Central Mississippi Correctional Facility

Summary Statement of Deficiencies D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records to include quality control (QC) logs, patient result logs, proficiency test records and temperature logs from 03/09/2022 until 10/27/2023, and interview with the laboratory manager at 1:30 p.m. on 10/27 /2023, the technical consultant (TC) failed to visit and directly observe performance of QC and patient testing since the last survey on 4/1/2022. Findings Include: 1. Based on surveyor review of laboratory records including QC logs, temperature logs, and patient result logs had been faxed to the TC for documented review. Records from 3/10/22 through 7/18/2023 were faxed to the TC according to the fax receipt date on the signed documents. Records fom 7/19/2023 through 10/23/2023 were faxed and signed on 10/23/2023. 2. The laboratory manager confirmed in an interview at 1:30 p. m. on 10/27/2023 that the TC had not visited the laboratory to directly observe any routine testing of patients and QC since 4/1/2022. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: 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 -- Based on surveyor review of laboratory temperature records from 3/10/22 through 10 /27/2023 and an interview with the laboratory manager at 12:00 p.m. on 10/27/2023, the technical consultant (TC) failed to document review of 17 of 17 months of freezer temperature logs (where the Troponin quality control was stored) from 3/10/2022 until 10/27/2023 performed for the evaluation of the competency of the staff. Findings Include: 1. Review of freezer temperature records from 3/10/2022 through 10/27/2023 revealed no documentation of review by the TC for 17 of 17 months. 2. In an interview the laboratory manager confirmed on 10/27/2023 at 12:00 p.m. that freezer temperature logs, where Troponin quality control material was being stored, were not documented as reviewed by the TC between 3/10/2022 and 10/27/2023. THIS IS A REPEAT DEFICIENCY 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 surveyor review of laboratory personnel records from 3/10/2022 through 10 /27/2023, including the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and personnel competency evaluations, and an interview with the laboratory manager at 1:30 p.m. on 10/27/2023, the technical consultant (TC) failed to evaluate and document the performance of testing personnel TP #1 (1 of 1 new testing personnel since 9/25/2021) at least semiannually during the first year of moderate complexity testing. The semiannual evaluation available the day of survey was performed by someone other than the TC. Findings include: 1. Review of the laboratory personnel records indicated that TP #1 was initially trained and began moderate complexity testing on 9/25/2021. 2. The 6-month competency evaluation available for review on TP #1 was performed on 3/25/2022 by the laboratory manager who does not qualify as a TC. 3. The laboratory manager confirmed in an interview at 1:30 p.m. on 10/27/2023 that the 6 month evaluation/competency was not performed by the TC during the first year of performing moderate complexity testing. 4. The TC failed to document 6 month competency evaluation on 1 of 1 new 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 testing personnel (TP) records including the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and laboratory personnel competency evaluations, and interview with the laboratory manager at 1:30 p.m. on 10 /27/2023, the technical consultant failed to evaluate the performance for testing personnel (TP) #1, listed on the CMS 209 form, at least annually for the years 2022 and 2023 (2 of 2 annual competencies due). Findings include: 1. The surveyor reviewed personnel records form 9/25/2021 through 10/27/2023 including -- 2 of 3 -- competency evaluations and the CMS 209 personnel form. 2. TP #1 completed initial training on 9/25/2021 and began moderate complexity testing. 3. There was no annual competency evaluation for TP#1 performed by the TC for 2022 (due in September 2022). 4. There was no annual competency evaluation for TP #1 performed by the TC for 2023 (due in September 2023). 5. The only annual competency on TP #1 available for review on the day of survey was completed on 3/25/23 and was performed by a staff member not qualified as a TC. 6. The laboratory manager confirmed in an interview at 1:30 p.m. on 10/27/2023 that no annual competency evaluations had been documented as performed by the TC for TP #1 from 9/25/21 through 10/27/2023(2 of 2 annual competency evaluations). -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records for 2020, 2021 and 1st event of 2022, surveyor review of the Centers for Medicare & Medicaid Services (CMS) 209 personnel form, and confirmation by the laboratory manager at 2:00 p.m. on 3/9/22, the laboratory failed to allow testing personnel (TP) who routinely perform Troponin I testing on patient samples to participate in proficiency testing events since 2019. Findings include: 1. Review of proficiency records since the last survey on 10/2 /19 revealed all 3 events of 2020, 2021 and the 1st event of 2022 were performed by laboratory personnel who do not perform Troponin I testing on patient specimens. TP #1, #2, and #3 as listed on the CMS 209 form perform all Troponin I testing on patients but did not participate in proficiency testing events. 2. According to an interview with the laboratory manager at 2:00 p.m. on the day of survey, the laboratory personnel that performed all proficiency testing events in 2020, 2021 and 2022 only perform waived testing. All Troponin I testing on patient samples is performed by the TP listed on the CMS-209. None of the TP listed on the CMS-209 participated in the proficiency testing for Troponin I. 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. 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 CONDITION is not met as evidenced by: Based on the review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, lack of qualifying documentation, and interview by phone with the Correctional Facility Medical Director at 1:30 p.m. on 3/9/22, the laboratory does not have a laboratory director who meets the qualification requirements of 493.1405 of this subpart. D6003 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1405 AND 493.1406 The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the Laboratory is located; and (b)(2)(ii) Have had laboratory training or experience consisting of: (b)(2)(ii)(A) At least one year directing or supervising non- waived laboratory testing; or (b)(2)(ii)(B) Beginning September 1, 1993, have at least 20 continuing medical education credit hours in laboratory practice commensurate with the director responsibilities defined in 493.1407; or (b)(2)(ii)(C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section obtained during medical residency. (For example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution; and (b)(3)(i) Be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (b)(3)(ii) Have had at least one year experience directing or supervising non-waived laboratory testing; (b)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; (b)(4)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing; and (b)(4)(iii) In addition, have at least one year of supervisory laboratory experience in non-waived testing; or (b)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; (b)(5)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing; and (b)(5)(iii) In addition, have at least 2 years of supervisory laboratory experience in non-waived testing; (b)(6) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under 493.1406; or (b)(7) On or before February 28, 1992, qualified under State law to direct a laboratory in the State in which the laboratory is located. Laboratory director qualifications on or before February 28, 1992 The laboratory director must be qualified to manage and direct the laboratory personnel and test performance. (a) The laboratory director must possess a current license as a laboratory director issued by the State, if such licensing exists; and (b) -- 2 of 5 -- The laboratory director must: (b)(1) Be a physician certified in anatomical or clinical pathology (or both) by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (b)(2) Be a physician who: (b)(2)(i) Is certified by the American Board of Pathology or the American Osteopathic Board of Pathology in at least one of the laboratory specialties; or (b)(2)(ii) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board in one of the laboratory specialties; or (b)(2)(iii) Is certified by the American Society of Cytology to practice cytopathology or possesses qualifications that are equivalent to those required for such certification; or (b)(2)(iv) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(3) For the subspecialty of oral pathology only, be certified by the American Board of Oral Pathology, American Board of Pathology or the American Osteopathic Board of Pathology or possesses qualifications that are equivalent to those required for certification; (b)(4) Hold an earned doctoral degree from an accredited institution with a chemical, physical, or biological science as a major subject and (b)(4)(i) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board acceptable to HHS in one of the laboratory specialties; or (b)(4)(ii) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(5) With respect to individuals first qualifying before July 1, 1971, have been responsible for the direction of a laboratory for 12 months between July 1, 1961, and January 1, 1968, and, in addition, either: (b)(5)(i) Was a physician and subsequent to graduation had at least 4 years of pertinent full-time laboratory experience; (b)(5)(ii) Held a master's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 4 years of pertinent full- time laboratory experience; (b)(5)(iii) Held a bachelor's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 6 years of pertinent full-time laboratory experience; or (b)(5)(iv) Achieved a satisfactory grade through an examination conducted by or under the sponsorship of the U.S. Public Health Service on or before July 1, 1970; or (b)(6) Qualify under State law to direct the laboratory in the State in which the laboratory is located. Note: The January 1, 1968 date for meeting the 12 months' laboratory direction requirement in paragraph (b)(5) of this section may be extended 1 year for each year of full-time laboratory experience obtained before January 1, 1958 required by State law for a laboratory director license. An exception to the July 1, 1971 qualifying date in paragraph (b)(5) of this section was made provided that the individual requested qualification approval by October 21, 1975 and had been employed in a laboratory for at least 3 years of the 5 years preceding the date of submission of his qualifications. This STANDARD is not met as evidenced by: Based on review of the CMS 209 personnel form, lack of qualifying documentation available for review, interview with the Correctional Facility Medical Director by phone and the laboratory manager at 1:30 p.m. on 3/9/22, the laboratory did not have an individual designated as laboratory director who meets the qualification requirements of 493.1405 of this subpart from 1/7/22 through 3/9/22. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY -- 3 of 5 -- CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the CMS 209 personnel form, lack of qualifying documentation, interview by phone with the Correctional Facility Medical Director, and interview with the laboratory manager at 1:30 p.m. on 3/9/22, the laboratory does not have a technical consultant who meets the qualification requirements of 493.1411 of this subpart. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on review of the CMS 209 personnel form, lack of qualifying documentation available for review, interview with the Correctional Facility Medical Director by -- 4 of 5 -- phone, and interview with the laboratory manager at 1:30 p.m. on 3/9/22, the laboratory did not have an individual designated as technical consultant who meets the qualification requirements of 493.1411 of this subpart from 1/7/22 through 3/9/22. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of laboratory testing records from 10/3/19 through 3/9/22 and interview with the laboratory manager at 12:30 p.m. on 3/9/22, the following records had not been documented as reviewed by the technical consultant (TC): Findings Include: 1. Review of the laboratory records from 10/3/19 through 3/9/22 revealed the following records were not documented as reviewed by the TC: a. Temperature logs (room and refrigerator) from 1/1/21 through 3/9/22 b. Life Sign Troponin I quality control (QC) from 12/22/20 through 2/12/22 c. Proficiency Testing results for the 1st, 2nd and 3rd events of 2021 and 1st event of 2022 2. Interview with the laboratory manager at 12:20 p.m. on 3/9/22 confirmed there was no documented review of these records by the TC. -- 5 of 5 --

Summary Statement of Deficiencies D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of laboratory records from 9/20/17 through 9/30/19 and interview at 12:00 pm on the day of survey with the laboratory supervisor/testing personnel #1 listed on the CMS (Centers for Medicare and Medicaid Services) 209 form, Troponin I quality control records had not been documented as reviewed by the technical consultant. Findings Include: 1. Review of the LifeSign MI Troponin I quality control (QC) and patient result logs from 9/20/17 through 9/30/19 revealed no documented review of Troponin I QC results (positive and negative controls) from 9/19/17 through 9/30/19 by the technical consultant. 2. Interview with the laboratory supervisor/testing personnel #1 confirmed Troponin I QC had not been documented as reviewed by the technical consultant since the last survey. 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 laboratory personnel records from last survey on 9/19/17 through the current survey on 10/2/19, the CMS 209 personnel form, and interview with the 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 -- laboratory supervisor/testing personnel #1 at 12:30 pm on the day of survey, the technical consultant failed to evaluate and document the performance of testing personnel (TP) #2, #3 and #6 responsible for performing moderate complexity testing at least semiannually during the first year of employment. The semiannual evaluations available the day of survey were performed by staff other than the technical consultant. Findings include: Interview with the laboratory supervisor at 12:30 pm on the day of survey confirmed the 6 month evaluation-competency was performed during the first year of employment on TP #2, #3 and #6 by staff other than the technical consultant. TP #2 was hired on 1/22/19, #3 was hired on 4/2/19 and #6 was hired on 6/12/18. 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 testing personnel (TP) records since the last survey (9/19/17) and confirmation with the laboratory supervisor/testing personnel #1 at 1:00 pm on 10/2 /19, the technical consultant failed to evaluate annually and document the performance competency of testing personnel #1 and #6, as listed on the CMS 209 form for 2018 and 2019. Findings include: 1. Review of the personnel records for TP #1 revealed the annual evaluation/competency for 2017 and 2018 was not documented as performed by the technical consultant. 2. Review of the personnel records for TP #6 revealed the annual evaluation/competency for 2019 was performed by someone other than the technical consultant. 3. Interview with the laboratory supervisor/TP #1 at 1:00 pm on the day of survey confirmed that the annual evaluation for TP #6 was performed by staff other than the technical consultant and that the annual evaluation for TP #1 was not documented as performed. -- 2 of 2 --