BILL NUMBER: SB 366	INTRODUCED
	BILL TEXT


INTRODUCED BY   Senator Aanestad

                        FEBRUARY 20, 2007

   An act to amend and repeal Section 1271 of the Business and
Professions Code, relating to clinical laboratories.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 366, as introduced, Aanestad. Clinical laboratories: personnel.

   Existing law generally establishes a maximum workload for the
examination of gynecologic slides by a cytotechnologist when
performing a manual review of slides. However, existing law, until
January 1, 2008, provides that specified federal workload
requirements shall apply when reviewing those slides using automated
or semiautomated screening devices approved by the Federal Food and
Drug Administration and requires the technical supervisor of an
individual who performs primary screening to establish the maximum
workload for that individual in accordance with specified federal
criteria. Existing law also provides, until January 1, 2008, that
where cytotechnologists are represented by a labor organization,
these maximum workload requirements shall be contained in a
collective bargaining agreement or memorandum of understanding.
   This bill would continue the operation of these provisions
indefinitely.
   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  Section 1271 of the Business and Professions Code, as
amended by Section 1 of Chapter 735 of the Statutes of 2004, is
amended to read:
   1271.  (a) A cytotechnologist shall not examine more than 80
gynecologic slides in a 24-hour period when performing a manual
review of slides.
   (b) The maximum workload limit in subdivision (a) is the maximum
number of gynecologic slides that a cytotechnologist shall examine in
a 24-hour period without regard to the number of clinical
laboratories or other persons for which the work is performed.
Cytotechnologists, who examine both gynecologic and nongynecologic
slides, shall do so on a pro rata basis so that the maximum workload
limit in subdivision (a) is not exceeded, and so that the number of
gynecologic slides examined is reduced proportionally if both
gynecologic and nongynecologic slides are examined in a 24-hour
period.
   (c) The maximum workload limit in subdivision (a) is for a
cytotechnologist who has no duties other than the evaluation of
gynecological slides. Cytotechnologists who have other duties,
including, but not limited to, the preparation and staining of
cytologic slides, shall decrease on a pro rata basis the number of
slides examined.
   (d) All cytologic slides shall be examined in a clinical
laboratory that has been licensed by the department, or in a
municipal or county laboratory established under Section 101150 of
the Health and Safety Code. All slides examined under the name of a
clinical laboratory shall be examined on the premises of that
laboratory.
   (e) Each clinical laboratory shall maintain records of the number
of cases and slides for gynecologic and nongynecologic samples
examined on a monthly and annual basis.
   (f) Each cytotechnologist shall maintain current records in a form
prescribed by the department of hours worked and the names and
addresses of the clinical laboratories or other persons for whom
slides are examined.
   (g) Each clinical laboratory shall retain all cytology slides and
cell blocks examined for a minimum of five years and all cytology
reports for a minimum of 10 years.
   (h) The presence of any factor that would prohibit the proper
examination of a cytologic slide, including, but not limited to,
damaged slides or inadequate specimens, as determined by the director
of the laboratory, shall result in the issuance of a statement of
inadequacy to the referring physician and no report of cytologic
findings shall be issued on that slide.
   (i) Each clinical laboratory shall maintain records of the number
of cases and slides for gynecologic and nongynecologic slides each
cytotechnologist in the laboratory reads each 24-hour period, the
number of hours devoted during each 24-hour period to screening
cytology slides by each individual, and shall determine weekly and
cumulatively the frequency of abnormal slides found by each
cytotechnologist employed.
   (j) Ten percent of the negative or normal slides examined by each
cytotechnologist employed by a clinical laboratory shall be
rescreened at least weekly by a cytopathologist or supervising
cytotechnologist other than the original examiner.
   (k) When reviewing gynecologic slides using automated or
semiautomated screening devices approved by the federal Food and Drug
Administration, a laboratory shall follow the workload requirements
established by Section 493.1274 of Title 42 of the Code of Federal
Regulations.
   (1) Any slide reviewed using automated or semiautomated screening
devices approved by the federal Food and Drug Administration that
requires full manual review shall be counted against the applicable
limits established in subdivision (a) and this subdivision.
   (2) On or before June 30, 2007, the State Department of Health
Services shall review published evidence-based peer review journal
articles that review the performance of both automated and
semiautomated screening devices, subsequent to the approval of the
device by the federal Food and Drug Administration, and shall
determine whether increasing the number of slides reviewed on a daily
basis increases the rate of error. If the department determines that
the volume of screening on these devices increases the rate of
error, the department may issue new regulations in that regard that
are consistent with Section 493.1274 of Title 42 of the Code of
Federal Regulations.
   () The technical supervisor of an individual who performs primary
screening shall establish the maximum workload limit for the
individual, based on the individual's performance, in accordance with
the criteria set forth in Section 493.1274(d)(1) of Title 42 of the
Code of Federal Regulations.
   (m) Where cytotechnologists are represented by a labor
organization, the maximum workload limitations otherwise established
pursuant to this section shall be contained in a collective
bargaining agreement or memorandum of understanding negotiated
between the employer and the labor organization. 
   (n) This section shall remain in effect only until January 1,
2008, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2008, deletes or extends
that date. 
  SEC. 2.  Section 1271 of the Business and Professions Code, as
added by Section 2 of Chapter 735 of the Statutes of 2004, is
repealed. 
   1271.  (a) A cytotechnologist shall not examine more than 80
gynecologic slides in a 24-hour period.
   (b) The maximum workload limit in subdivision (a) is the maximum
number of gynecologic slides that a cytotechnologist shall examine in
a 24-hour period without regard to the number of clinical
laboratories or other persons for which the work is performed.
Cytotechnologists who examine both gynecologic and nongynecologic
slides shall do so on a pro rata basis so that the maximum workload
limit in subdivision (a) is not exceeded, and so that the number of
gynecologic slides examined is reduced proportionally if both
gynecologic and nongynecologic slides are examined in a 24-hour
period.
   (c) The maximum workload limit in subdivision (a) is for a
cytotechnologist who has no duties other than the evaluation of
gynecological slides. Cytotechnologists who have other duties,
including, but not limited to, the preparation and staining of
cytologic slides, shall decrease on a pro rata basis the number of
slides examined.
   (d) All cytologic slides shall be examined in a clinical
laboratory that has been licensed by the department, or in a
municipal or county laboratory established under Section 101150 of
the Health and Safety Code. All slides examined under the name of a
clinical laboratory shall be examined on the premises of that
laboratory.
   (e) Each clinical laboratory shall maintain records of the number
of cases and slides for gynecologic and nongynecologic samples
examined on a monthly and annual basis.
   (f) Each cytotechnologist shall maintain current records in a form
prescribed by the department of hours worked and the names and
addresses of the clinical laboratories or other persons for whom
slides are examined.
   (g) Each clinical laboratory shall retain all cytology slides and
cell blocks examined for a minimum of five years and all cytology
reports for a minimum of 10 years.
   (h) The presence of any factor that would prohibit the proper
examination of a cytologic slide, including, but not limited to,
damaged slides or inadequate specimens, as determined by the director
of the laboratory, shall result in the issuance of a statement of
inadequacy to the referring physician and no report of cytologic
findings shall be issued on that slide.
   (i) Each clinical laboratory shall maintain records of the number
of cases and slides for gynecologic and nongynecologic slides each
cytotechnologist in the laboratory reads each 24-hour period, the
number of hours devoted during each 24-hour period to screening
cytology slides by each individual, and shall determine weekly and
cumulatively the frequency of abnormal slides found by each
cytotechnologist employed.
   (j) Ten percent of the negative or normal slides examined by each
cytotechnologist employed by a clinical laboratory shall be
rescreened at least weekly by a cytopathologist or supervising
cytotechnologist other than the original examiner.
   (k) This section shall become operative on January 1, 2008.