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: a. Based on surveyor review of the Procedure Manual (PM), analyzer comparison data and interview with the General Supervisor (GS), the laboratory failed to follow their PM policy for "Intra-Instrument Correlation" for Hematology tests ran on the Cell- Dyn Ruby #1 and #2 on 2/12/19. The findings include: 1) The PM stated "3. The values obtained on both analyzers are compared. 4. The average difference between two analyzers should be less than 10%". 2) The values were not compared. 3) The average difference was not calculated. 4) The GS #3 listed on the CMS form 209 confirmed on 12/17/19 at 11:05 am the above mentioned procedure was not followed. b. Based on surveyor review of the PM and interview with the GS, the laboratory failed to follow the procedure for Sample Collection and Preparation for Partial Thromboplastin Time (PTT) tests run on the ACL Elite analyzer from 11/16/17 to the date of survey. The finding includes: 1. The PM stated "Remove Plasma within sixty minutes of venipuncture." but a review of patients requisitions revealed Plasma wasn't removed until specimen was received by the laboratory. 2. Approximately 1500 tests were run and reported. 3. The GS #3 listed on CMS form 209 confirmed on 12/18/19 at 11:00 am that the laboratory did not follow the procedure for sample collection and preparation. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 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)