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 review of the laboratory's list of tests performed and interview with general supervisor, in 2019 the laboratory failed to enroll in an approved proficiency testing program for Human Chorionic Gonadoptropin, qualitative serum. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory performed forty four moderate complexity Human Chorionic Gonadoptropin, qualitative serum in 2019. 2. Interview with general supervisor on 1/30/2020 at 11:23 AM confirmed the laboratory had not enrolled in proficiency testing for moderate complexity Human Chorionic Gonadoptropin, qualitative serum in 2019. 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 --