Imgen Diagnostics, Inc

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for Imgen Diagnostics, Inc. pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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 record review and interview with the President/CEO and Testing Person (TP) on 10/17/2023, the laboratory failed to follow procedures and policies for twice annual verification of testing it performs that is not included in subpart I of this part as evidenced by the following: The surveyor reviewed the laboratory's procedure for histopathology urologic tissue slide case reviews. The review revealed that once per quarter within a calendar year, 10% of all histopathology cases performed by each of two TP-Pathologists would be reviewed by Laboratory Director for accuracy of diagnosis. A review of calendar years 2022 and 2023 quality assessment records for each of two TP-Pathologists revealed that no histopathology urologic tissue slide case reviews were performed at least twice annually between 1/22/22 and 4/26/23. The documented reviews were performed on 1/22/22, 4/26/23, 7/11/23, and 10/11/23. The President/CEO and TP interviewed on 10/17/23 at 11:02AM confirmed that twice annual accuracy verification for histopathology urologic tissue slide cases was not performed at least twice annually from February 2022 through April 2023. Laboratory performs 604 microbiology tests and 3351 pathology tests annually 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 D0000 A CLIA recertification survey was conducted for the Imgen Diagnostics, Inc. laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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. This STANDARD is not met as evidenced by: Based on interview and record review, the laboratory failed to follow policies and procedures in place for all tests, assays, and examinations performed by the laboratory as evidenced by the following: The surveyors reviewed the written procedure manual on 3/29/19. The review revealed that the laboratory failed to follow the procedure named Formaldehyde/Xylene Safety Monitoring for two (2) testing persons (TP) out of 2 TP performing gross descriptions. The procedure stated that TP be monitored for formaldehyde/xylene exposure on an annual basis. There was no evidence of monitoring for calendar years 2017, 2018, and 2019. The laboratory added histopathology on 10/15/17. The laboratory owner confirmed in an interview at 10:36 A.M. that annual safety monitoring was not performed since adding histopathology. 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 --