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 Clinical Supervisor, (CS), the laboratory failed to ensure that a qualified general supervisor was on-site during all normal scheduled working hours, in which tests were performed from 10/20/2022 through the day of the survey as required by PA state regulations. 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, 07/25/2024 at 10:00 AM, review of the PA laboratory personnel report revealed that the Laboratory Director also serves as a general supervisor. 3. Interview with the CS revealed that a qualified general supervisor was not on site when the Laboratory Director was not on site during all hours of testing from 10/20 /2022 to the day of survey. 4. The CS confirmed the findings above on 07/25/2024 during the survey. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. 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 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)