Summary:
Summary Statement of Deficiencies 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 observation, procedure manual review, and interview with the general supervisor (GS), the laboratory failed to ensure that there was an approved procedure for calibrating the scale used to measure reagents for urine toxicology testing. Findings: 1. During a tour of the laboratory at 9:30 AM, it was observed that the laboratory was using a "OHAUS" scale to measure reagents used for urine toxicology testing. Documentation of the scale's calibration is recorded in a binder. 2. A review of the binder showed that a procedure for calibrating the scale was placed on the outside of the binder. This procedure was not signed and approved by the laboratory director. 3. During an interview on 06/05/2023 at 11:30 AM, the GS stated that there was no book or instructions available which described how to operate the scale so they wrote a procedure. Procedure manual review confirmed that the laboratory did not have an approved procedure for how to operate the scale. 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 9 -- 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)