Northern Montana Hospital

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, the manufacturer's product insert, and an interview with the general supervisor (GS #3), the laboratory failed to label 11 out of 11 sets of chemistry and immunoassay quality control (QC) material once opened with the open- vial stability expiration date from March 18, 2023, to March 19, 2025. Findings: 1. Observed on March 19, 2025, at 12:35 PM, one tray with 11 sets of quality control for the Vitros 7600 chemistry and immunoassay analyzer in use in the refrigerator. The quality control labels lacked the open-vial stability expiration date. 2. A review of Bio- Rad's product inserts revealed the laboratory failed to label their quality control vials with the manufacturer's stability expiration date for the following sets of QC: Liquichek Pediatric, Liquichek Ethanol/Ammonia, Liquichek Diabetes, Liquichek Elevated CRP, Liquichek Urine Chemistry, Liquichek Specialty Immunoassay, Liquichek Immunoassay Plus, Lyphochek Specialty Immunoassay, Liquichek Spinal Fluid, VIROTROL I, II, III, Clear and Liquid Assayed Multiqual. 3. Interview with GS #3 on March 19, 2025, at 12:40 PM, confirmed the QC vials lacked the stability expiration date after the vail was opened to prevent QC being used past the manufacturer's recommend stability of their product from March 18, 2023, to March 19, 2025. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) 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 -- (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. This STANDARD is not met as evidenced by: Based on record review of instrument comparison documentation, procedure, and interview with Technical Supervisor (TS) #1, the laboratory failed to perform comparison studies twice a year and define the relationship between the test results of two different test methods or instruments for ABO Rhesus (RH) factor typing, blood gas, troponin, comprehensive metabolic panel (CMP), prothrombin, D-Dimer, differential counts, and hematology's two analytical modules, every six months from March 18, 2023 to March 19, 2025. Findings: 1. A review of instrument comparison documentation revealed the laboratory failed to perform comparison studies for years 2023 and 2024 for the following systems: Conventional tube and gel-based ABO Rh factor typing, ABL 90 and iSTAT blood gas, pH, Partial Pressure of Oxygen (PO2), Partial Pressure of Carbon Dioxide (PCO2) and Lactate, Triage and Vitros 7600 troponin, Piccolo and Vitros 7600 CMP: (alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN)), Sysmex CA-600 and iSTAT prothrombin, Sysemx CA-600 and Triage D-Dimer, Beckman Coulter DXH 600 two analytical modules, Automated and manual differential counts. 2. An interview with TS #1 on March 19, 2025, at 11:00 AM confirmed the laboratory failed to perform comparison studies twice a year and define the relationship between the test results between the systems listed above from March 18, 2023, to March 19, 2025. -- 2 of 2 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of chemistry calibration verification records, procedures, and an interview with the technical supervisor (TS #1), the laboratory failed to establish a procedure for the performance and evaluation of calibration verification data for five out of five analytes performed on the VITROS XT 7600 from July 26, 2021, to July 27, 2023. Findings: 1. The laboratory lacked a procedure for calibration verification for analytes Estradiol, Vitamin B-12, 25-OH Vitamin D, Total Iron Binding Capacity (TIBC), and Carcione Embryonic Antigen (CEA) to include the number, type, and concentration of calibration materials, frequency of studies, acceptable limits, and what to do when the calibration verification fails. 2. Calibration verification documents lacked evaluation of data for acceptability prior to patient testing for Estradiol, Vitamin B-12, 25-OH Vitamin D, TIBC, and CEA. 3. An interview with TS #1 on July 26, 2023, at 1:30 PM confirmed the laboratory failed to have a procedure and evaluate calibration verification data for five out of five analytes (Estradiol, Vitamin B-12, 25-OH Vitamin D, TIBC, and CEA) performed on the VITROS XT 7600 from July 26, 2021, to July 27, 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 3 -- D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration verification records, procedure, and interview with the Technical Supervisor (TS) #1, the laboratory failed to follow their procedures to perform at least three-point (minimal, mid-point, and maximum) calibration verification every six months for Triage Meter for analyte D-Dimer and for two of two Beckman Coulter DxH 600 hematology analyzers for complete blood counts (CBC) and from July 26, 2021, to July 27, 2023. Findings: 1. No records of calibration verification for the two Beckman Coulter DxH 600 hematology analyzers for complete blood count (red blood cells (RBC), white blood cells (WBC), platelets, hemoglobin, hematocrit and mean corpuscular volume (MCV)) and the Triage Meter for D-Dimer were available for review at the time of the survey. 2. The laboratory failed to follow their Individualized Quality Control Plan (IQCP) procedure for the Triage Meter to perform calibration verification every 6 months. 3. An interview with the TS #1 on July 27, 2023, at 11:30 AM, confirmed the laboratory failed to perform and retain documentation of calibration verification for the two Beckman Coulter DxH 600 analyzers for complete blood counts and the Triage Meter for D-dimer every six months from July 26, 2021, to July 27, 2023. 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. This STANDARD is not met as evidenced by: Based on a review of blood gas calibration records, procedure manual, and an -- 2 of 3 -- interview with Technical Supervisor (TS) #1, the laboratory failed to establish a procedure and perform at least three-point (a minimal, mid-point, and maximum) calibration verification every six months for the i-STAT CG 4+ cartridge and the Radiometer ABL80 Flex CO-OX blood gas analyzers from July 26, 2021, to July 27, 2023. Findings: 1. A review of calibration verification records for the Radiometer ABL80 Flex CO-OX lacked records of passing calibration verifications studies prior to patient testing for the year 2022 and for the i-STAT CG 4+ cartridge lacked documentation of calibration verification for the year 2021 and one of two studies for the year 2022. 2. A review of the test volume sheet revealed 471 patient tests performed for analytes pH, carbon dioxide partial pressure (pCO2), oxygen partial pressure (pO2), hydrogen carbonate ion (HCO3), Base Excess, and hemoglobin oxygen saturation (O2 SAT) from July 26, 2022, to July 26, 2023 (12-month time frame). 3. A review of the procedure manual lacked instruction for acceptable limits, frequency of calibration and what to do when the calibration verification fails for the Radiometer ABL80 Flex CO-OX and i-STAT CG 4+ cartridge. 4. Interview with TS #1 on July 27, 2023, at 9:00 AM, confirmed the laboratory failed to perform at least three-point calibration verification every six months for two of two blood gas analyzers from July 26, 2021, to July 27, 2023, and failed to define the frequency of calibration verification, acceptable limits, 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 record review of American Proficiency Institute (API) proficiency testing scores and interview with the Technical Supervisor (TS) #1, the laboratory failed to achieve satisfactory performance for two out of three testing events in bacteriology and chemistry for years 2019 and 2020. (Refer to D2028, D2097) D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for 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 3 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on record review of American Proficiency Institute (API) proficiency testing scores for bacteriology and interview with the Technical Supervisor (TS) #1, the laboratory failed to achieve satisfactory performance for Urine Colony Count for two out of three events in 2019 and 2020. Findings: 1. Review of American Proficiency Institute (API) proficiency testing scores for 2020 Microbiology under subspecialty bacteriology revealed unsuccessful proficiency testing for Urine Colony Count with a 0% score for 2019 Event 3 and 2020 Event 1. 2. Interview with the TS #1 on August 4, 2021 at 3:40 PM confirmed the laboratory failed to achieve satisfactory performance for Urine Colony Count for two out of three events in 2019 and 2020. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(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 record review of American Proficiency Institute (API) proficiency testing scores for chemistry and interview with the Technical Supervisor (TS) #1, the laboratory failed to achieve satisfactory performance for NT-proBNP (CM) for two out of three events in 2019. Findings: 1. Review of American Proficiency Institute (API) proficiency testing scores for 2019 Chemistry Core revealed unsuccessful proficiency testing for NT-proBNP (CM) with a 40% score for 2019 Event 1 and 20% score for 2019 Event 3. 2. Interview with the TS #1 on August 4, 2021 at 3:40 PM confirmed the laboratory failed to achieve satisfactory performance for NT-proBNP (CM) for two out of three events in 2019. 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, policy and procedures and interview with Technical Supervisor (TS) #1, the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood and blood products and of blood or blood products returned to the laboratory for years 2019 and 2020. Findings: 1. Review of Immunohematology records lacked documentation of temperatures of blood and blood products upon receipt of new shipments and of blood or blood products returned to the laboratory for years 2019 and 2020. 2. Review of Policy and Procedure Lab 3-05 lacks steps to ensure temperature documentation for receipt of new or returned blood or blood products. 3. Review of American Red Cross -- 2 of 3 -- Hospital Partner Resource Guide revealed (page 17), "If products are received out of shipping temperature range or are packed incorrectly, notify Red Cross Customer Service. These products will be managed based on the non-conformance." 4. Interview with TS #1 on August 4, 2021 at 11:16 AM, confirmed the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood and blood products and of blood or blood products returned to the laboratory for years 2019 and 2020. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: . Based on review of histology records, policy and procedures and interview with Technical Supervisor (TS) #1, the laboratory failed to retain histology slides for at least 10 years from the date of examination for 2020. Findings: 1. Review of histology patient #520-637, tissue stained with Giemsa stain performed on 6-5-2020 revealed the quality control slide could not be located. 2. Review of Policy and Procedure Lab 9-07 revealed "Stained slides are kept for 10 years.". 3. Interview with TS #1 confirmed the quality control slide for the histology patient #520-637 was not retained for at least 10 years from the date of examination of 6/5/2020. -- 3 of 3 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 D0000 Based on an off-site proficiency testing desk review conducted on 5/30/18, deficiencies were cited for Northern Montana Hospital in Havre, 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 antibody identification for two consecutive events (2017 event 3 and 2018 event 1), resulting in unsuccessful proficiency testing performance. See D2181. D2191 ANTIBODY IDENTIFICATION 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 -- CFR(s): 493.865(f) Failure to achieve an overall testing event score of satisfactory 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 review of proficiency testing scores and interview, the laboratory failed to achieve a score of 100 percent for antibody identification in two consecutive events in 2018, resulting in unsuccessful performance. The findings include: 1. During a review on 5/29/18 at 8:15 a.m. of the CMS-153 Unsuccessful Proficiency Testing Report included Northern Montana Hospital with unsuccessful proficiency testing scores for antibody identification. 2. During a review on 5/29/18 at 8:20 a.m. of the CMS-155 report, the American Proficiency Institute (API) antibody identification score for event 3 of 2018 was 0%. 3. During a review on 5/29/18 at 8:20 a.m. of the CMS-155 report, the API antibody identification score for event 1 of 2018 was 40%. 4. On 5/30 /18 at 12:45 p.m., the laboratory manager stated the results were not reported correctly and reported too late for grading. -- 2 of 2 --