Logan Health Primary Care Eureka

Summary Statement of Deficiencies D0000 The Montana CLIA Program conducted an announced CLIA recertification survey on October 22, 2025. 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 deficiency was identified during the survey. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observation, review of policy and procedure, and an interview with the Technical Consultant (TC) #1, the laboratory failed to follow its written policy to ensure positive identification of one of one patient's urine specimens at the time of collection on October 22, 2025. Findings: 1. On October 22, 2025, at 11:56 AM, one unlabeled urine specimen was observed in a blue bucket in one of the two laboratory testing areas. 2. A review of Policy POC 15: Labeling Specimen Tubes/Containers revealed that the laboratory did not follow its written policy requiring specimens to be labeled at the time of collection to ensure accurate identification. 3. An interview with the TC#1 on October 22, 2025, at 12:00 PM, confirmed the laboratory failed to follow its written policy to ensure positive identification of one of one patient's urine specimens at the time of collection on October 22, 2025. 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 D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) records, laboratory policies, and an interview with one of seventeen testing personnel (TP #1), the laboratory failed to perform two levels of external quality controls at the frequency and type as dictated by their policies for Troponin and CHEM 8+ cartridges performed on the Abbott i- STAT from January 1, 2022, to October 4, 2023. Findings: 1. A review of patient results reports dated 06/03/2022, 09/02/2022, and 06/12/2023 for CHEM 8+ (sodium, potassium, chloride, ionized calcium, total carbon dioxide, glucose, urea nitrogen (BUN), creatinine, hematocrit and anion gap) and for Troponin dated 06/06/2022, 09 /02/2022 and 06/12/2023 revealed no external QC was performed. 2. A review of QC records revealed the laboratory failed to perform Troponin external QC for six out of 12 months for year 2022; and failed to perform CHEM 8+ external QC for five out of 12 months for the year 2022. 3. A review of Policy No. POC. 144 revealed the laboratory failed to follow its policy to perform "Troponin and beta-hCG cartridges require two different levels of QC (low, mid or high) run monthly" and "Chem 8+ cartridge requires two levels of liquid QC (low, mid and high) run monthly." 4. A review of QC records revealed the laboratory failed to follow their procedures and perform the manufacturer's external liquid QC as dictated by their Policy No. POC. 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 -- 144 for materials used, "i-STAT controls storage and type specific to each cartridge type." for the month of June for years 2022 and 2023. 5. An interview with the TP #1 on October 4, 2023, at 11:45 AM confirmed the laboratory failed to perform two levels of external QC for the Abbott i-STAT Troponin and CHEM 8+ cartridges at the frequency and type dictated by their policies from January 1, 2022, to October 4, 2023. D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on a review of quality control (QC) records, calibration verification records, policies, and an interview with one of seventeen testing personnel (TP #1), the laboratory failed to use a different calibration verification lot number as external control than the lot number used to calibrate their i-STAT instruments for each month of June for years 2022 and 2023. Findings: 1. A review of QC records revealed the laboratory used calibration material lot# 22059 as external QC for Abbott i-STAT cartridges Troponin and CHEM 8+ (sodium, potassium, chloride, ionized calcium, total carbon dioxide, glucose, urea nitrogen (BUN), creatinine, hematocrit and anion gap) for the month of June for years 2022 and 2023. (Cross Refer D5445) 2. A review of the calibration verification records for the Abbott i-STAT revealed the calibration material's lot #22059 was used to perform the calibration in June of 2022 and June of 2023. 3. Interview with TP#1 on October 4, 2023, at 12:00PM, confirmed the (one of two) technical consultant (TC #2) used the calibration verification lot #22059 as the external quality control for the month of June for years 2022 and 2023. D5783

Summary Statement of Deficiencies 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 review of American Proficiency Institute (API) records, laboratory policy and interview with Testing Personnel (TP #1), the laboratory failed to review and evaluate the results obtained on proficiency testing performed for years 2020 and 2021. Findings: 1. Review of Quality Management Policy, Point of Care revealed, "7) Review- a) Clinics maintain QC records in a well-organized system that permits regular review by appropriate personnel such Medical Director or Designee." 2. API's Performance Review and Correction Action sheet states, "After reviewing the evaluation reports, complete the information below and retain this form along with enclosed reports for your records." Includes a "Reviewed by" signature line for the Lab Director or designee and date. 3. API's Performance Review and Correction Action sheets lacked documentation of review by the laboratory director for 2020 Immunology/Immunohematology, 2020 Microbiology, 2020 Hematology /Coagulation, 2020 Chemistry - Miscellaneous, 2020 Chemistry Core, 2021 Immunology/Immunohematology, 2021 Microbiology, 2021 Hematology /Coagulation, 2021 Chemistry - Miscellaneous, and 2021 Chemistry Core 4. Interview with TP #1 on October 20, 2021 at 2:00 PM, confirmed the laboratory failed to review and evaluate the results obtained on proficiency testing performed for years 2020 and 2021. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies 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 -- instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on record review and interview with Testing Personnel (TP) #1, the laboratory failed to perform instrument comparison for two out of two Abbott iSTAT analyzers performing cardiac troponin with the cTnI cartridge twice a year for 2020 and 2021. Findings: 1. Review of laboratory instrument comparison documentation showed the laboratory failed to perform and document comparison studies between the two Abbott iSTAT analyzers for analyte troponin for 2020 and 2021. 2. Interview with TP #1 on October 20, 2021 at 11:15 AM confirmed the laboratory failed to perform twice a year instrument comparison for two of two Abbott iSTAT analyzers for 2020 and 2021. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Consultant (TC) #1, the laboratory allowed unqualified testing personnel without an applicable state license to perform moderate complexity testing performed on the Abbott i-STAT from 2/28 /2020 to 10/02/2021. Findings: 1. A review on October 20, 2021 of the CMS-209 form filled out by the laboratory included 1 out of 18 testing personnel (TP) #18 listed as testing personnel. A review of the credentials lacked an applicable state license. 2. A review of 2020 and 2021 competency evaluations included TP#18 assessed as competent on the moderate complexity i-STAT analyzer for the CHEM 8+ cartridge for analytes sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, total carbon dioxide. 3. Interview with TC #1 on October 20, 2021 at 1:40 PM confirmed TP #18 performed and reported patent results for Abbott i-STAT between 2/28/2020 to 10/20/2021. 4. Interview with TP#1 on October 20, 2021 at 1:41 PM confirmed TP #18 lacked an applicable state license and was unqualified to perform moderate complexity testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 5/21/19, deficiencies were cited for Eureka Healthcare Primary Care in Eureka, 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 perform twice a year accuracy verification for wet mounts and potassium hydroxide (KOH) tests from 9/14/17 to 5/21/19. The findings include: 1. On 5/21/19 at 10:00 a.m. a microscope was observed in a cupboard in the laboratory. 2. A review on 5/21/19 at 10:30 a.m. of the College of American Pathologists (CAP) proficiency testing documentation lacked proficiency testing enrollment for wet mounts and KOH. 3. On 5/21/19 at 10:30 a.m., staff member A stated the laboratory did not have proficiency testing enrollment and had not performed accuracy verification for wet mounts and KOH. 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 examining specimens. This STANDARD is not met as evidenced 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 2 -- Based on observation, record review, and interview, the laboratory failed to perform quality control (QC) with the frequency stated in the laboratory procedure from 4/21 /18 to 5/8/19. The findings include: 1. On 5/21/19 at 10:00 a.m. a Coaguchek XS Pro analyzer was observed in the laboratory. 2. A review on 5/21/19 at 12:20 p.m. of the Coaguchek Result Summary list of QC results lacked monthly controls performed on the Coaguchek XS Pro between 4/21/18 and 5/8/19. 3. A review on 5/21/19 at 12:45 p. m. of the Coaguchek XS Pro/Plus Protime/INR Patient Testing Policy stated "two levels of liquid controls (low and high) are performed monthly, with each new shipment and/or lot number of strips. Whichever is more frequent." 4. On 5/21/19 at 12:45 p.m., staff member A stated the control data was not uploaded electronically due to a firewall and was deleted off the analyzer during a system upgrade. Printed copies were not available. 5. A review on 5/21/19 at 1:00 p.m. of the monthly reminder list for April 2019 checked the Coaguchek monthly controls as completed on 4/18/19. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform competency assessments for one of seventeen testing personnel in 2017, 2018, and 2019. The findings include: 1. A review on 5/21/19 at 11:15 a.m. of the competency assessments lacked competency assessments for staff member B. 2. On 5/21/19 at 11:45 a.m., staff member A stated staff member B had not completed competency assessments. -- 2 of 2 --