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 and an interview with the laboratory director/testing person, the laboratory failed to check each new batch, lot number and shipment of 0.04 bacitracin disc for positive and negative reactivity from October 1, 2017 through December 31, 2017. FINDINGS: 1. On June 20, 2018 at approximately 10:30 AM the laboratory director /testing person confirmed surveyor's findings that the laboratory failed to check each new batch, lot number and shipment of the bacitracin disc for positive and negative reactivity from October 1, 2017 through December 31, 2017. 2. the laboratory failed to record the lot number/expiration date for the shipment of bacitracin disc received in the lab on 5/24/2017, this was verified by the McKesson Invoice. 3. Approximately 142 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 --