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 the technical supervisor (TC) #1, the laboratory failed to ensure a general supervisor (GS ) who met the state requirement was on the laboratory premises during all hours in which tests were performed from 08 /17/2021 through the day of survey. Findings include 1) The PA regulations (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, 08/24/2023 at 01:20 pm., a review of Laboratory Personnel Report (Pennsylvania State), personnel credentials and personnel schedules for 3 of 3 months (Dec 2021, April 2022, and August 2022) requested during the survey revealed that the laboratory failed to ensure a qualified GS was on site every hour of patient testing as required per the state regulations. 3) The laboratory failed to provide personnel schedules for February 2023 and June 2023 requested during the survey. 4) On 08/24/2023 TC#1 confirmed the above findings around 02:00 pm. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved