N.Y. Pub. Health Law § 576-a

§ 576-a. Clinical laboratories and cytotechnologists examining Pap\nsmears. 1. Definitions. As used in this section, unless the context\nclearly requires otherwise, the following terms shall have the following\nmeanings:\n (a) "Cytotechnologist". A clinical laboratory professional\nspecializing in the analysis of cytopathology samples, including Pap\nsmears, for cervical cancer and related diseases who meets the\nqualifications specified by the department.\n (b) "Cytotechnologist work standard". (i) A limitation on the number\nof Pap smears (also known as gynecologic slides) and non-gynecologic\nslides a cytotechnologist may examine during a particular time period,\nor other limitation on the quantity, speed or manner of examination of\nslides by a cytotechnologist, under regulations of the department.\n (ii) Unless otherwise provided by the department, the cytotechnologist\nwork standard shall be: No cytotechnologist may examine more than eighty\none-slide gynecologic cases or fifty two-slide gynecologic cases per\nwork day. If a cytotechnologist also examines non-gynecologic slides in\na given work day the cytotechnologist's workload for gynecologic slides\nshall be correspondingly reduced, in accordance with written guidelines\nprepared by the clinical laboratory and filed with the department, so\nthat a cytotechnologist examines no more than a total of one hundred\ngynecologic and non-gynecologic slides per work day.\n (c) "Employ". To employ or contract with a cytotechnologist to examine\ngynecologic slides.\n (d) "Clinical laboratory". A clinical laboratory issued a permit\npursuant to this title.\n (e) "Work day". A twenty-four hour period during which a\ncytotechnologist examines gynecologic slides for a clinical laboratory.\n 2. Compliance with cytotechnologist work standard. No cytotechnologist\nshall exceed the applicable cytotechnologist work standard. No clinical\nlaboratory shall require, authorize, encourage or permit any\ncytotechnologist to exceed the applicable cytotechnologist work\nstandard. In determining whether a cytotechnologist exceeds the\napplicable cytotechnologist work standard, all work done by the\ncytotechnologist during a given work day shall be considered, without\nregard to which clinical laboratory or other person for which or whom it\nwas performed.\n 3. Registration of cytotechnologist. All cytotechnologists who are\nemployed by a clinical laboratory must register with the department. The\ndepartment shall, by regulation, prescribe a form and procedure for the\nregistration of cytotechnologists. The registration form shall include\nat least the name, address, and an individual identification number\ndetermined by the department. The department shall notify each\nregistrant of his or her identification number.\n 4. Employment of registered cytotechnologists. No clinical laboratory\nshall employ a cytotechnologist unless the cytotechnologist is\nregistered under this section.\n 5. Record-keeping. (a) Each clinical laboratory shall maintain\nrecords, in a form prescribed by the department, which set forth, for\neach cytotechnologist employed by the clinical laboratory:\n (i) the name and identification number of the cytotechnologist;\n (ii) the number of hours worked by the cytotechnologist in each work\nday;\n (iii) the number of gynecologic slides and non-gynecologic slides\nexamined by the cytotechnologist, and how many were one-slide and\ntwo-slide cases, during each work day; and\n (iv) such other information as the department may require by\nregulation.\n (b) Each cytotechnologist shall maintain records, in a form prescribed\nby the department, which set forth:\n (i) the number of hours worked by the cytotechnologist in each work\nday;\n (ii) the number of gynecologic slides and non-gynecologic slides\nexamined and how many were one-slide and two-slide cases, during each\nwork day;\n (iii) the name and address of the clinical laboratory or other person\nfor which or whom the slides were examined; and\n (iv) such other information as the department may require by\nregulation.\n (c) Such records of clinical laboratories and cytotechnologists shall\nbe made available for inspection and copying by the department upon\nrequest.\n 6. Multiple employers. Whenever a cytotechnologist is employed by more\nthan one clinical laboratory or other person during a work day, the\ncytotechnologist shall advise each clinical laboratory of any previous\nemployment during the work day and the amount of work performed, to\ninsure that the applicable cytotechnologist work standard is not\nexceeded.\n 7. Standards for gynecologic slides. (a) A gynecologic slide of a Pap\nsmear shall not be tested or reported on if:\n (i) the apparent condition of the specimen indicates that it is\nunsatisfactory for testing or that it is inappropriate for the test\nrequested;\n (ii) it has been collected, labeled, preserved or otherwise handled in\nsuch a manner that it has become unsatisfactory or unreliable as a test\nspecimen;\n (iii) the slide is broken;\n (iv) it contains insufficient cells or the cells are obscured by\ninflammation, blood or lubricating ointment, so that an adequate\ndiagnosis cannot be made; or\n (v) the slide is otherwise unsatisfactory, as defined by department\nregulations.\n (b) If the slide is unsatisfactory as set forth in this subdivision,\nthe clinical laboratory shall have an affirmative duty to advise the\ncollecting physician or other practitioner that the slide is\nunsatisfactory and request the submission of a new slide.\n 8. Re-examination of slides. The department shall prescribe, by\nregulation, a system of targeted re-examination of gynecologic slides\nexamined and found to be not abnormal or questionable. The factors to be\nconsidered in the targeted re-examination may include, but are not\nlimited to, the prior cancer and other history of the patient, the\nresults of previous slide examinations, and the experience and ability\nof the cytotechnologist. Each clinical laboratory shall follow the\nprescribed re-examination system.\n 9. Regulations. The department may, by regulation, establish\ncytotechnologist work standards. Those standards may include, but shall\nnot be limited to, standards which take into account the experience and\nqualifications of the cytotechnologists and the performance of the\nclinical laboratory in proficiency testing programs conducted by the\ndepartment. However, those standards shall not exceed by more than\ntwenty percent the maximum numbers of slides which may be examined in a\nwork day under clause (ii) of paragraph (b) of subdivision one of this\nsection. Such standards shall be at least as stringent as federal\nstandards promulgated under the federal clinical laboratory improvement\namendments of nineteen hundred eighty-eight.\n 10. Notwithstanding any provisions of subdivisions one and nine of\nthis section to the contrary, the department may, pursuant to\nregulation, increase the maximum number of slides which may be examined\nin a work day for clinical laboratories using slide examination or\npreparation technology approved by the federal food and drug\nadministration, provided that such standards shall be at least as\nstringent as federal standards promulgated under the federal clinical\nlaboratory improvement amendments of nineteen hundred eighty-eight or\nother applicable federal law.\n 11. Violations. (a) Sections twelve, twelve-a, and twelve-b of this\nchapter shall apply to violations of this section, except that the civil\npenalty for a violation of this section by a cytotechnologist shall not\nexceed five hundred dollars.\n (b) If a cytotechnologist violates this section, the department may\nsuspend or revoke the cytotechnologist's registration under this\nsection, pursuant to department regulations including appropriate due\nprocess protections for the cytotechnologist.\n (c) If any clinical laboratory or other person violating this section\nis licensed, certified or registered by the department under other\nprovisions of law, the violation of this section may be grounds for\ndisciplining the person under such law.\n