Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on July 20, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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: Based on review of the daily temperature and relative humidity charts for November 2020, to April 2022, and staff interview the laboratory failed to properly document the humidity. Findings: 1. Review of the Daily Humidity logs for November 2020 through April 2021, and November 2021 thru April 2022 shows that the humidity was documented out of range the following number of days: November 2020, out of 34 enteries the humidity was out of range 6 times December 2020, out of 36 entries the humidity was out of range 11 times January 2021, out of 31 entries the humidity was out of range 8 times February 2021, out of 30 entries the humidity was out of range 5 times March 2021, out of 30 entries the humidity was out of range 4 times April 2021, out of 44 entries the humidity was out of range 6 times May thru October 2021 all humidity entries were within the range November 2021, out of 38 entries the humidity was out of range 5 times December 2021, out of 42 entries the humidity was out of 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 -- range 5 times Janurary 2022, out of 41 entries the humidity was out of range 23 times February 2022, out of 39 entries the humidity was out of range 7 times March 2022, out of 46 entries the humidity was out of range 5 times April 2022, out of 42 entries the humidity was out of range 7 times Out of 18 months the humidity was out of range 92 times 2. Interview with the Laboratory Supervisor, on July 20, 2022, at approximately 3pm, in the laboratory office confirmed the aforementioned statements. D6010 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on review of the daily temperature and relative humidity charts for November 2020, to April 2022, and staff interview the Laboratory Director failed to provide oversight when the humidity was out of range. Findings: 1. Review of the Daily Humidity logs for November 2020 through April 2021, and November 2021 thru April 2022 shows that the humidity was documented out of range the following number of days: November 2020, out of 34 enteries the humidity was out of range 6 times December 2020, out of 36 entries the humidity was out of range 11 times January 2021, out of 31 entries the humidity was out of range 8 times February 2021, out of 30 entries the humidity was out of range 5 times March 2021, out of 30 entries the humidity was out of range 4 times April 2021, out of 44 entries the humidity was out of range 6 times May thru October 2021 all humidity entries were within the range November 2021, out of 38 entries the humidity was out of range 5 times December 2021, out of 42 entries the humidity was out of range 5 times Janurary 2022, out of 41 entries the humidity was out of range 23 times February 2022, out of 39 entries the humidity was out of range 7 times March 2022, out of 46 entries the humidity was out of range 5 times April 2022, out of 42 entries the humidity was out of range 7 times Out of 18 months the humidity was out of range 92 times Review of the humidity charts for the dates above the charts had been reviewed, signed and marked as being acceptable. 2. Interview with the Laboratory Supervisor, on July 20, 2022, at approximately 3pm, in the laboratory office confirmed the aforementioned statements. -- 2 of 2 --