Every finding on record at Hygeia Home Care, Inc.

Amended 9/5/2024 The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey conducted from 8/20/2024 to 8/23/2024. Complaint Number: 109046 Active Patients: 0 Discharge Census: 95 Sample Size - 7 Discharge Home Visits - 4 During a Complaint Validation Survey, the Department called three 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) situations when home health agency (HHA, a public or private organization that provides skilled nursing and other therapeutic services to patients in their homes). 1. On 8/20/2024 at 4:16 p.m., the Department called an Immediate Jeopardy in the presence of the HHA’s Administrator (ADM) related to failure to ensure to safeguard the patient clinical records for 95 out of 95 sampled Patients from unauthorized access. This failure has the potential to result in an unauthorized and inaccurate patient information or clinical record that could affect the patient’s quality of care and well-being. 2. On 8/23/2024, at 5:13 p.m., the Department called a second IJ in the presence of the HHA’s Administrator Designee (AD) related to failure to ensure completion of comprehensive assessment for seven out of seven sampled patients (Patient 1, 2, 3, 4, 5, 6 and 7) upon the patients’ discharge. This failure resulted to an incomplete documentation of the patients' medical status discharges and could potentially affect the patients' care and services, potential hospitalization, and death. 3. On 8/23/2024, at 5:15 p.m., the Department called a third IJ in the presence of the HHA’s Administrator Designee (AD) related to failure of the HHA's governing body assume and ensuring responsibility for the operations of the HHA for seven out of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6 and Patient 7). This failure has the potential to result for unsafe discharge of all seven discharged patients. On 8/23/2024 at 5:25 pm, the Administrator Designee (AD) told the survey team the agency would be closed (for business) and would no longer be opened. HHA was unable to submit an IJ removal plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely). The survey team was not able to complete the survey tasks and could not exit (end) the survey. The following Conditions of Participation were not met: 484.50 Patient Rights 484.55 Comprehensive Assessments of Patients 484.105 Organization and Administration of 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 patients in the comfort of their home) failed to ensure the Condition of Participation (conditions that healthcare organizations must meet in order to begin and continue participating in the Medicare [a federal system of health insurance for people over 65 years of age and for certain younger people with disabilities] program) for Patient Rights was met as follows: The HHA failed to ensure to inform three of seven sampled patients (Patients 1, Patient 2, and Patient 6), about discharge planning and being discharged and discontinued from the HHA services. This deficient practice resulted in Patient 1, Patient 2, and Patient 6 were not aware of being discharged from HHA services and had the potential for the discharge plan and needs were not identified and provided. (Refer to G434). The cumulative effect of this systemic practice resulted in the failure of the HHA to deliver statutorily (written law) mandated Federal compliance for Patient’s Rights to ensure Patients 1's, Patient 2's, and Patient 6's rights were not violated and patients received care and services.

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 observation, interview, and record review, the home health agency (HHA) failed to ensure to inform three of seven sampled patients (Patients 1, Patient 2, and Patient 6), about discharge planning and being discharged and discontinued from the HHA services. This deficient practice resulted in Patients 1, Patient 2, and Patient 6, were not aware of being discharged from HHA services and had the potential for the discharge plan and needs were not identified and provided. During a review of Patient 6’s record titled, “Patient Information”, indicated a start of care date on 1/16/2024 for the certification period of 5/15/2024 to 7/13/2024, with a primary diagnosis of idiopathic peripheral autonomic neuropathy (a condition that occurs when the nerves that control automatic body functions are damaged, but the cause of the damage is unknown). During a record review of Patient 6’s record titled, “Home Health Certification and Plan of Care” on 8/23/2024, indicated that the DPCS designee reviewed and is written as the clinical manager for the period of 5/15/2024 to 7/13/2024. During a phone interview on 8/23/2024 at 9:45 a.m., with Patient 6’s primary caregiver (PCG), PCG stated that Patient 6 is still being visited by a nurse and a physical therapist from this agency. PCG also confirmed that Patient 6 is not discharged from home health. PCG also complained that Patient 6 Medicare is billed by two agencies from 1/14/2024 to 2/11/2024 and another agency on 11/9/2023 to 12/8/2023 and another agency on 1/16/2024 to 2/14/2024. PCG stated that she called the owner of the agency to ask why and PCG was told by the ADM that ADM owns the other agencies and that the nurses from those other agencies were sent to do Patient 6’s home visits. During a review of Patient 6’s clinical records on 8/23/2024, indicated that Patient 6 was admitted on the following certification periods: 1/16/2024 to 3/15/2024, 3/16/2024 to 5/14/2024 and 5/14/2024 to 7/13/2024 on this agency. There was no discharge OASIS found in the medical record. a. During a review of Patient 1's record titled, “Patient Information”, the Patient Information, indicated, a start of care (SOC) date was on 5/14/2024, with diagnosis of diabetes mellitus (a group of diseases that result in too much sugar in the blood). During a review of Patient 1's record titled, “CMS 485 (the Home Health Certification and Plan of Care [POC] form)”, the CMS 485 with Plan of Care (POC) dated from 5/14/2024 to 7/21/2024, indicated an order for skilled nurse (SN) visits of twice a week for two weeks and once a week for seven weeks, SN to observe or assess all body systems focusing on respiratory system, SN to assess knowledge on disease process and management, medication knowledge and compliance, and instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). During Patient’s 1 a home visit on 8/21/2024, at 11 a.m., with RN 1, Patient 1 was observed lying in the family couch. During an interview with Family Member (FM 1), on 8/21/2024, at 11:30 a.m., FM 1 stated she and Patient 1 were not aware that they were discharged from the home health services. During a review of Patient 1's clinical record, found no discharge OASIS (Outcome and Assessment Information Set; standardized data set that measures quality care and outcomes) done. During an interview on 8/22/2024, at 12 p.m., with the Administrator, Administrator stated Patient 1 was discharged on 7/12/2024, and home health care goals were met. Administrator stated the visiting skilled nurse should have completed the discharge OASIS and should have instructed the patient regarding being discharge from their services. b. During a review of Patient 2's record titled, “Patient Information”, the Patient Information, indicated, a start of care (SOC) date was on 5/15/2024, with diagnosis of hypothyroidism (a condition in which the thyroid gland does not produce enough thyroid hormone). During a review of Patient 2's record titled, “CMS 485 (the Home Health Certification and Plan of Care [POC] form)”, the CMS 485 with Plan of Care (POC) dated from 5/15/2024 to 7/23/2024, included an order for skilled nurse (SN) visit of once a week for one week, twice a week for two weeks, once a week for six weeks, to observe or assess all body systems focusing on respiratory system, to assess knowledge on disease process and management, medication knowledge and compliance, and instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). During Patient 2 home visit on 8/21/2024, at 12 p.m., with RN 1, Patient 2 was observed ambulating with steady gait without the use of assistive device. During an interview on 8/21/2024, at 12 :30 p.m., with Patient 2, Patient 2 stated she was not aware she was discharge from the HHA services. She further stated the visiting nurse did not mention anything about discharge from their services. During an interview on 8/22/2024, at 12 p.m., with the Administrator, Administrator stated Patient 2 was discharged on 7/12/2024, and home health goals were met. Administrator stated the visiting skilled nurse should have completed the discharge OASIS and should have instructed the patient regarding being discharge from their services. During a review of Patient 2's clinical record, found no discharge OASIS done. A review of the HHA's undated policy and procedure, titled, "Discharge Criteria and Process", indicated patients are informed prior to discharging of plans for discharge and the reason for discharge. a. During a review of Patient 1's Patient Information, the Patient Information, indicated, Patient 1's start of care (SOC) date was on 5/14/2024, with diagnosis of diabetes mellitus (a group of diseases that result in too much sugar in the blood). During a review of Patient 1's CMS 485 form (the Home Health Certification and Plan of Care [POC] form)”, the CMS 485 with Plan of Care (POC) dated from 5/14/2024 to 7/21/2024, indicated an order for skilled nurse (SN) visits of twice a week for two weeks and once a week for seven weeks, SN to observe or assess all body systems focusing on respiratory system, SN to assess knowledge on disease process and management, medication knowledge and compliance, and instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). During a joint visit on 8/21/2024, at 11 a.m., with Registered Nurse 1 (RN 1) at Patient’s 1 home, Patient 1 was observed lying in the family couch. During an interview on 8/21/2024, at 11:30 a.m., with Family Member (FM 1), FM 1 stated she and Patient 1 were not aware that Patient 1 was discharged from the home health services. During a review of Patient 1's clinical record (in general), there was no discharge Outcome and Assessment Information Set (OASIS, a standardized data set that measures quality care and outcomes) was completed. During an interview on 8/22/2024, at 12 p.m., with the Administrator, the Administrator stated Patient 1 was discharged on 7/12/2024, and home health care goals were met. Administrator stated the visiting skilled nurse should have completed the discharge OASIS and should have instructed the patient regarding being discharge from their services. b. During a review of Patient 2's Patient Information, the Patient Information, indicated, Patient 2's start of care (SOC) date was on 5/15/2024, with diagnosis of hypothyroidism (a condition in which the thyroid gland does not produce enough thyroid hormone). During a review of Patient 2's CMS 485 form (the Home Health Certification and Plan of Care [POC] form), the CMS 485 with Plan of Care (POC) dated from 5/15/2024 to 7/23/2024, included an order for skilled nurse (SN) visit of once a week for one week, twice a week for two weeks, once a week for six weeks, to observe or assess all body systems focusing on respiratory system, to assess knowledge on disease process and management, medication knowledge and compliance, and instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). During a joint home visit on 8/21/2024, at 12 p.m., with RN 1, at Patient 2's home, Patient 2 was observed ambulating with steady gait without the use of assistive device. During an interview on 8/21/2024, at 12 :30 p.m., with Patient 2, Patient 2 stated she was not aware she was discharge from the HHA services. Patient 2 stated the visiting nurse did not mention anything about discharge from their services. During an interview on 8/22/2024, at 12 p.m., with the Administrator, the Administrator stated Patient 2 was discharged on 7/12/2024, and home health goals were met. Administrator stated the visiting skilled nurse should have completed the discharge OASIS and should have instructed the patient regarding being discharge from their services. During a review of Patient 2's clinical record (in general), there was no discharge OASIS done or completed for Patient 2's discharge . c. During a review of Patient 6’s Patient Information, the Patient Information indicated Patient 6 start of care date was on 1/16/2024 for the certification period of 5/15/2024 to 7/13/2024, with a primary diagnosis of idiopathic peripheral autonomic neuropathy (a condition that occurs when the nerves that control automatic body functions are damaged, but the cause of the damage is unknown). During a review of Patient 6’s “Home Health Certification and Plan of Care” on 8/23/2024, indicated Patient 6’s “Home Health Certification and Plan of Care that the DPCS designee reviewed and was written as the clinical manager for the period of 5/15/2024 to 7/13/2024. During a telephone interview on 8/23/2024 at 9:45 a.m., with Patient 6’s primary caregiver (PCG), Patient 6's PCG stated that Patient 6 was visited by a nurse and a physical therapist from the agency. Patient 6's PCG stated that Patient 6 was not discharged from home health. Patient 6's PCG stated and was concerned that Patient 6 Medicare currently billed by two agencies from 1/14/2024 to 2/11/2024 and another agency on 11/9/2023 to 12/8/2023 and another agency on 1/16/2024 to 2/14/2024. During a review of Patient 6’s clinical records (in general) on 8/23/2024, indicated that Patient 6 was admitted on the following certification periods: 1/16/2024 to 3/15/2024, 3/16/2024 to 5/14/2024 and 5/14/2024 to 7/13/2024. Patient 6's clinical record (in general) has no discharge OASIS done and completed for the discharge. A review of the HHA's undated policy and procedure, titled, "Discharge Criteria and Process", indicated patients are informed prior to discharging of plans for discharge and the reason for discharge.

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 interview and record review, the Home Health Agency (HHA, agency providing care to patients in the comfort of their home) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare [a federal system of health insurance for people over 65 years of age and for certain younger people with disabilities] program) for Comprehensive Assessment Of Patients was met as follows: The Home Health Agency failed to 1A. To ensure to complete the OASIS (also known as the Outcome and Assessment Information Set Code 9. This code is used when a patient is discharged from an agency for any reason other than death at home or transfer to an inpatient facility) comprehensive assessment for seven of seven sampled patients ( Patient 1,2,3,4,5,6 and 7) upon the patient's discharge. a. Patient 1, was admitted on 5/8/2024, with a diagnosis of diabetes mellitus and was discharged on 7/12/2024. There was no discharge OASIS. b. Patient 2, was admitted on 5/15/2024, with a diagnosis of arthritis and was discharged on 7/12/2024. There was no discharge OASIS c. Patient 3, was admitted on 4/16/2024, with a diagnosis of diabetes mellitus and was discharged on 6/29/2024. There was no discharge OASIS. d. Patient 4, was admitted on 3/21/2024, with a diagnosis of osteoarthritis and was discharged on 7/16/2024. There was no discharge OASIS. e. Patient 5, was admitted on 9/8/2023, with a diagnosis of hypertension and was discharged on 5/11/2024. There was no discharge OASIS f. Patient 6, was admitted on 1/16/2024, with a diagnosis of neuropathy and was discharged on 7/13/2024. There was no discharge OASIS. 2B. To ensure Patient 1 received the following prescribed medications prior to discharge as follows: a. Seroquel 25 milligrams (mg) one tab daily b. Hydroxyzine 10 mg one tab daily c. Donezepil 5 mg one tab daily d. Setraline 25 mg one tab daily. Family Member 1 (FM 1) administered these medications only twice a week for Patient 1. 3C. To ensure the visiting nurse performed medication reconciliation for Patient 1 and Patient 2 during home visit and checked all prescribed medications to ensure the patient was getting correct medication dosages as prescribed prior to discharged. The Cumulative effects of these systemic failures resulted to an incomplete documentation of the patients' medical status discharges that could potentially affect the patients' care and services and could lead to potential hospitalization and death. On 8/23/2024, at 5:13 p.m., the Department called a second IJ in the presence of the agency’s Administrator Designee (AA) related to the HHA's failure to ensure to complete the comprehensive assessment for seven of seven sampled patients (Patient 1,2,3,4,5,6 and 7) upon the patient's discharge. the home health agency (HHA) failed to ensure to complete the comprehensive assessment for seven of seven sampled patients (Patient 1,2,3,4,5,6 and 7) upon the patient's discharge. (Refer to G550).

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 maintain an accurate, current medication profile for two of seven patients (Patients 1 and Patient 2). This deficient practice has the potential to result in putting the patient at risk for medication errors and adverse drug reactions. a. During a review of Patient 1's Patient Information, the Patient Information, indicated, a start of care (SOC) date was on 5/14/2024, with diagnosis of diabetes mellitus (a group of diseases that result in too much sugar in the blood). During a review of Patient 1's CMS 485 (the Home Health Certification and Plan of Care [POC] form), the CMS 485 with Plan of Care (POC) dated from 5/14/2024 to 7/21/2024, indicated an order for skilled nurse (SN) visits of twice a week for two weeks and once a week for seven weeks, SN to observe or assess all body systems focusing on respiratory system, SN to assess knowledge on disease process and management, medication knowledge and compliance, and instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). During a review of Patient 1's CMS 485, the CMS 485 with physician order dated from 5/14/2024 to 7/21/2024, indicated: a. Seroquel (medication that treats several kinds of mental health conditions) 25 milligrams (mg, unit of measure) one tablet daily b. Hydroxyzine (used to treat itching caused by allergies) 10 mg one tablet daily c. Donepezil (medication that treats symptoms of memory loss and confusion) 5 mg one tablet daily d. Sertraline (medication for depression) 25 mg one tablet daily. During Patient’s 1 a home visit on 8/21/2024, at 11 a.m., with RN 1, observed RN 1 checked Patient 1’s medications. Found in Patient 1’s medication basket: one bottle of Seroquel 25 milligrams (mg) one tablet daily, one bottle of Hydroxyzine 10 mg one tablet daily, one bottle of Donepezil 5 mg one tablet daily, and one bottle of Sertraline 25 mg one tablet daily. During an interview with Family Member (FM 1), on 8/21/2024, at 11:30 a.m., FM 1 stated Patient 1 received the ordered medications (Seroquel, Hydroxyzine, Donepezil, and Sertraline) twice a week and thought dosages were too high for Patient 1. FM 1 further stated the visiting nurse did not check the patient's actual medication bottles or ask what the patient is taking during their visits. During an interview on 8/22/2024, at 12 p.m., with the Administrator, Administrator stated Patient 1 was discharged on 7/12/2024, and home health care goals were met. Administrator also stated the visiting skilled nurse should have checked all patient's medications and provided instruction on medication regimen prior to patient's discharge. b. During a review of Patient 2's Patient Information, the Patient Information, indicated, a start of care (SOC) date was on 5/15/2024, with diagnosis of hypothyroidism (a condition in which the thyroid gland does not produce enough thyroid hormone). During a review of Patient 2's CMS 485 (the Home Health Certification and Plan of Care [POC] form)”, the CMS 485 with Plan of Care (POC) dated from 5/15/2024 to 7/23/2024, included an order for skilled nurse (SN) visit of once a week for one week, twice a week for two weeks, once a week for six weeks, to observe or assess all body systems focusing on respiratory system, to assess knowledge on disease process and management, medication knowledge and compliance, and instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). During a review of Patient 2's CMS 485, the CMS 485 with physician order dated from 5/15/2024 to 7/23/2024, indicated: Propranolol (medication to treat high blood pressure) 10 mg one tablet twice daily. During Patient 2 home visit on 8/21/2024, at 12 p.m., with RN 1, observed RN 1 checked Patient 2’s medications were checked. Found on top of Patient’s 2 desk a bottle of Propranolol 10 mg one tablet daily. During an interview on 8/21/2024, at 12 :30 p.m., with Patient 2, Patient 2 stated Propranolol medication is being taken if systolic blood pressure (the pressure when the heart contracts) was greater than 140. Patient 2 further stated the visiting nurse did not check her actual medication bottles or ask her how many times she takes the Propranolol medication during their visits. During an interview on 8/22/2024, at 12 p.m., with the Administrator, Administrator stated Patient 2 was discharged on 7/12/2024, and home health goals were met. Administrator stated the visiting skilled nurse should have checked all patient's medications and provided instruction on medication regimen prior to patient's discharge. During a review of the undated agency's policy titled "Medication Profile/Reconciliation" indicated Patients receiving medications will 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. For accuracy and to completely reconcile medications across the continuum of care, the admitting organization w II obtain and document a complete list of the patient's current medications upon the patient's entry to the organization. A comparison of the medications ordered for the patient file under the organization's care will be made to those on the list. The admitting nurse will initiate a medication profile to document the current medication regimen, including name, dose, route, frequency and a diagnosis, condition, or indication for use for each medication ordered.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to ensure to complete the comprehensive assessment for seven out of seven sampled patients (Patient 1, 2, 3, 4, 5,6 and 7) upon patients’ discharge. This failure resulted to an incomplete documentation of the patients' medical status discharges and could potentially affect the patients' care and services, potential hospitalization, and death. On 8/23/2024, at 5:13 p.m., the Department called an IJ in the presence of the HHA’s Administrator Designee (AD) related to failure to ensure completion of comprehensive assessments for seven out of seven sampled patients (Patient 1, (Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7) upon the patients’ discharge. On 8/23/2024 at 5:22 pm, the HHA was unable to submit an IJ removal plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely). The Administrator Designee (AD) told the survey team the agency would be closed and would no longer be opened (for business). The survey team was not able to complete the survey tasks and could not exit. A complaint Validation Survey was conducted at this agency location on 8/20/2024 to 8/23/2024. Both Director of Patient care Services and her designee were not present in the agency. During an interview on 8/23/2024, at 11:45 a.m., with the ADM. ADM stated that the Administrator Designee (ADMD) went to the DPCS’s home to make sure she is there at home. ADM stated she has been calling and sending messages to her DPCS but she was not responding. ADM also stated that she kept the employee records in storage together with patient files and stated she can bring them back to the office. During a phone interview with the stated DPCSD on 8/23/2024 at 2:10 p.m., DPCSD stated that she is not working with the agency anymore and that she left last June or July this year. c). A review of Patient 3’s record titled, “Patient Face Sheet”, indicated a start of care date (SOC) on 4/16/2024 for the certification period of 4/16/2024 to 6/14/2024 with a primary diagnosis of type 2 diabetes (a chronic disease that causes high blood sugar levels) with hyperglycemia (a condition where there is too much sugar in the blood). During a record review on 8/23/2024, at 2:30 p.m., revealed that the DPCS designee reviewed and is written as the clinical manager on Patient 3’s record titled, “Home Health Certification and Plan of Care”. On concurrent record During a record review on 8/23/2024 of Patient 3’s record titled “Home Health Certification and Plan of Care” indicated that Patient 3 was admitted to another agency with run by the same ADM on 4/13/2024 for the certification period of 6/12/2024 to 8/10/2024 indicated the clinical manager is the DPCS of this agency. During a review of Patient 3’s OASIS E-Discharge ( also known as the Outcome and Assessment Information Set Code 9. This code is used when a patient is discharged from an agency for any reason other than death at home or transfer to an inpatient facility) was discharged on 8/10/2024. During a joint home visit on 8/21/2024 at 11:00 a.m., with Registered Nurse 1 (RN 1) at Patient 3’s residence observed that Patient 3 is alert and oriented to name, place and person, walks without assistance and denied pain. On concurrent interview with Patient 3, he confirmed that he signed the consent forms and the “Patient Discharge Instructions/Notification” (a form of instructions usually given by a nurse before the patient gets discharged from the hospital or any health service) on 6/29/2024. Patient 3 stated he knows he was discharged from the agency but was visited by a nurse from the agency last night at 10:30 p.m. and asked how he was doing and told him to call her for any assistance. d). A review of Patient 4’s record titled, “Patient Face Sheet”, indicated a start of care date on 3/21/2024 for the certification period of 5/20/2024 to 7/18/2024 with a primary diagnosis of hypertensive heart disease without heart failure (problems with your heart that can develop if you have high blood pressure but don't treat it for years). During a record review on 8/23/2024, revealed that the DPCS reviewed and is written as the clinical manager on Patient 4’s record titled, “Home Health Certification and Plan of Care” for the period of 3/21/2024 to 5/19/2024. During a joint home visit on 8/21/2024 at 12:00 p.m., with RN 1 at Patient 4’s residence observed that Patient 4 is alert and oriented to name, place and person, walks without assistance and denied pain. On concurrent interview with Patient 4, he confirmed that he signed the consent forms and the Patient Discharge Instructions/Notification on 3/21/2024. During a review of Patient 3’s OASIS E-Discharge (also known as the Outcome and Assessment Information Set Code 9. This code is used when a patient is discharged from an agency for any reason other than death at home or transfer to an inpatient facility) was discharged on 7/16/2024. e). A review of Patient 5’s record titled, “Patient Face Sheet”, indicated a start of care date on 9/8/2023 for the certification period of 5/5/2024 to 7/3/2024 with a primary diagnosis of hypertensive heart disease without heart failure During a record review on 8/23/2024, revealed that the DPCS designee reviewed and is written as the clinical manager on Patient 5’s record titled, “Home Health Certification and Plan of Care” for the period of 5/5/2024 to 7/3/2024. There was a discharge order for patient’s goals were met signed and dated by the DPCS on 5/31/2024 for this agency and an OASIS Discharge E was submitted, signed and exported on 5/31/2024 by the DPCS. During a record review on 8/23/2024, revealed that Patient 5 was admitted to another home health agency with a start of care of 2/10/2024 with a certification period of 4/10/2024 to 6/8/2024 with a primary diagnosis of dorsalgia (pain in the back or spine) with this agency’s DPCS written as the clinical manager. There was a discharge order for patient’s goals were met signed and dated by the DPCS on 5/31/2024 for this agency. f). A review of Patient 6’s record titled, “Patient Face Sheet”, indicated a start of care date on 1/16/2024 for the certification period of 5/15/2024 to 7/13/2024 with a primary diagnosis of idiopathic peripheral autonomic neuropathy ( a condition that occurs when the nerves that control automatic body functions are damaged, but the cause of the damage is unknown). During a record review on 8/23/2024, revealed that the DPCS designee reviewed and is written as the clinical manager on Patient 5’s record titled, “Home Health Certification and Plan of Care” for the period of 5/5/2024 to 7/3/2024. During a record review on 8/23/2024, revealed that Patient 6 did not have a discharge OASIS E for this agency in her electronic medical record. During a phone interview with on 8/23/2024 at 9:45 a.m., of Patient 6’s primary caregiver (PCG), PCG stated that her mom is still being visited by a nurse an a physical therapist from this agency. PCG also confirmed that she is not discharged from home health. PCG also complained that when she checked Patient 6’s Medicare profile online, PCG stated Patient 6 is billed by two agencies from 1/14/2024 to 2/11/2024 and another agency on 11/9/2023 to 12/8//2023 and another agency on 1/16/2024 to 2/14/2024. PCG stated that she called the owner of the agency to ask why and she was told by the ADM that she owns the other agencies and that the nurses from those other agencies were sent to do her mom’s home visits. During a record review on 8/23/2024 of Patient 6’s clinical record indicated that Patient 6 was admitted on the following certification periods: 1/16/2024 to 3/15/2024, 3/16/2024 to 5/14/2024 and 5/14/2024 to 7/13/2024 on this agency. During an interview with RN 1 on 8/21/2024 at 12:30 p.m., after the home visit, RN 1 stated that she works for this agency and her other agencies as needed and do admissions and discharges for them. RN 1 stated that the form “Patient Discharge Instructions/Notification” should be given and signed by the patient and nurse at the time of discharge. RN 1 stated the form should not be signed during admission because you won’t know what will happen to the patient in between the certification period. A review of the home health agency’s(HHA) undated policy titled ” Job Description: Administrator” indicated the Administrator is responsible for planning, coordinating, managing and directing all activities and programs of the Home Health. Essential job functions and responsibilities : 1. Planning and directing operations to ensure the provision of adequate and appropriate care and services. 2. Fiscal planning, budgeting and management. 3. Ensuring organizational compliance with legal, regulatory and accreditation standards. 4. Recruiting, employing and retaining qualified personnel to maintain appropriate staffing levels. 5. Establishing and maintaining effective open channels of communication. Fosters a no-blame culture that encourages reporting of safety and quality of services issues. 6. Ensuring program personnel have current clinical information and current practices. 7. Ensuring ongoing oversight of the agency's quality management system. 8. Evaluating services and programs. 9. Ensuring personnel development including orientation, in-service education and continuing education. 10. Coordinating with other program areas and management as appropriate. 11. Maintaining current on local trends and issues. 12. Ensuring that appropriate service policies are developed and implemented. 13. Directing personnel in performance of their duties including admission, discharge and provision of service to patients. 14. Assuring appropriate personnel supervision during all operating hours and is responsible for day to day operations . 15. Ensuring the accuracy of public information materials and activities 16. Appointing a similarly qualified alternate to be available at all times during operating hours in the absence of the administrator. • When the Administrator is not available, a qualified, pre-designated person, who is authorized in writing by the Administrator and the governing body, assumes the same responsibilities and obligations as the Administrator. The pre-designated person may be the clinical manager. • The Administrator or a pre-designated person is available during all operating hours A review of the HHA’s policy titled “Care/Service Coordination” dated 11/2022 indicated to ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services. Each patient will be assigned a Case Manager upon admission by the Clinical Director or Clinical Supervisor. It will be the responsibility of the Case Manager to facilitate communication about changes in the patient status among assigned personnel. Timely and ongoing communication is the responsibility of each team member of the interdisciplinary group and will be appropriate to the needs and abilities of the patient, and relevant to the care/service provided. The clinician will be responsible for facilitating communications about changes in the patient's status among the assigned personnel. The name of the Case Manager will be clearly documented in the clinical record. A review of the HHA’s undated policy titled "Discharge Planning, Transfer and Continuing care Needs" Discharge planning is provided as part of the ongoing assessment of the patient's continuing care needs and in accordance with the expected patient care outcomes. Provision of the patient's continuing care needs may require transfer of the patient to another level of care or service, such as hospice service or skilled nursing facility. If a transfer is required, the agency shall contact the physician and the facility to which the patient is being transferred. Appropriate information will be relayed to the receiving agency. The discharge summary and related documentation must be submitted for filing within thirty (30) days following discharge from service. The decision to discharge a patient from service is made in collaboration with the physician, patient/family and agency staff. Criteria for discharge may include, but are not limited to, the following: A. The patient is no longer under the care of a physician. B. The physician fails to give and/ or sign orders in a timely manner. C. Patient requests that services be discontinued, and the physician sanctions the request. D. A change in the patient's condition requires care or services other than that provided by the agency, or where patient's needs cannot be adequately met at home with agency services. E. The patient expires. F. The treatment objectives are attained or are no longer attainable. G. The patient is admitted to hospital for more; than 24 hours in duration. H. The patient is no longer homebound and/ or is able to receive services on an outpatient basis (Medicare patients). I. The patient moves out of the service area or transfers to another agency. J. The patient and/ or his or her family / caregiver refuses to cooperate in attaining treatment objectives. The staff member should prepare the patient for discharge by instructing the patient/caregiver to perform necessary care or should work toward making alternate plans for continuing care when further health care is needed. The agency will work with the physician and patient/ caregiver in arranging continuing care of the patient. Agency staff provide patients/caregivers with written and verbal information and assistance, if possible for resources to meet identified continuing care needs and with information on how to care for themselves. Agency staff complete a discharge summary that includes, but is not limited to, the following information: brief statement of patient problems and outcomes and a summary of care provided while on agency service. Status at discharge/last visit; current medications, diet, therapies; allergies. Continuing care needs a. A review of Patient 1's Patient Information indicated, a start of care (SOC) date of 5/14/2024, with diagnosis of diabetes mellitus ( a group of diseases that result in too much sugar in the blood). A review of Patient 1's plan of care (POC) from 5/14/2024 to 7/21/2024, included an order for skilled nurse (SN) visit of twice a week for two weeks, once a week for seven weeks, to observe/assess all body systems focusing on respiratory system. One of the SN intervention was to assess knowledge on disease process and management, medication knowledge and compliance. Instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). A review of physician's order that were included in the POC were as follows: a. Seroquel 25 milligrams (mg) one tab daily b. Hydroxyzine 10 mg one tab daily c. Donezepil 5 mg one tab daily d. Setraline 25 mg one tab daily. During a home visit on 8/21/2024, at 11 a.m., with RN 1, Patient 1’s medications were checked. There were one bottle of Seroquel 25 milligrams (mg) one tab daily, one bottle of Hydroxyzine 10 mg one tab daily, one bottle of Donezepil 5 mg one tab daily and one bottle of Setraline 25 mg one tab daily found in Patient 1’s medication basket. On 8/21/2024, at 11:30 a.m., during an interview with family member (FM l), she stated she only administers these medications twice a week because she thinks the dosages were too strong for Patient 1 . A further review of Patient 1's clinical record indicated that there was no discharge OASIS done. On 8/22/2024, at 12 p.m., during an interview with the administrator, she stated Patient 1 was discharged on 7/12/2024, due to goals were met. She further stated the visiting nurse should have checked all patient's medications and provided instruction on medication regimen prior to patient's discharge. b. A review of Patient 2's Patient Information indicated, a start of care (SOC) date of 5/15/2024, with diagnosis of hypothyroidism ( a condition in which the thyroid gland does not produce enough thyroid hormone). A review of Patient 2's plan of care (POC) from 5/15/2024 to 7/23/2024, included an order for skilled nurse (SN) visit of once a week for one week, twice a week for two weeks, once a week for six weeks, to observe/assess all body systems focusing on respiratory system. One of the SN intervention was to assess knowledge on disease process and management, medication knowledge and compliance. Instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). Patient 7, admitted on 10/7/2023, and discharged on 8/1/2024. There was no discharge OASIS done. A review of physician's order that were included in the POC was to administer Propranalol 10 mg one tab twice daily. During a home visit on 8/21/2024, at 12 p.m., with RN 1, Patient 2’s medications were checked. There was a bottle of Propranalol 10 mg one tab daily found on top of the desk. On 8/21/2024, at 12 :30 p.m., during an interview with Patient 2 , she stated she only takes the Propranalol medication if her systolic blood pressure was greater than 140. On 8/22/2024, at 12 p.m., during an interview with the administrator, she stated Patient 2 was discharged on 7/12/2024, due to goals were met. She further stated the visiting nurse should have checked all patient's medications and provided instruction on medication regimen prior to patient's discharge. A further review of Patient 2's clinical record indicated that there was no discharge OASIS done. c. A review of Patient 7's Patient Information indicated, a start of care (SOC) date of 10/7/2023, with diagnosis of hypertension ( a condition in which the force of the blood against the artery walls is too high). A review of Patient 7's plan of care (POC) from 6/3/2024 to 8/1/2024, included an order for skilled nurse (SN) visit of once a week for one week, twice a week for two weeks, once a week for six weeks, to observe/assess all body systems focusing on respiratory system. One of the SN intervention was to assess knowledge on disease process and management, medication knowledge and compliance. Instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). On 8/22/2024, at 1 p.m., during an interview with the administrator, she stated Patient 7 was discharged on 8/1/2024, due to goals were met. A further review of Patient 7's clinical record indicated that there was no discharge OASIS done. A review of the HHA's undated policy and procedure, titled, "Discharge Criteria and Process", indicated when the patient's plan of care changes and this change results in discharge from or reduction of services, a discharge summary will be completed and filed in the clinical record. A review of the HHA's document titled, "Provision of Care, Treatment and Service", revised November 2022, indicated a discharge summary will be completed for all discharged patients. A copy will be mailed to the physician. All discharge paperwork will be due in the office within 72 hours on the discharge date. This will include the discharge order, discharge summary and OASIS. The discharge record will be organized according to the organization policy regarding clinical record contents. Documentation will be reviewed by the Clinical Supervisor or designee and completed within 30 days of the discharge.

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on observations, interviews, and record reviews, the home health agency (HHA) failed to ensure to develop, implement safe and effective discharge planning for patients that were discharged from their care for two of 7 sampled patients (Patient 5 and Patient 6). This deficient practice had a potential or the discharge plan goal were not met. 1. A review of Patient 5’s Patient Face Sheet, indicated a start of care date on 9/8/2023 for the certification period of 5/5/2024 to 7/3/2024 with a primary diagnosis of hypertensive heart disease without heart failure (problems with your heart that can develop if you have high blood pressure but don't treat it for years). During a review of Patient 5's clinical records (in general) on 8/23/2024, indicated that Patient 5 was admitted to another home health agency with a start of care of 2/10/2024 with a certification period of 4/10/2024 to 6/8/2024 with a primary diagnosis of dorsalgia (pain in the back or spine) with this agency’s DPCS written as the clinical manager. Patient 5's clinical record indicated that there was a discharge order for Patient 5's signed and dated by the DPCS on 5/31/2024 for this agency. 2). A review of Patient 6’s Patient Face Sheet, indicated a start of care date on 1/16/2024 for the certification period of 5/15/2024 to 7/13/2024 with a primary diagnosis of idiopathic peripheral autonomic neuropathy (a condition that occurs when the nerves that control automatic body functions are damaged, but the cause of the damage is unknown). During a review on 8/23/2024, of Patient 6's OASIS E, the OASIS section E indicated that Patient 6 did not have a discharge OASIS E for this agency in the Patient 6's electronic medical record. During a review on 8/23/2024, of Patient 6's clinical record (in general) indicated that Patient 6 was admitted to another home health agency with a start of care of 2/10/2024 with a certification period of 4/10/2024 to 6/8/2024 with a primary diagnosis of dorsalgia (pain in the back or spine). During the survey process from 8/20/2024 to 8/23/2024, the Director of Patient Care Services (DPCS) could not be located and no reply from the telephone calls. During an interview on 8/23/2024 at 9:45 a.m., via telephone with Patient 6’s caregiver (CG), Patient 6's CG stated that Patient 6 was being seen by a nurse from the agency. Patient 6's CG stated that Patient 6 still being seen by the physical therapy (PT). Patient 6's CG stated that she only has been with the agency and had not signed any other paperwork for the other agencies mentioned. Patient 6's CG stated that when checked Patient 6's eligibility on the medicare website, CG saw that the agency billed her mom on the following dates but was under different agencies: 1. HHA 3 on1/24/24 to 2-11/24 2. HHA 2 on 1/16/24 to 2/14/2024 3. HHA 4 on 11/9/23 to 12/8/23 During an interview on 8/20/2024 at 1:20 p.m., with the Administrator, the Administrator stated that she did an early discharge of the patients and would transferred patients to one of the agencies that she owned. The Administrator stated the office and field staff are shared with all her four agencies. Admin also stated that “It is hard to pay one hundred thousand dollars’ worth of visiting staff doing the home visits in between her four agencies.” During an interview on 8/22/2024 at 12:58 p.m., with the Administrator, the Administrator stated she tried calling her Director of Patient care Services (DPCS) and DPCS Designee (DPCSD) but both had not responded to her calls and messages. During an interview on 8/23/2024 at 11:45 a.m., with the Administrator, the Administrator stated that she had to leave out of the country for a family emergency and called another registered nurse (RN) to assist with clinical inquiries. At 1:50 p.m., the Administrator informed the survey team that the Administrator Designee went to the DPCS’s home and was not found there. the Administrator left the agency at 2:00 p.m. During a telephone interview on 8/23/2024 at 2:10 p.m., with the DPCS Designee (DPCSD), DPCSD stated that she was not the designee because she resigned from the agency on the month June or July. The DPCSD stated that it has always been the DPCS who oversees the agency. During an interview on 8/23/2024 at 1:56 p.m., with the agency's Consultant, stated that she was a retired registered nurse and worked as Administrator. The agency's Consultant stated “they begged me to come because they do not have a DPCS and DPCSD available onsite and wanted me to assist her with the survey.” A review of the HHA’s policy titled “Care/Service Coordination” revised 11/2022, indicated that To ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services. Each patient will be assigned a Case Manager upon admission by the Clinical Director or Clinical Supervisor. It will be the responsibility of the Case Manager to facilitate communication about changes in the patient status among assigned personnel. Timely and ongoing communication is the responsibility of each team member of the interdisciplinary group and will be appropriate to the needs and abilities of the patient, and relevant to the care/service provided. The clinician will be responsible for facilitating communications about changes in the patient's status among the assigned personnel. A review of the undated HHA’s policy titled “Patient Bill of Rights” indicated to encourage awareness of patient rights and provide guidelines to assist patients in making decisions regarding care and for active participation in care planning. Each patient will be an active, informed participant in his/her plan of care. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. If a state court has not adjudged a patient to lack legal capacity to make health care decisions as defined by state law, the patient may designate someone to act as his/her representative to exercise the patient's rights. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. Be informed in advance about care to be furnished (including the Medicare Home Health Benefit, if applicable) organization scope of services and service limitations and of any changes in the care to be furnished. Be advised in advance of any change, orally and in writing, in the plan of care before the change is made. Be informed verbally and in writing of any changes in payment information as soon as possible, in advance of the next home visit, that the organization becomes aware of the change. A review of the undated HHA’s policy titled “Discharge Planning, Transfer and Continuing Care Needs” indicated When the agency identifies the need for discharge, a written discharge order or documented collaboration with the physician is required before the patient is discharged. The staff member should prepare the patient for discharge by instructing the patient/caregiver to perform necessary care or should work toward making alternate plans for continuing care when further health care is needed. The agency will work with the physician and patient/ caregiver in arranging continuing care of the patient. Agency staff provide patients/caregivers with written and verbal information and assistance, if possible􀀶 for resources to meet identified continuing care needs and with information on how to care for themselves. The patient/caregiver, when possible, actively participates in planning for his/her discharge, referral, or transfer. Patients are informed prior to discharge of plans for discharge and the reason for discharge. If the patient requests discharge from agency service, the agency staff will contact the primary physician to notify her/him of the patient's request and current status of the patient. Agency staff complete a discharge summary that includes, but is not limited to: a brief statement of patient problems and outcomes and a summary of care provided while on agency service. Status at discharge/last visit; current medications, diet, therapies; allergies. Continuing care needs. Instructions and referrals given to the patient, family, or caregiver. Reason for discharge and date of discharge.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on observation, interview, and record reviews, the home health agency failed to ensure a governing body assume responsibility for the governing body operations of the HHA by failing to: 1. Ensure the agency's Director of Patient Care Services (DPCS) provided oversight to ensure the clinical records were completed for seven out of seven sampled patients (Patient I, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6 and Patient 7). 2. Ensure the agency's Administrator (Admin) assumed responsibility for the day-to-day operations of the agency. 3. Ensure the agency's Administrator ensured a clinical manager was available during all operating hours As a result, seven sampled patients were discharged from the HHA without clear evidence the patients were provided a safe discharge. (Refer to G942) The cumulative effects of these systemic practices resulted in the agency's non-compliance with federal regulations to ensure clinical oversight was provided for patient care and personnel to ensure all patients were provided with a safe discharge in order to prevent serious harm that could lead to further hospitalization and death.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on observation, interview, and record reviews, the home health agency’s (HHA, a public or private organization that provides skilled nursing and other therapeutic services to patients in their homes) governing body failed to ensure administrative responsibility, patient safety, and quality improvements for seven out of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6 and Patient 7) by failing to: 1. Ensure the HHA's Administrator (ADM) assumed responsibility for the day-to-day operations of the agency. 2. Ensure the HHA's Administrator ensured a clinical manager was available during all operating hours. 3. Ensure the HHA's Director of Patient Care Services (DPCS) provided oversight to ensure the clinical records were completed for seven out of seven sampled patients (Patient I, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6 and Patient 7). These failures resulted to unsafe patients’ discharge of seven sampled patients from home health agency. On 8/23/2024, at 5:15 p.m., the Department called a third 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)IJ in the presence of the HHA’s Administrator Designee (AD) related to failure of the HHA's governing body assume and ensuring responsibility for the operations of the HHA and for the seven out of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6 and Patient 7). On 8/23/2024 at 5:25 pm, the Administrator Designee (AD) told the survey team the agency would be closed (for business) and would no longer be opened. HHA was unable to submit an IJ removal plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely). The survey team was not able to complete the survey tasks and could not exit (end) the survey. Findings: 1. During a concurrent observation and interview of the HHA’s office on 8/23/2024 at 11:45 a.m., with Office Manager (OM), observed empty filing cabinets with the no boxes inside. Requested employee records from the OM. The OM stated she does not know where the employee records are. During an interview on 8/23/2024, at 11:45 a.m., with the ADM, the ADM stated the DPCS was not responding to calls and messages. ADM also stated that the employee records are in the storage together with patient files and will bring it back to the office. Received the employee records on 8/23/2024 from the Office Personnel (OP) at 1:00 p.m., and on concurrent interview, OP stated that she does not know if the employee files sent was for this agency. 2. During an interview on 8/23/2024, at 1:50 p.m. with the ADM, ADM stated that the Director of Patient Care Designee (DPCSD) will come to the agency to help answer clinical issues for the agency. ADM stated that she must leave immediately to go to Germany. ADM left the agency. During an interview on 8/23/2024 at 1:56 p.m., with DPCSD, DPCSD stated that she is not the DPCSD of the agency but the HHA Consultant for one of the ADM’s agencies. HHA Consultant stated that she helped the ADM start her first agency 10 years ago and did not know that the ADM also started three more agencies. HHA Consultant stated the HHA “begged” her to come and assist because the DPCS and the DPCSD were not available. HHA Consultant stated that she does not know this agency and its patients. During a phone interview and concurrent record review, on 8/23/2024 at 2:10 p.m., with DPCSD, DPCSD stated that between month of June or July this year when the DPCSD left the HHA. Record reviews on the following dates 8/21/2024, 8/22/2024, 8/23/2024 indicated that both DPCS and DPCSD were still signing the CMS-485 (also known as the Home Health Certification and Plan of Care, is a form used by the Centers for Medicare & Medicaid Services (CMS) to establish and certify a patient's treatment plan for home health care. It can be used for the initial certification period and any subsequent 60-day recertification periods). 3. A. During a review of Patient 1's record titled, “Patient Information”, the Patient Information, indicated, a start of care (SOC) date was on 5/14/2024, with diagnosis of diabetes mellitus (a group of diseases that result in too much sugar in the blood). During a review of Patient 1's record titled, “CMS 485 (the Home Health Certification and Plan of Care [POC] form)”, the CMS 485 with Plan of Care (POC) dated from 5/14/2024 to 7/21/2024, indicated an order for skilled nurse (SN) visits of twice a week for two weeks and once a week for seven weeks, SN to observe or assess all body systems focusing on respiratory system, SN to assess knowledge on disease process and management, medication knowledge and compliance, and instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). During a review of Patient 1's record titled, “CMS 485”, the CMS 485 with physician order dated from 5/14/2024 to 7/21/2024, indicated: a. Seroquel (medication that treats several kinds of mental health conditions) 25 milligrams (mg, unit of measure) one tablet daily; b. Hydroxyzine (used to treat itching caused by allergies) 10 mg one tablet daily; c. Donepezil (medication that treats symptoms of memory loss and confusion) 5 mg one tablet daily; d. Sertraline (medication for depression) 25 mg one tablet daily. During Patient’s 1 a home visit on 8/21/2024, at 11 a.m., with RN 1, observed RN 1 checked Patient 1’s medications. Found in Patient 1’s medication basket: one bottle of Seroquel 25 milligrams (mg) one tablet daily, one bottle of Hydroxyzine 10 mg one tablet daily, one bottle of Donepezil 5 mg one tablet daily, and one bottle of Sertraline 25 mg one tablet daily. During an interview with Family Member (FM 1), on 8/21/2024, at 11:30 a.m., FM 1 stated Patient 1 received the ordered medications (Seroquel, Hydroxyzine, Donepezil, and Sertraline) twice a week and thought dosages were too high for Patient 1. During a review of Patient 1's clinical record, found no discharge OASIS (Outcome and Assessment Information Set; standardized data set that measures quality care and outcomes) done. During an interview on 8/22/2024, at 12 p.m., with the Administrator, Administrator stated Patient 1 was discharged on 7/12/2024, and home health care goals were met. Administrator stated the visiting skilled nurse should have checked all patient's medications and provided instruction on medication regimen prior to patient's discharge. B. During a review of Patient 2's record titled, “Patient Information”, the Patient Information, indicated, a start of care (SOC) date was on 5/15/2024, with diagnosis of hypothyroidism (a condition in which the thyroid gland does not produce enough thyroid hormone). During a review of Patient 2's record titled, “CMS 485 (the Home Health Certification and Plan of Care [POC] form)”, the CMS 485 with Plan of Care (POC) dated from 5/15/2024 to 7/23/2024, included an order for skilled nurse (SN) visit of once a week for one week, twice a week for two weeks, once a week for six weeks, to observe or assess all body systems focusing on respiratory system, to assess knowledge on disease process and management, medication knowledge and compliance, and instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). During a review of Patient 2's record titled, “CMS 485”, the CMS 485 with physician order dated from 5/15/2024 to 7/23/2024, indicated: Propranalol (medication to treat high blood pressure) 10 mg one tablet twice daily. During Patient 2 home visit on 8/21/2024, at 12 p.m., with RN 1, observed RN 1 checked Patient 2’s medications were checked. Found on top of Patient’s 2 desk a bottle of Propranolol 10 mg one tablet daily. During an interview on 8/21/2024, at 12 :30 p.m., with Patient 2, Patient 2 stated Propranalol medication is being taken if systolic blood pressure (the pressure when the heart contracts) was greater than 140. During an interview on 8/22/2024, at 12 p.m., with the Administrator, Administrator stated Patient 2 was discharged on 7/12/2024, and home health goals were met. Administrator stated the visiting skilled nurse should have checked all patient's medications and provided instruction on medication regimen prior to patient's discharge. During a review of Patient 2's clinical record, found no discharge OASIS done. During an interview on 8/23/2024, at 11:45 a.m., with the ADM, the employee records are in the storage together with patient files and will bring it back to the office. During a phone interview on 8/23/2024 at 2:10 p.m., with DPCSD, DPCSD stated that between month of June or July this year when the DPCSD left the HHA. C. During a review of Patient 3's record titled, “Patient Information”, the Patient Information, indicated, a start of care (SOC) date was on 4/16/2024 for the certification period of 4/16/2024 to 6/14/2024 with a primary diagnosis of type 2 diabetes (a chronic disease that causes high blood sugar levels) with hyperglycemia (a condition where there is too much sugar in the blood). During a review of Patient 3’s record titled, “CMS 485 (Home Health Certification and Plan of Care)”, on 8/23/2024, indicated Patient 3 was admitted to another agency run by the same ADM, on 4/13/2024, with the certification period of 6/12/2024 to 8/10/2024, and indicated the clinical manager is the DPCS of this agency. During a review of Patient 3’s record titled, “OASIS E-Discharge (Outcome and Assessment Information Set- standardized data set that measures quality care and outcomes)”, indicated Patient 3 was discharged on 8/10/2024. During a joint home visit with RN 1 and concurrent interview on 8/21/2024 at 11:00 a.m., with Patient 3, Patient 3 confirmed signing the consent forms and the “Patient Discharge Instructions or Notification (a form of instructions usually given by a nurse before the patient gets discharged from the hospital or any health service)” on 6/29/2024. Patient 3 stated he knows he was discharged from the agency but was visited by a nurse from the agency on 8/20/2024 at 10:30 p.m. and asked how he was doing and told him to call the nurse for any assistance. D. During a review of Patient 4’s record titled, “Patient Information”, indicated a start of care date on 3/21/2024 for the certification period of 5/20/2024 to 7/18/2024 with a primary diagnosis of hypertensive heart disease without heart failure (problems with your heart that can develop if you have high blood pressure but don't treat it for years). During a review Patient 4’s record titled, “Home Health Certification and Plan of Care” for the period of 3/21/2024 to 5/19/2024, indicated the DPCS as the clinical manager for Patient 4. During a joint home visit with RN 1 at Patient 4’s residence on 8/21/2024 at 12:00 p.m., observed that Patient 4 is alert and oriented to name, place and person, walks without assistance and denied pain. On concurrent interview with Patient 4, Patient 4 confirmed signing the consent forms and the Patient Discharge Instructions or Notification on 3/21/2024. During a review of Patient 4’s record titled, “OASIS E-Discharge”, indicated Patient 4 was discharged on 7/16/2024. E. During a review of Patient 5’s record titled, “Patient Information”, indicated a start of care date on 9/8/2023 for the certification period of 5/5/2024 to 7/3/2024 with a primary diagnosis of hypertensive heart disease without heart failure. During a review of Patient 5’s record titled, “Home Health Certification and Plan of Care”, indicated that the DPCS designee reviewed and written as the clinical manager for the period of 5/5/2024 to 7/3/2024, and discharge order for patient’s goals were met as signed and dated by the DPCS on 5/31/2024. The OASIS E-Discharge was submitted, signed, and exported on 5/31/2024 by the DPCS. During a record review of patient 5 clinical records on 8/23/2024, indicated Patient 5 was admitted to another home health agency with a start of care of 2/10/2024 and a certification period from 4/10/2024 to 6/8/2024, with a primary diagnosis of dorsalgia (pain in the back or spine). With this agency, the DPCS written as the clinical manager, and a discharge order for patient’s goals were met, signed, and dated by the DPCS on 5/31/2024 for this agency. F. During a review of Patient 6’s record titled, “Patient Information”, indicated a start of care date on 1/16/2024 for the certification period of 5/15/2024 to 7/13/2024, with a primary diagnosis of idiopathic peripheral autonomic neuropathy (a condition that occurs when the nerves that control automatic body functions are damaged, but the cause of the damage is unknown). During a record review of Patient 6’s record titled, “Home Health Certification and Plan of Care” on 8/23/2024, indicated that the DPCS designee reviewed and is written as the clinical manager for the period of 5/15/2024 to 7/13/2024. During a review of Patient 6 records on 8/23/2024, found no discharge OASIS. During a phone interview on 8/23/2024 at 9:45 a.m., with Patient 6’s primary caregiver (PCG), PCG stated that Patient 6 is still being visited by a nurse and a physical therapist from this agency. PCG also confirmed that Patient 6 is not discharged from home health. PCG also complained that Patient 6 Medicare is billed by two agencies from 1/14/2024 to 2/11/2024 and another agency on 11/9/2023 to 12/8/2023 and another agency on 1/16/2024 to 2/14/2024. PCG stated that she called the owner of the agency to ask why and PCG was told by the ADM that ADM owns the other agencies and that the nurses from those other agencies were sent to do Patient 6’s home visits. During a review of Patient 6’s clinical records on 8/23/2024, indicated that Patient 6 was admitted on the following certification periods: 1/16/2024 to 3/15/2024, 3/16/2024 to 5/14/2024 and 5/14/2024 to 7/13/2024 on this agency. During an interview after home visit on 8/21/2024 at 12:30 p.m., with RN 1, RN 1 stated that RN 1 works for this agency and to other agencies as needed and do admissions and discharges for the agency. RN 1 stated that the form “Patient Discharge Instructions/Notification” should be given and signed by the patient and by the nurse at the time of discharge. RN 1 stated the form should not be signed during admission and will not know what will happen to the patient in between the certification period. G. During a review of Patient 7's record titled, “Patient Information”, indicated, a start of care (SOC) date of 10/7/2023, with diagnosis of hypertension (a condition in which the force of the blood against the artery walls is too high). During a review of Patient 7's record titled, “CMS 485 (Home Health Certification and Plan of Care)” with Plan of Correction (POC) for the period of 6/3/2024 to 8/1/2024, included an order for skilled nurse (SN) visit of once a week for one week, twice a week for two weeks, once a week for six weeks, to observe or assess all body systems focusing on respiratory system, SN intervention was to assess knowledge on disease process and management, medication knowledge and compliance, and instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). During an interview on 8/22/2024, at 1 p.m., with the ADM stated Patient 7 was discharged on 8/1/2024, due to goals were met. During a review of Patient 7 clinical records on 8/23/2024, found no discharge OASIS. A review of the HHA's undated policy and procedure, titled, "Discharge Criteria and Process", indicated when the patient's plan of care changes and this change results in discharge from or reduction of services, a discharge summary will be completed and filed in the clinical record. A review of the home health agency’s (HHA) undated policy titled ” Job Description: Administrator” indicated the Administrator is responsible for planning, coordinating, managing and directing all activities and programs of the Home Health. Essential job functions and responsibilities: 1. Planning and directing operations to ensure the provision of adequate and appropriate care and services. 2. Fiscal planning, budgeting and management. 3. Ensuring organizational compliance with legal, regulatory and accreditation standards. 4. Recruiting, employing and retaining qualified personnel to maintain appropriate staffing levels. 5. Establishing and maintaining effective open channels of communication. Fosters a no-blame culture that encourages reporting of safety and quality of services issues. 6. Ensuring program personnel have current clinical information and current practices. 7. Ensuring ongoing oversight of the agency's quality management system. 8. Evaluating services and programs. 9. Ensuring personnel development including orientation, in-service education and continuing education. 10. Coordinating with other program areas and management as appropriate. 11. Maintaining current on local trends and issues. 12. Ensuring that appropriate service policies are developed and implemented. 13. Directing personnel in performance of their duties including admission, discharge and provision of service to patients. 14. Assuring appropriate personnel supervision during all operating hours and is responsible for day to day operations. 15. Ensuring the accuracy of public information materials and activities 16. Appointing a similarly qualified alternate to be available at all times during operating hours in the absence of the administrator. · When the Administrator is not available, a qualified, pre-designated person, who is authorized in writing by the Administrator and the governing body, assumes the same responsibilities and obligations as the Administrator. The pre-designated person may be the clinical manager. · The Administrator or a pre-designated person is available during all operating hours A review of the HHA’s policy titled “Care/Service Coordination” dated 11/2022 indicated to ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services. Each patient will be assigned a Case Manager upon admission by the Clinical Director or Clinical Supervisor. It will be the responsibility of the Case Manager to facilitate communication about changes in the patient status among assigned personnel. Timely and ongoing communication is the responsibility of each team member of the interdisciplinary group and will be appropriate to the needs and abilities of the patient, and relevant to the care/service provided. The clinician will be responsible for facilitating communications about changes in the patient's status among the assigned personnel. The name of the Case Manager will be clearly documented in the clinical record.

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 patients in the comfort of their home) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare [a federal system of health insurance for people over 65 years of age and for certain younger people with disabilities] program) for Clinical Records was met as follows: The HHA failed to ensure to safeguard the patient clinical records for 95 of 95 sampled Patients from unauthorized access. This failure has the potential to result in an unauthorized and inaccurate patient information or clinical record that could affect the patient’s quality of care and well-being. (Refer to G1028). The cumulative effect of this systemic practice resulted in the failure of the HHA to deliver statutorily (written law) mandated compliance with the Clinical Records to ensure quality of care was provided to the 95 of 95 patients who were assessed to receive home care and services.

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 an interviews and record reviews, the home health agency (HHA) failed to ensure there was documentation for the patient’s discharge goals of care and treatment summaries in the patients’ medical record to ensure a safe and effective transition of care or discharge for 75 out of 95 discharged patients. This deficient practice resulted in an incomplete documentation and communication of the patient’s plan of care on record. During a review of the HHA 2’s Discharge List on 8/20/2024 at 1:20 p.m., in comparison with the discharge list of HHA 1, HHA 3 and HHA 4 indicated that seventy-five (75) of the ninety-five (95) discharged patients admitted in HHA 2 were also admitted in HHA 3 and HHA 4. Patient 1 was admitted to HHA 2 with a certification period of 5/7/2024 to 7/5/2024 and HHA 3 with a certification period of 5/7/2024 to 7/5/2024 Patient 2 was admitted to HHA 2 with a certification period of 5/15/2024 to 7/13/2024 and to HHA 3 with a certification period of 5/12/2024 to 7/10/2024. Patient 3 was admitted to HHA 2 with a certification period of 5/25/2024 to 7/23/2024 and to HHA 3 with a certification period of 5/22/2024 to 7/20/2024. Patient 4 was admitted to HHA 2 with a certification period of 6/5/2024 to 8/3/2024 and to HHA 3 with a certification period of 6/1/2024 to 7/30/2024. Patient 5 was admitted to HHA 2 with a certification period of 5/27/2024 to 7/25/2024 and to HHA 3 with a certification period of 5/26/2024 to 7/24/2024. Patient 6 was admitted to HHA 2 with a certification period of 5/28/2024 to 7/26/2024 and to HHA 3 with a certification period of 5/27/2024 to 7/25/2024. Patient 7 was admitted to HHA 2 with a certification period of 6/5/2024 to 8/3/2024 and to HHA 3 with a certification period of 6/1/2024 to 7/30/2024. Patient 8 was admitted to HHA 2 with a certification period of 5/19/2024 to 7/17/2024 and to HHA 3 with a certification period of 5/11/2024 to 7/9/2024. Patient 9 was admitted to HHA 2 with a certification period of 5/15/2024 to 7/13/2024 and to HHA 3 with a certification period of 5/11/2024 to 7/9/2024. Patient 10 was admitted to HHA 2 with a certification period of 6/23/2024 to 8/1/2024 and to HHA 3 with a certification period of 6/3/2024 to 8/1/2024. Patient 11 was admitted to HHA 2 with a certification period of 5/28/2024 to 7/26/2024 and to HHA 3 with a certification period of 5/5/2024 to 7/23/2024. Patient 12 was admitted to HHA 2 with a certification period of 5/8/2024 to 7/6/2024 and to HHA 3 admitted on 5/4/2024 with a certification period of 5/20/2024 to 7/18/2024. Patient 13 was admitted to HHA 2 with a certification period of 5/8/2024 to 7/6/2024 and to HHA 3 admitted on 5/4/2024 with a certification period of 7/3/2024 to 8/31/2024. Patient 14 was admitted to HHA 2 with a certification period of 5/5/2024 to 7/3/2024 and was admitted to HHA 4 on 5/11/2024 with a certification period of 5/11/2024 to 7/31/2024. Patient 15 was admitted to HHA 2 with a certification period of 5/8/2024 to 7/6/2024 and was admitted to HHA 3 on 5/4/2024 with a certification period of 7/3/2024 to 8/31/2024. Patient 16 was admitted to HHA 2 with a certification period of 5/15/2024 to 7/13/2024 and to HHA 3 with a certification period of 5/12/2024 to 7/10/2024. Patient 17 was admitted to HHA 2 with a certification period of 5/15/2024 to 7/12/2024 and to HHA 3 with a certification period of 5/8/2024 to 7/6/2024. Patient 18 was admitted to HHA 2 with a certification period of 5/18/2024 to 7/16/2024 and to HHA 3 with a certification period of 5/15/2024 to 7/13/2024. Patient 19 was admitted to HHA 2 with a certification period of 6/15/2024 to 8/13/2024 and to HHA 3 with a certification period of 6/12/2024 to 8/10/2024. Patient 20 was admitted to HHA 2 with a certification period of 5/20/2024 to 7/18/2024 and to HHA 3 with a certification period of 5/18/2024 to 7/16/2024. Patient 21 was admitted to HHA 2 with a certification period of 6/5/2024 to 8/3/2024 and to HHA 3 with a certification period of 6/1/2024 to 7/30/2024. Patient 22 was admitted to HHA 2 with a certification period of 6/6/2024 to 8/4/2024 and to HHA 3 with a certification period of 6/4/2024 to 8/2/2024. Patient 23 was admitted to HHA 2 with a certification period of 5/28/2024 to 7/26/2024 and to HHA 3 with a certification period of 5/24/2024 to 7/22/2024. Patient 24 was admitted to HHA 1 on 5/10/2024 with a certification period of 7/9/2024 to 9/6/2024 and to HHA 2 with a certification period of 5/16/2024 to 7/14/2024. Patient 25 was admitted to HHA 2 with a certification period of 5/25/2024 to 7/23/2024 and to HHA 3 with a certification period of 5/21/2024 to 7/19/2024. Patient 26 was admitted to HHA 2 with a certification period of 5/25/2024 to 7/23/2024 and to HHA 3 with a certification period of 5/21/2024 to 7/19/2024. Patient 27 was admitted to HHA 2 with a certification period of 5/18/2024 to 7/16/2024 and to HHA 3 with a certification period of 5/15/2024 to 7/13/2024. Patient 28 was admitted to HHA 2 with a certification period of 5/21/2024 to 7/19/2024 and to HHA 3 with a certification period of 5/18/2024 to 7/16/2024. Patient 29 was admitted to HHA 2 with a certification period of 5/19/2024 to 7/17/2024 and to HHA 3 with a certification period of 5/15/2024 to 7/13/2024. Patient 30 was admitted to HHA 2 with a certification period of 6/6/2024 to 8/4/2024 and to HHA 3 with a certification period of 6/1/2024 to 7/30/2024. Patient 31 was admitted to HHA 2 with a certification period of 6/5/2024 to 8/3/2024 and to HHA 3 with a certification period of 5/31/2024 to 7/29/2024. Patient 32 was admitted to HHA 2 with a certification period of 5/15/2024 to 7/13/2024 and to HHA 3 with a certification period of 5/14/2024 to 7/12/2024. Patient 33 was admitted to HHA 2 with a certification period of 5/20/2024 to 7/18/2024 and to HHA 3 with a certification period of 5/15/2024 to 7/12/2024. Patient 34 was admitted to HHA 2 with a certification period of 5/21/2024 to 7/19/2024 and to HHA 3 with a certification period of 5/12/2024 to 7/10/2024. Patient 35 was admitted to HHA 2 with a certification period of 5/15/2024 to 7/13/2024 and to HHA 3 with a certification period of 5/14/2024 to 7/12/2024. Patient 36 was admitted to HHA 2 with a certification period of 5/15/2024 to 7/13/2024 and to HHA 3 with a certification period of 5/11/2024 to 7/9/2024. Patient 37 was admitted to HHA 2 with a certification period of 5/4/2024 to 7/2/2024 and to HHA 3 with a certification period of 7/1/2024 to 8/29/2024. Patient 38 was admitted to HHA 2 with a certification period of 5/18/2024 to 7/16/2024 and to HHA 3 with a certification period of 5/11/2024 to 7/9/2024. Patient 39 was admitted to HHA 2 with a certification period of 6/3/2024 to 8/1/2024 and to HHA 3 with a certification period of 6/1/2024 to 7/30/2024. Patient 40 was admitted to HHA 2 with a certification period of 6/16/2024 to 8/14/2024 and to HHA 3 with a certification period of 6/12/2024 to 8/10/2024. Patient 41 was admitted to HHA 2 with a certification period of 6/6/2024 to 8/4/2024 and to HHA 3 with a certification period of 6/3/2024 to 8/1/2024. Patient 42 was admitted to HHA 2 with a certification period of 5/18/2024 to 7/16/2024 and to HHA 3 with a certification period of 5/15/2024 to 7/13/2024. Patient 43 was admitted to HHA 2 with a certification period of 6/7/2024 to 8/5/2024 and to HHA 3 with a certification period of 6/6/2024 to 8/4/2024. Patient 44 was admitted to HHA 2 with a certification period of 5/12/2024 to 7/10/2024 and to HHA 3 with a certification period of 5/8/2024 to 7/6/2024. Patient 45 was admitted to HHA 2 with a certification period of 5/22/2024 to 7/20/2024 and to HHA 3 with a certification period of 5/18/2024 to 7/16/2024. Patient 46 was admitted to HHA 2 with a certification period of 5/7/2024 to 7/15/2024 and to HHA 3 with a certification period of 5/14/2024 to 7/12/2024. Patient 47 was admitted to HHA 2 with a certification period of 5/6/2024 to 7/24/2024 and to HHA 3 with a certification period of 5/22/2024 to 7/20/2024. Patient 48 was admitted to HHA 2 with a certification period of 6/8/2024 to 8/6/2024 and to HHA 3 with a certification period of 6/4/2024 to 8/2/2024. Patient 49 was admitted to HHA 2 with a certification period of 5/15/2024 to 7/28/2024 and to HHA 3 with a certification period of 5/15/2024 to 7/28/2024. Patient 50 was admitted to HHA 2 with a certification period of 5/28/2024 to 7/26/2024 and to HHA 3 with a certification period of 5/25/2024 to 7/23/2024. Patient 51 was admitted to HHA 2 with a certification period of 5/21/2024 to 7/19/2024 and to HHA 3 with a certification period of 5/14/2024 to 7/12/2024. Patient 52 was admitted to HHA 2 with a certification period of 5/22/2024 to 7/20/2024 and to HHA 3 with a certification period of 5/21/2024 to 7/19/2024. Patient 53 was admitted to HHA 2 with a certification period of 5/19/2024 to 7/17/2024 and to HHA 3 with a certification period of 5/17/2024 to 7/15/2024. Patient 54 was admitted to HHA 2 with a certification period of 5/11/2024 to 7/9/2024 and to HHA 3 with a certification period of 5/8/2024 to 7/6/2024. Patient 55 was admitted to HHA 2 with a certification period of 5/11/2024 to 7/9/2024 and to HHA 3 with a certification period of 5/8/2024 to 7/6/2024. Patient 56 was admitted to HHA 2 with a certification period of 5/11/2024 to 7/9/2024 and to HHA 3 with a certification period of 5/8/2024 to 7/6/2024. Patient 57 was admitted to HHA 2 with a certification period of 6/18/2024 to 8/16/2024 and to HHA 3 with a certification period of 6/8/2024 to 8/6/2024. Patient 58 was admitted to HHA 2 with a certification period of 5/17/2024 to 7/15/2024 and to HHA 3 with a certification period of 5/14/2024 to 7/12/2024. Patient 59 was admitted to HHA 2 with a certification period of 5/14/2024 to 7/12/2024 and to HHA 3 with a certification period of 5/11/2024 to 7/9/2024. Patient 60 was admitted to HHA 2 with a certification period of 5/18/2024 to 7/16/2024 and to HHA 3 with a certification period of 5/14/2024 to 7/12/2024. Patient 61 was admitted to HHA 2 with a certification period of 5/18/2024 to 7/16/2024 and to HHA 3 with a certification period of 5/14/2024 to 7/12/2024. Patient 62 was admitted to HHA 2 with a certification period of 5/18/2024 to 7/16/2024 and to HHA 3 with a certification period of 5/14/2024 to 7/12/2024. Patient 63 was admitted to HHA 2 with a certification period of 5/27/2024 to 7/25/2024 and to HHA 3 with a certification period of 5/22/2024 to 7/20/2024. Patient 64 was admitted to HHA 2 with a certification period of 6/2/2024 to 7/31/2024 and to HHA 3 with a certification period of 5/29/2024 to 7/27/2024. Patient 65 was admitted to HHA 2 with a certification period of 6/11/2024 to 8/9/2024 and to HHA 3 with a certification period of 6/8/2024 to 8/6/2024. Patient 66 was admitted to HHA 2 with a certification period of 5/16/2024 to 7/4/2024 and to HHA 3 with a certification period of 5/14/2024 to 7/12/2024. Patient 67 was admitted to HHA 2 with a certification period of 5/9/2024 to 7/7/2024 and to HHA 3 with a certification period of 5/7/2024 to 7/5/2024. Patient 68 was admitted to HHA 2 with a certification period of 5/26/2024 to 7/24/2024 and to HHA 3 with a certification period of 5/23/2024 to 7/21/2024. Patient 69 was admitted to HHA 2 with a certification period of 6/2/2024 to 7/31/2024 and to HHA 3 with a certification period of 5/29/2024 to 7/27/2024. Patient 70 was admitted to HHA 2 with a certification period of 5/11/2024 to 7/9/2024 and to HHA 3 with a certification period of 5/8/2024 to 7/6/2024. Patient 71 was admitted to HHA 2 with a certification period of 5/15/2024 to 7/13/2024 and to HHA 3 with a certification period of 5/11/2024 to 7/9/2024. Patient 72 was admitted to HHA 2 with a certification period of 6/5/2024 to 8/3/2024 and to HHA 3 with a certification period of 6/1/2024 to 7/30/2024. Patient 73 was admitted to HHA 2 with a certification period of 5/27/2024 to 7/25/2024 and to HHA 3 with a certification period of 5/25/2024 to 7/23/2024. Patient 74 was admitted to HHA 2 with a certification period of 5/21/2024 to 7/19/2024 and to HHA 3 with a certification period of 5/20/2024 to 7/18/2024. Patient 75 was admitted to HHA 2 with a certification period of 6/11/2024 to 8/9/2024 and to HHA 3 with a certification period of 6/8/2024 to 8/6/2024. During an interview with the Administrator (Admin) on 8/20/2024 at 1:20 p.m., Admin stated she does an early discharge when she transfers a patient to one of the agencies she owned. Admin further stated the office and field staff are shared with all her four agencies. Admin also stated that "it is hard to pay one hundred thousand dollars’ worth of visiting staff doing the home visits in between her four agencies." During an interview with the Admin on 8/22/2024 at 12:58 p.m., Admin stated she tried calling her Director of Patient care Services (DPCS) and DPCS Designee (DPCSD) but both had not responded to her calls and messages. A request was made to the Office Personnel (OP) on 823/2024 at 1:30 p.m., to provide log in for the electronic medical records for all patients. On concurrent interview with the OP, stated that she does not have permission to log into the medical records but the Office Manager (OM) only. During an observation on 8/23/2024 at 1:30 p.m., of Office Manager (OM) used the log in of the DPCS. Attempted to ask the OM why she was using the DPCS log in and password to view the medical record, she refused to answer the question. During an observation on 8/23/2024 at 1:35 p.m., the Admin came and took over the computer from the OM, logged her out of the program and entered her own log in information. Admin also stated repetitively, “I am logged in, this is my log in and not the DPCS log in you can see my name on top which means I am logged into the system.” During an interview with the Admin on 8/23/2024 at 11:45 a.m., stated that the Admin stated she had to leave out of the country for a family emergency and called another registered nurse (RN) to assist with clinical inquiries. At 1:50 p.m., Admin informed the survey team that the Admin Designee went to the DPCS’s home and was not found there. Admin left the agency at 2:00 p.m. During a telephone interview on 8/23/2024 at 2:10 p.m., with the stated DPCS Designee (DPCSD), DPCSD stated that she is not the designee because she resigned from the agency last June or July. DPCSD stated that it has always been the DPCS who oversees the agency. During an interview on 8/23/2024 at 1:56 p.m., with the Consultant, stated that she is a retired registered nurse and worked with this Admin to start her first home health agency 10 years ago. Consultant denied knowledge of HHA 2 and that that she is only a consultant for HHA 1. Consultant stated “They begged me to come because they do not have a DPCS and DPCSD available onsite and wanted me to assist her with the survey.” A review of the HHA’s policy titled “Care/Service Coordination” revised 11/2022, indicated that To ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services. Each patient will be assigned a Case Manager upon admission by the Clinical Director or Clinical Supervisor. It will be the responsibility of the Case Manager to facilitate communication about changes in the patient status among assigned personnel. Timely and ongoing communication is the responsibility of each team member of the interdisciplinary group and will be appropriate to the needs and abilities of the patient, and relevant to the care/service provided. The clinician will be responsible for facilitating communications about changes in the patient's status among the assigned personnel. A review of the undated HHA’s policy titled “Patient Bill of Rights” indicated to encourage awareness of patient rights and provide guidelines to assist patients in making decisions regarding care and for active participation in care planning. Each patient will be an active, informed participant in his/her plan of care. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. If a state court has not adjudged a patient to lack legal capacity to make health care decisions as defined by state law, the patient may designate someone to act as his/her representative to exercise the patient's rights. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. Be informed in advance about care to be furnished (including the Medicare Home Health Benefit, if applicable) organization scope of services and service limitations and of any changes in the care to be furnished. Be advised in advance of any change, orally and in writing, in the plan of care before the change is made. Be informed verbally and in writing of any changes in payment information as soon as possible, in advance of the next home visit, that the organization becomes aware of the change. A review of the undated HHA’s policy titled “Discharge Planning, Transfer and Continuing Care Needs” indicated When the agency identifies the need for discharge, a written discharge order or documented collaboration with the physician is required before the patient is discharged. The staff member should prepare the patient for discharge by instructing the patient/caregiver to perform necessary care or should work toward making alternate plans for continuing care when further health care is needed. The agency will work with the physician and patient/ caregiver in arranging continuing care of the patient. Agency staff provide patients/caregivers with written and verbal information and assistance, if possible􀀶 for resources to meet identified continuing care needs and with information on how to care for themselves. The patient/caregiver, when possible, actively participates in planning for his/her discharge, referral, or transfer. Patients are informed prior to discharge of plans for discharge and the reason for discharge. If the patient requests discharge from agency service, the agency staff will contact the primary physician to notify her/him of the patient's request and current status of the patient. Agency staff complete a discharge summary that includes, but is not limited to: a brief statement of patient problems and outcomes and a summary of care provided while on agency service. Status at discharge/last visit; current medications, diet, therapies; allergies. Continuing care needs. Instructions and referrals given to the patient, family, or caregiver. Reason for discharge and date of discharge.

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 to safeguard the patient clinical records for 95 of 95 sampled Patients from unauthorized access. This failure had the potential to result in an unauthorized and inaccurate patient information or clinical record that could affect the patient’s quality of care and well-being. On 8/20/2024 at 4:16 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) in the presence of the agency’s Administrator related to the home health agency’s (HHA, a public or private organization that provides skilled nursing and other therapeutic services to patients in their homes) failure to ensure to safeguard the patient clinical records for 95 of 95 sampled Patients from unauthorized access. As a result, this failure has the potential to result in an unauthorized and inaccurate patient information or clinical record that could affect the patient’s quality of care and well-being. On 8/23/2024 at 5:25 pm, the Administrator Designee (AD) told the survey team the agency would be closed (for business) and would no longer be opened. HHA was unable to submit an IJ removal plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely). The survey team was not able to complete the survey tasks and could not exit (end) the survey. A review of the agency's patient active census indicated a total of 95 discharge patients in the home health agency. During an initial tour of the agency, there were 15 patient’s discharge boxes stored on the floor by the main entrance hallway of the agency. During an interview on 8/20/2024, at 2:30 pm, with the ADM, the ADM stated there were15 boxes that were combined with different patient’s discharge records from four different agencies (Askleplus Home Health, Hygeia Home Care, Mg Home health Care, Prospect Home health Care). The ADM stated the agency did not safeguard the records. A review of agency's undated policy " Protection of Records", indicated that medical records should be stored in cabinets locked if not in use.