Mississippi State Penitentiary

Summary Statement of Deficiencies D0000 The following condition level deficiency was cited: D6033 42 C.F.R. 493.1409 Condition: Technical Consultant - Moderate Complexity D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records since 6/22/2021 and interview with testing personnel (TP) # 2 on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form on 2/21/2023, the laboratory failed to retain all proficiency testing (PT) records for at least 2 years. Findings include: 1. Review of PT records for 2021-3rd event revealed the laboratory did not retain the following records: a. Signed attestation statements b. Patient/PT lab result logs c. Submitted result sheets d. PT provider scores with documentation of review 2. Interview with TP # 2 at 11:30 a.m. on 2/21/2023 confirmed the 2021-3rd event proficiency testing documents were not retained. THIS IS A REPEAT DEFICIENCY. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory records since 6/22/2021 and interview with testing personnel (TP) #2 on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to verify the accuracy of Troponin I performed 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 -- on the LifeSign MI Troponin I test system at least twice annually in 2022. Findings Include: 1. Review of laboratory records revealed the laboratory used a proficiency testing module to verify accuracy of Troponin I performed on the LifeSign MI Troponin I test system twice annually in 2021. 2. Review of proficiency testing records for Troponin I revealed the laboratory had not enrolled in PT for Troponin I in 2022, nor had the laboratory performed any other verification of accuracy for this analyte in 2022. 3. TP #2 in an interview at 12:15 p.m. on 2/21/2023 confirmed the laboratory did not verify accuracy twice a year for Troponin I in 2022. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual for the Mississippi State Penitentiary Laboratory, the LifeSign MI Troponin I manufacturer instructions and interviews on 2/21/2023 at 12:00 p.m. with the Health Site Administrator (HSA), Director of Nursing (DON) and Testing Personnel (TP) #2 listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory procedure manual was not approved and signed by the new laboratory director who became responsible for the laboratory on 5/9/2022. Findings include: 1. The HSA, DON and TP#2 confirmed in an interview on 2/21/2023 at 12: 00 p.m. that the laboratory manual and Troponin I procedure manufacturer instructions were used as the procedures for performing Troponin I testing. 2. There was a laboratory director change on 5/9/2022. 3. On surveyor review of these manuals there was no documentation to indicate they had been approved by the new laboratory director. 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 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 the personnel testing records on 2/21/2023 and the lack of education documentation, the laboratory director did not ensure the testing personnel listed on the CMS (Centers for Medicare and Medicaid Services) 209 personnel form had the appropriate education to perform moderate complexity testing prior to testing patients. Findings include: There was no documentation on 2/21/2023 available for review to indicate the laboratory personnel listed on the CMS 209 form had the education required to perform moderate complexity testing in the laboratory. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY -- 2 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 number of deficiencies cited for technical consultant responsibilities, the technical consultant failed to provide technical oversight in accordance with paragraph 493.1413 of this subpart. Refer to D6036 - Failure to have a technical consultant who provides oversight of laboratory Refer to D6049 - Failure to document review of quality control records, temperature records and proficiency test results. Refer to D6053 - Failure to document competency evaluations for testing personnel performing moderate complexity testing at least semiannually during the first year of employment. Refer to D6054 - Failure to document annual competency evaluations for testing personnel performing moderate complexity testing. 38948 D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on review of the laboratory records on 2/21/2023 and an interview with the Health Site Administrator (HSA), Director of Nurses (DON) and Testing Personnel (TP) #2, the technical consultant listed on the CMS 209 form does not provide technical oversight of the laboratory. Findings include: 1. Review of the following deficiencies indicated the technical consultant did not provide technical oversight of the laboratory and its functions since assuming technical consultant responsibilities on 5/9/2022: a. Refer to D6049 - Failure to review quality control, temperature and proficiency testing records. b. Refer to D6053 - Failure to perform semi-annual competency evaluations on moderate complexity testing personnel c. Refer to D6054 - Failure to perform annual competency evaluations on moderate complexity testing personnel. 2. The HSA, DON and TP #2 confirmed in an interview that the technical consultant did not fulfill the responsibilities necessary to supervise the technical performance of the laboratory and staff. 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 (LifeSign MI Troponin quality control logs, patient result logs, temperature records, and proficiency test records) from 9/18 /2021 through 2/20/2023 and interviews with testing personnel (TP) #2 as listed on the Centers of Medicare & Medicaid Services 209 form, HSA (Health Site -- 3 of 5 -- Administrator) and the DON (Director of Nursing), at 1:00 p.m. on 2/21/2023, the technical consultant failed to document review of all records. Findings Include: 1. The surveyor reviewed laboratory records from 9/18/2021 through 2/21/2023. There was no documented review of the following records by the technical consultant: a. Life Sign MI Troponin I patient result logs which included quality control results for 9/18 /2021-2/20/2023 c. Laboratory temperature records (room, refrigerator, freezer) from 6 /23/2022 through 12/31/2022 d. Proficiency result records for 2nd event of 2021 2. The HSA, DON and TP #2 in an interview at 1:00 p.m. on 2/21/2023 confirmed there was no documented review of these records by the technical consultant. 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 testing personnel records (Centers for Medicare and Medicaid Services 209 personnel form) since 6/22/2021 and interview with the Health Site Administrator (HSA), Director of Nurses (DON) and Testing Personnel (TP) #2 at 3:00 p.m. on 2/21/2023, the technical consultant (TC) failed to evaluate and document the competency of TP #2, #3, #4, #5, #7 and #9 at least semiannually during the first year of employment. Findings include: 1. Review of the laboratory personnel records indicated there were no 6 month competency evaluations available for TP #2, #3, #4, #5, #7 and #9. TP #2 training date 8/4/21 - 6 month evaluation due February 2022 TP #3 hire date 3/21/2022 - 6 month evaluation due September 2022 TP #4 hire date 6/27/22 - 6 month evaluation due December 2022 TP #5 hire date 4/4 /2022 - 6 month evaluation due October 2022 TP #7 hire date 6/2022 - 6 month evaluation due December 2022 TP #9 hire date 2/1/2022 - 6 month evaluation due August 2022 2. Interview with the HSA, DON and TP #2 confirmed at 3:00 p.m. that no 6 month competency evaluation was performed on TP #2, #3, #4, #5, #7 or #9 during the first year of hire while performing moderate complexity testing. 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 laboratory testing personnel (TP) records including the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and interview with the Health Site Administrator (HSA), Director of Nursing (DON) and Testing Personnel (TP) #2, the technical consultant (TC) failed to evaluate annually and document the competency of testing personnel TP #2 and TP #9 who are responsible for performing moderate testing. Findings include: 1. The surveyor reviewed laboratory personnel records. There was no documentation of annual competency evaluations available for review: a. The TC failed to evaluate TP #2 (initial training date 8/4/2021) annually for competency in performing moderate complexity testing since 6/22/2021. b. The TC -- 4 of 5 -- failed to evaluate TP #9 (hire date 2/1/2022) at least annually for competency in performing moderate complexity testing. 2. Interview with the HSA, DON and TP #2 confirmed no annual competency evaluations for TP #2 and TP #9 had been documented as performed by the technical consultant for the year 2022 and 2023. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory testing personnel (TP) records available on 2/21/2023, the CMS (Centers for Medicare and Medicaid Services) 209 form and interview with the Health Site Administrator (HSA), Director of Nursing (DON) and TP#2 at 3:00 p. m. on 2/21/2023, the laboratory director did not ensure all testing personnel as listed on the CMS 209 personnel form had received the appropriate documented training prior to performing Troponin I testing on the Life Sign MI Troponin I test cassette kit. Findings Include: 1. Based on review of laboratory personnel records and lack of training documentation on 2/21/2023, TP#3 through TP #9 had no documented initial training for moderate complexity Troponin I testing prior to performing testing on patients. TP #3 - hire date - 3/21/2022 TP #4 - hire date - 6/27/2022 TP #5 - hire date - 4/4/2022 TP #6 - hire date - 10/3/2022 TP #7 - hire date - 6/2022 TP #8 - hire date - 10 /3/2022 TP #9 - hire date - 2/1/2022 2. The HSA, DON and TP #2 confirmed in an interview at 3:00 p.m. on 2/21/2023 that no initial training for Troponin I testing had been documented for TP #3 through TP #9 prior to testing patients. -- 5 of 5 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory proficiency testing records from 10/23 /2018 through 6/22/2021 and confirmation with the technical consultant (TC) at 11:30 am on 6/22/21, the laboratory failed to retain all proficiency records. Findings include: 1. Observation of proficiency testing records revealed the laboratory did not retain the following: a. Attestation statements for 3rd event of 2018, 1st, 2nd, and 3rd events of 2019, 1st and 2nd events of 2020, 1st event of 2021 b. Blood Gas analyzer printouts for 2nd and 3rd events of 2019, 1st, 2nd, and 3rd events of 2020, 1st event of 2021 2. Interview with the TC at 11:30 am on 6/22/2021 confirmed that previous listed proficiency records were not retained with the completion of each proficiency testing event. 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 9/24/20, the laboratory has not successfully participated in proficiency testing for HEMATOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY. PROFICIENCY TESTING PROVIDER: American Proficiency Institute HEMATOLOGY/WBC,RBC,Hemoglobin,Hematocrit,Platelets,WBC Diff: Year 2019 3rd Event 0% Year 2020 2nd Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of 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 -- analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 9/24/20, the laboratory has not successfully participated in proficiency testing for HEMATOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY. PROFICIENCY TESTING PROVIDER: American Proficiency Institute HEMATOLOGY/WBC,RBC,Hemoglobin,Hematocrit,Platelets,WBC Diff: Year 2019 3rd Event 0% Year 2020 2nd Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 9/24/20, the laboratory has not successfully participated in proficiency testing for HEMATOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY. PROFICIENCY TESTING PROVIDER: American Proficiency Institute HEMATOLOGY/WBC,RBC,Hemoglobin,Hematocrit,Platelets,WBC Diff: Year 2019 3rd Event 0% Year 2020 2nd Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records since the last survey on 1-24-17 and confirmation by the technical consultant, the laboratory failed to maintain a copy of attestation statements, signed by the analyst and laboratory director, proficiency testing report forms used by laboratory to record proficiency testing results, and graded results from the proficiency testing provider for a minimum of two years. Findings include: Review of proficiency testing (PT) records since the last survey on 1-24-17 and confirmation by the technical consultant revealed the laboratory failed to maintain, for a minimum of two years, a copy of the following proficiency testing records: 1. The attestation statements, signed by the analyst and laboratory director, for Immunohematology, Hematology/Coagulation, and Routine Chemistry for Events 1, 2, and 3 of 2017 and Events 1 and 2 of 2018. 2. The proficiency testing report forms used by the laboratory to record proficiency testing results for Hematology /Coagulation, and Routine Chemistry for Event 3 of 2017, Event 1 of 2018, and Event Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 2 of 2018. 3. The proficiency testing provider graded results for Immunohematology for Event 2 of 2017, Immunohematology and Hematology/Coagulation for Event 1 of 2018, and Immunohematology for Event 2 of 2018. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of documentation available for review and interview with staff, the laboratory had not followed written policies to assess employees and, if applicable, technical consultant competency at least annually since their last inspection, 1/24/17. On the day of survey, there was no documentation of an annual competency or evaluation for the technical consultant of the laboratory for the years 2017 or 2018 performed by the laboratory director. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A Based on review of the ACL 100 Coagulation analyzer maintenance records from 1 /24/17 to the day of survey, 10/23/18, the laboratory failed to document as performed the monthly maintenance required by the manufacturer. The following maintenance was not performed: Monthly Maintenance: Clean the air filter--not performed for 2/17 through 4/17 and 6/17 through 10/18. B Based on review of the ACL 100 Coagulation analyzer maintenance records from 1/24/17 through 10/23/18, the laboratory failed to document, as performed, the annual maintenance required by the manufacturer. No annual maintenance had been performed since the last survey on 1/24/17. This included: 1. Replace the filter 2. Replace the sample reagent tube 3. Replace the waste drain tube 4. Replace the needle block 5. Replace the waste reservoir D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of calibration records for the ABX Micros 60 hematology analyzer since the last survey on 1/24/17, the laboratory failed to document calibration on the analyzer every 6 months as required. Findings include: Review of calibration records for the ABX Micros 60 hematology analyzer since the last survey on 1/24/17 revealed calibration was performed on 7/26/17 then again on 7/18/18. This time period exceeds the manufacturer's calibration requirement of every 6 months. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records for the ACL 100 Coagulation analyzer from 2/28/17 through 10/19/18 and review of the patients in house log, it was determined 1 of the 2 levels of QC material performed were outside of the manufacturer's acceptable range on the following days when patients were tested and results reported. 11/29/17, 1/17/18, 3/12/18, 4/2/18, 4/30/18, 5/19/18, 9/17/18, 9/14 /18, 9/11/18, 9/10/18, 10/1/18, 10/8/18 Forty patients were tested on these days without QC being acceptable. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require