Thank you for inviting the Pennsylvania State Perfusion Society to discuss HB500 and HB 501establishing a modality for the licensing of perfusionists.

My name is Craig Gassmann and I am a perfusionist currently practicing in Lancaster, PA. I have been a perfusionist for over 23 years. I am also the Chairman of the Government Relations Committee of the Pennsylvania State Perfusion Society, (PSPS) and the state liaison to our national society, The American Society of Extracorporeal Technology, (AmSECT). My colleagues who have helped write this testimony are Mr. Ralph Montesano, the President of our State Society and Mr. John Mitchell, CCP, Member of the Government Relations Committee. Our state society represents the 227 perfusionists who live in Pennsylvania. They are employed by hospitals, physician practices, medical service corporations, and independent contractors.

Since many of you may not know what a perfusionist is, we would like to describe our profession. In HB’s 500 and 500, the terms "extracorporeal circulation" and "perfusion" are given strict definitions. "Extracorporeal circulation" is defined as "the diversion of a patient's blood through a heart-lung machine or similar device that assumes the functions of the patient's heart, lung, kidney, liver or other organs. "Perfusion" is defined as "the functions necessary for the support, treatment, measurement or supplementation of the cardiovascular systems or other organs, or a combination of those functions, and for ensuring the safe management of physiologic functions by monitoring and analyzing the parameters of the systems under the supervision of a physician."

A perfusionist’s primary work environment is the Open Heart Operating Room. In order to "open the heart," the surgeon needs to stop the heart from beating and remove the blood from inside it. Obviously, the patient needs to be kept alive while this is done. The heart-lung machine is the device used to do this. A temporary bypass is created around the heart and the lungs. Blood is circulated through the heart-lung machine wherein the function of the lungs, (gas exchange) is performed. The blood is then returned to the body with a pump and circulated to the organs and tissues. A perfusionist is the person who operates the heart-lung machine and keeps the patient alive while the heart is stopped.

The perfusionist’s primary responsibility is to monitor and adjust the patients total blood flow, ensuring that the brain, kidneys and other vital organs receive adequate oxygen and nourishment to sustain life. In addition, the perfusionist adjusts oxygen and carbon dioxide levels, the acid/base balance, the blood clotting status, fluid and electrolyte balance and a multitude of other physiologic parameters essential to life.

While the patient is on the heart-lung machine, the heart is usually stopped from beating, or "arrested". Without the aid of the heart-lung machine, cardiac arrest is a life threatening situation. However, with the aid of the HLM, induced cardiac arrest is a safe and effective technique. The perfusionist administers the chemical solutions which arrest the heart and monitors their effectiveness. In a joint effort with the surgeon, the perfusionist is responsible for the protection of the heart muscle during the period where it has no blood supply. At the end of the procedure, the arresting solutions are replaced with normal blood flow and the heart resumes beating and pumping blood. This process is truly one of the most amazing "miracles of modern medicine."

From this concise description, it is apparent that a perfusionist’s role is highly technical and specialized. It carries a very unique knowledge and skill set, unlike any other in medicine. It also carries tremendous responsibility. Every time a perfusionist utters the phrase, "Pump on," he or she literally has the patient’s life at their fingertips. There is no room for error, and mistakes in perfusion can be fatal. During an open heart surgery case, other than the surgeon, and perhaps the anesthesiologist, there is no one on the surgical team that can kill the patient faster than a perfusionist.

Perfusionists need to give medications and anesthetics during the course of the procedure. Drug errors such as over-dosage, under-dosage and incorrect drug administration can certainly cause patient injury and death. In addition, perfusionists sometimes need to give blood during the course of the pump run. If an incorrect unit of blood is given to a patient, it can cause a transfusion reaction leading to injury and death. Although rare, there are many other risks associated with blood transfusions, such as AIDS, hepatitis, Cytomegalovirus, (CMV) and other blood borne pathogens. Perfusionists must weigh the risk of transfusion against the risk of inadequate blood supply.

During a typical pump run, there are literally hundreds of other opportunities for error, either human or mechanical. Here is a list of some of the accidents that can (and do) happen:

This is a short and incomplete list of problems that can develop during the patient’s exposure to the heart-lung machine. Obviously, the actions, judgments and decisions made by a perfusionist can have a significant impact on the outcome of an open heart surgery procedure.

Perfusionists work "under the supervision of a physician," usually the cardiac surgeon or the anesthesiologist. While these physicians have a thorough understanding of the physiology of perfusion, the actual operation of the machine is usually not part of their training or expertise. Moreover, these physicians have their own functions to perform and they can, at times, be all-encompassing, leaving the perfusionist to make judgments and take actions without direct supervision. At these times, perfusionists rely on pre-written policies and protocols to guide their actions. They also depend on their training and experience to help them make correct clinical decisions and to safely operate the heart-lung machine.

Because perfusion encompasses such a unique knowledge base and skill set, it is imperative that perfusionists receive specialized training in a cross section of disciplines. This can only be accomplished at a specialized school of perfusion technology. There are currently two accredited schools of perfusion in Pennsylvania, Presbyterian Shadyside School of Cardiovascular Perfusion in Pittsburgh and Drexel University, College of Nursing and Health Professions in Philadelphia. There are an additional 19 perfusion training programs across the United States.

These schools are accredited by the Commission on Accreditation of Allied Health Education Programs (CAAHEP). In order to receive accreditation, each school is required to offer a specific curriculum for perfusionists with courses in math, chemistry, physics, anatomy, physiology, pathology, pharmacology, hematology and biomedical engineering. They are taught intra-operative monitoring, laboratory testing and quality control procedures. They are given instruction in the design and operation of the heart-lung machine, and management of clinical perfusion scenarios and catastrophic events. They are introduced to other related instruments, such as cardiovascular support devices, artificial hearts and blood processing and salvaging equipment.

The school provides classroom instruction for the didactic portion and an animal lab for practical, "hands-on" training. Once the perfusion student has shown competence in the animal lab, they are allowed to go into the operating room, where they are required to perform a minimum of 75 supervised perfusions for open heart procedures. A minimum of 10 of those procedures must be pediatric procedures. After completion of the clinical component, the perfusion student can "graduate" from perfusion school.

After graduating from an accredited school of perfusion and performance of an additional 50 perfusion procedures, a graduate is eligible to take the American Board of Cardiovascular Perfusion (ABCP) certification exam. This is a two-part exam, the Perfusion Basic Science Examination (Part 1) and the Clinical Applications in Perfusion Examination (Part 2). Upon successful completion of the exam, the graduate receives the title of Certified Clinical Perfusionist, (CCP).

This entire process from perfusion school to certification ensures that perfusionists have the thorough and rigorous training in all the areas of study necessary to safely operate the heart-lung machine on fellow human beings. There is just one problem: there is no legislative requirement for perfusionists to go through this process, at least not in Pennsylvania, (twelve other states do have some form of state mandated credentialing process). For many Pennsylvania perfusionists this process is voluntary. The only regulatory requirement is the following, excerpted from The Pennsylvania Code:

Graduation from an accredited school of perfusion and passage of a certification exam are laudable goals, and it appears to be the intent of this regulation to require this. However, close reading of the regulation shows that it only imposes the requirement on a certain segment of the perfusionist population; those who are employed at the same hospital for more than two years. What about perfusionists who are not employed by hospitals? Many perfusionists fall into this category: self-employed perfusionists who work at multiple hospitals, service-company employed perfusionists who move from program to program, perfusionists who are employed by physicians, perfusionists who travel into the state to do temporary work, etc. Also, what about perfusionists who work at a hospital for two years, never get certified, and then move on to another hospital? None of these perfusionists are required by law or regulation to be certified, or to demonstrate that they have been trained and have met, as proven by examination, the standards which will assure they are qualified to operate such a highly specialized and complex piece of equipment as the heart-lung machine.

There are other concerns with the referenced regulation. It does not address the full range of activities that perfusionists engage in, limiting the definition of a perfusionist’s scope of practice to "the operation of the extracorporeal pump oxygenator (heart-lung machine)." Perfusionists also operate blood salvaging and processing devices, cardiac assist devices, artificial hearts, pacemakers and numerous other modalities. Second, the regulation does not address the full range of venues in which those activities take place. Besides the open heart operating room, perfusionists can work in vascular, orthopedic, neurologic, oral and maxillo-facial, and general surgery OR’s, the cardiac catheterization laboratory, the intensive care unit, the oncology clinic, physician and dentist offices, wound centers and other medical care delivery sites.

Most importantly, this regulation places the oversight of the credentialing process at the hospital level. A hospital’s human resources department or medical staff office can set the standards for perfusionists working there, especially those working there for less than 2 years. Many hospitals outsource their perfusion services to service companies or other short-term service providers. They may not have any perfusionists who stay at the hospital for more than two years. Credential checking is left to the diligence of the hospital. Some hospitals may do an excellent job of checking potential perfusionist’s credentials; others may not.

To remove any doubt, the process for credentialing of perfusionists should to be at the state level. The state of Pennsylvania should require that all perfusionists practicing in the state and exposing Pennsylvania residents to the risks associated with cardio-pulmonary bypass have the proper credentials, the education and training to perform the procedure and the knowledge and skills to deal with any problems that develop. The requirement for proper education and training must include ALL perfusionists who work in Pennsylvania, not just those employed at a hospital for more than to years. The only way to ensure this is to enact state mandated licensing of perfusionists. Licensing of perfusionists will ensure that ALL perfusionists practicing in the state have met the minimum level of professional proficiency (i.e. graduation from an accredited training program and passage of a professional certification examination) as a practice entrance requirement.

As stated previously, perfusionists give medications, anesthetics and blood products. The state of Pennsylvania has already recognized that the administration of blood, drugs and anesthetics to patients can pose a serious risk to public health and safety. The state requires licensure for all other allied health professionals who give medications and blood products. There should not be a double standard for perfusionists. They should be held to the same high standards as their allied health professional colleagues. Licensure of perfusionists would ensure this.

According to the most recent Pennsylvania Health Care Cost Containment Council (PHC4) report on Coronary Artery Bypass Graft Surgery, in 2004, over 22,500 patients had open heart surgery in Pennsylvania. Of those, over 13,000 had Coronary Artery Bypass Grafting, (CABG). With an in-hospital mortality rate of 2.3%, this means that 309 Pennsylvanians lost their lives during the hospitalization for their coronary bypass surgery. It is not known whether any of these deaths is directly attributable to a perfusion error. Whether they are or not, no patient should die because the State of Pennsylvania was lax in ensuring the credentialing of perfusionists. If licensing of perfusionists eliminates even one patient death, it is well worth the effort, especially to that patient and everyone who cares about them.

Representative Santoni has introduced legislation to enact such a perfusionists licensing modality. HB’s 500 and 501 would add perfusionists to the list of other allied health professionals credentialed through the State Board of Medicine and the State Board of Osteopathic Medicine respectively. (In addition to physicians, other allied health professionals currently credentialed by the State Board of Medicine include physician assistants, radiology technicians, respiratory care practitioners, nurse-midwives, and acupuncturists.). The bills would rigorously define a perfusionist’s Scope of Practice along with the credentials required to perform that scope of practice. They would also give the Board the same type of oversight it has for physicians and licensed allied health professionals with respect to substance abuse, disciplinary action and the incompetent practice of medicine. These bills would protect the public by ensuring that all persons designated to operate a heart-lung machine and related technologies would possess the training and qualifications to do so safely. The large majority of the members of our profession believe that state licensing of perfusionists is in the best interests of the public and, in particular, of patients requiring a heart-lung machine for open heart surgery.