Wyoming State Hospital Laboratory

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 --