Mississippi Public Health Laboratory

Summary Statement of Deficiencies D0000 Federal surveyors from the Division of Clinical Laboratory Improvement and Quality (DCLIQ) Survey Branch conducted an announced CLIA recertification survey at the Mississippi Public Healthy Laboratory from December 16, 2025 to December 18, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA regulations and was found to be out of compliance with condition-level CLIA requirements, the following condition level and standard level deficiencies were found. 493.1250 - Analytical Sytems 493.1441 - Laboratory Director D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the section team leads, the laboratory failed to sign PT attestation forms for two out of three events in 2024 and two out of six events in 2025. Findings: 1. Review of the College of American Pathologist (CAP) hematology PT records on December 18, 2025 revealed the following attestation were not signed by the laboratory Director/ designees: a. CAP - FH13 - B - 2024. b. CAP - FH13 - C - 2024. 2. Review of the College of American Pathologist (CAP) Special Microbiology PT records on December 18, 2025 revealed the following attestation were not signed by the laboratory Director/ designees: a. CAP - GIP5 - A - 2025. b. CAP - IDR - A - 2025. 3. Interviews with the laboratory section teams leads on December 18, 2025 at 4:00 pm confirmed PT records were not signed by the LD or designee. Key: FH13 - HEMATOLOGY AUTOMATED DIFFERENTIAL SERIES. IDR - INFECTIOUS DISEASE, RESPIRATORY PANEL. GIP5 - GASTROINTESTINAL PANEL, 5 CHALLENGE. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 20 -- D5305 TEST REQUEST CFR(s): 493.1241(c) (c) The laboratory must ensure the test requisition solicits the following information: (c)(1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (c)(2) The patient's name or unique patient identifier. (c)(3) The sex and age or date of birth of the patient. (c)(4) The test(s) to be performed. (c)(5) The source of the specimen, when appropriate. (c)(6) The date and, if appropriate, time of specimen collection. (c)(7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (c)(8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on the review of the laboratory's client service manual, review of TB EIA request forms, and interview with the chemistry section lead, the laboratory failed to ensure the incubation temperature for patient specimens was documented on a sample of four of four request forms submitted for TB EIA testing in 2025. Findings: 1. The Mississippi Public Health Laboratory (MPHL) Guide to Services under TB EIA (QuantiFeronTB Gold Plus) - Incubation and Storage Requirements: stated, "After filling, the contents of the tubes MUST be thoroughly mixed by firmly shaking. The tubes must be transferred to a 37C 1C incubator as soon as possible and within 16 hours of collection. Prior to incubation, maintain tubes at room temperature (22C 5C); Do not refrigerate or freeze the blood samples. Incubate the tubes UPRIGHT at 37C for 16 to 24 hours. After incubation, tubes must be received within 72 hours and may be held between 4C and 27C. Do not centrifuge tubes prior to shipping." 2. A Review of four TB EIA test request forms on December 17, 2025 revealed incubation was not documented or provided by individuals submitting specimen to the laboratory: a. MRN: 4632253 b. MRN: 2173664 c. MRN: 4632320 d. MRN: 3355791 3. Annually the laboratory receives 1,864 TB EIA specimens for testing. 4. The Chemistry section lead confirmed the request forms did not include the incubation temperature on December 17, 2025 at 11:35 am. Key: MRN - Medical Record Number TB EIA - Tuberculosis enzyme immunoassay C - Celcuis. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's procedure manuals, manufacturer's instructions, laboratory records, patient records, and laboratory staff interviews, the laboratory -- 2 of 20 -- failed to meet the analytic system requirements. Findings: 1. The laboratory failed to follow their own procedure for monthly quality control testing. Refer to D5401, I. 2. The laboratory failed to follow their own procedure for documentation of MGIT sterility verification. Refer to D5401, II. 3. The laboratory failed to establish quality control procedures and procedure for entering results in the patient records for manual differential cell review. Refer to D5403. 4. The laboratory failed to follow manufacturer's instructions for acid fast bacterium (AFB) staining by Ziehl-Neelsen examination. Refer to D5411, I. 5. The laboratory failed to follow manufacturer's instructions for gram staining. Refer to D5411, II. 6. The laboratory failed to follow manufacturer's instructions for the aliquotting vials of reconstituted Bacterial Test Standard (BTS) used by the MALDI Biotyper. Refer to D5411, III. 7. The laboratory failed to define and/or monitor an acceptable room temperature and/or humidity range consistent manufacturer's requirements. Refer to D5413, I, II, III, IV, V, VI, VII, VIII, IX. 8. The laboratory failed to label secondary containers with reagent identification information, storage requirements and expiration dates. Refer to D5415, I and II. 9. The laboratory failed to ensure that expired reagents were not available for use. Refer to D5417, I, II, and III. 10. The laboratory failed to perform monthly maintenance per manufacturer's instructions for the Cepheid GeneXpert Infinity molecular diagnostic system. Refer to D5429. 11. The laboratory failed to perform quality control (QC) at least once each day of patient testing for Biofire Micro arrays in use. Refer to D5445. 12. The laboratory failed to test and document hematological staining materials for their staining characteristics. Refer to D5473. 13. The laboratory failed to check each batch of media for the ability to support growth for microbiology growth media. Refer to D5477 I and II. 14. The laboratory failed to perform comparison on the Biofire Filmarray used to perform the Gastrointestinal (GI) Panel. Refer to D5775. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on observation, review of laboratory procedure, Cepheid GeneXpert quality control (QC) records, patient records, and confirmed in staff interview, the laboratory failed to follow their own procedure for monthly quality control testing for one of four months in 2025. Findings: 1. During a tour of the mycobacteriology testing area (Room 4112) on 12/16/2025 at 2:10 pm, a Cepheid GeneXpert Infinity instrument (Serial Number 843224) was observed to be in use by the laboratory. 2. The laboratory procedure titled "GeneXpert MTB/RIF" stated " ...Quality Control Requirements ...External Controls At the beginning of each month, one negative control prepared from an ATCC non-tuberculous mycobacterial strain, one positive control prepared from a previously identified and confirmed Rifampin resistant MTB isolate and one control prepared from a previously identified Rifampin susceptible MTB isolate will be tested. Operators are required to perform external QC before reporting patient results ..." 3. Review of Cepheid GeneXpert quality control (QC) records from July 2025 through October 2025 revealed the laboratory failed to perform monthly QC for August 2025. 4. Review of the laboratory's patient records revealed the following patients were tested on the Cepheid GeneXpert in August 2025: Date tested 08/01/2025; Patient 25M-213TB0007 Date tested 08/04/2025; -- 3 of 20 -- Patient 25M-213TB0009 Date tested 08/04/2025; Patient 25M-214TB0001 Date tested 08/05/2025; Patient 25M-216TB0007 Date tested 08/05/2025; Patient 25M- 216TB0008 Date tested 08/04/2025; Patient 25M-216TB0009 Date tested 08/05/2025; Patient 25M-216TB0013 Date tested 08/05/2025; Patient 25M-217TB0016 Date tested 08/06/2025; Patient 25M-217TB0017 Date tested 08/07/2025; Patient 25M- 218TB0010 Date tested 08/11/2025; Patient 25M-220TB0008 Date tested 08/13/2025; Patient 25M-224TB0019 Date tested 08/15/2025; Patient 25M-226TB0010 Date tested 08/15/2025; Patient 25M-226TB0011 Date tested 08/15/2025; Patient 25M- 226TB0015 Date tested 08/19/2025; Patient 25M-230TB0003 Date tested 08/19/2025; Patient 25M-230TB0004 Date tested 08/26/2025; Patient 25M-233TB0008 Date tested 08/26/2025; Patient 25M-237TB0006 Date tested 08/26/2025; Patient 25M- 237TB0009 Date tested 08/26/2025; Patient 25M-237TB0010 Date tested 08/27/2025; Patient 25M-238TB0020 Date tested 08/29/2025; Patient 25M-240TB0011 Date tested 08/29/2025; Patient 25M-240TB0013 Date tested 08/29/2025; Patient 25M- 241TB0012 5. In an interview on 12/17/2025 at 7:50 am, the Mycobacteriology Technical Supervisor confirmed the findings. Word Key: ATCC=American Type Culture Collection II. Based on observation, review of laboratory procedure, BACTEC MGIT 960 records, and confirmed in staff interview, the laboratory failed to follow their own procedure for documentation of MGIT sterility verification for 59 of 59 days of specimen processing. 1. During a tour of the mycobacteriology testing area (Room 4411) on 12/16/2025 at 1:55 pm, a BACTEC MGIT 960 instrument (Serial Number MG7570) was observed to be in use by the laboratory. Two other MGIT 960 instrument were also observed but not in use by the laboratory. These were designed as MGIT 1 (Serial Number 3641 and MGIT 2 (Serial NumberMG3880). 2. In an interview on 12/16/2025 at 2:13pm, the Mycobacteriology Technical Supervisor stated that the laboratory stopped using MGIT 1 and MGIT 2 in August 2025. 3. The laboratory procedure titled "Growth and Detection-Liquid MGIT Media" stated " ... 3.0 Two sterility controls or blanks will be inoculated daily. 3.1 One MGIT tube without an accession number will be placed in the tube rack and one MGIT tube will be placed behind the last patient specimen. 3.2 These tubes will act as sterility QC tubes ..." 4. Review of the laboratory record titled "MGIT Processing Sterility Verification Log" from 08/04//2025 through 11/04/2025 revealed the laboratory documented sterility for MGIT bottles loaded onto MGIT 1 and MGIT 2 for each of the 59 days of patient testing. The laboratory failed to document sterility verification for the MGIT 960 in use (Serial Number MG7570). 5. In an interview on 12/16/2025 at 2:13pm, the Mycobacteriology Technical Supervisor confirmed the laboratory failed to document sterility verification for the MGIT currently in use. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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 and interview with the laboratory director, the laboratory failed to verify the accuracy HIV NAAT, EEE IgM, Zika Virus IgM, Chikungunya IgM, and Dengue IgM testing twice per year in 2021 and 2022. Finding included: 1. Review of in-house proficiency testing records for HIV NAAT revealed only one annual test verification was performed in 2021 and none in 2022. The laboratory performs approximately 40 tests each year. 2. Record review of in-house proficiency testing records for EEE IgM, Zike Virus IgM, chikungunya IgM, Dengue IgM revealed the laboratory did not perform verification twice annually in 2021 and 2022. The laboratory performed 4 tests between 2021 and 2023 to date of survey. 3. The laboratory director confirmed the above findings on May 18, 2023 at 1:30PM. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 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 -- 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 a proficiency testing desk review of Centers for Medicare and Medicaid 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 -- Services (CMS) form 0155 and American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) 2022 and 2023 proficiency testing records, revealed the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Immunology and for the Hepatitis B Surface Antigen and Anti-Hepatitis C analytes. Refer to D2084 and D2085. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in 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 a proficiency testing desk review of CMS form 0155 and American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) 2022 (3rd Event) and 2023 (1st Event) proficiency testing records, revealed the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of two consecutive testing events in the specialty of Immunology for the Hepatitis B Surface Antigen and Anti-Hepatitis C analytes. Findings included: 1. Review of the CMS 0155 report revealed the following results: General Immunology 2022 - 3rd Event laboratory The laboratory received an unsatisfactory score of 0 % for Hepatitis B Surface Antigen analyte. The laboratory received an unsatisfactory score of 0 % for the Anti-Hepatitis C analyte. General Immunology 2023- 1st Event The laboratory received an unsatisfactory score of 0 % for Hepatitis B Surface Antigen analyte. The laboratory received an unsatisfactory score of 0 % for the Anti-Hepatitis C analyte. 2. A review of the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) 2022 and 2023 proficiency testing records confirmed the laboratory received the above results. D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(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 a proficiency testing desk review of CMS form 0155 and American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) 2022 (3rd Event) and 2023 (1st Event) proficiency testing records, revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the overall specialty of Immunology in two of two consecutive testing events. Findings included: 1. Review of the CMS 0155 report revealed the following results: General Immunology 2022 - 3rd Event The laboratory received an unsatisfactory score of 0 % for Immunology. General Immunology 2023- 1st Event The laboratory received an unsatisfactory score of 0 % for Immunology. 2. A review of the American Association of Bioanalysts- Medical Laboratory Evaluation (AAB-MLE) 2022 and 2023 proficiency testing records confirmed the laboratory received the above results. -- 2 of 3 -- 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 a proficiency testing desk review of CMS form 0155 and American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) 2022 and 2023 proficiency testing records, revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 0155 and American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) 2022 and 2023 proficiency testing records, revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2084 and D2085. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on an onsite survey conducted 3-29-2021 to 4-2-2021 the laboratory was found NOT to be in compliance with the CLIA regulations at 42 CFR: 493.803 Condition: Successful participation 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 review of the laboratory's proficiency testing (PT) records from WSLH, CLIA database, and interview with the chemistry department head, the laboratory failed to demonstrate successful performance for Sodium (Na) with two of three 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 -- consecutive testing events for 2nd event 2020 and 1st event 2021, as evidenced by: 1. The laboratory failed to achieve satisfactory performance for Sodium (Na) with two of three consecutive testing events for 2nd event 2020 and 1st event 2021 (See D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 review of the laboratory's proficiency testing (PT) records from WSLH, CLIA database, and interview with the chemistry department head, the laboratory failed to achieve satisfactory performance for Sodium (Na) with two of three consecutive testing events for 2nd event 2020 and 1st event 2021, demonstrating unsuccessful performance as evidenced by: 1. In review of the laboratory's PT records from WSLH and confirmed with the CLIA database, the laboratory had received the following scores with Sodium: 2nd event 2020 - Na = 20% 1st event 2021 - Na = 60% 2. In interview with the chemistry department head on 3-29-2021 @1505 she was aware they failed both proficiency testing events and confirmed that they had received those scores. The Laboratory Director @1506 also confirmed that they had received those scores. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation, manufacturer's package insert, and interview with the CBC (complete blood count) supervisor, the laboratory failed to label new open vial stability expiration dates on their Beckman Coulter hematology controls on 3-31-2021 as evidenced by: 1. In review of the manufacturer's package insert (Beckman Coulter) table of expected results states, "16 open vial days." 2. In direct observation on 3-31- 2021 @1020 in the QC refrigerator, the following Beckman coulter controls did not have the open vial stability dates labeled on the control materials: 1 vial of open QC Level 1 lot# 123173620 opened 3/16/2021 1 vial of open QC level 2 lot# 133183520 opened 3/16/2021 1 vial of open QC leve 3 lot# 143193620 opened 3/16/2021 3. In interview with the CBC section supervisor on 3-31-2021 @1024 she states that she did not know how long the control were good for after they were opened. She was unaware that the control did have a new expiration date after opening. -- 2 of 2 --