Summary:
Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on a review of laboratory records and an interview with the laboratory consultant and the testing person, the laboratory failed to document the date and time that the specimens are received in the laboratory. Findings Include: 1. The technical consultant and the testing person confirmed in an interview on November 26, 2019, at approximately 12:30 PM that the receipt date and time of specimens are documented. 2. The specimen is taken at the doctor's office located at 104-40 Queens Blvd and transported to the laboratory located at 104-20 Queens Blvd. 3. Approximately 10 test requisitions forms were reviewed, and they failed to include receipt date and time. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of procedures and an interview with the technical consultant and the testing person, the laboratory failed to monitor and evaluate the overall quality system and prevent problems from occurring for the following: 1. Ensure that the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- laboratory had a complete procedure manual. Refer to D5403; 2. Ensure that storage freezer temperatures are within the acceptable range. Refer to D5413 3. Ensure that validation procedures are performed. Refer to D5421 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)