Jefferson City Correctional Center

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on of proficiency records for 2021, 2022 and to date April 11, 2023, review of patient reports and interview with the technical consultant (TC) #1, the laboratory failed to establish a means to verify the accuracy of the non-regulated analyte for troponin I testing twice a year. Findings: 1. Review of proficiency records for 2021, 2022 and to date April 11, 2023, showed the laboratory failed to prove accuracy on the non-regulated analyte troponon I exam since the 2nd event Chemistry - Core for 2022. 2. Review of patient results confirmed the laboratory reports out results for urine microscopic exams. 3. Interview with the TC #1 on April 11, 2023 at 1:00 PM confirmed the laboratory failed to establish a means to verify the accuracy of the non- regulated analyte troponin I testing twice a year. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on review of laboratory procedures, pharmacy refrigerator, pharmacy refrigerator/room temperature logs for 2021/2022/2023, and interview with the technical consultant (TC) #1, the laboratory failed to monitor and document refrigerator temperature for proper storage requirements of troponin quality control material. Findings: 1. Review of laboratory procedure "Troponin Testing: Quality Management" states "Temperatures of all refrigerators in which reagents are stored must have the temperature recorded daily." 2. Review of the pharmacy refrigerator showed 1 box of troponin quality control material lot # 22ASB0028F expiration date 05/31/2024. 3. Review of pharmacy refrigerator/room temperature logs for 2021 and 2022 showed no documented temperatures from January 2021 to October 2022. 4. Review of pharmacy refrigerator/room temperature logs for 2023 showed no documented temperature for February 5, 2023. 5. Interview with the TC #1 on April 11, 2023 at 1:00 PM confirmed the laboratory failed to monitor and document refrigerator temperature for storage of troponin quality control materials. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the 2021/2022/2023 proficiency testing (PT) records, lack of an approved

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of competency/performance evaluations and interview with the laboratory manager, the technical consultant failed to evaluate and document the competency for 23 of 23 testing personnel performing moderate complexity troponin testing for 2019 and 2020. Findings: 1. Review of competency/performance evaluations revealed no documentation to show the technical consultant evaluated and documented the competency for 23 testing personnel performing moderate complexity troponin testing. 2. Interview with laboratory manager on January 26, 2021 at 1:15 PM confirmed the technical consultant failed to evaluate and document the competency of all testing personnel for 2019 and 2020. 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 D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's "Quality Control Plan" (QCP), quality control (QC)and patient records for 2017/2018, and interview with testing personnel #1, the director failed to ensure the QCP was maintained and followed by testing personnel performing moderate complexity troponin testing. Findings: 1. The QCP states, "Two levels of external controls will be used once a month or each testing day, depending on the volume of testing. The results expected ( Level I being negative and Level II being positive) must match the results obtained. Document these results on the control log and keep on file for director's review." 2. Review of QC records (control log) for 2017/2018 revealed the laboratory performed and documented two levels of external controls on September 21, 2017 and not again until February 19, 2018. During this timeframe forty patient specimens were tested for qualitative troponin. 3. Interview with testing personnel #1 on October 24, 2018 at 11:00 AM confirmed, the laboratory director failed to ensure testing personnel perform two levels of controls at frequency required per QCP. 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 --