Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory did not ensure reagents were not used past expiration. This finding was corrected by the laboratory director at the time of survey. Findings: 1. The laboratory performs a differential stain for adequacy, but did not document the manufacturer name, lot number and expiration dates of the stains /reagents used; 2. This was confirmed during interview with the laboratory director at approximately 12:00 hours on the day of survey. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director, the laboratory did not specify which stain quality control results were reported for. This was corrected by the laboratory director at the time of survey. Findings: 1. The laboratory performed 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 -- microscopic analysis of slides stained by hematoxylin & eosin, PAP stain and Wriights stain, but the result of the quality control review was a single check mark and that check mark did not correspond to a specific stain, during interview at approximately 12:00 hours, the laboratory director stated that the check mark would apply to all stains reviewed that day. -- 2 of 2 --