Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories
Section 180.460 - Standard - Successful Participation
Current through Register 1531, September 27, 2024
Successful or satisfactory participation for individual analytes, specialties and sub-specialties in proficiency testing shall be determined as follows:
(A) Analytes: The determination of satisfactory performance for each analyte shall be based upon the achievement of results within the acceptable limits established by the proficiency testing service for that procedure or by other criteria approved by the Department.
(B) Specialty/Subspecialty: The determination of satisfactory performance for each specialty or subspecialty shall be based upon the average score for all analytes within that specialty or subspecialty. The Department shall develop and publish criteria for defining the minimum acceptable average performance for each specialty or subspecialty.
(C) Unsatisfactory participation for two successive proficiency tests for an analyte, a specialty, or a subspecialty may result in a request for a plan of correction.
(D) Unsatisfactory performance in a specialty or subspecialty for three consecutive or three out of the last four consignments, may result in revocation or limitation of a license for that specialty or subspecialty area. If a license is revoked or limited for reasons of unsatisfactory performance, reinstatement shall require demonstration of satisfactory proficiency over a period of two consignments, not to exceed six months.
(E) The laboratory shall maintain records of interpretation and remedial actions taken when proficiency testing results are determined to be unsatisfactory.
