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 procedures manual; patients test records; quality control (QC) records, and interview with the technical supervisor, the laboratory failed to test staining materials for intended reactivity each day it tested patient's specimens. Findings: 1. There were no procedures that described the laboratory's process for performing and documenting QC of the staining used to report morphology of semen specimens. 2. The surveyor reviewed 6 patients test records which included the patients' work sheets as well as the final report. 3. Review of QC records show that the laboratory documented its QC results on a form titled, "AQC Sperm Morphology Quality Control. 4. There was no documentation to show what date patients' morphology slides were stained. 5. The surveyor could not tell if QC of the morphology was performed when patients' slides were stained. 6. At 12:30 PM on March 3, 2020, the technical supervisor confirmed the surveyor's findings. 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 --