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 October 17, 2022. 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. 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 a review of the 2021 American Proficiency Institute (API) Proficiency Testing (PT) Immunology/Immunohematology results, a review of the director approved policy and procedure for Proficiency Testing, and an interview with the laboratory director and the laboratory supervisor, the laboratory failed to verify the accuracy of the SARS-CoV-2 antibody testing at least twice annually during 2021. Findings include: 1. The laboratory failed to obtain a passing score for the 2021 API Immunology/Immunohematology Proficiency Testing Events number 1 and 3 for the SARS-CoV-2 Antibody test. The laboratory received a score of 50% for both Event 1 and for Event 3. 2. The director approved procedure entitled, "Proficiency Testing" failed to include a provision for performing alternative proficiency testing in the event that the laboratory fails to obtain a passing score for two consecutive events, or two out of three events to verify the accuracy of analytes not listed in subpart I of 42 CFR 493, as required. 3. An interview with the laboratory director and the laboratory supervisor conducted on October 17, 2022 at approximately 12:00 PM confirmed the findings. The laboratory performs approximately 118 general immunology tests annually. 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 -- D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of the laboratory records for calibration verification for the sodium, potassium and chloride analytes on the Siemens Dimension EXL chemistry analyzer, a review of the director approved policy, and an interview with the laboratory supervisor, the laboratory testing personnel, and the laboratory director, and email correspondence received from the laboratory, the laboratory failed to ensure that the calibration verification was performed every six months in 2021. Findings include: 1. A review of the calibration verification records for the sodium, potassium, and chloride revealed that the laboratory failed to perform calibration verification in December, 2021. The verification was performed on June 12, 2021, and May 23, 2022. 2. The director approved policy and procedure stated, " Recalibration or calibration verification and AMR validation, must be performed at least once every 6 months as specified under CLIA-88 regulations at 42CFR493.1255(b)(3)." (sic) 2. An interview with the laboratory director, the laboratory supervisor, and the laboratory testing personnel confirmed that the records could not be located at approximately 4: 45 PM on October 17, 2022. 3. An email received from the laboratory on October 18, 2022 at approximately 4:57 PM confirmed that the calibration verification was not performed in December, 2021. The laboratory performs approximately 4638 Chemistry tests annually. -- 2 of 2 --