2023 New York Laws › PBH - Public Health › Article 5 - Laboratories › Title 5 - Clinical Laboratory and Blood Banking Services › 577 - Enforcement.

§ 577. Enforcement. 1. A permit or certificate of qualification may be
revoked, suspended, limited or annulled, or the holder thereof censured,
reprimanded or otherwise disciplined by the department on proof that the
certificate  holder, owner or director, or one or more persons in his or
her employ:
(a) has been guilty of misrepresentation in obtaining  the  permit  or
certificate  or  in  the  operation  of the clinical laboratory or blood
bank, including the submission to the  department  of  proficiency  test
results obtained from another clinical laboratory;
(b)  has  knowingly accepted or permitted to be accepted a specimen or
assignment for clinical laboratory examination from or rendered a report
thereon to a person or persons not authorized  by  law  to  submit  such
assignment or specimen or receive such report;
(c)  has  engaged  or  attempted  to  engage or represented himself or
herself as entitled to perform any procedure or category  or  procedures
or services he or she is not authorized to perform;
(d)  has  rendered  a  report  on  work  actually performed in another
clinical laboratory or blood bank without designating the fact that  the
examination or procedure was performed in another clinical laboratory or
blood bank;
(e)  has  demonstrated  incompetence  or  shown  consistent  errors in
performance of examinations or procedures;
(f) has failed to file any report required by the provisions  of  this
title or the rules and regulations promulgated thereunder;
(g)  has  violated  or  aided  and  abetted  in  the  violation of any
provision of this chapter, including  this  title,  title  six  of  this
article,  or  the  rules  and  regulations  promulgated pursuant to this
chapter or a violation of title eleven of article  five  of  the  social
services law or the rules and regulations promulgated thereunder related
to laboratory services; or
(h)  has violated or aided and abetted in the violation of local laws,
codes or regulations as specified in subdivision three of  section  five
hundred eighty of this title.
(i)  has  been  found  upon  inspection  by  the  department  to be in
noncompliance with a provision or provisions of this title or the  rules
and  regulations  promulgated  hereunder, and has failed to address such
findings as required by the department.
2. Proceedings under this section may  be  initiated  by  any  person,
corporation,  association  or  public  officer, or by the department, by
filing written charges with the department.
3. No permit or certificate shall be revoked,  suspended,  limited  or
annulled  without  a hearing, except as provided in subdivision three of
section five hundred seventy-six of this title.  However,  a  permit  or
certificate  may be temporarily suspended without a hearing for a period
not to exceed thirty days upon  notice  to  the  permit  or  certificate
holder  following  a  finding  by the department that the public health,
safety or welfare is in imminent danger.
4. The commissioner shall set a time and place for the hearing. A copy
of the charges, together with the notice of the time and  place  of  the
hearing,  shall  be  mailed  to the permit or certificate holder, at the
address specified on the permit at least fifteen days  before  the  date
set  for  the  hearing. The permit or certificate holder shall file with
the department, not less than five days prior to the hearing, a  written
answer to the charges.
5.  Any  person or entity which owns or operates a clinical laboratory
and who does not hold a valid laboratory permit shall be liable  to  the
people  of  the  state  for  a  civil penalty not to exceed two thousand

dollars for each day for the  unauthorized  operation  of  the  clinical
laboratory.