Pa Dept Of Health Bureau Of Labs

Summary Statement of Deficiencies D0000 Three Centers for Medicare & Medicaid Services (CMS) federal surveyors conducted an announced CLIA recertification survey at the PA DEPT OF HEALTH BUREAU OF LABS from July 18, 2023 to July 20, 2023. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following condition and standard level deficiencies were found during the announced routine CLIA recertification survey performed from July 18, 2023 to July 20, 2023. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview with General Supervisor #12 (GS #12), the laboratory failed to retain Quality Control (QC) records for at least two years for one of one lot number of BBL Taxo P Discs. Findings include: 1. Interview with GS #12 on 07/20/2023 at 10:50 AM confirmed one box of BBL Taxo P Discs (Lot# 9365316) was available for use in the presumptive identification of pneumococci. 2. On 07/20 /2023, a review of QC records from January 2021 through the third day of the survey (07/20/2023) revealed no QC documentation for BBL Taxo P Discs (Lot# 9365316). 3. Interview with GS #12 on 07/20/2023 at 11:00 AM confirmed the above findings. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with laboratory staff, the laboratory failed to review and document the

Summary Statement of Deficiencies 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. (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)