BILL ANALYSIS
SENATE COMMITTEE ON BILL NO.:SB 296
BUSINESS AND PROFESSIONS AUTHOR:Maddy
Senator Daniel Boatwright, Chairman As Amended : 4/17/95
HEARING DATE: April 24, 1995 FISCAL:Yes
SUBJECT: Human blood: collection - permitting oblood donor
phlebotomistso to collect blood in licensed blood
banks.
DIGEST:
Existing law establishes procedures regarding the collection of
human whole blood and licensure of blood banks administered by
the Department of Health Services (DHS). Existing law also
authorizes clinical laboratory bioanalysts, clinical laboratory
technologists and trainees, vocational nurses (LVNs) and
registered nurses (RNs) who are licensed to perform skin
puncture and venipuncture to collect human whole blood provided
this is performed in a licensed blood bank and under the
supervision of a licensed physician and surgeon.
Existing law also provides that nothing in the laws governing
blood collection procedures and licensure prohibit the
collection of blood at a state institution or other
establishment by the personnel of the institution, under
conditions established and accepted by DHS.
This bill would:
1. Authorize oblood donor phlebotomists,o as defined by the
American Association of Blood Banks (AABA) to collect human
whole blood under the same conditions currently applicable to
those personnel (e.g., registered nurses) currently authorized
to collect that blood.
2. Also provide that nothing in the blood collection laws shall
prohibit collection of blood at a licensed blood bank by the
personnel of the blood bank.
FISCAL EFFECT:
Unknown. This is a fiscal bill.
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COMMENTS:
1. Purpose of the bill; proponents.
This bill is sponsored by the Blood Centers of California and
the California Association of Hospitals and Health Systems
(CAHHS) to remove the current restriction placed on California
Blood Centers that only RNs, LVNs, licensed clinical lab techs
and trainees and bioanalysts can draw blood for normal blood
draws - and provide the option of also using oblood donor
phlebotomists.o Proponents believe that the bill would provide
for continued safe, competent blood collection and storage,
while reducing the costs .
Proponents note that California is the only state that requires
licensed personnel to perform this function, and that all other
states provide the option of utilizing phlebotomists or similar
health care personnel and follow standards developed by the
American Association of Blood Banks (AABB). They note that the
AABB sets standards, inspects and accredits blood collection and
transfusion facilities, and states that its members (including
the 46 American Red Cross Service Regions, and about 200
hospitals and blood centers and 1,000 individuals in California)
collect virtually all of the nationos blood supply. The AABB
also maintains a oBlood Donor Phlebotomist Certificate Programo
that is provided through its member blood collection facilities.
Supporters note that the bill would reduce the overall cost of
collecting blood in California. They argue that
California-collected blood is among the highest priced in the
nation (as much as 50% more), partially due to the high labor
costs resulting from the current limitation against the use of
phlebotomists, and for this reason a significant amount of blood
purchased by hospitals is imported from outside California. The
proponents further state blood banks provide training for its
blood collection personnel but that many of those who are
currently authorized by law (RNs and other licensees) frequently
move on to other positions for which their licenses qualify them
- causing expensive personnel turnover for the blood banks.
2. Opponents.
This bill is opposed by the California Nurses Association (CNA),
the Service Employees International Union (SEIU), the Engineers
and Scientists of California, MEBA, AFL-CIO, and three blood
bank nurses. Opponents state that the existing personnel
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requirements provide important protection for both the blood
donor/patient and the safety of the blood supply. Opponents
point out that a nurse is educated and trained (minimum of 6
weeks just to perform venipuncture) to anticipate and respond to
symptoms of incipient danger in an appropriate manner. They
note that drawing blood is not a simple mechanical function, but
a procedure that can lead to serious circumstances including
hypovolemic shock, shortness of breath, chest pain, faintness,
unconsciousness, falls, and post donation injury. Further, they
argue that nurses double-check a patientos medical history, and
that donor screening and assessment, including those who are
giving blood for their own surgery (autologous), requires a high
level of medical/nurse background to determine the safety and
potential hazard for the procedure. This is argued to be
especially true for ill or elderly patients with histories of
serious medical conditions.
Opponents state that the bill does not provide for any
educational requirements or training and that given the past
history of scandals in the U.S. blood bank industry, they cannot
be trusted to self-regulate the employees entrusted with the
safety of blood donors or the blood supply. They also argue
that similar legislation has been defeated in the past in
California, that there is no shortage of qualified nurses or
other personnel available to blood banks for blood collection,
and that there is no assurance that any reduction of personnel
costs to the blood banks would necessarily be passed along to
the purchasing hospitals and patients rather than to additional
profits for the blood banks. Opponents believe that there is no
justification for lowering Californiaos existing high standards
and permitting unlicensed, ill-paid, briefly-trained health
workers to perform this critical procedure, particularly given
the diversity of Californiaos population and concerns regarding
infectious diseases such as HIV.
3. Blood donor phlebotomist training.
The AABB states that it maintains a oBlood Donor Phlebotomist
Certificate Programo (offered by blood collection facilities)
through which individuals are trained in all aspects of blood
collection procedures, state and federal regulatory
requirements, and donor selection. Applicants are required to
be at least 18 years old, have a high school or equivalent
diploma, have 6 months experience within the previous year in a
blood bank or equivalent medical setting, have a current basic
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life support (BLS)/cardiopulmonary resuscitation (CPR)
certification, and have a written verification of employment and
satisfactory performance by the medical director of the blood
collection facility (blood bank). In order to obtain a
certification as a blood donor phlebotomist, an individual must
go through an educational course, pass a skills assessment
checklist and pass a written examination.
Proponents of the bill note that the Department of Health
Services (DHS) is currently drafting regulations for
phlebotomists, and that the bill requires direct and responsible
supervision of a licensed physician under conditions established
by the DHS.
4. Billos definition of oblood donor phlebotomists.o
The billos provisions refer to o...blood donor phlebotomists, as
defined by the American Association of Blood Banks....o (Page 2,
lines 7-8) However, it is unclear whether the AABB definition
specifically requires (refers to) only those individuals who
have successfully completed the AABBos Blood Donor Phlebotomist
Certificate Program. Also, it should be noted that there is no
specified curriculum required for that training program, and
that the related AABB program materials state that the program
itself does not provide all the training or skills needed to
perform phlebotomy satisfactorily, and that a personos job
performance may depend upon other factors such as prior training
and experience and appropriate on-the-job supervision.
(Arguably, these would be subject to DHS oversight and
specification).
Support and Opposition: (4/19/95 - 10 a.m.)
Support: The Blood Centers of California (co-sponsor)
California Associations of Hospitals and Health
Systems (CAHHS - co-sponsor)
American Association of Blood Banks (AABB)
American Red Cross
Kaiser Permanente Medical Care Program
Blood Bank of San Bernardino and Riverside Counties
Delta Blood Bank
Northern California Community Blood Bank
Peninsula Blood Bank
Child Net
Council of Community Blood Centers (Washington, D.C.)
California Medical Association
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4 physicians
3 Individuals
Opposition: Engineers and Scientists of California, MEBA,
AFL-CIO
California Nurses Association (CNA)
Service Employees International Union, AFL-CIO, CLC
(SEIU)
3 blood bank registered nurse
[The Department of Health Services has not expressed a position
on this bill]
Consultant:Jay J. DeFuria