Summary:
Summary Statement of Deficiencies D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor's review of the bacteriology Quality Control (QC) documentation, laboratory's QC policy and an interview with the laboratory director, the laboratory failed to check each new batch, lot number and shipment of 0.04 bacitracin disc for positive and negative reactivity from March 6, 2019 through the survey date. FINDINGS: 1. On July 18, 2019 at approximately 12:00 PM the laboratory director confirmed surveyor's findings that the laboratory failed to follow the laboratory's QC policy and check each new batch, lot number and shipment of the bacitracin disc for positive and negative reactivity using commercially prepared organisms. The laboratory performed bacteriology QC using patient samples from March 6, 2019 to survey date. 2. Approximately 50 patients specimens were tested and reported for throat culture during this time period. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --