Msu Student Health Services

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at MSU Student Health Partners on August 21, 2025, by the Montana CLIA Program. The laboratory was evaluated for compliance with the CLIA requirements under 42 CFR Part 493. Specific deficiencies were identified during the survey. 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. This STANDARD is not met as evidenced by: Based on a record review, laboratory policy and procedure, and an interview with Technical Supervisor (TS) #1, the laboratory failed to assess the competency of the technical supervisor and general supervisor listed on the CMS-209 Laboratory Personnel Report based on their position responsibilities, and failed to follow its procedure for conducting annual competency assessments for one of four testing personnel (TP) from August 21, 2023, to August 21, 2025. Findings: 1. A review of the CMS-209 Form revealed that one individual was listed as both the technical supervisor and the general supervisor. No competency assessments based on the responsibilities of these positions were available for review from August 21, 2023, to August 21, 2025. 2. A review of the "QA Program: Laboratory" policy and procedure revealed that the laboratory failed to follow its procedure for conducting an annual competency assessment for TP #4 using the six required elements for years 2024 and 2025. 3. An interview with TS #1 on August 21, 2025, at 9:20 AM confirmed that the laboratory failed to assess the competency of the technical supervisor and general Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- supervisor based on their respective position responsibilities, and failed to follow its procedure for conducting annual competency assessments for one of four testing personnel from August 21, 2023, to August 21, 2025. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) proficiency testing records and an interview with technical supervisor (TS) #1, the laboratory failed to verify the accuracy of "Not Graded" scores for eleven of eleven proficiency testing (PT) events from August 21, 2023, to August 21, 2025. Findings: 1. A review of proficiency testing records lacked documentation that the laboratory verified the accuracy of the "Not Graded" scores for the following PT events: API 2023 Hematology/Coagulation 3rd Event - Vaginal Wet Preparation (KOH) and Educational Blood Cell Identification API 2024 Chemistry Core 1st Event - Bilirubin, Total API 2024 Microbiology 1st Event - Gram Stain Morphology and Urine Culture Susceptibility Interpretation API 2024 Microbiology 2nd Event - Gram Stain and Urine Culture Susceptibility Interpretation API 2024 Microbiology 3rd Event - Gram Stain API 2024 Hematology/Coagulation 1st Event - Educational Blood Cell Identification API 2024 Hematology/Coagulation 2nd Event - Vaginal Wet Preparation (KOH) and Educational Blood Cell Identification API 2024 Hematology/Coagulation 3rd Event - Educational Blood Cell Identification API 2025 Hematology/Coagulation 1st Event - Educational Blood Cell Identification API 2025 Chemistry Core 2nd Event - Bilirubin, Total API 2025 Microbiology 2nd Event - Gram Stain Morphology 2. An interview with TS #1 on August 21, 2025, at 10:10 AM confirmed the laboratory failed to verify the accuracy of "Not Graded" scores for eleven PT events listed above from August 21, 2023, to August 21, 2025. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of patient test reports, verification records, and an interview with Technical Supervisor (TS) #1, the laboratory failed to verify that complete blood count (CBC) with automated 6-part differential reference ranges (normal values) used for reporting patient test results were appropriate for the laboratory's patient population from August 21, 2023, through August 21, 2025. Findings: 1. A review of CBC with automated 6-part differential patient results reports for Sample IDs 189401 -- 2 of 4 -- and 198093 listed reference intervals (normal values) for the following analytes: White Blood Cell count (WBC), Red Blood Cell count (RBC), Hemoglobin (HGB), Hematocrit (HCT), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Platelet count (PLT), Red Cell Distribution Width (RDW), Mean Platelet Volume (MPV), Absolute Neutrophil Count (NEUT#) and Neutrophil Percentage (NEUT%), Absolute Immature Granulocyte Count (IG#), Absolute Lymphocyte Count (LYMPH#) and Lymphocyte Percentage (LYMPH%), Absolute Monocyte Count (MONO#) and Monocyte Percentage (MONO%), Absolute Eosinophil Count (EO#) and Eosinophil Percentage (EO%), and Absolute Basophil Count (BASO#) and Basophil Percentage (BASO%). The CBC patient results reports failed to include a reference range for Immature Granulocyte Percentage (IG%), a reportable analyte on the Sysmex XN- 430. 2. The laboratory failed to provide documentation verifying that the reference intervals (normal values) listed in patients' CBC result reports were appropriate for its patient population for analytes performed on the Sysmex XN-430 hematology analyzer. 3. An interview with the TS #1 on August 21, 2025, at 2:20 PM, stated they were unaware of the origin of the reference ranges listed in the patients CBC results reports and confirmed the laboratory failed to verify the CBC reference ranges (normal values) were appropriate for its patient population from August 21, 2023, to August 21, 2025. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, review of maintenance records, policy and procedures, and an interview with technical supervisor (TS) #1, the laboratory failed to define and perform a function check protocol to verify the accuracy of two centrifuges and one microscope used in patient testing from August 21, 2023, to August 21, 2025. Findings: 1. On August 21, 2025, at 11:45 AM, two centrifuges and one microscope were observed in the laboratory. Maintenance records lacked documentation of the tachometer readings and timer checks for the centrifuges to verify accuracy, and there was no documentation describing what function check was performed for the microscope. 2. A review of the Test Volume Report showed that 480 microscopic urinalyses were performed in the past 12 months using the centrifuge and microscope as part of the testing process. 3. A review of the laboratory's policy and procedure revealed that no function check protocol had been established for the two centrifuges and the microscope. 4. An interview with TS #1 on August 21, 2025, at 12:15 PM confirmed the laboratory failed to define and perform a function check protocol to verify the accuracy of two centrifuges and one microscope from August 21, 2023, to August 21, 2025. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) -- 3 of 4 -- (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 a review of calibration records, laboratory policy and procedure, and an interview with Technical Supervisor (TS) #1, the laboratory failed to follow its procedure to perform one of two calibration verifications every six months for sodium, potassium, and chloride testing performed on the Siemens Dimension EXL 200 chemistry analyzer during the calendar year 2024. Findings: 1. A review of calibration records for sodium, potassium, and chloride testing performed on the Siemens Dimension EXL 200 chemistry analyzer lacked one of two calibration verifications studies for calendar year 2024. 2. A review of the "QA Program: Laboratory" policy and procedure revealed the laboratory failed to follow their procedure to perform calibration verifications every 6 months. 3. An interview with TS #1 on August 20, 2025, at 2:44 PM confirmed the laboratory failed to follow their procedure to perform one of two calibration verifications every six months for sodium, potassium, and chloride testing performed on the Siemens Dimension EXL 200 chemistry analyzer during the calendar year 2024. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Based on an off-site proficiency testing desk review conducted on 11/15/2020, deficiencies were cited for MSU University Health Partners in Bozeman, 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 white blood cell differentials (WBC Diff) for four of four events (2019 Event 3, 2020 Event 1, 2020 Event 2, and 2020 Event 3), resulting in unsuccessful proficiency testing performance. See D2130 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 -- D2130 HEMATOLOGY 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 four of four events (2019 Event 3, 2020 Event 1, 2020 Event 2, and 2020 Event 3), resulting in unsuccessful proficiency testing performance. The findings include: 1. Review of CMS-2567 with Conditions Out-First Unsuccessful PT Performance dated May 28, 2020 addressed to Cara Maletz. 2. Review of CMS-153 Unsuccessful Proficiency Testing Report on 05/4/20 at 12:06 p.m. and 11/16/20 at 9:10 a.m., which included MSU University Health Partners with unsuccessful proficiency testing scores for WBC Diff. 3. Review of the CMS-155 report on 5/18/20 at 2:35 a.m., revealed the American Association of Bioanalysts (AAB) WBC Diff scores for 2020 Event 3 was 72% and 2020 Event 1 was 60%. 4. Review of the CMS-155 report on 11/16/20 at 10:50 a.m., revealed the American Association of Bioanalysts (AAB) WBC Diff scores for 2020 Event 2 and Event 3 were 60%. 5. The laboratory manager confirmed on 12/01/20 at 10:06 a.m., failed scores due to clerical errors. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an offsite proficiency desk review conducted on 5/04/2020, deficiencies were cited for MSU University Health Partners, Bozeman, 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 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 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 -- D2130 HEMATOLOGY 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 MSU University Health Partners with unsuccessful proficiency testing scores for WBC Diff. 2. During a review on 5/18/20 at 2:35 p.m. of the CMS-155 report, the WBC Diff score for event 3 of 2019 was 72%. 3. During a review on 5/18/20 at 2:35 p. m. of the CMS-155 report, the WBC Diff score for event 1 of 2020 was 60%. 4. On 5 /27/2020 at 2:41 p.m., the laboratory manager indicated instrument setting errors for 2020 event 1. -- 2 of 2 --