Summary:
Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0096D CLIA Application and Survey Summary report and interview with the laboratory director, the laboratory did not authorize the American Proficiency Testing (API) agency to release the proficiency testing (PT) results to Center for Medicare & Medicaid Services (CMS) to determine successful participation. Findings: 1. The laboratory is required to authorize API to submit the PT results to CMS. The results are entered into the federal data base. These results are available to the state agency (SA) for periodic review. 2. Prior to the survey the CASPER Report 0096D CLIA Application and Survey Summary (individual laboratory profile for PT results) was pulled for review. The CASPER Report 0096D report lists the year, event number, each analyte tested in the laboratory and score for three consecutive years. The report that was pulled indicated that "No routine scores found for this provider" had been received. 3. During the survey at 12:00 PM on 02/20 /2018 the laboratory director confirmed that the PT results did not show up on the CASPER Report 0096D for review by the SA staff. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)