Summary:
Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the technical consultant (TC) and laboratory director (LD), the laboratory failed to be constructed, and arranged, to provide a safe environment to protect testing personnel from potential chemical hazards and biohazardous materials. Findings: 1. The laboratory is required to implement safety policies and procedures to ensure safety for the testing personnel. The Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA) provide guidelines for laboratory safety. 2. There are three analyzers in the laboratory space. The Medica EasyRA chemistry analyzer (W/D/H: 40"(inches) x 26" x 15") and Medonic M5 hematology analyzer (width (W)/depth (D)/ height (H): 16.97" x 14.33" x 19.53") are benchtop analyzers and the Tosoh AIA-900 immunoassay analyzer (W/D/H: 35.04" x 26.18" x 49.09") that stands alone. The lab has a portable air conditioner on the floor that vents through the ceiling and a refrigerator that is approximately (W/D/H: 18" x 25" x 36"). 3. The chemistry analyzer is on a table against the left wall. The benchtop space was overcrowded with two computer keyboards and the patient specimens were in a rack on top of the analyzer. 4. The immunoassay analyzer was along the back wall. There is about 10" between the table that holds the chemistry analyzer and the immunoassay analyzer extends in front of the chemistry analyzer by 26". The space in between is cluttered with at least six xerox size paper boxes and a gallon jug container. The immunoassay analyzer was cluttered with chemistry reagents, sani-wipes, tissues, plastic bags, patient specimen racks, and a barcode scanner. 5. The wall on the right side of the lab had a counter that extended the length of the wall. At the far left end of the counter top was a printer; then a stack of gloves; a monitor and keyboard with a rocker for 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 3 -- hematology specimens behind the monitor; eyewash bottle; spill kit; hand sanitizer and lotion; container with scissors and pens; and the hematology analyzer. On top of the hematology analyzer were two half full urine specimen cups; two purple top tubes with blood; a barcode scanner; and other assorted stuff. 6. Adjacent to the counter on the right side of the lab was the refrigerator that extended 25" from the front wall. There was approximately 2" between the counter and the refrigerator. In order for the testing person to perform a test on the hematology analyzer they would have to lean over the refrigerator that had two accordion files; three lab binders and assorted clutter to reach the front of the analyzer to perform the test. 7. In front of the refrigerator was a rolling stool. Next to the refrigerator was a tall plastic container with at least two boxes on top with a hole punch device on top. In front of the plastic container was the portable air conditioner that vented through the ceiling 8. Laboratory benchtop space was overcrowded with instrumentation, reagent packs, and patients' specimens leaving limited space for testing personnel to adequately perform patient testing without the potential for biohazardous contamination. 9. During the survey on 08/24/2022 at 1:15 PM, the TC confirmed that the laboratory was crowded and the LD stated that the owner of the building would not allow them to reconfigure the walls of the laboratory. The laboratory failed to be constructed, and arranged, to provide a safe environment to protect testing personnel from potential chemical hazards and biohazardous materials. 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)