Summary:
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 review of the Procedures Manual and interview with testing personnel 1 it is determined that each batch of purchased media received is not checked for ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response. Findings include: 1. In reviewing the procedure on Strep Cultures which has a revision date of 06/23/16 it is stated in the Quality Control section that the manufacturer of the plates does the Quality Control. Two sentences down the procedure on Strep Cultures states that "A known positive and a known negative are used to streak the blood agar plate." 2. In interviewing testing personnel #1 they confirmed that they do not perform Quality Control on incoming plates but rely on manufacturer's Quality Control certificate. It was also found in interviewing testing personnel #1 that in performing the Strep Cultures test that positive and negative conrols are not streaked on the blood agar plates as the procedure states. 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 --