Summary:
Summary Statement of Deficiencies D0000 The Integracare LTD laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on September 17, 2026. The following standard-level deficiencies were cited: 493.1413 Technical consultant responsibilities . D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant (TC) failed to ensure initial training and competency evaluation was completed for one of one tenured testing personnel prior to performing a new microscopic examination on patient specimens in 2026. Findings are as follows: 1. The laboratory performed Urinalysis testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:00 a.m. on 09/17/26. 2. An Olympus CX31 microscope was observed as present and available for use during the tour of the laboratory. Urine Sediment microscopic examinations (USed) using this microscope were implemented on 05/27/26 as indicated by the LD. 3. USed initial training and competency evaluation documents for tenured Testing Personnel 2 were not found during review of laboratory records. The laboratory was unable to provide the documents upon request. 4. In an interview at 11:00 a.m. on 09/17/26, the LD confirmed the above finding. 5. 37 USed patient test reports were released from 05/27 /26, through date of survey, 09/17/2026, as indicated by the LD in an interview at 1:10 p.m. on 09/17/26 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 --