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 lists of tests performed and email exchanges with the laboratory manager the laboratory failed to enroll the laboratory in an approved proficiency testing program for the specialty of cytology for 2021 and 2022. Findings are: 1. The laboratory's list of tests performed lists cytology testing. 2. Email exchange with the laboratory manager on 1/18/2023 confirmed the laboratory performed 868 gynecological cytology tests from April 2021 to December 2022. 3. Email exchange with the laboratory manager on 1/12/2023 confirmed the laboratory did not enroll in an approved proficiency testing program for the specialty of cytology for 2021 and 2022. 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 --