Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on a lack of procedures, surveyor observation and an interview with the technical consultant, the laboratory failed to establish and have accessible a safety procedure to protect the laboratory staff from physical, chemical, biochemical, biohazard material and electrical hazards. Findings Include: It was confirmed with technical consultants on January 30, 2018 at approximately 11:15 am that two medical assistants were eating and drinking in the laboratory where KOH slides are prepared and read. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on this surveyor review of the proficiency test verification records and an interview with the technican consultant, the laboratory failed to verify the accuracy of the KOH procedure. Findings Include: On January 30, 2018 at approximately 11:10 AM and confirmed by the technical consultant, the laboratory failed to perform twice 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 -- annual verification for the KOH procedure performed from January 26, 2016 through December 31, 2016. Approximately 344 patient specimens were tested and reported for the KOH procedure performed. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on this surveyors review of the laboratory procedure manual, patient records and an interview with the technical consultant, the laboratory failed to have a written or electronic request for the KOH procedure performed by the physicians. 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)