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 record review and staff interview on 07/28/2020 and 07/29/2020, it was determined the laboratory failed to perform and document a positive negative reactivity for each substrate tested on the Vitek Gram Negative and Gram Positive Identification Panels when a new lot number was received and put into use. Findings include: 1. Review of quality control documentation for the lot number 2411207203 Gram Negative Identification Panel failed to include quality control organisms producing a positive and negative reactivity for 24 of 47 substrates used to identify gram negative organisms. 2. Review of quality control documentation for the lot number 2421318403 Gram Positive Identification Panel failed to include quality control organisms producing a positive negative reactivity for 14 of 43 substrates used to identify gram positive organisms. The general supervisor acknowledged in an interview at 2:30 PM on 07/29/20209, the laboratory failed to have a system in place to ensure a positive and negative reactivity was confirmed for all substrates tested on the Vitek Gram Negative and Gram Positive Identification Panels prior to patient testing. 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 --