Pioneer Medical Center

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on December 1, 2025. At the time of the desk review, it was determined that the laboratory was not in compliance with all conditions required by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 Code of Federal Regulations, Part 493 (42 C.F.R. 493). The following condition level deficiency was cited: 493.803 Condition: Successful participation. 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 a proficiency testing desk review from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) 2025 records, the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Endocrinology and for the analytes Free Thyroxine and Thyroid Stimulating Hormone. Refer to D2107, D2108 D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (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 a proficiency testing desk review of CASPER 0155 report and 2025 American Proficiency Institute (API) proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or better) for two consecutive proficiency testing events in the subspecialty of Endocrinology for the analytes Free Thyroxine (FT4) and Thyroid Stimulating Hormone (TSH). Findings: 1. Review of the CASPER 0155 report revealed the following results: Endocrinology 2025-2nd Event, the laboratory received an unsatisfactory score of 0% for FT4 Endocrinology 2025-3rd Event, the laboratory received an unsatisfactory score of 0% for FT4 Endocrinology 2025-2nd Event, the laboratory received an unsatisfactory score of 0% for TSH Endocrinology 2025-3rd Event, the laboratory received an unsatisfactory score of 0% for TSH 2. A review of the 2025 API Proficiency Testing records confirmed the laboratory received the above results. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) (g) Failure to achieve an overall testing event score of satisfactory performance for 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 a proficiency testing desk review of the CASPER 0155 report and API 2025 records (2nd and 3rd events), the laboratory failed to achieve an overall satisfactory performance (80% or greater) for two consecutive testing events in the subspecialty of Endocrinology. Findings: 1. A review of the CASPER-0155 report revealed the following: Endocrinology 2025-2nd Event The Laboratory received an overall unsatisfactory score of 66% for Endocrinology. Endocrinology 2025-3rd Event. The Laboratory received an overall unsatisfactory score of 66% for Endocrinology. 2. A review of the 2025 proficiency testing records from API confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pioneer Medical Center on September 16, 2025, by the Montana CLIA Program. The laboratory was surveyed under 42 CFR Part 493 CLIA regulations and was found to be in compliance with condition-level 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 review of patient test records, the laboratory's electronic records system, and an interview with Testing Personnel (TP) #1, the laboratory failed to retain two years of patient testing data for 53 out of 69 patients across three out of three testing systems between April 12, 2024, and December 8, 2024. Findings: 1. A review of the patient results report (accession number 24-156-2680) for Troponin I testing performed on June 4, 2024, revealed that the laboratory was unable to produce the associated patient testing records (ISTAT chemistry printout or transcribed data) at the time of the survey. 2. A comparison of the "ISTAT TROPONIN" logs with the laboratory's electronic records for the number of patients tested from 4/12/24 to 6/16 /24 revealed 46 out of 56 patient testing events with no raw data records. 3. A review of the patient test report (accession number 24-234-3517) for H. pylori Ab IgG testing performed on August 21, 2024, revealed that the laboratory was unable to produce the associated patient testing records (transcribed data) for the Consult H. pylori test at the time of the survey. 4. A comparison of the "HPYLORI" logs with the laboratory's electronic records for the number of patients tested from 5/30/24 to 10/18/24 revealed 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 -- two out of six patient transcribed records were not found. 5. A review of the patient test report (accession number 24-287-0816) for Pregnancy Urine (Human Chorionic Gonadotropin, HCG) testing performed on October 13, 2024, revealed that the laboratory was unable to produce the associated patient testing record (transcribed data) for the Osom HCG Combo test at the time of the survey. 6. A comparison of the "HCG" logs with the laboratory's electronic records for the number of patients tested for either urine or serum pregnancy testing from 9/10/24 to 12/08/24 revealed five out of seven patient transcribed records were not found. 7. An interview with TP #1 on September 16, 2025, at 2:17 PM confirmed that the laboratory failed to retain two years of patient testing records for Troponin, H. pylori, and Human Chorionic Gonadotropin (HCG) pregnancy testing for 53 out of 69 patients tested between April 12, 2024, and December 8, 2024. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on a review of patient test records, quality control (QC) logs, the laboratory's electronic records system, and an interview with Testing Personnel (TP) #1, the laboratory failed to provide the quality control records for 29 out of 34 days on which Troponin tests were performed on patient samples between April 12, 2024, and June 16, 2024. Findings: 1. A review of the patient results report (accession number 24-156- 2680) for Troponin I testing performed on June 4, 2024, and the associated testing records revealed that the laboratory lacked documentation of two levels of quality control (Level 1 and Level 3) performed on the ISTAT analyzer for the day of patient testing. 2. A record comparison of the "ISTAT TROPONIN" logs with the laboratory's electronic records system for the period from April 12, 2024, to June 16, 2024, revealed that the laboratory failed to provide documentation of two levels of QC for 29 out of 34 days on which patient testing was performed. The following dates were affected: April 15, 2024; April 16, 2024; April 18, 2024; April 23, 2024; April 24, 2024; April 25, 2024; April 30, 2024; May 1, 2024; May 3, 2024; May 5, 2024; May 6, 2024; May 8, 2024; May 9, 2024; May 11, 2024; May 13, 2024; May 15, 2024; May 16, 2024; May 21, 2024; May 22, 2024; May 23, 2024; May 24, 2024; May 27, 2024; May 28, 2024; May 30, 2024; May 31, 2024; June 4, 2024; June 8, 2024; June 10, 2024; and June 11, 2024. 3. An interview with TP #1 on September 16, 2025, at 2:10 PM confirmed the absence of Troponin QC records for 29 out of 34 days on which tests were performed on patient samples between April 12, 2024, and June 16, 2024. -- 2 of 2 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review, policy and procedure review, and an interview with testing personnel (TP #1), the laboratory failed to provide a continual temperature monitored blood bank refrigerator with a functioning alarm system for storage of blood products from January 23, 2023 to October 26, 2023 (Cross refer D3007); failed to establish proper blood storage temperatures and document visual inspections as required by the laboratory policy and procedures for emergency release of blood units for transfusion (Cross refer D3021); failed to establish a procedure to prevent, identify, investigate and report transfusion reactions (Cross refer D3025); and failed to retain emergency release documents for three of three blood units and crossmatch document for one of one blood unit. (Cross refer D3035). D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. 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 observation, a review of policies and procedures and an interview with testing personnel (TP #1) the laboratory failed to provide a continual temperature monitored blood bank refrigerator with a functioning alarm system required by their policies and procedures to maintain blood units for emergency release from January 23, 2023, to October 26, 2023. Findings: 1. Observed on October 26, 2023, at 9:50 AM one blood bank refrigerator located in the laboratory with no alarm system. 2. A review of temperature logs revealed the laboratory lacked alarm checks from October 20, 2022, to October 26, 2023, and lacked temperature wheels for continual monitoring of temperature from January 23, 2023, to August 17, 2023. 3. A review of Storage and Monitoring of Blood revealed the laboratory failed to follow their procedure to keep blood for transfusion as stated, "in the temperature monitored and alarmed Blood Bank refrigerator located in the laboratory". 4. An interview with TP #1 on October 26, 2023, at 10:30 AM confirmed the blood bank refrigerator was not functional from January 23, 2023, to August 17, 2023. and the alarm system had not been connected. 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: REPEAT DEFICIENCY Based on record review, policy and procedure review, and interview with testing personnel (TP #1), the laboratory failed to have a procedure to maintain blood units for transfusion between 1 to 6 C to prevent the deterioration of the blood product, to have a

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 blood bank records, policy and procedure, and interview with Testing Personnel (TP) #1, the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood and blood products and of returned blood or blood products not used for transfusion and failed to perform and document regular alarm inspection checks for 1 of 1 blood bank refrigerator for years 2020 and 2021. Findings: 1. Review of blood bank 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. Review of Policy and Procedure, Storage and Monitoring of Blood lacks temperature requirements for acceptance of blood or returned blood products not used for transfusion. 3. Review of the Policy and Procedure, Blood Bank Refrigerator and Temperature and Alarm System Maintenance showed "D. Quarterly 1. Check audible and remote alarm system for both above and below range limits according to the manufacturer's instructions." 4. Review of the 2020, 2021 documentation for alarm checks revealed the laboratory performed alarm checks on January 2020; May 2020; September 2020; January 2021 and July 2021. 5. Interview with TP #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 returned blood or blood products not used for transfusion and failed to regularly perform quarterly alarm inspection checks for years 2020 and 2021. 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 -- D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or 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 regularly perform instrument comparison for chemistry analyzers VITROS 350 and Abbott iSTAT testing analytes sodium, potassium, chloride, ionized calcium, total CO (2), glucose, blood urea nitrogen (BUN) and creatinine from January 1, 2020 to January 13, 2022 Findings: 1. Interview with TP#1 on January 12, 2022 at 9:50 AM revealed the Abbott iSTAT analyzer was used as a backup system for the VITROS 350. 2. Review of laboratory instrument comparison records for VITROS 350 and Abbott iSTAT revealed the laboratory performed no comparison studies for 2020 and one comparison study out of two for 2021. 3. Interview with TP#1 on January 13, 2022 at 10:00 A.M., confirmed the laboratory failed to regularly perform twice a year instrument comparison between VITROS 350 and Abbott i-STAT testing analytes sodium, potassium, chloride, ionized calcium, total CO (2), glucose, blood urea nitrogen (BUN) and creatinine from January 1, 2020 to January 13, 2022. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and interview with the testing personnel (TP) #1, the laboratory failed to have a mechanism to periodically verify the laboratory information system (LIS) accuracy of its calculated data for LDL Cholesterol and hemoglobin A1C from January 1, 2020 to January 13, 2022. Findings: 1. No documentation was available for review to verify the LIS accuracy of its calculated data for LDL Cholesterol and hemoglobin A1C. 2. Interview with TP#1 on January 13, 2022 at 12:30 P.M., confirmed the laboratory failed to have a mechanism to verify their LIS accuracy of its calculated data for LDL Cholesterol and hemoglobin A1C from January 1, 2020 to January 13, 2022. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an off-site proficiency testing desk review conducted on 11/4/19, deficiencies were cited for Pioneer Medical Center in Big Timber, MT. 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 total bilirubin and total creatine kinase for two consecutive events (2019 event 2 and 2019 event 3), resulting in unsuccessful proficiency testing performance. See D2096. 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 -- D2096 ROUTINE CHEMISTRY 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 total bilirubin and total creatine kinase (CK) in two consecutive events in 2019, resulting in unsuccessful performance. The findings include: 1. During a review on 11/4/19 at 7:45 a.m. of the CMS-153 Unsuccessful Proficiency Testing Report included Pioneer Medical Center with unsuccessful proficiency testing scores for total bilirubin and total CK. 2. During a review on 11/4 /19 at 8:00 a.m. of the CMS-155 report, the American Proficiency Institute (API) total bilirubin score for event 2 of 2019 was 60%. 3. During a review on 11/4/19 at 8:00 a. m. of the CMS-155 report, the API total bilirubin score for event 3 of 2019 was 40%. 4. During a review on 11/4/19 at 8:00 a.m. of the CMS-155 report, the API total CK score for event 2 of 2019 was 20%. 5. During a review on 11/4/19 at 8:00 a.m. of the CMS-155 report, the API total CK score for event 3 of 2019 was 20%. 6. On 11/4/19 at 10:24 a.m., the laboratory manager stated the laboratory was troubleshooting both total bilirubin and total CK. -- 2 of 2 --