Relates to restricted clinical laboratory licenses issued under the clinical laboratory technology practice act

BILL NUMBER:S7199A

Title of bill

An act to amend the education law, in relation to restricted clinical laboratory licenses issued under the clinical laboratory technology practice act

Purpose

Allow individuals employed at National Cancer Institute (NCI)-designated cancer centers who meet the requirements for a restricted license to receive a certification allowing them to perform tests using proteomics, including mass spectrometry.

Summary of provisions

Section 1 of the bill amends section 8610 of the education law, as amended by section 1 of chapter 336 of the laws of 2013, by allowing employees of NCI-designated cancer centers to obtain restricted licenses in the practice of proteomics including mass spectrometry.

Section 2 of the bill is the effective date.

Justification

The purpose of this legislation is to ensure that New York's state-of-the-art cancer facilities can recruit and retain highly qualified personnel to perform specialized clinical laboratory procedures. The statute already recognizes the need for restricted licenses to be made available for some specialized procedures apart from the generally applicable requirements for clinical laboratory technologists. This bill expands the categories of restricted licenses to include the practice of proteomics including but not limited to mass spectrometry.

Proteomics is a branch of biotechnology that applies the techniques of molecular biology, biochemistry, and genetics to analyzing proteins produced by the genes of a particular cell, tissue, or organism. Proteomics, through the use of mass spectrometry, can be used to ensure that patients receive appropriate doses of cancer-treating drugs. Busulfan, a highly toxic chemotherapeutic agent, is used to treat individuals receiving bone marrow or stem cell transplants The drug destroys the patient's own cancerous marrow cells before new cells are transplanted. However, too little of the drug is ineffective and too much is toxic. This makes accurate dosing critical for effective treatment, and mass spectrometry provides the most accurate measurement.

Currently, Memorial Sloan Kettering Cancer Center (MSKCC) has a laboratory approved to use mass spectrometry to perform busulfan analysis. If the proposed bill is not enacted, MSKCC may lose the only employee qualified to oversee mass spectrometry testing. Without sufficient lab personnel MSKCC must send tests out of state, delaying the receipt of test results and significantly impacting quality of care and research.

Such extremely specialized personnel hold advanced degrees in the sciences but do not typically hold clinical laboratory technologist licenses, nor has their education and training focused on standard clinical lab procedures. This inhibits the ability of cancer centers to hire researchers from other states or countries who do not usually meet the full licensure requirements in New York. This bill would

continue to limit these restricted licenses to personnel employed at National Cancer Institute-designated cancer centers. By allowing these researchers the ability to use new technologies in NYS cancer centers, we can ensure that New York remains a leader in cancer research and care.

Legislative history

New Bill.

Fiscal implications

None.

Effective date

This act shall take effect immediately.