Summary:
Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (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. This STANDARD is not met as evidenced by: Based on interview, the laboratory failed to document that the intended reactivity of the staining reagents used to perform sperm morphology testing for semen analysis reacted as expected for the first patient tested each day of patient testing. Findings: 1. The laboratory used slides that are preloaded with methylene blue and cresyl violet acetate to stain sperm cells and round cells so testing staff can observe and report their morphology. 2. The laboratory failed to have an approved written quality control procedure ensuring that the staining quality and reactivity of the stained slide for first patient tested each day of testing met the laboratory's criteria for acceptability. 3. The laboratory failed to document that the dyes stained patient specimens in an expected manner (e.g. dyes did not precipitate and specimens took up dye reliably). 4. Staff member 1 confirmed these findings during interview on 09/03/2026 at 12:00 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 --