Greater North Texas Pediatrics

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representative. The survey process was discussed, and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The laboratory representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be NOT in compliance with the CLIA conditions for specialties /subspecialties surveyed for 42 CFR 493.1409 Technical Consultant 493.1421 Testing Personnel (moderate complexity) Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies 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 a review of the laboratory's procedure manual, approved by the laboratory director in May 1998, manufacturer assay records of new quality control (QC) reagent received during the period 1/1/l7 to 1/11/18 and staff interview, the laboratory failed to follow their own instructions on verifying each new lot of QC reagent. Findings were: A. On page 47 of 50 of the laboratory's procedure manual it stated, "New lot numbers of reagents, test kits and media are verified for quality before use." B. Upon request, the laboratory was unable to provide evidence that new lot numbers of QBC quality control reagent were verified for quality before being placed into service. C. During interview with testing person #2, who was also the clinic manager, she stated that she was unaware of this requirement. The finding was confirmed with the clinic manager on 1/11/18 at 1615 hours in an administrative office. Also see D6021 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. 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 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other 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)