Uab Ob/Gyn Research And Diagnostic 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 by the Laboratory Supervisor. The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 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 -- 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and verified by a telephone interview with the Laboratory Supervisor, the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Hepatitis B Surface Antigen (HBS AG), an analyte in the specialty of General Immunology. The laboratory failed two out of three PT events in 2024-2025, resulting in initial unsuccessful proficiency testing performance. Refer to D2084. . D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) (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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and verified by interview with the Laboratory Supervisor, the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Hepatitis B Surface Antigen (HBS AG). The laboratory failed two out of three PT events in 2024-2025, resulting in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for HBS AG in two out of three CAP PT events, as follows: A) 2024 Immunology Event #3: 60 % B) 2025 Immunology Event #2: 60 % 2. During a telephone interview on 7/9/2025 at 2:12 PM, the Laboratory Supervisor confirmed these findings. . 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and verified by interview with the Laboratory Supervisor, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D6016. . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and -- 2 of 3 -- 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and verified by interview with the Laboratory Supervisor, the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for Hepatitis B Surface Antigen (HBS AG) in two out of three 2024-2025 CAP PT events. Refer to D2084. -- 3 of 3 --

Summary Statement of Deficiencies 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 a review of the College of American Pathologists (CAP) Proficiency Testing (PT) records, CAP PT Kit Instructions, and an interview with Technical Consultant (TC), the surveyor determined the Laboratory Director (or Designee) failed to sign the Attestation statements for three out of five Microbiology PT events in 2024-2025. The findings include: 1. A review of the 2024-2025 CAP PT records revealed the Laboratory Director (or Designee) did not sign the Attestation statements for the following PT events: A) Viral Markers VM-A 2024 event B) Chlamydia GC HC6-C 2024 event C) Maternal Screenings FP-A 2025 event 2. A further review of the CAP PT Kit Instructions and Result Form Resource revealed the following instructions on page 4; 9. "Attestation Page: The laboratory director or designee and the testing personnel must sign the attestation page included with the kit or print the online result form with attestation page for physical signature". 3. TC confirmed the above findings during the exit conference on 06-03-2025 at 4:00 PM. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologists (CAP) Proficiency Testing (PT) records, and an interview with the Technical Consultant (TC), the laboratory failed to implement a mechanism to verify the accuracy of the Gestational Age US Ultrasound Quant (GAUUQ), a non-regulated analyte. The surveyor noted the PT evaluation failures occurred in two consecutive events for 2024-2025. The findings include: 1. A review of the CAP PT records revealed the GAUUQ PT grade of zero percent for the following events: A) Maternal Screenings FP-C 2024 event B) Maternal Screenings FP-A 2025 event 2. An interview with the TC on 06-03-2025 at approximately 1:43 PM revealed the age information required was not provided during submission. 3. During the exit conference on 06-03-2025 at 4:00 PM, TC confirmed the above findings. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on a review of the Complete Blood Count (CBC) Quality Control (QC) records and an interview with the Technical Consultant (TC), the laboratory had no documentation of a mechanism to monitor for shifts and trends of test performance over time. The surveyor noted 5 of 5 months reviewed in 2025 were missing at the time of the survey. The findings include: 1. A review of the CBC QC records for the Beckman Coulter DxH 520 revealed there was no evidence of Levey Jennings charts or peer group comparison data for January through May of 2025. 2. During the exit conference on 06-03-2025 at 4:00 PM, TC confirmed the above findings. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on reviews of the validation records for the Beckman Coulter (BC) DxH 520 analyzer, the BC Operation Qualification Checklist (OQC), and an interview with Technical Consultant (TC), the Laboratory Director (LD) failed to document and date review and approval of procedures verifying the manufacturer's performance specifications before patient testing began. This was noted from the date of validation on 06-24-2024 to the date of the current survey, 06-03-2025. The findings include: 1. A review of BC DxH 520 validation records and BC OQC revealed no documentation of the LD's review and approval (indicated by signature and date) of the BC DxH 520 -- 2 of 3 -- validation studies, which included the following: A) Repeatability (Precision) B) Carryover C) Linearity D) Hematology Method Comparison E) Calibration 2. During the exit conference on 06-03-2025 at 4:00 PM, the TC confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on a review of the Procedure Manual, validation of the Revogene Group B Streptococcus, and an interview with the Technical Supervisor, the laboratory failed to maintain a copy of the "Revogene Group B Streptococcus (GBS) Lim Broth (LB) Assay Procedure" with the date of initial use and the previous Laboratory Director's signature for review. The findings include: 1. A review of the Procedure Manual revealed the current Laboratory Director signed the Revogene Group B Streptococcus (GBS) Lim Broth (LB) Assay Procedure on 09/01/2020. 2. A review of the validation of the Revogene Group B Streptococcus revealed the previous Laboratory Director approved the validation on 11/20/2019 and patient testing started on 11/25/2019. 3. During an interview on 06/03/2021 at 4:30 PM, the Technical Supervisor stated she cleaned the Procedure Manual out before the survey and accidentally misplaced the original "Revogene Group B Streptococcus (GBS) Lim Broth (LB) Assay Procedure" which obtained the date of initial use and signature of the previous Laboratory Director. 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 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 a review of the Policy and Procedures Manuals and an interview with the Technical Consultant, the surveyor determined the laboratory failed to ensure the new Laboratory Director reviewed, approved, signed and dated the procedures for use by the testing personnel. The findings include: 1. A review of the Policy and Procedure manuals revealed no signature and date by the current Laboratory Director. According to the quality assurance records, the new Laboratory Director assumed his responsibilities on 3/26/2018. [The laboratory also filed a Form CMS-116 with the CLIA State Agency for the Change in Director in March 2018.] There was no evidence the procedures had been reviewed and approved by the new Laboratory Director for use by the testing personnel. 2. During a review of the manuals in an interview on 11/28/2018 at 4:45 PM, the Technical Consultant stated the Laboratory Director had signed a letter delegating this responsibility to the "Assistant Laboratory Director" (the Clinical Consultant on Form CMS-116). The surveyor explained this responsibility must be performed by the Laboratory Director and cannot be delegated. Thus, the above noted findings were confirmed. . . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's 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 -- instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on reviews of the environmental logs and the Beckman Coulter Access 2 Operator's Manual, and an interview with the Technical Consultant, the laboratory failed to monitor and document room humidity in Room 365, where the Beckman Access 2 analyzer was operated; the laboratory further failed to determine whether analyzers and tests in two other rooms also had environmental operating requirements. The findings include: 1. During the initial tour on 11/28/2018 at 9:00 AM with the Technical Consultant, the surveyor observed the Access 2 Immunoassay Chemistry analyzer was located in Room 365. The laboratory also ran other tests and analyzers in Rooms 360 and 537. 2. A review of the logs revealed only the room temperature for Room 365 was documented. 3. During an interview on 11/28/2018 at 5:00 PM, the Technical Consultant was asked if Humidity was monitored in Room 365 where the Beckman Access 2 analyzer was operated; the Technical Consultant answered, "No, we don't monitor room humidity". 4. As the interview continued, the surveyor and Technical Consultant reviewed the Environment Requirements in the Beckman Coulter Access 2 Operator's Manual on page 2-6 which included the following: "... Humidity: Operational 20% (percent) to 80% Exposure 10-80%...". 5. The surveyor then asked if the laboratory had reviewed the manufacturer's environmental requirements for analyzers and tests in use in Rooms 360 and 537, and whether room temperature and humidity required monitoring to ensure the laboratory was operating within the required parameters. The Technical Consultant stated she was not sure whether room temperature and humidity were being monitored in Rooms 360 and 537 or whether it was required. Thus, the above noted findings were confirmed. . D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the installation and quality control (QC) records for the Illumigene analyzer (for the detection of Group B streptococcus) and an interview with the Technical Consultant, the surveyor determined the laboratory failed to implement a valid IQCP (Individualized Quality Control Plan) which included an QC plan and Quality Assessment Plan before patient testing began on 10/4/2017. The findings include: 1. A review of the records for the illumipro-10 Illumigene analyzer (for the detection of Group B Strep) revealed the instrument was validated 9/6 thru 10 /3/2017. The previous Laboratory Director had reviewed the data and approved the analyzer for use for patient specimens on 10/4/17. 2. A review of the QC and patient -- 2 of 3 -- worksheets revealed positive and negative QC was performed monthly and with new lot numbers of reagent cartridges. However patient samples were tested three to five times each week on days when QC was not run. 3. During an interview on 11/28/2018 at 4:30 PM, the Technical Consultant was asked if the laboratory had implemented an IQCP to allow for decreased QC testing frequency. The Technical Consultant stated the validation documentation included an IQCP. The surveyor then reviewed the "Validation IQCP", and determined it was not an "IQCP" as per CLIA regulations; it was actually only the method the manufacturer suggested to validate the analyzer. The surveyor explained an IQCP must include a Risk Assessment, a QC Plan, and a QA Plan. 4. As the interview continued the Technical Consultant provided a Risk Assessment, and stated the laboratory always ran QC monthly and with all new lot numbers of reagent cartridges. When asked if the laboratory had their QC and QA Plans in writing for their IQCP with the approval and signature of the Laboratory Director, the Technical Consultant stated they did not. Thus, the above noted findings were confirmed. SURVEYOR: Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 3 of 3 --