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 #3 (TC), 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 11/11/2021 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. On the day of the survey, 09/20/2023 at 01:45 pm, 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 from 11/11/2021 to 09/20/2023. 3. TC#3 confirmed during an interview at 02:00 pm on 09/20/2023, that the laboratory director was not on site a reasonable amount of time each day and the laboratory did not have a qualified supervisor on site during all normal scheduled working hours in which tests were performed. D5783