Bigfork Valley Laboratory - Northome

Summary Statement of Deficiencies D0000 The Bigfork Valley Laboratory - Northome 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 July 16, 2026. The following standard-level deficiencies were cited: 493.1236 Evaluation of proficiency testing performance . 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 one unacceptable Hematology proficiency testing (PT) result out of fifteen challenges completed in 2024. 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 1:05 p.m. on 07/16/26. 2. The laboratory performed PT using the American Proficiency Institute (API) proficiency testing provider. 3. The laboratory received one unacceptable Lymphocyte (LYM) PT result of fifteen testing challenges completed in 2024 as indicated in the API 2024 Hematology 3rd Event Comparative Evaluation report. See below. 2024 - 3rd Hematology Event Test: LYM Sample: HSY-14 Laboratory result: 18.1 API expected result: 18.6-23.0 4. Unsatisfactory PT result investigation was required as established in the laboratory's Proficiency Testing procedure found in the Northome Lab Manual. 5. Investigation documentation for the unacceptable LYM score was not found during review of laboratory PT records. The laboratory was unable to provide investigation and

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 document review and interview with laboratory personnel, the laboratory failed to retain quality control and maintenance documents for a retired Hematology analyzer. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 07/19 /18 at 10:05 a..m. 2. A Sysmex KX-21N hematology analyzer was used in the laboratory until 12/01/16. 3. The discontinued Sysmex KX-21N procedure indicated three levels of quality control (QC) were performed each day of patient testing. The procedure also indicated maintenance was required daily, weekly, monthly, and quarterly. 4. QC and maintenance records for the time period of October - November 2016 were not present in laboratory documents on date of survey. The laboratory was unable to provide the missing records upon request. 5. The laboratory was given an opportunity to locate the missing QC and maintenance records and provide them to the surveyor within 7 days of the survey. 6. In an email message received on 07/24/18 at 1:12 p.m., the TC indicated the missing Sysmex KX-21N QC and maintenance records could not be located. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. 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 retain proficiency testing (PT) records for at least 2 years. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 07/19/18 at 10:05 a..m. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. The API PT result documents for the 3rd Hematology event of 2016 were not present in laboratory records on date of survey. The laboratory was unable to provide these documents upon request. 4. The laboratory was given an opportunity to locate the missing original result documents and provide them to the surveyor within 7 days of the survey. 5. In an email message received on 07/25/18 at 3:02 p.m., The TC indicated the original result documents for the 2016 Hematology 3rd PT event could not be located. -- 2 of 2 --