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 a surveyor's review of records and confirmed in an interview with the testing person at the time of this survey, the laboratory failed to perform bacteriology QC as required in calendar year 2018 and through the survey date. The laboratory failed to: 1. Perform and document the sterility for the Selective Strep Agar (SSA) Media; 2. Document the physical characteristics of the SSA Media for any deterioration. Approximately 200 patient specimens were tested and reported for throat culture during the above 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 --