Minnesota Urology Plymouth

Summary Statement of Deficiencies D0000 The Minnesota Urology Plymouth laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F. R. part 493) upon completion of the recertification survey performed on June 20, 2024. The following standard-level deficiencies were cited: 493.1251 Procedure Manual 493.1255 Calibration and calibration verification procedures . D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory director failed to approve all procedures in use by the laboratory in 2022, 2023, and 2024. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:15 a.m. on 06/20/24. 2. Three Qualigen FastPack test systems were observed as present and available for use during the tour. The laboratory performed Prostate-Specific Antigen testing using the FastPack systems during the time period reviewed; July 2022 through June 2024. 3. Laboratory procedures were found in the Procedure and Safety Manual and the Clinitek, Qualigen, and Orchard Procedure Manual, both located in the Education, Training, Competency 3-ring binder. 4. Laboratory Director approval of laboratory procedures located in the above procedure manuals was not found on date of survey: 5. In an interview at 11:35 a.m. on 06/20/24, the TC confirmed the above finding. . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) 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 -- 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 and document Chemistry analyzer calibration verification at least once every 6 months in 2023. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:15 a.m. on 06/20/24. 2. Three Qualigen FastPack test systems were observed as present and available for use during the tour. The laboratory performed Prostate-Specific Antigen testing using the FastPack systems during the time period reviewed; July 2022 through June 2024. 3. FastPack system method verification (calibration verification) was required every six months as established in the Qualigen procedure found in the Clinitek, Qualigen, and Orchard Procedure Manual. 4. Calibration verification was performed on 10/30 /22 and 10/13/23 as indicated in laboratory records. Eleven months and thirteen days elapsed between these calibration verification dates. 5. Calibration verification documentation was not found in laboratory records from between 10/30/22 and 10/13 /23. The laboratory was unable to provide records for a calibration verification during this time period upon request. 6. In an interview at 12:10 p.m. on 06/20/24, the TC confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure proficiency testing (PT) samples from one of two 2021 PT events were tested consistent with the number of times the laboratory routinely tested patient specimens. Findings are as follows: 1. The laboratory performed Prostrate Specific Antigen (PSA) testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:00 a.m. on 07/29/22. 2. The laboratory performed PT in 2021 using the American Proficiency Institute (API) proficiency testing provider. 3. The Proficiency Testing Procedure found in the laboratory's Procedure Manual indicated PT samples would be tested in the same manner as patient specimens. 4. The PSA PT samples were tested by multiple testing personnel (TP) in one of two PT events reviewed from 2021 as indicated on the API attestation statement. See below. 2021 Chemistry 2nd event Samples: IA-06, IA-07 Tested by: TP4, TP5, former TP's RG and EP 5. In an interview at 11:10 a.m. on 07/29/22, the TC confirmed the above finding and indicated patient specimens would not be tested in this manner. . D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 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 -- This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Consultant (TC) failed to ensure four of seven testing personnel were assessed at least annually in 2021 through testing previously analyzed specimens, blind samples, or proficiency testing samples. Findings are as follows: 1. The laboratory performed Prostrate Specific Antigen (PSA) testing as confirmed by the TC during a tour of the laboratory at 10:00 a.m. on 07/29/22. 2. The Employee Training and Competency procedure found in the Education, Training, and Competency manual indicated competency assessments were documented on the laboratory Training and Competency Review form. This form included the assessment of blind samples or proficiency testing samples. 3. PSA proficiency testing or blind sample competency assessments were not found in 2021 laboratory records for the following four of seven TP in 2021: TP1, TP2, TP3, TP7 4. The laboratory was unable to provide the missing blind sample evaluation documents upon request. 5. In an interview at 11:40 a.m. on 07/29/22, the TC confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to verify performance specifications for 1 of 1 Chemistry test systems implemented in 2019. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 03/10/21, at 9:05 a.m. 2. Three Qualigen Fastpack test systems, identified as Units "A", "B", and "C," were observed as present and available for use for Prostate Specific Antigen (PSA) testing during the tour. 3. In an interview on 03/10 /21, at 10:55 a.m., TP1 indicated that Unit "C" was put into use for patient PSA testing on 10/14/19. 4. Performance verification (PV) documentation for the Qualigen Fastpack Unit "C" test system was not found in laboratory records. The laboratory was unable to provide PV documents upon request. 5. The PSA patient testing log indicated that patient PSA testing on Unit "C" was initiated in October, 2019. A total of 134 PSA patient specimens were tested on Unit "C" between 10/14/19 and date of survey, 03/10/21. 6. In an interview on 03/10/21, at 10:55 a.m., TP1 confirmed the above findings. . D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) 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 -- (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to establish and follow a system to evaluate and define the relationship between test results obtained from different Chemistry analyzers at least twice annually. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 03/10/21, at 9:05 a.m. 2. Three Qualigen Fastpack test systems, identified as Units "A", "B", and "C," were observed as present and available for use for Prostate Specific Antigen (PSA) testing during the tour. 4. The laboratory's procedure manuals did not include a system to define and evaluate the relationship between PSA test results obtained from different Chemistry analyzers at least twice annually. 5. Documentation of such an evaluation was missing during review of laboratory records for the following time periods: 2019 Performed 4/25/2019 for Units "A" and "B" - Unit "C" not in use at this time. No other records found for 2019. 2020 Performed 7/20 /2020 for Units "A", "B", and "C" No other records found for 2020. 6. In an interview on 03/10/21, at 10:55 a.m., TP1 confirmed the above findings. . -- 2 of 2 --