North Carolina State Laboratory of Public Health
Laboratory Improvement
PO Box 28047
Raleigh, NC 27611-8047
September, 2005 ’’'Phlebotomy
Sticking to the Standard of Care Vol. 2, No. 3
Phlebotomy. It's performed thousands of times a day
in healthcare facilities across our state. And we’ve all
experienced it. As consumers of healthcare, each of
us has been on the receiving end of a needle in order
to obtain results reflective of our health. Chances
are we, as well as our family and friends, will undergo
this procedure numerous times over the course of our
lifetimes. As healthcare professionals, many of us
also play an important role in the proper delivery of
this service to others.
Phlebotomy’s Inherent Risks
Most clinical laboratories that provide direct patient
services practice the art of blood collection on their
customers. This is done regardless of a laboratory's
test menu, certif ication, or staffing. Of great
concern, for both those who deliver and receive
phlebotomy services is that currently, in most states,
no minimum training requirements exist for this
invasive procedure, which carries with it inherent
risks to both the employee and the patient. For the
employee, at least 20 different diseases can be
transmitted through an accidental needlestick (1). For
the patient, the most common types of injury
associated with phlebotomy include nerve injuries,
arterial laceration, uncontrolled bleeding, injuries
resulting from fainting, and improper identification of
patient and/or specimens (1). Consider that the
cosmetologist who cuts and colors your hair is
required by law to be licensed to practice his/her
craft, as is the bartender who mixes drinks for the
happy hour crowd. Not so, for those assigned the all-
important task of collecting your blood.
Why No Minimum Requirements?
In 1999, California enacted legislation mandating
phlebotomy certification; however, such legislation
does not exist in most states (1). One possible reason
for this is that the procedure itself is poorly
understood. Because it appears deceptively easy to
perform, phlebotomy is thought by many to be a skill
easily acquired by the untrained in a matter of hours
or days through casual observation. Also, there exists
among some, who long ago received formal phlebotomy
instruction as part of an allied health curriculum, the
inaccurate philosophy of “once trained, always
trained". This attitude negates the importance of
remaining current with the industry's standard of care
for blood collection and may subsequently put the
collector, their employer, as well as their patients, at
risk.
CLSI and the Standard of Care
So, what's the standard of care? Essentially, it is
what a well-trained, competent, and cautious
phlebotomist would do in the performance of their
blood collection duties. Though no legislation exists in
North Carolina mandating minimum training
requirements for those who practice phlebotomy, the
industry does have its own established standards for
the procedure, which are based on current literature,
regulations, and expert opinion. One such source is
the Clinical and Laboratory Standards Institute
(CLSI). CLSI, formerly known as the National
Committee for Clinical Laboratory Standards (NCCLS),
is a nonprofit, international organization that
promotes the development and use of voluntary
consensus standards and guidelines within the
healthcare community. With representatives from
public and private healthcare facilities, educational
institutions, as well as industry and government, CLSI
volunteer committees draw from their collective
expertise as well as existing literature, to develop
documents that serve as the gold standards for a
multitude of clinical laboratory practices, policies, and
procedures worldwide. Two such approved standards
developed by CLSI specifically address the collection
of blood specimens. They are H3-A5, Procedures for
the Collection of Diagnostic Blood Specimens by
Venipuncture, and H4-A5, Procedures and Devices for
the Collection of Diagnostic Capillary Blood Specimens
(2,3). These documents, along with textbooks and
literature that reflect the current CLSI standards,
should serve as the basis on which each facility
develops and periodically evaluates its own specimen
collection procedures, protocols, and practices.
