Centracare - Monticello Hospital

Summary Statement of Deficiencies 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 a review of Center for Medicare and Medicaid Services reports and American Proficiency Institute (API) proficiency testing reports, the laboratory failed to successfully participate in proficiency testing (PT) under the subspecialty of ABO /RHO. Findings include: 1. The CASPER Report 0155D, reviewed on October 13, 2022, indicated the the laboratory failed to successfully participate in ABO/RHO PT in 2021 and 2022. Findings are as follows: D2153 - the laboratory failed to obtain a PT score of at least 100 percent for ABO Type testing D2154 - the laboratory failed to obtain an overall testing event score of at least 100 percent for the ABO/RHO Subspecialty D2162 - the laboratory failed to achieve satisfactory analyte 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 3 -- performance for ABO Type testing in two out of three consecutive events D2163 - the laboratory failed to achieve satisfactory performance for the ABO/RHO Subspecialty in two out of three consecutive events . D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to obtain a PT score of at least 100 percent for ABO Type testing which resulted in unsatisfactory performance for the analyte. Unsatisfactory PT performance of ABO Type testing was obtained in the following events. - 2021 3rd event 90% - 2022 2nd event 0% . D2154 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(b) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to obtain a PT score of at least 100 percent for the ABO/RHO Subspecialty which resulted in overall unsatisfactory performance in the Subspecialty. Overall unsatisfactory PT performance for the ABO/RHO Subspecialty was obtained in the following API events: - 2021 3rd event 80% - 2022 2nd event 0% . D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte in 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 review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory analyte PT performance for ABO Type testing in two out of three consecutive testing events which led to unsuccessful performance for the analyte. API results indicated the laboratory had unsatisfactory performance for ABO Type testing in two out of three consecutive events leading to unsuccessful performance for the analyte. Unsatisfactory PT performance of ABO Type testing was obtained in the following events. - 2021 3rd event 90% - 2022 2nd event 0% . D2163 ABO GROUP AND D(RHO) TYPING -- 2 of 3 -- CFR(s): 493.859(g) 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 review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for the ABO /RHO Subspecialty in two out of three consecutive testing events which led to unsuccessful PT performance in the Subspecialty. API reports indicated the laboratory had unsatisfactory performance for the ABO/RHO Subspecialty in two out of three consecutive events leading to unsuccessful PT performance for Subspecialty. Unsatisfactory PT performance for the ABO/RHO Subspecialty was obtained in the following API events. - 2021 3rd event 80% - 2022 2nd event 0% . -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Laboratory Director (LD) failed to attest to the integration of proficiency testing samples into the routine patient workload on three of six occasions reviewed from 2022. Findings are as follows: 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:15 a.m. on 08/03/22. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) PT provider. 3. The LD's signature was required on the attestation statements for all PT events as indicated in the Proficiency Testing Process procedure found in the electronic procedures General Folder. 4. The Laboratory Director failed to sign the attestation statement for three of six API PT events reviewed in the January 2022 through June 2022 timeframe. See below. Event Specialty missing attestation 2022-1 Microbiology 2022-1 Chemistry (miscellaneous) 2022-1 Immunohematology 5. In an interview at 11:30 a.m. on 08/03/22, the GS confirmed the above finding. . D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. 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 -- 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 non-graded proficiency testing (PT) results from a regulated Specialty when the PT program did not evaluate or score the results in one of six events reviewed from 2022. Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:15 a.m. on 08/03/22. 2. The laboratory performed PT using the American Proficiency Institute (API) PT provider. 3. Evaluation of non- graded PT results was required as indicated in the Proficiency Testing Process procedure found in the electronic procedures General Folder. 4. The following PT results from the 2022 Microbiology first event were not graded by API: CSF Culture MIC/Zone Diameter Value Sample SF-01 for 9 antibiotics API instructed to See Data Summary Gram Stain Sample GS-05 API instructed to See Data Summary Urine Culture MIC/Zone Diameter Value Sample UR-06 for 12 antibiotics API instructed to See Data Summary 5. The API Data Summary for the 2022 Microbiology first event was not present in laboratory records. An evaluation of the non-graded results was not found in laboratory records. 6. The laboratory was unable to provide an evaluation of the non-graded results upon request. 7. In an interview at 11:30 a.m. on 08/03/22, the GS confirmed the above finding. . D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (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 comprehensive initial training for four of four new testing personnel was performed and documented in 2022. Findings are as follows: 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:15 a.m. on 08/03/22. 2. The following non- waived analyzers, systems, and test kits were present and available for use during the tour: Biomerieux BacT/Alert microbial detection system Radiometer ABL 80 - blood gas analyzer Abbott Architect - chemistry analyzer Abbott i-STAT analyzer (back-up) Biomerieux Vidas - chemistry analyzer MedTox Diagnostics MedToxScan - chemistry analyzer Hologic TliQ - chemistry analyzer Werfen ACL TOP - coagulation analyzer Sysmex XT-4000i - hematology analyzer Sysmex XP-300 hematology analyzer (back-up) Polymedco Sedimat 13 hematology analyzer Bio-Rad gel cards, IH incubator, IH centrifuge - immunohematology system Serum hCG, Amnisure ROM test kits Microscopes - manual differential, body fluid count, urine sediment, vaginal wet preparation, KOH preparation, gram stain 3. Competency assessment of new testing personnel was required before testing specimens independently as established in the Laboratory Competency Assessment procedure found in the electronic procedures General Folder. 4. Four new testing personnel (TP) were hired in 2022 in the following timeframes as indicated by the GS at 12:20 p.m. on 08/03/22: TP5 - March 2022 TP6 - May 2022 TP7 - April 2022 TP8 - May 2022 5. Initial training documents for the new TP were not found in laboratory records as -- 2 of 3 -- indicated below. TP5 - TliQ, i-STAT, MedToxScan, Vidas, Architect TP6 - None found TP7 - None found TP8 - Serum hCG, Amnisure, TliQ, body fluid count, vaginal wet preparation, gram stain, BacT/Alert, ABL 80, i-STAT, Architect, Vidas Incomplete initial training documents were found in laboratory records as indicated below. TP5 - Immunohematology TP8 - Manual differential, immunohematology 7. The laboratory was unable to provide the missing training records upon request. 8. In an interview at 12:45 p.m. on 08/03/22, 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 observation, document review, and interview with laboratory personnel, the Technical Consultant failed to assess competency at least semi-annually during the first year of patient specimen testing for one of one testing personnel hired in 2021. Findings are as follows: 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:15 a.m. on 08/03/22. 2. The following non-waived analyzers, test systems, and test kits were present and available for use during the tour: Biomerieux BacT/Alert microbial detection system Radiometer ABL 80 - blood gas analyzer Abbott Architect - chemistry analyzer Abbott i-STAT analyzer (back-up) Biomerieux Vidas - chemistry analyzer MedTox Diagnostics MedToxScan - chemistry analyzer Hologic TliQ - chemistry analyzer Werfen ACL TOP - coagulation analyzer Sysmex XT-4000i - hematology analyzer Sysmex XP-300 hematology analyzer (back-up) Polymedco Sedimat 13 hematology analyzer Bio-Rad gel cards, IH incubator, IH centrifuge - immunohematology system Serum hCG, Amnisure ROM test kits Microscopes - manual differential, body fluid count, urine sediment, vaginal wet preparation, KOH preparation, gram stain 3. Competency assessment of new testing personnel was required six months post-hire as established in the Laboratory Competency Assessment procedure found in the electronic procedures General Folder. 4. Initial training was performed and documented for Testing Personnel 4 (TP4) in October and November 2021 as indicated in personnel records. 5. Semi-annual competency assessment documents for TP4 were not found during review of laboratory records. 6. The laboratory was unable to provide the missing documents upon request. 7. In an interview at 12:45 p.m. on 08 /03/22, the GS confirmed the above finding. . -- 3 of 3 --