Deer Lodge Medical Center

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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) and American Association of Bioanalysts (AAB) proficiency testing records and an interview with the technical supervisor (TS) #1, the laboratory failed to have an attestation form signed by testing personnel and the laboratory director to attest to the routine integration of the samples into the patient workload using the laboratory's routine methods for six of six proficiency testing events from June 17, 2023, to June 18, 2025. Findings: 1. Review of proficiency testing records failed to have an Attestation Statement for the following proficiencies: API 2024 Hematology/Coagulation 1st Event AAB 2024 Urine Drug Screen 2nd Event AAB Viral Markers 2024 1st Event AAB Blood Gases 2024 1st Event AAB Infectious Mono 2024 3rd Event AAB Blood Cell Identification 2024 3rd Event 2. An interview with TS #1 on June 17, 2025, at 4:00 PM confirmed the laboratory failed to have an attestation form signed by testing personnel and the laboratory director to attest to the routine integration of the samples into the patient workload using the laboratory's routine methods for six of six proficiency testing events from June 17, 2023, to June 18, 2025. 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 4 -- This STANDARD is not met as evidenced by: Based on a record review and an interview with technical supervisor (TS) #1, the laboratory failed to include in its procedure and the general supervisor' competency assessment criteria, failed to perform the competency assessment for six of the six general supervisors (GS) listed on the CMS-209 Personnel Report form and failed to follow its procedure to annually assess five of the five testing personnel (TP) for each specific test procedure they perform using the six competency assessment procedures from June 17, 2023, to June 18, 2025. Findings: 1. A review of the CMS-209 Personnel Report Form revealed six of the six personnel listed as general supervisors (GS #1, GS #2, GS #3, GS #4, GS #5, and GS #6) lacked a competency assessment based on the position responsibilities from June 17, 2023, to June 18, 2025. 2. A review of the "Laboratory Competency Assessments" procedure lacked the frequency of the general supervisor competency assessment based on their federal regulatory responsibilities. 3. The laboratory failed to follow its "Laboratory Competency Assessments" procedure and assess the competency of TP #1, TP #3, TP #4, TP #5, and TP #6 annually for each test procedure they performed using the six competency assessment procedures from June 17, 2023, to June 18, 2025. 4. An interview with TS #1 on June 17, 2023, at 12:30 PM confirmed that the laboratory failed to include in its procedure the general supervisor' competency assessment criteria, failed to perform the competency assessment for six of the six general supervisors, and failed to follow its procedure to annually assess five of the five testing personnel for each specific test procedure they perform using the six competency assessment procedures from June 17, 2023, to June 18, 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 the technical supervisor (TS) #1, the laboratory failed to verify the accuracy of "Not Graded" scores for four of the four proficiency testing (PT) events from June 17, 2023, to June 18, 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 2024 Hematology/Coagulation - 3rd Event for Body Fluid Cell Count-C sample BFC-03 API 2024 Microbiology - 1st Event for Gram Stain Morphology sample GS-02 API 2024 Microbiology - 2nd Event for Gram Stain sample GS-08 API 2024 Microbiology - 3rd Event for Gram Stain sample GS-13 2. An interview with TS #1 on June 17, 2025, at 4:10 PM confirmed the laboratory failed to verify the accuracy of "Not Graded" scores for four of the four PT events from June 17, 2023, to June 18, 2025. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, -- 2 of 4 -- storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

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 hematocrit (Hct) for two consecutive testing events, resulting in unsuccessful proficiency testing performance in 2024 and 2025. (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 -- (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 and an email communication with technical supervisor (TS) # 1, the laboratory failed to achieve a score of at least 80% for two consecutive testing events for hematocrit (Hct) in 2024 and 2025. Findings: 1. A review of API's Blood Oximetry PT records on April 2, 2025, revealed the laboratory failed to achieve a satisfactory performance score of 80% or greater for the following events: 2024 Hematocrit Event 3 - 20% 2025 Hematocrit Event 1 - 40% 2. An email communication with TS #1 on April 03, 2025, at 7:37 AM, confirmed the laboratory's unsuccessful proficiency testing scores were due to entering the measured hematocrit values into API as a calculated hematocrit result for two consecutive PT testing events in 2024 and 2025. -- 2 of 2 --

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 routine desk audit of the CMS-155 report for proficiency testing (PT) performance, a review of College of American Pathology (CAP) records and interview with the technical supervisor (TS) #1, the laboratory failed to achieve satisfactory performance for prothrombin time performed on the Xprecia Stride Coagulation Analyzer 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 review of College of American Pathology (CAP) proficiency testing (PT) scores and interview with technical supervisor (TS) #1, the laboratory failed to achieve a score of at least 80% for two consecutive testing events (2023 WP9-B and WP9-C) for prothrombin time performed on the Xprecia Stride Coagulation Analyzer. Findings: 1. A review of the CAP total prothrombin time proficiency testing scores revealed that in year 2023, WP9-B scored 0% and WP9-C scored 0%. 2. An interview with TS #1 on October 23, 2023, at 12:31 PM confirmed the laboratory's failed prothrombin time proficiency scores for 2023 WP9-B and WP9-C were due to the lack of submitting an appropriate response to CAP. -- 2 of 2 --

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 September 16, 2022, to May 16, 2023. Findings: 1. A review of Immunohematology records revealed the laboratory failed to take and document the temperatures of blood or blood products upon receipt of new shipments from September 16, 2022, to May 16, 2023. 2. A review of "Receipt and Processing of Blood Products" policy lacked a temperature requirement for the acceptance of blood or blood product and instructions for documentation. 3. An interview with TS #1 on May 16, 2023 at 11:00 AM, confirmed laboratory staff failed to take the temperature upon receipt of new shipments of blood or blood products and document the information from September 16, 2022 to May 16, 2023. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of bacteriology, chemistry, hematology, and blood bank records, and policies, the laboratory failed to verify the laboratory's patient population reference ranges (normal values) for the chemistry and hematology analyzers (See D5421); failed to establish the mean and standard deviation for each new lot of unassayed Bio-Rad chemistry controls (See 5469); failed to perform quality checks and record visual checks for each new lot or shipment of microbiology media (See 5477); failed to perform one control in duplicate on the hemocytometer (See 5543); failed to follow their procedure to perform visual inspection checks of blood or blood products upon receipt (See D5553); and failed to follow their procedure to perform and document monthly alarm checks for blood bank refrigerator and freezer (See D5555). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 routine desk audit of CMS-153 and 155 reports of proficiency testing performance and interview with laboratory manager, the laboratory failed to achieve satisfactory performance for compatibility testing for two out of three events (2021 Event 2 and 2022 Event 1), resulting in unsuccessful proficiency testing performance. (Refer to D2181) D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 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 American Association of Bioanalysts (AAB) proficiency testing scores and interview with laboratory manager, the laboratory failed to achieve a score of 100% for Compatibility Testing for two out of three events (2021 Event 2 and 2022 Event 1). Findings: 1. Review of CMS-153 Unsuccessful Proficiency Testing Report on 05/11/2022 at 10:00 AM, which included Deer Lodge Medical Center with unsuccessful proficiency testing scores for Compatibility Testing. 2. Review of the CMS-155 Individual Laboratory Profile on 05/12/2022 at 9:59 AM, revealed Compatibility Testing scores for 2021 Event 2 was 80% and 2022 Event 1 was 20%. 3. Interview with laboratory manager on 05/12/2022 at 10:48 AM, confirmed unsuccessful proficiency scores for Compatibility Testing due to the quality of testing material. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review of American Proficiency Institute (API) and American Association of Bioanalysts (ABB) proficiency testing scores for Hematology and interview with Technical Supervisor (TS) #1, the laboratory failed to ensure the laboratory was enrolled in a HHS-approved proficiency testing program for Hematology (Reticulocyte counts) performed on the Sysmex CA-600 for years 2020 and 2021. Findings: 1. Review of American Proficiency Institute (API) and American Association of Bioanalysts (ABB) proficiency testing scores for Hematology lacked results for Reticulocytes Counts. 2. Review of 2021 Test Volume Sheet revealed 18 Reticulocytes Counts were performed. 3. Interview with TS #1 on November 9, 2021 at 10:00 AM, confirmed the laboratory failed to be enrolled in a HHS-approved proficiency testing program for Hematology (Reticulocyte counts) performed on the Sysmex CA-600 for years 2020 and 2021. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the 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 -- 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 chemistry and hematology calibration records and interview with the Technical Supervisor (TS) #1, the laboratory failed to perform at least three-point (a minimal, mid-point, and maximum) calibration verification every six months or after CLEW software updates for the Abbott i-STAT Analyzer and failed to verify sodium citrate tubes every 6 months to achieve platelet poor plasma from January 2020 to November 2021. Findings: 1. Review of 2020 and 2021 calibration records for Abbott i-STAT analyzer for analytes sodium, potassium, chloride, bicarbonate, blood urea nitrogen, creatinine, calcium, and glucose revealed the laboratory failed to perform a calibration verification including, at least, a minimal, midpoint, and maximum value for each analyte, performed every six months or after CLEW software updates. 2. No platelet poor plasma studies using sodium citrate tubes were available for review from January 2020 to November 2021. 3. Interview with the TS #1 on November 9, 2021 at 1:50 PM, confirmed the laboratory failed to perform at least a three-point calibration verification for analytes performed on the i-STAT Analyzer every six months or after CLEW software updates and failed to verify sodium citrate tubes every 6 months to achieve platelet poor plasma from January 2020 to November 2021. 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 instrument comparison documentation and interview with Technical Supervisor (TS) #1, the laboratory failed to evaluate and define the relationship between test results using different instruments from January 2020 to -- 2 of 3 -- November 2021 for analyzers Abbott i-STAT and the Siemens Dimension EXL for analytes sodium, potassium, chloride, bicarbonate, blood urea nitrogen, creatinine, calcium and glucose; analyzers bioMrieux VIDAS and PATHFAST for analyte D- Dimer; and analyzers Siemens Dimension EXL and PATHFAST for analyte troponin two times a year. Findings: 1. No instrument comparison studies for Abbott i-STAT and the Siemens Dimension EXL for analytes sodium, potassium, chloride, bicarbonate, blood urea nitrogen, creatinine, calcium and glucose were available to review from January 2020 to November 2021. 2. No instrument comparison studies for bioMrieux VIDAS and PATHFAST for analyte D-Dimer were available to review from January 2020 to November 2021. 3. No instrument comparison studies for Siemens Dimension EXL and PATHFAST for analyte troponin were available to review from January 2020 to November 2021. 4. Interview with TS #1 on November 9, 2021 at 3:18 PM, confirmed the laboratory failed to evaluate and define the relationship between test results using different instruments from January 2020 to November 2021, for analyzers Abbott i-STAT and the Siemens Dimension EXL for analytes sodium, potassium, chloride, bicarbonate, blood urea nitrogen, creatinine, calcium and glucose; analyzers bioMrieux VIDAS and PATHFAST for analyte D- Dimer; and analyzers Siemens Dimension EXL and PATHFAST for analyte troponin. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 3/6/19, deficiencies were cited for Deer Lodge Medical Center in Deer Lodge, 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 observation, record review, and interview, the laboratory failed to enroll in proficiency testing for two of three molecular panels performed on the Biofire Filmarray from 6/30/17 through 3/6/19. The findings include: 1. On 3/6/19 at 9:15 a. m., a Biofire Filmarray was observed in the laboratory. 2. On 3/6/19 at 9:15 a.m., staff member A stated the respiratory panel, gastrointestinal (GI) panel, and blood panels were performed on the Biofire Filmarray. 3. A review on 3/6/19 at 10:00 a.m. of the American Proficiency Institute (API) and American Association of Bioanalysts (AAB) proficiency testing binders lacked documentation of enrollment for the GI and blood panels performed on the Biofire Filmarray. 4. On 3/6/19 at 10:00 a.m., staff member A stated plate culture enrollment was used for the Biofire Filmarray GI and blood panels. 5. On 3/6/19 at 11:30 a.m., staff member A stated the plate culture enrollment did not report all of the viruses, bacteria, and parasites identified by the GI and blood panels. 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 -- 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 perform annual competency evaluations on one of four testing personnel in 2017 and 2018. The findings include: 1. A review on 3/6/19 at 11:15 a.m. of the competency assessments lacked documented competency on staff member A. 2. On 3/6/19 at 11: 15 a.m., staff member A stated competency assessments were not performed. -- 2 of 2 --