§ 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.