Every finding on record at Shas Inc.

This visit was for a Federal and State complaint survey of a Home Health Agency Provider. Survey Dates: 4/18, 4/19, 4/20, and 4/21/2022 Complaint: IN00062528: Unsubstantiated. Federal deficiency, unrelated, was cited. Census: 76 Sunshine Home Healthcare was found to be in compliance with 410 IAC 17 in regard to this allegation.

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 record review and interview, the agency failed to ensure a COVID – 19 request for a medical exemption met the criteria from the Center for Medicare and Medicaid Services (CMS) and / or the Centers for Disease Control and Prevention (CDC) in 1 of 1 medical exemption reviewed. Findings include: Review of an agency policy titled “COVID Vaccination” dated 01/18/2022, revealed a definition of an exempt staff member “… means staff who are exempted from the requirements of this policy due to a medical contraindication, sincerely held religious belief or those staff for who the vaccination must temporarily be delayed due to clinical contraindications.” The policy further revealed the medical exemption must be based on one of the three CDC contraindications and stated, “However, if a Covered Service Member produces documentation from their primary care practitioner … states it is the practitioner’s medical opinion that due to another medical consideration or condition … request will be evaluated as a request for an accommodation under the ADA [Americans with Disabilities Act] ….” Review of the employee medical file for Employee C, revealed a document titled “Exemption Decision and Communication Form” that contained the exemption request of “Medical Contraindication.” The other options for a request were religious accommodation or disability. The exemption was granted by Employee B, the Alternate Administrator, and Employee I, Human Resources representative, based on a “medical letter.” Attached to the request was a letter from Physician A, dated 01/31/2022, which stated, “[Employee C] has natural immunity to Covid. [He / she] doesn’t require the Covid Vaccines.” During the daily conference, on 4/20/2022, employee B, the Alternate Administrator, indicated the letter followed the agency policy.