At its February 2005 meeting, the Board of Trustees of the American Association of Medical Assistants (AAMA) authorized Executive Director Donald A. Balasa, JD, MBA, to explore the advisability of the AAMA joining the Coalition for Phlebotomy Personnel Standards. The position paper of this coalition is reprinted below.

Background

Phlebotomy, or the removal of blood through venous, arterial, and capillary access, has its origins in health care centuries ago when physicians drained their afflicted patients of large volumes of blood in attempts to cure illness. This ancient art of bloodletting has evolved to the removal of small quantities of blood for clinical testing to aid the physician in the diagnosis, treatment and management of patients. Also through phlebotomy, larger quantities of blood are withdrawn from healthy donors for eventual transfusion and withdrawn from patients with certain disease states to reduce the concentration of circulating red blood cells and iron. In modern health care, phlebotomy is the most frequently performed invasive medical procedure.

Traditionally, blood collection for diagnostic testing has been performed by clinical laboratory testing personnel. In the 1970s, laboratories created blood collection specialists—phlebotomists—to collect and process specimens so that the higher paid testing personnel could concentrate on the more technical aspects of clinical laboratory testing. Organizations that certified phlebotomists emerged and provided a voluntary means by which facilities could establish and maintain a competent staff of phlebotomists.

Through the 70s and 80s, phlebotomists honed their skills by virtue of being able to master this singular function. But in the 1990s, administrators reassigned them from the laboratory to the nursing department and gave them other patient-care responsibilities. Relocated phlebotomists were given the title “patient care assistants” or some variation.

It became evident to most facilities that the efficiencies gained in the redeployment of phlebotomists to other health care professions were lost to poor specimen quality, unacceptably high recollection rates and patient complaints of multiple painful venipuncture attempts, excessive bruising and permanent injuries. Patient satisfaction surveys plummeted. As a result, many reclaimed oversight of specimen collection personnel.

Today, anyone can perform blood specimen collection procedures without a license, certificate or even a mandated minimum-training requirement (except in California). The vast majority of health care personnel with specimen collection responsibilities are trained by their employers, who determine for themselves what constitutes adequate training based on a multitude of variables, including the following:

  • Availability of resources for obtaining and updating training materials
  • Cost of maintaining the skills of training personnel
  • Staff productivity
  • Availability of dedicated training personnel

While some in-house training programs are exceptionally comprehensive, the training given to others is woefully inadequate. Some receive no classroom training at all.

Those who are subjected to training by observation alone do not receive the necessary didactic training on anatomy and physiology to understand the risk of injury to the patient directly—when the needle is excessively manipulated in an area in which other structures can be damaged—or how specimens can be altered during the collection process, leading the laboratory to report, and the physician to react to, incorrect results.

Injuries that can be inflicted at the hands of the unskilled include the following:

  • Temporary or permanent disabling nerve injury from excessive probing
  • Temporary or permanent disabling nerve injury from failure to prevent or recognize subcutaneous hemorrhage
  • Lymphedema caused by drawing blood from the same side as a prior mastectomy
  • Tissue necrosis due to drawing blood from the lower extremities of diabetic patients
  • Thrombophlebitis arising from venipunctures performed on the lower extremities of patients with coagulation disorders
  • Nerve/tendon damage inflicted during attempts to draw blood from an unorthodox site
  • Arterial perforation
  • Arterial laceration
  • Injuries, including fractures and paralysis, sustained from falls due to a loss of consciousness
  • Complications, including stroke, hemorrhage, seizures, coma, and death, arising from medical decisions based on results obtained from specimens altered during the specimen collection or processing phase of clinical testing
  • Complications from medication and transfusion errors—including stroke, hemorrhage, seizures, coma, multi-organ failure, and death—arising from medical decisions based on results obtained from misidentified patients and/or mislabeled specimens

Poor specimen quality also compromises the ability of laboratory instrumentation to obtain accurate results. Physicians rely on laboratory results obtained from blood specimens for 70 percent of the objective information they receive on their patients’ health status. In addition, patients can be permanently injured during the specimen collection process at the hands of the unskilled. Therefore, it is imperative that specimen collection personnel are subjected to minimum training requirements. Such training requirements must include content to protect patients from injury and medical errors that can occur when physicians treat patients according to results obtained from specimens altered during the collection process by those with inadequate training.

Position

The Coalition affirms that phlebotomy is an invasive procedure that requires significant skill and training to protect patients from injury and the consequences of results obtained from improperly collected specimens.

The Coalition affirms that specimens collected by health care personnel without proper training threatens the integrity of specimen collection systems and compromises the ability of clinical laboratory instrumentation to produce reliable and accurate results.

The Coalition affirms that specimen collection personnel who are not trained according to a minimum standard threaten the ability of physicians to properly diagnose, medicate and manage their patients and can be directly attributable to negative patient outcomes, including death.

The Coalition affirms that it is in the best interest of the patient, the physician and the clinical laboratory industry for health care personnel with blood collection responsibilities to be subject to mandatory minimum training requirements, certification/licensure, continuing education and continued competency assessment.

The Coalition affirms that, because many specimen collection personnel perform point-of-care testing and direct the training of other health care personnel in point-of-care testing, unskilled personnel can contribute to inaccurate results that lead to medication errors and other patient management errors.

The Coalition affirms that specimen collection personnel responsible for training other health care personnel are capable of perpetuating medication errors and other patient management errors when training others to perform the procedure, including nurses and patients themselves.

The Coalition affirms that specimen collection personnel who also process specimens prior to testing can significantly alter the specimen so that it renders inaccurate results, which can lead to patient mismanagement, medical errors and death.

The Coalition is dedicated to improving the quality of blood specimens collected through encouraging legislation that establishes minimum training requirements and certification/licensure for all phlebotomists.

The Coalition is dedicated to recruiting the support of organizations, corporations, institutions and governmental agencies as members and allies in establishing phlebotomy as a regulated profession.

Call to Action

In light of these affirmations and dedications, the Coalition seeks to accomplish the following:

  • Promote and advance legislation that mandates all health care personnel with blood specimen collection responsibilities be certified or licensed.
  • Promote and advance minimum training and ongoing competency requirements for all health care personnel with blood specimen collection responsibilities.
  • Promote and advance education in proper blood specimen collection and processing procedures.
  • Recruit organizations, companies, facilities and individuals dedicated to improving the quality of specimen collection personnel to achieve our objectives.
  • Identify and assist individuals who are interested in advancing phlebotomy certification/licensure legislation.

Comments regarding the AAMA’s possible participation in this coalition are welcomed and may be e-mailed to Executive Director Balasa at dbalasa@aama-ntl.org.

Questions? Contact Donald A. Balasa, JD, MBA, at dbalasa@aama-ntl.org or 800/228-2262.