Benefis Helena Northeast

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on record review, product inserts, and an interview with a laboratory representative (not listed on the CMS-209 form), laboratory staff failed to follow the manufacturer's instructions to perform external positive and negative quality control (QC) onsite for each new shipment of Abbott ID Now kits from June 2, 2023, to June 2, 2025. Findings: 1. A review of quality control (QC) records for Abbott ID Now assays (Influenza A & B (Flu A & B), 2019 Coronavirus Disease (COVID-19), Respiratory Syncytial Virus (RSV) and Group A streptococcus (Strep A) revealed the laboratory failed to perform external positive and negative quality control onsite with each new shipment received per the manufacturer's instructions. 2. An interview with the laboratory representative (not listed on the CMS-209 form) on June 2, 2025, at 4: 00 PM confirmed testing personnel failed to perform an external positive and negative quality control onsite with each new shipment of Flu A & B, COVID-19, RSV and Strep A kits received from June 2, 2023, to June 2, 2025. 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. 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 with the general supervisor (GS) #1, the laboratory failed to verify the number and frequency of the quality control for two of two Individualized Quality Control Plans (IQCP) used for the Quidel Triage and the Sure Vue pregnancy kit for serum hCG from June 2, 2023, to June 2, 2025. Findings: 1. A review of the laboratory Individual Quality Control Plan (IQCP) records failed to have a verification study performed onsite that supports the quality control (QC) frequency for the Quidel Triage (d-dimer, creatine kinase, myoglobin (CK-MB), and troponin I) and Sure Vue pregnancy kit for serum hCG. 2. An interview with GS #1 on June 2, 2025, at 10:20 AM, confirmed the laboratory failed to provide QC data that verified their IQCP quality control number and frequency for the assays performed on the Quidel Triage (d-dimer, CK-MB, and troponin I) and the Sure Vue pregnancy kit for serum hCG, from June 2, 2023, to June 2, 2025. 3. A review of the test volume sheet revealed 358 troponin I and 341 d-dimer patient tests were performed in the last 12 months (May 1, 2024, to May 30, 2025). D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D0000 Based on an off-site complaint survey finalized on February 05, 2025, 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 deficiencies were cited: CFR(s): 493.801 ENROLLMENT AND TESTING OF SAMPLES Definitions: Laboratory #1 located in Helena, MT Laboratory #2 located in Great Falls, MT 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 an off-site review of American Proficiency Institute (API) proficiency testing (PT) records, laboratory policy and procedures, and e-mail communications with testing personnel (TP) #1 located at laboratory #1, technical supervisor (TS) #1, and laboratory manager located at laboratory #2, the laboratory failed to ensure laboratory staff did not engage in inter-laboratory communications (refer to D2012) and failed to ensure the laboratory director signed the proficiency testing attestation page, final results, and

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on December 24, 2024. 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 deficiencies were cited: 493.803 Condition: Successful participation. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. 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 an off-site review of the CMS-155 reports of 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 3 -- performance, American Proficiency Institute (API) proficiency testing (PT) scores and corresponding laboratory records, and email communication with testing personnel (TP) #1, the laboratory failed to achieve satisfactory performance for hematology for three out of four testing events, resulting in subsequent unsuccessful proficiency testing performance in 2023 and 2024. See D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site review of American Proficiency Institute (API) proficiency testing (PT) scores and corresponding laboratory proficiency testing records submitted by email on January 02, 2025, by testing personnel (TP) # 1, the laboratory failed to prevent a subsequent unsuccessful performance in the specialty of hematology for manual cell differentials performed in 2023 and 2024. Findings: 1. A review of API's hematology PT records on January 02, 2025, revealed the laboratory failed to achieve a satisfactory performance score of 80% or greater for the following events: 2023 Blood Cell Identification Event 3 - 0% 2024 Blood Cell Identification Event 2 - 60% 2024 White Blood Cell Differential Event 3 - 64% 2. An email communication with TP #1 on January 02, 2025, at 1:14 PM, confirmed the laboratory's subsequent unsuccessful proficiency testing scores were due to failure to submit results, transcription errors, and proper sample handling. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on an off-site review of 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) scores and corresponding laboratory records, and email communication with technical supervisor (TS) #1, the laboratory director failed to provide overall management of the proficiency testing program to ensure laboratory staff perform and submit their proficiency testing results for 2023 Hematology /Coagulation - 3rd Event. (Refer to D6089). D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on an off-site review of 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) scores and corresponding laboratory records, and an email -- 2 of 3 -- communication with technical supervisor (TS) #1, the laboratory director failed to ensure laboratory staff perform and submit their proficiency testing results for 2023 Hematology/Coagulation - 3rd Event. Findings: 1. A review of API's Performance Summary Form for 2023 Hematology/Coagulation - 3rd Event revealed the laboratory's "failure to participate" resulting in an overall score of 0%. 2. A review of the laboratory's Performance Review and

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 review of American Proficiency Institute records and an interview with the technical supervisor, the laboratory failed to achieve satisfactory performance for Blood Cell Identification which includes Eosinophils, Neutrophil, segmented, Neutrophil, band, and Lymphocytes for two out of three testing events, resulting in unsuccessful proficiency testing performance. (See D2130) D2130 HEMATOLOGY CFR(s): 493.851(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 in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) proficiency testing (PT) scores and an interview with technical supervisor (TS) # 1, the laboratory failed to achieve a score of at least 80% for two out of three testing events for Blood Cell Identification. Findings: 1. A review of the API Blood Cell Identification which includes Eosinophils, Neutrophil, segmented, Neutrophil, band and Lymphocytes proficiency testing scores revealed that in 2023, Event 3 scored 0% and in 2024, Event 2 scored 60%. 2. An interview with TS #1 on November 10, 2024, at 7:11 PM confirmed the laboratory's unsuccessful proficiency testing scores were due to failure to submit results to API and transcription errors. -- 2 of 2 --

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of chemistry quality control (QC) records, procedures, manuals, and interview with the Technical Supervisor (TS) #1, the laboratory failed to establish acceptable criteria (mean and standard deviation) for new lots of Bio-Rad liquid unassayed multiqual controls performed on the Ortho Vitros XT 3400 chemistry analyzer from December 22, 2021, to May 10, 2023. Findings: 1. The laboratory failed to follow their Vitros Quality Control procedure as stated "Target ranges for each lot of control material are established by performing correlation studies that include control materials that have ranges previously established. For unassayed material, the acceptable tolerance limits are +/- 2SD of the established means." 2. No correlations studies for new lots of quality control materials to establish statistical limits for the Ortho Vitros XT 3400 chemistry analyzer were available for review. 3. A review of the test volume sheet revealed 1352 (albumin, alk phosphate, bilirubin), 1355 (ALT/SGPT and AST SGOT), 1473 urea nitrogen (BUN), 1453 calcium, 1459 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 -- (chloride and CO2), 1480 (creatinine, glucose, potassium, and sodium), 53 lactic acid, 401 lipase results were reported from May 10, 2022, to May 10, 2023 (12 month period). 4. An interview with (TS) #1 on May10, 2023, at 1:10 PM, confirmed the laboratory failed to establish acceptable QC statistical parameters for each analyte tested on the Ortho Vitros XT 3400 chemistry analyzer from December 22, 2021, to May 10, 2023. -- 2 of 2 --