Summary:
Summary Statement of Deficiencies 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 lack of documents and interview at 08:30 am on 06/22/2018, the laboratory did not verify the accuracy of the direct wet mount preparations and potassium hydroxide (KOH) preparations examinations performed, twice yearly Findings was as follows:. a. Based upon a review of Proficiency the laboratory failed to have any documentation for KOH . which does not meet the standard for twice a year verifying the accuracy. b. This was confirmed in a interview with the Office Manager 06/22 /2018 at 09:30 am D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: A review of Temperature and humidity logs and interview with staff revealed the laboratory failed to meet the humidity requirements for the laboratory as the Leica 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 -- cryostat Findings were as follows: a. Based upon review of manufacture's operator guide for Leica cryostat the laboratory failed to meet the humidity requirement of 0% to 60% and a temperature of 18 to 35 C. . At the time of the survey 06/22/2018 at 9:30 the laboratory failed to produce any documentation for room temperature or humidity -- 2 of 2 --