State Codes and Statutes

Statutes > California > Bpc > 1260-1275

BUSINESS AND PROFESSIONS CODE
SECTION 1260-1275



1260.  The department shall issue a clinical laboratory bioanalyst's
license to each person who is a lawful holder of a degree of master
of arts, master of science, or an equivalent or higher degree as
determined by the department with a major in chemical, physical,
biological, or clinical laboratory sciences. This education shall
have been obtained in one or more established and reputable
institutions maintaining standards equivalent, as determined by the
department, to those institutions accredited by the Western
Association of Schools and Colleges or an essentially equivalent
accrediting agency, as determined by the department. The applicant
also shall have a minimum of four years' experience as a licensed
clinical laboratory scientist, performing clinical laboratory work
embracing the various fields of clinical laboratory activity in a
clinical laboratory approved by the department. The quality and
variety of this experience shall be satisfactory to the department
and shall have been obtained within the six-year period immediately
antecedent to admission to the examination. The applicant shall
successfully pass a written examination and an oral examination
conducted by the department or a committee designated by the
department to conduct the examinations, indicating that the applicant
is properly qualified. The department may issue a license without
conducting a written examination to an applicant who has passed a
written examination of a national accrediting board having
requirements that are, in the determination of the department, equal
to or greater than those required by this chapter and regulations
adopted by the department. The department shall establish by
regulation the required courses to be included in the college or
university training.



1260.1.  The department shall issue a histocompatibility laboratory
director's license to each person who meets the qualifications
specified in Section 1209.1.



1260.3.  (a) The department shall issue a medical laboratory
technician license to each person who meets the following
requirements:
   (1) Has met the requirements of this chapter and any reasonable
qualifications established by regulations of the department,
including, but not limited to, any of the following:
   (A) Lawfully holds an associate degree or an equivalent or higher
degree in chemical, physical, biological, or clinical laboratory
science, which includes a minimum of 36 semester units of physical or
biological sciences.
   (B) The completion of 60 semester (90 quarter) units from an
accredited college or university, with 36 semester units in physical
or biological sciences.
   (C) Graduation from a medical laboratory technician training
program accredited by the National Accrediting Agency for Clinical
Laboratory Sciences or other recognized accrediting program approved
by the department.
   (D) Graduation from an advanced military medical laboratory
specialist program approved by the department.
   (2) Has applied for the license on forms provided by the
department.
   (3) Has paid a license fee established in regulations of the
department in accordance with subdivision (v) of Section 1300.
   (b) A licensed medical laboratory technician may perform clinical
laboratory tests or examinations classified as waived or of moderate
complexity under CLIA, and may report the test results. However, a
licensed medical laboratory technician shall not perform microscopic
analysis or immunohematology procedures. The medical laboratory
technician shall work under the supervision of a licensed physician
and surgeon or a baccalaureate, masters, or doctoral level person
licensed pursuant to this chapter. The supervision shall be required
during the entire time a medical laboratory technician performs
clinical laboratory tests or examinations.
   (c) The department shall adopt emergency regulations to implement
this section as soon as possible.



1261.  The department shall issue a clinical laboratory scientist's
or a limited clinical laboratory scientist's license to each person
who is a lawful holder of a baccalaureate or an equivalent or higher
degree, who has applied for the license on forms provided by the
department and has met the requirements of this chapter and any
reasonable qualifications established by regulations of the
department. However, an exception to the degree requirement may be
made by the department for the clinical laboratory scientist's
license only if the applicant for the license has completed a minimum
of two years of experience as a licensed trainee or the equivalent
thereof, as determined by the department, doing clinical laboratory
work embracing the various fields of clinical laboratory activity in
a clinical laboratory approved by the department. In addition, the
applicant applying under this section must have 90 semester hours or
equivalent quarter hours of university or college work or the
equivalent thereof, as may be determined by the department, which
shall have included at least 23 semester hours or equivalent quarter
hours of science courses as specified by regulations of the
department. Additional college or university work that includes
courses in the fundamental sciences may be substituted for one of the
two years of experience in the ratio of 30 semester hours or
equivalent quarter hours for each year of experience. This exception
shall not apply to the limited clinical laboratory scientist's
license. The department shall hold examinations to aid it in judging
the qualifications of applicants. Licenses may be issued in any or
all of the sciences applied in a clinical laboratory as determined by
regulation established by the department. The department shall
establish by regulation the college courses or majors to be included
in the college or university training and the amount and kind of
training or experience required. Examinations, training, or
experience requirements for limited licenses shall cover only the
science concerned. The department may identify by regulation the
appropriate sciences and shall establish the minimum requirements for
training and experience and required courses or major for each.
   Experience as a clinical laboratory technician in any branch of
the armed forces of the United States may be considered equivalent to
the experience as a trainee, if the experience is approved by the
department. Each year of training and experience as a clinical
laboratory technician in the armed forces shall be equivalent to 15
semester hours, which shall be credited to the minimum number of
hours required to qualify for licensure as a trainee. The semester
hours acquired in this manner shall not consist of the science
courses required by the department under this section. The maximum
number of hours granted shall not exceed 60 semester hours or its
equivalent.



1261.5.  The department may issue limited clinical laboratory
scientist's licenses in chemistry, microbiology, toxicology,
histocompatibility, immunohematology, genetic molecular biology,
cytogenetics, or other areas of laboratory specialty or subspecialty
when determined to be necessary by the department in order for
licensure categories to keep abreast of changes in laboratory or
scientific technology. Whenever the department determines that a new
limited clinical laboratory scientist license category is necessary,
it shall adopt regulations identifying the category and the areas of
specialization included within the category.
   To qualify for admission to the examination for a special clinical
laboratory scientist's license, an applicant shall have all the
following:
   (a) Have graduated from a college or university maintaining
standards equivalent, as determined by the department, to those
institutions accredited by the Western Association of Schools and
Colleges or an essentially equivalent accrediting agency with a
baccalaureate or higher degree with a major appropriate to the field
for which a license is being sought.
   (b) Have one year of full-time postgraduate training or experience
in the various areas of analysis in the field for which a license is
being sought in a laboratory that has a license issued under this
chapter or which the department determines is equivalent thereto.
   (c) Whenever a limited clinical laboratory scientist's license is
established for a specific area of specialization, the department may
issue the license without examination to applicants who had met
standards of education and training, defined by regulations, prior to
the date of the adoption of implementing regulations.
   (d) The department shall adopt regulations to implement this
section.


1261.6.  The department may issue a limited clinical laboratory
scientist's license in cytogenetics to any person with a minimum of
seven years of work experience in this state as a cytogenetic
technologist who provides evidence of satisfactory performance on a
written examination administered by the National Credentialing Agency
for Laboratory Personnel on or before December 31, 1991, in the
specialty of cytogenetics, and who meets the federal regulatory
requirements for personnel performing high-complexity testing.



1262.  No clinical laboratory scientist's or limited clinical
laboratory scientist's license shall be issued by the department
except after examination; provided, that a temporary clinical
laboratory scientist's license or a temporary limited clinical
laboratory scientist's license may be issued to an individual who
fulfills the requirements for admission to the examination unless the
individual has failed a previous examination for the license. The
department may issue licenses without examination to applicants who
have passed examinations of the national accrediting boards whose
requirements are equal to or greater than those required by this
chapter and regulations established by the department. The department
may issue licenses without further examination to applicants who
have passed examinations of another state whose laws and regulations
are equal to or greater than those required by this chapter and
regulations established by the department. The evaluation of national
or state accrediting boards for the purposes of this chapter shall
be carried out by the department with assistance of representatives
from the licensed groups. This section shall not apply to persons who
have passed an examination by a national board or another state
examination prior to the establishment of requirements that are equal
to or exceed those of this chapter or the regulations of the
department. The department may, however, make exceptions if
individuals are otherwise qualified.



1262.5.  Notwithstanding Section 135, an applicant for a clinical
laboratory or limited technologist license who fails to pass the
written examination two times shall not be eligible to be reexamined
a third time until at least one year has elapsed from the date of the
second examination. An applicant who fails the third examination
shall not be eligible to take the examination a fourth time until two
years have elapsed from the date of the third examination.
Thereafter, the examination may not be taken more frequently than
once in two years.


1263.  The department shall license as trainees those individuals
desiring to train for either a clinical laboratory scientist's
license or a limited clinical laboratory scientist's license,
providing those individuals meet the academic requirements.
   No trainee license shall be issued unless the applicant has
completed at least 90 semester hours or equivalent quarter hours of
university or college work or the essential equivalent as determined
by the department which must have included at least 23 semester hours
or equivalent quarter hours of courses in the sciences as determined
by regulations of the department. Applicants who have completed
military training schools may be granted academic credit toward
licensure by the department on the basis of recommendations made by
the American Council on Education.
   Applicants shall apply for the license on forms provided by the
department and meet the requirements of this chapter and any
standards as are established by regulations of the department.



1264.  The department shall issue a clinical chemist, clinical
microbiologist, clinical toxicologist, clinical molecular biologist,
or clinical cytogeneticist license to each person who has applied for
the license on forms provided by the department, who is a lawful
holder of a master of science or doctoral degree in the specialty for
which the applicant is seeking a license and who has met such
additional reasonable qualifications of training, education, and
experience as the department may establish by regulations. The
department shall issue an oral and maxillofacial pathologist license
to every applicant for licensure who has applied for the license on
forms provided by the department, who is a registered Diplomate of
the American Board of Oral and Maxillofacial Pathology, and who meets
any additional and reasonable qualifications of training, education,
and experience as the department may establish by regulation.
   (a) The graduate education shall have included 30 semester hours
of coursework in the applicant's specialty. Applicants possessing
only a master of science degree shall have the equivalent of one year
of full-time, directed study or training in procedures and
principles involved in the development, modification or evaluation of
laboratory methods, including training in complex methods applicable
to diagnostic laboratory work. Each applicant must have had one year
of training in his or her specialty in a clinical laboratory
acceptable to the department and three years of experience in his or
her specialty in a clinical laboratory, two years of which must have
been at a supervisory level. The education shall have been obtained
in one or more established and reputable institutions maintaining
standards equivalent, as determined by the department, to those
institutions accredited by an agency acceptable to the department.
The department shall determine by examination that the applicant is
properly qualified. Examinations, training, or experience
requirements for specialty licenses shall cover only the specialty
concerned.
   (b) The department may issue licenses without examination to
applicants who have passed examinations of other states or national
accrediting boards whose requirements are equal to or greater than
those required by this chapter and regulations established by the
department. The evaluation of other state requirements or
requirements of national accrediting boards shall be carried out by
the department with the assistance of representatives from the
licensed groups. This section shall not apply to persons who have
passed an examination by another state or national accrediting board
prior to the establishment of requirements that are equal to or
exceed those of this chapter or regulations of the department.
   (c) The department may issue licenses without examination to
applicants who had met standards of education and training, defined
by regulations, prior to the date of the adoption of implementing
regulations.
   (d) The department shall adopt regulations to conform to this
section.



1265.  (a) (1) A clinical laboratory performing clinical laboratory
tests or examinations classified as of moderate or of high complexity
under CLIA shall obtain a clinical laboratory license pursuant to
this chapter. The department shall issue a clinical laboratory
license to any person who has applied for the license on forms
provided by the department and who is found to be in compliance with
this chapter and the regulations pertaining thereto. No clinical
laboratory license shall be issued by the department unless the
clinical laboratory and its personnel meet the CLIA requirements for
laboratories performing tests or examinations classified as of
moderate or high complexity, or both.
   (2) A clinical laboratory performing clinical laboratory tests or
examinations subject to a certificate of waiver or a certificate of
provider-performed microscopy under CLIA, shall register with the
department. The department shall issue a clinical laboratory
registration to any person who has applied for the registration on
forms provided by the department and is found to be in compliance
with this chapter, the regulations pertaining thereto, and the CLIA
requirements for either a certificate of waiver or a certificate of
provider-performed microscopy.
   (b) An application for a clinical laboratory license or
registration shall include the name or names of the owner or the
owners, the name or names of the laboratory director or directors,
the name and location of the laboratory, a list of the clinical
laboratory tests or examinations performed by the laboratory by name
and total number of test procedures and examinations performed
annually (excluding tests the laboratory may run for quality control,
quality assurance, or proficiency testing purposes). The application
shall also include a list of the tests and the test kits,
methodologies, and laboratory equipment used, and the qualifications
(educational background, training, and experience) of the personnel
directing and supervising the laboratory and performing the
laboratory examinations and test procedures, and any other relevant
information as may be required by the department. If the laboratory
is performing tests subject to a provider-performed microscopy
certificate, the name of the provider or providers performing those
tests shall be included on the application. Application shall be made
by the owners of the laboratory and the laboratory directors prior
to its opening. A license or registration to conduct a clinical
laboratory if the owners are not the laboratory directors shall be
issued jointly to the owners and the laboratory directors and the
license or registration shall include any information as may be
required by the department. The owners and laboratory directors shall
be severally and jointly responsible to the department for the
maintenance and conduct thereof or for any violations of this chapter
and regulations pertaining thereto.
   (c) The department shall not issue a license or registration until
it is satisfied that the clinical laboratory will be operated within
the spirit and intent of this chapter, that the owners and
laboratory directors are each of good moral character, and that the
granting of the license will not be in conflict with the interests of
public health.
   (d) A separate license or registration shall be obtained for each
laboratory location, with the following exceptions:
   (1) Laboratories that are not at a fixed location, that is,
laboratories that move from one testing site to another, such as
mobile units providing laboratory testing, health screening fairs, or
other temporary testing locations, may apply for and obtain one
license or registration for the designated primary site or home base,
using the address of that primary site.
   (2) Not-for-profit, or federal, state, or local government
laboratories that engage in limited (not more than a combination of
15 moderately complex or waived tests, as defined under CLIA, per
license) public health testing may apply for and obtain a single
license or registration.
   (3) Laboratories within a hospital that are located at contiguous
buildings on the same campus and under common direction, may file a
single application or multiple applications for a license or
registration of laboratory locations within the same campus or street
address.
   (4) Locations within a single street and city address that are
under common ownership may apply for and obtain a single license or
registration or multiple licenses or registrations, at the discretion
of the owner or owners.
   (e) (1) A license or registration shall be valid for one year
unless revoked or suspended. A clinical laboratory license or
registration shall be automatically revoked 30 days from a major
change of laboratory directorship or ownership. The clinical
laboratory shall be required to submit a completed application for a
new clinical laboratory license or registration within those 30 days
or cease engaging in clinical laboratory practice.
   (2) If a clinical laboratory intends to continue to engage in
clinical laboratory practice during the 30 days after a major change
in directorship occurs and before the laboratory license or
registration is automatically revoked, the laboratory owner may
appoint an interim director who meets the requirements of this
chapter and CLIA. The interim director shall be appointed within five
business days of the major change of the directorship. Written
notice shall be provided to the department of the appointment of the
laboratory director pursuant to this paragraph within five business
days of the appointment.
   (f) If the department does not within 60 days after the date of
receipt of the application issue a license or registration, it shall
state the grounds and reasons for its refusal in writing, serving a
copy upon the applicant by certified mail addressed to the applicant
at his or her last known address.
   (g) The department shall be notified in writing by the laboratory
owners or delegated representatives of the owners and the laboratory
directors of any change in ownership, directorship, name, or
location, including the addition or deletion of laboratory owners or
laboratory directors within 30 days. However, notice of change in
ownership shall be the responsibility of both the current and new
owners. Laboratory owners and directors to whom the current license
or registration is issued shall remain jointly and severally
responsible to the department for the operation, maintenance, and
conduct of the clinical laboratory and for any violations of this
chapter or the regulations adopted thereunder, including any failure
to provide the notifications required by this subdivision, until
proper notice is received by the department. In addition, failure of
the laboratory owners and directors to notify the department within
30 days of any change in laboratory directors, including any
additions or deletions, shall result in the automatic revocation of
the clinical laboratory's license or registration.
   (h) The withdrawal of an application for a license or registration
or for a renewal of a license, or registration, issuable under this
chapter, shall not, after the application has been filed with the
department, deprive the department of its authority to institute or
continue a proceeding against the applicant for denial of the
license, registration, or renewal upon any ground provided by law or
to enter an order denying the license, registration, or renewal upon
any such ground, unless the department consents in writing to the
withdrawal.
   (i) The suspension, expiration, or forfeiture by operation of law
of a license or registration issued under this chapter, or its
suspension, forfeiture, or cancellation by order of the department or
by order of a court of law, or its surrender without the written
consent of the department, shall not deprive the department of its
authority to institute or continue an action against a license or
registration issued under this chapter or against the laboratory
owner or laboratory director upon any ground provided by law or to
enter an order suspending or revoking the license or registration
issued under this chapter.
   (j) (1) Whenever a clinical laboratory ceases operations, the
laboratory owners, or delegated representatives of the owners, and
the laboratory directors shall notify the department of this fact, in
writing, within 30 calendar days from the date a clinical laboratory
ceases operation. For purposes of this subdivision, a laboratory
ceases operations when it suspends the performance of all clinical
laboratory tests or examinations for 30 calendar days at the location
for which the clinical laboratory is licensed or registered.
   (2) (A) Notwithstanding any other provision of law, owners and
laboratory directors of all clinical laboratories, including those
laboratories that cease operations, shall preserve medical records
and laboratory records, as defined in this section, for three years
from the date of testing, examination, or purchase, unless a longer
retention period is required pursuant to any other provision of law,
and shall maintain an ability to provide those records when requested
by the department or any duly authorized representative of the
department.
   (B) For purposes of this subdivision, "medical records" means the
test requisition or test authorization, or the patient's chart or
medical record, if used as the test requisition, the final and
preliminary test or examination result, and the name of the person
contacted if the laboratory test or examination result indicated an
imminent life-threatening result or was of panic value.
   (C) For purposes of this subdivision, "laboratory records" means
records showing compliance with CLIA and this chapter during a
laboratory's operation that are actual or true copies, either
photocopies or electronically reproducible copies, of records for
patient test management, quality control, quality assurance, and all
invoices documenting the purchase or lease of laboratory equipment
and test kits, reagents, or media.
   (D) Information contained in medical records and laboratory
records shall be confidential, and shall be disclosed only to
authorized persons in accordance with federal, state, and local laws.
   (3) The department or any person injured as a result of a
laboratory's abandonment or failure to retain records pursuant to
this section may bring an action in a court of proper jurisdiction
for any reasonable amount of damages suffered as a result thereof.



1265.1.  (a) A primary care clinic that submits an application to
the State Department of Public Health for clinic licensure pursuant
to subdivision (a) of Section 1204 of the Health and Safety Code may
submit prior to that submission, or concurrent therewith, an
application for licensure or registration of a clinical laboratory to
be operated by the clinic.
   (b) An application for licensure of a clinical laboratory
submitted pursuant to this section shall be subject to all applicable
laboratory licensing laws and regulations, including, but not
limited to, any statutory or regulatory timelines and processes for
review of a clinical laboratory application.



1266.  The clinical laboratory license and the license or current
renewal permit of each person performing tests shall be conspicuously
posted in the clinical laboratory.



1267.  Any denial, suspension, or revocation of a license under this
chapter shall be conducted in compliance with Section 100171 of the
Health and Safety Code.



1268.  Upon filing application therefor, containing such information
as the department may require, and the payment of the license fee,
the department shall issue to any person duly licensed under this
chapter a duplicate license for one previously issued or, where there
has been a change of name, another license in lieu of one previously
issued.



1269.  (a) Unlicensed laboratory personnel may perform any of the
activities identified in subdivision (b), in a licensed clinical
laboratory, under the direct and constant supervision of a physician
and surgeon, or a person licensed under this chapter other than a
trainee, upon meeting all of the following criteria:
   (1) Have earned a high school diploma, or its equivalent, as
determined by HCFA under CLIA.
   (2) Have documentation of training appropriate to ensure that the
individual has all of the following skills and abilities:
   (A) The skills required for proper specimen collection, including
patient preparation, labeling, handling, preservation or fixation,
processing or preparation, and transportation and storage of
specimens.
   (B) The skills required for assisting a licensed physician and
surgeon or personnel licensed under this chapter, other than
trainees, in a licensed clinical laboratory.
   (C) The skills required for performing preventive maintenance, and
troubleshooting.
   (D) A working knowledge of reagent stability and storage.
   (E) The skills required for assisting in the performance of
quality control procedures, and an understanding of the quality
control policies of the laboratory.
   (F) An awareness of the factors that influence test results.
   (b) The activities that may be performed are:
   (1) Biological specimen collection, including patient preparation,
labeling, handling, preservation or fixation, processing or
preparation, and transportation and storage of specimens.
   (2) Assisting a licensed physician and surgeon or personnel
licensed under this chapter, other than trainees, in a licensed
clinical laboratory.
   (3) Assisting in preventive maintenance, and troubleshooting.
   (4) Preparation and storage of reagents and culture media.
   (5) Assisting in the performance of quality control procedures.
   (c) Notwithstanding subdivision (a), unlicensed laboratory
personnel, other than a trainee, may, under the supervision and
control of a physician and surgeon or person licensed under this
chapter, perform specimen labeling, handling, preservation or
fixation, processing or preparation, transportation, and storing if
he or she meets the requirements of subparagraph (A) of paragraph (2)
of, and paragraph (1) of, subdivision (a).
   (d) Unlicensed laboratory personnel shall not do any of the
following:
   (1) Record test results, but he or she may transcribe results that
have been previously recorded, either manually by a physician and
surgeon or personnel licensed under this chapter, or automatically by
a testing instrument.
   (2) Perform any test or part thereof that involves the
quantitative measurement of the specimen or test reagent, or any
mathematical calculation relative to determining the results or the
validity of a test procedure.
   (3) Perform any phase of clinical laboratory tests or examinations
in the specialty of immunohematology beyond initial collection and
centrifugation.
   (e) When any of the following manual methods are employed, the
activities of unlicensed laboratory personnel shall be limited as
follows:
   (1) In the case of qualitative and semi-quantitative "spot,
tablet, or stick" tests, the personnel may add the test reagent to
the specimen or vice versa, but the results must be read by a
physician and surgeon or person licensed under this chapter.
   (2) In the case of microbiological tests the unlicensed laboratory
personnel may make primary inoculations of test material onto
appropriate culture media, stain slide preparations for microscopic
examination, and subculture from liquid media.
   (f) When any of the following mechanical or electronic instruments
are employed, unlicensed laboratory personnel shall not perform any
of the following activities:
   (1) Standardizing or calibrating the instrument or assessing its
performance by monitoring results of appropriate standards and
control.
   (2) Reading or recording test results, except that the personnel
may transcribe results that have been previously recorded
automatically by a testing instrument.
   (3) Quantitatively measuring any sample or reagents unless done
automatically by the instrument in the course of its normal operation
or by the use of previously calibrated and approved automatic
syringes or other dispensers.



1269.3.  (a) Notwithstanding Sections 1206.5 and 1269, within the
specialty of pathology, a person certified as a pathologists'
assistant by the American Association of Pathologists' Assistants,
the Board of Registry of the American Society for Clinical Pathology,
or another national accrediting agency approved by the department,
who demonstrates competency to perform all job duties and
responsibilities before an assignment to those duties and
responsibilities, at the completion of six months of performing those
duties and responsibilities, and annually thereafter, may perform
the following activities under the supervision and control of a
pathologist:
   (1) Prepare human surgical specimens for gross description and
dissection, including, but not limited to, description of gross
features and selection of tissues for histological examination.
   (2) Prepare and perform human postmortem examinations, including,
but not limited to, selection of tissues and fluids for further
examination.
   (3) Gather other information necessary for an autopsy report.
   (4) Prepare a body for release.
   (b) Notwithstanding Section 1206.5 or subdivisions (b), (c), and
(d) of Section 1269, the following persons may prepare human surgical
specimens for gross description and dissection under the direct
supervision of a qualified pathologist, including, description of
gross features and selection of tissues for histological examination,
if they meet the requirements specified in subdivision (a) of
Section 1269 and the minimum education and training requirements for
high complexity testing personnel under the CLIA:
   (1) A pathologists' assistant who does not meet the certification
requirements of subdivision (a).
   (2) A histologic technician.
   (3) A histotechnologist.
   (c) For the purposes of subdivision (b), direct supervision means
that a qualified pathologist shall be physically present onsite in
the vicinity of the clinical laboratory where the specialty of
pathology is performed and shall be available for consultation and
direction during the time the personnel specified in subdivision (b)
are engaged in the processing of specimens that involve dissection.
For tissue processing that does not involve dissection, a qualified
pathologist may be available by telephone or other electronic means.
   (d) A histologic technician or histotechnologist who meets the
requirements specified in subdivision (a) of Section 1269, may
accession specimens, perform maintenance of equipment, stain, cover
slip, label slides, and process tissues by embedding in paraffin or
performing microtomy.
   (e) On and after January 1, 2011, the department may adopt
regulations establishing additional qualification requirements to
perform the duties described in this section.



1269.5.  The department may deny, suspend, or revoke any license,
registration, or certificate issued under this chapter for
performance by unlicensed laboratory personnel of any activity that
is not authorized by Section 1269.


1270.  (a) On and after January 1, 1991, no person may perform
examinations of cytological slides without first obtaining a license
as a cytotechnologist from the department, except that those persons
employed by licensed clinical laboratories as cytotechnologists and
certified as cytotechnologists by the department on or before January
1, 1991, shall be licensed by the department on or before January 1,
1993. Cytotechnologist licenses shall be issued and renewed by the
department for periods of two years. This subdivision shall not apply
to persons holding a valid, unrevoked, unsuspended physician's and
surgeon's certificate issued pursuant to Chapter 5 (commencing with
Section 2000).
   (b) The issuance of a cytotechnologist license shall be contingent
upon the applicant's satisfactory performance, as defined in
regulation, in a competency testing program for cytotechnologists
which may be administered by the department or by a competency
testing service or program approved by the department. The competency
testing program established pursuant to this section shall be
periodically reviewed and revised by the department, if necessary, to
ensure that the program is consistent with federal competency
testing requirements issued under the Clinical Laboratory Improvement
Amendments of 1988 (P.L. 100-578; 42 U.S.C. Sec. 263a, Section 353
of the Public Health Service Act).
   (c) Notwithstanding subdivision (b), the department may issue a
temporary cytotechnologist's license to a person who satisfies the
requirements for admission to the examination unless the person has
failed a previous examination for a cytotechnologist's license. A
temporary license issued by the department pursuant to this
subdivision shall be valid for a period of time not exceeding 90 days
after the date the department has adopted a competency testing
program pursuant to subdivision (b).
   (d) The department may issue a cytotechnologist's license without
examination to an applicant who satisfies one of the following:
   (1) Passage of an examination of a national accrediting board
whose requirements are equal to or greater than those required by
this chapter or by regulations adopted pursuant to this chapter, as
determined by the department.
   (2) Passage of an examination of another state in which the
requirements imposed by laws and regulations regarding the
examination are equal to or greater than those required by this
chapter or by regulations adopted pursuant to this chapter, as
determined by the department.
   This subdivision shall not apply to a person who has passed an
examination of a national accrediting board or another state prior to
that board's or state's establishment of requirements which are
equal to or greater than those required by this chapter or by
regulations adopted pursuant to this chapter, as determined by the
department. The department may, however, make exceptions to the
requirements of this subdivision in cases where the department
determines that the applicant is otherwise qualified for licensure.
   (e) The department shall not issue any temporary cytotechnologist'
s license pursuant to subdivision (c) or any cytotechnologist's
license without examination pursuant to subdivision (d) after the
department adopts a competency testing program pursuant to
subdivision (b).


1270.5.  (a) Notwithstanding Section 1301, an application for the
renewal of, and payment of the renewal fees for, a cytotechnologist
license shall be governed by this section.
   (b) Application for renewal of a cytotechnologist license,
accompanied by the fee set forth in Section 1300, shall be filed with
the department not less than 30 days prior to the expiration date.
   (c) If the renewal fee is not paid during the 30 days prior to the
expiration date, the license shall automatically expire at midnight
on the expiration date. However, a cytotechnologist who has failed to
timely pay a renewal fee may have his or her license reinstated,
without completing a competency testing program, provided that he or
she mails to the department a written request for reinstatement
postmarked no later than the 60th day after the expiration date of
the license and a reinstatement fee equal to two times the annual
renewal fee set forth in Section 1300. The license shall be
reinstated on the date the request for reinstatement and fee are
received by the department. If the request for reinstatement and fee
are received prior to the expiration date of the license, there shall
be no lapse in licensure. No cytotechnologist shall perform services
for which a license or certification is required under this chapter
during any period for which licensure or certification has lapsed.




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.
   (l) 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.



1271.1.  (a) Clinical laboratories which are licensed pursuant to
this chapter and provide cytology services shall, if the licensee
ceases operation, preserve records, reports, cytology slides, and
cell blocks as prescribed in subdivision (g) of Section 1271 and
Section 1274.
   (b) Any person injured as a result of the licensee's abandonment
of records may bring an action in any court of competent jurisdiction
for the amount of any damages suffered as a result. In the event the
licensee was a corporation or partnership which has been dissolved,
the person injured may bring an action against that corporation's or
partnership's principal officers of record at the time of the
dissolution.
   (c) For purposes of this section, the following definitions shall
apply:
   (1) "Abandonment of records" means violating subdivision (a) and
thereby leaving patients and physicians and surgeons without access
to information to which they are entitled pursuant to this chapter.
   (2) "Principal officers" means:
   (A) In the case of a partnership other than a limited partnership,
any partner.
   (B) In the case of a limited partnership, any general partner, as
defined in subdivision (i) of Section 15611 of the Corporations Code.
   (C) In the case of a corporation, the chairperson of the board,
the chief executive officer, and the president of the corporation.




1272.  A clinical laboratory shall participate in a state-approved
proficiency testing program and demonstrate satisfactory performance
in all of the laboratory specialities that include tests performed in
the laboratory. Proficiency shall be tested in the following
specialties: microbiology, serology, clinical chemistry, hematology,
cytology, and immunohematology.



1272.4.  The department shall establish standards for the evaluation
of cytologic slides, for reporting the adequacy of cytologic slides,
for a cytotechnologist competency program, and for a proficiency
testing program for clinical laboratories providing cytology
services.



1272.6.  The department shall, on or before January 1, 1992, develop
or adopt a proficiency testing program for laboratories providing
cytology services which may be administered by the department or by a
proficiency testing service or program approved by the department.
The proficiency program established pursuant to this section shall
include announced and unannounced onsite proficiency testing, with
that testing to take place, to the extent practicable, under normal
working conditions.



1274.  (a) A laboratory shall document to persons submitting
cytologic samples for evaluation, on a quarterly basis, informational
letters on all cases of HSIL (high-grade squamous intraepithelial
lesions), adenocarcinoma, or other malignant neoplasm. Documentation
may consist of followup correspondence, telephone calls, or requests
included in the report. Copies of that documentation, and any
responses received to those letters, shall be maintained on file by
the laboratories for a period of five years.
   (b) Whenever it becomes known to a clinical laboratory that an
abnormality of HSIL (high-grade squamous intraepithelial lesions,
adenocarcinoma, or other malignant neoplasm) has been identified for
a patient for whom the clinical laboratory earlier reported a normal
finding, all previous available cytologic slides on that patient
shall be reexamined by the clinical laboratory.
   (c) Records of the review of previous slides required by
subdivision (b) shall be maintained by the clinical laboratory,
including the name of the individual performing the earlier
examination.
   (d) A clinical laboratory shall maintain records of all false
positive and false negative cases.
   When any errors in the reporting of a smear evaluation are
discovered, a corrected report shall be immediately sent, when
medically applicable. Copies of corrected reports shall be maintained
in the laboratory records for a period of 10 years.



1275.  The department shall develop and implement regulations for
continuing education for persons licensed pursuant to this chapter on
or before January 1, 1992, after consulting with the
multidisciplinary committee established pursuant to Section 1228, and
other appropriate organizations. On and after January 1, 1994, the
department shall require not more than 12 hours of continuing
education completed within a 12-month period or not more than 24
hours of continuing education completed within a 24-month period as a
condition for renewal of a license issued under this chapter. The
department may establish a fee for the implementation of this
section, the total fees collected not to exceed the total costs to
the program for the implementation of this requirement.


State Codes and Statutes

Statutes > California > Bpc > 1260-1275

BUSINESS AND PROFESSIONS CODE
SECTION 1260-1275



1260.  The department shall issue a clinical laboratory bioanalyst's
license to each person who is a lawful holder of a degree of master
of arts, master of science, or an equivalent or higher degree as
determined by the department with a major in chemical, physical,
biological, or clinical laboratory sciences. This education shall
have been obtained in one or more established and reputable
institutions maintaining standards equivalent, as determined by the
department, to those institutions accredited by the Western
Association of Schools and Colleges or an essentially equivalent
accrediting agency, as determined by the department. The applicant
also shall have a minimum of four years' experience as a licensed
clinical laboratory scientist, performing clinical laboratory work
embracing the various fields of clinical laboratory activity in a
clinical laboratory approved by the department. The quality and
variety of this experience shall be satisfactory to the department
and shall have been obtained within the six-year period immediately
antecedent to admission to the examination. The applicant shall
successfully pass a written examination and an oral examination
conducted by the department or a committee designated by the
department to conduct the examinations, indicating that the applicant
is properly qualified. The department may issue a license without
conducting a written examination to an applicant who has passed a
written examination of a national accrediting board having
requirements that are, in the determination of the department, equal
to or greater than those required by this chapter and regulations
adopted by the department. The department shall establish by
regulation the required courses to be included in the college or
university training.



1260.1.  The department shall issue a histocompatibility laboratory
director's license to each person who meets the qualifications
specified in Section 1209.1.



1260.3.  (a) The department shall issue a medical laboratory
technician license to each person who meets the following
requirements:
   (1) Has met the requirements of this chapter and any reasonable
qualifications established by regulations of the department,
including, but not limited to, any of the following:
   (A) Lawfully holds an associate degree or an equivalent or higher
degree in chemical, physical, biological, or clinical laboratory
science, which includes a minimum of 36 semester units of physical or
biological sciences.
   (B) The completion of 60 semester (90 quarter) units from an
accredited college or university, with 36 semester units in physical
or biological sciences.
   (C) Graduation from a medical laboratory technician training
program accredited by the National Accrediting Agency for Clinical
Laboratory Sciences or other recognized accrediting program approved
by the department.
   (D) Graduation from an advanced military medical laboratory
specialist program approved by the department.
   (2) Has applied for the license on forms provided by the
department.
   (3) Has paid a license fee established in regulations of the
department in accordance with subdivision (v) of Section 1300.
   (b) A licensed medical laboratory technician may perform clinical
laboratory tests or examinations classified as waived or of moderate
complexity under CLIA, and may report the test results. However, a
licensed medical laboratory technician shall not perform microscopic
analysis or immunohematology procedures. The medical laboratory
technician shall work under the supervision of a licensed physician
and surgeon or a baccalaureate, masters, or doctoral level person
licensed pursuant to this chapter. The supervision shall be required
during the entire time a medical laboratory technician performs
clinical laboratory tests or examinations.
   (c) The department shall adopt emergency regulations to implement
this section as soon as possible.



1261.  The department shall issue a clinical laboratory scientist's
or a limited clinical laboratory scientist's license to each person
who is a lawful holder of a baccalaureate or an equivalent or higher
degree, who has applied for the license on forms provided by the
department and has met the requirements of this chapter and any
reasonable qualifications established by regulations of the
department. However, an exception to the degree requirement may be
made by the department for the clinical laboratory scientist's
license only if the applicant for the license has completed a minimum
of two years of experience as a licensed trainee or the equivalent
thereof, as determined by the department, doing clinical laboratory
work embracing the various fields of clinical laboratory activity in
a clinical laboratory approved by the department. In addition, the
applicant applying under this section must have 90 semester hours or
equivalent quarter hours of university or college work or the
equivalent thereof, as may be determined by the department, which
shall have included at least 23 semester hours or equivalent quarter
hours of science courses as specified by regulations of the
department. Additional college or university work that includes
courses in the fundamental sciences may be substituted for one of the
two years of experience in the ratio of 30 semester hours or
equivalent quarter hours for each year of experience. This exception
shall not apply to the limited clinical laboratory scientist's
license. The department shall hold examinations to aid it in judging
the qualifications of applicants. Licenses may be issued in any or
all of the sciences applied in a clinical laboratory as determined by
regulation established by the department. The department shall
establish by regulation the college courses or majors to be included
in the college or university training and the amount and kind of
training or experience required. Examinations, training, or
experience requirements for limited licenses shall cover only the
science concerned. The department may identify by regulation the
appropriate sciences and shall establish the minimum requirements for
training and experience and required courses or major for each.
   Experience as a clinical laboratory technician in any branch of
the armed forces of the United States may be considered equivalent to
the experience as a trainee, if the experience is approved by the
department. Each year of training and experience as a clinical
laboratory technician in the armed forces shall be equivalent to 15
semester hours, which shall be credited to the minimum number of
hours required to qualify for licensure as a trainee. The semester
hours acquired in this manner shall not consist of the science
courses required by the department under this section. The maximum
number of hours granted shall not exceed 60 semester hours or its
equivalent.



1261.5.  The department may issue limited clinical laboratory
scientist's licenses in chemistry, microbiology, toxicology,
histocompatibility, immunohematology, genetic molecular biology,
cytogenetics, or other areas of laboratory specialty or subspecialty
when determined to be necessary by the department in order for
licensure categories to keep abreast of changes in laboratory or
scientific technology. Whenever the department determines that a new
limited clinical laboratory scientist license category is necessary,
it shall adopt regulations identifying the category and the areas of
specialization included within the category.
   To qualify for admission to the examination for a special clinical
laboratory scientist's license, an applicant shall have all the
following:
   (a) Have graduated from a college or university maintaining
standards equivalent, as determined by the department, to those
institutions accredited by the Western Association of Schools and
Colleges or an essentially equivalent accrediting agency with a
baccalaureate or higher degree with a major appropriate to the field
for which a license is being sought.
   (b) Have one year of full-time postgraduate training or experience
in the various areas of analysis in the field for which a license is
being sought in a laboratory that has a license issued under this
chapter or which the department determines is equivalent thereto.
   (c) Whenever a limited clinical laboratory scientist's license is
established for a specific area of specialization, the department may
issue the license without examination to applicants who had met
standards of education and training, defined by regulations, prior to
the date of the adoption of implementing regulations.
   (d) The department shall adopt regulations to implement this
section.


1261.6.  The department may issue a limited clinical laboratory
scientist's license in cytogenetics to any person with a minimum of
seven years of work experience in this state as a cytogenetic
technologist who provides evidence of satisfactory performance on a
written examination administered by the National Credentialing Agency
for Laboratory Personnel on or before December 31, 1991, in the
specialty of cytogenetics, and who meets the federal regulatory
requirements for personnel performing high-complexity testing.



1262.  No clinical laboratory scientist's or limited clinical
laboratory scientist's license shall be issued by the department
except after examination; provided, that a temporary clinical
laboratory scientist's license or a temporary limited clinical
laboratory scientist's license may be issued to an individual who
fulfills the requirements for admission to the examination unless the
individual has failed a previous examination for the license. The
department may issue licenses without examination to applicants who
have passed examinations of the national accrediting boards whose
requirements are equal to or greater than those required by this
chapter and regulations established by the department. The department
may issue licenses without further examination to applicants who
have passed examinations of another state whose laws and regulations
are equal to or greater than those required by this chapter and
regulations established by the department. The evaluation of national
or state accrediting boards for the purposes of this chapter shall
be carried out by the department with assistance of representatives
from the licensed groups. This section shall not apply to persons who
have passed an examination by a national board or another state
examination prior to the establishment of requirements that are equal
to or exceed those of this chapter or the regulations of the
department. The department may, however, make exceptions if
individuals are otherwise qualified.



1262.5.  Notwithstanding Section 135, an applicant for a clinical
laboratory or limited technologist license who fails to pass the
written examination two times shall not be eligible to be reexamined
a third time until at least one year has elapsed from the date of the
second examination. An applicant who fails the third examination
shall not be eligible to take the examination a fourth time until two
years have elapsed from the date of the third examination.
Thereafter, the examination may not be taken more frequently than
once in two years.


1263.  The department shall license as trainees those individuals
desiring to train for either a clinical laboratory scientist's
license or a limited clinical laboratory scientist's license,
providing those individuals meet the academic requirements.
   No trainee license shall be issued unless the applicant has
completed at least 90 semester hours or equivalent quarter hours of
university or college work or the essential equivalent as determined
by the department which must have included at least 23 semester hours
or equivalent quarter hours of courses in the sciences as determined
by regulations of the department. Applicants who have completed
military training schools may be granted academic credit toward
licensure by the department on the basis of recommendations made by
the American Council on Education.
   Applicants shall apply for the license on forms provided by the
department and meet the requirements of this chapter and any
standards as are established by regulations of the department.



1264.  The department shall issue a clinical chemist, clinical
microbiologist, clinical toxicologist, clinical molecular biologist,
or clinical cytogeneticist license to each person who has applied for
the license on forms provided by the department, who is a lawful
holder of a master of science or doctoral degree in the specialty for
which the applicant is seeking a license and who has met such
additional reasonable qualifications of training, education, and
experience as the department may establish by regulations. The
department shall issue an oral and maxillofacial pathologist license
to every applicant for licensure who has applied for the license on
forms provided by the department, who is a registered Diplomate of
the American Board of Oral and Maxillofacial Pathology, and who meets
any additional and reasonable qualifications of training, education,
and experience as the department may establish by regulation.
   (a) The graduate education shall have included 30 semester hours
of coursework in the applicant's specialty. Applicants possessing
only a master of science degree shall have the equivalent of one year
of full-time, directed study or training in procedures and
principles involved in the development, modification or evaluation of
laboratory methods, including training in complex methods applicable
to diagnostic laboratory work. Each applicant must have had one year
of training in his or her specialty in a clinical laboratory
acceptable to the department and three years of experience in his or
her specialty in a clinical laboratory, two years of which must have
been at a supervisory level. The education shall have been obtained
in one or more established and reputable institutions maintaining
standards equivalent, as determined by the department, to those
institutions accredited by an agency acceptable to the department.
The department shall determine by examination that the applicant is
properly qualified. Examinations, training, or experience
requirements for specialty licenses shall cover only the specialty
concerned.
   (b) The department may issue licenses without examination to
applicants who have passed examinations of other states or national
accrediting boards whose requirements are equal to or greater than
those required by this chapter and regulations established by the
department. The evaluation of other state requirements or
requirements of national accrediting boards shall be carried out by
the department with the assistance of representatives from the
licensed groups. This section shall not apply to persons who have
passed an examination by another state or national accrediting board
prior to the establishment of requirements that are equal to or
exceed those of this chapter or regulations of the department.
   (c) The department may issue licenses without examination to
applicants who had met standards of education and training, defined
by regulations, prior to the date of the adoption of implementing
regulations.
   (d) The department shall adopt regulations to conform to this
section.



1265.  (a) (1) A clinical laboratory performing clinical laboratory
tests or examinations classified as of moderate or of high complexity
under CLIA shall obtain a clinical laboratory license pursuant to
this chapter. The department shall issue a clinical laboratory
license to any person who has applied for the license on forms
provided by the department and who is found to be in compliance with
this chapter and the regulations pertaining thereto. No clinical
laboratory license shall be issued by the department unless the
clinical laboratory and its personnel meet the CLIA requirements for
laboratories performing tests or examinations classified as of
moderate or high complexity, or both.
   (2) A clinical laboratory performing clinical laboratory tests or
examinations subject to a certificate of waiver or a certificate of
provider-performed microscopy under CLIA, shall register with the
department. The department shall issue a clinical laboratory
registration to any person who has applied for the registration on
forms provided by the department and is found to be in compliance
with this chapter, the regulations pertaining thereto, and the CLIA
requirements for either a certificate of waiver or a certificate of
provider-performed microscopy.
   (b) An application for a clinical laboratory license or
registration shall include the name or names of the owner or the
owners, the name or names of the laboratory director or directors,
the name and location of the laboratory, a list of the clinical
laboratory tests or examinations performed by the laboratory by name
and total number of test procedures and examinations performed
annually (excluding tests the laboratory may run for quality control,
quality assurance, or proficiency testing purposes). The application
shall also include a list of the tests and the test kits,
methodologies, and laboratory equipment used, and the qualifications
(educational background, training, and experience) of the personnel
directing and supervising the laboratory and performing the
laboratory examinations and test procedures, and any other relevant
information as may be required by the department. If the laboratory
is performing tests subject to a provider-performed microscopy
certificate, the name of the provider or providers performing those
tests shall be included on the application. Application shall be made
by the owners of the laboratory and the laboratory directors prior
to its opening. A license or registration to conduct a clinical
laboratory if the owners are not the laboratory directors shall be
issued jointly to the owners and the laboratory directors and the
license or registration shall include any information as may be
required by the department. The owners and laboratory directors shall
be severally and jointly responsible to the department for the
maintenance and conduct thereof or for any violations of this chapter
and regulations pertaining thereto.
   (c) The department shall not issue a license or registration until
it is satisfied that the clinical laboratory will be operated within
the spirit and intent of this chapter, that the owners and
laboratory directors are each of good moral character, and that the
granting of the license will not be in conflict with the interests of
public health.
   (d) A separate license or registration shall be obtained for each
laboratory location, with the following exceptions:
   (1) Laboratories that are not at a fixed location, that is,
laboratories that move from one testing site to another, such as
mobile units providing laboratory testing, health screening fairs, or
other temporary testing locations, may apply for and obtain one
license or registration for the designated primary site or home base,
using the address of that primary site.
   (2) Not-for-profit, or federal, state, or local government
laboratories that engage in limited (not more than a combination of
15 moderately complex or waived tests, as defined under CLIA, per
license) public health testing may apply for and obtain a single
license or registration.
   (3) Laboratories within a hospital that are located at contiguous
buildings on the same campus and under common direction, may file a
single application or multiple applications for a license or
registration of laboratory locations within the same campus or street
address.
   (4) Locations within a single street and city address that are
under common ownership may apply for and obtain a single license or
registration or multiple licenses or registrations, at the discretion
of the owner or owners.
   (e) (1) A license or registration shall be valid for one year
unless revoked or suspended. A clinical laboratory license or
registration shall be automatically revoked 30 days from a major
change of laboratory directorship or ownership. The clinical
laboratory shall be required to submit a completed application for a
new clinical laboratory license or registration within those 30 days
or cease engaging in clinical laboratory practice.
   (2) If a clinical laboratory intends to continue to engage in
clinical laboratory practice during the 30 days after a major change
in directorship occurs and before the laboratory license or
registration is automatically revoked, the laboratory owner may
appoint an interim director who meets the requirements of this
chapter and CLIA. The interim director shall be appointed within five
business days of the major change of the directorship. Written
notice shall be provided to the department of the appointment of the
laboratory director pursuant to this paragraph within five business
days of the appointment.
   (f) If the department does not within 60 days after the date of
receipt of the application issue a license or registration, it shall
state the grounds and reasons for its refusal in writing, serving a
copy upon the applicant by certified mail addressed to the applicant
at his or her last known address.
   (g) The department shall be notified in writing by the laboratory
owners or delegated representatives of the owners and the laboratory
directors of any change in ownership, directorship, name, or
location, including the addition or deletion of laboratory owners or
laboratory directors within 30 days. However, notice of change in
ownership shall be the responsibility of both the current and new
owners. Laboratory owners and directors to whom the current license
or registration is issued shall remain jointly and severally
responsible to the department for the operation, maintenance, and
conduct of the clinical laboratory and for any violations of this
chapter or the regulations adopted thereunder, including any failure
to provide the notifications required by this subdivision, until
proper notice is received by the department. In addition, failure of
the laboratory owners and directors to notify the department within
30 days of any change in laboratory directors, including any
additions or deletions, shall result in the automatic revocation of
the clinical laboratory's license or registration.
   (h) The withdrawal of an application for a license or registration
or for a renewal of a license, or registration, issuable under this
chapter, shall not, after the application has been filed with the
department, deprive the department of its authority to institute or
continue a proceeding against the applicant for denial of the
license, registration, or renewal upon any ground provided by law or
to enter an order denying the license, registration, or renewal upon
any such ground, unless the department consents in writing to the
withdrawal.
   (i) The suspension, expiration, or forfeiture by operation of law
of a license or registration issued under this chapter, or its
suspension, forfeiture, or cancellation by order of the department or
by order of a court of law, or its surrender without the written
consent of the department, shall not deprive the department of its
authority to institute or continue an action against a license or
registration issued under this chapter or against the laboratory
owner or laboratory director upon any ground provided by law or to
enter an order suspending or revoking the license or registration
issued under this chapter.
   (j) (1) Whenever a clinical laboratory ceases operations, the
laboratory owners, or delegated representatives of the owners, and
the laboratory directors shall notify the department of this fact, in
writing, within 30 calendar days from the date a clinical laboratory
ceases operation. For purposes of this subdivision, a laboratory
ceases operations when it suspends the performance of all clinical
laboratory tests or examinations for 30 calendar days at the location
for which the clinical laboratory is licensed or registered.
   (2) (A) Notwithstanding any other provision of law, owners and
laboratory directors of all clinical laboratories, including those
laboratories that cease operations, shall preserve medical records
and laboratory records, as defined in this section, for three years
from the date of testing, examination, or purchase, unless a longer
retention period is required pursuant to any other provision of law,
and shall maintain an ability to provide those records when requested
by the department or any duly authorized representative of the
department.
   (B) For purposes of this subdivision, "medical records" means the
test requisition or test authorization, or the patient's chart or
medical record, if used as the test requisition, the final and
preliminary test or examination result, and the name of the person
contacted if the laboratory test or examination result indicated an
imminent life-threatening result or was of panic value.
   (C) For purposes of this subdivision, "laboratory records" means
records showing compliance with CLIA and this chapter during a
laboratory's operation that are actual or true copies, either
photocopies or electronically reproducible copies, of records for
patient test management, quality control, quality assurance, and all
invoices documenting the purchase or lease of laboratory equipment
and test kits, reagents, or media.
   (D) Information contained in medical records and laboratory
records shall be confidential, and shall be disclosed only to
authorized persons in accordance with federal, state, and local laws.
   (3) The department or any person injured as a result of a
laboratory's abandonment or failure to retain records pursuant to
this section may bring an action in a court of proper jurisdiction
for any reasonable amount of damages suffered as a result thereof.



1265.1.  (a) A primary care clinic that submits an application to
the State Department of Public Health for clinic licensure pursuant
to subdivision (a) of Section 1204 of the Health and Safety Code may
submit prior to that submission, or concurrent therewith, an
application for licensure or registration of a clinical laboratory to
be operated by the clinic.
   (b) An application for licensure of a clinical laboratory
submitted pursuant to this section shall be subject to all applicable
laboratory licensing laws and regulations, including, but not
limited to, any statutory or regulatory timelines and processes for
review of a clinical laboratory application.



1266.  The clinical laboratory license and the license or current
renewal permit of each person performing tests shall be conspicuously
posted in the clinical laboratory.



1267.  Any denial, suspension, or revocation of a license under this
chapter shall be conducted in compliance with Section 100171 of the
Health and Safety Code.



1268.  Upon filing application therefor, containing such information
as the department may require, and the payment of the license fee,
the department shall issue to any person duly licensed under this
chapter a duplicate license for one previously issued or, where there
has been a change of name, another license in lieu of one previously
issued.



1269.  (a) Unlicensed laboratory personnel may perform any of the
activities identified in subdivision (b), in a licensed clinical
laboratory, under the direct and constant supervision of a physician
and surgeon, or a person licensed under this chapter other than a
trainee, upon meeting all of the following criteria:
   (1) Have earned a high school diploma, or its equivalent, as
determined by HCFA under CLIA.
   (2) Have documentation of training appropriate to ensure that the
individual has all of the following skills and abilities:
   (A) The skills required for proper specimen collection, including
patient preparation, labeling, handling, preservation or fixation,
processing or preparation, and transportation and storage of
specimens.
   (B) The skills required for assisting a licensed physician and
surgeon or personnel licensed under this chapter, other than
trainees, in a licensed clinical laboratory.
   (C) The skills required for performing preventive maintenance, and
troubleshooting.
   (D) A working knowledge of reagent stability and storage.
   (E) The skills required for assisting in the performance of
quality control procedures, and an understanding of the quality
control policies of the laboratory.
   (F) An awareness of the factors that influence test results.
   (b) The activities that may be performed are:
   (1) Biological specimen collection, including patient preparation,
labeling, handling, preservation or fixation, processing or
preparation, and transportation and storage of specimens.
   (2) Assisting a licensed physician and surgeon or personnel
licensed under this chapter, other than trainees, in a licensed
clinical laboratory.
   (3) Assisting in preventive maintenance, and troubleshooting.
   (4) Preparation and storage of reagents and culture media.
   (5) Assisting in the performance of quality control procedures.
   (c) Notwithstanding subdivision (a), unlicensed laboratory
personnel, other than a trainee, may, under the supervision and
control of a physician and surgeon or person licensed under this
chapter, perform specimen labeling, handling, preservation or
fixation, processing or preparation, transportation, and storing if
he or she meets the requirements of subparagraph (A) of paragraph (2)
of, and paragraph (1) of, subdivision (a).
   (d) Unlicensed laboratory personnel shall not do any of the
following:
   (1) Record test results, but he or she may transcribe results that
have been previously recorded, either manually by a physician and
surgeon or personnel licensed under this chapter, or automatically by
a testing instrument.
   (2) Perform any test or part thereof that involves the
quantitative measurement of the specimen or test reagent, or any
mathematical calculation relative to determining the results or the
validity of a test procedure.
   (3) Perform any phase of clinical laboratory tests or examinations
in the specialty of immunohematology beyond initial collection and
centrifugation.
   (e) When any of the following manual methods are employed, the
activities of unlicensed laboratory personnel shall be limited as
follows:
   (1) In the case of qualitative and semi-quantitative "spot,
tablet, or stick" tests, the personnel may add the test reagent to
the specimen or vice versa, but the results must be read by a
physician and surgeon or person licensed under this chapter.
   (2) In the case of microbiological tests the unlicensed laboratory
personnel may make primary inoculations of test material onto
appropriate culture media, stain slide preparations for microscopic
examination, and subculture from liquid media.
   (f) When any of the following mechanical or electronic instruments
are employed, unlicensed laboratory personnel shall not perform any
of the following activities:
   (1) Standardizing or calibrating the instrument or assessing its
performance by monitoring results of appropriate standards and
control.
   (2) Reading or recording test results, except that the personnel
may transcribe results that have been previously recorded
automatically by a testing instrument.
   (3) Quantitatively measuring any sample or reagents unless done
automatically by the instrument in the course of its normal operation
or by the use of previously calibrated and approved automatic
syringes or other dispensers.



1269.3.  (a) Notwithstanding Sections 1206.5 and 1269, within the
specialty of pathology, a person certified as a pathologists'
assistant by the American Association of Pathologists' Assistants,
the Board of Registry of the American Society for Clinical Pathology,
or another national accrediting agency approved by the department,
who demonstrates competency to perform all job duties and
responsibilities before an assignment to those duties and
responsibilities, at the completion of six months of performing those
duties and responsibilities, and annually thereafter, may perform
the following activities under the supervision and control of a
pathologist:
   (1) Prepare human surgical specimens for gross description and
dissection, including, but not limited to, description of gross
features and selection of tissues for histological examination.
   (2) Prepare and perform human postmortem examinations, including,
but not limited to, selection of tissues and fluids for further
examination.
   (3) Gather other information necessary for an autopsy report.
   (4) Prepare a body for release.
   (b) Notwithstanding Section 1206.5 or subdivisions (b), (c), and
(d) of Section 1269, the following persons may prepare human surgical
specimens for gross description and dissection under the direct
supervision of a qualified pathologist, including, description of
gross features and selection of tissues for histological examination,
if they meet the requirements specified in subdivision (a) of
Section 1269 and the minimum education and training requirements for
high complexity testing personnel under the CLIA:
   (1) A pathologists' assistant who does not meet the certification
requirements of subdivision (a).
   (2) A histologic technician.
   (3) A histotechnologist.
   (c) For the purposes of subdivision (b), direct supervision means
that a qualified pathologist shall be physically present onsite in
the vicinity of the clinical laboratory where the specialty of
pathology is performed and shall be available for consultation and
direction during the time the personnel specified in subdivision (b)
are engaged in the processing of specimens that involve dissection.
For tissue processing that does not involve dissection, a qualified
pathologist may be available by telephone or other electronic means.
   (d) A histologic technician or histotechnologist who meets the
requirements specified in subdivision (a) of Section 1269, may
accession specimens, perform maintenance of equipment, stain, cover
slip, label slides, and process tissues by embedding in paraffin or
performing microtomy.
   (e) On and after January 1, 2011, the department may adopt
regulations establishing additional qualification requirements to
perform the duties described in this section.



1269.5.  The department may deny, suspend, or revoke any license,
registration, or certificate issued under this chapter for
performance by unlicensed laboratory personnel of any activity that
is not authorized by Section 1269.


1270.  (a) On and after January 1, 1991, no person may perform
examinations of cytological slides without first obtaining a license
as a cytotechnologist from the department, except that those persons
employed by licensed clinical laboratories as cytotechnologists and
certified as cytotechnologists by the department on or before January
1, 1991, shall be licensed by the department on or before January 1,
1993. Cytotechnologist licenses shall be issued and renewed by the
department for periods of two years. This subdivision shall not apply
to persons holding a valid, unrevoked, unsuspended physician's and
surgeon's certificate issued pursuant to Chapter 5 (commencing with
Section 2000).
   (b) The issuance of a cytotechnologist license shall be contingent
upon the applicant's satisfactory performance, as defined in
regulation, in a competency testing program for cytotechnologists
which may be administered by the department or by a competency
testing service or program approved by the department. The competency
testing program established pursuant to this section shall be
periodically reviewed and revised by the department, if necessary, to
ensure that the program is consistent with federal competency
testing requirements issued under the Clinical Laboratory Improvement
Amendments of 1988 (P.L. 100-578; 42 U.S.C. Sec. 263a, Section 353
of the Public Health Service Act).
   (c) Notwithstanding subdivision (b), the department may issue a
temporary cytotechnologist's license to a person who satisfies the
requirements for admission to the examination unless the person has
failed a previous examination for a cytotechnologist's license. A
temporary license issued by the department pursuant to this
subdivision shall be valid for a period of time not exceeding 90 days
after the date the department has adopted a competency testing
program pursuant to subdivision (b).
   (d) The department may issue a cytotechnologist's license without
examination to an applicant who satisfies one of the following:
   (1) Passage of an examination of a national accrediting board
whose requirements are equal to or greater than those required by
this chapter or by regulations adopted pursuant to this chapter, as
determined by the department.
   (2) Passage of an examination of another state in which the
requirements imposed by laws and regulations regarding the
examination are equal to or greater than those required by this
chapter or by regulations adopted pursuant to this chapter, as
determined by the department.
   This subdivision shall not apply to a person who has passed an
examination of a national accrediting board or another state prior to
that board's or state's establishment of requirements which are
equal to or greater than those required by this chapter or by
regulations adopted pursuant to this chapter, as determined by the
department. The department may, however, make exceptions to the
requirements of this subdivision in cases where the department
determines that the applicant is otherwise qualified for licensure.
   (e) The department shall not issue any temporary cytotechnologist'
s license pursuant to subdivision (c) or any cytotechnologist's
license without examination pursuant to subdivision (d) after the
department adopts a competency testing program pursuant to
subdivision (b).


1270.5.  (a) Notwithstanding Section 1301, an application for the
renewal of, and payment of the renewal fees for, a cytotechnologist
license shall be governed by this section.
   (b) Application for renewal of a cytotechnologist license,
accompanied by the fee set forth in Section 1300, shall be filed with
the department not less than 30 days prior to the expiration date.
   (c) If the renewal fee is not paid during the 30 days prior to the
expiration date, the license shall automatically expire at midnight
on the expiration date. However, a cytotechnologist who has failed to
timely pay a renewal fee may have his or her license reinstated,
without completing a competency testing program, provided that he or
she mails to the department a written request for reinstatement
postmarked no later than the 60th day after the expiration date of
the license and a reinstatement fee equal to two times the annual
renewal fee set forth in Section 1300. The license shall be
reinstated on the date the request for reinstatement and fee are
received by the department. If the request for reinstatement and fee
are received prior to the expiration date of the license, there shall
be no lapse in licensure. No cytotechnologist shall perform services
for which a license or certification is required under this chapter
during any period for which licensure or certification has lapsed.




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.
   (l) 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.



1271.1.  (a) Clinical laboratories which are licensed pursuant to
this chapter and provide cytology services shall, if the licensee
ceases operation, preserve records, reports, cytology slides, and
cell blocks as prescribed in subdivision (g) of Section 1271 and
Section 1274.
   (b) Any person injured as a result of the licensee's abandonment
of records may bring an action in any court of competent jurisdiction
for the amount of any damages suffered as a result. In the event the
licensee was a corporation or partnership which has been dissolved,
the person injured may bring an action against that corporation's or
partnership's principal officers of record at the time of the
dissolution.
   (c) For purposes of this section, the following definitions shall
apply:
   (1) "Abandonment of records" means violating subdivision (a) and
thereby leaving patients and physicians and surgeons without access
to information to which they are entitled pursuant to this chapter.
   (2) "Principal officers" means:
   (A) In the case of a partnership other than a limited partnership,
any partner.
   (B) In the case of a limited partnership, any general partner, as
defined in subdivision (i) of Section 15611 of the Corporations Code.
   (C) In the case of a corporation, the chairperson of the board,
the chief executive officer, and the president of the corporation.




1272.  A clinical laboratory shall participate in a state-approved
proficiency testing program and demonstrate satisfactory performance
in all of the laboratory specialities that include tests performed in
the laboratory. Proficiency shall be tested in the following
specialties: microbiology, serology, clinical chemistry, hematology,
cytology, and immunohematology.



1272.4.  The department shall establish standards for the evaluation
of cytologic slides, for reporting the adequacy of cytologic slides,
for a cytotechnologist competency program, and for a proficiency
testing program for clinical laboratories providing cytology
services.



1272.6.  The department shall, on or before January 1, 1992, develop
or adopt a proficiency testing program for laboratories providing
cytology services which may be administered by the department or by a
proficiency testing service or program approved by the department.
The proficiency program established pursuant to this section shall
include announced and unannounced onsite proficiency testing, with
that testing to take place, to the extent practicable, under normal
working conditions.



1274.  (a) A laboratory shall document to persons submitting
cytologic samples for evaluation, on a quarterly basis, informational
letters on all cases of HSIL (high-grade squamous intraepithelial
lesions), adenocarcinoma, or other malignant neoplasm. Documentation
may consist of followup correspondence, telephone calls, or requests
included in the report. Copies of that documentation, and any
responses received to those letters, shall be maintained on file by
the laboratories for a period of five years.
   (b) Whenever it becomes known to a clinical laboratory that an
abnormality of HSIL (high-grade squamous intraepithelial lesions,
adenocarcinoma, or other malignant neoplasm) has been identified for
a patient for whom the clinical laboratory earlier reported a normal
finding, all previous available cytologic slides on that patient
shall be reexamined by the clinical laboratory.
   (c) Records of the review of previous slides required by
subdivision (b) shall be maintained by the clinical laboratory,
including the name of the individual performing the earlier
examination.
   (d) A clinical laboratory shall maintain records of all false
positive and false negative cases.
   When any errors in the reporting of a smear evaluation are
discovered, a corrected report shall be immediately sent, when
medically applicable. Copies of corrected reports shall be maintained
in the laboratory records for a period of 10 years.



1275.  The department shall develop and implement regulations for
continuing education for persons licensed pursuant to this chapter on
or before January 1, 1992, after consulting with the
multidisciplinary committee established pursuant to Section 1228, and
other appropriate organizations. On and after January 1, 1994, the
department shall require not more than 12 hours of continuing
education completed within a 12-month period or not more than 24
hours of continuing education completed within a 24-month period as a
condition for renewal of a license issued under this chapter. The
department may establish a fee for the implementation of this
section, the total fees collected not to exceed the total costs to
the program for the implementation of this requirement.



State Codes and Statutes

State Codes and Statutes

Statutes > California > Bpc > 1260-1275

BUSINESS AND PROFESSIONS CODE
SECTION 1260-1275



1260.  The department shall issue a clinical laboratory bioanalyst's
license to each person who is a lawful holder of a degree of master
of arts, master of science, or an equivalent or higher degree as
determined by the department with a major in chemical, physical,
biological, or clinical laboratory sciences. This education shall
have been obtained in one or more established and reputable
institutions maintaining standards equivalent, as determined by the
department, to those institutions accredited by the Western
Association of Schools and Colleges or an essentially equivalent
accrediting agency, as determined by the department. The applicant
also shall have a minimum of four years' experience as a licensed
clinical laboratory scientist, performing clinical laboratory work
embracing the various fields of clinical laboratory activity in a
clinical laboratory approved by the department. The quality and
variety of this experience shall be satisfactory to the department
and shall have been obtained within the six-year period immediately
antecedent to admission to the examination. The applicant shall
successfully pass a written examination and an oral examination
conducted by the department or a committee designated by the
department to conduct the examinations, indicating that the applicant
is properly qualified. The department may issue a license without
conducting a written examination to an applicant who has passed a
written examination of a national accrediting board having
requirements that are, in the determination of the department, equal
to or greater than those required by this chapter and regulations
adopted by the department. The department shall establish by
regulation the required courses to be included in the college or
university training.



1260.1.  The department shall issue a histocompatibility laboratory
director's license to each person who meets the qualifications
specified in Section 1209.1.



1260.3.  (a) The department shall issue a medical laboratory
technician license to each person who meets the following
requirements:
   (1) Has met the requirements of this chapter and any reasonable
qualifications established by regulations of the department,
including, but not limited to, any of the following:
   (A) Lawfully holds an associate degree or an equivalent or higher
degree in chemical, physical, biological, or clinical laboratory
science, which includes a minimum of 36 semester units of physical or
biological sciences.
   (B) The completion of 60 semester (90 quarter) units from an
accredited college or university, with 36 semester units in physical
or biological sciences.
   (C) Graduation from a medical laboratory technician training
program accredited by the National Accrediting Agency for Clinical
Laboratory Sciences or other recognized accrediting program approved
by the department.
   (D) Graduation from an advanced military medical laboratory
specialist program approved by the department.
   (2) Has applied for the license on forms provided by the
department.
   (3) Has paid a license fee established in regulations of the
department in accordance with subdivision (v) of Section 1300.
   (b) A licensed medical laboratory technician may perform clinical
laboratory tests or examinations classified as waived or of moderate
complexity under CLIA, and may report the test results. However, a
licensed medical laboratory technician shall not perform microscopic
analysis or immunohematology procedures. The medical laboratory
technician shall work under the supervision of a licensed physician
and surgeon or a baccalaureate, masters, or doctoral level person
licensed pursuant to this chapter. The supervision shall be required
during the entire time a medical laboratory technician performs
clinical laboratory tests or examinations.
   (c) The department shall adopt emergency regulations to implement
this section as soon as possible.



1261.  The department shall issue a clinical laboratory scientist's
or a limited clinical laboratory scientist's license to each person
who is a lawful holder of a baccalaureate or an equivalent or higher
degree, who has applied for the license on forms provided by the
department and has met the requirements of this chapter and any
reasonable qualifications established by regulations of the
department. However, an exception to the degree requirement may be
made by the department for the clinical laboratory scientist's
license only if the applicant for the license has completed a minimum
of two years of experience as a licensed trainee or the equivalent
thereof, as determined by the department, doing clinical laboratory
work embracing the various fields of clinical laboratory activity in
a clinical laboratory approved by the department. In addition, the
applicant applying under this section must have 90 semester hours or
equivalent quarter hours of university or college work or the
equivalent thereof, as may be determined by the department, which
shall have included at least 23 semester hours or equivalent quarter
hours of science courses as specified by regulations of the
department. Additional college or university work that includes
courses in the fundamental sciences may be substituted for one of the
two years of experience in the ratio of 30 semester hours or
equivalent quarter hours for each year of experience. This exception
shall not apply to the limited clinical laboratory scientist's
license. The department shall hold examinations to aid it in judging
the qualifications of applicants. Licenses may be issued in any or
all of the sciences applied in a clinical laboratory as determined by
regulation established by the department. The department shall
establish by regulation the college courses or majors to be included
in the college or university training and the amount and kind of
training or experience required. Examinations, training, or
experience requirements for limited licenses shall cover only the
science concerned. The department may identify by regulation the
appropriate sciences and shall establish the minimum requirements for
training and experience and required courses or major for each.
   Experience as a clinical laboratory technician in any branch of
the armed forces of the United States may be considered equivalent to
the experience as a trainee, if the experience is approved by the
department. Each year of training and experience as a clinical
laboratory technician in the armed forces shall be equivalent to 15
semester hours, which shall be credited to the minimum number of
hours required to qualify for licensure as a trainee. The semester
hours acquired in this manner shall not consist of the science
courses required by the department under this section. The maximum
number of hours granted shall not exceed 60 semester hours or its
equivalent.



1261.5.  The department may issue limited clinical laboratory
scientist's licenses in chemistry, microbiology, toxicology,
histocompatibility, immunohematology, genetic molecular biology,
cytogenetics, or other areas of laboratory specialty or subspecialty
when determined to be necessary by the department in order for
licensure categories to keep abreast of changes in laboratory or
scientific technology. Whenever the department determines that a new
limited clinical laboratory scientist license category is necessary,
it shall adopt regulations identifying the category and the areas of
specialization included within the category.
   To qualify for admission to the examination for a special clinical
laboratory scientist's license, an applicant shall have all the
following:
   (a) Have graduated from a college or university maintaining
standards equivalent, as determined by the department, to those
institutions accredited by the Western Association of Schools and
Colleges or an essentially equivalent accrediting agency with a
baccalaureate or higher degree with a major appropriate to the field
for which a license is being sought.
   (b) Have one year of full-time postgraduate training or experience
in the various areas of analysis in the field for which a license is
being sought in a laboratory that has a license issued under this
chapter or which the department determines is equivalent thereto.
   (c) Whenever a limited clinical laboratory scientist's license is
established for a specific area of specialization, the department may
issue the license without examination to applicants who had met
standards of education and training, defined by regulations, prior to
the date of the adoption of implementing regulations.
   (d) The department shall adopt regulations to implement this
section.


1261.6.  The department may issue a limited clinical laboratory
scientist's license in cytogenetics to any person with a minimum of
seven years of work experience in this state as a cytogenetic
technologist who provides evidence of satisfactory performance on a
written examination administered by the National Credentialing Agency
for Laboratory Personnel on or before December 31, 1991, in the
specialty of cytogenetics, and who meets the federal regulatory
requirements for personnel performing high-complexity testing.



1262.  No clinical laboratory scientist's or limited clinical
laboratory scientist's license shall be issued by the department
except after examination; provided, that a temporary clinical
laboratory scientist's license or a temporary limited clinical
laboratory scientist's license may be issued to an individual who
fulfills the requirements for admission to the examination unless the
individual has failed a previous examination for the license. The
department may issue licenses without examination to applicants who
have passed examinations of the national accrediting boards whose
requirements are equal to or greater than those required by this
chapter and regulations established by the department. The department
may issue licenses without further examination to applicants who
have passed examinations of another state whose laws and regulations
are equal to or greater than those required by this chapter and
regulations established by the department. The evaluation of national
or state accrediting boards for the purposes of this chapter shall
be carried out by the department with assistance of representatives
from the licensed groups. This section shall not apply to persons who
have passed an examination by a national board or another state
examination prior to the establishment of requirements that are equal
to or exceed those of this chapter or the regulations of the
department. The department may, however, make exceptions if
individuals are otherwise qualified.



1262.5.  Notwithstanding Section 135, an applicant for a clinical
laboratory or limited technologist license who fails to pass the
written examination two times shall not be eligible to be reexamined
a third time until at least one year has elapsed from the date of the
second examination. An applicant who fails the third examination
shall not be eligible to take the examination a fourth time until two
years have elapsed from the date of the third examination.
Thereafter, the examination may not be taken more frequently than
once in two years.


1263.  The department shall license as trainees those individuals
desiring to train for either a clinical laboratory scientist's
license or a limited clinical laboratory scientist's license,
providing those individuals meet the academic requirements.
   No trainee license shall be issued unless the applicant has
completed at least 90 semester hours or equivalent quarter hours of
university or college work or the essential equivalent as determined
by the department which must have included at least 23 semester hours
or equivalent quarter hours of courses in the sciences as determined
by regulations of the department. Applicants who have completed
military training schools may be granted academic credit toward
licensure by the department on the basis of recommendations made by
the American Council on Education.
   Applicants shall apply for the license on forms provided by the
department and meet the requirements of this chapter and any
standards as are established by regulations of the department.



1264.  The department shall issue a clinical chemist, clinical
microbiologist, clinical toxicologist, clinical molecular biologist,
or clinical cytogeneticist license to each person who has applied for
the license on forms provided by the department, who is a lawful
holder of a master of science or doctoral degree in the specialty for
which the applicant is seeking a license and who has met such
additional reasonable qualifications of training, education, and
experience as the department may establish by regulations. The
department shall issue an oral and maxillofacial pathologist license
to every applicant for licensure who has applied for the license on
forms provided by the department, who is a registered Diplomate of
the American Board of Oral and Maxillofacial Pathology, and who meets
any additional and reasonable qualifications of training, education,
and experience as the department may establish by regulation.
   (a) The graduate education shall have included 30 semester hours
of coursework in the applicant's specialty. Applicants possessing
only a master of science degree shall have the equivalent of one year
of full-time, directed study or training in procedures and
principles involved in the development, modification or evaluation of
laboratory methods, including training in complex methods applicable
to diagnostic laboratory work. Each applicant must have had one year
of training in his or her specialty in a clinical laboratory
acceptable to the department and three years of experience in his or
her specialty in a clinical laboratory, two years of which must have
been at a supervisory level. The education shall have been obtained
in one or more established and reputable institutions maintaining
standards equivalent, as determined by the department, to those
institutions accredited by an agency acceptable to the department.
The department shall determine by examination that the applicant is
properly qualified. Examinations, training, or experience
requirements for specialty licenses shall cover only the specialty
concerned.
   (b) The department may issue licenses without examination to
applicants who have passed examinations of other states or national
accrediting boards whose requirements are equal to or greater than
those required by this chapter and regulations established by the
department. The evaluation of other state requirements or
requirements of national accrediting boards shall be carried out by
the department with the assistance of representatives from the
licensed groups. This section shall not apply to persons who have
passed an examination by another state or national accrediting board
prior to the establishment of requirements that are equal to or
exceed those of this chapter or regulations of the department.
   (c) The department may issue licenses without examination to
applicants who had met standards of education and training, defined
by regulations, prior to the date of the adoption of implementing
regulations.
   (d) The department shall adopt regulations to conform to this
section.



1265.  (a) (1) A clinical laboratory performing clinical laboratory
tests or examinations classified as of moderate or of high complexity
under CLIA shall obtain a clinical laboratory license pursuant to
this chapter. The department shall issue a clinical laboratory
license to any person who has applied for the license on forms
provided by the department and who is found to be in compliance with
this chapter and the regulations pertaining thereto. No clinical
laboratory license shall be issued by the department unless the
clinical laboratory and its personnel meet the CLIA requirements for
laboratories performing tests or examinations classified as of
moderate or high complexity, or both.
   (2) A clinical laboratory performing clinical laboratory tests or
examinations subject to a certificate of waiver or a certificate of
provider-performed microscopy under CLIA, shall register with the
department. The department shall issue a clinical laboratory
registration to any person who has applied for the registration on
forms provided by the department and is found to be in compliance
with this chapter, the regulations pertaining thereto, and the CLIA
requirements for either a certificate of waiver or a certificate of
provider-performed microscopy.
   (b) An application for a clinical laboratory license or
registration shall include the name or names of the owner or the
owners, the name or names of the laboratory director or directors,
the name and location of the laboratory, a list of the clinical
laboratory tests or examinations performed by the laboratory by name
and total number of test procedures and examinations performed
annually (excluding tests the laboratory may run for quality control,
quality assurance, or proficiency testing purposes). The application
shall also include a list of the tests and the test kits,
methodologies, and laboratory equipment used, and the qualifications
(educational background, training, and experience) of the personnel
directing and supervising the laboratory and performing the
laboratory examinations and test procedures, and any other relevant
information as may be required by the department. If the laboratory
is performing tests subject to a provider-performed microscopy
certificate, the name of the provider or providers performing those
tests shall be included on the application. Application shall be made
by the owners of the laboratory and the laboratory directors prior
to its opening. A license or registration to conduct a clinical
laboratory if the owners are not the laboratory directors shall be
issued jointly to the owners and the laboratory directors and the
license or registration shall include any information as may be
required by the department. The owners and laboratory directors shall
be severally and jointly responsible to the department for the
maintenance and conduct thereof or for any violations of this chapter
and regulations pertaining thereto.
   (c) The department shall not issue a license or registration until
it is satisfied that the clinical laboratory will be operated within
the spirit and intent of this chapter, that the owners and
laboratory directors are each of good moral character, and that the
granting of the license will not be in conflict with the interests of
public health.
   (d) A separate license or registration shall be obtained for each
laboratory location, with the following exceptions:
   (1) Laboratories that are not at a fixed location, that is,
laboratories that move from one testing site to another, such as
mobile units providing laboratory testing, health screening fairs, or
other temporary testing locations, may apply for and obtain one
license or registration for the designated primary site or home base,
using the address of that primary site.
   (2) Not-for-profit, or federal, state, or local government
laboratories that engage in limited (not more than a combination of
15 moderately complex or waived tests, as defined under CLIA, per
license) public health testing may apply for and obtain a single
license or registration.
   (3) Laboratories within a hospital that are located at contiguous
buildings on the same campus and under common direction, may file a
single application or multiple applications for a license or
registration of laboratory locations within the same campus or street
address.
   (4) Locations within a single street and city address that are
under common ownership may apply for and obtain a single license or
registration or multiple licenses or registrations, at the discretion
of the owner or owners.
   (e) (1) A license or registration shall be valid for one year
unless revoked or suspended. A clinical laboratory license or
registration shall be automatically revoked 30 days from a major
change of laboratory directorship or ownership. The clinical
laboratory shall be required to submit a completed application for a
new clinical laboratory license or registration within those 30 days
or cease engaging in clinical laboratory practice.
   (2) If a clinical laboratory intends to continue to engage in
clinical laboratory practice during the 30 days after a major change
in directorship occurs and before the laboratory license or
registration is automatically revoked, the laboratory owner may
appoint an interim director who meets the requirements of this
chapter and CLIA. The interim director shall be appointed within five
business days of the major change of the directorship. Written
notice shall be provided to the department of the appointment of the
laboratory director pursuant to this paragraph within five business
days of the appointment.
   (f) If the department does not within 60 days after the date of
receipt of the application issue a license or registration, it shall
state the grounds and reasons for its refusal in writing, serving a
copy upon the applicant by certified mail addressed to the applicant
at his or her last known address.
   (g) The department shall be notified in writing by the laboratory
owners or delegated representatives of the owners and the laboratory
directors of any change in ownership, directorship, name, or
location, including the addition or deletion of laboratory owners or
laboratory directors within 30 days. However, notice of change in
ownership shall be the responsibility of both the current and new
owners. Laboratory owners and directors to whom the current license
or registration is issued shall remain jointly and severally
responsible to the department for the operation, maintenance, and
conduct of the clinical laboratory and for any violations of this
chapter or the regulations adopted thereunder, including any failure
to provide the notifications required by this subdivision, until
proper notice is received by the department. In addition, failure of
the laboratory owners and directors to notify the department within
30 days of any change in laboratory directors, including any
additions or deletions, shall result in the automatic revocation of
the clinical laboratory's license or registration.
   (h) The withdrawal of an application for a license or registration
or for a renewal of a license, or registration, issuable under this
chapter, shall not, after the application has been filed with the
department, deprive the department of its authority to institute or
continue a proceeding against the applicant for denial of the
license, registration, or renewal upon any ground provided by law or
to enter an order denying the license, registration, or renewal upon
any such ground, unless the department consents in writing to the
withdrawal.
   (i) The suspension, expiration, or forfeiture by operation of law
of a license or registration issued under this chapter, or its
suspension, forfeiture, or cancellation by order of the department or
by order of a court of law, or its surrender without the written
consent of the department, shall not deprive the department of its
authority to institute or continue an action against a license or
registration issued under this chapter or against the laboratory
owner or laboratory director upon any ground provided by law or to
enter an order suspending or revoking the license or registration
issued under this chapter.
   (j) (1) Whenever a clinical laboratory ceases operations, the
laboratory owners, or delegated representatives of the owners, and
the laboratory directors shall notify the department of this fact, in
writing, within 30 calendar days from the date a clinical laboratory
ceases operation. For purposes of this subdivision, a laboratory
ceases operations when it suspends the performance of all clinical
laboratory tests or examinations for 30 calendar days at the location
for which the clinical laboratory is licensed or registered.
   (2) (A) Notwithstanding any other provision of law, owners and
laboratory directors of all clinical laboratories, including those
laboratories that cease operations, shall preserve medical records
and laboratory records, as defined in this section, for three years
from the date of testing, examination, or purchase, unless a longer
retention period is required pursuant to any other provision of law,
and shall maintain an ability to provide those records when requested
by the department or any duly authorized representative of the
department.
   (B) For purposes of this subdivision, "medical records" means the
test requisition or test authorization, or the patient's chart or
medical record, if used as the test requisition, the final and
preliminary test or examination result, and the name of the person
contacted if the laboratory test or examination result indicated an
imminent life-threatening result or was of panic value.
   (C) For purposes of this subdivision, "laboratory records" means
records showing compliance with CLIA and this chapter during a
laboratory's operation that are actual or true copies, either
photocopies or electronically reproducible copies, of records for
patient test management, quality control, quality assurance, and all
invoices documenting the purchase or lease of laboratory equipment
and test kits, reagents, or media.
   (D) Information contained in medical records and laboratory
records shall be confidential, and shall be disclosed only to
authorized persons in accordance with federal, state, and local laws.
   (3) The department or any person injured as a result of a
laboratory's abandonment or failure to retain records pursuant to
this section may bring an action in a court of proper jurisdiction
for any reasonable amount of damages suffered as a result thereof.



1265.1.  (a) A primary care clinic that submits an application to
the State Department of Public Health for clinic licensure pursuant
to subdivision (a) of Section 1204 of the Health and Safety Code may
submit prior to that submission, or concurrent therewith, an
application for licensure or registration of a clinical laboratory to
be operated by the clinic.
   (b) An application for licensure of a clinical laboratory
submitted pursuant to this section shall be subject to all applicable
laboratory licensing laws and regulations, including, but not
limited to, any statutory or regulatory timelines and processes for
review of a clinical laboratory application.



1266.  The clinical laboratory license and the license or current
renewal permit of each person performing tests shall be conspicuously
posted in the clinical laboratory.



1267.  Any denial, suspension, or revocation of a license under this
chapter shall be conducted in compliance with Section 100171 of the
Health and Safety Code.



1268.  Upon filing application therefor, containing such information
as the department may require, and the payment of the license fee,
the department shall issue to any person duly licensed under this
chapter a duplicate license for one previously issued or, where there
has been a change of name, another license in lieu of one previously
issued.



1269.  (a) Unlicensed laboratory personnel may perform any of the
activities identified in subdivision (b), in a licensed clinical
laboratory, under the direct and constant supervision of a physician
and surgeon, or a person licensed under this chapter other than a
trainee, upon meeting all of the following criteria:
   (1) Have earned a high school diploma, or its equivalent, as
determined by HCFA under CLIA.
   (2) Have documentation of training appropriate to ensure that the
individual has all of the following skills and abilities:
   (A) The skills required for proper specimen collection, including
patient preparation, labeling, handling, preservation or fixation,
processing or preparation, and transportation and storage of
specimens.
   (B) The skills required for assisting a licensed physician and
surgeon or personnel licensed under this chapter, other than
trainees, in a licensed clinical laboratory.
   (C) The skills required for performing preventive maintenance, and
troubleshooting.
   (D) A working knowledge of reagent stability and storage.
   (E) The skills required for assisting in the performance of
quality control procedures, and an understanding of the quality
control policies of the laboratory.
   (F) An awareness of the factors that influence test results.
   (b) The activities that may be performed are:
   (1) Biological specimen collection, including patient preparation,
labeling, handling, preservation or fixation, processing or
preparation, and transportation and storage of specimens.
   (2) Assisting a licensed physician and surgeon or personnel
licensed under this chapter, other than trainees, in a licensed
clinical laboratory.
   (3) Assisting in preventive maintenance, and troubleshooting.
   (4) Preparation and storage of reagents and culture media.
   (5) Assisting in the performance of quality control procedures.
   (c) Notwithstanding subdivision (a), unlicensed laboratory
personnel, other than a trainee, may, under the supervision and
control of a physician and surgeon or person licensed under this
chapter, perform specimen labeling, handling, preservation or
fixation, processing or preparation, transportation, and storing if
he or she meets the requirements of subparagraph (A) of paragraph (2)
of, and paragraph (1) of, subdivision (a).
   (d) Unlicensed laboratory personnel shall not do any of the
following:
   (1) Record test results, but he or she may transcribe results that
have been previously recorded, either manually by a physician and
surgeon or personnel licensed under this chapter, or automatically by
a testing instrument.
   (2) Perform any test or part thereof that involves the
quantitative measurement of the specimen or test reagent, or any
mathematical calculation relative to determining the results or the
validity of a test procedure.
   (3) Perform any phase of clinical laboratory tests or examinations
in the specialty of immunohematology beyond initial collection and
centrifugation.
   (e) When any of the following manual methods are employed, the
activities of unlicensed laboratory personnel shall be limited as
follows:
   (1) In the case of qualitative and semi-quantitative "spot,
tablet, or stick" tests, the personnel may add the test reagent to
the specimen or vice versa, but the results must be read by a
physician and surgeon or person licensed under this chapter.
   (2) In the case of microbiological tests the unlicensed laboratory
personnel may make primary inoculations of test material onto
appropriate culture media, stain slide preparations for microscopic
examination, and subculture from liquid media.
   (f) When any of the following mechanical or electronic instruments
are employed, unlicensed laboratory personnel shall not perform any
of the following activities:
   (1) Standardizing or calibrating the instrument or assessing its
performance by monitoring results of appropriate standards and
control.
   (2) Reading or recording test results, except that the personnel
may transcribe results that have been previously recorded
automatically by a testing instrument.
   (3) Quantitatively measuring any sample or reagents unless done
automatically by the instrument in the course of its normal operation
or by the use of previously calibrated and approved automatic
syringes or other dispensers.



1269.3.  (a) Notwithstanding Sections 1206.5 and 1269, within the
specialty of pathology, a person certified as a pathologists'
assistant by the American Association of Pathologists' Assistants,
the Board of Registry of the American Society for Clinical Pathology,
or another national accrediting agency approved by the department,
who demonstrates competency to perform all job duties and
responsibilities before an assignment to those duties and
responsibilities, at the completion of six months of performing those
duties and responsibilities, and annually thereafter, may perform
the following activities under the supervision and control of a
pathologist:
   (1) Prepare human surgical specimens for gross description and
dissection, including, but not limited to, description of gross
features and selection of tissues for histological examination.
   (2) Prepare and perform human postmortem examinations, including,
but not limited to, selection of tissues and fluids for further
examination.
   (3) Gather other information necessary for an autopsy report.
   (4) Prepare a body for release.
   (b) Notwithstanding Section 1206.5 or subdivisions (b), (c), and
(d) of Section 1269, the following persons may prepare human surgical
specimens for gross description and dissection under the direct
supervision of a qualified pathologist, including, description of
gross features and selection of tissues for histological examination,
if they meet the requirements specified in subdivision (a) of
Section 1269 and the minimum education and training requirements for
high complexity testing personnel under the CLIA:
   (1) A pathologists' assistant who does not meet the certification
requirements of subdivision (a).
   (2) A histologic technician.
   (3) A histotechnologist.
   (c) For the purposes of subdivision (b), direct supervision means
that a qualified pathologist shall be physically present onsite in
the vicinity of the clinical laboratory where the specialty of
pathology is performed and shall be available for consultation and
direction during the time the personnel specified in subdivision (b)
are engaged in the processing of specimens that involve dissection.
For tissue processing that does not involve dissection, a qualified
pathologist may be available by telephone or other electronic means.
   (d) A histologic technician or histotechnologist who meets the
requirements specified in subdivision (a) of Section 1269, may
accession specimens, perform maintenance of equipment, stain, cover
slip, label slides, and process tissues by embedding in paraffin or
performing microtomy.
   (e) On and after January 1, 2011, the department may adopt
regulations establishing additional qualification requirements to
perform the duties described in this section.



1269.5.  The department may deny, suspend, or revoke any license,
registration, or certificate issued under this chapter for
performance by unlicensed laboratory personnel of any activity that
is not authorized by Section 1269.


1270.  (a) On and after January 1, 1991, no person may perform
examinations of cytological slides without first obtaining a license
as a cytotechnologist from the department, except that those persons
employed by licensed clinical laboratories as cytotechnologists and
certified as cytotechnologists by the department on or before January
1, 1991, shall be licensed by the department on or before January 1,
1993. Cytotechnologist licenses shall be issued and renewed by the
department for periods of two years. This subdivision shall not apply
to persons holding a valid, unrevoked, unsuspended physician's and
surgeon's certificate issued pursuant to Chapter 5 (commencing with
Section 2000).
   (b) The issuance of a cytotechnologist license shall be contingent
upon the applicant's satisfactory performance, as defined in
regulation, in a competency testing program for cytotechnologists
which may be administered by the department or by a competency
testing service or program approved by the department. The competency
testing program established pursuant to this section shall be
periodically reviewed and revised by the department, if necessary, to
ensure that the program is consistent with federal competency
testing requirements issued under the Clinical Laboratory Improvement
Amendments of 1988 (P.L. 100-578; 42 U.S.C. Sec. 263a, Section 353
of the Public Health Service Act).
   (c) Notwithstanding subdivision (b), the department may issue a
temporary cytotechnologist's license to a person who satisfies the
requirements for admission to the examination unless the person has
failed a previous examination for a cytotechnologist's license. A
temporary license issued by the department pursuant to this
subdivision shall be valid for a period of time not exceeding 90 days
after the date the department has adopted a competency testing
program pursuant to subdivision (b).
   (d) The department may issue a cytotechnologist's license without
examination to an applicant who satisfies one of the following:
   (1) Passage of an examination of a national accrediting board
whose requirements are equal to or greater than those required by
this chapter or by regulations adopted pursuant to this chapter, as
determined by the department.
   (2) Passage of an examination of another state in which the
requirements imposed by laws and regulations regarding the
examination are equal to or greater than those required by this
chapter or by regulations adopted pursuant to this chapter, as
determined by the department.
   This subdivision shall not apply to a person who has passed an
examination of a national accrediting board or another state prior to
that board's or state's establishment of requirements which are
equal to or greater than those required by this chapter or by
regulations adopted pursuant to this chapter, as determined by the
department. The department may, however, make exceptions to the
requirements of this subdivision in cases where the department
determines that the applicant is otherwise qualified for licensure.
   (e) The department shall not issue any temporary cytotechnologist'
s license pursuant to subdivision (c) or any cytotechnologist's
license without examination pursuant to subdivision (d) after the
department adopts a competency testing program pursuant to
subdivision (b).


1270.5.  (a) Notwithstanding Section 1301, an application for the
renewal of, and payment of the renewal fees for, a cytotechnologist
license shall be governed by this section.
   (b) Application for renewal of a cytotechnologist license,
accompanied by the fee set forth in Section 1300, shall be filed with
the department not less than 30 days prior to the expiration date.
   (c) If the renewal fee is not paid during the 30 days prior to the
expiration date, the license shall automatically expire at midnight
on the expiration date. However, a cytotechnologist who has failed to
timely pay a renewal fee may have his or her license reinstated,
without completing a competency testing program, provided that he or
she mails to the department a written request for reinstatement
postmarked no later than the 60th day after the expiration date of
the license and a reinstatement fee equal to two times the annual
renewal fee set forth in Section 1300. The license shall be
reinstated on the date the request for reinstatement and fee are
received by the department. If the request for reinstatement and fee
are received prior to the expiration date of the license, there shall
be no lapse in licensure. No cytotechnologist shall perform services
for which a license or certification is required under this chapter
during any period for which licensure or certification has lapsed.




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.
   (l) 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.



1271.1.  (a) Clinical laboratories which are licensed pursuant to
this chapter and provide cytology services shall, if the licensee
ceases operation, preserve records, reports, cytology slides, and
cell blocks as prescribed in subdivision (g) of Section 1271 and
Section 1274.
   (b) Any person injured as a result of the licensee's abandonment
of records may bring an action in any court of competent jurisdiction
for the amount of any damages suffered as a result. In the event the
licensee was a corporation or partnership which has been dissolved,
the person injured may bring an action against that corporation's or
partnership's principal officers of record at the time of the
dissolution.
   (c) For purposes of this section, the following definitions shall
apply:
   (1) "Abandonment of records" means violating subdivision (a) and
thereby leaving patients and physicians and surgeons without access
to information to which they are entitled pursuant to this chapter.
   (2) "Principal officers" means:
   (A) In the case of a partnership other than a limited partnership,
any partner.
   (B) In the case of a limited partnership, any general partner, as
defined in subdivision (i) of Section 15611 of the Corporations Code.
   (C) In the case of a corporation, the chairperson of the board,
the chief executive officer, and the president of the corporation.




1272.  A clinical laboratory shall participate in a state-approved
proficiency testing program and demonstrate satisfactory performance
in all of the laboratory specialities that include tests performed in
the laboratory. Proficiency shall be tested in the following
specialties: microbiology, serology, clinical chemistry, hematology,
cytology, and immunohematology.



1272.4.  The department shall establish standards for the evaluation
of cytologic slides, for reporting the adequacy of cytologic slides,
for a cytotechnologist competency program, and for a proficiency
testing program for clinical laboratories providing cytology
services.



1272.6.  The department shall, on or before January 1, 1992, develop
or adopt a proficiency testing program for laboratories providing
cytology services which may be administered by the department or by a
proficiency testing service or program approved by the department.
The proficiency program established pursuant to this section shall
include announced and unannounced onsite proficiency testing, with
that testing to take place, to the extent practicable, under normal
working conditions.



1274.  (a) A laboratory shall document to persons submitting
cytologic samples for evaluation, on a quarterly basis, informational
letters on all cases of HSIL (high-grade squamous intraepithelial
lesions), adenocarcinoma, or other malignant neoplasm. Documentation
may consist of followup correspondence, telephone calls, or requests
included in the report. Copies of that documentation, and any
responses received to those letters, shall be maintained on file by
the laboratories for a period of five years.
   (b) Whenever it becomes known to a clinical laboratory that an
abnormality of HSIL (high-grade squamous intraepithelial lesions,
adenocarcinoma, or other malignant neoplasm) has been identified for
a patient for whom the clinical laboratory earlier reported a normal
finding, all previous available cytologic slides on that patient
shall be reexamined by the clinical laboratory.
   (c) Records of the review of previous slides required by
subdivision (b) shall be maintained by the clinical laboratory,
including the name of the individual performing the earlier
examination.
   (d) A clinical laboratory shall maintain records of all false
positive and false negative cases.
   When any errors in the reporting of a smear evaluation are
discovered, a corrected report shall be immediately sent, when
medically applicable. Copies of corrected reports shall be maintained
in the laboratory records for a period of 10 years.



1275.  The department shall develop and implement regulations for
continuing education for persons licensed pursuant to this chapter on
or before January 1, 1992, after consulting with the
multidisciplinary committee established pursuant to Section 1228, and
other appropriate organizations. On and after January 1, 1994, the
department shall require not more than 12 hours of continuing
education completed within a 12-month period or not more than 24
hours of continuing education completed within a 24-month period as a
condition for renewal of a license issued under this chapter. The
department may establish a fee for the implementation of this
section, the total fees collected not to exceed the total costs to
the program for the implementation of this requirement.