Centracare Clinic St Joseph

Summary Statement of Deficiencies D0000 The CentraCare Clinic St Joseph 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 November 21, 2025. The following standard-level deficiencies were cited: 493.1413 Technical consultant responsibilities . D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant failed to ensure initial training and competency assessment for a new hematology analyzer was performed and documented for four of four testing personnel (TP) in 2023. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 12:05 p.m. on 11/21/25. 2. An Alcor Scientific mini iSED ESR analyzer was observed as present and available for use during the tour: The laboratory began testing patients using this analyzer in November 2023 as indicated by the TC and confirmed in laboratory records.. 3. Initial training and competency assessment of testing personnel was required before testing specimens independently as established on the New Employee Training Checklist and Competency Verification Form found in the Laboratory QA Manual Book #1. 4. Initial mini iSED ESR analyzer training and competency assessment documentation for TP1, TP2, TP3, and former TP MG was not found during review of 2023 laboratory records. The laboratory was unable to provide the missing documents upon request. 5. In an interview at 3:05 p.m. on 11/21 /25, the TC confirmed the above finding. The TC stated an on-line training module 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 -- provided by the manufacturer had been completed by the TP but no documentation was obtained. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 The CentraCare Clinic St Joseph 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 November 20, 2023. The following standard-level deficiencies were cited: 493.801 Enrollment and testing of proficiency samples 493.1253 Establishment and verification of performance specifications . D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: . Based on laboratory document review and Centers for Medicare and Medicaid Services (CMS) report review, the laboratory failed to ensure proficiency testing results for six of six regulated Chemistry analytes tested by the laboratory were released to CMS in 2022 and 2023 as required. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:15 a.m. on 11/20/23. 2. An i-STAT blood analyzer was observed as present and available for use during the tour. The laboratory performed testing for the following regulated Chemistry analytes using the i-STAT CHEM8+ cartridge: Sodium Potassium Chloride Glucose Urea Nitrogen Creatinine 3. The laboratory participated in proficiency testing (PT) using the College of American Pathologists (CAP) provider. CAP PT result documents from 2022 and 2023 were reviewed on date of survey. PT performance documentation for the i-STAT CHEM8+ analytes was found for 2022 and 2023 during review 4. PT results for the six regulated Chemistry analytes from the 2022 and 2023 CAP PT 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 -- events were not found during CMS database review completed on 11/17/23. The Individual Laboratory Profile report from the database was provided to the laboratory on 11/20/23. The report included Hematology analyte results but no Chemistry analyte results. 5. In an interview at 11:57 a.m. on 11/20/23, the LD confirmed the above finding. . 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 two of five Hematology reportable ranges obtained during performance verification (PV) activities were adopted by the laboratory in 2022. Findings are as follows: 1. The laboratory performed moderate complexity Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:15 a.m. on 11/20/23. 2. A Beckman Coulter DxH 520 hematology analyzer was observed as present and available for use during the tour of the laboratory. The laboratory began using this analyzer to perform Complete Blood Count testing in March 2022 as indicated by the LD. 3. PV activities on the DxH 520 analyzer were completed in March 2022 as indicated in laboratory records found in the Performance Verification Data Manual. The former LD approved the PV on 03/09 /22. 4. The Hematocrit (HCT) and Hemoglobin (HGB) 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 laboratory documents. See below. Analyte PV Adopted HCT 6.8-72.9 0.0-85.0 HGB 0.01-19.20 0.2-25.0 4. In an interview at 1:20 p.m. on 11/20/23, the LD confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to document function checks for a refrigerator thermometer in 2018. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry and Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory on 01/16/20, at 8:05 a..m. 2. A Whirlpool refrigerator (asset tag = SJ00034) with a Stanley Mobileview thermometer (serial number = 6W3 PY071617) was observed as present and available for use during the tour of the laboratory. 3. The Policy for Equipment Maintenance Checks procedure found in the CentraCare - St Joseph - Lab QA Manual indicated that thermometers are factory calibrated / certified to NIST standards. 4. Documentation of the thermometer function check for the equipment noted above was not found in laboratory records for 2018. The laboratory was unable to provide this documentation upon request. 5. In an email dated 1/20/20, the LD confirmed that the 2018 documentation could not be located, as the information entered in tracking software for 2019 had overwritten that from 2018, rendering it unretrievable. 6. In an interview at 11:15 a.m. on 01/16/20, the LD 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 2 -- 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 a reference interval was consistent between a Hematology procedure and a patient test report. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory on 01/16/20, at 8:05 a..m. 2. An PolyMedco Sedimat 15 ESR (*) analyzer was observed as present and available for use during the tour. 3. The ESR reference intervals listed in the Erythrocyte Sedimentation Rate (ESR) procedure, located in the CentraCare - St Joseph - Lab QA Manual #2 were not consistent with those included on patient test reports reviewed on date of survey, as indicated below. Patient #00166678 - adult male tested on 5/28/18 Patient #00235549 - adult female tested on 9/16/19 Sex Procedure Report Males = 0 - 15 mm/Hr 0 - 22 mm/Hr Females = 0 - 20 mm/Hr 0 - 18 mm/Hr 4. In an interview at 12:30 p.m., on 01 /16/20, the LD confirmed the above finding. (*) ESR = erythrocyte sedimentation rate . -- 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 observation, document review and interview with laboratory personnel, the laboratory failed to ensure hematology proficiency testing samples were tested consistent with the number of times the laboratory routinely tested patient samples. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Technical Consultant 2 (TC2) during a tour of the laboratory on 03/29 /18 at 10:00 a.m. A Beckman Coulter AcT 5diff hematology analyzer was observed as present and available for use during the tour. 2. The laboratory performed proficiency testing (PT) for Hematology using the College of American Pathologists (CAP) proficiency testing provider. 3. Hematology PT samples FH10-06 through FH10-10 from the CAP 2017 FH10-B event were tested on multiple days as indicated on test result documents generated by the Beckman Coulter AcT 5diff hematology analyzer. See below for dates and time of day testing was performed. 05/10/17 05/10/17 05/15 /17 Sample FH10-06 1:39 2:25 10:51 FH10-07 2:27 2:32 10:54 FH10-08 1:49 1:55 10: 56 FH10-09 1:56 2:30 10:57 FH10-10 2:00 2:02 10:59 4. In an interview on 03/29/18 at 1:45 p.m., TC2 confirmed the PT samples had been tested on multiple days and patient specimens would not routinely be handled in this manner. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 failed to ensure competency was assessed at least semiannually during the first year of patient specimen testing for 1 of 2 new testing personnel. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry and Hematology testing as confirmed by Technical Consultant 2 (TC2) during a tour of the laboratory on 03/29/18 at 10:00 a.m. 2. Testing Personnel 1 (TP1) was listed on the Laboratory Personnel Report (CLIA) Form CMS-209 as a full time employee performing moderate complexity testing. 3. Laboratory records indicated TP1 was trained and initially assessed for testing competency in December 2015 through February 2015. 4. A semiannual competency assessments for TP1 was not found during review of laboratory records. The laboratory provided a competency assessment labeled "6 month" which was performed in December 2016; 10 months after the initial competency assessment was completed. 5. In an interview on 03/29/18 at 10:55 a.m., TC2 confirmed the semiannual competency assessment for TP1 was completed after the 6 month timeframe had been exceeded. *This is a repeat deficiency. This issue was previously cited during the 11/18/15 survey.* -- 2 of 2 --