Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory records and procedures from 2020 and 2021 and confirmed with interview, the laboratory failed to establish and follow policies to verify the accuracy of two of two nonregulated analytes twice annually either through enrollment in proficiency testing or method comparison studies. (FSH, LH) Findings were: 1. Review of the laboratory records from 2020 and 2021 revealed the laboratory performed twice annually method comparison studies of the following 2 nonregulated analytes: FSH and LH. 2. A review of the laboratory's policies and procedures revealed the laboratory did not have a procedure to verify the accuracy of the non- regulated analytes FSH and LH at least twice annually. 3. An interview with the primary testing person on 2/16/22 at 1145 hours in the break room confirmed the above findings. key: FSH - follicle-stimulating hormone LH - luteinizing hormone D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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)