Colstrip Medical Center

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing records from the American Proficiency Institute (API), biannual verification records, the test volume report, and an interview with laboratory director (LD) #1, the laboratory failed to perform two out of two biannual verifications for microscopic urinalysis for the year 2024. Findings: 1. A review of the Test Volume Report revealed eight patients' urine samples were microscopically examined from December 2023 to December 2024 (12 months). 2. A review of API records and biannual verification records lacked verification of microscopic urinalysis in 2024. 3. Interview on December 11, 2024, at 9:00 AM with the LD #1 confirmed the laboratory failed to perform biannual verification of microscopic urinalysis in 2024. 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 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 White Blood Cell Automated Differential which includes Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils for two consecutive 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 consecutive testing events for White Blood Cell Automated Differential, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils, performed on the Sysmex XN-450 hematology analyzer. Findings: 1. A review of the API White Blood Cell Automated Differential, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils proficiency testing scores revealed that in 2023, Event 3 scored 0% and in 2024, Event 1 scored 0%. 2. An interview with TS #1 on May 16, 2024, at 8:29 AM confirmed the laboratory's unsuccessful proficiency testing scores were due to entering absolute counts instead of percent. -- 2 of 2 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 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, instrument manuals and interview with the Laboratory Director (LD) #1, the laboratory failed to follow manufacturer's instructions for the intended use of UniStrip 1 Generic Blood Glucose Test Strips analyzed on the OneTouch Ultra meter from January 1, 2021 to January 11, 2023 and for testing quality control (QC) material on the Siemens DCA Vantage from May 1, 2022 to January 11, 2023. Findings: 1. A review of American Proficiency Institute revealed the laboratory had unsuccessful whole blood glucose (waived) proficiency testing results for 2022 Events 2 and 3, due to not following manufacturer's instructions to enter the correct calibration code. 2. A review of UniStrip 1 Generic Blood Glucose Test Strips product insert revealed the laboratory failed to follow manufacturer's intended use as stated, "This device is not intended for use in healthcare or assisted use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in theses settings" from January 1, 2021 to January 11, 2023. 3. A review of hemoglobin A1C quality control records revealed the laboratory failed to perform normal and abnormal QC with the control card as recommended by the DCA Vantage Operator's Guide, DCA Hemoglobin A1c Control product insert and the DCA Systems HbA1c reagent cartridges product insert from May 1,2022 to January 11, 2023. 4. Interview with LD #1 on January 11, 2023 at 1:00 PM, confirmed laboratory staff failed to follow manufacturer's instructions for running QC on the DCA Advantage from May 1, 2022 to January 11, 2023 and removed the UniStrip 1 Generic Blood Glucose Test Strips and the OneTouch Ultra meter for glucose testing on January 11, 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 2 -- D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) records and an interview with the laboratory director (LD) #1, the laboratory testing personnel (TP) failed to review, sign, and date the Proficiency Testing Attestation Statement forms for four out of 12 events in 2022. Findings: 1. A review of API's Proficiency Testing Attestation Statement lacked the signatures of the testing person(s) performing the test for the following proficiencies: a) 2022 Chemistry Core - 2nd Event b) 2022 Chemistry- Miscellaneous - 2nd Event c) 2022 Hematology/Coagulation - 3rd Event d) 2022 Chemistry Core - 3rd Event 2. Review of Standard Operating Procedures revealed that four out of four TP failed to follow their procedures as stated, "The Laboratory Director and all testing personnel will sign the attestation statement for each testing event they participate in". 3. An interview with LD #1 on January 11, 2023 at 12:30 PM confirmed four out of four TP failed to follow their procedures to sign and date API's Proficiency Testing Attestation Statement forms for four out of 12 events in 2022. -- 2 of 2 --

Summary Statement of Deficiencies 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 laboratory records and interview with General Supervisor (GS) #1, the laboratory failed to perform preventative maintenance (PM) for 1 of 2 centrifuges for years 2019 and 2020. Findings: 1. Observed two centrifuges in the laboratory, each with a calibration sticker. The calibration sticker for the UNICO PowerSpin LX Centrifuge was dated 4/16 (month /year) by BTM 2. No PM or calibrations records for the UNICO PowerSpin LX Centrifuge were available for review for years 2019 and 2020. 3. Interview with GS #1 on 6/24/2021 at 10:15 AM confirmed the laboratory failed to perform preventative maintenance for 1 of 2 centrifuges for years 2019 and 2020. 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 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 -- 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 IQCP Quality Control Plan, calibration records for the Abbott i- STAT Analyzer for CHEM8+ cartridge (analytes: Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Urea Nitrogen (BUN), Creatinine, Hematocrit), and i- STAT Troponin cartridge (analyte Troponin), and interview with the General Supervisor (GS) #1, the laboratory failed to perform at least a three point (a minimal, mid-point, and maximum) calibration verification every six months for years 2019 and 2020. Findings: 1. Review of 2019 and 2020 calibration records for Abbott i- STAT analyzer for Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Urea Nitrogen (BUN), Creatinine, Hematocrit and Troponin, revealed the laboratory failed to perform a calibration verification including, at least, a minimal, midpoint, and maximum value for each analyte, every six months for years 2019 and 2020 2. Review of IQCP Quality Control Plan for i-STAT Troponin revealed Calibration Verification should be performed with a linearity kit every 6 months. 3. Interview with the GS #1 on June 24, 2021 at 9:24 AM, confirmed the laboratory failed to perform at least a three point calibration verification for Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Urea Nitrogen (BUN), Creatinine, Hematocrit and Troponin, on the i-STAT analyzer every six months for years 2019 and 2020. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an off-site proficiency testing desk review conducted on 5/04/2020, deficiencies were cited for Colstrip Medical Center, Colstrip, MT 59323. 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 white blood cell differentials (WBC Diff) for two of three events (2019 event 3, 2020 event 1), resulting in unsuccessful proficiency testing performance. See D2130 D2130 HEMATOLOGY 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): 493.851(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 review of proficiency testing scores and interview, the laboratory failed to achieve a score of 80 percent for WBC Diff in two of three events in 2019 and 2020, resulting in unsuccessful performance. The findings include: 1. During a review on 5 /04/20 at 12:06 p.m. of the CMS-153 Unsuccessful Proficiency Testing Report included Colstrip Medical Center with unsuccessful proficiency testing scores for WBC Diff. 2. During a review on 5/04/20 at 12:35 p.m. of the CMS-155 report, the American Proficiency Institute (API) WBC Diff score for event 3 of 2019 was 0%. 3. During a review on 5/04/19 at 12:35 p.m. of the CMS-155 report, the API WBC Diff score for event 1 of 2020 was 0%. 4. On 4/23/19 at 4:36 p.m., the laboratory manager by email sent documents which reported errors for 2019 event 3 and 2020 event 1. Documents indicated the wrong values were submitted to API. -- 2 of 2 --