Parsons State Hospital & Training Center

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) documentation and interview, the laboratory failed to test proficiency samples the same number of times that it routinely tests patient samples. Findings: 1. Review of the laboratory's 2022 PT documentation found the laboratory was testing PT samples multiple times over a 3 day period for 2022 - Q2 Non- Chemistry-Hematology. Five Hematology samples: Vials 6, 7, 8, 9, and 10 were analyzed for 6 regulated analytes of the Complete Blood Count (CBC): Red Bloodcell Count (RBC), Hemoglobin, Hematocrit, Platelet, White Bloodcell Count (WBC), and WBC diff or Cell I.D as follows: a. Sample 6: CBC performed 3 times 5/16/22, 3 times 5/17/22 and 1 time 5/18/22. b. Sample 7: CBC performed 1 time 5/16/22, 1 time 5/17/22 and 1 time 5/18/22. c. Sample 8: CBC performed 1 time 5/16/22, 1 time 5/17 /22 and 1 time 5/18/22.. d. Sample 9: CBC performed 2 times 5/16/22, 2 times 5/17 /22 and 1 time 5/18/22. e. Sample 10: CBC performed 2 times 5/16/22, 2 times 5/17 /22 and 1 time 5/18/22. 2. No documentation for the reason of the repeated testing was provided at survey. The Technical Consultant (TC) was asked if patient samples were routinely tested by multiple runs and multiple day analysis on the same sample. The TC response was she did not know why samples were run multiple times over multiple days. The TC was also the testing personnel for these samples. 3. Interview with TC on 12/29/22 at 10:35 a.m. confirmed, the laboratory failed to test proficiency samples the same number of times that it routinely tests patient samples. 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 D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview, the laboratory failed to include the address of the laboratory location were the test was performed on the patient report. Findings: 1. Review of selected patient test reports for reference laboratory testing showed the name and city only. It lacked the referred laboratory street address where the test was performed. 2. Interview with the Technical Consultant on April 1, 2021 at 12:30 p.m. confirmed the laboratory failed to include the address of the laboratory location were the test was performed on the patient report. 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 --