Care (POC) form for certification period of 3/27/2024 to 5/25/2024, the HHC and POC indicated patient’s diagnoses included hypertensive heart disease without heart failure (heart disease due to unmanaged high blood pressure for a long time that cases added strain on the heart and leads to heart failure, diabetes mellitus type 2 with polyneuropathy (a peripheral nerve dysfunction, with long term use of insulin). The HHC and POC indicated an order for the skilled nurse (SN) to visit the patient two times a week for 8 weeks, and then once a week for 8 weeks to observation and evaluation of all body systems, assessment of vital signs (measures the basic function of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level and ability to perform activities of daily living (ADL) tasks, and to evaluate therapeutic response to current/new medications and compliance to medication/diet regimen. During a joint home visit, on 6/14/2024 at 11:30 a.m., at Patient 11’s residence with the Registered Nurse (RN 2), Patient 11’s was observed awake and alert. During a concurrent interview and review of Patient 11’s current medication, on 6/14/2024 at 12:05p.m. with the RN 2, a bottle of Risperdal (medicine to treat schizophrenia, bipolar disorder, and irritability caused by autism) 1 mg (milligram, unit of measure) 1 tablet by mouth two times a day with a filled date on 6/11/2024, and Levothyroxine (treat hypothyroidism) 75mcg (microgram) 1 tablet by mouth daily with a filled date on 6/11/2024, were observed. However, the current medication list provided by the HHA indicated Patient 11 was taking Risperdal 3 mg 1 tablet by mouth daily and Levothyroxine 125 mcg 1 tablet by mouth daily. During the interview with RN 2, RN 2 stated, Patient 11’s medication profile/list was not updated. During an interview, on 6/15/2024, at 12:15 p.m., with the Director of Patient Care Services (DPCS), the DPCS stated patient’s medication profile should have been reconciled and updated on every SN visits. During a review of the agency’s undated policy and procedure titled, “Medication Profile/Reconciliation,” indicated patient receiving medications should have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications.

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 for Care planning, coordination, quality of care was met as follows: The HHA failed to ensure the insulin (medication, helps your body turn food into energy and controls your blood sugar levels) was administered as ordered by the primary care physician (PCP) for two of 17 sampled patients (Patient 1 and Patient 2) who had a diagnosis of diabetes Type 2 (a medical condition characterized by the body's inability to regulate blood sugar levels) by failing to: 1. Ensure to coordinate with Patient 1 and Patient 2’s PCP to clarify the correct prescribed insulin dose and add to Patient 1 and Patient 2’s Plan of Care (POC). 2.Ensure Registered Nurse 1 (RN 1) conducted a medication reconciliation (a process of comparing pre-discharge medications for Patient 1 during home visit and checked all prescribed medications) for Patient 1 and Patient 2 during home visits. 3.Ensure Patient 1’s Family Member 1 (FM 1) administered the correct insulin dose as ordered by Patient 1’s PCP. 4. Ensure RN1 administer the correct insulin dose for Patient 2. Patient 1’s PCP ordered on 7/25/2023, for Patient 1 to receive Novolog (fast acting insulin) two units subcutaneous (SQ, injected under the skin) once a day before lunch. Patient 1’s FM 1 would administer eight to ten units of Novolog insulin if Patient 1’s blood sugar (BS) reading was greater than 200 milligrams per deciliter (mg/dl, measures fluid volume) and two units if Patient 1’s BS reading was less than 200 mg/dl before lunch daily. Patient 2’s PCP ordered for Patient 2 who weighed 185 pounds to receive Lantus insulin (long acting) 0.2 units per kilogram (kg) daily (16.8 units) and RN 1 administered 15 units of Lantus insulin in the morning and 15 units at bedtime daily. As a result, Patient 1 and Patient 2 received the incorrect insulin doses and placed Patient 1 and Patient 2 at risk for serious side effect of hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar) that could include confusion, slurred speech, loss of coordination, blurry vision, and unresponsiveness, that could lead to hospitalization and death. (Refer to G580). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated (written law) compliance with the Care planning, coordination, quality of care to ensure the quality of care was provided to the patients who were assessed to receive hospice care and services. 1. The HHA failed to provide physical therapy services (type of treatment to help you move better or strengthen weakened muscles and to relieve pain after an injury or surgery) as indicated in the plan of care for two of 22 sampled patients (Patient 20 and Patient 22). This failure had the potential for patients not to receive the needed services and treatments as prescribed and could potentially affect the patient's health and well-being. (Refer to G572) 3. The agency’s skilled nurse (SN) failed to notify the physician while visiting a patient with an increased blood pressure reading for one of 19 sampled patients (Patient 19). This deficient practice places the patient at a potential risk for complications that could affect their overall health status. (Refer to G602)

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 interview and record review, the home health agency (HHA) failed to provide physical therapy services (type of treatment to help you move better or strengthen weakened muscles and to relieve pain after an injury or surgery) as indicated in the plan of care for two of 22 sampled patients (Patient 20 and Patient 22). This deficient practice had the potential for Patient 20 and Patient 22 not to receive the needed services and treatments as prescribed and could potentially affect the patient's health and well-being. Findings: a. During a review of Patient 20’s Patient Information sheet indicated, Patient 20's start of care (SOC) date of 3/22/2024, with diagnoses including intervertebral disc degeneration lumbar region (the wear and tear of the lower region of the spinal column [backbone]), hypertensive heart disease (high blood pressure), and hyperlipidemia (a condition in which there are high levels of fat particles [lipids] in the blood). During a review of Patient 20's Home Health Certification and Plan of Care for the certification period starting from 3/22/2024 to 5/20/2024, included an order for the skilled nurse (SN) frequency of visits of once a week for one week and then two times a week for 8 weeks, and for the physical therapy to conduct an evaluation and set up a treatment plan. During a review of Patient 20's clinical record (in general) indicated there was no documented evidence that Patient 20 was seen and evaluated by a physical therapist. During a telephone interview, on 6/13/2024 at 9:58 a.m., with Patient 20, Patient 20 stated that he was not visited or treated by the HHA’s physical therapist at home. b. During a review of Patient 22’s Patient Information sheet indicated Patient 22's start of care date of 3/22/2024, with diagnoses including spondylosis lumbosacral region (an age-related degeneration of the vertebrae and discs of the lower back), and primary generalized osteoarthritis (characterized by joint pain, stiffness, limited range of motion, and weakness). During a review of Patient 22's Home Health Certification and Plan of Care for the certification period starting from 3/22/2024 to 5/20/2024, included an order for the skilled nurse (SN) frequency of visits of once a week for one week and then two times a week for 8 weeks, and for the physical therapy to conduct an evaluation and set up a treatment plan. During a review of Patient 22's clinical record (in general) indicated there was no documented evidence Patient 22 was seen and evaluated by a physical therapist. During a concurrent interview and record review, on 6/15/2024 at 12:15 p.m., with the Director of Patient Care Services Designee (DPCSD), the DPCSD stated she did not to find documented evidence the agency’s physical therapist conducted an evaluation and/or treated Patient 20 and Patient 22. DPCSD stated services and treatment should be conducted in accordance with the plan of care. During a review of the agency’s policy and procedure titled, “Care Planning Process”, revised November 2022, indicated a written plan of care will be initiated within 5 days of start of care and updated at least every 60 days or as patient’s condition warrants. The plan of care will be based upon the physician’s (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies, and services required to meet the patient’s needs.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to ensure the insulin (medication, helps your body turn food into energy and controls your blood sugar levels) was administered as ordered by the primary care physician (PCP) for two of 17 sampled patients (Patient 1 and Patient 2) who had a diagnosis of diabetes Type 2 (a medical condition characterized by the body's inability to regulate blood sugar levels) by failing to: 1. Ensure to coordinate with Patient 1 and Patient 2’s PCP to clarify the correct prescribed insulin dose and add to Patient 1 and Patient 2’s Plan of Care (POC). 2.Ensure Registered Nurse 1 (RN 1) conducted a medication reconciliation (a process of comparing pre-discharge medications for Patient 1 during home visit and checked all prescribed medications) for Patient 1 and Patient 2 during home visits. 3.Ensure Patient 1’s Family Member 1 (FM 1) administered the correct insulin dose as ordered by Patient 1’s PCP. 4. Ensure RN1 administer the correct insulin dose for Patient 2. Patient 1’s PCP ordered on 7/25/2023, for Patient 1 to receive Novolog (fast acting insulin) two units subcutaneous (SQ, injected under the skin) once a day before lunch. Patient 1’s FM 1 would administer eight to ten units of Novolog insulin if Patient 1’s blood sugar (BS) reading was greater than 200 milligrams per deciliter (mg/dl, measures fluid volume) and two units if Patient 1’s BS reading was less than 200 mg/dl before lunch daily. Patient 2’s PCP ordered for Patient 2 who weighed 185 pounds to receive Lantus insulin (long acting) 0.2 units per kilogram (kg) daily (16.8 units) and RN 1 administered 15 units of Lantus insulin in the morning and 15 units and 15 units at bedtime daily. As a result, Patient 1 and Patient 2 received the incorrect insulin doses and placed Patient 1 and Patient 2 at risk for serious side effect of hyperglycemia (high blood sugar), and hypoglycemia (low blood sugar) that could include confusion, slurred speech, loss of coordination, blurry vision, and unresponsiveness, that could lead to hospitalization and death. On 6/14/2024, at 5:20 p.m., 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) was called in the presence of the agency’s Administrator (ADM) and Director of Patient Care Services Designee (DPCSD) related to the HHA's failure to ensure the insulin was administered as ordered by the primary care physician (PCP) for Patient 1 and Patient 2 who had a diagnosis of diabetes mellitus that caused Patient 1 and Patient 2 to receive the incorrect insulin doses and placed Patient 1 and Patient 2 at risk for harm. Findings: a. During a review of Patient 1's Start of Care (SOC) record indicated the HHA admitted Patient 1 on 11/22/2023, with a diagnosis of diabetes Type 2. During a review of Patient 1’s PCP Doctor Authorization Orders, dated 3/19/2024, the Doctor Authorization Orders indicated for Patient 1 to receive Novolog two units SQ once a day before lunch. During a review of Patient 1's Plan of Care (POC) for the certification period of 3/21/2024 to 5/19/2024, indicated a skilled nurse (SN, a licensed nurse in general) was to assess and instruct Patient 1 and Patient 1’s caregiver (PCG) the importance of medication compliance and high-risk medication use, side effects, contraindications, and possible drug to drug interactions (occur when two or more drugs react with each other). Patient 1’s POC indicated one of the SN interventions was to assess Patient 1 and PCG’s knowledge of diabetic condition and instruct on knowledge deficits on every visit. During a review of Patient 1’s HHA Physician's Order dated 11/22/2023, the HHA’s Physician Orders indicated for Patient 1 to receive Novolin (is an intermediate [middle] acting insulin that is slower to act and lasts longer) SQ to administer eight units daily. During a review of Patient 1’s HHA’s Physician's Order dated 11/22/2023, the Physician Orders indicated for Patient 1 to receive Tresiba (long acting insulin) SQ 50 units daily. During a home visit observation on 6/12/2024, at 12:15 p.m., at Patient 1's residence with Registered Nurse 1 (RN1). Patient 1 was sitting on the couch. Family Member 2 (FM 2) was seen heading towards the refrigerator to show Patient 1's insulin medication. While checking Patient 1’s medication, there was one Novolog flex pen (pre-filled pen/syringe) with a label showing to inject two units SQ once a day before lunch. During an interview on 6/12/2024, at 12:30 p.m., with FM 2, FAM2 stated FM 1 would give Patient 1 eight to ten units of Novolog insulin after lunch time. During a telephone interview on 6/12/2024, at 1 p.m., with FM 1, FM1 stated he would administer Novolog two units to Patient 1 if Patient 1’s blood sugar (BS) readings were below 200 mg/dl. FM1 stated he would administer Novolog eight to ten units if Patient 1’s BS reading were greater than 200 mg/dl daily at noon. During an interview on 6/12/2024, at 1:10 p.m., with RN 1, RN1 stated she would administer Tresiba 50 units to Patient 1 at nighttime and FM 1 would administer the Novolog insulin during lunch time daily. RN1 stated she was not aware FM 1 would administer Novolog eight to ten units when Patient 1’s BS reading were greater than 200 mg/dl and two units below 200 mg/dl without an order of a sliding scale (varies the dose of insulin based on blood glucose level). During an observation on 6/12/2024, at 1:20 p.m., Patient 1's glucometer (an instrument for measuring the concentration of glucose in the blood) was checked and the BS reading registered in the glucometer on 6/11/2024, at 12 p.m., was 264 mg/dl (mg/dl, unit of measurement). During a telephone interview on 6/12/2024, at 3 p.m., with Patient 1's pharmacist, the pharmacist stated the only insulin prescription order for Patient 1 was ordered on 7/25/2023, for Novolog flex pen to inject two units SQ once a day before lunch and Tresiba insulin to administer 50 units SQ daily. b. During a review of Patient 2's Start of Care (SOC) record indicated the HHA admitted Patient 2 on 11/30/2023, with a diagnosis of diabetes Type 2. During a review of Patient 2's POC for the certification period of 3/28/2024 to 5/27/2024, the POC indicated a skilled nurse was to assess and instruct Patient 2 and Patient 2’s PCG the importance of medication compliance and high-risk medication use, side effects, contraindications, and possible drug to drug interactions (occur when two or more drugs react with each other). Patient 2’s POC indicated one of the SN interventions was to assess Patient 2 and PCG’s knowledge of diabetic condition and instruct on knowledge deficits on every visit. During a review of Patient 2’s HHA’s Physicians Order dated 11/30/2023, included in the POC, indicated for Patient 2 to receive Lantus (long acting insulin) 10 units to 15 units SQ twice daily. During a home visit observation on 6/13/2024, at 12 p.m., at Patient 2’s residence with RN 1, Patient 2 was sitting on a chair. While checking Patient 2’s medication, there was one undated half- filled vial that was open of Lantus insulin with a label showing to inject 0.2 units per Kilogram (kg, a unit of mass) SQ daily. During an interview on 6/13/2024, at 12:30 p.m., with RN 1, RN1 stated she did not know of Patient 2’s insulin order on the label of the vial for Lantus to inject 0.2 units per kg. RN1 stated she would administer Lantus 15 units in the morning at 15 units nighttime. During an observation on 6/13/2024, at 12:50 p.m., Patient 2's glucometer was checked and Patient 2’s BS reading registered in the glucometer on 6/13/2024, at 11 a.m., was 297 mg/dl. During an interview on 6/14/2024, at 10 am, the DPCS stated the HHA’s Medical Director was not available for interview as he was on vacation and no other provider covered. During a telephone phone interview on 6/14/2024, at 11 a.m., with Patient 2's pharmacist, the pharmacist stated the only insulin prescription order for Patient 2 was ordered on 11/30/2023, for Lantus insulin to inject 0.2 units per kg SQ daily. During an interview on 6/14/2024, at 11:45 a.m., with the Director of Patient Care Services (DPCS), the DPCS stated RN 1 should have conducted a medication reconciliation on every home visit and verify the insulin dosages with Patient 1 and Patient 2’s and their family members to ensure Patient 1 and Patient 2 received the correct insulin dosages. The DPCS stated RN 1 did not administer the correct insulin dosages from the prescription order for Novolog two units to Patient 1, and the prescription order for Lantus to inject 0.2 units per kg to Patient 2. During a review of the HHA’s policy and procedure titled Administration and Documentation of Medications with a revised date of November 2022 indicated a comparison will be made between the physician ‘s (or other authorized licensed independent practitioner’s) orders and the current medications the patient is taking. Any discrepancies or contraindications should be reported to the physician for resolution. The policy indicated the nurse will provide instruction to the patient on a continuing basis. This instruction will include medication administration, route, how medication relates to disease process, contraindications, side effects, adverse reactions. During a review of the agency’s policy and procedure titled, "Care Planning Process," revised April 2018, indicated the plan of care will be based upon the physician's (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies, and services required to meet the patient’s needs.

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 (HHA) failed to ensure that the Plan of Care was revised and updated to reflect the current health status of two of 22 sampled patients (Patient 1 and 2). This deficient practice had a potential to result in miscommunication among health care providers and lack of care and treatment for Patient 1 and 2's diabetes (a condition that happens when your blood sugar is too high) management to meet their care goals. a. During a review of Patient 1's Start of Care (SOC) record indicated the HHA admitted Patient 1 on 11/22/2023, with a diagnosis of diabetes Type 2 (a chronic condition that happens when you have persistently high blood sugar levels). During a review of Patient 1’s primary care physician (PCP) Doctor Authorization Orders form, dated 3/19/2024, the Doctor Authorization Orders form indicated for Patient 1 to receive Novolog two units SQ once a day before lunch. During a review of Patient 1's Plan of Care (POC) for the certification period of 3/21/2024 to 5/19/2024, indicated a skilled nurse (SN, a licensed nurse in general) was to assess and instruct Patient 1 and Patient 1’s caregiver (PCG) the importance of medication compliance and high-risk medication use, side effects, contraindications, and possible drug to drug interactions (occur when two or more drugs react with each other). Patient 1’s POC indicated one of the SN interventions was to assess Patient 1 and PCG’s knowledge of diabetic condition and instruct on knowledge deficits on every visit. During a home visit observation on 6/12/2024, at 12:15 p.m., at Patient 1's residence with Registered Nurse 1 (RN1). Patient 1 was sitting on the couch. Family Member 2 (FM 2) was seen heading towards the refrigerator to show Patient 1's insulin medication. While checking Patient 1’s medication, there was one Novolog flex pen (pre-filled pen/syringe) with a label showing to inject two units SQ once a day before lunch. During an observation on 6/12/2024, at 1:20 p.m., Patient 1's glucometer (an instrument for measuring the concentration of glucose in the blood) was checked and the BS reading registered in the glucometer on 6/11/2024, at 12 p.m., was 264 mg/dl (mg/dl, unit of measurement). During an interview on 6/14/2024, at 12 p.m., with the Director of Patient Care Services (DPCS), when the DPCS was asked for a copy of the most current revision of the POC from dates 5/20/2024 to 7/18/2024, the DPCS stated the current POC was not completed at this time. b. During a review of Patient 2's Start of Care (SOC) record indicated the HHA admitted Patient 2 on 11/30/2023, with a diagnosis of diabetes Type 2. During a review of Patient 2's POC for the certification period of 3/28/2024 to 5/27/2024, the POC indicated a skilled nurse was to assess and instruct Patient 2 and Patient 2’s PCG the importance of medication compliance and high-risk medication use, side effects, contraindications, and possible drug to drug interactions (occur when two or more drugs react with each other). Patient 2’s POC indicated one of the SN interventions was to assess Patient 2 and PCG’s knowledge of diabetic condition and instruct on knowledge deficits on every visit. During a home visit observation on 6/13/2024, at 12 p.m., at Patient 2’s residence with Registered Nurse 1 (RN 1), Patient 2 was sitting on a chair. While checking Patient 2’s medication, there was one undated half- filled vial that was open of Lantus insulin with a label showing to inject 0.2 units per Kilogram (kg, a unit of mass) SQ daily. During an interview on 6/14/2024, at 12 p.m., with the Director of Patient Care Services (DPCS), when the DPCS was asked for a copy of the most current revision of the POC from 5/28/2024 to 7/28/2024, the DPCS stated the current POC was not completed. A review of the agency's undated policy and procedure titled, "Plan of Care," indicated, "An individualized Plan of Care will be developed for each patient for admitted and reviewed/revised as needed to meet the patient's needs.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) skilled nurse (SN) failed to notify the physician while visiting a patient with an increased blood pressure reading for one of 22 sampled patients (Patient 19). This deficient practice had the potential to placed Patient 22 at risk for complications from increase blood pressure that could affect their overall health status. Findings: During a review of Patient 19’s Patient Information sheet indicated a start of care (SOC) of 3/22/2024, with diagnoses including type 2 diabetes mellitus (a condition that results in too much sugar circulating in the bloodstream), hypertensive heart disease (high blood pressure), and hyperlipidemia (a condition in which there are high levels of fat particles [lipids] in the blood). During a review of Patient 19's Home Health Certification and Plan of Care (POC) for the certification period starting from 5/21/2024 to 7/19/2024, included an order for the skilled nurse (SN) frequency of visits of twice a week for one week and then once a week for 8 weeks, for comprehensive skilled nursing assessment, observation and evaluation of all body systems, perform every visits vital signs (measures the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), assessment of pain, and evaluate therapeutic response to current/new medications and compliance to medication/diet regimen. The POC included an order for the SN to report to PMD (primary physician) if systolic (top number) blood pressure is greater than 160 mm (millimeter)Hg (mercury) or less than 90 mmHg, and the diastolic (bottom number) blood pressure greater than 90 mmHg or less than 60 mmHg. During a joint home visit on 6/13/2024, at 12:05 p.m., conducted at Patient 19’s residence with a registered nurse (RN 3), Patient 19 was observed awake, alert, oriented (to person, place, and time), and ambulatory using a cane. RN 3 checked Patient 19’s blood pressure and it was 167/93. During a concurrent interview and record review, on 6/15/2024 at 12:15 p.m., with the Director of Patient Care Services Designee (DPCSD), the DPCSD stated she did not find documented evidence that the visiting nurse notified and reported to the physician regarding Patient 19's elevated blood pressure reading during the visit on 6/13/2024. DPCSD stated the field nurse should have notified patient’s physician about the elevated blood pressure for further instructions. During a review of the agency’s policy and procedure titled, “Care Planning Process”, revised November 2022, indicated the purpose of this policy is to provide clinical direction to the clinicians providing direct patient care. The plan of care will be based upon the physician’s (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies, and services required to meet the patient’s needs. Clinicians will inform the patient’s physician (or other authorized licensed independent practitioner) of any changes that suggest a need to alter the plan of care. Changes must be written, dated, and signed by the professional making the changes.

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, interview and record review, the Home Health Agency (HHA) failed to ensure diabetic management education was provided to the patient and Family Member 1 (FM 1) and FM 2 for two of 22 sample patients (Patients 1 and 2). This deficient practice had the potential for the Patient 1, Patient 2, and FM1 and FM2 not to have knowledge on how to manage the patient during a hypoglycemic (low blood sugar levels)/hyperglycemic (high blood sugar levels) crisis that could affect the patient’s health and safety, resulting to hospitalization or death. a. During a review of Patient 1's Start of Care (SOC) record indicated the HHA admitted Patient 1 on 11/22/2023, with a diagnosis of diabetes Type 2 (a chronic condition that happens when you have persistently high blood sugar levels). During a review of Patient 1’s primary care physician (PCP) Doctor Authorization Orders form, dated 3/19/2024, the Doctor Authorization Orders form indicated for Patient 1 to receive Novolog (a fast acting insulin) two units SQ once a day before lunch. During a review of Patient 1's Plan of Care (POC) for the certification period of 3/21/2024 to 5/19/2024, indicated a skilled nurse (SN, a licensed nurse in general) was to assess and instruct Patient 1 and Patient 1’s caregiver (PCG) the importance of medication compliance and high-risk medication use, side effects, contraindications, and possible drug to drug interactions (occur when two or more drugs react with each other). Patient 1’s POC indicated one of the SN interventions was to assess Patient 1 and PCG’s knowledge of diabetic condition and instruct on knowledge deficits on every visit. During a review of Patient 1's electronic medical record (EMR), the EMR did not indicate documented evidence the visiting nurse had provided patent teachings on diabetic management. The EMR did not indicate a return demonstration (when the learner demonstrate understanding) was performed by FM 1 and 2 on how to use the glucometer and how to administer the insulin to Patient 1. During a review of Patient 1’s HHA Physician's Order dated 11/22/2023, the HHA’s Physician Orders indicated for Patient 1 to receive Novolin (is an intermediate [middle] acting insulin that is slower to act and lasts longer) SQ to administer eight units daily. During a review of Patient 1’s HHA’s Physician's Order dated 11/22/2023, the Physician Orders indicated for Patient 1 to receive Tresiba (long acting insulin) SQ 50 units daily. During a home visit observation on 6/12/2024, at 12:15 p.m., at Patient 1's residence with Registered Nurse 1 (RN1). Patient 1 was sitting on the couch. Family Member 2 (FM 2) was seen heading towards the refrigerator to show Patient 1's insulin medication. While checking Patient 1’s medication, there was one Novolog flex pen (pre-filled pen/syringe) with a label showing to inject two units SQ once a day before lunch. During an observation on 6/12/2024, at 1:20 p.m., Patient 1's glucometer (an instrument for measuring the concentration of glucose in the blood) was checked and the BS reading registered in the glucometer on 6/11/2024, at 12 p.m., was 264 mg/dl (mg/dl, unit of measurement). During an interview on 6/12/2024, at 12:30 p.m., with FM 2, FAM 2 stated she was not provided instructions on how to use a glucometer (machine used to check blood sugar levels) by the visiting nurse. During a telephone interview on 6/12/2024, at 1 p.m., with FM 1, when FM1 was asked if the visiting nurse had provided instructions on how to use glucometer and administer insulin for Patient 1, FM1 stated the visiting nurse had not provided instructions on how to use the glucometer. b. During a review of Patient 2's Start of Care (SOC) record indicated the HHA admitted Patient 2 on 11/30/2023, with a diagnosis of diabetes Type 2. During a review of Patient 2's POC for the certification period of 3/28/2024 to 5/27/2024, the POC indicated a skilled nurse was to assess and instruct Patient 2 and Patient 2’s PCG the importance of medication compliance and high-risk medication use, side effects, contraindications, and possible drug to drug interactions (occur when two or more drugs react with each other). Patient 2’s POC indicated one of the SN interventions was to assess Patient 2 and PCG’s knowledge of diabetic condition and instruct on knowledge deficits on every visit. During a review of Patient 2's electronic medical record (EMR), the EMR did not indicate documented evidence the visiting nurse had provided patent teachings on diabetic management. The EMR did not indicate a return demonstration (when the learner demonstrate understanding) was performed by Patient 2 or caregiver on how to use the glucometer and how to administer the insulin to Patient 2. During a review of Patient 2’s HHA’s Physicians Order dated 11/30/2023, included in the POC, indicated for Patient 2 to receive Lantus (long acting insulin) 10 units to 15 units SQ twice daily. During a home visit observation on 6/13/2024, at 12 p.m., at Patient 2’s residence with RN 1, Patient 2 was sitting on a chair. While checking Patient 2’s medication, there was one undated half- filled vial that was open of Lantus insulin with a label showing to inject 0.2 units per Kilogram (kg, a unit of mass) SQ daily. During an interview with Patient 2, when he was asked if the visiting nurse had provided instructions on how to use glucometer and administer insulin, he stated the visiting nurse had not provided to him or to his caregiver instructions on how to use the glucometer. During an interview on 6/14/2024, at 12 p.m., with the Director of Patient Care Services (DPCS), the DPCS stated she (DPCS) could not find any documentation from the visiting nurse that patient teaching on diabetic management was provided to Patients 1 and 2. During a review of the HHA's undated policy and procedure (P&P) titled, " Patient Education Process," the P&P indicated patients and family/caregiver should receive education in verbal, visual, and written format, as appropriate. The P&P indicated education is the responsibility of each clinician.

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 observation, interview, and record review, the Home Health Agency (HHA, agency providing care to home bound patients [patients with difficulty leaving the house]) failed to ensure the Conditions of Participations regarding Skilled professional services were met as follows: 1). The HHA failed to ensure patient clinical records for the skilled nurse routine visit were available and reflected the patients’ current health status for eight out of 22 sampled patients (Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, and Patient 13). (Refer to G716) 2). The HHA failed to perform Registered Nurse (RN) supervisory visits (evaluation of the care performed by a Licensed Vocational Nurse [LVN]) to LVN providing patient care and services to four of 22 sampled patients, (Patient 6, Patient 11, Patient 12 and Patient 17) as indicated in the facility's job description for Clinical Manager (RN in charge of the day to day operation), which indicated, to evaluate the skills and services of the field employee under its supervision. (Refer to G726) 3). The HHA failed to ensure documentation of training were available for three of three Certified Home Health Aides (CHHA1, CHHA2, and CHHA3). (Refer to G778). The cumulative effect of these systemic practices resulted in the failure of the agency to deliver statutorily mandated compliance with federal regulations for skilled nursing services.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure patient clinical records for the skilled nurse routine visit were available and reflected the patients’ current health status for eight out of 22 sampled patients (Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, and Patient 13). As a result, Patient 6, Patient 7, Patient 8, and Patient 9, Patient 10, Patient 11, Patient 12, Patient 13, did not have completed clinical records that could result to the needs not identified promptly, and had the potential to affect the quality of care provided to the patients under the HHA’s care. Findings: a. A review of Patient 6’s Patient Profile indicated a Start of Care (SOC) date of 5/3/2024, with a primary diagnosis of type 2 diabetes mellitus (abnormal blood sugar levels) without diabetic kidney complications and secondary diagnosis of unilateral primary left knee osteoarthritis (one side degenerative (declining) joint disease in which the tissues in the joint break down over time). A review of Patient 6’s Home Health Certification and Plan Of Care (POC) for the certification period 5/03/2024 to 7/1/2024, indicated an order for Skilled Nurse (SN) to visit Patient 6 once for one week, then two times a week for eight weeks to perform the at every visit: 1) Vital signs (temperature (T), pulse (P), respiratory rate RR) and blood pressure (BP) checks every visit. 2) Pain scale (0 no pain to 10, worst possible pain), intensity and severity, implement pain relief measures and evaluate their effectiveness. 3) Blood sugar checking/recording, calibration/quality control (checking to ensure machine to check blood sugar (BS) levels is accurate) of BS machine, observing universal precautions and infection control measures, safe/proper disposal of sharps. 4) Assess pain severity/location/character and effectiveness of pain control measures. 5) Compliance with medical treatment and regimen. A review of Patient 6’s History of SN Visits did not indicate SN visit notes for the on 5/6/2024, 5/9/2024, 5/14/2024, 5/17/2024, 5/20/2024, 5/23/2024, 6/10/2024. Patient 6’s History of SN Visits form for the following dates of 5/28/2024, 6/01/2024, 6/04/2024, 6/07/2024 indicated the SN visit notes were blank and was signed by an unknown clinician. During a concurrent interview and record review on 6/13/2024 at 1:09 p.m., with the Director of Patient Care Services (DPCS), DPCS Designee (DPCSD), and Administrator (AD), Patient 6’s Electronic Health Record (EHR) for certification period 5/3/2024 to 7/1/2024 was reviewed. The DPCS stated Patient 6’s SN visit notes on 5/28/2024, 6/1/2024, 6/4/2024, and 6/7/2024 that were submitted by the SN were not filled out. The DPCS stated that Patient 6’s SN visit dated 5/6/2024 to 5/23/2024, 6/10/2024 and 6/12/2024 in the EHR indicated status was complete, however, the SN notes were blank. The DPCS stated all SN visit notes should be in Patient 6’s EHR. During an interview on 6/14/2024 at 4:50 p.m., with DPCSD, the DPCSD could not provide all route sheets for Patient 6’s SN visits for dates of 5/6/2024, 5/9/2024, 5/14/2024, 5/17/2024, 5/20/2024, 5/23/2024, 5/28/2024, 6/1/2024, 6/4/2024, 6/7/2024 and 6/10/2024. b. A review of Patient 7’s “Patient Information,” indicated a SOC of 11/08/2023, with a primary diagnosis of type 2 diabetes mellitus and generalized osteoarthritis. A review of Patient 7’s “Home Health Certification and POC,” dated 11/8/2023, indicated a certification period from 11/8/2023- 1/6/2024. Patient 7’s “Home Health Certification and POC,” indicated for the SN to visit Patient 7, two times a week for eight weeks (11/8/2023- 12/30/2023), followed by SN visit one time for the week of 12/31/2023 to 1/6/2024. Patient 7’s “Home Health Certification and POC,” indicated SN to perform in every visit: 1) Vital signs: : T/P/RR/ BP every visit. 2) Assess of pain using pain scale (0-10), intensity and severity, implement pain relief measures and evaluate their effectiveness. 3). Assess and monitor for signs and symptoms of Covid-19. 4) SN to record blood sugar test results checked by pt/caregiver during the visits and report any significant changes to physician (MD). 5) SN to perform diabetic foot exam upon every visit. A review of Patient 7’s “Physician Order,” dated 11/27/2023 indicated that Patient 7 was discharged on 11/27/2023. During an interview and concurrent record review of Patient 7’s clinical records on 6/13/2024 at 11:00 a.m., with the DPCS, Patient 7’s clinical records were reviewed. The DPCS stated Patient 7’s clinical record indicated that SN visits were scheduled for 6 visits (11/10/2023, 11/13/2023, 11/17/1023, 11/20/2023, 11/24/2023, 11/26/2023). The DPCS stated there were no documented evidence in Patient 7’s clinical record the SN visits were conducted. c. A review of Patient 8’s Patient Profile indicated a SOC of 5/30/2024, with a primary diagnosis of type 2 diabetes mellitus with diabetic polyneuropathy (damaged peripheral nerves) and a secondary diagnosis of primary generalized osteoarthritis. A review of Patient 8’s Physician Telephone Orders dated 5/30/2024, indicated Patient 8’s SN visit once for one week and then twice a week for eight weeks to provide and perform a skilled nursing assessment of the patient’s clinical condition and report any significant finding, to provide health teachings/ instructions/intervention as per updated plan of care. A review of Patient 8’s Home Health Certification and POC for the certification period 5/30/2024 to 7/28/2024, indicated an order for SN to perform at every visit the following, 1) VS: T, P, R, BP checks every visit. 2) Pain Scale (0-10), intensity and severity, implement pain relief measures and evaluate their effectiveness. 3) Follow COVID-19 (viral respiratory infection) infection precaution guidelines for health care professionals. 4) Screen patients for COVID-19 following home health agency triage procedures compliant with Health Insurance Portability and Accountability Act (HIPPA) guidance prior to visit. 5) Assess and monitor patient (pt)/caregiver (PCG) for any concerns regarding home health visits related to COVID-19. 6) Perform weekly weight; report any weight changes of more than 5 pounds (lbs, unit of measurement) per week. 7) SN to record blood sugar test results checked by Pt/PCG during the visits and report any significant changes to MD. SN to perform diabetic foot exam upon every visit. SN/Caregiver to administer Admelog and Basaglar injections (medications for diabetes). A review of Patient 8’s History of SN Visits did not indicate SN visits were conducted on the dates of 6/1/2024, 6/4/2024, 6/7/2024, 6/10/2024. During a concurrent interview and record review on 6/13/2024 at 1:09 p.m., with the DPCS, DPCSD, and AD, Patient 8’s EHR for certification period 5/30/2024 to 7/28/2024 was reviewed. The DPCS stated that SN visits for the dates of 6/1/2024, 6/04/2024, 6/07/2024, and 6/10/2024 indicated a status as complete in the EHR but had no SN visit notes. The DPCS stated all SN visit notes should have been in Patient 8’s EHR. During an interview on 6/14/2024 at 4:50 p.m., with DPCSD, the DPCSD stated she could not provide all route sheets for Patient 8’s SN visits on 6/1/2024, 6/4/2024, 6/7/2024, 6/10/2024. d. A review of Patient 9’s Patient Profile indicated a SOC of 5/30/2024, with a primary diagnosis of type 2 diabetes mellitus with diabetic and a secondary diagnosis of primary generalized osteoarthritis. A review of Patient 9’s Physician Telephone Orders dated 5/30/2024, indicated Patient 9’s SN visit once for one week and then twice a week for eight weeks to provide and perform a skilled nursing assessment of the patient’s clinical condition and report any significant finding, to provide health teachings/ instructions/intervention as per updated plan of care. A review of Patient 9’s Home Health Certification and POC for the certification period 5/30/2024 to 7/28/2024, indicated an order for SN to perform at every visit the following, 1) VS: T/P/RR/ BP checks every visit. 2) Pain Scale (0-10), intensity and severity, implement pain relief measures and evaluate their effectiveness. 3) Follow COVID-19 infection precaution guidelines for health care professionals. 4) Screen patients for COVID-19 following home health agency triage procedures compliant with HIPPA guidance prior to visit. 5) Assess and monitor patient/caregiver for any concerns regarding home health visits related to COVID-19. 6) Perform weekly weight; report any weight changes of more than 5 lbs. per week. 7) SN to record blood sugar test results checked by Pt/PCG during the visits and report any significant changes to MD. SN to perform diabetic foot exam upon every visit. SN/Caregiver to administer Admelog, and Basaglar injections. A review of Patient 9’s History of SN Visits did not indicate SN visit on 6/1/2024, 6/4/2024, 6/7/2024, 6/10/2024. During a concurrent interview and record review on 6/13/2024 at 1:09 p.m., with the DPCS, DPCSD, and AD, Patient 9’s EHR for certification period 5/30/2024 to 7/28/2024 was reviewed. The DPCS stated SN visits for the dates of 6/1/2024, 6/4/2024, 6/7/2024, and 6/10/2024, indicated a complete status in the EHR but had no SN visit notes. The DPCS stated all SN visit notes should be in Patient 9’s EHR. During an interview on 6/14/2024 at 4:50 p.m., with DPCSD, the DPCSD stated she was not able to provide all route sheets for Patient 9’s SN visits for dates of 6/1/2024, 6/4/2024, 6/7/2024, 6/10/2024. e. A review of Patient 10’s Patient Profile indicated a SOC of 1/10/2024, with primary diagnosis of type 2 diabetes mellitus with hyperglycemia (elevated blood sugar levels) and a secondary diagnosis of intervertebral disc degeneration, lumbar region (condition that is characterized by the breakdown of one or more of the discs that separate the bones of the spine, causing pain in the back or neck and frequently in the legs and arms). A review of Patient 10’s Home Health Certification and POC for the certification period 5/9/2024 to 7/7/2024, indicated an order for SN to visit the Patient 10 daily for sixty days to perform the following at every visit 1) VS: T/P/RR/BP checks every visit. 2) Pain Scale (0-10), intensity and severity, implement pain relief measures and evaluate their effectiveness. 3) Follow COVID-19 infection precaution guidelines for health care professionals. 4) Screen patients for COVID-19 following home health agency triage procedures compliant with HIPPA guidance prior to visit. 5) Assess and monitor patient/caregiver for any concerns regarding home health visits related to COVID-19. 6) SN to record blood sugar test results checked by Pt/PCG during the visits and report any significant changes to MD. SN to perform diabetic foot exam upon every visit. SN/Caregiver to administer Humalog, Trulicity, and Basaglar injections. A review of Patient 10’s History of SN Visits did not indicate SN visit notes for the dates of 5/9/2024, 5/10/2024, 5/11/2024, 5/12/2024, 5/13/2024, 5/14/2024, 5/15/2024, 5/16/2024, 5/17/2024, 5/18/2024, 5/19/2024, 5/25/2024, 5/26/2024, 5/27/2024. During a concurrent interview and record review on 6/13/2024 at 1:09 p.m., with the DPCS, DPCSD, and AD, Patient 10’s EHR for certification period of 5/9/2024 to 7/7/2024 was reviewed. The DPCS stated that for SN visit dates of 5/9/2024 to 5/19/2024 and 5/25/2024 to 5/27/2024, Patient 10’s EHR indicated a status of complete but had no SN visit note. The DPCS stated all SN visit notes should have been in Patient 10’s EHR. During an interview on 6/13/2024 at 1:20 p.m., with the AD, the AD stated the nurses document on paper forms for home visits, keep the documentation with them until they have time to bring it into the office and then upload those notes onto the EHR. The AD further stated that the nurses has not brought in their paper documentation, and whatever notes were not in the system at this time he did not have on hand. During an interview on 6/14/2024 at 4:50 p.m., with DPCSD, the DPCSD stated she could not provide all route sheets for Patient 10’s SN visits for dates of 5/9/2024, 5/10/2024, 5/11/2024, 5/12/2024, 5/13/2024, 5/14/2024, 5/15/2024, 5/16/2024, 5/17/2024, 5/18/2024, 5/19/2024, 5/25/2024, 5/26/2024, 5/27/2024. During an interview on 6/13/2024 at 1:20 p.m. with the AD, the AD stated “the nurses document visit notes on paper forms for home visits, keep the documentation with them until they have time to bring it to the office. The AD stated, “then the nurses upload the notes onto the EHR later.” The AD stated that “the nurses for Patients 6, 8, and 9 have not brought in their paper documentation, and whatever notes not in the system at this time, the AD stated he did not have the notes on hand.” When AD was asked how he got the updated information on the patient’s health and physical status for re-certification, the AD stated he called the patients’ nurses to obtain the information they gathered from their home visits. f. A review of Patient 11’s “Patient Information,” indicated a start of care (SOC) of 9/9/2023, with a primary diagnosis of hypertensive heart disease (heart problems that occur because of high blood pressure that is present over a long time) and secondary diagnosis of type 2 diabetes mellitus. A review of Patient 11’s “Physician Order,” dated 9/9/2023, indicated a certification period from 9/9/2023 to 11/7/2023. Patient 10’s “Physician Order,” indicated an order for SN to visit Patient 11 one time for the first week and two times a week for the following eight weeks. A review of Patient 11’s “Physician Order,” dated 11/4/2023, indicated a recertification period of 11/8/2023 to 1/6/2024. Patient 11’s “Physician Order” indicated a skilled nursing visits two times weekly for 8 weeks followed by one skilled nursing visit for one week. A review of Patient 11’s “Home Health Certification and POC,” dated 1/2/2024, indicated a recertification for 1/7/2024-3/6/2024. Patient 11’s “Home Health Certification and POC,” indicated skilled nursing visits twice weekly for eight weeks, followed by one skilled nursing for one week. The document indicated, “SN to continue to perform at every visit the following, 1. Vital signs- T/P/RR/BP 2. Pain assessment using pain scale (0-10), intensity and severity 3. Assess for COVID-19 signs and symptoms. 4. Check oxygen saturation levels (oxygen levels in the blood) with signs and symptoms of respiratory distress (breathing difficulty). 4. SN to record blood sugar tests results checked by patient/caregiver and report any significant changes to MD. 5. Perform diabetic foot exam. During an interview and concurrent record review on 6/13/2024 at 11:00 a.m., with the DPCS, Patient 11’s clinical records was reviewed. The DPCS stated Patient 11’s clinical records did not have nursing visits notes for the period 9/11/23 to 10/12/23, 10/26/23 to 11/4/2023, 11/8/2023 to 1/2/2024, 1/7/24 to 2/26/24. g. A review of Patient 12’s Patient Information indicated Patient 12 was admitted on 3/27/2024, with diagnosis of hypertensive heart disease without heart failure (heart disease due to unmanaged high blood pressure for a long time that cases added strain on the heart and leads to heart failure, diabetes mellitus type 2 with polyneuropathy (a peripheral nerve dysfunction, with long term use of insulin. A review of Patient 12’s EHR Home Health Certification and Plan of care for the certification Period of 3/27/2024 to 5/25/2024, indicated the physician instructed skilled nurse visit two times a week for 8 weeks, and one time a week for 1 week to monitor vital signs and blood sugar. SN visit notes were missing from 3/30/2024 to 5/17/2024. Certification period 5/25/2024 to 7/24/2024, nursing notes missing from 5/26/2024 -6/6/2024, Patient 12 is still active. h. A review of Patient 13’s Patient Information indicated the home health agency (HHA) admitted Patient 13 on 12/8/2023, with diagnosis of cerebral ischemia (insufficient blood flow to the brain to meet the metabolic demands). A review of Patient 13’s EHR for the certification Period of 12/8/2023 to 2/5/2023, indicated the physician instructed skilled nurse visit two times a week for 8 weeks, to monitor vital signs and blood sugar. SN Visit notes were missing from 12/11/2023 to 1/30/2024. Certification period 2/6/2024 to 3/30/2024, nursing notes missing from 2/6/2024 -3/30/2024. Patient 13 is still active. During an interview on 6/13/2024, at 1 p.m., with the AD, the AD stated the Skilled nurses have up to 365 days to submit their nursing notes. The AD stated the SN’s document their notes on paper form for home visit. The AD stated the nurses does not have time to document in the HER. The AD stated the skilled nurses kept the patients’ documented notes until they (nurses) can bring it into the office where it is uploaded in the EHR. The AD stated they did not have the nurses’ notes for Patient 11 and Patient 13 on 12/11/2023 to 1/30/2024, Certification period 2/6/2024 to 3/30/2024, because the nurses did not bring them in. During an interview with the DPCSD on 6/15/2024, at 1:25 p.m., the DPCSD stated the SN’s had their notes with them. The DPCSD stated she was not aware of Patient 13’s current health status due to the notes not being available. A review of the Home Health agency’s policy and procedure (P&P) titled, “Contents of Clinical Records”, dated 11/2022, the P&P indicated, “staff notes will be submitted within 7 to 365 days of clinical visit date with patient from paper to EMR system.”

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 Registered Nurse (RN) supervisory visits (evaluation of the care performed by a Licensed Vocational Nurse [LVN]) to LVN providing patient care and services to four of 22 sampled patients, (Patient 6, Patient 11, Patient 12 and Patient 17) as indicated in the facility's job description for Clinical Manager (RN in charge of the day to day operation), which indicated, to evaluate the skills and services of the field employee under its supervision. This failure had the potential to result in a poor-quality care when staffs are not being evaluated and supervised. A review of Patient 6’s Patient Profile indicated a Start Of Care (SOC) of 5/3/2024, with a primary diagnosis of Type 2 diabetes mellitus without diabetic kidney complications (a chronic condition that affects the way the body processes blood sugar) and secondary diagnosis of Unilateral primary osteoarthritis (one side degenerative (declining) changes to the cartilage and joint that occur without a known cause), left knee. During a concurrent interview and record review on 6/13/2024 at 1:09pm with Director of Patient Care Services (DPCS) and Director of Patient Care Services Designee (DPCSD), Patient 6’s Electronic Health Record (EHR) was reviewed. The DPCS acknowledged that Patient 6’s EHR indicated an LPN/LVN – Skilled Nursing Visit for the dates of 5/6/24, 5/9/24, 5/14/24, 5/17/24, 5/20/24, 5/23/24, 5/28/24, 6/01/24, 6/04/24, 6/07/24, and 6/10/24 and stated there are no Registered Nurse (RN) supervisory visits documented. The DPCS stated RN supervisory visits for the LVN should be done every 30 days. Both the DPCS and DPCSD stated they did not know who scheduled the RN supervisory visits. During an interview on 6/13/2024 at 1:20om with the Administrator (AD), the AD stated he is not in charge of scheduling the RN supervisory visits, the RN’s themselves schedule their own supervisory visits and input the dates into the patient’s EHR, and office staff oversee that the scheduling has been done. During a review of the HHA’s organization chart, it was indicated the DPCS was also the Clinical Manager for the agency. During a review of the HHA’s job description for Clinical Manager, undated, it indicated “6. Evaluates the employees under his/her supervision…. 8. Monitors the skills and services of the field employee. 9. Supervises the implementation of the Physician’s Plan of Treatment.” A review of Patient 11’s Patient Information indicated Patient 11 was admitted on 3/27/2024, with diagnosis of hypertensive heart disease without heart failure (heart disease due to unmanaged high blood pressure for a long time that cases added strain on the heart and leads to heart failure, diabetes mellitus type 2 with polyneuropathy (a peripheral nerve dysfunction, with long term use of insulin. A review of the Patient 11’s Physician Order form dated 5/22/2024, instructed the Skilled Nurse to visit two times a week for 8 weeks, and one time a week for 1 week to perform skilled nursing assessment of the patient’s clinical condition, report any significant findings, provide health teachings/instructions/interventions per updated plan of care. During a concurrent record review of Patient 11’s electronic Medical Record on 6/13/2024 at 2:09pm with Director of Patient Care Services (DPCS) and Director of Patient Care Services Designee (DPCSD), there was no Supervisory visit notes in her medical record. During an interview while reviewing Patient 11’s EMR, the DPCS stated there are no Registered Nurse (RN) supervisory visits documented. The DPCS stated RN supervisory visits for the LVN should be done every 30 days. Both the DPCS and DPCSD stated they did not know who scheduled the RN supervisory visits. During a review of Patient 17’s Patient Information indicated a start of care (SOC) date of 9/27/2023, for the certification period of 1/25/2024 to 3/24/2024, with diagnosis Atherosclerosis heart disease of native coronary artery w/o angina pectoris( a buildup of fats, cholesterol and other substances in an on artery walls that can lead to chest pain) A review of the HHH’s Physician Order form dated 1/21/2024, instructed the Skilled Nurse to visit one time a week for 1 week, and two times a week for 8 weeks to to perform skilled nursing assessment of the patient’s clinical condition, report any significant findings, provide health teachings/instructions/interventions per updated plan of care. During a concurrent interview and record review on 6/13/2024 at 2:20pm with Director of Patient Care Services (DPCS) and Director of Patient Care Services Designee (DPCSD), Patient 17’s Electronic Health Record (EHR) indicated the RN visited patient 17 on 1/25/2024,1/29/2024, 2/2/2024,2/6/2024,2/9/2024,2/13/2024,2/16/2024,3/8/2024,3/12/2024,3/15/2024,3/19/2024,3/22/2024, and 3/244/2024, was reviewed however the dated and forms were blank. . The DPCS stated there are no Registered Nurse (RN) supervisory visits documented. The DPCS stated RN supervisory visits for the LVN should be done every 30 days. Both the DPCS and DPCSD stated they did not know who scheduled the RN supervisory visits. During an interview on 6/13/2024 at 1:20om with the Administrator (ADM), the ADM stated he is not in charge of scheduling the RN supervisory visits, the RN’s themselves schedule their own supervisory visits and input the dates into the patient’s EHR, and office staff oversee that the scheduling has been done. During a review of the HHA’s organization chart, it was indicated the DPCS was also the Clinical Manager for the agency. During a review of the HHA’s job description for Clinical Manager, undated, it indicated “6. Evaluates the employees under his/her supervision…. 8. Monitors the skills and services of the field employee. 9. Supervises the implementation of the Physician’s Plan of Treatment.” A review of Patient 12’s medical record titled “Patient Information,” indicated a start of care of 2/15/2024, with a primary diagnosis of Type 2 diabetes and secondary diagnosis of primary generalized osteoarthritis. A review of Patient 12’s medical record titled, “Home Health Certification and Plan of Care (POC),” dated 2/15/2024, indicated certification for home health care for the period from 2/15/2024- 4/14/2024. The record also indicated an order for Skilled Nurse (SN) to visit the patient one time for the first week, followed by two times a week for eight weeks. The record further indicated that SN to perform at every visit: 1) Vital signs: temperature, respiratory rate, heart rate, blood pressure checks every visit. 2) Pain assessment using pain scale (0-10), intensity and severity, implement pain relief measures and evaluate their effectiveness. 3). Assess and monitor for signs and symptoms of Covid-19. 4) SN to record blood sugar test results checked by patient/caregiver during the visits and report any significant changes to MD. 5) SN to perform diabetic foot exam upon every visit. 5) Perform weekly week and report any weight changes of more than 5 pounds per week. A review of Patient 12’s medical record titled, “Home Health Certification and Plan of Care (POC),” dated 4/13/2024, indicated certification for home health care for the period from 4/15/2024- 6/13/2024. The record did not indicate the frequency of skilled nursing visits to be performed. During an interview and concurrent record review on 6/13/2024 at 1:09 p.m., DPCSD stated that Patient 12’s medical record did not indicate any supervisory visits for the period of 5/20/2024- 6/9/2024. DPSCD stated that Patient 12 was under the care of a licensed vocational nurse (LVN) during those dates. DPSCD stated that supervisory visits should be made every 30 days when an LVN was taking care of a patient. During an interview on 6/13/2024 at 1:12 pm, AD stated that supervisory visits should be conducted every 30 days on LVNs. ADM stated that it is the responsibility of the registered nurses to schedule and perform the supervision.

Documentation of inservice training CFR(s): 484.80(d)(2) The HHA must maintain documentation that demonstrates the requirements of this standard have been met. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA, health care services that can be given in the home for an illness or injury) failed to ensure to have documentation of training for three of three Certified Home Health Aides (CHHA1, CHHA2, and CHHA3). This deficient practice had the potential to affect the care and safety of the HHA’s 421 active patients. Findings: During a concurrent interview and a record review, on 6/14/2024, at 11 a.m., with the Director of Patient Care Services (DPCS), the HHA’s in-service training records were reviewed. The DPCS stated the HHA’s in-service training records did not indicate the HHA conducted in-services to the licensed staff and CHHAs. During an interview on 6/14/2024, at 11:20 a.m., with the DPCS, the DPCS stated she could not find documented evidence of the 12 hours in-service training provided to their CHHAs. A review of the undated, untitled HHA's policy and procedure, indicated documentation relating to the training and competency evaluation program should include: A. Description of the training/competency program, including qualifications of the instructor. B. Documentation that confirms that competency was determined by direct observation and the results of those observations. C. A record which identifies skills, taught and demonstrated during patient care, and those taught in laboratory. D. How additional skills beyond the basic skills are taught and tested if the admission policies and case-mix of patients require aides to assist medically complex patients. E. A record which identifies between skills taught and demonstrated (direct observation) at a patient bedside (with supervision). F. Documentation of “satisfactory” performance in all areas. G. Date training/competency program was completed with signatures of the employee, supervisor and registered nurse conducting the program. The Policy indicated a home health aide will not be considered competent in any task in which they are evaluated “Unsatisfactory.” The aide must not perform that task without direct supervision. The aide may perform the task that was evaluated as unsatisfactory after retesting in that area and receiving a satisfactory evaluation. There is no limit on the number of times that an individual may be retested.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure that the designated Administrator (ADM) assumed responsibility for the overall management of the agency’s daily operation. The Administrator did not oversight when the HHA was providing services outside of the approved Geographic Service Area (GSA, the geographic boundary within which a healthcare provider or health plan operates and provides medical services to patients) for four out of 421 active patients. This deficient practice had the potential for the patients not to receive care and services. A review of the HHA’s Active Patient list indicated the agency's active patients the two patients lived in Sacramento, CA, one active patient lived in El Centro, California (Imperial County), and that another active patient lived in San Diego, CA (San Diego County). During a review of the State’s Facility information, and employee files of the Director of Patient Care Services Designee (DPCSD), indicated the DPCSD had received her license as a Register Nurse (RN) on 2/7/2023, and was hired by the HHA to be the DPCSD on 7/28/2023. The DPCSD did not meet the qualifications. During an interview on 6/14/2024, at 11 a.m., with the ADM and DPCSD, the ADM and DPCSD, stated he did not have any skilled nurses (SN) who live in that geographical area’s El Centro, California and San Diego, California. The ADM and DPCSD stated that a few of his SN’s drives from Los Angeles County to Sacramento County on the weekends to provide care as well as the other counties. The ADM stated that the HHA had applied to Centers of Medicaid Services (CMS) for approval to deliver services in San Bernardino, Riverside, Orange, Kern County and Los Angeles, and has not approve. Review of the CMS form section: Medicare Enrollment Information dated 12/26/2023, indicated in section “: Changed Information – Geographical Location” San Diego County, Imperial County, and Sacramento County were not included in the HA’s request for coverage. A review of facility’s policy and procedure titled “Admission Criteria and Process” revised 4/2020, indicated “Once a patient is admitted to service, the organization will be responsible for providing care and services within its financial and service capabilities, mission, and applicable law and regulations. The patient must reside within the geographical area that (HHA) serves.” A review of facility’s policy and procedure titled “Scope of Services” revised 1/2023, indicated “(HA) will provide care to persons living within the following counties: Los Angeles, Riverside, San Bernardino, Orange, San Diego, Imperial, and Venture.” The CMS form for additions did not indicate San Diego and Imperial.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on interview and record review the home health agency (HHA) failed to ensure that a qualified administrator and administrator designee were hired to oversee the day-to-day operation of the agency. This deficient practice has the potential for the HHA’s operational plans, and its quality assessment and performance improvement program not addressed and reviewed that could affect the quality of patient care provided to all the patients receiving services. Findings: During a review of the Administrator’s employee record on 6/13/2024, at 11:44 p.m., indicated that the Administrator’s application of employment form, did not indicate trainings were completed and met to be the administrator (personnel who’s duty is to shape the policy that runs the facility and improve the patients’ experience and are essential to successful and efficient health care facilities). During an interview on 6/13/2024, at 1:20 p.m., with the Administrator (ADM), the ADM stated he was not in-charge of scheduling the Registered Nurse (RN) supervisory visits, and that the RN’s themselves scheduled their own supervisory visits and input the dates into the patient’s EHR. The ADM stated that the office staff oversee that the scheduling has been done. The ADM stated he was not involved in Quality Assurance and Performance Improvement (QAPI- a data-driven proactive approach to improving quality). The ADM stated the skilled nurses have 7 to 365 days to submit their clinical notes and could not provide documented evidence the skilled nurses prepared and submitted their notes for eight of 22 sample patients (Patient 6, patients 7, patient 8, patient 9, patient 10, patient 11, Patient 12, and Patient 13) During a review of the DPCS designee’s employee record indicated that she received her registered nurse license on 2/17/2023 and was hired by the agency on 7/28/2023. During a review of the Job description for DPCSD, the job description indicated the DPCSD required three (3) years of experience as a Registered Nurse with 1 year experience in Home Health. During the investigation from 6/10/2024 to 6/14/2024, the Administrative staff could not get in contact with the Medical Director (a medical professional in charge of overseeing a health-care facility and ensuring it runs efficiently and smoothly) for questions the survey team had and stated the agency did not have an alternate MD and did not know or have contact information of the HHA's Patients' primary care physicians.

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, agency providing care to a love one in the comfort of home) failed to ensure the Condition of Participation for Clinical Records was met as follows: 2. The HHA failed to ensure patients' clinical records were completed, signed, and dated for two of 22 sampled patients (Patient 20 and Patient 21). This deficient practice resulted in incomplete clinical records. (Refer to G1024) Findings: The HHA failed to ensure the clinical records included the routine visit notes that reflected the patients’ current health status and route sheets (document the purpose of home visits) to reflect that the visits were conducted and care and treatment was provided for eight out of 22 sampled patients (Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, and Patient 13). As a result, Patient 6, Patient 7, Patient 8, and Patient 9, Patient 10, Patient 11, Patient 12, Patient 13, did not have completed clinical records that can potentially not identify a change in patients’ conditions and affect the patients’ care and services that could lead to hospitalization and death when clinical records did not include current, correct, and updated nursing visits notes of the patients. (Refer to G1012) The cumulative effect of these systemic practice resulted in the failure of the HHA to deliver statutorily (written) mandated compliance with maintaining clinical records that reflect the patients' past and current information which can potentially affect the patients’ care and services that could lead to potential hospitalization and death.

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 observation, interview and record review, the home health agency (HHA) failed to ensure the clinical records included the routine visit notes that reflected the patients’ current health status and route sheets to reflect that the visits were conducted and care and treatment was provided for eight out of 22 sampled patients (Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, and Patient 13). As a result, Patient 6, Patient 7, Patient 8, and Patient 9, Patient 10, Patient 11, Patient 12, Patient 13, did not have completed clinical records that can potentially not identify a change in patients’ conditions and affect the patients’ care and services that could lead to hospitalization and death when clinical records did not include current, correct, and updated nursing visits notes of the patients. On 6/14/2024, at 5:21 p.m., the Department of Public Health called an Immediate Jeopardy (IJ, a situation in which the provider's non-compliance with one or more requirements of participation has caused, or likely to cause, serious injury, harm impairment, or death to a patient) in the presence of the agency’s Administrator (ADM) and the Director of Patient Care Services Designee (DPCSD) related to the HHA failure to ensure to maintain complete clinical records for eight sampled patients, Patient 6, Patient 7, Patient 8, and Patient 9, Patient 10, Patient 11, Patient 12, Patient 13. As a result, the non-compliance resulted in incomplete clinical records that does not reflect patients' current condition and needs which likely to cause unidentified needs, serious injury, harm, impairment, or death to a patient. On 6/15/2024, at 12:25 p.m., the HHA submitted an IJ Removal Plan (the facility’s plan of action to correct the deficient practices). The survey team reviewed the IJ Removal Plan and on 6/15/2024, at 4:25 p.m., the survey team notified the ADM and DPCSD that the IJ Removal Plan was not accepted. On 6/15/2024, at 4:30 p.m., the survey team completed the survey tasks and conducted an exit conference, with the IJ situation not removed. a.) A review of Patient 6’s Patient Profile indicated a Start Of Care (SOC) of 5/3/2024, with a primary diagnosis of Type 2 diabetes mellitus without diabetic kidney complications (a chronic condition that affects the way the body processes blood sugar) and secondary diagnosis of Unilateral primary osteoarthritis (one side degenerative (declining) changes to the cartilage and joint that occur without a known cause), left knee. A review of Patient 6’s Home Health Certification and Plan Of Care (POC) for the certification period from 05/03/2024 to 07/01/2024, indicated an order for Skilled Nurse (SN) to visit the patient once for one week, then two times a week for eight weeks to perform at every visit: 1) Vital signs: temp/RR/HR/BP checks every visit. 2) Pain scale (0-10), intensity and severity, implement pain relief measures and evaluate their effectiveness. 3) Blood sugar checking/recording, calibration/quality control of BS machine, observing universal precautions and infection control measures, safe/proper disposal of sharps. 4) Assess pain severity/location/character and effectiveness of pain control measures. 5) Compliance with medical treatment and regimen. A review of Patient 6’s History of SN Visits indicated there was no SN visit note submitted for the dates of 5/6/24, 5/9/24, 5/14/24, 5/17/24, 5/20/24, 5/23/24, 6/10/24 and for the dates of 5/28/24, 6/01/24, 6/04/24, 6/07/24 indicated a SN visit note signed by the clinician but is blank. During a concurrent interview and record review on 6/13/24 at 1:09pm with the Director of Patient Care Services (DPCS), Director of Patient Care Services Designee (DPCSD), and Administrator (AD), Patient 6’s Electronic Health Record (EHR) for certification period of 05/03/2024 to 07/01/2024 was reviewed. The DPCS acknowledged that an SN visit note was submitted for the dates of 5/28/24, 6/1/24, 6/4/24, and 6/7/24 but was not filled out and left blank. The DPCS acknowledged that for SN visit dates of 5/6/24 to 5/23/24, 6/10/24 and 6/12/24 the status indicated complete but there was no visit note present. DPCS further stated all SN visit notes should be in patient’s EHR. During an interview on 6/14/2024 at 4:50pm with DPCSD, the DPCSD stated she was not able to provide all route sheets for Patient 6’s SN visits for dates of 5/6/24, 5/9/24, 5/14/24, 5/17/24, 5/20/24, 5/23/24, 5/28/2, 6/01/24, 6/04/24, 6/07/24 and 6/10/24. c.) A review of Patient 8’s Patient Profile indicated a Start Of Care (SOC) of 5/30/2024, with a primary diagnosis of Type 2 diabetes mellitus with diabetic polyneuropathy (a chronic condition that affects the way the body processes blood sugar with nerve damage) and a secondary diagnosis of Primary generalized osteoarthritis (cartilage that lines your joints is worn down over time and your bones rub against each other when you use your affected joints). A review of Patient 8’s Physician Telephone Orders dated 5/30/2024, indicated SN visit frequency: once for one week and then twice a week for eight weeks to provide and perform a skilled nursing assessment of the patient’s clinical condition and report any significant finding, to provide health teachings/instructions/intervention as per updated plan od care. A review of Patient 8’s Home Health Certification and Plan Of Care (POC) for the certification period from 05/30/2024 to 07/28/2024, indicated an order for SN to perform at every visit: 1) VS: Temp/RR/HR/BP checks every visit. 2) Pain Scale (0-10), intensity and severity, implement pain relief measures and evaluate their effectiveness. 3) Follow Covid-19 infection precaution guidelines for health care professionals. 4) Screen patients for covid-19 following home health agency triage procedures compliant with HIPPA guidance prior to visit. 5) Assess and monitor patient/caregiver for any concerns regarding home health visits related to Covid-19. 6) Perform weekly weight; report any weight changes of more than 5 lbs. per week. 7) SN to record blood sugar test results checked by Pt/PCG during the visits and report any significant changes to MD. SN to perform diabetic foot exam upon every visit. SN/Caregiver to administer Admelog, and Basaglar injections. A review of Patient 8’s History of SN Visits indicated there was no SN visit note submitted for the dates of 6/01/2024, 6/04/2024, 6/07/2024, 6/10/2024. During a concurrent interview and record review on 6/13/24 at 1:09pm with the Director of Patient Care Services (DPCS), Director of Patient Care Services Designee (DPCSD), and Administrator (AD), Patient 8’s Electronic Health Record (EHR) for certification period of 5/30/2024 to 7/28/2024 was reviewed. The DPCS acknowledged that SN visits for the dates of 6/01/2024, 6/04/2024, 6/07/2024, and 6/10/2024 were inputted and indicated a status of complete but no SN visit note is present. DPCS further stated all SN visit notes should be in patient’s EHR. During an interview on 6/14/2024 at 4:50pm with DPCSD, the DPCSD stated she was not able to provide all route sheets for Patient 8’s SN visits for dates of 6/01/2024, 6/04/2024, 6/07/2024, 6/10/2024. d.) A review of Patient 9’s Patient Profile indicated a Start Of Care (SOC) of 1/10/2024, with a primary diagnosis of Type 2 diabetes mellitus with hyperglycemia (a chronic condition that affects the way the body processes blood sugar with high blood sugar) and a secondary diagnosis of other intervertebral disc degeneration, lumbar region (condition that is characterized by the breakdown of one or more of the discs that separate the bones of the spine, causing pain in the back or neck and frequently in the legs and arms). A review of Patient 9’s Home Health Certification and Plan Of Care (POC) for the certification period from 05/09/2024 to 07/07/2024, indicated an order for SN to visit the patient daily for sixty days to perform at every visit 1) VS: Temp/RR/HR/BP checks every visit. 2) Pain Scale (0-10), intensity and severity, implement pain relief measures and evaluate their effectiveness. 3) Follow Covid-19 infection precaution guidelines for health care professionals. 4) Screen patients for covid-19 following home health agency triage procedures compliant with HIPPA guidance prior to visit. 5) Assess and monitor patient/caregiver for any concerns regarding home health visits related to Covid-19. 6) SN to record blood sugar test results checked by Pt/PCG during the visits and report any significant changes to MD. SN to perform diabetic foot exam upon every visit. SN/Caregiver to administer Humalog, Trulicity, and Basaglar injections. A review of Patient 9’s History of SN Visits indicated there was no SN visit note submitted for the dates of 5/09/2024, 5/10/2024, 5/11/2024, 5/12/2024, 5/13/2024, 5/14/2024, 5/15/2024, 5/16/2024, 5/17/2024, 5/18/2024, 5/19/2024, 5/25/2024, 5/26/2024, 5/27/2024. During a concurrent interview and record review on 6/13/24 at 1:09pm with the Director of Patient Care Services (DPCS), Director of Patient Care Services Designee (DPCSD), and Administrator (AD), Patient 9’s Electronic Health Record (EHR) for certification period of 5/09/2024 to 7/07/2024 was reviewed. The DPCS acknowledged that for SN visit dates of 5/09/2024 to 5/19/2024 and 5/25/2024 to 5/27/2024 were inputted and indicated a status of complete but no SN visit note present. DPCS further stated all SN visit notes should be in patient’s EHR. During an interview on 6/14/2024 at 4:50pm with DPCSD, the DPCSD stated she was not able to provide all route sheets for Patient 9’s SN visits for dates of 5/09/2024, 5/10/2024, 5/11/2024, 5/12/2024, 5/13/2024, 5/14/2024, 5/15/2024, 5/16/2024, 5/17/2024, 5/18/2024, 5/19/2024, 5/25/2024, 5/26/2024, 5/27/2024. During an interview on 6/13/2024 at 1:20pm with the Administrator (AD), the AD stated the nurses document on paper forms for home visits, keep the documentation with them until they have time to bring it into the office and then upload those notes onto the EHR later. The AD further stated that the nurses for patients 6, 8, and 9 have not brought in their paper documentation, and whatever notes are not in the system at this time he does not have on hand. When AD was asked how he gets updated information on the patient’s health and physical status for re-certification, the AD stated he calls the patients nurses to obtain the information they gathered from home visits. During a review of the Home Health (HH) agency’s policy and procedure titled, “Contents of Clinical Records”, with a revision date of November 2022, indicated “Staff notes will be submitted within 7 to 365 days of clinical visit date with patient from paper to EMR system.” b. A review of Patient 7’s medical record titled “Patient Information,” indicated a start of care (SOC) of 11/08/2023, with a primary diagnosis of Type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar) and secondary diagnosis of primary generalized osteoarthritis (degenerative (declining) changes to the cartilage and joint that occur without a known cause). A review of Patient 7’s medical record titled, “Home Health Certification and Plan Of Care (POC),” dated 11/8/2023, indicated certification for home health care for the period from 11/8/2023- 1/6/2024. The record also indicated an order for Skilled Nurse (SN) to visit the patient two times a week for eight weeks (11/8/8/2023- 12/30/2023, followed by SN visit one time for the week of 12/31/2023 to 1/6/2024. The record further indicated that SN to perform at every visit: 1) Vital signs: temperature respiratory rate (breathing rate), heart rate, blood pressure checks every visit. 2) Assess of pain using pain scale (0-10), intensity and severity, implement pain relief measures and evaluate their effectiveness. 3). Assess and monitor for signs and symptoms of Covid-19. 4) SN to record blood sugar test results checked by pt/caregiver during the visits and report any significant changes to MD. 5) SN to perform diabetic foot exam upon every visit. A review of Patient 7’s medical record titled, “Physician Order,” dated 11/27/2023 indicated that Patient 7 was discharged from home health services on 11/27/2023. During an interview and concurrent record review of Patient 7’s medical records on 6/13/2024 at 11:00 a.m, Director of Patient Care Services (DPCS) stated that Patient 7’s medical record indicated SN visits were scheduled for 6 visits (11/10/2023, 11/13/2023, 11/17/1023, 11/20/2023, 11/24/2023, 11/26/2023) after admission on 11/8/2023. DPCS stated there was no evidence of documentation of those visits in the patient’s medical record. e. A review of Patient 10’s medical record titled “Patient Information,” indicated a start of care of 9/9/2023, with a primary diagnosis of hypertensive heart disease (heart problems that occur because of high blood pressure that is present over a long time) and secondary diagnosis of type 2 diabetes mellitus. A review of Patient 10’s medical record titled, “Physician Order,” dated 9/9/2023, indicated certification for home health care for the period from 9/9/2023 – 11/7/2023. The record also indicated an order for Skilled Nurse (SN) to visit the patient 1 time for the first week and twice a week for the following 8 weeks. A review of Patient 10’s medical record titled, “Physician Order,” dated 11/4/2023, indicated recertification for home health services for the period of 11/8/2023-1/6/2024. The document also indicated skilled nursing visits twice weekly for 8 weeks followed by once for one week. A review of Patient 10’s medical record titled “Home Health Certification and Plan of Care,” dated 1/2/2024, indicated a recertification for home health services for the dates 1/7/2024-3/6/2024. The document also indicated skilled nursing visits twice weekly for eight weeks, followed by one skilled nursing for one week. The document also indicated, “SN to continue to perform at every visit: 1. Vital signs- temperature, respiration rate, heart rate, and blood pressure. 2. Pain assessment using pain scale (0-10), intensity and severity 3. Assess for Covid-19 signs and symptoms. 4. Check oxygen saturation levels (oxygen levels in the blood) with signs and symptoms of respiratory distress (breathing difficulty). 4. SN to record blood sugar tests results checked by patient/caregiver and report any significant changes to MD. 5. Perform diabetic foot exam. During an interview and concurrent record review of Patient 10’s medical records on 6/13/2024 at 11:00 a.m, DPCS stated Patient 10’s medical record indicated no record of nursing notes for the period 9/11/23-10/12/23, 10/26/23-11/4/2023, 11/8/2023-1/2/2024, 1/7/24-2/26/24. g. A review of Patient 12’s medical record titled “Patient Information,” indicated a start of care of 2/15/2024, with a primary diagnosis of Type 2 diabetes and secondary diagnosis of primary generalized osteoarthritis. A review of Patient 12’s medical record titled, “Home Health Certification and Plan of Care (POC),” dated 2/15/2024, indicated certification for home health care for the period from 2/15/2024- 4/14/2024. The record also indicated an order for Skilled Nurse (SN) to visit the patient one time for the first week, followed by two times a week for eight weeks. The record further indicated that SN to perform at every visit: 1) Vital signs: temperature, respiratory rate, heart rate, blood pressure checks every visit. 2) Pain assessment using pain scale (0-10), intensity and severity, implement pain relief measures and evaluate their effectiveness. 3). Assess and monitor for signs and symptoms of Covid-19. 4) SN to record blood sugar test results checked by pt/caregiver during the visits and report any significant changes to MD. 5) SN to perform diabetic foot exam upon every visit. 5) Perform weekly week and report any weight changes of more than 5 pounds per week. A review of Patient 12’s medical record titled, “Home Health Certification and Plan of Care (POC),” dated 4/13/2024, indicated certification for home health care for the period from 4/15/2024- 6/13/2024. The record did not indicate the frequency of skilled nursing visits to be performed. During an interview and concurrent record review of Patient 7’s medical records on 6/13/2024 at 11:00 a.m, DPCS stated that Patient 12’s medical record notes titled, “skilled nursing visits” for the dates of 2/20/2024, 2/23/2024, 2/27/2024, 3/1/2024, 3/4/2024, 3/8/2024, 3/11/2024, and 3/15/204 had nursing visit notes that were blank. DPCS also stated that Patient 12’s medical record indicated that there were no skilled nursing notes submitted for skilled nursing visits scheduled for 3/18/24, 3/22/24, 3/25/24, 3/29/2024, 4/3/2024, 4/6/2024, 4/10/24, 4/14/2024, 4/19/2024, 4/22/2024, 4/26/2024, 4/29/2024. 5/2/2024, 5/7/2024, 5/10/2024 5/14/2024, 5/17/2024. 5/20/2024, 5/23/2024, 5/28/2024, 5/31/2024, 6/3/2024, and 6/7/2024. During an interview on 6/13/2024 at 12:50pm, Office Manager (OM) stated that if there are no notes in the electronic medical record (EMR) that the agency does not have a copy of the skilled nursing notes. f. During a review of Patient 11’s information Report (admission Record), the Patient Information indicated the home health agency (HHA) admitted Patient 11 on 3/27/2024, with diagnosis of hypertensive heart disease without heart failure (heart disease due to unmanaged high blood pressure for a long time that cases added strain on the heart and leads to heart failure, diabetes mellitus type 2 with polyneuropathy (a peripheral nerve dysfunction, with long term use of insulin During a review of Patient 11’s Electronic Medical Record (EMR) Home Health Certification and Plan of care for the certification Period of 3/27/2024 to 5/25/2024, the physician instructed skilled nurse visit two times a week for 8 weeks, and one time a week for 1 week to monitor vital signs and blood sugar. SNV notes missing from 3/30/2024 to 5/17/2024. Certification period 5/25/2024 to 7/24/2024, nursing notes missing from 5/26/2024 -6/6/2024, Patient 11 is still active. h.. During a review of Patient 13’s information Report (admission Record), the Patient Information indicated the home health agency (HHA) admitted Patient 13 on 12/8/2023, with diagnosis of Cerebral Ischemia (insufficient blood flow to the brain to meet the metabolic demands. During a review of Patient 13’s Electronic Medical Record (EMR) Home Health Certification and Plan of care for the certification Period of 12/8/2023 to 2/5/2023, the physician instructed skilled nurse visit two times a week for 8 weeks, to monitor vital signs and blood sugar. SNV notes missing from 12/11/2023 to 1/30/2024. Certification period 2/6/2024 to 3/30/2024, nursing notes missing from 2/6/2024 -3/30/2024. Patient 13 is still active. During an interview on 6/13/2024, at 1pm., with the Administrator he states the Skilled nurses have up to 365 days to submit their nursing notes and stated the SN’s document their notes on paper form for home visit due to them nit having time to document in the EMR and that the skilled nurses keep the patients documented notes until they can bring it into the office where it is uploaded in the EMR. The Administrator stated they did not have the nurses’ notes for patient 11 and patient 13 due to the nurses have not brought them in and there are no documented nurses notes in the EMR. During an interview with the DPCSD) on 6/15/2024, in the HA, she stated the SN’s have their notes with them and stated she did not know the patient’s current health status due to the notes not being available. During a review of the Home Health (HH) agency’s policy and procedure titled, “Contents of Clinical Records”, with a revision date of November 2022, indicated “Staff notes will be submitted within 7 to 365 days of clinical visit date with patient from paper to EMR system.”

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 patients' clinical records were completed, signed, and dated by an authorized staff for two of 22 sampled patients (Patient 20 and Patient 21). The deficient practice resulted in incomplete clinical records and had the potential for incomplete patients' care information. Findings: a. During a review of Patient 20’s Patient Information sheet indicated a start of care (SOC) date of 3/22/2024, with diagnoses including intervertebral disc degeneration lumbar region (the wear and tear of the lower region of the spinal column [backbone]), hypertensive heart disease (high blood pressure), and hyperlipidemia (a condition in which there are high levels of fat particles [lipids] in the blood). During a review of Patient 20's Home Health Certification and Plan of Care for the certification period starting from 3/22/2024 to 5/20/2024, included an order for the skilled nurse (SN) frequency of visits of once a week for one week and then two times a week for 8 weeks, and for the physical therapy to conduct an evaluation and set up a treatment plan. During a review of Patient 20's physician’s admission orders for the certification period starting from 3/22/204 to 5/20/2024 indicated the areas for the clinician signature, physician signature, and date the form was signed was blank. b. During a review of Patient 21’s Patient Information sheet indicated a start of care date of 3/22/2024, with diagnoses including primary generalized osteoarthritis (a degenerative joint disease, in which the tissues in the joint break down over time), intervertebral disc degeneration lumbar region, and unspecified abnormalities of gait and mobility. During a review of Patient 21's Home Health Certification and Plan of Care for the certification period starting from 3/22/2024 to 5/20/2024, included an order for the skilled nurse frequency of visits of once a week for one week and then two times a week for 8 weeks, for comprehensive skilled nursing assessment, observation and evaluation of all body systems, perform every visits vital signs, pain assessment, and evaluate therapeutic response to current/new medications and compliance to medication/diet regimen. During a review of Patient 21's physician’s admission orders for the certification period starting from 3/22/204 to 5/20/2024 indicated the areas for the clinician signature, physician signature, and date the form was signed was blank. During a concurrent record review and interview with the Director of Patient Care Services Designee (DPCSD), on 6/15/2024 at 12:15 p.m., DPCSD stated and acknowledged Patient 20 and Patient 21's physician orders was not signed, and further stated that all pertinent patients' clinical records including physician orders, should all be signed and dated. During a review of agency’s policy and procedure titled, “Contents of Clinical Record”, revised November 2022, indicated a clinical record will be maintained for each patient receiving care. The following information will be available in the clinical record for patients receiving skilled care: legible, complete, and individualized diagnostic and therapeutic orders authenticated within the time frame by the organization or according to law and regulation.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to ensure the clinical record, was safeguarded against loss or unauthorized use. This deficient practice had the potential for unauthorized use and access of patients' health record. Findings: During an observation on the agency on 6/11/2024, at 11:10 a.m., the agency located in Suite 204, the second floor of the building. There were two different agency on the second floor, Suite 205 and Suite 206. The hallway passage going to these HHA suites 204, 205 and 206 had five cubicles stands set up along the middle of this hall way . Each cubicle had a staff working in it , each was observed sitting on a chair with a computer, printer and terminal working on site. The agency office location were separated with a cubicle work station. During an interview on 6/11/2024, at 11:30 a.m., with the Administrator, the Administrator stated that two of five cubicles belong to the their agency and remaining three cubicles belong to another two different HHA. The Administrator stated that the two cubicles were extensions of their HHA offices. The Administrator stated that there could be a possibility that a staff from the other two HHA sitting in their cubicles could easily look at a patient's information from the computer system of the HHA or hear out conversation from staff phone call regarding patient's health condition. The Administrator agreed this could violated confidentiality and privacy of patient's health information. A review of the HHA’s undated policy “Protection of Clinical Records, indicated patient's records, its contents, and the information contained therein must be safeguarded against loss or unauthorized use.