Every finding on record at Venerate Home Health Express, LLC

The Oklahoma State Department of Health conducted an unannounced Medicare Emergency Preparedness Program survey at the agency on 03/25/26 to 03/26/26. Deficiencies were cited as a result of the Emergency Preparedness Program survey.

Policies/Procedures for Medical Documentation CFR(s): 484.102(b)(4) §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure that the Emergency Preparedness Plan had policies and procedures for patient data management and information sharing for all patients and employees. Findings: A review of emergency preparedness records showed no Emergency Preparedness Plan policies and procedures for patient data management and information sharing On 03/26/26 at 9:40 a.m., Staff A stated the agency had no emergency preparedness policy for patient information sharing.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure its Emergency Preparedness communication plan included current employee and physician contact information for all patients and employees. Findings: A review of emergency preparedness records showed no communication plan which included current employee and physician contact information. On 03/26/26 at 9:40 a.m., Staff A stated the emergency preparedness plan did not include contact information for current employees and the patient’s physicians.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure an emergency preparedness training program was developed, implemented and reviewed at least annually for all employees. Findings: A review of emergency preparedness records showed no emergency preparedness plan training program for employees. On 03/26/26 at 9:40 a.m., Staff A stated the agency had no emergency preparedness training program.

The Oklahoma State Department of Health conducted an unannounced Medicare re-certification and complaint (#103850 and #115267) survey at the agency on 03/25/26 to 03/26/26. An entrance conference was conducted with Staff A. The survey process was explained. Questions were answered. Staff A was identified as the contact person for administrative issues and Staff B was identified as the contact person for clinical issues. Findings were discussed during an informal exit conference with Staff A and B. Standard level deficiencies were cited as a result of the survey. Glossary: PIP performance improvement project POC Plan of Care QAPI quality assessment performance improvement SN skilled nurse

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record reviews and interviews, the agency failed to ensure transfer or discharge summaries were completed for two (Patients #3 and #4) of nine patients. Findings: An agency policy titled, "Discharge, Transfer of Patients" stated any discharge or transfer of patients shall occur ensuring that information is communicated to promote positive patient outcomes. Within 48 hours of transfer to in patient care or with discharge a summary will be completed and sent to the physician ordering care and to the receiving service provider. Patient #3 A review of the clinical record showed the patient was transferred to in-patient hospital services on 03/05/26 and showed no transfer summary was completed. On 03/26/26 at 9:23 a.m., Staff B stated a transfer summary was not completed. Patient #4 A review of the clinical record showed the patient was discharged from agency services on 05/14/24 and showed no discharge. On 03/26/26 at 9:35 a.m., Staff B stated a discharge summary was not completed.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a POC included a SN visit frequency duration for four (Patients #1, 2, 3 and #4) of nine patients. Findings: Patient #1 A review of a POC dated 03/04/26 to 05/02/26 showed a SN visit frequency of one time a week and showed no duration of service. On 03/26/26 at 9:20 a.m., Staff B stated the POC did not include the length of time the patient was going to have SN visits. Patient #2 A review of a POC dated 01/31/26 to 03/31/26 showed a SN visit frequency of one time a week and showed no duration of service. On 03/26/26 at 9:22 a.m., Staff B stated the POC did not include the length of time the patient was going to have SN visits. Patient #3 A review of a POC dated 01/13/26 to 03/13/26 showed a SN visit frequency of one time a week and showed no duration of service. On 03/26/26 at 9:23 a.m., Staff B stated the POC did not include the length of time the patient was going to have SN visits. Patient #4 A review of a POC dated 03/16/24 to 05/14/24 showed a SN visit frequency of one time a week and showed no duration of service. On 03/26/26 at 9:35 a.m., Staff B stated the POC did not include the length of time the patient was going to have SN visits.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the QAPI Program included patient indicator data for all patients and employees. Findings: An agency policy, titled "Organizational Performance Improvement Plan" stated the agency organizational plan will continually improve performance of key functions and processes relative to patient care by collecting data to monitor performance and utilize reports generated from OASIS data. A review of QAPI program records showed no patient indicator data was utilized in the QAPI program for calendar years 2024 and 2025. On 03/26/26 at 9:45 a.m., Staff B stated the QAPI program did not use patient OASIS data in 2024 and 2025.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure baseline and goal measurements of the QAPI performance improvement projects for all patients and employees. Findings: A review of QAPI records showed no PIP baseline and goal measurements in calendar years 2024 and 2025. On 03/26/26 at 9:45 a.m., Staff A stated the PIPs in 2024 and 2025 showed no measurable goals.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body oversite of patient centered QAPI Program activities for all patients and employees. Findings: An agency policy, titled Quality Assessment and Performance Improvement, stated the governing body is responsible for ensuring ongoing QAPI program efforts address priorities for improved quality of care and patient safety and improvement actions are evaluated. A review of governing body meeting minutes showed no oversite in the conduction of QAPI Program for calendar years 2024 and 2025. On 03/26/26 at 9:45 a.m., Staff A stated the governing body did not oversee the QAPI Program.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record reviews and interviews, the agency failed to ensure a transfer or discharge summary was provided to the receiving service providers for two (Patients #3 and #4) of nine patients. Findings: An agency policy titled, "Discharge, Transfer of Patients" stated any discharge or transfer of patients shall occur ensuring that information is communicated to promote positive patient outcomes. Within 48 hours of transfer to in patient care or with discharge a summary will be completed and sent to the physician ordering care and to the receiving service provider. Patient #3 A review of the clinical record showed a transfer from the agency on 03/05/26 to inpatient hospital services and showed no coordination of care and no transfer summary was provided to the hospital provider or to the ordering physician. On 03/26/26 at 9:23 a.m., Staff B stated no transfer summary was provided to the hospital or the physician. Patient #4 A review of the clinical record showed a discharge from the agency on 05/14/24 and showed no coordination of care and no discharge summary was provided to the physician. On 03/26/26 at 9:35 a.m., Staff B stated the discharge summary was not provided to the physician.

The Oklahoma State Department of Health conducted an unannounced Medicare Emergency Preparedness Program survey at the agency on 03/20/23. No deficiencies were cited as a result of the Emergency Preparedness Program survey.

The Oklahoma State Department of Health conducted an unannounced Medicare re-certification survey at the agency on 03/20/23. An entrance conference was conducted with Staff A. The survey process was explained. Questions were answered. Staff A was identified as the contact person for clinical issues and Staff B was identified as the contact person for administrative issues. Findings were discussed during an informal exit conference with Staff A, B and C. Standard level deficiencies were cited as a result of the survey. Glossary: HHA Home Health Agency OT Occupational therapy PIP Performance Improvement Project POC Plan of Care QAPI Quality Assessment and Performance Improvement SN skilled nurse

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure completion of a transfer/discharge summary for one (Patient #5) of five patients. Findings: Patient #5 A review of the clinical record showed the patient was discharged from the agency on 02/22/23. Documentation showed no discharge summary. On 03/20/23 at 2:30 p.m., Staff A stated patient #5 showed no discharge summary of care.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure individualized patient POC included: 1. SN visit frequency and duration of nursing services for one (Patient #1) of five and; 2. Updated medication dose changes for one (Patient #4) of five patients. Findings: Patient #1 A review of the POC dated 01/29/23 to 03/29/23 showed orders for SN services to be conducted during the certification period. POC documentation showed no SN visit frequency and duration of nursing services. Documentation showed no physician notifications and no change in orders. On 03/20/23 at 2:00 p.m., Staff A stated the POC for patient #1 showed no SN visit frequency and duration of services. Patient #4 A review of the POC dated 02/14/23 to 04/14/23 showed orders for SN services to conduct blood sugar testing and to administer Basaglar 28 units subcutaneous injection every morning and Novolin R sliding scale dose subcutaneous two times a day prior to the start of the certification period. POC documentation showed a Lantus 32 units injection every morning and a different Novolin R sliding scale dose subcutaneous two times a day. Documentation showed no physician notifications and no change in orders. On 03/20/23 at 2:20 p.m., Staff A stated the POC for patient #4 did not get updated with the change in the patient’s medication doses at the time of the last recertification/new POC was developed.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed ensure update of the POC to include orders to decrease the SN visit frequency to two times a week, effective 03/16/23 for one (Patient #2) of five patients. Findings: Patient #2 Review of a POC dated 01/19/23 to 03/19/23 showed a SN visit frequency of daily. Documentation showed no SN visit was conducted on 03/14/23, 03/15/23, 03/16/23, 03/17/23, 03/18/23 and on 03/19/23. Documentation showed no physician notification the SN visits were not conducted. On 03/20/23 at 2:05 p.m., Staff A stated a physician’s order was received to decrease the SN visit frequency to two times a week but was entered as effective on 03/20/23 instead of 03/16/23 and SN should have documented a verbal order from the physician with the correct effective date for the reduction in the SN visit frequency.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record reviews and interview, the agency failed to ensure SN visits were ordered by the physician for one (Patient #5) of five patients. Findings: Patient #5 A review of the POC dated 12/27/22 to 02/24/23 showed a SN visit frequency of once every other week. Documentation showed a SN visit was conducted on 02/24/23 (two days after the agency discharge on 02/22/23). Documentation showed no physician notification of the conducted SN visit and documented no orders. On 03/20/23 at 2:30 p.m., Staff A stated no SN visit should have been conducted after the patient’s discharge from agency services.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure utilization of QAPI data to improve program effectiveness, quality of patient care and overall program improvement for all patients and employees. Findings: Administrative records of ongoing patient centered QAPI program for the agency which showed data collection activities utilized in the agency's QAPI Program for calendar years 2021 and 2022 were requested. No documentation was provided. On 03/20/23 at 3:00 p.m., Staff B stated there was no documentation that showed program improvement data or an analysis of collected data that showed improved quality of patient care for calendar years 2021 and 2022.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure conduction of patient centered QAPI Program activities for all patients and employees. Findings: Administrative records of an ongoing patient centered QAPI program for the agency which showed conduction of QAPI program activities for calendar years 2021 and 2022 was requested. No documentation was provided. On 03/20/23 at 3:00 p.m., Staff B stated there was no documentation that showed ongoing QAPI program activities for calendar years 2021 and 2022.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the initiation and review of a PIP through their QAPI Program for calendar years 2021 and 2022 for all patients and employees. Findings: Administrative records of an ongoing patient centered QAPI program for the agency which showed conduction of a QAPI program PIP for calendar years 2021 and 2022 was requested. Documentation of a PIP for calendar year 2020 was provided. Additional request for administrative records yielded no results. On 03/20/23 at 3:00 p.m., Staff B stated there was documentation of a PIP for calendar years 2021 and 2022.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body oversite of the conduction of patient centered QAPI Program activities for all patients and employees. Findings: Administrative records which showed governing body oversite of the conduction of patient centered QAPI Program activities for calendar years 2021 and 2022 was requested. No documentation was provided. On 03/20/23 at 3:00 p.m., Staff B stated there was no documentation which showed governing body oversite of the conduction of patient centered QAPI Program activities for calendar years 2021 and 2022.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure: its infection control program included surveillance monitoring and reporting and was included in QAPI program activities for all patients and staff. Findings: Administrative records which showed the agency’s infection control program for calendar years 2020 and 2021 was requested. No documentation was provided. On 03/20/23 at 3:00 p.m., Staff B stated there was no documentation of the agency’s infection control program or evidence of its inclusion in QAPI program activities for calendar years 2021 and 2022.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on a record review and interview, the agency failed to ensure COVID pandemic related policies and procedures were in place for all patients and staff. Findings: Review of administrative records showed no agency policies and procedures for the COVID pandemic were in place for the agency. On 03/20/23 at 3:30 p.m., Staff B stated the agency did not have policies and procedures related to the COVID pandemic.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure SN visit notes were completed for one (Patient #3) of five patients. Findings: Patient #3 A plan of care dated 02/16/23 to 04/16/23 documented a principal diagnosis of unspecified convulsive disorder. Documentation showed a SN visit frequency of one time a week for nine weeks. Documentation showed no SN visit for week of 03/12/23 to 03/18/23 was conducted (one visit ordered, no visit documented). On 03/20/23 at 2:15 p.m., Staff A stated a SN visit was conducted but visit notes were completed and signed every one to two weeks. At 3:30 p.m., Staff B stated visit notes are to be completed and signed by staff within 24 to 48 hours of when the visit was conducted.

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 record review and interview, the agency failed to ensure governing body oversite of: 1. A patient centered QAPI Program; 2. An operating budget, capital expenditure plan and allocation of resources activities for calendar years 2021 and 2022; and 3. Agency program evaluation for calendar years 2021 and 2022 effecting all patients and staff. Findings: Administrative records which showed governing body over-site and responsibility for the agency for calendar years 2021 and 2022 were requested. No documentation was received. On 03/20/23 at 3:30 p.m., Staff B stated there were no administrative records which showed evidence of ongoing governing body QAPI program oversite, approval of operating budget and capital expenditures and overall responsibility for the agency, including annual program evaluations.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record reviews and interview, the agency failed to ensure a completed transfer/discharge summary was provided for one (Patient #5) of five patients. Findings: Patient #5 A review of the clinical record documented discharge from the agency on 02/22/23. Documentation showed no discharge summary was provided to the patient or physician service provider. On 03/20/23 at 2:35 p.m., Staff A stated no discharge summary was sent to the patient or the physician service provider.