Senate Bill S5189

                                 BILL NUMBER:  S5189

 TITLE OF BILL :  An act to amend the public health law, in relation
to authorization to conduct clinical laboratory tests

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

 SUMMARY OF PROVISIONS :  Section 1 of the bill would amend Public
Health Law §571(6) to authorize optometrists to perform microscopy
procedures within their scope of practice.

Section 2 of the bill would amend Public Health Law §579(1) to clarify
that optometrists may conduct certain clinical laboratory procedures
solely as an adjunct to the treatment of their patients.

 EXISTING LAW :  Public Health Law Article 5, Title 5 provides that
clinical laboratories (i.e., facilities for the examination of
materials derived from the human body for the purpose of obtaining
information for the diagnosis, prevention, or treatment of disease or
the assessment of a health condition) must be permitted by the
Department of Health. Public Health Law 579(1) exempts from the
permitting requirement those licensed physicians, osteopaths,
dentists, midwives, nurse practitioners, and podiatrists who perform
laboratory procedures as part of the treatment of their patients; to
the extent authorized by federal and state law; and consistent with
              

any written practice agreement.

Public Health Law §579(3) exempts from the clinical laboratory
permitting requirement licensed physicians, dentists, podiatrists,
physician assistants, specialist assistants, nurse practitioners, and
midwives who, within their scopes of practice, perform microscopy
procedures authorized pursuant to federal law; provided such qualified
health practitioners hold a certificate of registration from the
Department of Health and only perform those tests authorized by such
certificate.

 STATEMENT IN SUPPORT :  The purpose of this bill is to improve the
diagnosis and treatment of eye disease by providing optometrists with
the authority to improve the quality of care for their patients. The
authority to perform clinical laboratory tests and microscopy can be
integral in the ability of optometrists to accurately diagnose eye
disease and properly treat any conditions identified through such
testing. The federal Clinical Laboratory Improvement Act (CLIA) of
1988 and state law currently require certain proficiency standards,
testing requirements and inspections depending on the type of clinical
laboratory tests undertaken. However, these laws also recognize that
many tests are performed by healthcare professionals in their clinics
and offices as part of patient examinations. Accordingly, existing
statute exempts from the clinical laboratory requirements certain
tests undertaken by enumerated professionals (i.e., licensed
physicians, osteopaths, dentists, midwives, nurse practitioners, and
podiatrists), who are viewed as well-trained in such testing and for
whom there is a compelling public health need to be able to test
patient specimens on-site.

Similarly, federal and state law recognize that certain tests are
exempt from the clinical laboratory permitting requirement because
they are generally considered low or moderate in complexity and
therefore do not require the same level of regulatory oversight
necessary for other tests. Generally, these are categorized as waived
tests and provider-performed microscopy procedures. Microscopy
generally involves the use of optical, electron or scanning probe
microscopes to examine specimens taken from patients. For over one
hundred years microscopy has been used to diagnose common and rare
diseases and has become a critical tool for healthcare practitioners.
CLIA designates, and state law recognizes, several microscopy
procedures that may be performed by various healthcare professionals
including physicians, physician's assistants, nurse practitioners,
midwives and dentists without the need for a clinical laboratory
permit. This bill would include optometrists to the list of those
professions.

Optometrists are specifically educated, trained and experienced in the
provision of eye care, including diagnosis and treatment of
eye-related injuries and conditions. 'Consistent with this expertise,
optometrists should reasonably have available those tools which enable
them to provide the very best care to their patients. In fact, in
1995, optometrists were provided broad statutory authority related to
the diagnosis and treatment of eye conditions. In order to ensure that
optometrists are able to properly utilize that authority, it is
necessary to clarify that optometrists, like other healthcare
professionals are authorized to perform laboratory tests as part of
the treatment of their patients.

In addition, due to the current limitations in the law, optometrists
must now refer their patients to one of the statutorily-listed
practitioners who, in turn, can then perform such tests. This process
of referral is both unnecessary and costly to patients in terms of
additional co-payments, time away from work and other
responsibilities, and increased costs to the healthcare system for
multiple visits to the enumerated licensed professionals so they may
perform and/or order a laboratory test. These costs to the patient and
healthcare system would be avoided if optometrists are simply provided
the authority to perform clinical laboratory tests as part of the
treatment of their patients.

 LEGISLATIVE HISTORY :  This is a new bill.

 FISCAL IMPLICATIONS ; None.

 EFFECTIVE DATE :  This act shall take effect immediately.