Every finding on record at Holistic Life Home Health Care LLC

EMERGENCY PREPAREDNESS SURVEY The following deficiency is based on the emergency preparedness survey completed on 02/13/23.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the agency failed to conduct and maintain evidence of one testing exercise annually, the facility failed to participate in a full-scale exercise that is community-based every two years; or when a community-based exercise is not accessible, conduct a facility-based functional exercise every two years; or if the agency experiences an actual natural or man-made emergency that requires activation of the emergency plan, the agency is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. This could affect all patients receiving services from this agency. The census was nine. Findings include: Review of the emergency preparedness documents revealed a lack of documentation of full scale or tabletop exercises conducted in the last two years. The emergency preparedness documents revealed a lack of documentation of actual events for the last two years. The findings were verified in an interview with Staff A on 02/13/23 at 9:30 AM.

Partial Extended Recertification Survey An entrance conference was conducted on 02/08/23 at 11:20 AM with administrative personnel, and an exit conference was completed on 02/13/23 at 4:15 PM with administrative personnel. The following deficiencies are based on the Partial Extended Recertification survey completed on 02/13/23. Holistic Life Home Health Care LLC 369120, is not in compliance with the requirements at 42 CFR Part 484 Subpart B, C for Home Health Agencies.

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 document review and staff interview, the agency failed to electronically transmit each completed Outcome Assessment and Information Set (OASIS) assessment to the Centers for Medicare & Medicaid Services (CMS) system within 30 days of completing the assessment for four of four patients reviewed who were receiving skilled services (Patient #1, #3, #4, and #7). The total sample was seven. The agency census was nine. Findings include: 1. Review of the medical record for Patient #1 revealed a recertification OASIS assessment dated 12/28/22. The medical record contained documentation the patient was receiving skilled nursing services. 2. Review of the medical record for Patient #3 revealed a recertification OASIS assessment dated 12/08/22. The medical record contained documentation the patient was receiving skilled nursing and physical therapy services. 3. Review of the medical record for Patient #4 revealed a recertification OASIS assessment dated 01/02/23. The medical record contained documentation the patient was receiving skilled nursing and physical therapy services. 4. Review of the medical record for Patient #7 revealed a recertification OASIS assessment dated 09/15/21 and a discharge OASIS assessment dated 10/16/21. The medical record contained documentation the patient was receiving skilled nursing services. The findings were verified in an interview with Staff A on 02/13/23 at 4:00 PM. Staff A could not remember when OASIS was last submitted to the CMS system and could not locate any documentation. Review of the "HHA Activity Report" run on 02/14/23 revealed the last OASIS submission to the CMS system by the agency was on 05/06/21.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on medical record review and staff interview, the agency failed to ensure patients received the home health services as written in the plan of care for three of seven medical records reviewed (Patient #2, #3, and #6). The agency census was 9. Findings include: 1. Review of the medical record for Patient #2 revealed a plan of care dated 12/21/22 to 02/18/23 with orders for home health aide services 38.5 hours per week. Review of the medical record revealed only 16.5 hours of home health aide services were provided the week of 12/21/22 through 12/24/22. The medical record lacked documentation of physician notification the services were not provided as ordered. 2. Review of the medical record for Patient #3 revealed plans of care dated 10/13/22 to 12/11/22 and 12/12/22 to 02/09/23 with orders for skilled nursing visits twice a week. The medical record lacked documentation of a second skilled nursing visit the week of 12/04/22. The medical record contained orders dated 10/11/22 and 12/12/22 for physical therapy three times a week for nine weeks. The therapy orders were not signed by a physician and the medical record lacked documentation of verbal orders for physical therapy. The medical record contained documentation of only one physical therapy visit the week of 12/11/22. The medical record contained documentation of only two physical therapy visits the weeks of 12/18/22, 12/25/22, and 01/08/23. The medical record lacked documentation of any physical therapy visits the week of 01/15/23. The medical record contained physical therapy missed visit documentation dated 12/17/22, 12/23/22, and 12/26/22; however, the missed visits lacked documentation the physician had been notified of these missed visits. The medical record lacked documentation of physician notification the services were not provided as ordered. 3. Review of the medical record for Patient #6 revealed plans of care dated 10/19/21 to 12/17/21 and 12/18/21 to 02/15/22 with orders for home health aide services 35 hours per week with an increase to 40 hours per week effective 12/02/21. The medical record contained documentation of home health aide services for 35.8 hours the week of 10/31/21, 37.8 hours the week of 11/14/21, and 37 hours the week of 11/28/21. The medical record lacked documentation of any additional orders for home health aide services or physician notification the services were not provided as ordered. The findings were verified in an interview with Staff A on 02/13/23 at 4:00 PM.

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 medical record review and staff interview, the agency failed to ensure the plans of care included the patient's mental/cognitive status, functional limitations, activities permitted/restricted, safety measures to protect against injury, and a description of the patient's risk for emergency department visits and hospital re-admission for seven of seven medical records reviewed (Patient #1, #2, #3, #4, #5, #6, and #7). The agency census was 9. Findings include: 1. Review of the medical record for Patient #1 revealed plans of care dated 11/30/22 to 01/28/23 and 01/29/23 to 03/29/23. Both plans of care lacked documentation of a description of the patient's risk for emergency department visits and hospital re-admission. The plan of care dated 01/29/23 to 03/29/23 also lacked documentation of mental/cognitive status. 2. Review of the medical record for Patient #2 revealed a plan of care dated 12/21/22 to 02/18/23. The plan of care lacked documentation of a description of the patient's risk for emergency department visits and hospital re-admission. 3. Review of the medical record for Patient #3 revealed plans of care dated 10/13/22 to 12/11/22 and 12/12/22 to 02/09/23 with orders for skilled nursing visits. The medical record contained documentation of physical therapy visits. Both plans of care lacked documentation of physical therapy orders, functional limitations, and a description of the patient's risk for emergency department visits and hospital re-admission. 4. Review of the medical record for Patient #4 revealed plans of care dated 11/08/22 to 01/06/23 and 01/07/23 to 03/07/23 with orders for skilled nursing visits. The medical record contained documentation of physical therapy visits. Both plans of care lacked documentation of physical therapy orders and a description of the patient's risk for emergency department visits and hospital re-admission. 5. Review of the medical record for Patient #5 revealed plans of care dated 11/16/22 to 01/14/23 and 01/15/23 to 03/15/23. Both plans of care lacked documentation of mental/cognitive status, functional limitations, activities permitted/restricted, and a description of the patient's risk for emergency department visits and hospital re-admission. The plan of care dated 01/15/23 to 03/15/23 also lacked documentation of safety measures to protect against injury. 6. Review of the medical record for Patient #6 revealed plans of care dated 10/19/21 to 12/17/21 and 12/18/21 to 02/15/22. Both plans of care lacked documentation of mental/cognitive status and a description of the patient's risk for emergency department visits and hospital re-admission. 7. Review of the medical record for Patient #7 revealed plans of care dated 07/22/21 to 09/19/21 and 09/20/21 to 11/18/21. Both plans of care lacked documentation of a description of the patient's risk for emergency department visits and hospital re-admission. The findings were verified in an interview with Staff A on 02/13/23 at 4:00 PM.

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 medical record review and staff interview, the agency failed to provide services and treatments only as ordered by a physician or allowed practitioner for two of two medical records reviewed with physical therapy services (Patient #3 and #4). A total of seven medical records were reviewed. The agency census was nine. Findings include: 1. Review of the medical record for Patient #3 revealed plans of care dated 10/13/22 to 12/11/22 and 12/12/22 to 02/09/23 which did not include orders for physical therapy services. The medical record contained orders dated 10/11/22 and 12/12/22 for physical therapy three times a week for nine weeks that were not signed by a physician and the medical record lacked documentation of verbal orders for physical therapy. The medical record contained documentation of one to three physical therapy visits per week from 12/04/22 through 02/04/23. 2. Review of the medical record for Patient #4 revealed plans of care dated 11/08/22 to 01/06/23 and 01/07/23 to 03/07/23 which did not include orders for physical therapy services. The medical record contained orders dated 11/10/22 and 01/04/23 for physical therapy twice a week for nine weeks that were not signed by a physician and the medical record lacked documentation of verbal orders for physical therapy. The medical record contained documentation of physical therapy visits twice a week from 12/04/22 through 02/04/23. The findings were verified in an interview with Staff A on 02/13/23 at 4:00 PM.

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 review of QSO memo 23-02-ALL Attachment G, policy review, and staff interview, the agency failed to develop a policy for COVID-19 vaccination that included a process for staff to request an exemption from the staff COVID-19 vaccination requirements, a process for granting exemptions, and a process for ensuring all documentation for medical exemptions contained the required elements. This had the potential to affect all patients receiving services from the agency. The census was nine patients Findings include: Review of QSO memo 23-02-ALL Attachment G revealed policies and procedures must include, at a minimum, the following components: (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; and (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. Review of the undated agency policy titled, "COVID-19 Vaccination Mandate Policy," revealed it lacked a process for staff to request an exemption from the staff COVID-19 vaccination requirements, a process for granting exemptions, and a process for ensuring all documentation for medical exemptions contained the required elements. The findings were verified in an interview with Staff A on 02/13/23 at 10:46 AM.