Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Adult & Pediatric Dermatology, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow policies and procedures for twice annual verification of testing it performs that is not included in subpart I of this part as evidenced by the following: A review of the laboratory's polices for histopathology skin slide case reviews for accuracy of diagnoses stated that the laboratory, "performs biannually intra/inter reliability test of 10 randomly selected cases...". A review of histopathology skin slide case reviews performed in calendar year 2016 and 2017 revealed that skin slide case reviews for accuracy verification were not performed semiannually in calendar year 2017. Record review revealed that a 10 case review was performed, for cases chosen between January and June of 2017, on 7/25/17. For cases chosen between July and December of 2017 the case reviews were not performed until 2/6/18. The histotechnician interviewed on 5/31/18 at 12:35 PM confirmed that twice annual accuracy verification for histopathology cases had not been performed twice annually during calendar year 2017. 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 --