Every finding on record at Nizhoni Health Systems

A recertification survey was conducted at Innovive Health, located at 10 Cabot Road, Suite 201, Medford, MA 02155, on September 23, 2025 and September 24, 2025, for compliance with 42 CFR Part 484.102 Emergency Preparedness for Home Health Agencies. As a result of this survey, it was determined the agency was in compliance with the Condition of Participation for Emergency Preparedness. No deficiencies were cited.

A recertification survey was conducted at Innovive Health, located at 10 Cabot Road, Suite 201, Newton, MA 02155, on September 23, 2025 and September 24, 2025, to determine compliance with 42 CFR Part 484 requirements for Home Health Agencies. As a result of this survey, it was determined the agency was not in compliance with these requirements. Deficiencies were cited.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Outcome and Assessment Information Set (OASIS) data accurately reflected the patient's status at the time of the assessment for 1 patient (#8), out of a total sample of 17 patients. Findings include: Patient #8 was admitted to the agency in August 2025 with a diagnosis of major depressive disorder and required skilled home care services for medication management. Review of the physician ordered Home Health Certification and Plan of Care, dated 8/12/25 through 10/10/25, indicated the following: *Skilled Nursing visits (SNVs): 2 times a day for 60 days. Review of clinical record indicated Patient #8 was hospitalized 7/17/25 through 8/11/25. Review of the hospital discharge documentation indicated that Patient #8 have a Deep Tissue Pressure Injury (DTI) (classified as stage 2 pressure ulcer/a non-blanchable deep red, purple or maroon areas of intact skin, non-intact skin or blood-filled blister caused by damage to the underlying soft tissue) to right medial heel. Review of the OASIS initial certification assessment, dated 8/12/25, indicated the following: *No unhealed Pressure Ulcer/Injury at Stage 2 or higher designated as unstageable. *No stasis ulcer. *No surgical wounds. During an interview on 9/24/25 at 2:30 P.M., the Chief Compliance Officer and VP of Quality Improvement and Education reviewed the Electronic Medical Record (EMR) and said that the OASIS initial assessment was coded incorrectly.

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on record review, policy review, and staff interview, the agency failed to ensure that the initial and comprehensive assessment identified a skin injury and develop a plan of care (POC) for 1 patient (#8), out of a total sample of 17 patients. Findings include: Review of the facility policy titled “Comprehensive Assessment” with the reviewed date of April 2024 indicated the following: *During the comprehensive patient assessment, all baseline data and other relevant information will be documented in the patient clinical record, including at least the following information: -includes relevant past medical history as well as active health and medical problems. Review of the facility policy titled “Care Planning Process” with the reviewed date of April 2024 indicated the following: *All clinicians will consider the elements of initial and on-going assessments in their care planning process, including (but not limited to). -individualized patient needs and resultant problems, related to care/service, functional status, family/caregiver support. -changes in patient’s condition. *Based on those assessments and conclusions, the plan of care will include, but is limited to: -identified patient problems and needs. -reasonable, measurable and individualized goals. Patient #8 was admitted to the agency in August 2025 with a diagnosis of major depressive disorder and required skilled home care services for medication management. Review of the physician ordered Home Health Certification and Plan of Care, dated 8/12/25 through 10/10/25, indicated the following: *Skilled Nursing visits (SNVs): 2 times a day for 60 days. Review of clinical record indicated Patient #8 was hospitalized 7/17/25 through 8/11/25. Review of the hospital discharge documentation indicated that patient #8 have a Deep Tissue Pressure Injury (DTI) (classified as stage 2 pressure ulcer/a non-blanchable deep red, purple or maroon areas of intact skin, non-intact skin or blood-filled blister caused by damage to the underlying soft tissue) to right medial heel. Review of the initial and comprehensive assessment dated 8/12/25 failed to identify and address patient #8’s DTI on his/her right medial heel. Treatment and plan of care to address patient #8’s’ DTI on his/her right medial heel was not developed/implemented until 8/29/25 (17 days after the admission). During an interview on 9/24/25 at 2:30 P.M., the Chief Compliance Officer and VP of Quality Improvement and Education reviewed the Electronic Medical Record (EMR) and said that plan of care to address patient #8’s DTI on his/her right medial heel should have been developed and implemented during the initial assessment.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review, policy review, observation, and interview, the agency failed to provide services that are ordered by the physician or allowed practitioner as indicated in the plan of care for 2 patients (#2 and #13), out of a total sample to 17 patients. Findings include: 2. Patient #13 was admitted to the agency July 2025 with diagnoses including opioid dependence, and diabetes. a.) During the home visit on 9/23/25 at 5:30 P.M., the surveyor observed the skilled nurse performing a finger stick blood sugar check for Patient #13. The results indicated that Patient #13's blood sugar was 124. Patient #13 said that the finger sticks were being performed because she/he was waiting for the pharmacy to fill the prescription for the CGM (a continuous blood glucose monitoring system (this system uses a small sensor applied to the skin-usually the back of the upper arm, with the data sent to a dedicated receiver-usually a smart phone-providing a 24/7 picture of glucose levels). Review of the physician ordered Home Health Certification and Plan of Care, dated 8/27/25 through 10/25/25, did not indicate a physician's order for the finger sticks or for the CGM system, with a frequency. During an interview on 9/24/25 at 4:45 P.M. the Chief Compliance Officer said that if the skilled nurses and/or the patient are performing finger stick blood sugar checks, there should be a physician's order for the skilled nurse and/or patient which should also include a frequency to perform the blood sugar checks, and there was not. b. For Patient #13 the agency failed to notify the patients physician when there was a change to the plan of care. Patient #13 was admitted to the agency with diagnoses of opioid dependance and diabetes. Clinical record review indicated that Patient #13 was receiving Home Health Aide (HHA) services with the first visit occurring on 7/14/2025. Further review of the clinical record indicated the last HHA visit occurred on 8/11/25 and the patient would be discharged from services as of 8/12/25. The physician ordered Home Health Certification and Plan of Care, dated 8/27/2025 through 10/25/2025, indicated that HHA services were to continue with the frequency of visits ordered as: -HHA visits: 5 to 7 times a week for 9 weeks. The clinical record did not indicate any communication and/or a verbal order from the provider updating the plan of care regarding the last HHA visit occurred on 8/11/2025 and that HHA visits had been discharged on 8/12/2025. Review of the clinical record indicated no HHA visits had been provided after 8/11/25. During an interview on 9/24/25 at 4:50 P.M., the Chief Operating Officer said there was no notification/update to the physician regarding the HHA services being discontinued as of 8/12/2025, and a verbal order from the physician was not obtained to update the plan of care, as required per the policy. Review of the agency's policy entitled Care Planning and Process, dated April 2025, indicated the following: *At the time of the initial assessment, the clinical manager/designee, along with other involved clinicians, will develop the plan of care based upon the patient's identified needs and will review it with the patient and/or family, caregiver and/or representative. *The plan of care (POC) will be based upon the provider's orders and encompass the equipment, supplies and services required to meet the patient's needs. *Services to be provided will be based on the prioritized needs of the patient. *A plan of care will be developed within twenty-four (24) hours of admission and updated at least every sixty (60) days or as needed based on changes in the patient’s health status or environment. *The care planning process will be documented on the plan of care, clinical, OASIS assessments, evaluations, medication profiles, home health aide care plan, supplemental provider orders, care management/summary forms and discharge/clinical summaries. *Clinicians will inform the patient’s provider of any changes that suggest a need to alter the plan of care. Interim revisions to the plan of care shall be accomplished through communication with the provider, documented as verbal orders and signed by the provider. Review of the agency's policy entitled Missed Visit: Patient Not Seen, Not Found (NSNF), dated April 2024, indicated the following: *Patient not seen not found for a visit refers to circumstances where the service provider is unable to deliver a scheduled visit as the patient is either not at home, refuses the visit and/or does not answer clinician's attempts to contact patient by phone. Consistency and clarity in identifying these visits and timely reporting is critical to maintaining patient safety and preventing patient's condition from deteriorating, *Documentation expectations: Must include that a missed visit occurred, whom the clinician notified, and all visit attempts the clinician made. 1.Patient #2 was admitted to the agency in March 2025 with a diagnosis of Opioid Dependence and required skilled home care services. Review of the physician ordered Home Health Certification and Plan of Care, dated 7/10/25 through 9/7/25, indicated the following: -Skilled Nurse visits (SNVs): once a day for 60 days, and 3 as needed visits. a.) Review of the clinical record indicated 2 SNVs were provided on the following days, not one as ordered: -7/11/25, 7/19/25, 8/3/25, 8/7/95 and 8/9/25. b.) Review of the clinical record indicated a SNV was not provided daily as ordered, and there was no documentation to indicate why the visits were not provided on the following days: -7/18/25, 8/6/25, 8/8/25, 8/10/25, 8/13/25, 8/15/25, 8/25/25, and 8/27/25 During an interview on 9/24/25 at 8:30 A.M., the Chief Compliance Officer (COO) said for the days the patient received 2 SNVs it may have been due to a visit that was not provided the day before. She said the POC had daily SNVs ordered so if additional daily SNVs were required, the POC should have been updated to allow staff to do more than one SNV a day when needed. She also said when visits are missed, staff should have documented why they were not provided, and the missed visits noted above did not have documentation as to why the visit was not provided as ordered.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on record review, policy review and interview, the agency failed to ensure staff communicated with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care for 7 patients (#5, #6, #7, #9, #16, #8 and #13), out of a total sample of 17 patients. Findings include: 7.Patient #13 was admitted to the agency in July 2025 with a diagnosis of opioid dependance and diabetes. Review of the Home Health Certification and Plan of Care, dated 6/28/25 through 8/26/25, indicated the following: -SNV: 1 time a day for one day, 1 time a week for one week, then 3-4 times a week for 9 weeks and 3 visits as needed for complications/Med changes. Review of the physician ordered Home Health Certification and Plan of Care, dated 8/27/25 through 10/25/2025, indicated the following: SNV: 5 to 7 times a week for 9 weeks, and 3 visits as needed for complications/Med changes. Review of the clinical record indicated that SNVs were not provided on the following days, and documentation did not indicate the physician was notified: 7/26/25, 8/1/25, 8/3/25, 8/5/25, 8/11/25, 8/13/25, 8/22/25, 8/27/25, 9/6/25, and 9/7/25. During an interview on 9/24/25 at 4:30 P.M., the Chief Compliance Officer said that staff should be notifying the physician of a missed visit and that the documentation should indicate physician notification. She said the above missed visits documentation did not indicate that the physician was notified that the plan of care was not implemented as ordered 6.Patient #8 was admitted to the agency in August 2025 with a diagnosis of major depressive disorder and required skilled home care services for medication management. Review of the physician ordered Home Health Certification and Plan of Care, dated 8/12/25 through 10/10/25, indicated the following: *Skilled Nursing visits (SNVs): 2 times a day for 60 days. Review of clinical record indicated Patient #8 was hospitalized 7/17/25 through 8/11/25. Review of the hospital discharge documentation indicated that patient #8 have a Deep Tissue Pressure Injury (DTI) (classified as stage 2 pressure ulcer/a non-blanchable deep red, purple or maroon areas of intact skin, non-intact skin or blood-filled blister caused by damage to the underlying soft tissue) to right medial heel. Review of the initial and comprehensive assessment dated 8/12/25 failed to identify patient #8’s DTI on his/her right medial heel and that the physician was notified about the skin injury. During an interview on 9/24/25 at 2:30 P.M., the Chief Compliance Officer and VP of Quality Improvement and Education reviewed the Electronic Medical Record (EMR) and said that the physician was not notified about patient #8’s DTI on his/her right medial heel because it was not identified during the initial and comprehensive assessment. Review of the agency's policy entitled Missed Visit: Patient Not Seen, Not Found, dated April 2024, indicated the following: *Documentation expectations: Must include that a missed visit occurred, whom the clinician notified, and all visit attempts the clinician made. Review of the agency's policy entitled Provider Communication, dated April 2024, indicated the following: *Professional agency personnel contact the patient's provider when there is a problem implementing the plan of care. *All conferences or attempts to communicate with provider will be documented in the clinical record. 1.Patient #5 was admitted to the agency in July 2025 with a diagnosis of Severe Persistent Asthma and required home care services. Review of the physician ordered Health Home Certification and Plan of Care (POC), dated 7/10/25 through 9/7/25, indicated the following: -Skilled Nurse visit (SNV): once a day for 60 days and 3 as needed (PRN) visits. Review of the clinical record indicated a SNV was not provided on the following days, and documentation did not indicate the physician was notified: -7/11/25, 7/20/25 and 7/21/25. 2. Patient #6 was admitted to the agency in August 2025 with a diagnosis of Atherosclerotic Heart Disease (block arteries of the heart) and required home care services. Review of the physician ordered Health Home Certification and POC, dated 8/8/25 through 10/6/25, indicated the following: -SNV: once a day for 60 days and 3 PRN visits. Review of the clinical record indicated a SNV was not provided on the following day, and documentation did not indicate the physician was notified: -9/21/25. 3. Patient #7 was admitted to the agency in July 2025 with a diagnosis of Type 2 Diabetes Mellitus (sugar build up in the blood due to insulin resistance) and required home care services. Review of the physician ordered Health Home Certification and POC, dated 7/28/25 through 9/25/25, indicated the following: -Effective 7/28/25 through 8/3/25: 1 SNV a day for 8 days. -Effective 8/4/25 through 9/25/25: 2 SNVs a day for 53 days and 3 PRN visits. Review of the clinical record indicated a second SNV was not provided on the following day, and documentation did not indicate the physician was notified: -8/30/25. 4. Patient #9 was admitted to the agency in July 2015 with a diagnosis of Type 2 Diabetes Mellitus (sugar build up in the blood due to insulin resistance) and required home care services. Review of the physician ordered Health Home Certification and POC, dated 7/27/25 through 9/24/25, indicated the following: -SNV: once a day for 60 days and 3 PRN visits. Review of the clinical record indicated a second SNV was not provided on the following day, and documentation did not indicate the physician was notified: -7/29/25, 7/30/25, 7/31/25, 8/1/25, 8/4/25, 8/6/25, 8/8/25, and 8/10/25. 5. Patient #16 was admitted to the agency in December 2021 with a diagnosis of Diabetes Mellitus (sugar build up in the blood when the body is not using insulin correctly) and required home care services. Review of the physician ordered Health Home Certification and POC, dated 8/3/25 through 10/11/25, indicated the following: -SNV: twice a day for 60 days and 3 PRN visits. Review of the clinical record indicated a second SNV was not provided on the following day, and documentation did not indicate the physician was notified: -8/3/25, 8/6/25, 8/16/25, 8/18/25, 9/6/25, 8/24/25, 9/6/25, and 9/20/25. During an interview on 9/24/25 at 8:30 A.M., the Chief Compliance Officer said that staff should document in a missed visit not why the services were not provided and that the physician was notified of the missed visit. She said the above missed visits documentation did not indicate the physicians were notified that the plan of care was not implemented as ordered.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review, policy review and interview, the agency failed to ensure documentation was appropriately authenticated, dated, and timed for 9 Patients (#2, #5, #6, #7, #9, #14, #16, #8 and #11), out of a total sample of 17 patients. Findings include: 8. Patient #8 was admitted to the agency in August 2025 with a diagnosis of major depressive disorder and required skilled home care services for medication management. Review of the physician ordered Home Health Certification and Plan of Care, dated 8/12/25 through 10/10/25, indicated the following: -SNVs: 2 times a day for 60 days. Further review of the clinical record indicated that documentation for the visits was not completed and incorporated into the patient's record within 24 hours, as required, including the following: *The SNV note for 8/27/25 was completed and signed 9/2/25. *The SNV note for 8/28/25 was completed and signed 9/2/25. *The SNV note for 9/10/25 was completed and signed 9/15/25. *The SNV note for 9/17/25 was completed and signed 9/23/25. *The SNV note for 9/18/25 was completed and signed 9/23/25. 9. Patient #11 was admitted to the agency in February 2019 with a diagnosis of Major Depressive Disorder and required skilled home care services for medication management. Review of the physician ordered Home Health Certification and Plan of Care, dated 7/24/25 through 9/21/25, indicated the following: -SNVs: 1-2 times a day for 60 days. Further review of the clinical record indicated that documentation for the visits was not completed and incorporated into the patient's record within 24 hours, as required, including the following: *The SNV note for 7/29/25 was completed and signed 8/4/25. *The SNV note for 8/5/25 was completed and signed 8/12/25. *The SNV note for 8/13/25 was completed and signed 8/19/25. *The SNV note for 8/20/25 was completed and signed 9/1/25. *The SNV note for 9/4/25 was completed and signed 9/8/25. *The SNV note for 9/8/25 was completed and signed 9/15/25. *The SNV note for 9/15/25 was completed and signed 9/22/25. *The SNV note for 9/17/25 was completed and signed 9/22/25. During an interview on 9/24/25 at 8:30 A.M., the Chief Compliance Officer said that staff start their notes when they are providing the visit and are expected to complete and sign the notes within 24 hours. She said the agency has an internal monitoring system for timeliness of documentation; however, notes continue to be signed late, and not within 24 hours per the policy. Review of the agency's policy entitled Patient Visit Note Documentation, dated April 2024, indicated the following: *As the responsibility of all visit staff is performing the visit and completing and submitting the visit documentation, all notes are to be submitted by twenty-four (24) hours after the visit. 1.Patient #2 was admitted to the agency in March with a diagnosis of Opioid Dependence and required home care services. Review of the clinical record included the following visit notes that were not completed and signed within 24 hours as required: -6/30/25 skilled nurse visit (SNV) note was signed on 7/5/25. -8/5/25 SNV note was signed on 8/11/25. -8/12/25 SNV note was signed 8/21/25. 2.Patient #5 was admitted to the agency in July with a diagnosis of Severe Persistent Asthma and required home care services. Review of the clinical record included the following visit notes that were not completed and signed within 24 hours as required: -7/10/25 SNV note was signed on 7/16/25. -7/22/25 SNV note was signed 7/27/25. 3.Patient #6 was admitted to the agency in August 2025 with a diagnosis of Atherosclerotic Heart Disease (blocked arteries of the heart) and required home care services. Review of the clinical record included the following visit notes that were not completed and signed within 24 hours as required: -8/8/25 SNV note was signed 8/11/25. -8/12/25 SNV note was signed 8/18/25. -8/15/25 physical therapy visit (PTV) note was signed on 8/18/25. -8/22/25 PTV note was signed on 8/26/25. -9/1/25 occupational therapy visit (OTV) note was signed on 9/4/25. -9/10/25 SNV note was signed on 9/16/25. 4.Patient #7 was admitted to the agency in July 2025 with a diagnosis of Type 2 Diabetes Mellitus (high blood sugar due to insulin resistance) and required home care services. Review of the clinical record included the following visit notes that were not completed and signed within 24 hours as required: -8/9/25 SNV note was signed on 8/12/25. -8/23/25 SNV note was signed on 8/26/25 -9/5/25 SNV note was signed on 9/8/25. 5.Patient #9 was admitted to the agency in July 2025 with a diagnosis of Type 2 Diabetes Mellitus (high blood sugar due to insulin resistance) and required home care services. Review of the clinical record included the following visit notes that were not completed and signed within 24 hours as required: -8/19/25 SNV note was signed on 8/23/25. -9/1/25 SNV note was signed on 9/6/25 -9/17/25 SNV note was signed on 9/22/25. 6.Patient #14 was admitted to the agency in August 2025 with a diagnosis of Major Depressive Disorder and required home care services. Review of the clinical record included the following visit notes that were not completed and signed within 24 hours as required: -8/9/25 SNV note was signed on 8/12/25. -8/17/25 SNV note was signed on 8/22/25. -9/1/25 SNV note was signed on 9/5/25. -9/17/25 SNV note was signed on 9/22/25. 7.Patient #16 was admitted to the agency in August 2025 with a diagnosis of Diabetes Mellitus (high blood sugar due to insulin resistance) and required home care services. Review of the clinical record included the following visit notes that were not completed and signed within 24 hours as required: -8/11/25 SNV note was signed on 8/19/25. -8/17/25 SNV note was signed on 8/21/25 -9/2/25 SNV note was signed on 9/8/25. -9/18/25 SNV note was signed on 9/23/25.

Complaint Reference Number: 104845 A Complaint Survey was conducted at Innovive Health on 02/21/24 to determine compliance with the following Conditions of Participation related to home health care: -CFR 484.50 Patient Rights -CFR 484.60 Care planning, coordination of services, and quality of care A statement of deficiencies was generated as a result of the investigation of this complaint.

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on records reviewed and interviews, for one of three sampled patients (Patient #1), the Agency failed to ensure services were provided in accordance with patient’s plan of care related to medication administration. Patient #1’s Clozaril (antipsychotic) and Clonazepam (anxiolytic and antipsychotic) were not administered for seven days, the physician was not notified, and as a result, Patient #1 was hospitalized. Findings include: The Agency’s Policy, titled Administration and Documentation of Medications, dated 09/2023, indicated nursing would administer and document medications that had been ordered as part of the plan of care by the provider. The Agency’s Policy, titled Care Planning Process, dated 09/2022, indicated the plan of care would be based on the provider’s orders and include the services required to meet the patient’s needs. The Agency’s Protocol titled Medication Management, undated, indicated use of the medication Clozaril required careful monitoring, close communication with the prescribing physician, and if more than two doses were missed, Nursing staff would notify the physician and document any new orders received. The FDA.gov Clonazepam Medication Guide, dated 08/2010, indicated that abruptly stopping Clonazepam could cause serious side effects, including seizures that would not stop. Patient #1 was admitted to the Agency in January 2023, diagnoses included Schizoaffective Disorder, Depression, and Post Traumatic Stress Disorder. Review of Patient #1’s Home Health Certification and Plan of Care, dated 11/20/23 through 01/18/24, indicated Patient #1 required skilled nursing visits three times weekly related to medication compliance, was at risk for hospitalization in the event of medication noncompliance, and skilled nursing services would monitor the effectiveness of medication therapy, administer medications per physician’s orders, and pre-pour Patient #1’s medications through the next home visit. The Plan of Care indicated Patient #1 had physician's orders for Clonazepam 0.5 milligrams (mg), by mouth, twice daily, and Clozaril 250 mg, by mouth, once daily at bedtime. Review of the Agency’s Missed Medication Investigation for Patient #1, dated 01/26/24, indicated that Patient #1 did not have refills available of his/her Clonazepam and Clozaril from 12/04/23 through 12/11/23, that Nurse #1, Nurse #2, and the Clinical Nurse Manager were aware that Patient #1 was without the medications, had not notified Physician #1, and that Patient #1 was admitted to the Hospital as a result. During a telephone interview on 02/21/24 at 12:33 P.M., Nurse #1 said that on Monday, 12/04/23, she was the nurse assigned to visit Patient #1 in his/her home, and said she was unable to prepare his/her Clonazepam and Clozaril medications up to his/her next home visit by nursing, as he/she did not have either of the medications, that she called the Pharmacy, but it was closed, and said she notified Clinical Manager #1 via email later that night. Nurse #1 said she called the Pharmacy again on 12/05/23, and was told there were no refills left, so the pharmacy would reach out to Physician #1. Nurse #1 said she again called the Pharmacy on 12/06/23 and was told there was no response from Physician #1, therefore Patient #1 still did not have Clonazepam and Clozaril. Nurse #1 said that on Friday, 12/11/23, she visited Patient #1 again, and said she was shocked that the medication was still unavailable. Nurse #1 said Patient #1 was unresponsive, would not talk, and was transferred to the Hospital Emergency Department via 911. Nurse #1 said she did not at any time call Physician #1 to report that Patient #1’s did not have Clonazepam and Clozaril, and therefore these medications were not administered. During a telephone interview on 01/21/24 at 12:14 P.M., Nurse #2 said that on Thursday, 12/09/23, he was the nurse assigned to visit Patient #1, in his/her home, and said he/she did not have Clonazepam and Clozaril, therefore these medications could not be prepared up to his/her next nursing visit. Nurse #2 said he continued with his scheduled patients for the rest of the day, and later went to the pharmacy to try to pick up Patient #1’s medications, but the pharmacy was closed. Nurse #2 said he did not notify Physician #1 that Patient #1’s Clonazepam and Clozaril were unavailable and said he did not notify Clinical Manager #1. During a telephone interview on 02/21/24 at 12:14 P.M., Clinical Manager #1 said that on 12/05/24 she was notified via an email from Nurse #1 that Patient #1 did not have any Clonazepam and Clozaril to be administered or prepared up to his/her next nursing visit, and the pharmacy was closed. Clinical Manager #1 said she Emailed Nurse #1 on 12/05/23 to follow up on the medication. Clinical Manager #1 said later that day, Nurse #1 told her that the pharmacy said they would reach out to Physician #1 for new prescriptions. Clinical Manager #1 said she was aware that from 12/04/23 to 12/11/23 Patient #1 did not receive Clonazepam and Clozaril and said she did not notify Physician #1 or instruct Nurse #1 or Nurse #2 to do so either. During a telephone interview on 02/26/24 at 1:03 P.M., Physician #1 said abruptly stopping Clonazepam is very dangerous, and can cause seizures, or in Patient #1’s case, catatonia (a disorder that disrupts a person’s awareness of the world around them. People with this condition sometimes react very little or not at all to their surroundings, or might behave in ways that are unusual, unexpected or unsafe to themselves or others. It can have life-threatening complications.) Physician #1 said Clozaril should not just be restarted after missing two days of the prescribed dosing, and would need to be re-titrated up to the therapeutic dose. Physician #1 said that she was not notified by the Agency that Patient #1 had missed any doses of the Clonazepam and Clozaril or that he/she had gone seven days without his/her Clozaril and Clonazepam until Patient #1 was already admitted to the Hospital. Physician #1 said she expected that Nursing staff would call her to notify her of any missing doses of these medications. Physician #1 said Patient #1 was admitted to the Hospital as a direct result of missing those medication doses.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on records reviewed and interviews, for one of three sampled patients (Patient #1), the Agency failed to ensure nursing staff promptly informed his/her Physician of a lapse in administration of his/her Clozaril (antipsychotic) and Clonazepam (anxiolytic and antipsychotic), which resulted in Patient #1 requiring a Hospital admission. Findings include: The Agency’s Protocol, titled Communication, undated, indicated Nursing staff would notify the patient’s physician with any change in condition, including missed medication doses or if there were no refills available for medications. The Agency’s Policy, titled Administration and Documentation of Medications, dated 09/2023, indicated that if medications ordered to be administered were omitted, the physician would be notified. The Agency’s Protocol titled Medication Management, undated, indicated use of the medication Clozaril required careful monitoring, close communication with the prescribing physician, and if more than two doses were missed, Nursing staff would notify the physician and document any new orders received. The FDA.gov Clonazepam Medication Guide, dated 08/2010, indicated stopping Clonazepam could cause serious side effects, including seizures that would not stop. Patient #1 was admitted to the Agency in January 2023, diagnoses included Schizoaffective Disorder, Depression, and Post Traumatic Stress Disorder. Review of Patient #1’s Home Health Certification and Plan of Care, dated 11/20/23 through 01/18/24, indicated Patient #1 required skilled nursing visits three times weekly related to medication compliance, was at risk for hospitalization in the event of medication noncompliance, and skilled nursing services would monitor the effectiveness of medication therapy, administer medications per physician’s orders, and pre-pour Patient #1’s medications through the next home visit. The Plan of Care indicated Patient #1 was prescribed Clonazepam 0.5 milligrams (mg), by mouth, twice daily, and Clozaril 250 mg, by mouth, once daily at bedtime. Review of the Agency’s Missed Medication Investigation for Patient #1, dated 01/26/24, indicated that Patient #1 did not have refills available of his/her Clonazepam and Clozaril from 12/04/23 through 12/11/23, that Nurse #1, Nurse #2, and the Clinical Nurse Manager were aware that Patient #1 was without the medications, had not notified Physician #1, and that Patient #1 was admitted to the Hospital as a result. During a telephone interview on 02/21/24 at 12:33 P.M., Nurse #1 said that on Monday, 12/04/23, she was the nurse assigned to visit Patient #1 in his/her home, and said he/she did not have any Clonazepam and Clozaril to be administered or for her to pre pour for Patient #1 to take until his/her next nurse visit. Nurse #1 said she called the Pharmacy, but it was closed, and said she notified Clinical Manager #1 via email later that night. Nurse #1 said she called the Pharmacy again on 12/05/23, and was told there were no refills left, so the pharmacy would reach out to Physician #1. Nurse #1 said she again called the Pharmacy on 12/06/23 and was told there was no response from Physician #1, therefore Patient #1’s Clonazepam and Clozaril were not available. Nurse #1 said she did not, at any time call Physician #1 to report that Patient #1’s medications were unavailable, and therefore not administered. During a telephone interview on 01/21/24 at 12:14 P.M., Nurse #2 said that on Thursday, 12/09/23, he was the nurse assigned to visit Patient #1 in his/her home, and said he/she did not have any Clonazepam and Clozaril available to administer or pre pour until his/her next nursing visit. Nurse #2 said he did not promptly notify Physician #1 that Patient #1’s Clonazepam and Clozaril were unavailable and said he did not notify Clinical Manager #1. During a telephone interview on 02/21/24 at 12:14 P.M., Clinical Manager #1 said that on 12/05/24 she was notified via an Email from Nurse #1 that Patient #1’s Clonazepam and Clozaril were unavailable, and the pharmacy was closed. Clinical Manager #1 said she emailed Nurse #1 on 12/05/23 to follow up on the medication. Clinical Manager #1 said she did not notify Physician #1 that Patient #1 did not have any Clonazepam and Clozaril or instruct Nurse #1 or Nurse #2 to do so either. During a telephone interview on 02/26/24 at 1:03 P.M., Physician #1 said abruptly stopping Clonazepam is very dangerous, and can cause seizures, or in Patient #1’s case, catatonia (a disorder that disrupts a person’s awareness of the world around them. People with this condition sometimes react very little or not at all to their surroundings, or might behave in ways that are unusual, unexpected or unsafe to themselves or others. It can have life-threatening complications.) Physician #1 said Clozaril should not be restarted after missing two days of the prescribed dosing, and it would need to be re-titrated up to the therapeutic dose. Physician #1 said that she was not promptly notified by the Agency that Patient #1 had missed any doses of the Clonazepam and Clozaril or that he/she had gone seven days without his/her Clozaril and Clonazepam until Patient #1 was already admitted to the Hospital, and said she expected that Nursing staff would call her to notify her of any missing doses of these medications. Physician #1 said Patient #1 was admitted to the Hospital as a direct result of missing those medication doses.