Pennsylvania Department of Health
MAIN LINE SURGERY CENTER, LLC
Patient Care Inspection Results

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Severity Designations


Minimal Citation - No Harm	Minimal Harm	Actual Harm	Serious Harm

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MAIN LINE SURGERY CENTER, LLC - Inspection Results	Scope of Citation Number of Residents Affected By Deficient Practice

Initial comments:

This report is the result of a full Medicare recertification survey conducted on January 19-20,2023, at Main Line Surgery Center, Llc. It was determined the facility was not in compliance with the requirements of 42 CFR, Title 42, Part 416 - Conditions for Coverage for Ambulatory Surgical Centers.

It was also determined the facility was not in compliance with 42 CFR, Title 42, Part 416 - Conditions for Coverage for Ambulatory Surgical Centers at 416.51(c)(1)-(3)(i)-(x) COVID-19 Vaccination of Facility Staff.

Plan of Correction:

Initial comments:

This report is the result of a State Relicensure survey conducted on January 19-20, 2023, at Main Line Surgery Center, Llc. It was determined the facility was in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999.

Plan of Correction:

416.51(c)(1)-(3)(i)-(x) STANDARD COVID-19 Vaccination of Facility Staff:

416.51 Condition for coverage-Infection control.
(c) Standard: COVID-19 vaccination of staff. The ASC 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 center staff, who provide any care, treatment, or other services for the center and/or its patients:
(i) Center employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for the center and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following center staff:
(i) Staff who exclusively provide telehealth or telemedicine services outside of the center setting and who do not have any direct contact with patients and other staff specified in paragraph (c)(1) of this section; and

(ii) Staff who provide support services for the center that are performed exclusively outside of the center setting and who do not have any direct contact with patients and other staff specified in paragraph (c)(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 (c)(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 center and/or its patients;

(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 (c)(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 center 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 or licensed 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 center's COVID-19 vaccination requirements 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.

Effective 60 Days After Publication:
(ii) A process for ensuring that all staff specified in paragraph (c)(1) of this section are fully vaccinated, 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;

Observations:

Based upon a review of facility documents, and interview with staff (EMP) it was determined that the facility policy for COVID-19 Vaccination of Staff did not include all the required elements as outlined in 416.51(c)(1)-(3)(i)-(x).

Based on a review of facility documents and interview with staff (EMP), it was determined that facility policy failed to include a policy, process or plan for staff to request an exemption from the employee COVID-19 vaccination requirements.

Findings include:

A review of the facility policy on January 20, 2023, "Employee COVID-19 Vaccination Status" (Last Revised: March 4, 2022) revealed, "Purpose: Main Line Surgery Center is committed to providing a safe and healthy workplace for all employees, customers clients and vendors. Proof of vaccination will be required for active and potential employees. Policy: All employees and potential employees will be required to provide proof of COVID-19 vaccination status..." There was no provision for employees to request an exemption from the Covid-19 vaccination requirements.

Interview on January 20, 2023 at 11:45 AM with EMP1 confirmed the facility does not have an exemption policy, process or plan for the COVID-19 vaccine requirement. Further interview confirmed there is no exception to this policy, all employees are required to be vaccinated.

Plan of Correction - To be completed: 02/07/2023

The facility changed the policy to include federally regulated exemptions to the Covid- 19 vaccine employee policy. This policy was approved by the board of directors on January 24th,2023.
Human resources will monitor all new employees to make sure we are in compliance of the policy.

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