Summary:
Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Review of the College of American Pathologist (CAP) proficiency testing (PT) records, review of laboratory's procedure manual and discussion with the staff reveals that the laboratory tested PT samples not the same number of times that it routinely test patient samples. Findings include: 1. Record review of the CAP 3rd event 2017 proficiency testing for Progesterone, Estradiol and Human chronic gonadotropin (HCG) shows that the proficiency testing samples were tested in duplicates. The average of the two runs were computed and the mean value were resulted. 2. Review of the laboratory's procedure manual for testing Progesterone, Estradiol and HCG does not specify to run patients samples in duplicate. 3. The Lead testing personnel confirmed that routine patient samples are NOT run in duplicates. 4. The Lead testing personnel and the Technical Supervisor confirmed these findings 01/22/2018 at 13:00 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 --