Summary:
Summary Statement of Deficiencies D0000 An unannounced complaint investigation was performed on March 20, 2025, for Intake #TX 00533429. The laboratory was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements. The following IMMEDIATE JEOPARDY findings were: D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; D6108 - 42 C.F. R. 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor; D6134 - 42 C.F.R. 493.1453 Condition: Laboratories performing high complexity testing; clinical consultant; D6141 - 42 C.F.R. 493.1459 Condition: Laboratories performing high complexity testing; general supervisor; D6168 - 42 C.F. R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel; The IJ Template was provided to the laboratory at the exit conference and the immediate jeopardy conditions were abated on 3/20/25. And the following CONDITION LEVEL findings were: D5028 - 42 C.F.R. 493.1219 Condition: Histopathology; D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of the laboratory's records and staff interview, the laboratory failed to meet the requirements for the specialty of histopathology for the grossing of patient's tissue specimens from January to March 2025. Findings include: 1. The laboratory failed to have documentation of a written procedure for the laboratory personnel to follow for the grossing of patient specimens. (Refer to D5403) 2. The laboratory failed to include the name and address of the testing facility on patient's test reports reviewed. (Refer to D5805) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- 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)