Stillwater Billings Clinic

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Stillwater Billings Clinic on August 20, 2025, by the Montana CLIA Program. The laboratory was evaluated for compliance with the CLIA requirements under 42 CFR Part 493. Specific deficiencies were identified during the survey. 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 a review of proficiency testing (PT) records from the American Proficiency Institute (API) and an interview with the technical supervisor (TS) #1, the laboratory failed to perform one of the two required biannual verifications in 2023 and did not perform any biannual verifications from January 1, 2024, through August 20, 2025, for urine protein confirmation using Exton's reagent test. Findings: 1. A review of API PT records for urine protein confirmation using Exton's reagent test revealed that the laboratory failed to perform one of the two required biannual verifications in 2023 and did not perform any biannual verifications from January 1, 2024, through August 20, 2025. 2. An interview conducted on August 20, 2025, at 10:30 AM with TS #1 confirmed that the laboratory failed to perform one of the two required biannual verifications in 2023 and did not perform any biannual verifications from January 1, 2024, through August 20, 2025, for urine protein confirmation using Exton's reagent test. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 a review of records, laboratory policies and procedures, and an interview with Technical Supervisor (TS) #1, the laboratory failed to establish a policy and procedure for the review of historical blood bank patient data to determine previously identified antibodies and other serological anomalies, and a policy and procedure for the verification of performance specifications for new analytes, methods, or instruments from August 20, 2023, to August 20, 2025. Findings: 1. The laboratory lacked a policy and procedure for the review of historical blood bank patient data to determine previously identified antibodies and other serological anomalies. 2. The laboratory lacked a policy and procedure for the verification of performance specifications for new analytes, methods, or instruments. 3. An interview with TS #1 on August 20, 2025, at 1:00 PM confirmed that the laboratory did not have a policy and procedure for the review of historical blood bank patient data to determine previously identified antibodies and other serological anomalies or for the verification of performance specifications for new analytes, methods, or instruments from August 20, 2023, to August 20, 2025. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on review of Immunohematology records, policy and procedure, and interview with Technical Supervisor (TS) #1, the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood and blood products and unused blood or blood products returned to the laboratory for years 2020 and 2021. Findings: 1. Review of Immunohematology records lacked documentation of temperatures of blood and blood products upon receipt of new shipments and unused blood or blood products returned to the laboratory for years 2020 and 2021. 2. No procedure for receipt of incoming blood products was available for review. 3. Review of Policy and Procedure Lab-158, Criteria for Return of Unused Blood lacks temperature requirements for acceptance of blood or blood products not used for transfusion. 4. Interview with TS #1 on January 12, 2022 at 12:00 PM, confirmed the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood and blood products and of unused blood or blood products returned to the laboratory for years 2020 and 2021. 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 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 -- examining specimens. This STANDARD is not met as evidenced by: Based on Immunohematology's record review, policy and procedures, and interview with Technical Supervisor (TS) #1, the laboratory failed to ensure written procedures were followed for documenting the return of unused blood product and/or samples of each unit of transfused blood. Findings: 1. Review of Policy and Procedure Lab-158, Criteria for Return of Unused Blood states "2. Indicate on the Transfusion Service Record that the blood was returned and note the time." 2. Review of Transfusion Service Record lacked documentation of returned samples for each unit of transfused blood for blood products issued 3/9/2020, 7/27/2020, 7/28/2020, 8/25/2020, 9/28 /2020, 3/31/2021, and 4/7/2021. 3. Interview with TS #1 on January 12, 2022 at 12:15 PM, confirmed the laboratory failed to ensure written procedures were followed for documenting the return of unused blood product and/or samples of each unit of transfused blood. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of