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 lack of documentation and interview with staff, the laboratory failed to check 1 of 1 lot number of Chlorizol Black reagent prior to or concurrent with use. The laboratory performed approximately 10 to 20 potassium hydroxide preparations using Chlorizol Black reagent. Findings include: 1. The laboratory failed to document they checked Chlroizol Black reagent for lot number 8094 expiring 2020/04/04. 2. In an interview conducted on 08/16/2018 at approximately 10 :00 A.M., staff confirmed they had not recorded they checked each new lot number of reagents in use prior to performing patient tests. 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 --