Central Montana Medical Center

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 an off-site review of the CMS-155 reports of proficiency testing performance, American Proficiency Institute (API) proficiency testing (PT) scores and corresponding laboratory records, and email communication with technical supervisor (TS) #1, the laboratory failed to achieve satisfactory performance for Alcohol (ETOH) for two out of three testing events, resulting in unsuccessful proficiency testing performance in 2024 and 2025. (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 -- (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 American Proficiency Institute (API) proficiency testing (PT) scores, laboratory records 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 Alcohol (ETOH) in 2024 and 2025. Findings: 1. A review of API's Chemistry Core PT scores and laboratory records for ETOH on March 31, 2025, revealed the laboratory failed to achieve a satisfactory performance score of 80% or greater for the following events: 2024, Event 2 scored 60% 2025, Event 1 scored 0% 2. An email communication with TS #1 on March 31, 2025, at 3:47 PM confirmed the failed results were due to failure to submit test results and clerical errors. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on a record review and interview with Technical Supervisor (TS) #1, the laboratory failed to retain two years of records for their maintenance checks of four out of four centrifuges for the year 2022 and calibration documents for new lots of d- dimer and fibrinogen reagents for 2023. Findings: 1. A record review of maintenance function checks for four out of four centrifuges revealed the laboratory failed to retain 2022 records. 2. The laboratory lacked calibration records for 2023 for new lots of d- dimer and fibrinogen performed on the Stago Compact Max and Stago Satellite hematology analyzers. 3. An interview with TS #1 on July 23, 2024, at 9:30 AM confirmed that the laboratory failed to retain 2022 maintenance check records for their centrifuges and calibration records for new lots of d-dimer and fibrinogen reagents performed in 2023. 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 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 Immunohematology records, policies, and interview with technical supervisor (TS) #1, the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood or blood products from January 1, 2021 to November 3, 2022. Findings: 1. Review of Immunohematology records revealed the laboratory failed to take and document the temperatures of blood or blood products upon receipt of new shipments to the laboratory from January 1, 2021 to November 3, 2022. 2. Review of Policy "LAB-BB-002-1; Inventory Management: Order, Receipt, Return and Transfer" lacked temperature requirements for acceptance of blood or blood product and instructions for documentation. 3. Interview with TS #1 on November 3, 2022 at 1:00 PM, confirmed the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood or blood products from January 1, 2021 to November 3, 2022. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 -- This STANDARD is not met as evidenced by: Based on review of annual competency files for 2021 and 2022, and interview with the technical supervisor (TS) #1, the laboratory failed to establish and follow a written policy to assess six of eleven employee's competencies for year 2021. Findings: 1. Review of personnel records lacked documentation to prove either semiannually competency during the 1st year of patient testing or annual competency of testing personnel for year 2021 for 6 out of 11 testing personnel (TP#6, TP#7, TP#8, TP#9, TP#10, and TP#11) listed on the CMS Form 209. 2. Review of Blood Gas Analysis and CO-Oximetry policy CPC-DT-ABG.005 lacks description of the six required procedures for competency assessment over time and the required training prior to patient testing. 3. Interview on November 3, 2022 at 10:15 AM with TS #1, confirmed the lack of documentation to prove competency assessments for 6 of 11 testing personnel listed on the CMS Form 209 for year 2021. D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(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 observation, record review and interview with the technical supervisor (TS) #1, the laboratory failed to establish one of one Individualized Quality Control Plan (IQCP) for the AVOXimeter 4000 Co-Oximetry to include a risk assessment (RA), quality control plan (QCP) and quality assessment (QA) from January 1, 2021 to November 3, 2022. Findings: 1. Observed in the Respiratory Unit on November 3, 2022 at 10:00 AM, an AVOXimeter 4000 analyzer testing analytes: total hemoglobin (tHb), oxyhemoglobin saturation (%O2Hb), carboxyhemoglobin (%COHb), and methemoglobin (%MetHb). 2.Review of AVOXimeter 4000 Operator's Manual revealed the laboratory failed to follow the manufacturer's instructions to perform and document "Daily optical quality control" and "Weekly testing of one level of liquid controls.". 3. Review of Blood Gas Analysis and CO-Oximetry policy CPC-DT-ABG. 005 lacks description for daily and weekly QC requirements for the AVOXimeter 4000 Co-Oximetry analyzer. 4. No daily QC records of the yellow and orange filters were available for review to ensure the results for THb, %O2Hb, %COHb, and % MetHb were within expected range and the instrument was properly calibrated. 5. No weekly QC records of Multi-4 CO-Oximeter or RNA CO-Oximeter liquid control results for THb, %O2Hb, %COHb, and %MetHb were available for review to verify results are within expected range. 6. No IQCP was available to review that established a RA, QCP or QA for the AVOXimeter 4000 Co-Oximetry to allow for alternative QC frequency. 7. Interview with the TS #1 on November 3, 2022 at 11:15 AM, confirmed these findings. D5535 ROUTINE CHEMISTRY CFR(s): 493.1267(a)(d) For blood gas analyses, the laboratory must perform the following: (a) Calibrate or verify calibration according to the manufacturer's specifications and with at least the frequency recommended by the manufacturer. (d) Document all control procedures performed, as specified in this section. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of blood gas calibration records, Individualized Quality Control Plan (IQCP), OPTI CCA-TS Operator's Manual, and an interview with Technical Supervisor (TS) #1, the laboratory failed to perform and document quarterly tHb calibration as per their procedures from January 1, 2021, to November 3, 2022. Findings: 1. Review of blood gas IQCP revealed the laboratory failed to perform tHb calibration verification as stated, "calibrate or verify calibration according to the manufacturer's specifications and with at least the frequency recommended by the manufacturer." 2. Review of the OPTI CCA-TS Operator's Manual revealed the laboratory failed to perform calibrations as stated: "4.1 Calibration of the tHb channel is required every 3 months." 3. No records of tHb calibrations were available for review. 4. Interview with the (TS) #1 on November 3, 2022, at 11:30 AM, confirmed the laboratory failed to perform tHb calibration every three months on the OPTI CCA- TS Blood Gas Analyzer as per their IQCP from January 1, 2021, to November 3, 2022. D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review, Avoximeter 4000 Operator's Manual and interview with technical supervisor (TS) #1, the laboratory failed to test one sample of quality controls (QC) material within eight hours of patient testing on the AVOXimeter 4000 whole blood CO-Oximeter from January 1, 2021 to November 3, 2022. Findings: 1. A review of patient results report #22-148-2287 for arterial blood gas released on 5/29 /2022 revealed the laboratory failed to perform both a low and high level of QC the day of patient specimen testing on the AVOXimeter 4000 Co-Oximetry. 2. No IQCP was available to review that established a RA, QCP or QA for the AVOXimeter 4000 Co-Oximetry to allow for alternative QC frequency. (See 5425) 3. Review of test volume sheet revealed 56 arterial blood gas tests were performed from October 1, 2021 to November 1, 2022. 4. Interview on November 3, 2022 at 11:00 AM with the TS #1, confirmed the laboratory failed to run a control each 8 hours of patient testing on the AVOXimeter 4000 whole blood oximeter analyzer from January 1, 2021 to November 3, 2022. -- 3 of 3 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on record review, and interview with the General Supervisor (GS)#1, the laboratory failed to retain the quality control (QC) documentation for blood gases tests (pH, PCO2, PO2) performed on the OPTI CCA-TS2 Analyzer for years 2019 and 2020. Findings: 1. No QC documentation for blood gasses performed in 2019 and 2020 on the OPTI CCA-TS2 Analyzer were available for review. 2. Interview on April 27, 2021 4:00 PM with (GS)#1 confirmed the QC documentation for blood gases tests (pH, PCO2, PO2) performed on the OPTI CCA-TS2 Analyzer was not retained for years 2019 and 2020. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation, review of maintenance records and interview with General Supervisor (GS)#1, the laboratory failed to recertify the Biosafety Cabinet located in the Microbiology Section for 2020. Findings: 1. Observed Microbiology Biosafety Cabinet's certification sticker had expired May of 2020. 2. No 2020 maintenance 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 -- record for recertification of the Biosafety Cabinet was available for review. 3. Interview on April 27, 2021 2:30 PM with (GS)#1, confirmed the Biosafety Cabinet certification had expired as of May 2020. . 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 of patient results reports, laboratory policies and interview with the general supervisor (GS)#1, the laboratory failed to have a system in place to verify patient result reports found in Cerner EHR System provided by Billings Clinic in Billings, MT, two times a year or after pertinent software upgrades for accuracy. Findings: 1. No verification documents of the Cerner EHR System were available for review. 2. Review of Accession # 20-318-2166 patient results report revealed the CBC Reference Range for HGB, Hct, and MPV differed from the references ranges listed in Policy No. Lab-HEM-001-20 reference ranges. 3. Review of Accession # 20- 318-2166 patient results report revealed the Automated Differential reference ranges for Imm Grans%, Neut Abs, Lymph Abs, Mono Abs, Eos Abs, Baso abs, and Imm Grans Abs differed from the reference ranges values listed in Policy No. Lab-HEM- 001-20. 4. Interview on April 27, 2021 9:13 AM with (GS)#1 stated the results report's reference values listed in Cerner EHR System are from their affiliate, Billings Clinic and had not been compared against Central Montana Medical Centers policies and laboratory's verified reference ranges twice a year or after pertinent software upgrades for accuracy. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 6/25/18-6/26/18, deficiencies were cited for Central Montana Medical Center in Lewistown, MT. D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain in-house data for 12 of 12 Individual Quality Control Plans (IQCPs) reviewed. The findings include: 1. A record review on 6/26/18 at 11:15 a.m. of the IQCP binder lacked the in-house data utilized to support the number and frequency of controls for 12 IQCPs. a. Human immunodeficiency virus (HIV), blood culture identification panels, clostridium difficile (C. diff), campylobacter, gastrointestinal identification panels, group b strep, human chorionic gonadotropin (hCG), antimicrobial susceptibility tests, respiratory syncytial virus (RSV), shiga toxin, and urine drug screens. 2. On 6/26/18 at 11:30 a. m., staff member A stated the data was not retained in the binder and some data was not retrievable anymore. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 record review and interview, the laboratory director failed to sign and date approval of 12 of 12 Individual Quality Control Plans (IQCPs). The findings include: 1. A review on 6/25/18 at 2:25 p.m. of the IQCP binder lacked signatures of approval by the current laboratory director on 12 IQCPs. a. Human immunodeficiency virus (HIV), blood culture identification panels, clostridium difficile (C. diff), campylobacter, gastrointestinal identification panels, group b strep, human chorionic gonadotropin (hCG), antimicrobial susceptibility tests, respiratory syncytial virus (RSV), shiga toxin, and urine drug screens. 2. On 6/25/18 at 2:25 p.m., staff member A stated the IQCPs were not signed by the laboratory director. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to document the temperature of the cryostat when in use from 8/3/16 to 6/25/18. The findings include: 1. On 6/25 /18 at 11:30 a.m., a cryostat was observed in the laboratory. 2. On 6/26/18 at 11:00 a. m., staff member A stated the temperature of the cryostat when in use was not documented. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory technical supervisor failed to evaluate and document competency on one of 8 testing personnel in 2017 and 2018. The findings include: 1. A review on 6/25/18 at 1:30 p.m. of the competency evaluations lacked evaluations for staff member A in 2017 and 2018. 2. On 6/25/18 at 1:30 p.m., staff member A stated competency evaluations were not completed for staff member A. -- 2 of 2 --