Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) document review and an interview with the laboratory manager, the laboratory director and the testing personnel failed to retain the American Association of Bioanalysts (AAB) test reports used to grade the PT events and failed to sign the attestation statements since the last survey on March 1, 2016. Findings: 1. A record review of PT documents from AAB revealed the laboratory failed to retain the AAB PT test result reports for urine sediment examination since the last survey on March 1, 2016. 2. A record review of PT documents from AAB revealed the laboratory director and the testing personnel failed to sign the attestation statements for urine sediments since the last survey on March 1, 2016. 3. A record review of PT documents from AAB revealed the laboratory failed to make available urine sediment PT records for 2016. 4. An interview on January 26, 2018 at 10:00 AM, with the laboratory manager, confirmed the laboratory failed to retain PT result reports or sign the attestation statements. D5403 PROCEDURE MANUAL 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 -- 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 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)