Summary:
Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory director, the histotech failed to label the stain containers for staining tissues during 2018. Findings include: 1. The surveyor observes tissue staining dishes with no labels directly attached at 9:30 AM on August 23, 2018. 2. An interview with the laboratory director at 10:00 AM on Augst 23, 2018 confirms there are tissue staining dishes with no labels directly attached. 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 observation, review of the cutting instrument maintenance, and interview with the laboratory director, the laboratory failed to follow daily cleaning instructions for the instrument used to cut tissue during 2018. Findings include: 1. The surveyor Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- observes stacks of cut tissue on and surrounding the cutting blade at 9:30 AM on August 23, 2018. 2. The manufacture rmaintenance requires daily cleaning of the cutting instrument. 3. The laboratory director states at 10:30 AM on August 23, 2018, after seeing a photo of the cutting instrument, it is unacceptable to allow shavings to pile up in the cutting instrument. -- 2 of 2 --