Includes optometrists within provisions relating to clinical laboratories

BILL NUMBER:S5539

Title of bill

An act to amend the public health law, in relation to conducting certain clinical laboratory tests

Purpose

To authorize persons licensed to practice optometry to conduct certain clinical laboratory tests.

Summary of provisions

Amends Public Health Law § 571(6) to add optometrists to the definition of "qualified health care professional." Being, added to this definition will authorize optometrists to perform certain clinical laboratory tests that do not use an invasive modality as defined in section 7101 of the education law when a Limited Testing Registration is issued by the Department of Health under § 579.

Amends Public Health Law § 579(1) to add optometrists to the list of health care professionals who may conduct certain clinical laboratory tests that do not use an invasive modality as defined in section 7101 of the education law, without a clinical laboratory permit, provided such tests are solely as an adjunct to the treatment of their patients. (Section 579 uses the defined term "qualified health care professional." but also lists those professionals in this subdivision.)

Existing law

Public Health Law § 579 provides that licensed physicians, osteopaths, dentists, midwives, nurse practitioners, and podiatrists who perform laboratory procedures as part of the treatment of their patients within their scope of practice do not require a clinical laboratory license. The law requires that they obtain a Certificate of Waiver and Limited Testing Registration from the Health Department. They may only perform those tests authorized by the registration.

Justification

In 1995, optometrists were provided expanded statutory authority related to the diagnosis and treatment of eye disease. Current law still requires optometrists to refer their patients to other statutorily-listed practitioners in order to perform clinical laboratory tests. The purpose of this bill is to improve the diagnosis and treatment of eye disease by providing optometrists with the authority to perform non-invasive clinical laboratory tests relevant to the diagnosis and treatment of their patients within their scope of practice.

The federal Clinical Laboratory Improvement Act (CLIA) of 1988 and state law require certain proficiency standards, testing requirements and inspections depending on the type of tests undertaken. However, these laws also recognize that many tests are performed by healthcare professionals as part of patient examinations. Accordingly, federal and state laws exempt from the clinical laboratory requirements certain tests performed by enumerated professionals.

Federal and state laws also exempt certain low or moderate complexity tests from the clinical laboratory permitting requirement. CLIA designates several waived tests that may be performed by various healthcare professionals holding Limited Testing, Registrations from the Department of Health rather than full clinical laboratory permits.

This bill would add optometrists to the list of those professionals and would enable them to perform only non-invasive waived tests in accordance with existing federal and state requirements.

Legislative history

2009-10: S. 5189, referred to Health

Fiscal implications

None.

Effective date

This act shall take effect immediately.