Summary:
Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure, a review of the patient instructions for collection, validation documents and patient result review, and staff interview, the patient instructions for post-vasectomy semen collection were not consistent with the timeframe in the laboratory procedure, and failed to provide instructions for sexual abstinence requirements prior to collection, the method to be used for collection, the type of container or condom acceptable to use for collection, specimen labeling requirements, or transport temperature requirements. The findings include: 1. A review of the laboratory procedure for Post-Vasectomy Semen analysis revealed that "Specimen must be examined within 1 hour of collection." 2. A review of the patient instructions for collection revealed that the samples were to be brought to the office within 2 hours of collection. The patient instructions did not include instructions for sexual abstinence requirements prior to collection, the method to be used for collection, the type of container acceptable to use for collection, specimen labeling requirements, or transport temperature requirements. 3. A review of test validation documents revealed authorization for patient testing beginning 06/09/25, with patient medical record number 14518296 Post-Vasectomy Semen analysis reported on 06/18 /25. 4. A phone interview with the technical consultant on 07/18/25 at 9:00 a.m. confirmed the survey 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 --