Summary:
Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's manual differential quality control (QC) log, procedure manual, and interview with technical consultant (TC) and administrative laboratory director, the laboratory failed to establish criteria for intended reactivity to ensure acceptable staining characteristics for manual differentials stained using Wright's stain from January 2021 to May 2023. Findings: 1. On the day of inspection, 06/05/2023 at 11:45 AM, a review of manual differential QC logs and the laboratory's quality control procedure for manual differential staining revealed that the laboratory did not establish or document criteria for intended reactivity for acceptable staining characteristics of manual differentials stained using Wrights's stain from January 2021 to May 31, 2023. 2. On the day of the survey, 6/05/2023 around 11:45 AM the laboratory provided a new QC log implemented on June 1, 2023 that contained the acceptable criteria for intended reactivity to ensure acceptable staining characteristics for manual differentials. 3. TC and administrative laboratory director confirmed these findings 6/05/2023 at around 12:45 PM. 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 --