CEO SUMMARY: State certification of phlebotomists is under way in the Golden State. By April 9, 2006, all phlebotomists in California will need to maintain state certification. This development adds complexity to laboratory management in California. However, there are no signs that other states intend to follow California’s lead in requiring certification of phlebotomists.
WHEN IT COMES TO laboratory regulation, California is usually first to break new ground. That is certainly true of a new regulatory requirement that phlebotomists in the state must be certified.
Multiple laws affecting phlebotomy were passed in the California legislature in recent years. In 1999, AB 1557 (Migdin) amended the Business and Professions Code. The law took effect on April 9, 2003. It requires all phlebotomists working in California to obtain a state-issued certificate for either a “Limited Phlebotomy Technician” (LPT) or “Certified Phlebotomy Technician” (CPT 1 or 2) by April 9, 2006.
Several other laws that affect phlebotomy services were also passed. Among other things, Assembly Bill 371 (LaSuer) requires CPTs (certified phlebotomy technologists) to draw blood for “driving under the influence” (DUI) violations at the direction of a law enforcement officer. Assembly Bill 1087 (Frommer) authorizes insurance company phlebotomy for physical examinations and allows CPTs to draw blood for contractors under the supervision of a physician, registered nurse or clinical laboratory scientist (CLS).
Implementation of these various legislative mandates is handled by Lab Field Services (LFS), a division of the California Department of Health Services (DHS). It started the phlebotomy certification program in April 2003 to meet an April 2006 deadline that requires all phlebotomists to be certified by that date.
Chief of Lab Field Services
Recently Karen Nichols, Ph.D., Chief of Lab Field Services (LFS) addressed the meeting of the Greater Los Angeles Chapter of the Clinical Laboratory Management Association (CLMA). She spoke about phlebotomy certification and other regulatory issues affecting laboratories in California. “As of this date, there are 3,000 persons certified in phlebotomy,” said Nichols.
“There are another 4,000 applications awaiting review by LFS staff,” she continued. “Across the state, 100 phlebotomy training programs are in place and six exams have been approved. Within Lab Field Services, a shortage of staff is creating a delay of about three-months in processing phlebotomy certification applications.”
Nichols can already recognize some of the changes triggered by this new legislative mandate, although the deadline for certification is still another year away. “What is interesting about the flow of applications is that most are applications from people seeking to get a certificate so they can enter the field of phlebotomy,” explained Nichols. “These are very different types of applicants from experienced phlebotomists already at work.
“For example, most applicants new to phlebotomy say they have a job waiting. A large percentage of these people are also single mothers,” added Nichols. “Starting in August 2005, all phlebotomists will get a notice to apply for certification in advance of the April 2006 deadline. We expect that August notice will motivate experienced, working phlebotomists to send in their applications.”
Laboratory managers and pathologists will recognize that state certification of phlebotomists introduces another level of complexity and cost in the management of laboratories. In California, laboratories accustomed to dealing with such regulatory initiatives, consider the new phlebotomy certification program to be another “fact of life.”
As the sidebar at right points out, the requirement that phlebotomists be certified is a direct consequence of the 1999 episode where a San Francisco- area phlebotomist was discovered to be washing and reusing butterfly needles on her patients. This caught the attention of state legislators and led to the passage of AB 1557 (Migden) just months later.
What will be important to watch is the April 9, 2006 deadline, when all phlebotomists must have certificates. Because this will increase the cost of phlebotomy, it is likely to change aspects of how laboratories staff and use phlebotomists.
Calif. Needle-Reuse Case Triggered Certification Law
WHY DID CALIFORNIA’S LEGISLATURE pass a law requiring certification of phlebotomists? It was in response to the shocking discovery that a phlebotomist working in the San Francisco Bay area had been reusing needles on patients.
It was April 15, 1999 when the San Francisco Chronicle published the news that a phlebotomist employed by Smith-KlineBeecham Clinical Laboratories (SBCL) was “washing” and reusing butterfly needles on “difficult to draw” patients at her patient service center in Palo Alto, California. (See TDR, April 26, 1999.)
SBCL quickly offered free testing to as many as 3,700 patients seen in SBCL’s Palo Alto patient service center during the 22 months she worked there. Officials from California’s Department of Health Services (DHS) quickly decided to offer free testing to any patient ever seen in a patient service center where phlebotomist Elaine Giorgi had been working. At least 15,000 people were offered free testing to determine whether they may have become infected due to Giorgi’s practice of washing and reusing butterfly needles.
California’s legislature reacted swiftly to this lab industry scandal. Before 1999 ended, it passed AB 1557 (Midgen). This law mandated certification of phlebotomists working in the state by April 9, 2006.