Every finding on record at Blue Shield Health Care Services, LLC

EMERGENCY PREPAREDNESS SURVEY At the time of the emergency preparedness survey completed on 07/20/22, Blue Shield Health Care Services, LLC is in compliance with the provisions of 42 CFR Part 484.102, Conditions of Participation for Home Health Agencies.

Partial Extended Recertification Survey An entrance conference was conducted with administrative staff on 07/18/22, and an exit conference was completed with the administrative staff on 07/20/22. The following deficiencies are based on the partial extended recertification survey completed on 07/20/22. Blue Shield Health Care Services, LLC 368425, is not in compliance with the requirements at 42 CFR Part 484, Subpart B, C for Home Health Agencies.

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-22-09-All Revised Attachment G, facility COVID-19 vaccination records, staff interview, and policy review, the agency failed to ensure the policy and procedure included a process for tracking and securely documenting the COVID-19 vaccination status of all staff and 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. The agency vaccination rate was 100%. The active census was 44. Findings include: Review of QSO-22-09-All Revised Attachment G revealed the facility policy and procedure must include a process for tracking and securely documenting the COVID-19 vaccination status of all staff and 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. Review of the policy titled, "Covid19 Vaccination Mandate Policy,” approved date 01/10/22, revealed it failed to include the component for tracking the vaccination status and/or qualifying exemption status for all agency employees and contracted therapy staff. Review of the COVID-19 vaccination records for 24 agency employees lacked a process to securely document and track the vaccination and/or qualifying exemption status of all agency employees. Interview on 07/18/22 at 3:23 PM with Staff B confirmed the policy did not address tracking the vaccination and/or exemption status of employees. Staff B also confirmed the vaccination status and/or exemption status tracking document was created during the survey process.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on observation and staff interview, the agency facility to ensure the Administrator was responsible for the day-to-day operations of the agency. The agency census was 44. Findings include: On 07/18/22 at 8:45 AM it was observed that another agency was advertising and occupying the location at 1150 Morse Rd. Suite 335, Columbus, Ohio 43229 which was the address of record for Blue Shield Health Care Services, LLC. Review of historical provider information submitted to the Ohio Department of Health revealed no evidence the agency notified the Ohio Department of Health that the agency had moved nor was there an approved CMS-855 A for notification of the change of address. An internet search determined the agency was operating at 4889 Sinclair Rd. Suite 207, Columbus, Ohio 43229. Staff B stated in an interview on 07/18/22 at 9:48 AM that he/she had attempted multiple times to submit the change of address in the internet-based (PECOS) system however received an error message with each attempted submission. Staff B provided written documentation on 07/20/22 that the agency relocated to the new address effective September 2021. Staff B was attempting to submit the updated enrollment information through (PECOS) during the survey process. Review of the undated policy titled, The President/Administrator Policy No: 7-003.1 revealed the individual is responsible for planning, coordinating, managing and directing all activities and programs of the agency. The essential job functions/responsibilities include complying with applicable law and regulation.