Minnesota Urology, Pa

Summary Statement of Deficiencies D0000 The Minnesota Urology, PA 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 which concluded on October 4, 2024 . The following standard-level deficiencies were cited: 493.1255 Calibration and calibration verification procedures 493.1413 Technical consultant responsibilities . D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for 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 hematology analyzer calibration as required by the manufacturer on two of four occasions in 2023 and 2024. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor during a tour of the laboratory on at 9:10 a.m. on 10/03/24. 2. A Beckman Coulter DxH 500 hematology analyzer was observed as present and available for use during the tour of the laboratory. The laboratory performed approximately 5,541 hematology tests annually as indicated on the Form CMS-116 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 -- obtained from the laboratory on date of survey. 3. DxH calibration was required when indicated on calibration verification reports as established in the manufacturer's DxH 500 Instructions for Use manual 4. The laboratory performed calibration verification on four dates in the time period reviewed; 04/21/23, 10/16/23, 05/20/24, and 08/21/24. The laboratory failed to perform calibration on two of four occasions when calibration verification results listed on the analyzer Cal. Report indicated this activity was required. See below 10/16/23 Calibration Report Cal: WBC, HGB, PLT 05/20/24 Calibration Report Cal: WBC, HGB, MCV Fail: RBC 5. In an interview at 3:25 p.m. on 10/03/24, the Technical Consultant confirmed the above finding and stated testing personnel did not perform calibration on the two occasions when the calibration report indicated calibration was needed.. . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant failed to ensure three of three tenured testing personnel were evaluated for test procedure competency in all testing areas in 2022 and 2023. Findings are as follows: 1. The laboratory performed KOH preparation (KOH), vaginal wet preparation (VWP), and quantitative sperm analysis (SA) microscopic examination testing as confirmed by the General Supervisor during a tour of the laboratory at 9:10 a.m. on 10/03//24 2. An Olympus CH30 microscope was observed as present and available for use during the tour. 3. The Competency Assessments for MLT Personnel procedure provided by the laboratory indicated testing personnel were evaluated for competency in all testing areas during training, after 6 months of work, and annually thereafter. 4. Competency assessments for KOH, VWP, and SA microscopic examination testing were not included in the Competency Assessment Worksheet (Testing Personnel) forms completed for three of three tenured testing personnel in 2022 and 2023. The laboratory was unable to provide the missing evaluations upon request. 5. In an interview at 11:10 a.m. on 10/03/24, the Technical Consultant confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, statistical records and interviews with the Laboratory Director/Technical Supervisor A and the Laboratory Manager, the laboratory failed to follow written policies and procedures for the evaluation and comparison of one of three nongynecologic cytology statistics. The laboratory failed to document one of three required annual nongynecologic statistics in 2021 and 2022. Findings include: 1. The laboratory failed to follow the policy CYTOLOGY/HISTOLOGY QUALITY ASSURANCE: QUARTERLY REPORT which stated: "Quarterly report will contain the following metrics: Cytology Statistics; Total number of cytology cases, and a percentage of each diagnostic category (Negative for High-Grade Urothelial Carcinoma (NHGUC) , Atypical Urothelial Cells (AUC), Suspicious for High-Grade Urothelial Carcinoma (SHGUC), High-Grade Urothelial Carcinoma (HGUC), Low-Grade Urothelial Neoplasia (LGUN), Other Primary and Metastatic Malignancy and Unsatisfactory." a. During an interview on 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 -- October 11, 2023 at 3:00 PM with the Laboratory Director/Technical Supervisor A and the Laboratory Manager it was stated that the QUARTERLY REPORT STATISTICS for the second and third quarters of 2023 were for Facility A and Facility B combined. b. The laboratory was not following the policy to compile statistics for cytology cases that were examined only at this facility (Facility A). 2. The Survey Team requested and the laboratory failed to provide records of one of three required annual nongynecologic statistics in 2021 and 2022. Statistics include: - Number of nongynecologic cases reported by diagnosis, including the number reported as unsatisfactory. a. The laboratory provided 2021 ANNUAL LAB STATISTICS AND 2022 ANNUAL LAB STATISTICS, which did not include the number of cases reported as unsatisfactory. 3. During an interview on October 11, 2023 at 3:00 PM the Laboratory Director/Technical Supervisor A confirmed these findings. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 2 of 2 --

Summary Statement of Deficiencies D5034 CLINICAL CYTOGENETICS CFR(s): 493.1225 If the laboratory provides services in the specialty of Clinical cytogenetics, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1276, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on laboratory record review, direct observation, and interview with laboratory personnel, the laboratory failed to meet the requirements as specified in 493.1256 for Clinical cytogenetics. Findings are as follows: 1. The laboratory failed to check Clinical cytogenetic fluorescent stains for positive reactivity 115 of 115 days of use in 2021 and 2022. Refer to D5475. . 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 ensure five of five reviewed reportable ranges obtained during the single performance verification (PV) activity completed in 2022 were adopted by 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 -- the laboratory. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 3 during a tour of the laboratory at 8:10 a. m. on 10/19/22. 2. A Beckman Coulter DxH 500 hematology analyzer was observed as present and available for use during the tour of the laboratory. The laboratory began performing Complete Blood Counts with Automated Differentials on this analyzer on 08/30/22. 3. PV activities on the DxH were completed in August 2022 as indicated in laboratory records found in the Performance Verification Data Manual DxH 500. Five analytes were reviewed for reportable range accuracy as indicated below. WBC - White Blood Cells RBC - Red Blood Cells HGB - Hemoglobin PLT - Platelets HCT - Hematocrit 4. The upper and/or lower reportable range limits adopted by the laboratory did not reflect the actual reportable range values obtained by the laboratory during the PV as indicated in the PV documents and the CBC with Automated Leukocyte Differential Beckman Coulter DxH procedure found in the DxH 500 Instructions for Use and SOP's manual. The Technical Consultant indicated the values found in the procedure were the analytical measuring ranges provided by the manufacturer. See below. Analyte PV Procedure WBC 0.03-103.0 0.05-400.0 RBC 0.01-7.95 0.005-8.5 HGB 0.01-19.3 0.10-25.5 PLT 0.9-1800.0 3.0-3000.0 HCT 28.4-53.8 Not in procedure 5. In an interview at 2:15 p.m. on 10/19/22, the TC confirmed the above finding. . D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to check Clinical cytogenetic fluorescent stains for positive reactivity 115 of 115 days of use in 2021 and 2022. The laboratory performed approximately 367 Clinical cytogenetics tests on patient samples annually. Findings are as follows: 1. The laboratory performed Clinical cytogenetic fluorescence in-situ hybridization (FISH) testing as confirmed by Testing Personnel 3 during a tour of the laboratory at 8:10 a.m. on 10/19/22 2. Positive and negative quality control (QC) slide testing was required with each batch of FISH testing as indicated in the Bladder Cancer FISH Analysis using CELLAY Probes procedure found in the FISH Procedure manual. 3. The Bladder Cancer Fluorescence In-Situ Hybridization Scoring Sheets, found in the Fluorescence In-Situ Hybridization Binder, were used to document QC testing. The scoring sheets did not include documentation of positive QC slide testing from January 2021 through October 2022. Scoring sheets for negative QC slide testing were found for this time period. 4. The Clinic Operations Director (COD) discussed this issue with Testing Personnel 1 (TP1) at 4:30 p.m. on 10/19/22. Per the COD, TP1 stated positive QC slides were not tested with each batch of FISH testing in 2021 and 2022. 5. The laboratory performed FISH testing on 589 patient samples over 115 days of testing between 01/01/21 and 10/19/22 as indicated on an internal report generated by the laboratory on 10/19/22. 6. In an interview at 4:35 p.m. on 10 /19/22, the Technical Consultant confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of laboratory policies and procedures and interview it was determined that the laboratory failed to ensure that two of seventeen written policies and procedures were approved, signed and dated by the Laboratory Director. Findings include: 1. The Laboratory Director failed to approve, sign and date two of seventeen laboratory procedures in the cytology manual. Procedures include: - The Paris System for Reporting Urinary Cytology - Creating Pathology Reports 2. During an interview at 11:30 AM on October 6, 2021, the Laboratory Director/Technical Supervisor #1 confirmed these findings. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. 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 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 document review and interview with laboratory personnel, the laboratory failed to evaluate unacceptable proficiency testing (PT) results. Findings are as follows: 1. The laboratory performed Hematology and Microbiology testing as confirmed by the Technical Consultant 2 (TC2) during a tour of the laboratory on 12 /18/20, at 10:05 a.m. 2. The laboratory performed proficiency testing (PT) using the College of American Pathologists (CAP) and American Proficiency Institute (API) as PT providers. 3. The laboratory received unacceptable PT results for the following API PT events: Event = 2019 - Heme / Coag - 3rd Event Sample = BCI-13 Test = Blood Cell ID Event = 2019 - Microbiology - 3rd Event Sample = GS-14 Test = Gram Stain Morphology Event = 2020 - Heme / Coag - 1st Event Sample = COU-05 Test = Monocytes 4. An evaluation of the unacceptable PT results was not found during review of laboratory records. The laboratory was unable to provide evaluations upon request. 5. In an interview on 12/18/20, at 10:20 a.m., TC2 confirmed the above finding. . 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). 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 laboratory failed to verify the accuracy of proficiency testing (PT) results that were not scored by the PT provider. Findings are as follows: 1. The laboratory performed Hematology, Parasitology, Urinalysis, and Microbiology testing as confirmed by the Technical Consultant 2 (TC2) during a tour of the laboratory on 12/18/20, at 10:05 a.m. 2. The laboratory performed proficiency testing (PT) using the College of American Pathologists (CAP) and American Proficiency Institute (API) as PT providers. 3. An evaluation for accuracy of non-graded results for the following API PT events was not found during review of the following laboratory documents: Event: 2019 - Heme / Coag - 1st Event Sample: COU-02 Test: Nucleated RBC's* Sample: US-02 Test: PPM / Urine Sediment Sample: VKP-01 Test: Vaginal Wet Prep (KOH)* Sample: UA-01 Test: Urobilinogen Event: 2019 - Microbiology - 3rd Event Sample: UR-11 Test: Urine Culture MIC* Event: 2020 - Heme / Coag - 1st Event Sample: US-06 Test: PPM / Urine Sediment Event: 2020 - Microbiology - 1st Event Sample: UR-01 Test: Urine Culture MIC* 4. The laboratory was unable to provide an evaluation of non-graded results upon request. 5. In an interview on 12/18/20, at 10:20 a.m., TC2 confirmed the above finding. * RBC = Red Blood Cells * KOH = Potassium hydroxide * MIC = Minimum Inhibitory Concentration . D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to retain proficiency testing records for at least 2 years. Findings are as follows: 1. The laboratory performed Chemistry and Microbiology testing as confirmed by General Supervisor 3 (GS3) during a tour of the laboratory on 10/22/18 at 8:05 a.m. 2. The laboratory performed proficiency testing (PT) using the College of American Pathologists (CAP) and Wisconsin State Lab of Hygiene (WSLH) as PT providers. 3. The following PT evaluation reports and documentation of review by the Laboratory Director (LD) were not present in laboratory records: PT provider Event WSLH 2017 - BactiReg 2 WSLH 2017 - BactiReg 3 WSLH 2018 - Chem / Endo / Tx 2 4. The laboratory was unable to provide the documentation of review by the Laboratory Director (LD) for these PT events upon request. 5. In an interview on 10/22/18 at 12: 15 p.m., GS3 confirmed the above finding. . 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 document review and interview with laboratory personnel, the laboratory failed to evaluate unacceptable proficiency testing (PT) results. Findings are as follows: 1. The laboratory performed Chemistry, Hematology and Microbiology Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- testing as confirmed by General Supervisor 3 (GS3) during a tour of the laboratory on 10/22/18 at 8:05 a.m. 2. The laboratory performed proficiency testing (PT) using the College of American Pathologists (CAP) and Wisconsin State Lab of Hygiene (WSLH) as PT providers. 3. The laboratory received unacceptable PT results for the following WSLH PT events: Event = 2017 - HemeReg3 Sample = AFA-14 Test = Eosinophils Event = 2017 - BactiReg2 Sample = UC-10 Test = Sensitivity (Levofloxacin) + (Quinupristin / Dalfopristin) Event = 2017 - BactiReg3 Sample = UC-13 Test = Organism ID Event = 2018 - Chem/Endo/Tx 2 Sample = CET-8 Test = Sodium Sample = CET-10 Test = Carbon Dioxide 4. An evaluation of the unacceptable PT results was not found during review of laboratory records. The laboratory was unable to provide evaluations upon request. 5. In an interview on 10/22 /18 at 12:15 p.m., GS3 confirmed the above finding. . 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 proficiency testing (PT) results that were not scored by the PT provider. Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by General Supervisor 3 (GS3) during a tour of the laboratory on 10/22/18 at 8:05 a.m. 2. The laboratory performed proficiency testing (PT) using the College of American Pathologists (CAP) and Wisconsin State Lab of Hygiene (WSLH) as PT providers. 3. An evaluation for accuracy of non-graded results for the following WSLH PT events was not found during review of the following laboratory documents: Event Sample Test 2017 - BactiReg2 UC-6 Gram Stain UC-7 Gram Stain UC-8 Organism ID Gram Stain UC-9 Gram Stain 2017 - BactiReg3 UC-11 Gram Stain UC-13 Gram Stain UC-14 Gram Stain UC-15 Trimethoprim 2018 - BactiReg3 UC-11 Gram Stain UC-12 Gram Stain UC-13 Gram Stain UC-14 Gram Stain UC-15 Rifampin 4. The laboratory was unable to provide an evaluation of non-graded results upon request. 5. In an interview on 10/22/18 at 12:15 p.m., GS3 confirmed the above finding. . D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to ensure reference intervals were consistent between a Chemistry procedure and a patient final test report. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by General Supervisor 3 (GS3) during a -- 2 of 3 -- tour of the laboratory on 10/22/18 at 8:05 a.m.. 2. A Beckman Coulter DxI 600 immunoassay chemistry analyzer was observed as present and available for use during the tour. 3. The TSH reference interval listed in the TSH (3rd IS) procedure, located in the on-line procedure manual, was not consistent with those included on a patient test report (Male - 28 years, Date performed = 8/29/18) reviewed on date of survey. See below. Procedure Report 0.45 - 5.33 0.340 - 5.600 4. In an interview on 10/23/18 at 10:15 a.m., GS3 confirmed the above finding. -- 3 of 3 --