Centracare - Long Prairie

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to enroll in an HHS approved proficiency testing (PT) program as required under 493.801 for Chemistry testing performed in 2021. Findings are as follows: 1. The laboratory performed C-Reactive Protein (CRP) Chemistry testing in 2021 as indicated in the laboratory test menu provided by the Technical Supervisor (TS) prior to survey and confirmed by the TS during a tour of the laboratory at 8:10 a.m. on 04 /26/23. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. The CRP analyte was not included in API documentation for the three 2021 Chemistry PT events reviewed on date of survey. 4. In an interview at 11: 20 a.m. on 04/26/23, the TS confirmed the above finding. . 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. 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 perform and document activities used to verify the accuracy of one of one manual Endocrinology test performed in the laboratory at least twice annually in 2021. Findings are as follows: 1. The laboratory performed serum hCG testing using the Sekisui OSOM hCG Combo Test as as indicated by the laboratory test menu provided by the Technical Supervisor (TS) prior to survey and confirmed by the TS during a tour of the laboratory at 8:10 a.m. on 04/26/23. 2. The Laboratory performed proficiency testing using the American Proficiency Institute (API) proficiency testing provider in 2021. 3. Twice annual serum hCG accuracy verifications documentation for the Sekisui OSOM hCG Combo Test was not found for 2021 during review of API documents and laboratory records. The laboratory was unable to provide the missing accuracy verification documentation upon request. 4. In an interview at 4:00 p.m. on 04/26/23, the TS confirmed the above finding. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to follow their proficiency testing (PT) written procedure in 2023. Findings are as follows: 1. The laboratory performed serum hCG testing using the Abbott Architect ci4100 analyzer and the Sekisui OSOM hCG Combo Test as as indicated in the laboratory test menu provided by the Technical Supervisor (TS) prior to survey and confirmed by the TS during a tour of the laboratory at 8:10 a.m. on 04/26/23. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. The laboratory was enrolled in serum hCG PT on the Architect ci4100 in the Chemistry Core package and used the serum hCG Verification package for the OSOM hCG Combo Test in 2023 3. The Proficiency Testing Policy found in the electronic procedure software PolicyStat indicated the laboratory must follow all PT instructions. 4. The API instructions for the 2023 Chemistry - Core 1st event directed the laboratory to wait until after the Chemistry Core event submission deadline on 02 /01/23 had passed before testing the serum hCG verification samples. 5. Architect ci4100 printed results dated 01/19/23 for serum hCG Chemistry - Core 1st event PT samples HCG-01 through HCG-05 were found in the API 3 ring binder. 6. The API Serum HCG Quantitative result form included the serum hCG results obtained on the Architect ci4100 handwritten in the designated text boxes. 7. Electronic medical record system HCG Serum QU labels generated on 01/19/23 for serum hCG verification samples HCG-01 through HCG-05 were found at the bottom of the API Serum HCG Quantitative result form. Each EMR label had a handwritten result of positive or negative. 8. In an interview at 10:55 a.m. on 04/26/23, the TS 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 failed to investigate an unacceptable Chemistry proficiency testing (PT) result for 1 analyte in 2021. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 10:05 a.m. on 05/12/21. 2. The laboratory performed PT using the American Proficiency Institute (API) program. 3. The laboratory received an unacceptable total carbon dioxide (tco2) PT result for 1 of 5 tco2 PT challenges completed in 2021. See below. API 2021 Chemistry / Core 1st event Sample Test IB-04 tco2 4. Investigation of unacceptable PT results was required as established in the Proficiency Testing Policy located in the on-line policy and procedure manual. 5. An investigation of the unacceptable PT result was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 6. In an interview at 12:45 p.m., on 05/12/21, the GS 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 one 2019 proficiency testing (PT) result when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 10:05 a.m. on 05/12/21. 2. The laboratory performed PT using the American Proficiency Institute (API) program. 3. One urine culture minimum inhibitory concentration (MIC), for a total of 16 antibiotics, from the third 2019 Microbiology PT event was not graded by API due to lack of consensus. See below. Sample ID Analyte UR-11 Urine culture MIC 4. Investigation of non-graded PT results was required as established in the Proficiency Testing Policy located in the on-line policy and procedure manual. 5. 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 analyte was not present in laboratory records. Evaluation of the non-graded result was not found in laboratory records. 6. In an interview at 12:45 p.m., on 05/12/21, the GS confirmed the above finding. . D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (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 evaluate the relationship between test results obtained from the Hematology analyzer and a manual testing method at least twice annually. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 10:05 a.m. on 05/12/21. 2. A Beckman Coulter DxH hematology analyzer was observed as present and available for use during the tour. The GS indicated the laboratory performed and reported automated and manual White Blood Cell differential testing. 3. The Beckman Coulter DxH procedure located in the on-line policy and procedure manual did not include a requirement to compare automated and manual differential testing twice annually. Twice annual comparisons of these test methods was not found in laboratory records. The laboratory was unable to provide comparison records upon request. 4. In an interview at 09:15 a.m., on 05/13/21, the GS confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to enroll in an HHS approved proficiency testing program as required under 493. 801 for testing performed under the subspecialty of Hematology. Findings are as follows: The laboratory failed to enroll in an HHS approved proficiency testing program for Blood Cell Identification. Failure to enroll in an HHS approved proficiency program as required under 493.801 constitutes Condition level non- compliance. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- failed to ensure microscopic examination proficiency testing (PT) was performed consistent with the number of times the laboratory routinely tested patient samples. Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 04/25/19. 2. The laboratory performed PT using the American Proficiency Institute (API) proficiency testing provider. 3. Microscopic examination PT for Gram Stain and Morphology from the API 2018 Microbiology 3rd event was completed by the GS, Testing Personnel 2, Testing Personnel 3 and a former employee as indicated on hand written result documents. 4. In an interview at 10:50 a.m. on 04/25/19, the GS confirmed the PT had been performed by multiple testing personnel prior to the submission date and patient specimens would not routinely be handled in this manner. 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 all Hematology calibration records for at least 2 years. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 04/25/19. 2. A Beckman Coulter Unicel DxH 600 hematology analyzer was observed as present and available for use during the tour of the laboratory. 3. Calibration verification was required every 6 months as established in the Performing Complete Blood Count with WBC Differential (and Parameters) on the Unicel DxH 600 Coulter Cellular Analysis System procedure located in the Lab Policies manual. 4. Each calibration document from the 06/12/18 was not retained and comprehensive calibration records were not retrievable from the analyzer software on date of survey. 5. In an interview at 2:10 p.m. on 04/25/19, the GS confirmed the above finding and indicated the CBC Calibration Summary Report from 06/12/18 was the only document available. 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 investigate an unacceptable Hematology proficiency testing (PT) result for 1 analyte in 2017. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 04/25/19. 2. The laboratory performed PT through the American Proficiency Institute (API) program. 3. The laboratory received unacceptable PT result in the API 2017 Hematology/Coagulation 2nd event for the analyte listed below. Sample Test Lab result API range COU-07 Mono* 6.2 6.4-10.0 4. Investigation of unacceptable results was required as established in the Proficiency -- 2 of 6 -- Testing Policy located in the Lab Policies manual. 5. An investigation of the unacceptable PT results was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 6. In an interview on at 10:50 a.m. on 04/25/19, the GS confirmed a documented investigation of the unacceptable result was not performed. * Note Mono - Monocytes D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)