Summary:
Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) proficiency testing (PT) record review and interview with staff, the laboratory failed to handle PT testing samples in the same manner as patient samples for 1 of 1 testing events reviewed (1st event of 2019). Finding include: 1. The laboratory enrolled in PT for potassium hydroxide (KOH) wet mount preparations and mycology cultures. 2. Laboratory PT records for event 1 of 2019 document 4 laboratory personnel performed KOH testing before the results were submitted to API for grading on 02/25/2019. 3. The laboratory manager stated on 05 /01/2019 at approximately 2:30 p.m., KOH tests were reviewed by a technical consultant (TC) before submitting results to API. 4. The laboratory manager stated on 0/01/2019 at approximately 2:30 p.m. that patient KOH testing was routinely performed by only 1 test person and that patient results were not routinely reviewed by a TC before reporting. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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)