Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on May 28, 2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the laboratory Quality Assurance Plan, a random patient audit between the dates of December 12, 2018 and November 20, 2019, and an interview with the Laboratory Director, and Laboratory Supervisor, the laboratory failed to maintain the quality control records for the Sysmex XS1000i hematology analyzer, Beckman Coulter AU400 chemistry analyzer, and the Beckman Coulter Access 2 immunoassay analyzer, and failed to maintain the maintenance records for the Beckman Coulter Access 2 immunoassay analyzer for a minimum of two years. Findings include: 1. A random audit of patient records tested between the dates of December 12, 2018 and November 20, 2019 revealed that there were no quality control records available for review for five of six dates of testing performed on the Beckman Coulter Access 2 immunoassay analyzer. There were no control records available for the following dates: December, 12, 2018, May 29, 2019, July 31, 2019, October 15, 2019, and November 20, 2019. 2. A random audit of patient records tested between the dates of December 12, 2018 and November 20, 2019 revealed that there were no quality control records available for review for two of six dates 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 5 -- testing performed on the Beckman Coulter AU400 chemistry analyzer. There were no control records available for the following dates: May 29, 2019, and July 31, 2019. 3. A random audit of patient records tested between the dates of December 12, 2018 and November 20, 2019 revealed that there were no quality control records available for review for two of six dates of testing performed on the Sysmex XS1000i analyzer. There were no control records available for review for the following dates: July 31, 2019, and November 20, 2019. 4. A random audit of patient records tested between the dates of December 12, 2018 and November 20, 2019 revealed that there were no instrument maintenance records available for review for five of six dates of testing performed on the Beckman Coulter Access 2 immunoassay analyzer. There were no maintenance records available for the following dates: March 11, 2019, May 29, 2019, July 31, 2019, October 15, 2019, and November 20, 2019. 5. The director approved policy number QA 100.0 entitled "Quality Assurance Plan (QMP)," section II. "Analytical Quality Assurance Areas," sub-section E. "Test Specific Quality Control" stated in step 4, "Retain QC and patient test records, including instrument print-outs if applicable, for 2 years." 6. An interview conducted with the Laboratory Director on May 28, 2021 at approximately 4:00 PM revealed that there were 49 patients tested on December 12, 2018, 34 patients tests on March 11, 2019, seven patients tested on May 29, 2019, six patients tested on July 31, 2019, 13 patients tested on October 15, 2019, and eight patients tested on November 20, 2019 that were potentially affected. 7. The Laboratory Director and the Laboratory Supervisor confirmed that the records were not available for review during an interview conducted on May 28, 2021 at approximately 3:45 PM. The laboratory performs approximately 4500 chemistry tests, and 1300 hematology tests annually. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the director approved Quality Assurance Plan, and an interview with the Laboratory Director, and the Laboratory Supervisor, the laboratory failed to retain all laboratory quality assessment records for a minimum of 2 years. Findings include: 1. The director approved policy number QA 100.0 entitled "Quality Assurance Plan (QMP)," in the section entitled "Quality Assurance Procedure" stated in step 5, "Retain quality assessment records for a minimum of two years." 2. The Laboratory Director and the Laboratory Supervisor confirmed that there were no records of quality assessment available for review at the time of the survey during an interview conducted on May 28, 2021 at approximately 3:30 PM. The laboratory performs approximately 4500 chemistry tests, and 1300 hematology tests annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) 2020 and 2021 -- 2 of 5 -- proficiency testing (PT) reports, a review of the director approved Quality Assurance Policy, and an interview with the Laboratory Director, and the Laboratory Supervisor, the laboratory failed to ensure that the PT results were evaluated, and that