N.Y. Public Health Law § 576-a: Clinical laboratories and cytotechnologists examining Pap smears

§ 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

specializing in the analysis of cytopathology samples, including Pap

smears, for cervical cancer and related diseases who meets the

qualifications specified 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) The department may establish regulations for cytotechnologist

workload standards 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

cytotechnologist examines gynecologic slides for a clinical laboratory.

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

cytotechnologist to exceed the applicable cytotechnologist work

standard. In determining whether a cytotechnologist exceeds the

applicable cytotechnologist 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. 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 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 during each work day; and

(iv) such other information as the department may require by

regulation.

(b) Such records of clinical laboratories and cytotechnologists shall

be made available for inspection and copying by the department upon

request.

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.

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

unsatisfactory for testing or that it is inappropriate for the test

requested;

(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

diagnosis 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

unsatisfactory and request the submission of a new slide.

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.

7. Notwithstanding any provisions of subdivision one 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 examination or preparation technology

approved by the federal food and drug administration, provided that such

standards shall be at least as stringent as federal standards

promulgated under the federal clinical laboratory improvement amendments

of nineteen hundred eighty-eight or other applicable federal law.

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 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.