Current through Register Vol. 46, No. 39, September 25, 2024
(a) In determining
whether to deny an application for a certificate of qualification in whole or
in part, the department shall consider: the applicant's education, experience,
and licensure as required in sections
19.2
and
19.3
of this Part; the applicant's demonstrated ability to discharge the
responsibilities set forth in section
19.3(c)
of this Part; the character and competence of the applicant and the laboratory
or laboratories directed; and any other factors the department considers
relevant, including, but not limited to:
(1)
prior sustained charges of administrative violations of state or federal laws,
rules and regulations related to the provision of health care services or
reimbursement for such services, against the applicant individually or any
laboratory directed by the applicant;
(2) conviction of any crime, including, but
not limited to, any offense relating to the furnishing of, or billing for,
laboratory services and medical care, services, or supplies, or which is
considered an offense involving theft or fraud;
(3) false representation or omission of any
material fact in making an application in any state or city of the United
States for any license, permit, certificate, or registration related to a
profession or business, or in making an application for a certificate of
qualification or laboratory permit to New York State;
(4) submission of a laboratory permit
application which conceals an ownership or controlling interest by any person
who otherwise would be ineligible for a permit;
(5) failure to supply additional
documentation of training and/or experience, pursuant to a written request for
such documentation, in the course of applying for a certificate of
qualification;
(6) on the part of
any laboratory, category, or subcategory directed by the applicant, a pattern
of repetitive failures of required proficiency testing performance in one or
more proficiency testing categories, excluding failure for administrative
reasons such as late result submission;
(7) on the part of any laboratory, category,
or subcategory directed by the applicant, a pattern of deficiencies on onsite
inspection, especially in areas of quality control, quality assurance,
laboratory management, and handling of regulated medical waste and radioactive
materials, including refusal or inability to produce records as requested by
department employees, which deficiencies are not corrected from inspection to
inspection or which recur at each inspection despite written notice of
violations by a state or Federal licensing or auditing agency and which
jeopardize the quality of test results and resulting patient care, even if
interim corrections have occurred;
(8) on the part of any laboratory, category,
or subcategory directed by the applicant, performance of any laboratory
procedures not authorized by the laboratory permit issued pursuant to article
5, Title V of the Public Health Law; or operation or direction of a laboratory
without a permit; or continuing operation or failure to notify the department
after a change in director, ownership, or location has voided the
permit;
(9) on the part of any
laboratory, category, or subcategory directed by the applicant, referral of
specimens collected in New York State to laboratories which do not possess a
New York State permit;
(10) on the
part of any laboratory, category, or subcategory directed by the applicant,
knowing acceptance of specimens or requisitions for laboratory examination
from, or issuance of reports to, a person or persons not authorized by law to
submit such specimens or requisitions, or receive such reports;
(11) on the part of any laboratory, category,
or subcategory directed by the applicant, issuance of reports on laboratory
work, including both patient samples and proficiency testing, actually
performed in another laboratory, without designating the fact that the
examinations or procedures were performed in another laboratory; and/or testing
and reporting results on unsatisfactory specimens as defined by the department,
including unlabeled specimens or specimens of insufficient quantity to conduct
the analyses requested;
(12) on
the part of any laboratory, category, or subcategory directed by the applicant,
failure to establish and ensure that employees follow procedures for disposal
or handling of specimens or infectious or radioactive medical waste, in
violation of applicable state and Federal laws, rules and regulations, or in a
manner which endangers the public, the laboratory's employees, or the
environment;
(13) employment of
unqualified or unlicensed technical personnel or an insufficient number of such
personnel;
(14) failure of the
applicant to be responsible for adequately supervising laboratory personnel to
ensure the proper performance of all tests conducted in the laboratory;
and
(15) any other factor having a
direct bearing on the applicant's ability to provide or supervise the provision
of high quality laboratory services, or to ensure compliance with statutory and
regulatory requirements.
(b) If an application for a certificate of
qualification is denied, the applicant shall be given written notice of the
proposed denial, stating the reason or reasons for the denial. Such notice
shall be sent by certified mail and shall be a final determination to be
effective 30 days from the date of the notice, unless a hearing is requested
pursuant to subdivision (c) of this section.
(c) If the department gives notice of the
proposed denial of an application for a certificate of qualification, the
applicant may request a hearing on the proposed denial by submitting a written
request for a hearing to the department within 10 days of the date of the
notice. Submission of a request for a hearing within 10 days shall stay any
action to deny the application for a certificate of qualification, pending the
department's decision following the hearing on such proposed denial.
