Boonville Correctional Center

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of chemistry individualized quality control plan (IQCP), quality control (QC) logs for 2021, 2022 and to date July 12, 2023 and interview with testing personnel (TP) #7, the laboratory failed to follow the IQCP for troponin quality control (QC) for 4 of 31 months. Findings: 1. Review of troponin IQCP stated troponin QC must be performed monthly. 2. Review of troponin QC showed no troponin QC documented from January 2021 to July 2023 for the following dates: 2021 -August -October 2022 -February -July 3. Interview with TP #7 on July 12, 2023 at 2:00 PM confirmed the laboratory failed to follow IQCP and perform troponin QC monthly. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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 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 -- director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of 2021, 2022, and 2023 testing personnel (TP) training documents and interview with TP#7, the LD failed to ensure two of six TP received the appropriate training before performing moderate complexity patient testing. Findings: 1. Review of TP training records showed TP #4 and TP #10 had no documented training before patient testing was performed. 2. Interview with TP #7 on July 12, 2023 at 2:00 PM confirmed the LD failed to ensure two of six TP received the appropriate training before performing moderate complexity patient testing. D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on lack of education, training, review of performance evaluations in 2021, 2022 and 2023 and interview with testing personnel (TP) #7, the laboratory failed to employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties of service in which the laboratory performs moderate complexity tests or procedures. Findings: 1. Lack of documentation for education and training showed the laboratory failed to document education and training needed to qualify the technical consultant. 2. Reveiw of performance evaluations showed the semiannual performance evaluation for TP # 8 was not performed by a qualified TC. 3. Review of 2021, 2022 and to date July 12, 2023 performance evaluations showed no qualified TC performed annual performance evaluation for the following: -2021: Testing personnel #2 -2022: Testing personnel #2, #3, and #5 -2023: Testing personnel #2, #3, #4, #5, #9, and #10. 4. Interview with the TP #7 at 2:00 PM on July 12, 2023 showed the laboratory failed to have a qualified technical consultant with proof of education and training or experience. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the performance evaluations for 2021, 2022 and to date July 12, 2023 and interview with testing personnel (TP) #7, the technical consultant (TC) -- 2 of 3 -- failed to evaluate and document performance evaluations at least semiannually during the first year for two of three testing personnel. Findings: 1. Review of performance evaluations showed no semiannual performance evaluation was documented for testing personnel #4 and TP #10. 2. Interview with testing personnel #7 on July 12, 2023 at 2:00 PM confirmed the TC failed to evaluate and document performance evaluations at least semiannually during the first year for two of three testing personnel. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of 2021, 2022 and to date July 12, 2023 performance evaluations and interview with testing personnel (TP) #7, the technical consultant (TC) failed to evaluate and document annual performance evaluations for one of four TP in 2022. Findings: 1. Review of 2022 performance evaluations showed no annual performance evaluation for testing personnel #9 in 2022. 2. Interview with testing personnel #7 on July 12, 2023 at 2:00 PM confirmed the technical consultant failed to evaluate and document annual performance evaluations for one of four TP in 2022. -- 3 of 3 --

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of personnel records and interview with the technical consultant (TC) #1, the laboratory failed to provide academic qualifications required to perform moderate complexity testing for one of seventeen testing personnel. (Refer to D6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of academic credentials and interview with the technical consultant 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 -- #1, the laboratory failed to provide academic credentials to qualify one of seventeen testing personnel (TP). Findings: 1. The laboratory could not provide academic credentials to show TP #7 was qualified to perform moderate complexity testing. 2. Telephone interview with the technical consultant #1 on January 10, 2022 at 2:00 PM confirmed the laboratory failed to provide academic credentials for one TP. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D6022 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 and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's individualized quality control plan (IQCP), quality control (QC) and patient records for 2018,and interview with technical consultant #2, the laboratory director failed to maintain the quality control / quality assessment programs and identify failures when they occur. Findings: 1. The IQCP policy, "Monthly review of results and control documentation" shows the technical consultant is responsible to ensure external positive and negative control materials are completed and documented monthly. The "Quarterly Quality Assessment (QA) Record Review", stated, "results will be reviewed by the CQI Committee. Identification of problems should be discussed and actions to correct the problem should be implemented." 2. Review of QC records for 2108 revealed the laboratory performed and documented an external positive and negative QC result on January 11, 2018 and not again until April 16, 2018. The laboratory performed and documented an external positive and negative QC results on July 25, 2018 and not again until October 29, 2018. The laboratory did not have documentation to show it performed a monthly positive and negative QC for February, March, August and September 2018. 3. Review of patient troponin records for 2018 revealed the laboratory tested and reported ten patient specimens from January 14, 2018 through April 15, 2018. Nine patient specimen were tested and reported from August 19, 2018 through October 13, 2018. 4. No documentation was available to show the laboratory detected the QC 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 -- problems and implemented