Every finding on record at Excellence Home Health Care Agency Inc

The following reflects the findings of the California Department of Public Health for Emergency Preparedness during a recertification survey conducted February 24, 2025, through February 27, 2025. All Conditions of Participation were met. No deficiencies were issued during this survey

The following reflects the findings of the California Department of Public Health during a recertification survey conducted February 24, 2025, through February 27, 2025. Census: Unduplicated Admissions: 193 Home Visits with Record Reviews: 3 Record Reviews without home visits: 4 Sample Size: 7 All Conditions of Participation were met. Three deficiencies were issued during this survey.

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on interview and record review, the facility failed to ensure Patient 6’s discharge summary entered into the Outcome and Assessment Information Set (OASIS - a data collection system used by home health agencies (HHAs) to collect and report patient information) accurately reflected services the patient received by the HHA when the OASIS discharge summary incorrectly indicated Patient 6 received physical therapy services when in fact, he did not. This failure resulted in the facility’s transmission of incorrect information to be submitted into the Oasis system for Patient 6 which had the potential for inaccurate information to be used in the calculation of quality reports which are utilized to monitor quality of care, guide performance improvement, and determine reimbursement. During a review of Patient 6’s “Patient Profile,” (a document which provides medical and demographic information), undated, indicated Patient 1 had a start of care date of November 7, 2024, and diagnoses which included malignant neoplasm of central portion of right female breast (breast cancer), type 2 diabetes mellitus (disease characterized by persistently high blood sugar levels) and muscle weakness. During a review of Patient 6’s OASIS discharge summary, dated January 5, 2025, the summary indicated, “…Care summary: (care given, progress, regress including therapies)…services provided: skilled nursing, PT [physical therapy]…” However, during further review of Patient 6’s Electronic Medical Record (EMR), there was no evidence that physical therapy services were provided to Patient 6. During a concurrent interview and record review on February 27, 2025, at 2:10 PM, with the Assistant Administrator (ASST ADMIN), Patient 6’s OASIS discharge summary, dated January 5, 2025, was reviewed. The ASST ADMIN acknowledged the OASIS discharge summary indicated Patient 6 received physical therapy services. Patient 6’s EMR was also reviewed and the ASST ADMIN stated the OASIS discharge summary, dated January 5, 2025, was incorrect and Patient 6 did not receive physical therapy services. The ASST ADMIN further stated it was his expectation that information transmitted through the OASIS system was supposed to be accurate and correct. During a review of the facility’s policy and procedure titled, “Oasis Data Transmission,” revised November 2021, the policy indicated, “Purpose – To outline the OASIS data transmission requirements…Policy – The organization will adhere to all OASIS data transmission requirements as outlined in the Medicare Conditions of Participation, Reporting of OASIS information 42 CFR 484.45…2. The encoded OASIS data must accurately reflect the patient’s status at the time of assessment. 3. The organization must electronically transmit accurate, complete and encoded OASIS data for each patient…” During a review of the facility’s policy and procedure titled, “Entries Into the Clinical Record,” revised November 2021, the policy indicated, “…Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided…the medical record should accurately reflect a clear account of the patient’s entire course of care…3. Entries into the clinical record will be clear, concise, and specific statements of fact…”

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on interview and record review, the facility failed to ensure background checks were performed on three of six sampled staff upon hire Registered Nurse 1 [RN 1], Assistant Administrator [ASST ADMIN] and Physical Therapist 1 [PT 1]). This failure resulted in the facility hiring of staff members without first ensuring their background was clear of criminal history related to abuse, neglect, or mistreatment and had the potential to result in mistreatment of patients by the staff members. During a review of RN 1’s employee file, RN 1’s hire date was listed as October 26, 2009. Further review of RN 1’s employee file indicated there was no documented evidence the facility had performed a background check for RN 1 when initially hired. During a review of the ASST ADMIN employee file, the ASST ADMIN’s hire date was listed as November 23, 2009. Further review of the ASST ADMIN employee file indicated there was no documented evidence the facility had performed a background check for the ASST ADMIN when initially hired. During a review of PT 1’s employee file, PT 1’s hire date was listed as March 26, 2007. Further review of PT 1’s employee file indicated there was no documented evidence the facility had performed a background check for PT 1 when initially hired. During an interview on February 27, 2025, at 2:13 PM, with the ASST ADMIN, the ASST ADMIN stated he was unable to find background checks done upon hire for RN 1, ASST ADMIN, or PT 1. The ASST ADMIN further stated the facility was doing background checks on staff at the time the staff were hired but he could not find documented evidence that they were completed upon hire. During a review of the facility’s policy and procedure titled, “Selection/Hiring of Personnel,” revised November 2021, the policy indicated, “Purpose – To specify the criteria for the recruitment and hiring of staff to meet the care needs of appropriate patients…2. A criminal background check will be obtained for positions required by law, regulation, or organizational policy…”

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on interview and record review, the facility failed to ensure Electronic Medical Records (EMR) for one of seven sampled patients (Patient 4) was accurate when an occupational therapy assessment (an assessment of an individuals in terms of their specific physical or mental difficulties, to determine how they are functioning at home and what therapy is needed to enable them to perform daily activities) and physicians orders for another patient were entered into Patient 4’s EMR in error. This failure resulted in Patient 4’s medical records to inaccurately reflect Patient 4’s health status and include physicians orders not intended for the patient which had the potential for Patient 4 to receive care and services not in accordance with the patients actual plan of care. During a review of Patient 4’s “Patient Profile,” (a document which provides medical and demographic information), undated, indicated Patient 1 had a start of care date of January 18, 2025, and diagnoses which included pressure ulcer of left buttocks stage 3 (a localized area of skin and/or underlying tissue damage caused by prolonged pressure on the skin), and type 2 diabetes mellitus (disease characterized by persistently high blood sugar levels) with diabetic nephropathy (damage to the kidneys due to diabetes). During a review of Patient 4’s EMR, there was a document titled “OT [occupational therapy] Evaluation and Physician’s Order” dated February 6, 2025, which indicated an occupational therapy evaluation was performed and OT services were needed to meet long term and short term goals. During a concurrent interview and record review on February 24, 2025, at 1:45 PM, with Office Assistant 1 (OF 1), OF 1 reviewed Patient 4’s Electronic Medical Record and acknowledged there was an occupational therapy assessment and occupational therapy physician’s order, dated February 6, 2025, in Patient 4’s medical record. Upon further review of the “OT Evaluation and Physician’s Order” in Patient 4’s medical record, OF 1 stated he made an error and mistakenly took the occupational assessment and physician’s orders for another patient and input them into Patient 4’s Electronic Medical Record. OF 1 further stated he got confused because the resident’s last names were identical. OF 1 acknowledged the error had not previously been identified. During an interview on February 24, 2025, at 2:00 PM, with the Administrator (ADMIN), the ADMIN stated OF 1 mistakenly entered physician’s orders and occupational therapy information into the wrong patient’s electronic medical record. The ADMIN further stated Patient 4, never had physician’s orders for occupational therapy services. During an interview on February 27, 2025, at 2:00 PM, with the Assistant Administrator (ASST ADMIN), the ASST ADMIN stated the facility expectation was that all patients’ electronic medical records were to be maintained with accurate and correct information. During a review of the facility’s policy and procedure titled, “Entries Into the Clinical Record,” revised November 2021, the policy indicated, “…Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided…the medical record should accurately reflect a clear account of the patient’s entire course of care…3. Entries into the clinical record will be clear, concise, and specific statements of fact…”

The following reflects the findings of the California Department of Public Health during a recertification survey conducted February 14, 2022 through February 17, 2022. Representing the Department: Surveyors: 35183 and 41794 Census: 32 Unduplicated Admissions: 297 Home Visits with record reviews: 3 Record Reviews without home visits: 4 Sample Size: 7 All conditions of participation were met.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to provide training to contracted staff on the emergency preparedness policies and procedures and “Emergency Operational Plan” for 14 of 14 months reviewed, in a universe of 32 patients. This failure had the potential to place the agency’s patients at risk when the agency was not prepared to respond in an emergency or disaster. A review of the agency’s policy and procedure titled, “Emergency Management Plan,” dated November 2021, indicated, “Organization leadership will provide for orientation of all personnel regarding participation in the emergency management plan. Education to include: Specifics of organization’s emergency management plan; Specific assigned emergency response role; Information on developing their family’s emergency response plan; Information regarding accessing housing and transportation for staff if necessary. All training will be documented in the personnel record of staff, individuals under arrangement and volunteers, if applicable.” A review of the agency emergency plan titled, “Emergency Operational Plan,” undated, indicated the following: “Training: The current staff will be trained on the new or updated EOP [Emergency Operational Plan] at the time of its publication. All new staff will be trained on the EOP in orientation… Emergency Preparedness training will be conducted annually. Documentation of the training on the EOP and annual emergency preparedness training will be maintained… Knowledge of EOP and emergency preparedness will be shown by return demonstration, if applicable, and participation in the facility Testing Program.” During an interview with a Physical Therapist (PT 1) on February 14, 2022, at 11:50 AM, PT 1 stated he had not received training on the agency’s emergency preparedness program. A review of PT 1’s personnel file was conducted. There was no documented evidence to show PT 1 had received training on the agency’s emergency preparedness program. A review of the agency’s in-service binder dated 2021-2022 was conducted. There was no documented evidence to show PT 1 had received training on the agency’s emergency preparedness program. During an interview and concurrent record review with the Administrator Designee (AD) on February 17, 2022, at 10:30 PM, the AD stated he was responsible for the emergency preparedness program. The AD stated contracted staff had not received training on the agency’s emergency preparedness program because he was unaware of the requirement. The AD verified that PT 1 had not received training on the agency’s emergency preparedness program.

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 agency failed to ensure that all medications were recorded in initial assessment for one of seven sampled patients (Patient 2). This failure had the potential to cause ineffective drug therapy, significant side effects and noncompliance with drug therapy. During a record review of the Patient 2’s face sheet (Document with demographic and health information) had a start of care date of January 14, 2022, and a certification period through March 14, 2022. Patient 2 was diagnosed with Parkinson’s Disease, (A progressive nervous system disorder that affects movement). During a home visit on February 15, 2022 at 11:50 AM, with a Physical Therapist, the Caretaker and Patient 2, the Caretaker was asked to bring all of Patient 2’s current medications. During an initial medication review with the actual medications and medication profile (A list of medications the patient is using or has used) showed that Exelon 9.5 mg (Milligram a unit of measurement)/(every)24-hour patch (used to treat mild to moderate dementia caused by Parkinson’s Disease) was not listed on the medication profile. During an interview with Patient 2’s daughter, she stated the Exelon 9.5 mg patch had been in use since November of 2021. The prescription label had a dispensing date of November 16, 2021, and the daughter stated she has been using the patch on her mother (Patient 2) daily. During an interview with the Director of Patient Care Services Designee (DPCS-D), on February 16, 2022 at 9:50 AM, she stated all licensed staff are in-serviced on providing an initial assessment and medications review. The DPCS-D stated it was her expectation that all licensed staff accurately document the patient’s current medication. The DPCS-D states the Registered Nurse (RN) did not follow the agency’s policy and procedure for documenting all the patient’s current medications. A review of the agency’s policy and procedure titled, “Initial and Comprehensive Assessment" revised November 2021 indicated, “The purpose to provide guidelines for the initial assessments of patients admitted to the service and for completing plans of care. An initial patient assessment will be performed and documented by a registered nurse, physical therapist, occupational therapist, or speech therapist…Review of medication history, current medication use, including prescription, over-the-counter medications and herbal medications and identifying significant drug interactions, duplicative drug therapy, ineffective drug therapy, potential adverse effects, significant side effects and noncompliance with therapy.”

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 interview and record review, the agency failed to ensure performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems and intervening for improvements) were evaluated for effectiveness for 14 of 14 months reviewed, in a universe of 32 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care to go unaddressed and continue. A review of the agency’s Quality Assessment and Performance Improvement (QAPI) binder from January 1, 2021, to February 16, 2022, was conducted. The QAPI binder contained four PIPs as follows: 1. “Infection Rate/[per] 1000 Care Days Improvement,” dated Quarter 1 (one) – 2021. 2. “Personal Protective Equipment/Supplies related to COVID-19/Infection Control,” dated Quarter 2 (two) = 2021. 3. “OASIS [Outcome and Assessment Information Set] Submission Tardiness,” dated Quarter 3 (three) – 2021. 4. “Readmissions (Transfer) Rate,” dated Quarter 4 – 2021. During an interview with the Administrator Designee (AD) on February 16, 2022, at 3:53 PM, the AD stated he was the QAPI Coordinator and responsible for the QAPI Program. The AD stated the PIPs were evaluated for effectiveness or revision, as needed, on a quarterly basis. The AD stated he could not show documented evidence the PIPs had been evaluated for effectiveness or revision. A review of the agency’s QAPI Plan, undated, indicated the following: “Responsibilities of QAPI Coordinator: The QAPI Coordinator chairs the QAPI Committee and is responsible for coordinating and facilitating all quality improvement activities. This includes, but is not limited to: … Evaluating the effectiveness of planned and implemented actions. Responsibilities of QAPI Committee: The QAPI Committee is responsible for evaluating and prioritizing QAPI activities based on the aggregation of data collected. …Under the direction of the QAPI Coordinator, the committee issues a quarterly report summarizing QAPI activities and result of actions taken. …”

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure staff followed the agency’s policy and procedure and professionally accepted infection control practices for one of seven sampled patients (Patient 3) when the Registered Nurse (RN 2) did not follow clean bag technique (a set of procedures to follow to prevent the healthcare worker’s bag from contaminating a patient’s home or becoming contaminated itself) when obtaining Patient 3’s vital signs, (Vital signs show how well your body is functioning. They include blood pressure, temperature, pulse rate and breathing rate measured by healthcare professionals.) This failure had the potential to cause spread of infection and disease among the agency’s patients. During a record review of Patient 3’s face sheet (Contains demographic and health information) indicated a start of care date of January 9, 2022 and a certification period through March 9, 2022. Patient 3 was diagnosed with hypertensive heart disease with heart failure. (a heart condition caused by high blood pressure and the heart muscle is weak, so it doesn’t pump blood as well and leads to build up of fluids in the lungs and surrounding body tissues.) During a home visit on February 15, 2022 at 1:55 PM, with a Registered Nurse (RN 2), the RN was observed informing Patient 3 that he will take his vital signs in his bedroom. The RN placed his medical bag directly on a chair in the living room. The RN did not place a barrier between his medical bag and the chair. The caretaker placed Patient 3 in a wheelchair and moved Patient 3 to his room. The RN followed Patient 3 to his room and picked up his medical bag and placed the bag directly on the seat of the chair in Patient 3’s bedroom. The RN again did not place a barrier between his medical bag and chair. The RN took Patient 3’s blood pressure, heart rate, temperature, and oxygen saturation level. In an interview with RN 2 on February 15, 2022 at 3:00 PM, the RN stated that he was aware of using a bag barrier for his medical bag to prevent infection or cross contamination. RN 2 stated he forgot and left the large barriers in his car. RN 2 pulled out a very small barrier sheet of four inches wide by eight inches long which dids not provide adequate barrier for his large medical bag. During an interview with the Director of Patient Care Services Designee (DPCS-D) states all staff are in-serviced on infection control policy to use a bag barrier with their medical bags. The DPCS-D states it was her expectation that all staff sent to patients’ home would follow the clean bag technique. The DPCS-D stated the RN did not follow the agency’s policy and procedure. A review of the agency’s policy and procedure titled, “Infection Prevention and Control/Bag Technique" revised November 2021, indicted” The purpose of the procedure for maintaining a clean patient care supply bag/computer bag and preventing cross contamination. As part of the infection/exposure control plan, [Name of Home Health agency]. Personnel will consistently implement principles to maximize efficient use of the patient care supply bag when used in caring for patients...Paper towels or newspapers have been used as protective barrier for bag placement in the patient home, they will be discarded after use”

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 interview and record review, the agency failed to maintain an infection control program when four employees' vaccination status was not tracked and policies and procedures were not developed to address contingency plans for staff that refused a COVID 19 vaccination, for four of four months reviewed, in a universe of 32 patients. This failure had the potential to cause unvaccinated employees to continue to work without extra precautions to minimize the spread of COVID 19 and the agency to experience a staff shortage. A review of the agency’s employee roster and the COVID 19 staff vaccination tracking was conducted. The agency’s employee roster indicated four (4) employees that were not indicated on the COVID 19 staff vaccination tracking. During an interview with the Director of Patient Care Services Designee (DPCSD) on February 16, 2022, at 12:00 PM, the DPCSD stated she was responsible for the COVID 19 vaccination program. The DPCSD stated three (3) of the four (4) employees were office staff and she did not know they needed to be tracked. The DPCSD stated the 4th employee had been missed. The DPCSD stated she had not followed the agency’s policy and procedure to track all employees COVID 19 vaccination status. A review of the agency’s COVID-19 Vaccination Binder from November 5, 2021, to February 16, 2022, and COVID-19 Vaccination Policies and Procedures dated November 2021, was conducted. There was no documented evidence to show a policy and procedure that addressed the following: 1. Contingency plans for staff who are not fully vaccinated that included actions the facility would take when staff decline vaccination and do not qualify for an exemption, such as: obtaining temporary vaccinated staff until permanent vaccinated staff could be hired and actively seeking vaccinated staff through advertising. During an interview with the DPCSD on February 16, 2022, at 12:00 PM, the DPCSD stated a policy and procedure had not been developed to address a contingency plan for staff who are not fully vaccinated that included actions the facility would take when staff declined vaccination and did not qualify for an exemption, such as: obtaining temporary vaccinated staff until permanent vaccinated staff could be hired and actively seeking vaccinated staff through advertising. A review of the agency’s policy and procedure titled “COVID-19 Vaccination,” dated November 2021, indicated, “[Name of agency] shall track, verify and securely document the COVID-19 vaccination status of all staff.”