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Clinical Laboratory Reference System

Laboratory testing methods are constantly evolving: new methods are adopted rapidly, reflecting escalating advances in scientific and medical knowledge, and laboratory technology. Many methods emerging into use today use molecular techniques and reagents that did not exist just a few years ago. Implementation and management of Wadsworth Center's mandate under the statutory laboratory reference system require that the Center possess and maintain expert knowledge of new methods and advances in technology, as well as expertise in generally accepted, established methods currently in use.

The laboratory reference system has three components:

  1. validation and approval of standard laboratory methods and materials;
  1. cooperative research relevant to advancement, development and assessment of laboratory methods and materials; and
  1. inspection of laboratory facilities and distribution of proficiency test specimens for laboratory examination, or other measures of laboratory performance.

On July 1, 1965, New York became the first state in the nation to initiate a certification and licensing program for a limited number of clinical laboratories operating within the state in selected areas of patient testing. Since then the program has expanded and now monitors, through the Clinical Laboratory Evaluation Program (CLEP) of the Wadsworth Center, the overall quality of testing conducted by all clinical laboratories and blood banks throughout the state, as well as out-of-state facilities and international laboratories that accept clinical specimens obtained in New York State. CLEP draws on the expertise of the Wadsworth Center's scientific staff to help meet the three components of the clinical laboratory reference system.