Centracare Laboratory Services-Urology

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of two 2019 and one 2020 proficiency testing (PT) scores when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Urinalysis testing as indicated on the Clinical Laboratory Improvements (CLIA) Application for Certification Form CMS-116, and as confirmed by the Technical Consultant 2 (TC2) during a tour of the laboratory on 1 /26/21, at 9:05 a.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) as PT provider. 3. The following PT events / samples / test results were not graded by API due to lack of consensus. See below. Event Sample ID Analyte Heme / Coag US-02 Urine Sediment 2019 / 1st UA-02 Urobilinogen Heme / Coag US-06 Urine Sediment 2020 / 3rd 4. The API report referred the laboratory to the expected result data summary for evaluation of the non- graded test results. The data summary for the above analytes were not present in laboratory records. Evaluation of the non-graded results were not found in laboratory records. The laboratory was unable to provide an evaluation of the non-graded results upon request. 5. In an interview on 1/26/21, at 9:35 a.m., TC2 confirmed the above finding . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 observation, document review and interview with laboratory personnel, the laboratory failed to perform calibration verification on two chemistry analyzers at least every 6 months. Findings are as follows: 1. The laboratory performed chemistry testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 11/21/18 at 8:10 a.m. 2. Three Qualigen FastPack IP System chemistry analyzers were observed as present and available for use during the tour of the laboratory. 3. 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 -- Calibration verification was required every 6 months as indicated in the Total PSA procedure located in the Adult and Pediatric Urology procedure manual. 3. The 6 month calibration verification (cal.) interval for analyzer #0791 and analyzer #1142 was exceeded on one occasion in the time period reviewed; February 2017 through date of survey, 11/21/18. See below. Qualigen FastPack IP System #0791 Previous cal. Subsequent cal. Time elapsed 10/20/17 10/30/18 12 mo., 11 days Qualigen FastPack IP System #1142 Previous cal. Subsequent cal. Time elapsed 12/04/17 10/30 /18 10 mo., 27 days 4. In an interview on 11/21/18 at 11:00 a.m., the TC confirmed the 6 month calibration verification interval had been exceeded for the two analyzers.. -- 2 of 2 --