Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 23, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: 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 records and an interview with the Clinic's Laboratory coordinator , the laboratory failed to enroll in a CMS approved Proficiency Testing (PT) program or Peer review for the speciality of Histopathology. Findings include: 1.) A review of laboratory documents revealed that there was no enrollment in a CMS approved proficiency testing program or peer reviews for the years of 2016 and 2017 for the speciality of Histopathology. 2.) An interview with the Clinic's laboratory coordinator at approximately 12:00 pm, on January 23, 2018 in the review room confirmed that the laboratory was not enrolled in a CMS approved PT program or Peer review program. 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 --