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 review of the coagulation procedure manual, coaguation/prothrombin time records for 2017 and to date June 27, 2018 and interview with technical supervisor #6, the laboratory failed to follow procedures for validating reference intervals (normal values) before each lot number of Innovin reagent is put into service for patient testing. Findings: 1. The coagulation procedure manual revised August 28, 2017 states," reference interval values are validated before each Innovin lot number is put into service." 2. Review of prothrombin time coagulation records revealed no documentation to show the laboratory validated reference intervals for Innovin reagent lot number 539393 in service from April 2017 through April 19, 2018. No documentation was available to show the laboratory validated reference intervals for Innovin lot number 549717 in service after April 19, 2018 and to date June 27, 2018. 3. Interview with technical supervisor #6 on June 27, 2018 at 12:30 PM confirmed, the laboratory failed to follow the coagulation procedure for validating reference intervals for each lot number of Innovin reagent before reporting patient results. 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 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 -- 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 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)