Biogenica Laboratories Llc

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Supervisors (TS), the laboratory failed to evaluate results obtained by the PT provider for Urinary Tract Infection (UTI), Toxicology and Pharmacogenetics (PGX) tests from 1/1/23 to 7/15/25. The findings include: 1. There was no documented evidence coded and ungraded results for the following tests were evaluated by the laboratory: A) UTI: Code 11 for "no appropriate peer group" for all events in 2024 and the 1st event of 2025. B) PGX: Code 26 for "educational challenges" for all events in 2023 and 2024. C) Toxicology: Not graded results for the 2nd event of 2024 and 1st event of 2025. 2. The TS confirmed on 7/15/25 at 1:00 pm, the laboratory did not evaluate coded and ungraded results for PT results obtained from the PT provider. 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 surveyor review of the Procedure Manual (PM), Proficiency Testing (PT) records and interview with the Technical Supervisors (TS), the laboratory failed to verify the accuracy and reliability for all analytes for Urinary Tract Infection (UTI), 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 -- Wound Pathogen Panel (WPP) and Respiratory Pathogen Panel (RPP) tests performed on the Quantstudio 12 k Flex from 1/1/23 to 7/15/25. The finding includes: 1. Surveyor review of PT records revealed all non-regulated analytes for UTI, WPP and RPP were not included by the PT provider performed in events 2023, 2024 and the 1st event of 2025. 2. The laboratory did not verify the accuracy twice annually on the Quantstudio 12 k Flex analyzer for non-regulated analytes for the following tests: A) WPP: 36 out 42 analytes were not verified. B) UTI: 3 out of 26 analytes were not verified. C) RPP: 8 out of 28 analytes were not verified. 3. The TS confirmed on 7/15 /25 at 1:10 pm, the laboratory did not verify the accuracy for all non-regulated analytes performed on the Quantstudio 12 k Flex. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Technical Supervisors (TS), the laboratory failed to establish procedures when the Proficiency Testing (PT) program assigned the laboratory an artificial score of 100% from 1/1/23 to 7/15/25. The finding includes: 1. The laboratory was assigned artificial 100% scores by the PT provider for events performed in 2023, 2024 and the 1st event of 2025 for the specialities of Microbiology, Virology, Mycology, Clinical Cytogentics and Toxicology. 2. The laboratory lacked a procedure for review of its reported PT results against the PT provider's participant summary results. 3. The TS confirmed on 7/15/25 at 1:35 pm, the laboratory did not establish procedures in the general laboratory systems requirements requirements for review of its reported PT results against the PT provider's participant summary results. 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 D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on surveyor observation of the area where Molecular testing was performed and interview with the Technical Consultant (TC), the laboratory failed to have a unidirectional workflow for specimen preparation, reagent preparation, product detection and amplification from August 2017 to the date of the survey. The TC confirmed on 6/18/19 at 10:00 am the laboratory did not have a unidirectional work flow. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Performance Specification (PS) data and interview with the Technical Consultant (TC), the laboratory failed to retain PS work records for the AB Sciex Triple Quad 4500 MD used to perform confirmatory Drug Testing from April 2017 to the date of survey. The TC confirmed on 6/18/19 at 10:15 am that PS analyzer work records were not retained. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to evaluate results when they received Not Graded score in Chemistry - Miscellaneous with American Proficiency Institute in the 1st event of 2018 and 2019. The findings include: 1. There was no evaluation documented when the laboratory received "Not Graded" for Opiate sample UDS-02 in 1-2018 and UDS -01 in 2019. 2. There was no documented evidence the laboratory evaluated the failures. 3. This deficiency was cited on the previous survey 7 /7/17. 4. The