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.