Thyroid Specialty Laboratory, Inc

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of procedure, 2024 and 2025 proficiency testing (PT) results, and interview with the general supervisor (GS) #3, the laboratory failed to evaluate PT results that did not reflect laboratory test performance. Findings: 1. Review of the procedure titled "Proficiency Testing" for ungraded PT results states, "If the method is quantitative, TEN Healthcare's results should be compared with the median and range reported by the PT supplier. Acceptability limits should be established for each analyte at the discretion of the laboratory director. If the method is qualitative, TEN Healthcare's results should be compared to the consensus results of the other participants". 2. Review of College of American Pathologists (CAP) and American Proficiency Institute (API) PT records showed no

Summary Statement of Deficiencies 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 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)