Nemhs Trinity Hospital Lab

Summary Statement of Deficiencies D0000 The Montana CLIA Program conducted a recertification survey ending on June 18, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA regulations and was found to be in compliance with condition-level CLIA requirements. However, the following standard-level deficiencies were identified during the survey. 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on a microbiology record review and interview with Technical Supervisor (TS1), the laboratory failed to retain two years of patients' BD BACTEC blood culture test records from June 17, 2024 to May 5, 2026. Findings: 1. A review of patient result reports (25 065 0430 dated March 6, 2025, and 25 055 6113 dated February 24, 2025) and related microbiology records showed that no BD BACTEC FX blood culture patient test records had been retained. 2. An interview with TS1 on June 17, 2026, at 4:30 PM confirmed the BD BACTEC FX only retained patients records through May 5, 2026, and that earlier records had not been retained. 3. A review of the test volume sheet revealed 903 patient blood cultures were performed between June 17, 2025, to June 17, 2026 (12 months). 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 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 -- 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 microbiology record review and interview with Technical Supervisor (TS1), the laboratory failed to follow its procedure to report positive BD BBL Taxo P Disc test results as presumptive or perform a definitive identification test for Streptococcus pneumoniae for 11 of 12 patients' blood cultures tested from January 1, 2024, to June 18, 2026. Findings: 1. A review of patient result report (25 065 0430) showed the final report was issued as "Streptococcus pneumoniae isolated". A review of the patient's microbiology test records confirmed a positive BD BBL Taxo P Disc test was performed and no additional definitive identification test for Streptococcus pneumoniae was performed. 2. A review of the laboratory's procedure "Staff Micro - Presumptive Identification of S. Pneumoniae Using The BD P Disk" states "BD BBL Taxo P Disc tests are presumptive" and "Positive results should be followed with more specific tests". The laboratory did not follow the procedure when reporting positive P Disc results. 3. An interview with TS1 on June 18, 2026, at 8:00 AM confirmed the laboratory did not follow its procedure and reported 11 of 12 patient blood cultures definitively as Streptococcus pneumoniae based solely on the presumptive P Disc test result from January 1, 2024, to June 18, 2026. -- 2 of 2 --

Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation, instrument manual, and interview with the technical supervisor (TS) #1, the laboratory failed to provide sufficient workbench space for the microbiology laboratory to prevent unsafe use of one Nuaire Biological Safety Cabinet Class II (BSL II hood) from October 30, 2022, to October 30, 2024. Findings: 1. Observed on October 30, 2024, at 8:40 AM, one BSL II hood in the microbiology laboratory. The BSL II hood's front grill was covered with paperwork, specimens, and stacks of media plates in use, and the back grill was blocked by new media plates, an incinerator, and supplies. No available counter space next to the hood was available for use. 2. A review of the BSL II hood manual revealed the laboratory failed to use the BSL II hood as instructed for its intended purpose (1.2 Safety Instructions) and minimize the number of items placed in the cabinet, prevent placing items on the front grill, and prevent blocking the rear grill (6.2 Operating Guidelines). 3. An interview on October 30, 2024, at 8:45 AM with the TS#1 confirmed the BSL II hood was being used as an extra workbench when not in use and had no other counter space available to allow items in the hood to be stored elsewhere from October 30, 2022 to October 20, 2024. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 9/10/18-9/12/18, deficiencies were cited for Trinity Hospital Lab in Wolf Point, MT. 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 record review and interview, the laboratory director failed to sign 6 proficiency testing attestation statements between 1/1/17 and 9/10/18. The findings include: 1. A review on 9/10/18 at 4:45 p.m. of the American Proficiency Institute (API) binders from 2017 and 2018 lacked the laboratory director's signature on 6 attestations. a. 2017 event 2-miscellaneous chemistry. b. 2017 event 2-microbiology. c. 2017 event 3-hematology/coagulation. d. 2017 event 3- immunology /immunohematology. e. 2018 event 1-chemistry core. f. 2018 event 1-hematology /coagulation. 2. On 9/10/18 at 4:45 p.m., staff member A stated the API binder is to be signed by the laboratory director each site visit. A sticky note is placed on each page to be signed before the laboratory director visit. 3. A review on 9/10/18 at 5:00 p.m. of the API binders included unsigned attestations without a sticky note on the page. 4. A review on 9/11/18 at 8:46 a.m. of the General Lab-Proficiency Testing policy in PolicyStat included instructions that "during the Laboratory Medical Director's visit, all attestation sheets for submitted and completed Proficiency Surveys will be signed by the Laboratory Medical Director." D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- 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, record review, and interview, the laboratory failed to retain Pentra 400 calibration data from 9/11/16-9/10/18, failed to retain the previous mean of the patient normal range for one of two lots of RecombiPlasTin 2G, and quality control data on chocolate agar from 2/1/18 through 9/10/18. The findings include: 1) ABX Pentra 400 Calibration Data. a. On 9/10/18 at 3:00 p.m., an ABX Pentra 400 analyzer was observed in the laboratory. b. On 9/10/18 at 3:00 p.m., staff member A stated the Pentra 400 is used for high sensitivity C-reactive protein (hsCRP), rheumatoid factor, urine creatinine, and vancomycin. c. A review on 9/11/18 at 2:07 p. m. of the Pentra binders lacked calibration data for any of the Pentra 400 tests. d. On 9 /11/18 at 2:07 p.m., staff member A stated the calibrations were not printed and could not get the data off the analyzer. 2) Mean of the Patient Normal Range. a. On 9/10/18 at 3:00 p.m., a Stago ACL Elite coagulation analyzer was observed in the laboratory. b. A review on 9/11/18 at 2:56 p.m., of the coagulation binders lacked the calculation of the mean of the patient normal range for the previous lot number of RecombiPlasTin 2G reagent (N0378719) used approximately 8/2017-9/2018. A current mean of 11.4 seconds for the current lot number of RecombiPlasTin (N0285578) was the only calculation of the mean of the patient normal range located. c. On 9/11/18 at 3:15 p.m., staff member stated the old patient mean data was not found. 3) Chocolate Agar Quality Control Records. a. On 9/11/18 at 4:12 p.m., Remel chocolate agar plates were observed in the microbiology refrigerator. b. A review on 9 /11/18 at 4:38 p.m. of the microbiology binder containing weekly quality control results lacked documentation of sterility, growth, and plate condition for new lots of chocolate media received after 1/30/18. c. On 9/11/18 at 4:55 p.m., staff member A stated the sterility and growth for chocolate agar should be documented in the computer program Kapios but the testing personnel have not entered any data for media into the Kapios program. d. On 9/11/18 at 4:55 p.m., staff member B stated growth and sterility are completed weekly on chocolate agar but are not documented anywhere at this time. 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 fetal fibronectin from 1/1/17 through 9/10/18. The findings include: 1. On 9/10/18 at 3:00 p.m. a Hologic TLi analyzer was observed in the laboratory. 2. On 9/10 /18 at 3:00 p.m., staff member stated fetal fibronectin was performed on the TLi analyzer. 3. A review on 9/10/18 at 4:25 p.m. of the 2017 and 2018 American Proficiency Institute (API) binders lacked documentation for fetal fibronectin. 4. On 9 /10/18 at 4:25 p.m., staff member A stated the enrollment was missed in 2018. 5. A review on 9/10/18 at 4:50 p.m. of the API 2018 Renewal Order Form lacked enrollment for fetal fibronectin. -- 2 of 13 -- D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to follow written procedures (see D5401), verify the reportable range of new analytes (see D5421), document biochemical quality controls (see D5471), document media physical characteristics resulting in a repeat deficiency (see D5477), properly store blood products (see D5555), compare test results (see D5775), and document