Bill Text: NY A09235 | 2023-2024 | General Assembly | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Amends various provisions governing certificates of qualification for clinical laboratories and blood banks; provides for the department of health to prescribe minimum qualifications; provides that certificates shall cover all laboratory work; increases fees; requires work standards for cytotechnologists to be as stringent as federal regulations; removes registration requirement.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Engrossed) 2024-06-06 - RETURNED TO ASSEMBLY [A09235 Detail]
Download: New_York-2023-A09235-Introduced.html
Bill Title: Amends various provisions governing certificates of qualification for clinical laboratories and blood banks; provides for the department of health to prescribe minimum qualifications; provides that certificates shall cover all laboratory work; increases fees; requires work standards for cytotechnologists to be as stringent as federal regulations; removes registration requirement.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Engrossed) 2024-06-06 - RETURNED TO ASSEMBLY [A09235 Detail]
Download: New_York-2023-A09235-Introduced.html
STATE OF NEW YORK ________________________________________________________________________ 9235 IN ASSEMBLY February 22, 2024 ___________ Introduced by M. of A. PAULIN -- read once and referred to the Committee on Health 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: 1 Section 1. Section 572 of the public health law, as amended by chapter 2 436 of the laws of 1993, is amended to read as follows: 3 § 572. Certificates of qualification. No person shall act as a direc- 4 tor in a clinical laboratory located in or accepting specimens from New 5 York state or in a blood bank located in or collecting, processing, 6 storing or distributing blood products in New York state unless a valid 7 certificate of qualification has been issued as provided in section five 8 hundred seventy-three of this title. [A certificate shall be issued9authorizing the holder to perform or direct one or more procedures or10one or more categories of such procedures.] 11 § 2. Section 573 of the public health law, as amended by chapter 436 12 of the laws of 1993, is amended to read as follows: 13 § 573. Issuance of certificates of qualification. 1. [The public14health council shall prescribe minimum qualifications for directors in15areas of testing, including, but not limited to, microbiology, immunolo-16gy, chemistry, hematology, biophysics, cytology, pathology, genetics and17blood banking.182.] The department shall issue a certificate of qualification to any 19 person who meets [such] prescribed minimum qualifications and who other- 20 wise demonstrates to the department that such person possesses the char- 21 acter, competence, training and ability to administer properly the tech- 22 nical and scientific operation of a clinical laboratory or blood bank, 23 including supervision of procedures and reporting of findings of tests. 24 [3.] 2. Application for a certificate of qualification shall be made 25 on forms provided by the department [and shall contain the procedures or26categories of procedures for which the certificate is sought] and such 27 other information as the department may require. EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD14434-01-4A. 9235 2 1 [4.] 3. The certificate shall be valid for a period of two years from 2 the date of issuance and may be renewed for successive [two year] two- 3 year periods thereafter. The original application and each renewal 4 application shall be accompanied by a registration fee of [forty] one 5 hundred fifty dollars. 6 [5.] 4. Notwithstanding the provisions of this section, the commis- 7 sioner may issue a temporary certificate of qualification to any person 8 pending the issuance of a certificate as provided in this section. A 9 temporary certificate shall be valid for a period of thirty days from 10 the date of its issuance and may be renewed for a maximum of four 11 successive periods of thirty days. 12 § 3. Subdivision 2 of section 575 of the public health law, as amended 13 by section 19 of part A of chapter 59 of the laws of 2011, is amended to 14 read as follows: 15 2. A permit [or permit category] shall not be issued unless a valid 16 certificate of qualification [in the category of procedures for which17the permit is sought] has been issued [to the director] pursuant to the 18 provisions of section five hundred seventy-three of this title, unless 19 all fees and outstanding penalties, if any, have been paid, and the 20 department finds that the clinical laboratory or blood bank is compe- 21 tently staffed and properly equipped, and will be operated in the manner 22 required by this title. 23 § 4. Section 576-a of the public health law, as amended by chapter 436 24 of the laws of 1993, is amended to read as follows: 25 § 576-a. Clinical laboratories and cytotechnologists examining Pap 26 smears. 1. Definitions. As used in this section, unless the context 27 clearly requires otherwise, the following terms shall have the following 28 meanings: 29 (a) "Cytotechnologist". A clinical laboratory professional specializ- 30 ing in the analysis of cytopathology samples, including Pap smears, for 31 cervical cancer and related diseases who meets the qualifications speci- 32 fied by the department. 33 (b) "Cytotechnologist work standard". (i) A limitation on the number 34 of Pap smears (also known as gynecologic slides) and non-gynecologic 35 slides a cytotechnologist may examine during a particular time period, 36 or other limitation on the quantity, speed or manner of examination of 37 slides by a cytotechnologist, under regulations of the department. 38 (ii) [Unless otherwise provided by the department, the cytotechnolo-39gist work standard shall be: No cytotechnologist may examine more than40eighty one-slide gynecologic cases or fifty two-slide gynecologic cases41per work day. If a cytotechnologist also examines non-gynecologic42slides in a given work day the cytotechnologist's workload for gyneco-43logic slides shall be correspondingly reduced, in accordance with writ-44ten guidelines prepared by the clinical laboratory and filed with the45department, so that a cytotechnologist examines no more than a total of46one hundred gynecologic and non-gynecologic slides per work day.] The 47 department may establish regulations for cytotechnologist workload stan- 48 dards that shall be at least as stringent as federal regulations. 49 (c) "Employ". To employ or contract with a cytotechnologist to examine 50 gynecologic slides. 51 (d) "Clinical laboratory". A clinical laboratory issued a permit 52 pursuant to this title. 53 (e) "Work day". A twenty-four hour period during which a cytotechnolo- 54 gist examines gynecologic slides for a clinical laboratory. 55 2. Compliance with cytotechnologist work standard. No cytotechnologist 56 shall exceed the applicable cytotechnologist work standard. No clinicalA. 9235 3 1 laboratory shall require, authorize, encourage or permit any cytotech- 2 nologist to exceed the applicable cytotechnologist work standard. In 3 determining whether a cytotechnologist exceeds the applicable cytotech- 4 nologist work standard, all work done by the cytotechnologist during a 5 given work day shall be considered, without regard to which clinical 6 laboratory or other person for which or whom it was performed. 7 3. [Registration of cytotechnologist. All cytotechnologists who are8employed by a clinical laboratory must register with the department. The9department shall, by regulation, prescribe a form and procedure for the10registration of cytotechnologists. The registration form shall include11at least the name, address, and an individual identification number12determined by the department. The department shall notify each regis-13trant of his or her identification number.144. Employment of registered cytotechnologists. No clinical laboratory15shall employ a cytotechnologist unless the cytotechnologist is regis-16tered under this section.175.] Record-keeping. (a) Each clinical laboratory shall maintain 18 records, in a form prescribed by the department, which set forth, for 19 each cytotechnologist employed by the clinical laboratory: 20 (i) the name [and identification number] of the cytotechnologist; 21 (ii) the number of hours worked by the cytotechnologist in each work 22 day; 23 (iii) the number of gynecologic slides and non-gynecologic slides 24 examined by the cytotechnologist[, and how many were one-slide and two-25slide cases,] during each work day; and 26 (iv) such other information as the department may require by regu- 27 lation. 28 (b) [Each cytotechnologist shall maintain records, in a form29prescribed by the department, which set forth:30(i) the number of hours worked by the cytotechnologist in each work31day;32(ii) the number of gynecologic slides and non-gynecologic slides exam-33ined and how many were one-slide and two-slide cases, during each work34day;35(iii) the name and address of the clinical laboratory or other person36for which or whom the slides were examined; and37(iv) such other information as the department may require by regu-38lation.39(c)] Such records of clinical laboratories and cytotechnologists shall 40 be made available for inspection and copying by the department upon 41 request. 42 [6.] 4. Multiple employers. Whenever a cytotechnologist is employed by 43 more than one clinical laboratory or other person during a work day, the 44 cytotechnologist shall advise each clinical laboratory of any previous 45 employment during the work day and the amount of work performed, to 46 insure that the applicable cytotechnologist work standard is not 47 exceeded. 48 [7.] 5. Standards for gynecologic slides. (a) A gynecologic slide of a 49 Pap smear shall not be tested or reported on if: 50 (i) the apparent condition of the specimen indicates that it is unsat- 51 isfactory for testing or that it is inappropriate for the test 52 requested; 53 (ii) it has been collected, labeled, preserved or otherwise handled in 54 such a manner that it has become unsatisfactory or unreliable as a test 55 specimen; 56 (iii) the slide is broken;A. 9235 4 1 (iv) it contains insufficient cells or the cells are obscured by 2 inflammation, blood or lubricating ointment, so that an adequate diagno- 3 sis cannot be made; or 4 (v) the slide is otherwise unsatisfactory, as defined by department 5 regulations. 6 (b) If the slide is unsatisfactory as set forth in this subdivision, 7 the clinical laboratory shall have an affirmative duty to advise the 8 collecting physician or other practitioner that the slide is unsatisfac- 9 tory and request the submission of a new slide. 10 [8.] 6. Re-examination of slides. The department shall prescribe, by 11 regulation, a system of targeted re-examination of gynecologic slides 12 examined and found to be not abnormal or questionable. The factors to be 13 considered in the targeted re-examination may include, but are not 14 limited to, the prior cancer and other history of the patient, the 15 results of previous slide examinations, and the experience and ability 16 of the cytotechnologist. Each clinical laboratory shall follow the 17 prescribed re-examination system. 18 [9. Regulations. The department may, by regulation, establish cyto-19technologist work standards. Those standards may include, but shall not20be limited to, standards which take into account the experience and21qualifications of the cytotechnologists and the performance of the clin-22ical laboratory in proficiency testing programs conducted by the depart-23ment. However, those standards shall not exceed by more than twenty24percent the maximum numbers of slides which may be examined in a work25day under clause (ii) of paragraph (b) of subdivision one of this26section. Such standards shall be at least as stringent as federal stand-27ards promulgated under the federal clinical laboratory improvement28amendments of nineteen hundred eighty-eight.2910.] 7. Notwithstanding any provisions of [subdivisions] subdivision 30 one [and nine] of this section to the contrary, the department may, 31 pursuant to regulation, increase the maximum number of slides which may 32 be examined in a work day for clinical laboratories using slide examina- 33 tion or preparation technology approved by the federal food and drug 34 administration, provided that such standards shall be at least as strin- 35 gent as federal standards promulgated under the federal clinical labora- 36 tory improvement amendments of nineteen hundred eighty-eight or other 37 applicable federal law. 38 [11.] 8. Violations. (a) Sections twelve, twelve-a, and twelve-b of 39 this chapter shall apply to violations of this section, except that the 40 civil penalty for a violation of this section by a cytotechnologist 41 shall not exceed five hundred dollars. 42 (b) [If a cytotechnologist violates this section, the department may43suspend or revoke the cytotechnologist's registration under this44section, pursuant to department regulations including appropriate due45process protections for the cytotechnologist.46(c)] If any clinical laboratory or other person violating this section 47 is licensed, certified or registered by the department under other 48 provisions of law, the violation of this section may be grounds for 49 disciplining the person under such law. 50 § 5. This act shall take effect immediately.