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 observations and interview with the Mohs Technician and a management staff on July 2, 2018 at approximately 1:30 PM and 2:00 PM respectively, the laboratory failed to ensure that an adequate space is provided for staining Mohs surgery slides. The findings included: 1. The laboratory uses a moveable staining station with a table top hood (G-Series Containment Hood). The staff moves the staining station from storage to the laboratory / patient exam room /Mohs room on the days the laboratory performed Mohs procedure. The staining station is placed behind a big unmovable examination chair. 3. The station is on top of a very low table. The Mohs Technician demonstrated to the surveyor how the staff process the slides, by squatting. In addition, due to the height of the table and the position of the exam chair, the lighting inside the hood is inadequate. There is very little room between the chair and the processing station. 4. Interview with the Mohs Technician revealed that he/she had been able to use the station with some difficulty. 5. The lack of adequate space was discussed with management staff at the time of the exit conference. 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 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 -- 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)