Opinion
No. 74-709
Decided June 4, 1975.
Physicians and surgeons — "Practice of medicine" construed — Collecting blood plasma from donors by "plasmapheresis."
APPEAL from the Court of Appeals for Franklin County.
Appellant is engaged in the business of collecting blood plasma from donors by a process known as "plasmapheresis." This technique, involving more complicated procedures than the taking of whole blood, may be described in the following manner.
When a potential donor arrives at appellant's office, he is met by a receptionist who takes a complete medical history. The donor is read a release form, mandated by federal regulations, which releases appellant and its agents from any dangers that may be caused to the donor by the procedure.
At this time, the receptionist informs the donor of the possibility of "hyperimmunization," an allergic reaction to the presence of antigens which are later injected into the donor's system. He is told that he may go into shock if hyperimmunization occurs. The donor is also warned that a "hemolytic transfusion reaction" may result if he would happen to receive another donor's blood cells during the process. The possibility that one could go into shock and die as a result of this reaction is explained. The donor must sign the release form.
The donor is then given a physical examination which includes the taking of blood pressure, pulse, temperature, weight, and a hematocrit (a blood test measuring the ratio of the volume of blood cells to the volume of whole blood). The examiner must also evaluate whether the donor has any stigmata of drug addiction or alcoholic habituation. From this data, a determination is made, based upon established standards of the American Association of Blood Banks, as to whether the person is suitable for appellant's process.
The donor is taken to the donor room where a paramedical technician performs the veni-puncture and collects the requisite amount of blood in a bag. The bag is then placed in a centrifuge which separates the plasma from the blood cells, and the plasma is extracted into a pooling bag. After that step is completed, the remaining blood cells are mixed with a saline solution, and the mixture is allowed to run through a filtering tube back into the donor's vein at a set rate. This procedure of taking whole blood, and returning the blood cells to the donor, is then repeated to obtain the agreed upon amount of plasma.
After completion of this stage, the donor is asked if he will allow the injection of a tetanus toxoid. If he consents, he is given the toxoid in a stipulated schedule in order to produce an antibody in his blood from which an immune globulin is produced for use in treating tetanus. The antibody is obtained if, as desired by appellant, the donor returns for subsequent donations. Finally, the donor is paid for his donation.
Appellant maintains a physician on call for emergency needs, and its manual of operating procedures contains a representative list of instructions to be available to its staff for dealing with possible donor reactions to the procedure, including fainting, nausea and vomiting, convulsions, cardiac or respiratory difficulties, and hyperventilation.
Appellant sells the plasma to pharmaceutical firms which use it to produce the immune globulin for treating or preventing tetanus. The advantage of this process over whole blood donation is in volume, in that one may donate plasma approximately twice a week while giving whole blood only once every eight weeks.
Faced with the probability of imminent criminal prosecution for an alleged violation of R.C. 4731.34, appellant filed a declaratory judgment action in the Court of Common Pleas seeking a determination that its operation was not the practice of medicine as defined by the above section. The court found that appellant was not engaged in the practice of medicine. However, the Court of Appeals reversed, finding the procedures to be the practice of medicine within the meaning of R.C. 4731.34.
The cause is now before this court pursuant to the allowance of a motion to certify the record.
Messrs. Dargusch Day, Mr. Robert M. Draper and Mr. Langdon D. Bell, for appellant.
Mr. William J. Brown, attorney general, and Mr. Charles R. Jones, for appellees.
The sole issue in this appeal is whether the conduct of a blood donor center using the process of plasmapheresis is the practice of medicine as defined by R.C. 4731.34. That section, in pertinent part, provides:
"A person shall be regarded as practicing medicine * * * within the meaning of Sections 4731.01 to 4731.60, inclusive, of the Revised Code * * * who examines or diagnoses for compensation of any kind, or prescribes, advises, recommends, administers, or dispenses for compensation of any kind, direct or indirect, a drug or medicine, appliance, mold or cast, application, operation, or treatment, of whatever nature, for the cure or relief of a wound, fracture or bodily injury, infirmity, or disease * * *."
Appellant argues that the relevant provisions of R.C. 4731.34 make the receipt of a fee, or compensation, essential to a finding that one is practicing medicine within the terms of the statute. It asserts that not only is no compensation received from the donor, but, to the contrary, the blood center reimburses the donor for the plasma.
From a reading of the applicable provisions of R.C. 4731.34, we agree that the receipt of "compensation of any kind" is a necessary element to a finding that one engages in the practice of medicine, and past cases have so indicated. See State v. Marble (1905), 72 Ohio St. 21, 73 N.E. 1063; Cincinnati v. Vilardo (1965), 5 Ohio App.2d 169, 214 N.E.2d 683. However, there is no requirement within R.C. 4731.34 that the compensation be of a monetary nature; indeed the statutory language "compensation of any kind" indicates compensation in forms other than money was perceived by the General Assembly in enacting the statute. In this case, appellant obtains blood plasma from donors, which it sells to pharmaceutical firms. Therefore, it receives "compensation" within the meaning of R.C. 4731.34.
Appellant's procedures include the initial in-depth medical history and a physical examination consisting of a series of tests outlined in the above statement of facts. From the medical history and results of these tests, appellant must evaluate whether the prospective donor is acceptable. This determination necessarily involves a diagnosis of the donor's current health on the basis of a medical examination. Medical decisions also arise in the return of the isolated blood cells, and in the injection of the tetanus toxoid.
From all of the above, we conclude that appellant engages in the practice of medicine within the scope of R.C. 4731.34. Therefore, the judgment of the Court of Appeals is affirmed.
Judgment affirmed.
O'NEILL, C.J., HERBERT, CORRIGAN, STERN, CELEBREZZE, W. BROWN and P. BROWN, JJ., concur.