Genentox Laboratories, Llc

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the review of the American Proficiency Institute (API) proficiency testing (PT), and the College of American Pathologists (CAP) PT testing records, six (6) randomly selected patient test records, and interviews with the testing personnel (TP); it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for LDH for the first event of 2024 and Creatinine (Urine) for the third event of 2024. The findings include: 1. Review of PT records for the first event of 2024 (Q1-2024), API reported an unsatisfactory score report as follows: LD/LDH PT Q1-2024 Overall score: 60% Specimen Reported Expected CH-01 105 69-104 * CH-02 639 423-635 * CH-03 482 324-487 CH-04 145 98-148 CH-05 850 568-854 * indicates unacceptable result 2. Review of CAP - PT records for Creatinine (Urine) Microgenic DRI for the third event of 2024, for out of ten PT samples tested a score of 50% was obtained which is unacceptable. 3. TP confirmed by interview on March 5, 2025, at approximately 11:00 a.m. that the laboratory obtained the PT scores mentioned in statements #1 and #2 above. 4. According to the laboratory's testing declaration submitted on the day of the survey March 5, 2025, the laboratory performed approximately 18,000 Routine Chemistry tests, including LD/LDH and approximately 8,140 Urine Creatinine tests, during the time the laboratory received unsatisfactory proficiency testing results. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) 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 -- (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 review of the validation/verification documentation and interview with the laboratory technical supervisor (TS) and testing personnel (TP); the laboratory failed to have validation/verification plans, documents, and new protocols approved, signed, and dated by the current laboratory director before use. The findings included: 1. On the day of the survey March 5, 2025, at approximately 1:00 p.m. the validation /verification records including new protocols in place for various new tests validated /verified (Abbot HIV, Hepatitis panel, AIC, TSH, Vit B12, etc.) in the laboratory had not been approved, signed, and dated by the laboratory director before placing them in use. 2. The TS and TP confirmed by interview on March 5, 2025, that the laboratory failed to have the laboratory director approve, sign, and dated validation/verification plan, records, and new protocols for testing performed in the laboratory with the effective date and the laboratory director's signature. 4. The laboratory's testing declaration form stated that the laboratory processes approximately 77,698 patients' samples annually. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's quality control records, six (6) randomly chosen patient records, and interviews the technical supervisor (TS) and testing personnel (TP ); the laboratory failed to perform control procedures using the number and frequency specified by the manufacturer to support control procedures for Microbiology Gastrointestinal (GI) panel. Findings included: 1. Review of a randomly chosen patients test results, for one (1) out of six (6), the laboratory failed to run Quality Controls on May 22, 2024. 2. The TP confirmed by interview unable to find QC results for GI panels tested on 5/22/2024. 3. Based on the laboratory testing declaration submitted at the time of the survey March 5, 2025, the laboratory reported approximately 22,634 Microbiology testing samples annually including GI panels. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; -- 2 of 3 -- This STANDARD is not met as evidenced by: ased on surveyor's review of laboratory's proficiency testing records, validation /verification of new tests, six (6) randomly selected patients' test samples results, and interview with the laboratory's technical supervisor and testing personnel testing personnel on March 5, 2025; the laboratory director failed to provide effective analytical direction of the laboratory. See D2087, D 5407, and D5445. -- 3 of 3 --

Summary Statement of Deficiencies D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(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-- When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's quality control material, calibrator, and interview with the laboratory technical supervisor on February 6, 2024, at 12:00 pm, the laboratory failed to use different lot's control material from the calibrator. The findings include: 1. The laboratory used an LC-MS/MS method to detect various drugs in the patient sample. It used a calibrator to calibrate the system by a standard curve and ran quality control each time of testing. However, it used the calibrator material from the same lot of quality control material. Therefore, the validity of the test method cannot be assured and might have had harmed patient. 2. The laboratory technical supervisor on February 6, 2024, at 12:00 pm, affirmed that the laboratory used the calibrator material from the same lot of quality control material. 3. The laboratory's testing declaration form, signed by the laboratory director on 2/2/2024, stated that the laboratory performs approximately 201,872 LC-MS tests, annually. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory 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 -- director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, quality control and patient test records, and interview with the laboratory technical supervisor on February 6, 2024, at 12:00 pm, the laboratory director failed to assure laboratory's compliance with the applicable regulations and potentially harmed patients. The findings include: See D5467, D6093 and D6107. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's quality control material, calibrator, and interview with the laboratory technical supervisor on February 6, 2024, at 12:00 pm, the laboratory director failed to ensure that the laboratory established and maintained the quality control programs to assess the quality of laboratory services provided. The findings include: See D5467. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's personnel records, and interview with the laboratory technical supervisor on February 6, 2024, at 11:50 am, the laboratory director failed to specify, in writing, the responsibilities and duties of each individual involved in the laboratory operation including consultants and supervisors. The findings include: The laboratory's personnel report form signed by the laboratory director on February 2, 2024, showed that it had 1 TS/GS and 3 TP. However, the laboratory did not have any record showing that the laboratory director have specified, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each -- 2 of 3 -- individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. -- 3 of 3 --