Relates to authorization to conduct clinical laboratory tests

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.