S T A T E O F N E W Y O R K
________________________________________________________________________
8966--A
I N S E N A T E
April 3, 2024
___________
Introduced by Sen. RIVERA -- read twice and ordered printed, and when
printed to be committed to the Committee on Health -- committee
discharged, bill amended, ordered reprinted as amended and recommitted
to said committee
AN ACT to amend the public health law, in relation to certificates of
qualification for clinical laboratories and blood banks
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Section 572 of the public health law, as amended by chapter
436 of the laws of 1993, is amended to read as follows:
§ 572. Certificates of qualification. No person shall act as a direc-
tor in a clinical laboratory located in or accepting specimens from New
York state or in a blood bank located in or collecting, processing,
storing or distributing blood products in New York state unless a valid
certificate of qualification has been issued as provided in section five
hundred seventy-three of this title. [A certificate shall be issued
authorizing the holder to perform or direct one or more procedures or
one or more categories of such procedures.]
§ 2. Section 573 of the public health law, as amended by chapter 436
of the laws of 1993, is amended to read as follows:
§ 573. Issuance of certificates of qualification. 1. [The public
health council shall prescribe minimum qualifications for directors in
areas of testing, including, but not limited to, microbiology, immunolo-
gy, chemistry, hematology, biophysics, cytology, pathology, genetics and
blood banking.
2.] The department shall issue a certificate of qualification to any
person who meets [such] PRESCRIBED minimum qualifications UNDER FEDERAL
REGULATIONS, INCLUDING BOARD CERTIFICATION AS REQUIRED and who otherwise
demonstrates to the department that such person possesses the character,
competence, training and ability to administer properly the technical
and scientific operation of a clinical laboratory or blood bank, includ-
ing supervision of procedures and reporting of findings of tests.
[3.] 2. Application for a certificate of qualification shall be made
on forms provided by the department [and shall contain the procedures or
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD14434-05-4
S. 8966--A 2
categories of procedures for which the certificate is sought] and such
other information as the department may require.
[4.] 3. The certificate shall be valid for a period of two years from
the date of issuance and may be renewed for successive [two year] TWO-
YEAR periods thereafter. The original application and each renewal
application shall be accompanied by a registration fee of [forty] ONE
HUNDRED FIFTY dollars.
[5.] 4. Notwithstanding the provisions of this section, the commis-
sioner may issue a temporary certificate of qualification to any person
pending the issuance of a certificate as provided in this section. A
temporary certificate shall be valid for a period of thirty days from
the date of its issuance and may be renewed for a maximum of four
successive periods of thirty days.
§ 3. Subdivision 2 of section 575 of the public health law, as amended
by section 19 of part A of chapter 59 of the laws of 2011, is amended to
read as follows:
2. A permit [or permit category] shall not be issued unless a valid
certificate of qualification [in the category of procedures for which
the permit is sought] has been issued [to the director] pursuant to the
provisions of section five hundred seventy-three of this title, unless
all fees and outstanding penalties, if any, have been paid, and the
department finds that the clinical laboratory or blood bank is compe-
tently staffed and properly equipped, and will be operated in the manner
required by this title.
§ 4. Section 576-a of the public health law, as amended by chapter 436
of the laws of 1993, is amended to read as follows:
§ 576-a. Clinical laboratories and cytotechnologists examining Pap
smears. 1. Definitions. As used in this section, unless the context
clearly requires otherwise, the following terms shall have the following
meanings:
(a) "Cytotechnologist". A clinical laboratory professional specializ-
ing in the analysis of cytopathology samples, including Pap smears, for
cervical cancer and related diseases who meets the qualifications speci-
fied by the department.
(b) "Cytotechnologist work standard". (i) A limitation on the number
of Pap smears (also known as gynecologic slides) and non-gynecologic
slides a cytotechnologist may examine during a particular time period,
or other limitation on the quantity, speed or manner of examination of
slides by a cytotechnologist, under regulations of the department.
(ii) [Unless otherwise provided by the department, the cytotechnolo-
gist work standard shall be: No cytotechnologist may examine more than
eighty one-slide gynecologic cases or fifty two-slide gynecologic cases
per work day. If a cytotechnologist also examines non-gynecologic
slides in a given work day the cytotechnologist's workload for gyneco-
logic slides shall be correspondingly reduced, in accordance with writ-
ten guidelines prepared by the clinical laboratory and filed with the
department, so that a cytotechnologist examines no more than a total of
one hundred gynecologic and non-gynecologic slides per work day.] THE
DEPARTMENT MAY ESTABLISH REGULATIONS FOR CYTOTECHNOLOGIST WORKLOAD STAN-
DARDS THAT SHALL BE AT LEAST AS STRINGENT AS FEDERAL REGULATIONS.
(c) "Employ". To employ or contract with a cytotechnologist to examine
gynecologic slides.
(d) "Clinical laboratory". A clinical laboratory issued a permit
pursuant to this title.
(e) "Work day". A twenty-four hour period during which a cytotechnolo-
gist examines gynecologic slides for a clinical laboratory.
S. 8966--A 3
2. Compliance with cytotechnologist work standard. No cytotechnologist
shall exceed the applicable cytotechnologist work standard. No clinical
laboratory shall require, authorize, encourage or permit any cytotech-
nologist to exceed the applicable cytotechnologist work standard. In
determining whether a cytotechnologist exceeds the applicable cytotech-
nologist work standard, all work done by the cytotechnologist during a
given work day shall be considered, without regard to which clinical
laboratory or other person for which or whom it was performed.
3. [Registration of cytotechnologist. All cytotechnologists who are
employed by a clinical laboratory must register with the department. The
department shall, by regulation, prescribe a form and procedure for the
registration of cytotechnologists. The registration form shall include
at least the name, address, and an individual identification number
determined by the department. The department shall notify each regis-
trant of his or her identification number.
4. Employment of registered cytotechnologists. No clinical laboratory
shall employ a cytotechnologist unless the cytotechnologist is regis-
tered under this section.
5.] Record-keeping. (a) Each clinical laboratory shall maintain
records, in a form prescribed by the department, which set forth, for
each cytotechnologist employed by the clinical laboratory:
(i) the name [and identification number] of the cytotechnologist;
(ii) the number of hours worked by the cytotechnologist in each work
day;
(iii) the number of gynecologic slides and non-gynecologic slides
examined by the cytotechnologist[, and how many were one-slide and two-
slide cases,] during each work day; and
(iv) such other information as the department may require by regu-
lation.
(b) [Each cytotechnologist shall maintain records, in a form
prescribed by the department, which set forth:
(i) the number of hours worked by the cytotechnologist in each work
day;
(ii) the number of gynecologic slides and non-gynecologic slides exam-
ined and how many were one-slide and two-slide cases, during each work
day;
(iii) the name and address of the clinical laboratory or other person
for which or whom the slides were examined; and
(iv) such other information as the department may require by regu-
lation.
(c)] Such records of clinical laboratories and cytotechnologists shall
be made available for inspection and copying by the department upon
request.
[6.] 4. Multiple employers. Whenever a cytotechnologist is employed by
more than one clinical laboratory or other person during a work day, the
cytotechnologist shall advise each clinical laboratory of any previous
employment during the work day and the amount of work performed, to
insure that the applicable cytotechnologist work standard is not
exceeded.
[7.] 5. Standards for gynecologic slides. (a) A gynecologic slide of a
Pap smear shall not be tested or reported on if:
(i) the apparent condition of the specimen indicates that it is unsat-
isfactory for testing or that it is inappropriate for the test
requested;
S. 8966--A 4
(ii) it has been collected, labeled, preserved or otherwise handled in
such a manner that it has become unsatisfactory or unreliable as a test
specimen;
(iii) the slide is broken;
(iv) it contains insufficient cells or the cells are obscured by
inflammation, blood or lubricating ointment, so that an adequate diagno-
sis cannot be made; or
(v) the slide is otherwise unsatisfactory, as defined by department
regulations.
(b) If the slide is unsatisfactory as set forth in this subdivision,
the clinical laboratory shall have an affirmative duty to advise the
collecting physician or other practitioner that the slide is unsatisfac-
tory and request the submission of a new slide.
[8.] 6. Re-examination of slides. The department shall prescribe, by
regulation, a system of targeted re-examination of gynecologic slides
examined and found to be not abnormal or questionable. The factors to be
considered in the targeted re-examination may include, but are not
limited to, the prior cancer and other history of the patient, the
results of previous slide examinations, and the experience and ability
of the cytotechnologist. Each clinical laboratory shall follow the
prescribed re-examination system.
[9. Regulations. The department may, by regulation, establish cyto-
technologist work standards. Those standards may include, but shall not
be limited to, standards which take into account the experience and
qualifications of the cytotechnologists and the performance of the clin-
ical laboratory in proficiency testing programs conducted by the depart-
ment. However, those standards shall not exceed by more than twenty
percent the maximum numbers of slides which may be examined in a work
day under clause (ii) of paragraph (b) of subdivision one of this
section. Such standards shall be at least as stringent as federal stand-
ards promulgated under the federal clinical laboratory improvement
amendments of nineteen hundred eighty-eight.
10.] 7. Notwithstanding any provisions of [subdivisions] SUBDIVISION
one [and nine] of this section to the contrary, the department may,
pursuant to regulation, increase the maximum number of slides which may
be examined in a work day for clinical laboratories using slide examina-
tion or preparation technology approved by the federal food and drug
administration, provided that such standards shall be at least as strin-
gent as federal standards promulgated under the federal clinical labora-
tory improvement amendments of nineteen hundred eighty-eight or other
applicable federal law.
[11.] 8. Violations. (a) Sections twelve, twelve-a, and twelve-b of
this chapter shall apply to violations of this section, except that the
civil penalty for a violation of this section by a cytotechnologist
shall not exceed five hundred dollars.
(b) [If a cytotechnologist violates this section, the department may
suspend or revoke the cytotechnologist's registration under this
section, pursuant to department regulations including appropriate due
process protections for the cytotechnologist.
(c)] If any clinical laboratory or other person violating this section
is licensed, certified or registered by the department under other
provisions of law, the violation of this section may be grounds for
disciplining the person under such law.
§ 5. This act shall take effect immediately.
