Adph-Bureau Of Clinical Laboratories

Summary Statement of Deficiencies D0000 A recertification survey was performed on 06/03/25 through 06/05/25. Standard-level deficiencies were cited. 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: Based on laboratory's written policy and procedure, record review, and interview with technical supervisor# 19 (TS# 19), the laboratory failed to follow a written laboratory procedure for monthly quality control (QC) checks for one of three months. Findings include: 1. Review of the laboratory's written policy and procedure titled, "ADPH BCL Prattville Mycotics Quality Control" section, "3. BACKGROUND INFORMATION:" stated, "The Mycotics Section of the Bureau of Clinical Laboratories (BCL) performs quality control (QC) procedures with each test; each new lot of media, stains, or test kits; and monthly (or as needed to ensure valid results are reported)". 2. Review of QC record for Sabourad Dextrose Agar Plates and Mycosel media from 06/10/2024 through 08/08/24 revealed monthly QC not performed as follows: a. Sabourad Dextrose Agar Plates Monthly QC not performed in July 2024. b. Mycosel Media Monthly QC not performed in July 2024. 3. Interview on 06/04/25 at 10:50 am with TS# 19 confirmed the laboratory findings above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for 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 -- 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 instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: I. Based on direct observation, review of the manufacturer's operator's manual, and interview with Technical Supervisor (TS) #8, the laboratory failed to monitor and document temperature and humidity conditions in Room C44 for 2024 and 2025, where newborn screening testing is performed using Revvity GSP analyzers. Findings: 1. During a laboratory tour conducted on June 4, 2025, at approximately 2: 00 PM, three Revvity GSP analyzers were observed in operation for newborn screening testing in Room C44. No devices for monitoring temperature or humidity (e. g., hygrometers or thermohygrometers) were observed in the workspace. 2. Review of the Revvity GSP manufacturer's operator's manual revealed the following required environmental conditions for instrument operation: Temperature: 18 - 27 C; Relative Humidity: 10 - 80% Temperature: 28 - 30 C; Relative Humidity: 10 - 65% 3. During an interview on June 4, 2025, at approximately 2:15 PM, the TS #8 confirmed that the laboratory did not monitor or document temperature and humidity levels in Room C44 where the GSP analyzers are located. II. Based on direct observation, review of temperature records, and interview with the Laboratory Director (LD), the laboratory failed to defined criteria for proper storage of reagents, and failed to review temperature conditions in Warehouse Room B62B for 2024 and 2025, where temperature-sensitive materials were stored, including nine of nine boxes of Remel Cary Blair w/Indicator Fecal Transport System. Findings: 1. During a tour of Warehouse Room B62B on June 3, 2025, at approximately 10:00 AM, 9 boxes (containing 120 units each) of Remel Cary Blair w/Indicator Fecal Transport System were observed in storage. The product label specified a required storage temperature of 15 - 25 C. The laboratory did not have a define temperature range for proper storage of reagents. The folllowing reagents were also observed: a. Hologic Aptima Assay Fluid containing: Wash Solution, Lot # 915165, Oil, Lot # 894898, and Buffer for Deactivation Buffer, Lot # 914551, with a required storage temperature of 15 - 30 C. b. Aptima Urine Specimen Collection Kit, Lot # 916819, with a required storage temperature of 15 - 30 C. c. Puritan UniTranz-RT Transport System, Lot # 240523, with a required storage temperature of 2 - 25 C. 2. A review of warehouse temperature records identified instances where temperatures exceeded the acceptable limit of 25 C on the following dates: -August 3, 2024 - 25.4 C -August 4, 2024 - 25.6 C -August 10, 2024 - 26.0 C -August 11, 2024 - 26.0 C -August 17, 2024 - 26.1 C -August 18, 2024 - 26.1 C No documentation of

Summary Statement of Deficiencies D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on record review and interview with laboratory general supervisor (GS), the laboratory failed to enroll in Proficiency Testing (PT) for FT4II performed in chemistry section on the Roche Cobas e601 in 2022 and 2023. Findings includes: 1. A review revealed the laboratory College of American Pathologists (CAP) PT test report did not include FT4II analyte in 2022 or 2023. The laboratory failed to include the FT4II test as one of PT assays performed in chemistry section. The laboratory procedure and service manual included the FT4II on the test list offered by the laboratory. The laboratory service manual listed the Free T4 test under their Thyroid Panel. 2. A review revealed the laboratory performs quality control for FT4II daily. The laboratory performs approximately 112 tests annually. 3. During the interview with the GS revealed the laboratory used a calculation based on the package insert titled, "Elecys T-Uptake Cobas", to determine FT4II results and did not use the values generated directly from the Roche Cobas e601 analyzer . The laboratory chemistry procedure manual failed to include documentation pertaining to the FT4II proficiency testing or calculation information for the FT4II test results. 4. Interview with the laboratory general supervisor on September 7, 2023 at 09:00 am confirmed the laboratory did not enroll in PT for the FT4II analyte. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- (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 record review and interview with the laboratory general supervisor, the technical supervisor failed to sign the College of American Pathologists proficiency testing (PT) attestation statements for 5 of 30 PT events between 2022 and 2023. Findings includes: 1. A review revealed the laboratory technical supervisor (TS) failed to sign the attestation statements for the College of American Pathologists PT events C-C 2022-A, C-A 2023-A, HIV-A 2023, HCV-A 2023, and VM-A 2023. 2. Interview with the laboratory general supervisor on September 6, 2023 at 1:00 pm confirmed the laboratory TS did not sign all attestation documents listed above. 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 proficiency testing records and interview, the laboratory failed to verify accuracy of the Hologic Aptima HIV-RNA Qualitative Assay twice annually for 2022. Findings included: a. A review of the laboratory's STD section proficiency testing records for 2022 revealed the laboratory had not completed twice annual verification of accuracy for the Hologic Aptima HIV-1 RNA Qualitative Assay. b. During an interview 9/06/23 at 12:30 PM in the conference room, the Quality Manager stated a PT company could not be sourced to provide samples for this assay, and the twice annual accuracy verification study had been done on the HIV quantitative assay run on plasma, but not on the Hologic Aptima HIV-1 RNA Qualitative assay run on serum which was brought to their active test menu in March 2022. The interview corroborated the findings. Word Key: STD - Sexually Transmitted Diseases PT - Proficiency Testing D5401 PROCEDURE MANUAL CFR(s): 493.1251(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. -- 2 of 8 -- This STANDARD is not met as evidenced by: I. Based on record review and interview with the general supervisor, the laboratory failed to include the specimen collection temperature range for the storage of samples for the Chemical Threat (CT) procedure manual for Abrine and Ricinine (ABRC) in Urine by Tandem Mass Spectrometry. Findings included: 1. A review revealed the ABRC procedure manual did not include the temperature range documented in the laboratory service manual under "Storage and Shipment Temperatrue Requirements". The laboratory service manual listed the temperature range for the specimen storage at -20C. The procedure manual titled, Abrine and Ricinine (ABRC) in Urine by Tandem Mass Spectrometry on page 1 of 14, states " 4.3 Samples should be frozen as soon as possible and stored on dry ice for shipping ...All samples should be stored -70C or colder". 2. Interview with the laboratory general supervisor on September 6, 2023 at 1: 00 pm confirmed the laboratory did not ensure the specimen collection temperature range in the laboratory service manual was consistent with the ABRC procedure manual. 47107 II. Based on review of the laboratory's procedure, direct observation, and interview with the Technical Supervisor of the STD section, the laboratory failed to follow their own written policy in preparing a 3% concentration sodium hypochlorite solution for preparation of equipment and testing materials, for 4 of 4 Hologic Panther System Analyzers. Findings included: a. A review of the laboratory's procedure titled, "ADPH-BCL-Prattville and Mobile - Serology Aptima Combo 2 Assay Panther System" revealed on page 6 of 14 the following: "Preparation of Equipment and Testing Materials: Prior to starting assay, wipe down work surfaces with 3% bleach solution. Allow bleach to remain on surfaces for at least 1 minute (do not bleach solution dry) then rinse with DI water. Cover bench surfaces with clean absorbent lab towels." b. In direct observation, on 9/07/23 at 10:06 AM, in the STD section of the laboratory, two bleach cleaning solution bottles were observed for use on the four Hologic Panther System Analyzers at 4.125% (50% of commercial 8.25% Clorox Germicidal Bleach bottle) and 10% concentrations. c. An interview with the Technical Supervisor of the STD section on 9/07/23 at 10:06 AM in the laboratory corroborated these findings. Word Key: STD - Sexually Transmitted Diseases 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)