Advocare Washington Avenue Pediatrics

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 review of the Quality Control (QC) records, Bacitracin discs in use and interview with the Office Manager (OM) the laboratory failed to check each lot number and shipment of BD Bacitracin Discs for positive and negative reactivity from 8/1/23 to the date of the survey. The finding includes: 1. There was no record of Bacitracin QC for Lot # 2025098 currently in use. 2. Approximately 70 patient run and reported each week. 3. The OM confirmed on 11/1/23 at 10:30 asm that the laboratory did not perform QC on Bacitracin disc as stated above. 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 --

Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check QC on each batch of Selective Strep Agar (SSA) used for Throat Culture testing from 9/27/16 to the date of the survey. The findings include: 1. The laboratory did not check SSA for: a. Ability to support growth b. Ability to select or inhibit specific organisms 2. This was cited on the previous survey performed 9/27/16 and the