Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and interview with technical consultant (TC) #1, the laboratory failed to ensure that the State of Pennsylvania (PA) regulations were met regarding having a supervisor on site during all normal scheduled working hours in which tests were performed from 01/19/2022 through the day of the survey. Findings include: 1. The PA regulation (5.23(b)(1) states: "A general supervisor who meets all the requirements of subsection (a)(1), (2) or (3) and is on the laboratory premises during all normal scheduled working hours in which tests are being performed." 2. Review of the application for Exception to Section 5.22 (f) form signed by the laboratory director (LD) on 04/19/2022 states: " the laboratory director will appoint a qualified general supervisor for each laboratory who will be on-site to oversee laboratory operations during all hours in which testing is being performed and who will review quality control records on a weekly basis". 3. The laboratory's Quality Assurance: Laboratory Supervisor Job Description police (page 5) states, " Employee must be a High School graduate (or equivalent) and must meet one of the following requirements: - Incumbent must hold a Bachelor's Degree in medical technology or chemical, physical, or biological science and six years experience. - Incumbent must hold a doctoral degree from an accredited institution and have acceptable lab experience. 4. On the day of the survey, 12/06/2023 at 09:20 am, review of the laboratory personnel report (PA State) and personnel credentials revealed that the laboratory failed to ensure that the PA regulations were met regarding having a qualified supervisor on site during all hours of patient testing and to ensure laboratory supervisor qualifications were met per the laboratory's procedure from 01/19/2022 to 12/06/2023. 5. TC#1 confirmed the findings above on 12/06/2023 at 01:30 pm. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D5783