Summary:
Summary Statement of Deficiencies D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of quality assurance data during the period 5/1/16 to 1/23/18 and staff interview, the laboratory failed to define and perform accuracy verification for tests approved by the laboratory director at least twice annually. Findings were: A. A review of any method or system approved by the lab director to perform and verify accuracy revealed that no policy or method was defined. The laboratory performed tests for the presence or absence of dermatophytes, other fungi, yeast, presence /absence of scabies, and the KOH (potassium hydroxide) test. B. Upon request for evidence of accuracy verification testing, the laboratory was unable to provide this data for the tests: Acu-DTM Acu-Sabouraud Acu-Nickersons Medium Presence /absence of scabies KOH (potassium hydroxide) test The laboratory failed to perform this testing twice annually for calendar years 2016 and 2017. C. The above findings were confirmed by interview with the back office manager on 1/23/18 at 1020 hours in the lunch room. 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 5 -- 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)