Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) and quality control (QC) records and interview with the testing personnel (TP), the laboratory failed to perform serum pregnancy PT using the laboratory's routine methods in three of seven PT events. Findings: 1. The TP stated that external QC was performed for serum pregnancy testing each day patient testing was performed. 2. The serum pregnancy QC results were recorded on a log that included the date of testing, lot numbers, expiration dates, QC results and TP initials. 3. Attestation sheets, which included the dates the serum pregnancy PT was performed, were reviewed for seven PT events from 2020 to 2022. 4. There was no record that external QC was performed on the days when PT samples were tested for three of the seven serum pregnancy PT events reviewed (2020 Q1, 2020 Q2 and 2022 Q1). 5. During the survey on 03/04/2022 at 2:50 pm, the TP confirmed that external QC was not always recorded on the log on days that PT samples were tested 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 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 -- 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)