Summary:
Summary Statement of Deficiencies D0000 The AFC Urgent Care Laboratory was surveyed pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendment of 1988 (CLIA). This was an initial survey performed on January 25, 2018. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview testing personnel (TP) were not following laboratory policies and procedures in the sub-specialty of toxicology. Findings include: 1. Record review of the laboratory's standard operating procedure for "initial testing procedure" (document # 1484.03 - section 9) on 1/25/18 revealed new lot of assayed quality control (QC) and calibrators are to be run in parallel with the current lot and documented on the new reagent lot log. 2. Record review of the laboratory's QC and calibrator lot to lot verification sheets on 1/25/18 revealed the TP were not following the above procedure for verifying and documenting new lot of QC and calibrator materials before placing them in use, specifically: a) Fentanyl QC lot# E30476 placed into service on 1/18/18 b) Ethyl glucuronide (ETG) QC lot# 72426703 used for alcohol testing placed into service on 1/16/18. c) pH 4.5 and 9 calibrators lot# 3T448UL-K1 4.5 placed into service on 1/12/18. 3. Staff interview with the technical supervisor on 1/25/18 at 1:30 PM confirmed TP did not follow the laboratory's lot to lot verification procedure for the above QC and calibrator materials before placing them into service. 4. The laboratory performs an estimated volume of 92,076 toxicology tests annually. 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 -- 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)