Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, the laboratory (lab) did not ensure that the refrigerator located in the testing area and used to store lab reagents, was free from food items to ensure protection from biohazard materials. Findings: 1. It was observed on the day of survey that the side by side refrigerator/freezer located in the lab testing area had signage on the door showing the image of a hand reaching for a drinking cup and a red circle with a line through the circle, imaged overtop of the hand and cup, symbolizing that the refrigerator be free of food or drink; and 2. Inside the freezer on the bottom shelf was a bag of frozen squeeze pops. 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)