Georgia Public Health Laboratory

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] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high 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 the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and Wisconsin State Laboratory of Hygiene (WSLH) records, 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 subspecialty of Virology. Refer to D2064. D2064 VIROLOGY CFR(s): 493.831(e) (e) 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 the CASPER 0155 report and WSLH 2025 proficiency testing records, the laboratory failed to achieve overall satisfactory performance (80% or greater) for the subspecialty of Virology for two consecutive testing events (2025, Events 1 and 2). Findings included: 1. Review of the CASPER 0155 report revealed the following results: WSLH Chemistry 2025 - 1st Event. The laboratory received an unsatisfactory score of 75% for Virology. WSLH Chemistry 2025 - 2nd Event. The laboratory received an unsatisfactory score of 75% for Virology. 2. A review of WSLH 2025 proficiency testing records confirmed the laboratory received the above results. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) 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 the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, 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 D2064. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted from 08/21/2023 through 08/25/2023. Standard level deficiencies were cited. 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 the laboratory test list, laboratory proficiency testing (PT) records and confirmed in interview with the Laboratory Quality Manager, revealed the laboratory failed to perform twice annual accuracy assessments for Hepatitis A IgM antibody (HAVM) testing for 2 of 2 years (2021 and 2022). Findings included: 1. Review of the laboratory's submitted test list revealed the laboratory tested specimens for Hepatitis A IgM antibodies. 2. Review of the laboratory's proficiency testing and twice annual accuracy assessment records for 2021 and 2022 revealed no documentation of twice annual accuracy assessment for HAVM. 3. In an interview on 08/23/2023 at 11:27 AM, the Laboratory Quality Manager confirmed that the laboratory failed to perform twice annual accuracy assessment for HAVM. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- This STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer's instructions, laboratory policy, patient records, and confirmed in staff interview, the laboratory failed to follow written policies and procedures for preanalytical requirements for the Hologic Aptima Trichomonas Vaginalis Assay, the Hologic Aptima Combo 2 Chlamydia-Gonorrhea Assay, and the Aptima Herpes Simplex Viruses 1 and 2 Assay for 82 of 82 patient specimens. Findings included: 1. On 08/22/2023 at 12:05 PM and 2:30 PM the delivery of patient specimens to the laboratory was observed. Multiple specimens from an individual location or clinic were submitted in one biohazard bag. From the receiving area, the patient specimens were transported to the accessioning area where biohazard bags were opened, and specimens were sorted according to tests requested. During the accessioning process, multiple patients with multiple Aptima specimens' tubes in the same biohazard bag were observed in direct contact with each other. Eighty-two Aptima specimen containers were processed. 2. The manufacturer's instructions revealed the following: a. Aptima Trichomonas vaginalis Assay (503684 Rev. 008) stated, " ...Warnings and Precautions ...Specimen Related ...I. Avoid cross- contamination during the specimen handling steps. Specimens can contain extremely high levels of organisms. Ensure that specimen containers do not contact one another ..." b. Aptima Combo 2 Assay (AW-20535-001 Rev. 004) stated, " ...Warnings and Precautions ...Specimen Related ...M. Avoid cross-contamination during the specimen handling steps. Specimens can contain extremely high levels of organisms. Ensure that specimen containers do not contact one another ..." c. Aptima Herpes Simplex Virus 1&2 Assay (AW-15636 Rev. 005) stated, " ...Warnings and Precautions ... Specimen Related ...I. Avoid cross-contamination during the specimen handling steps. Be especially careful to avoid contamination by the spread of aerosols when loosening or uncapping specimens. Specimens can contain extremely high levels of virus. Ensure that specimen containers do not contact one another ..." 3. The laboratory policies stated the following: a. MVI-VI 6 Hologic Aptima Trichomonas vaginalis Assay (Approved by the laboratory director 12/31/2022) stated, " ...5.4 Specimen- related precautions: ...5.4.3 Avoid cross-contamination while handling specimens. Specimens may contain extremely high levels of organisms. Therefore, ensure that specimen containers do not contact one another ..." b. MVI-VI 7 Hologic Aptima Combo 2 Assay Chlamydia-Gonorrhea (Approved by the laboratory director) stated, " ...5.4 Specimen-related precautions: ...5.4.4 Avoid cross-contamination while handling specimens. Specimens may contain extremely high levels of organisms. Therefore, ensure that specimen containers do not contact one another ..." c. MVI-VI 18 Aptima Herpes Simplex Virus 1&2 Assay (Approved by the laboratory director 12 /31/2022) stated, " ...5.0 Special Safety Precautions ...5.8 Avoid cross-contamination during the specimen handling steps. Be especially careful to avoid contamination by the spread of aerosols when loosening or uncapping specimens. Specimens can contain extremely high levels of organisms. Ensure that specimen containers do not contact one another ..." 4. A random review of records of the 82 patient specimens received 08/22/2023 revealed the following patient specimens were tested and reported by the laboratory: Patient 24B0004651; Specimen: Urine; Aptima Combo-2 Assay Patient 24B0004655; Specimen: Urine; Aptima Combo-2 Assay Patient 24X1233019; Specimen: Urine; Aptima Combo-2 Assay Patient 24X1233088; Specimen: Urine; Aptima Combo-2 Assay Patient 24X1229085; Specimen: Urine; Aptima Combo-2 Assay Patient 24X1233048; Specimen: Swab; Aptima Combo-2 Assay Patient 24X1233113; Specimen: Swab; Aptima Combo-2 Assay Patient 24X1230047; Specimen: Swab; Aptima Combo-2 Assay 5. In an interview on 08/23 /2023 at 1:55 PM, the Laboratory Director and the Laboratory Quality Manager -- 2 of 10 -- confirmed that the laboratory failed to ensure specimen containers did not contact one another. 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 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: I. Based on review of Molecular Biology and Microbiology competency records and staff interview, the Technical Supervisor failed to evaluate and document the semi- annual competencies within the first year of patient testing for all new testing personnel since the last survey. Findings: 1. A review of Molecular Biology and Microbiology competency records revealed the General Supervisor not the Technical Supervisor documented the performance and evaluation of semi-annual competencies within the first year. 2. An interview of the Molecular Biology and Microbiology Technical Supervisor on 5/18/2021 at 1:00pm confirmed the Technical Supervisor did not perform competency assessment for new testing personnel. 27526 Based on review of competency assessment records and interview with laboratory staff, Technical Supervisor A (TS-A) failed to perform semi-annual competency assessments (CA) for testing personnel for years 2020 and 2021. Findings: TS-A is the only Technical Supervisor for the Bacteriology section of the laboratory. Testing personnel A (TP-A), Testing personnel B (TP-B), Testing personnel C (TP-C), Testing Personnel D (TP-D) and Testing personnel E (TP-E) perform CLIA laboratory testing in the laboratory. Review of competency assessment records revealed the following: TP-A's semi-annual CA for Enterics dated 5-4-2020 was not performed by TS-A. TP-B's semi-annual CA for the Biofire dated 3-6-2020 was not performed by TS-A. TP-C's semi-annual CAs for the MiSeq dated 8-22-2020 and 12- 4-2020 were not performed by TS-A. TP-D's semi-annual CA for the MiSeq dated 3-5- 2021 was not performed by TS-A. TP-E's semi-annual CAs for the Cepheid dated 3- 27-2020 and 9-20-2020 were not performed by TS-A. During interview the afternoon 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 -- of June 7, 2021, TS-A confirmed she did not perform the above semi-annual CAs for TP-A, TP-B, TP-C, TP-D and TP-E. -- 2 of 2 --

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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for the Bacteriology specialty in 2019 events two and three for Wisconsin State Lab of Health resulting in the first unsuccessful PT occurrence. (Refer to D2028). D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2019 Wisconsin State Lab of Health (WSLH) proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for two consecutive PT events for the specialty of Bacteriology, resulting in the first unsuccessful proficiency testing occurrence. The findings include: 1) Review of the CMS 155 report revealed the following unsatisfactory scores for Bacteriology: 2019 event two-34%, and 2019 event three- 73%. 2) Review of the laboratory's 2019 WSLH microbiology event two PT summary report revealed sample numbers MC-10 through MC-18 scored as Fail, No result(s) received, resulting in an overall event score of 34% for bacteriology. 3) Review of the laboratory's 2019 WSLH microbiology event three PT summary report revealed sample numbers MC- 26 and MC-27 scored as Fail, No result(s) received, resulting in an overall event score of 73% for bacteriology. -- 2 of 2 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on suveyor record review and interview of Virology records, the laboratory failed to perform comparison of test instrumentation and evaluation two times a year for the same clincal test procedures performed on multiple instruments. Findings Include: 1. The labortory HIV Viral Load records did not incude any documentation of comparison studies during 2017 and 2018 for the Abbott m2000. The surveyor found the laboratory was performing the same test on two different Abbott m2000's. CLIA requires laboratories performing the same test on mulitple instruments to compare results two times a year. 2. The laboratory Quality Assessment Plan did not include any language detailing when and how laboratories should complete comparison studies and evaluations. 3. The laboratory General Supervisor confirmed during the interview on February 28, 2019 at 11:00 am, the laboratory did not perform comparison studies in 2017 and 2018. 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 --