N.Y. Public Health Law § 579: Scope and exceptions

§ 579. Scope and exceptions. 1. This title is applicable to all

clinical laboratories and blood banks operating within the state, except

clinical laboratories and blood banks operated by the federal government

and clinical laboratories operated by a licensed physician, osteopath,

dentist, midwife, nurse practitioner, optometrist performing a clinical

laboratory test that does not use an invasive modality as defined in

section seventy-one hundred one of the education law or podiatrist who

performs laboratory tests or procedures, personally or through his or

her employees, solely as an adjunct to the treatment of his or her own

patients; to the extent authorized by federal and state law, including

the education law.

2. This title shall not be applicable to and the department shall not

have the power to regulate pursuant to this title: (a) any examination

performed by a state or local government of materials derived from the

human body for use in criminal identification or as evidence in a

criminal proceeding or for investigative purposes; (b) any test

conducted pursuant to paragraph (c) of subdivision four of section

eleven hundred ninety-four of the vehicle and traffic law and paragraph

(c) of subdivision eight of section 25.24 of the parks, recreation and

historic preservation law; (c) any examination performed by a state or

local agency of materials derived from the body of an incarcerated

individual, pretrial releasee, parolee, conditional releasee or

probationer to (i) determine, measure or otherwise describe the presence

or absence of any substance whose possession, ingestion or use is

prohibited by law, the rules of the department of corrections and

community supervision, the conditions of release established by the

board of parole, the conditions of release established by a court or a

local conditional release commission or the conditions of any program to

which such individuals are referred and (ii) to determine whether there

has been a violation thereof; or (d) any examination performed by a

coroner or medical examiner for the medical-legal investigation of a

death. Nothing herein shall prevent the department from consulting with

the division of criminal justice services, the department of corrections

and community supervision, the state police, or any other state agency

or commission, at the request of the division of criminal justice

services, the department of corrections and community supervision, the

state police, or such other agency or commission, concerning examination

of materials for purposes other than public health.

3. (a) This title shall not be applicable to any person, partnership,

corporation or other entity performing any waived test or

provider-performed microscopy procedure, provided such person,

partnership, corporation or other legal entity: (i) holds a valid

certificate of registration issued by the department authorizing the

performance of one or more waived tests or provider-performed microscopy

procedures; and (ii) only performs tests authorized by the certificate

of registration; and (iii) otherwise complies with all applicable

requirements of this subdivision.

(b) The department may issue a certificate of registration authorizing

the performance of one or more waived tests or provider-performed

microscopy procedures for a period of up to two years if the applicant:

(i) files a completed application with the department on such forms as

the commissioner may prescribe; (ii) provides documentation acceptable

to the department demonstrating the ability to comply with the

requirements of this subdivision; and (iii) pays a two hundred dollar

biennial registration fee for each location where services are rendered;

except that a voluntary ambulance service as defined in article thirty

of the public health law and operated under section two hundred nine-b

of the general municipal law shall be exempt from the requirement to pay

a fee to obtain this certificate of registration; and except that the

following may operate multiple locations under a single registration and

pay a single registration fee: (A) not-for-profit, state or local

government laboratories or programs engaged in limited public health

testing not exceeding fifteen types of tests per registration; or (B)

applicants that maintain a fixed location in the state and are approved

by the department to move from testing site to testing site.

(c) Laboratory test registrants shall: (i) provide only the tests and

services listed on the registration issued by the department hereunder;

(ii) advise the department of any change in the registrant's name,

ownership, location or qualified health care professional or laboratory

director designated to supervise testing within thirty days of such

change; (iii) provide the department with immediate access to all

facilities, equipment, records, and personnel as required by the

department to determine compliance with this subdivision; (iv) comply

with all public health law and federal requirements for reporting

reportable diseases and conditions to the same extent and in the same

manner as a clinical laboratory; (v) perform one or more tests as

required by the department to determine the proficiency of the persons

performing such tests; and (vi) designate a qualified health care

professional or qualified individual holding a certificate of

qualification pursuant to section five hundred seventy-three of this

title, who shall be jointly and severally responsible for: (A)

establishing, approving and continuously updating policies, procedures

and personnel qualifications for each test employed; (B) establishing a

comprehensive quality assurance system which includes, but is not

limited to, test selection, test quality, laboratory proficiency and

personnel competency; (C) ensuring all tests are performed in accordance

with the manufacturers' instructions and standards of practice in

laboratory medicine; (D) maintaining complete and accurate records of

the tests performed, including but not limited to, the patient's name,

results, person performing the test, and quality control data; (E)

ensuring that persons do not participate in diagnostic or treatment

decisions using such test results unless such persons are authorized by

law to do so; (F) ensuring that provider-performed microscopy procedures

are performed only by a qualified health care professional operating

within the scope of practice for his or her profession and as part of

the physical examination performed by such professional; and (G)

complying with other applicable laws, rules and regulations.

(d) A certificate of registration shall become void by a change in the

owner of the laboratory test registrant or location of testing.

(e) Notwithstanding the foregoing, if the commissioner determines that

the performance of a particular waived test or provider-performed

microscopy procedure in a facility or location which does not possess a

New York state clinical laboratory permit creates a risk of harm to the

subjects of such test, the commissioner may issue an order prohibiting

such test from being performed in any location other than a permitted

clinical laboratory, physician's office or other location exempted by

subdivision one or two of this section.

(f) Registration under this subdivision may be denied, limited,

suspended, revoked or annulled by the department upon a determination

that a laboratory services registrant: (i) failed to comply with the

requirements of this subdivision; (ii) provided services that constitute

an unwarranted risk to human health; (iii) intentionally provided any

false or misleading information to the department relating to

registration or performing laboratory services; or (iv) has demonstrated

incompetence or shown consistent errors in the performance of

examinations or procedures. A registration shall not be limited,

suspended, revoked or annulled without a hearing conducted in accordance

with subdivision four of section five hundred seventy-seven of this

title. However, a registration may be temporarily limited, suspended,

revoked or annulled without a hearing for a period not to exceed thirty

days upon notice to the registrant following a finding by the department

that the public health, safety or welfare is in imminent danger.

(g) The commissioner may adopt such rules and regulations as may be

necessary to effectuate the purposes of this subdivision.

(h) Any person, partnership, corporation or other entity performing

waived tests or provider-performed microscopy procedures without being

authorized to do so pursuant to this title shall be subject to a civil

penalty of up to five hundred dollars for each test performed, not to

exceed two thousand dollars per day for each day tests are performed, in

violation of this subdivision.

(i) All fees and civil penalties collected pursuant to this

subdivision shall be deposited in the special revenue account

established for the receipt of inspection and reference fees collected

pursuant to section five hundred seventy-six of this title and shall be

subtracted from the operating expenses of the department prior to

calculation of such inspection and reference fees.