Centracare - Benson

Summary Statement of Deficiencies D0000 The CentraCare - Benson 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 proficiency testing desk review survey performed on June 9, 2025. The following condition-level deficiencies were cited: 493.803 Successful Participation The following standard-level deficiency was cited: 493.863 Compatibility testing . D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the 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 -- laboratory failed to successfully participate in Compatibility Testing PT under specialty of Immunohematology in 2024 and 2025. Findings are as follows: 1. The CMS CASPER Report 0155D and the API 2024 Immunohematology/Immunology - 3rd Event Performance Summary and Comparative Evaluation and the API 2025 Immunohematology/Immunology - 1st Event Performance Summary and Comparative Evaluation were reviewed on June 9, 2025. 2. The reports indicated the laboratory failed to achieve satisfactory performance for Compatibility Testing in two of three consecutive testing events from 2024 and 2025, resulting in unsuccessful performance of the analyte (see D2181). . D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) scores from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for Compatibility Testing in two out of three consecutive testing events in 2024 and 2025, constituting unsuccessful participation for the analyte. Findings are as follows: 1. API Performance Summary and Comparative Evaluation PT reports from the 2024 Immunohematology/Immunology 3rd Event and the 2025 Immunohematology /Immunology 1st Event were reviewed on June 9, 2025. 2. The reports indicated the laboratory had unsatisfactory performance for Compatibility Testing in two out of three consecutive events, leading to unsuccessful participation. Unsatisfactory PT performance for Compatibility Testing was obtained in the following events: Event Score -2024 3rd event 80% -2025 1st event 80% . -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to retain Chemistry calibration records for at least 2 years. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 11:45 a.m. on April 11, 2024. 2. An Abbott Alinity Ci Chemistry analyzer was observed as present and available for use during the tour of the laboratory. 3. Chemistry analyzer calibration records were requested for the second quarter of 2023 (April, May and June 2023). The laboratory provided records calibration records for March and June 2023. Calibration records for April and May 2023 were missing. 4. In an interview at 9:28 a. m. on April 12, 2024, the GS confirmed she was unable to recover the calibration records for April and May 2023. Further stating the calibration data is sent from the Chemistry analyzer to Abbott through the AbbottLink connection. The GS had requested the information from Abbott; however there must have been a communication issue at that time as Abbott was unable to pull any date for April and May 2023. The GS further confirmed the laboratory was not storing the data in any other way. . 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 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 one 2020 non-graded proficiency testing (PT) result for a non-regulated analyte when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Urinalysis testing as confirmed by the General Supervisor during a tour of the laboratory at 8:15 a.m. on 07/07/22. 2. The laboratory performed PT using the American Proficiency Institute (API) PT provider. 3. One Urine Sediment (US) result from the third 2020 Hematology/Coagulation PT event was not graded by API due to lack of consensus. See below. Sample ID Analyte US-06 US 4. The API report referred the laboratory to the expected result data summary for evaluation of the non-graded test result. The data summary for the above sample was not present in laboratory records. An evaluation of the non-graded result was not found in laboratory records. The laboratory was unable to provide an evaluation of the non-graded result upon request. 5. The laboratory's Proficiency Testing Procedure found in the General Laboratory policy and procedure manual indicated the manager would review and evaluate all non-graded PT results. 6. In an interview at 10:45 a.m. on 07/07/22, the Technical Supervisor confirmed the above finding. . D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) 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 -- (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. 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 alarm system function checks for the blood storage refrigerator in 2020 and 2021 with the frequency defined by the laboratory. Findings are as follows: 1. The laboratory performed Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on at 8:15 a.m. on 07/07/22. 2. The laboratory stored blood products in a designated refrigerator. The blood storage refrigerator had a temperature alarm system. 3. Monthly blood product storage alarm check requirements were established on the Blood Bank Alarm Checks form. 4. Blood product storage alarm checks were not performed on one of twelve required occasions in 2020 and on one of twelve required occasions in 2021 as indicated on the Blood Bank Alarm Checks form. The alarm checks were not completed in December 2020 and August 2021. 5. The laboratory provided approximately 246 Immunohematology results to patients annually as indicated on the Form CMS-116 provided by the laboratory on date of survey, 07/07 /22. 6. In an interview at 2:45 p.m. on 07/07/22/22, the Technical Supervisor confirmed the above finding. 7. The laboratory was given five days to provide documentation of alarm checks completed by an outside vendor. In an email received on 07/11/22 at 7:08 a.m., the GS indicated no other alarm check records were found. . 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 document review and interview with laboratory personnel, the Technical Consultant failed to ensure five of six testing personnel in 2020 and six of six testing personnel in 2021 were evaluated for test procedure competency in all testing areas. Findings are as follows: 1. The laboratory performed Endocrinology testing as confirmed by General Supervisor during a tour of the laboratory at 8:15 a.m. on 07/07 /22. 2. Cardinal Health hCG test kits were observed as present and available for use during the tour. The laboratory used serum for this test as indicated by the GS during the tour. 3. The laboratory's Technical Competency procedure, found in the General Laboratory policy and procedure manual, indicated TP were evaluated for competency in all testing areas during training, after 6 months of work, and annually thereafter. 4. Competency assessments for Serum hCG testing were not included in the Competency Assessment forms completed for 5 of 6 testing personnel in 2020 and 6 of 6 TP in 2021. 5. The laboratory was unable to provide the missing evaluations upon request. 6. In an interview at 9:55 a.m. on 07/07/22, the Technical Supervisor confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies 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 observation, document review, and interview with laboratory personnel, the laboratory failed to verify the accuracy of all tests performed at least twice annually. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor during a tour of the laboratory at 8:05 a.m. on 09 /28/20 2. A Siemens Dimension EXL 200 chemistry analyzer was observed as present and available for use during the tour. 3. The laboratory performed Lidocaine testing beginning in May 2019 as confirmed by the GS. 4. The laboratory utilized the American Proficiency Institute (API) as the Proficiency Testing (PT) provider. Twice annual verification of accuracy documents for Lidocaine were not found during review of API PT records from 2019. The laboratory was unable to provide these documents upon request. 5. In an interview at 12:10 p.m. on 09/28/20, the Technical Consultant confirmed the above finding. . 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. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical 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 -- consultant failed to ensure 1 of 5 testing personnel were assessed at least annually in 2019 through testing Microbiology, Chemistry,and Hematology previously analyzed specimens, blind samples, or proficiency testing samples. Findings are as follows: 1. The laboratory performed microscopic examinations for Post Vasectomy, Vaginal Wet Preparations, and Urine Sediment as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 09/28/20. 2. Laboratory records indicated Testing Personnel 4 (TP4) was a fully trained staff member performing microscopic examinations in 2019. A microscopic examination blind sample competency assessment for TP6 was not found in 2019 laboratory records. 3. The laboratory was unable to provide the missing blind sample evaluation document upon request. 4. In an interview at 11:10 a.m. on 09/28/20, the GS confirmed the above finding. 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. 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 1 new testing personnel hired in 2018. Findings are as follows: 1. The laboratory performed microscopic examinations for Post Vasectomy, Vaginal Wet Preparations and Urine Sediment as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 09/28/20. 2. Laboratory records indicated Testing Personnel 6 (TP6) was trained and initially assessed for microscopic examination competency in November 2018. A semiannual microscopic examination competency assessment for TP6 was not found in laboratory records. 3. The laboratory was unable to provide the missing semiannual competency document upon request. 4. In an interview at 10:10 a.m. on 09/28/20, the GS confirmed the above finding. . -- 2 of 2 --

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 Director or designee failed to review and evaluate proficiency testing (PT) results for 1 of 14 PT events in 2017. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 7/19/18 at 11:05 a.m. 2. The laboratory performed Proficiency Testing (PT) using American Proficiency Institute (API) as the provider. 3. Review of API PT documents revealed the following results were graded as unacceptable: Year: 2017 Survey: Chemistry / Core Event: 3rd Sample: CH-14 Tests: Lactic Acid 4. Documentation of review and