Summary:
Summary Statement of Deficiencies D0000 As a result of the CLIA recertification inspection, the laboratory is not in compliance with the following Conditions of Participation required for certification in the CLIA program at 42 CFR part 493: D2000 - 42 C.F.R. 493.801 Condition: Enrollment and testing of [proficiency testing] samples; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; 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 laboratory proficiency testing records and interview with facility personnel, the laboratory failed to enroll in an HHS approved proficiency testing program (three testing events per year) for the regulated analytes in the specialty of hematology for the first event of 2018. The findings included: 1. Based on review of the CMS-155D proficiency testing report, no scores had been sent from a proficiency testing agency for the first (1st) event of 2018. 2. Based on review of laboratory