Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing records for gynecologic examinations (Pap smears), lack of proficiency testing enrollment, and interview with the laboratory Director, the Condition: Enrollment and testing of samples was not met. The findings include: a. The laboratory performs Pap smears test on the patients' specimen since 5/19/2017. The laboratory Director/Technical supervisor successfully participated in CAP cytology proficiency testing in 10/3/2016. Subsequently, the laboratory Director/Technical supervisor passed the American Board of Pathology MOC Part III examination in Cytopathology on 12/4/2017. However, the laboratory did not enroll in the cytology PT program for the year 2018. b. The laboratory Director /Technical supervisor is the only testing person who performs the Pap smears test in the laboratory. c. The laboratory Director/Technical supervisor, on 8/7/2019 at 1:10 pm, confirmed that the laboratory did not enroll in the cytology PT program for the year 2018. d. The laboratory's testing declaration form, signed by the laboratory Director on 8/7/2019, stated that the laboratory performs 200 Pap smears tests, annually. 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 --