BILL ANALYSIS
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|Hearing Date:March 20, 2006 |Bill No:SB |
| |169 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC
DEVELOPMENT
Senator Liz Figueroa, Chair
Bill No: SB 169Author:Migden
As Amended:March 7, 2006 Fiscal: No
SUBJECT: Certified phlebotomy technicians.
SUMMARY: Extends from April 2006 to January 1, 2007, the
date by which an unlicensed person employed by a clinical
laboratory to perform venipuncture (puncture of a vein) or
skin puncture to draw blood must become certified as a
certified phlebotomy technician. As an urgency measure,
these provisions would take effect immediately upon
enactment.
Existing law:
1)Provides for the licensing and regulation of clinical
laboratories and various clinical health personnel by the
Department of Health Services (DHS), and regulates the
conditions under which laboratory tests are to be
performed and the type of personnel who may perform them
based on the type and complexity of the test as
classified by the federal Clinical Laboratory Improvement
Act of 1988 (CLIA).
2)Requires DHS to adopt regulations for the certification
of phlebotomy technicians by January 1, 2001 (the
regulations were finally adopted on January 9, 2003, and
became effective on April 9, 2003), and requires those
regulations to require applicants for certification to:
a) Hold a current certification as a phlebotomist
issued by a national accreditation agency approved by
DHS.
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b) Complete education, training and experience that
includes specified amounts of didactic and practical
instruction and at least 50 successful venipunctures
or, in the alternative, have at least 1,040 hours of
specified work experience.
3)Requires that on or after the effective date of the
regulations, any unlicensed person employed by a clinical
laboratory to perform venipuncture or skin puncture to
draw blood, as specified, must hold a current and valid
certification from DHS as a certified phlebotomy
technician.
4)Provides that an unlicensed person employed by a clinical
laboratory on the effective date of the regulations
(i.e., April 9, 2003), must comply with the certification
requirement by requirement by April 2006.
This bill:
1)Extends the date for compliance with the certification
requirement to January 1, 2007 for a person who was
employed by a clinical laboratory on the effective date
of the regulations, provided that the application for
certification is submitted to DHS by July 1, 2006.
2)As an urgency measure, would take effect immediately upon
enactment.
FISCAL EFFECT: None. This bill has not been keyed
"fiscal" by Legislative Counsel.
COMMENTS:
1.Purpose. According to the Author, DHS has not been
adequately staffed to certify all phlebotomists with
pending applications by the statutory deadline. In fact
DHS estimates a backlog of 3,000 pending applications
that will not be completed in time for the current April
2006 deadline, according to the Author.
By extending the current April 2006 deadline to January
1, 2007, the Author intends to give DHS enough time to
process applications and allow phlebotomists to continue
serving patients and doctors while their applications are
being processed.
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2.Background. AB 1557 (Migden, Chapter 695, Statutes of
1999) was introduced after an incident in which a lab
technician was found to be reusing needles. The bill
required phlebotomy technician certification for
unlicensed individuals performing venipuncture and skin
puncture, and required DHS to adopt regulations for
certification by January 1, 2001. The bill required that
person who is hired by a clinical lab as a phlebotomy
technician after the effective date of the regulations
must hold a certificate as a certified phlebotomy
technician from DHS. The bill additionally, provided
that phlebotomy technician certification would not be
required for individuals who were employed as
phlebotomists at the time the DHS regulations were
adopted until three years after the effective date of
regulations.
The regulations for the certification of phlebotomy
technicians were not adopted by DHS until January 9,
2003, and became effective on April 9, 2003.
3.Related Legislation.
AB 1087 (Frommer, Chapter 18, Statutes of 2004)
established the April 2006 deadline date for phlebotomy
technician certification in the Code. The bill also
allowed a certified phlebotomy technician to perform
venipuncture or skin puncture for insurance underwriting
purposes, provided the technician is under the general
supervision of a specified health care provider.
AB 371 (La Suer, Chapter 14, Statutes of 2004) allowed a
certified phlebotomy technician to withdraw blood in
specified locations, with general supervision, at the
direction and in the presence of a peace officer, for
purposes such as to permit blood draws in the field on
driving under the influence cases.
4.DHS Regulations. To become a certified phlebotomy
technician, a person must have a high school or
equivalent degree, complete a DHS-approved training
program, document specified minimum experience
requirements, pass a phlebotomy certification examination
by one of six DHS-approved organizations and obtain a
certificate of completion. The person must submit
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documentation of meeting the requirements along with a
completed application to DHS and a $54 fee for the 2-year
certificate.
There are three levels of phlebotomy certification by
DHS:
a. Limited Phlebotomy Technician - performs skin
puncture only.
b. Certified Phlebotomy Technician I - performs
skin puncture and venipuncture.
c. Certified Phlebotomy Technician II - performs
skin puncture, venipuncture and arterial puncture.
5.DHS Backlogs. The Assembly Health Committee Analysis
(February 28, 2006) states that according to DHS, over
6,500 phlebotomists have been certified in the last two
and half years, but about 7,000 are awaiting review and
certification at this time (half of whom were working as
of April 2003). DHS states that most of the applications
have been received in the last six months. DHS estimates
that there are at least 20,000 to 24,000 unlicensed
phlebotomists.
6.Arguments in Support. A number of individuals and
organizations support this bill. Quest Diagnostics
indicates that without this bill, phlebotomists awaiting
certification will lose their jobs with their laboratory
employer, and patients will face delays at blood draw
centers, delaying testing and diagnosis and eventually
causing increases in illness and health care costs. The
California Clinical Laboratory Association fears that
unless the deadline is pushed back, there will be an
artificial crisis in the availability of personnel who
may serve as phlebotomists for clinical laboratories.
The Project Director of the Study of Women's Health
Across the Nation states that the regulations were not
effectively publicized and experienced phlebotomists were
not notified of the new regulations in a timely fashion.
Kaiser Permanente states that every reasonable effort
possible has been made over the last three years to
ensure the training and application for certification of
their phlebotomy employees, but DHS has been unable to
meet its responsibility to timely process those
applications.
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7.April 2006 Deadline. The bill is an urgency measure in
order to extend the April 2006 deadline. AB 1557
(Migden) provided a grace period for clinical lab
employees to become certified by DHS. The legislation
allowed employees three years after the effective date of
the DHS regulations to work without the certification.
The legislation additionally established a January 1,
2001 deadline by which DHS must adopt the regulations.
The regulations were finally adopted on January 9, 2003
(more than two years after the deadline), and became
effective on April 9, 2003. Therefore, under the terms
of the initial legislation and the subsequent delay in
the regulations, lab employees would have until April 9,
2006 to become certified by DHS. In 2004, clarifying
legislation (AB 1087, Frommer) specifically established
April 2006 as the deadline for compliance.
Therefore in order to avoid any gaps in compliance by
clinical laboratories and their employees, or any
stoppage in blood-drawing services to the public, it is
essential that this urgency legislation be enacted by
April 9, 2006.
8.Questions. According to the Author, DHS estimates a
backlog of 3,000 pending applications that will not be
completed in time to meet the April 2006 deadline. The
Author believes that extending the deadline to January 1,
2007, will give DHS enough time to process applications
and allow phlebotomists to continue serving patients and
doctors while their applications are being processed. In
this light, the following questions may be raised:
Will DHS be able to process the backlog of applications
within the new timeframe if the deadline is extended to
January 1, 2007? Is DHS prioritizing applications for
phlebotomy technician certification? What are the
staffing resources that DHS believes are necessary to
process the pending applications? Have the staffing
shortages which led to the backlogs been resolved?
SUPPORT AND OPPOSITION:
Support:
Alta Bates Summit Medical Center
American Council of Life Insurers
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Association of California Life and Health Insurance
Companies
Board of Supervisors, County of Santa Clara
California Association for Medical Laboratory Technology
California Clinical Laboratory Association
California Primary Care Association
California Hospital Association
Cedars-Sinai Health System
Colusa Regional Medical Center
Kaiser Permanente Medical Care Program
Long Beach Memorial Medical Center
Mercy Hospital of Folsom
Miller Children's Hospital at Long Beach
Palm Drive Hospital
Pacific Hospital of Long Beach
Quest Diagnostics
Ridgecrest Regional Hospital
Redlands Community Hospital
Saint Agnes Medical Center, Fresno
Scripps Memorial Hospital Laboratory
Sharp Healthcare
Sonora Regional Medical Center (individuals)
St. Joseph Hospital, Orange
St. Mary Medical Center
Study of Women's Health Across the Nation
Tehachapi Valley Healthcare District
Several Individuals
Opposition:
None on file
Consultant:G. V. Ayers