Wyoming State Hospital Laboratory

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing records, policy and procedure review, and staff interview, the laboratory failed to have a system in place for reviewing proficiency testing results that received an artificial score of 100% for 4 out of 29 API (American Proficiency Institute) and CAP (College of American Pathologists) proficiency testing events reviewed from July 2024 through July 2026. The findings were: 1. Review of the 2024 API Hematology event #2 comparative evaluation report showed the laboratory received an artificial score of 100% for the microscopic vaginal wet preparation challenge. Further review of the comparative evaluation report showed sample VA-02 was not graded due to "no consensus" and the laboratory was directed to "See Data Summary." There was no documentation the laboratory had performed a self-evaluation. 2. Review of the 2025 API Microbiology event #1 comparative evaluation report showed the laboratory received an artificial score of 100% for the molecular detection of parainfluenza virus. Further review of the comparative evaluation report showed sample RSV-04 was not graded due to "no appropriate peer group" and the laboratory was directed to "See Data Summary." There was no documentation the laboratory had performed a self-evaluation. 3. Review of the 2025 API Chemistry Core event #3 comparative evaluation report showed the laboratory received an artificial score of 100% on the analyte of measured LDL (low-density lipoprotein) cholesterol. Further review of the comparative evaluation report showed sample CH-11 and CH-13 were not graded due to "no consensus". There was no 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 -- documentation the laboratory had performed a self-evaluation. 4. Review of the 2026 CAP Toxicology event #1 comparative evaluation report showed the laboratory received an artificial score of 100% on the analyte of clozapine. Further review of the comparative evaluation report showed sample ZE-03 was not graded due to "result is outside the method/instrument range." There was no documentation the laboratory had performed a self-evaluation. 5. Interview with the technical consultant on 8/18/26 at 11:45 AM confirmed no further documentation was available. 6. Review of the policy "Proficiency Testing", last reviewed by the laboratory director on 5/10/24, showed "... Any discrepancy or failure of a PT sample must be evaluated and investigated. Remedial actions are then taken to prevent recurrence. These may include policy and /or procedural changes. The accuracy of patient testing must also be evaluated to ensure accuracy and precision of reported results..." -- 2 of 2 --

Summary Statement of Deficiencies 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on review of the CMS-116 form, lack of documentation, and staff interview, the laboratory failed to have a written procedure for reporting SARS-CoV-2 positive and negative test results. The laboratory had performed 126 SARS-CoV-2 patient test using a molecular platform since the test was implemented in January 2022. The findings were: 1. Review of the CMS-116 form showed the laboratory performed molecular testing for SARS-CoV-2 using the BD MAX molecular system. 2. Review of the laboratory's procedure manuals showed no evidence the laboratory had developed a policy and procedure for reporting SARS-CoV-2 positive and negative test results to the appropriate agencies. 3. Interview with the laboratory manager on 5 /23/22 at 3:53 PM confirmed the laboratory did not have a written procedure for reporting positive and negative SARS-CoV-2 patient test results. . 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. 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 -- (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 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 D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on proficiency testing records review, patient test reports review, and interview with the laboratory technical consultant, the laboratory failed to report proficiency samples using the same test method as for patient tests for 6 of 6 hematology testing events reviewed from October 2016 to October 2018. Findings include: 1. Proficiency testing records review included documentation the laboratory reported manual white blood cell identification as the test method performed for American Proficiency Institute Hematology: event 3 in 2016, events 1, 2, and 3 in 2017; and events 1 and 2 in 2018. 2. Patient test records review included documentation the laboratory performed white blood cell differentials by the Advia complete blood cell counting automated instrument for 10 of 10 complete blood count reports reviewed from 11/14 /2016 to 02/23/2018. 3. In an interview conducted on 10/22/2018 at approximately 12: 00 noon with the laboratory technical consultant (who is the testing person), the technical consultant stated patient's differentials were reported using the automated method and that the laboratory no longer performed manual differentials. 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 --