Summary:
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 record review and interview the laboratory failed to follow its own procedure for the documentation of failed quality control limits for hematology. Findings: 1) A review of the Laboratory Policy and Procedure under General in the Laboratory Control Policy stated- 3.2 "3.2 All quality control data that exceeds the manufacturers established tolerance limits will be documented on the ASPR Laboratory Quality Control Problem Log along with the action performed to correct the quality control discrepancy." 2) In an interview with the laboratory director on 12/7 /2022 at 3pm the surveyor requested a sample of the Laboratory Quality Control Problem Log. The laboratory director confirmed that the laboratory did not have a QC problem log. 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. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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)