Mohammed Ogaily, Md

Summary Statement of Deficiencies 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 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)

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to perform and document daily shutdown maintenance for the Beckman Coulter DxH 520 hematology analyzer for 27 days of 11 months reviewed. Findings include: 1. A review of the laboratory's "DxH Instrument Maintenance Checklist" revealed the following days when daily shutdown maintenance was not documented: a. 10/10/19 b. 10/11/19 c. 10/14/19 d. 10/15/19 e. 10/21/19 f. 11/4/19 g. 11/6/19 h. 11/12/19 i. 11/15/19 j. 11/26/19 k. 12/13/19 l. 12/19/19 m. 12/23/19 n. 12 /27/19 o. 2/19/20 p. 2/26/20 q. 3/20/20 r. 4/21/20 s. 4/30/20 t. 5/13/20 u. 5/29/20 v. 6 /10/20 w. 6/23/20 x. 7/2/20 y. 7/31/20 z. 8/12/20 aa. 8/18/20 2. A review of the laboratory's established "Performing Shutdown" procedure revealed a section stating, "Beckman Coulter recommends a shutdown once every 24 hours. Shutdown removes diluent and replaces it with cleaner for 30 minutes. It also checks the expiration date and volume of the reagents." 3. A review of the laboratory's quality assurance documentation revealed a lack of documentation of