Barrett Hospital & Healthcare Laboratory

Summary Statement of Deficiencies D0000 The Montana CLIA Program conducted an announced CLIA recertification survey, completed on December 10, 2025. The laboratory was found out of compliance with the following conditions: 42 CFR 493.1217 Condition: Immunohematology. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the Immunohematology procedures, laboratory records, manufacturer's instructions, and interview with the Technical Supervisor (TS) #1, the laboratory failed to ensure the requirements for the specialty of Immunohematology. Findings: 1.The laboratory failed to establish two of two procedures. (Refer to D5401) 2. The laboratory failed to have written procedures for Immunohematology ORTHO Vision Swift quality control. (Refer to D5403) 3. The laboratory failed to document the quality control's antibody and antigen reactivity performed on the ORTHO Vision Swift analyzer. (Refer to D5551) 4. The laboratory failed to perform visual inspection of stored red blood cells. (Refer to D5553) D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory procedures and an interview with Technical Supervisor (TS) #1, the laboratory failed to establish two of two procedures to detect ABO discrepancies and weak D testing. Findings: 1. On 12/10/25 at 1:15 PM, TS #1 confirmed the laboratory performed ABO and weak D testing using the ORTHO Vision Swift analyzer. 2. A review of the laboratory's written procedure revealed no procedures for the following: a. To detect and resolve ABO discrepancies b. When to perform weak D testing. 3. An interview with TS #1 on December 10, 2025, at 1:20 PM confirmed the laboratory did not have a procedure to detect and resolve ABO discrepancies or weak D testing. 4. A review of the laboratory's test volume sheet revealed 423 ABO group, and Rh tests were performed on patient specimens from December 9, 2024 to December 9, 2025 (12 months). 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 returned blood and blood products not used for transfusion from January 1, 2020 to February 2, 2022 Findings: 1. Review of Immunohematology records lacked documentation of temperatures for blood and blood products upon receipt of new shipments and for unused blood or blood products returned to the laboratory from January 1, 2020 to February 2, 2022. 2. Review of Receiving, Sending, and Retesting Blood Products procedure lacks temperature requirements for acceptance of blood and and blood products. 3. Review of Emergency Release of Blood procedure revealed "3(a)(ii). The blood must not have been allowed to warm above 10 degrees C or cool below 1 degree C during storage or transport." 3. Interview with TS #1 on February 2, 2022 at 1:00 PM, confirmed the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood and blood products and returned blood or blood products not used for transfusion from January 1, 2020 to February 2, 2022 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, 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 -- 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)

Summary Statement of Deficiencies D0000 Based on an off-site proficiency testing desk review condcuted on 11/15/2020, deficiencies were cited for Barrett Hospital and Healthcare in Dillon 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 routine desk audit of CMS-153 and 155 reports of proficiency testing performance and interview, the laboratory failed to achieve satisfactory performance for Lactic Acid Dehydrogenase (LDH), Total (2020 Event 2, and 2020 Event 3), resulting in unsuccessful proficiency testing performance. D2096 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test 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 scores and interview, the laboratory failed to achieve a score of 80 percent for LDH, Total in 2 of 3 events (2020 Event 2, and 2020 Event 3), resulting in unsuccessful proficiency testing performance. The findings include: 1. Review of CMS-153 Unsuccessful Proficiency Testing Report on 11/16/20 at 9:10 a.m., which included Barrett Hospital and Healthcare in Dillon, with unsuccessful proficiency testing scores for LDH, total. 2. Review of the CMS-155 report on 11/16/20 at 10:50 a.m., revealed the American Proficiency Institute (API) LDH, Total scores for 2020 Event 2 and Event 3 were 0%. 5. The laboratory manager confirmed on 12/01/20 at 8:25a.m., unsuccessful results due to human error with the reporting selection in API. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 11/5/19, deficiencies were cited for Barrett Hospital & Healthcare in Dillon, MT. 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, record review, and interview, the laboratory failed to verify the accuracy of the lactoferrin test twice annually from 1/1/19 through 11/5/19. The findings include: 1. On 11/5/19 at 11:30 a.m., a Leuko EZ test kit for lactoferrin was observed in the laboratory. 2. A review on 11/5/19 at 12:00 p.m. of the American Proficiency Institute proficiency testing binders lacked proficiency testing for the lactoferrin test performed on the Leuko EZ test kit. 3. A review on 11/5/19 at 12:09 p. m. of the API Order History information lacked enrollment for lactoferrin. 4. On 11/5 /19 at 12:09 p.m., staff member A stated the laboratory began using the Leuko EZ test kit in January of 2019 but did not have proficiency testing enrollment. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. 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 record review and interview, the laboratory technical supervisor failed to perform and document competency on four of thirteen testing personnel on the blood gas analyzer. The findings include: 1. On 11/5/19 at 12:09 p.m., staff member A stated the blood gas analyzer was located in the respiratory therapy department outside of the laboratory. The blood gas analyzer was operated by the respiratory staff. 2. A review on 11/5/19 at 12:30 p.m. of the laboratory competency documentation lacked competency assessments for staff members B, C, D, and E. 3. On 11/5/19 at 4:00 p.m., staff member A stated the respiratory staff did not have competency documented on the blood gas analyzer. -- 2 of 2 --