Biogenics Medical Laboratories

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the quality control (QC) records and interview with the laboratory consultant (LC), the laboratory failed to ensure that the QC results from each lot has been printed, reviewed, and saved prior to the new lot of QC material being entered into the ImmTox 270 toxicology analyzer. Findings: 1. The laboratory started using the ImmTox 270 at the end of May 2024. The QC records were reviewed. The QC records that were available showed results from September 20, 2024 through December 18, 2024. According the the LC, the analyzer holds QC results until the new lot is entered, then the previous QC data is over ridden with the new lot of QC materials. 2. During the exit interview on 12/18/2024 at 12:30 PM, the LC confirmed that the QC records on the ImmTox 270 had not been maintained for the required two years. 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 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 -- 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 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. This STANDARD is not met as evidenced by: Based on review of the specimen handling guide and interview with the testing person (TP) and quality manager (QM), the laboratory's specimen handling guide did not include accurate specimen storage and shipping conditions. Findings: 1. The laboratory received urine toxicology specimens from two outside facilities. 2. The document titled "Toxicology Specimen and Handling Guide" (guide) included instructions for outside facilities to collect, store, and transport patient specimens. 3. The guide stated that "Samples may be stored for up to 7 days refrigerated at 2-8 C after date of collection" and "Samples may be stored at -20C for up to 30 days after collection." At the time of the survey the laboratory had stability data showing that samples were stable when stored at -20C for up to 14 days, not 30 days. 4. The TP stated that all specimens were received on ice packs and typically shipped via United Parcel Service (UPS). The guide stated "A courier will transport specimens" and did not mention that samples must be shipped on ice or refrigerated conditions and could be shipped via UPS. 5. During the survey on 08/16/2023 at 3:00 PM, the TP and QM confirmed that the specimen handling guide did not include accurate specimen storage and shipping conditions. D6148 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(a)(4) 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 -- The general supervisor is responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained. This STANDARD is not met as evidenced by: Based on review of the laboratory records, and interview with the testing person (TP) and quality manager (QM), the general supervisor (GS) failed to monitor the test analysis to ensure that acceptable levels of analytic performance was being maintained. Findings: 1. The laboratory records show that the new TP started performing testing on the liquid chromatography mass spectrometer (LC-MS/MS) analyzer in April 2023. 2. Since the new TP does not have the required one year of experience performing testing on the LC-MS/MS analyzer they are not qualified as the GS. 3. The "Laboratory Personnel Report (CLIA)" form lists the name of the GS. The laboratory records show the initial training of the GS on 05/30/2023. There were no records available at the time of the survey showing that the GS was routinely monitoring the test analyses of the new TP. 4. During the exit interview on 08/16 /2023 at 3:00 PM, the TP and QM confirmed that there were no records available at the time of the survey showing that the GS was routinely monitoring the test analyses of the new TP to ensure acceptable levels of analytic performance was being maintained. -- 2 of 2 --