Bitterroot Health Daly

Summary Statement of Deficiencies D0000 The Montana CLIA Program conducted a recertification survey ending on April 28, 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. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a record review, observation, manufacturer's package inserts, and interviews with Technical Supervisors (TS1 and TS3), the laboratory failed to follow the manufacturer's package insert to ensure 23 out of 25 microbiology American Type Culture Collection (ATCC) quality control material were not used past their expiration date from April 28, 2024, to April 28, 2026. Findings: 1. During an interview on April 28, 2026, at 9:15 AM, TS3 was asked to provide a list of all ATCC quality control organisms with associated lot numbers and expiration dates used for quality checks of media, stains, reagents, and kits. No document was produced. 2. A container holding ATCC quality control organisms was provided on April 28, 2026, at 9:20 AM by TS3 for review, and the following expired products were observed along with the expiration dates listed on the packaging: Culti-Loops Arcanobacterium pyogenes ATCC 19411 expired 7/31/2016 Bacteroides thetaiotaomicron ATCC 29741 expired 2/20/24 Enterococcus faecalis ATCC 51299 expired 3/13/24 and expired 6/3 /1016 Escherichia coli ATCC 25922 expired 5/31/2016 and expired 2/28/24 Listeria monocytogenes ATCC BAA 751 expired 4/24/24 and expired 2/29/16 Neisseria gonorrhoeae ATCC 43069 expired 3/19/2024 Pseudomonas aeruginosa ATCC 9721 expired 10/31/2016 Pseudomonas aeruginosa ATCC BAA 1744 expired 4/30/2016 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 -- Staphylococcus aureus ATCC BAA 976 expired 2/15/2024 Staphylococcus saprophyticus ATCC BAA 750 expired 02/13/2024 and expired 2/13/24 Staphylococcus scuri ATCC 29061 expired 3/13/24 Streptococcus agalactiae ATCC 12386 expired 11/30/2016 Streptococcus equi ATCC 43079 expired 6/8/23 Streptococcus thermophilus ATCC 19258 expired 7/25/23 Inocu Swabs S. aureus ATCC BAA 976 expired 4/8/2016 S. enterica ATCC 10708 expired 11/25/2016 KWIK-STIK Enterobacter hormaechei ATCC 700323 expired 4/30/21 Proteus vulgaris ATCC 6380 expired 4/30/24 Quanti-Cult Pseudomonas aeruginosa ATCC 27853 exp 3/19/2024 3. A review of the Culti Loops, Inocu Swabs, KWIK STIK, and Quanti Cult product inserts showed the laboratory did not follow the manufacturer's instructions to discontinue use of products after the listed expiration date. 4. An interview with TS1 on April 28, 2026, at 9:30 AM confirmed that 23 out of 25 ATCC quality controls were expired from April 28, 2024, to April 28, 2026. 5. A review of the test volume sheet revealed 5811 microbology cultures were performed on patients in the last 12 months, from April 28, 2025, to April 28, 2026. D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) (b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on a review of microbiology records and interview with Technical Supervisor (TS1), the laboratory failed to perform a verification study for its Individualized Quality Control Plans (IQCP) to support the quality control (QC) frequency for new lots of three of three medias used for patient blood cultures from April 28, 2024, to April 28, 2026. Findings: 1. A review of microbiology's IQCP failed to include in- house verification data in its Quality Control Plan (QCP) to support the QC frequency for new lots of BacT/ALERT FA Plus Culture Bottle, BacT/ALERT FN Plus Culture Bottle, and BacT/ALERT PF Plus Culture Bottle 2. An interview with the TS1 on April 28, 2026, at 9:40 AM confirmed the laboratory had not conducted a verification study to support its QC frequency for new lots of BacT/ALERT FA Plus, BacT /ALERT FN Plus, and BacT/ALERT PF Plus culture media used for patient blood cultures from April 28, 2024, to April 28, 2026. 3. A review of the test volume sheet revealed 2018 blood cultures were performed on patients in the last 12 months from April 28, 2025, to April 28, 2026. -- 2 of 2 --

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 Association of Bioanalysts (AAB) 2025 records, the laboratory failed to successfully participate in a proficiency 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 -- testing 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 subspecialties of Endocrinology and Routine Chemistry for analytes Folate and Hemoglobin A1c. Refer to D2096, D2107 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 Association of Bioanalysts (AAB) proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or better) for two consecutive proficiency testing events in the subspecialty of Routine Chemistry for the analyte Hemoglobin A1c. Findings: 1. Review of the CASPER 0155 report revealed the following results: Routine Chemistry 2025-2nd Event, the laboratory received an unsatisfactory score of 60% for Hemoglobin A1c Routine Chemistry 2025-3rd Event, the laboratory received an unsatisfactory score of 0% for Hemoglobin A1c 2. A review of the 2025 AAB Proficiency Testing records confirmed the laboratory received the above results. 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 Association of Bioanalysts (AAB) 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 analyte Folate. Findings: 1. Review of the CASPER 0155 report revealed the following results: Endocrinology 2025-2nd Event, the laboratory received an unsatisfactory score of 60% for Folate Endocrinology 2025-3rd Event, the laboratory received an unsatisfactory score of 0% for Folate 2. A review of the 2025 AAB Proficiency Testing records confirmed the laboratory received the above results. -- 2 of 2 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) and College of American Pathologists (CAP) proficiency testing records and an interview with technical supervisor (TS) #1, the laboratory failed to provide

Summary Statement of Deficiencies 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 routine desk audit of the CMS-155 report for proficiency testing (PT) performance, a review of College of American Pathology (CAP) records and interview with the technical supervisor (TS) #1, the laboratory failed to achieve satisfactory performance for urea nitrogen performed on the VITROS 7600 chemistry analyzer for two out of three testing events, resulting in unsuccessful proficiency testing performance. (See D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 (PT) scores and interview with technical supervisor (TS) # 1, the laboratory failed to achieve a score of at least 80% for two out of three PT events (2023 CAP C-A and C-C) for urea nitrogen. Findings: 1. A review of the CAP urea nitrogen PT scores revealed that in 2023, CAP C-A scored 20% and CAP C-C scored 0%. 2. An interview with (TS) #1 on November 20, 2023, at 2:36 PM confirmed the failed urea nitrogen PT events were due to calibration and transcription errors. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of College of American Pathology (CAP) proficiency testing (PT) scores and email communication with technical supervisor (TS) # 1, the laboratory failed to provide signed attestation statements, documentation of review, records of

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview with Testing Supervisor (TS) #1, the laboratory failed to ensure the laboratory was enrolled in an HHS-approved proficiency testing program for Chemistry (C-Reactive Protein (CRP)) and Hematology (Reticulocyte Counts) from January 1, 2020 to March 14, 2022. Findings: 1. Review of Test Volume Report revealed 2,671 CRP tests and 77 Reticulocyte Counts were performed for 2021. 2. Review of 2020 and 2021 American Proficiency Institute (API), College of American Pathologists (CAP), and American Association of Bioanalysts (AAB) testing program records lacked documentation of proficiency testing for CRP and Reticulocyte Counts. 3. Interview on March 14, 2022 at 4:30 PM with the TS#1 confirmed the laboratory failed to enroll in an HHS-approved proficiency testing program for CRP and Reticulocyte Counts from January 1, 2020 to March 14, 2022. 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 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 -- 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 record review and interview with Testing Supervisor (TS) #1, the laboratory failed to achieve satisfactory performance scores of 80% for analytes Bilirubin, Direct (Neonatal) and NT pro-BNP (CM) for two out of three events in year 2021, resulting in unsuccessful proficiency testing performance. See D2096 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 2021 American Proficiency Institute (API) proficiency testing scores and interview with technical supervisor (TS) #1, the laboratory failed to achieve a score of 80% for Chemistry analytes Bilirubin, Direct (Neonatal) and NT pro-BNP (CM) for two of three events. Findings: 1. Review of API proficiency testing scores for Bilirubin, Direct (Neonatal) revealed scores of 50% for 2021 Event 1 and 3. 2. Review of API proficiency testing scores for NT pro-BNP (CM) revealed scores of 60% for 2021 Event 2 and 3. 3. Interview on March 14, 2022 at 4:20 PM with the TS#1, confirmed unsuccessful proficiency scores for Chemistry analytes Bilirubin, Direct (Neonatal) and NT pro-BNP (CM) for two of three events. -- 2 of 2 --

Summary Statement of Deficiencies 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 LDH testing for 2 out of 3 events (2020 Event 3 and 2021 Event 1), resulting in unsuccessful proficiency testing performance. See D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 with General Supervisor (GS)#1, the laboratory failed to achieve a score of 80 percent for LDH, Total in 2 of 3 events (2020 Event 3 and 2021 Event 1), resulting in unsuccessful proficiency testing performance. The findings include: 1. Review of CMS-153, Unsuccessful Proficiency Testing Report included Marcus Daly Hospital located in Hamilton, MT with unsuccessful proficiency testing scores for LDH, Total. 2. Review of the CMS-155, Individual Laboratory Report revealed the College of American Pathologists (CAP) LDH, Total scores for 2020 Event 3 and 2021 Event 1 were 0%. 5. Interview with GS#1 on 05/06/2021 at 10:41a.m., confirmed the CAP proficiency test scores for 2020 Event 3 and 2021 Event 1, LDH, Total were unsuccessful due to clerical error with the reagent code. . -- 2 of 2 --

Summary Statement of Deficiencies 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 rheumatoid factor for two consecutive events (2 and 3) in 2017, resulting in unsuccessful proficiency testing performance. See D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 rheumatoid factor (RF) in two consecutive events in 2017, resulting in unsuccessful performance. The findings include: 1. During a review on 1/17/18 at 5:00 p.m. of the CMS-153 Unsuccessful Proficiency Testing Report included Marcus Daly Memorial Hospital with unsuccessful proficiency testing scores for RF. 2. During a review on 1/18/18 at 7:10 a.m. of the CMS-155 report, the American Association of Bioanalysts (AAB) RF score for event 2 of 2017 was 0%. 3. During a review on 1/18/18 at 7:10 a.m. of the CMS-155 report, the AAB RF score for event 3 of 2017 was 0%. 4. On 1/18/18 at 12:45 p.m., the laboratory manager stated the samples were not run and a titer not reported for the two events. -- 2 of 2 --