Standard - Proficiency Test Program Participation

(A) The laboratory shall participate in an approved proficiency testing program which adequately covers the level of services offered. (B) The laboratory shall authorize the approved proficiency testing service to report all proficiency test results to the Department. (C) The laboratory shall maintain proficiency testing results in each of the categories or subcategories which it is authorized or licensed to perform. These records shall be made available to the Department and shall be kept on file for two years. (D) The laboratory shall test applicable proficiency testing materials only in the laboratory to which the license and proficiency test requirements applies using personnel, equipment, and reagentsroutinely used in that facility. (E) An exception to the requirements of this section may occur ifthe Department determines that an appropriate proficiency testing program is not readily available. If a proficiency testing program acceptable to the Department is developed for a specialty or subspecialty in which no previous program had been approved, the clinical laboratory shall have one year in which to enroll. (F) All clinical laboratories requesting licensure shall show evidence that they have enrolled in a proficiency testing program acceptable to the Department. (G) The laboratory must select an appropriate service approved by the Department which has the ability to evaluate the specific laboratory methodology and/or instrumentation.