An advanced practice nurse, who performed a periosteal puncture to collect bone marrow under the guidance and supervision of a physician at Asan Medical Center (AMC), has been convicted of conducting an unlicensed medical act by a local court.
The decision overturned a lower court ruling that had found such a procedure legal because it was ordered or delegated by a physician.
A periosteal puncture, performed to diagnose hematologic and oncologic diseases, is an invasive test in which a needle is inserted into the pelvic bone area to collect bone marrow blood, and a thicker, longer needle is used to collect bone marrow tissue.
The Seoul Eastern District Court has recently overturned the original verdict of not guilty against AMC, which was accused of violating the Medical Service Act by ordering nurses to perform unlicensed medical procedures, and sentenced it to a fine of 20 million won ($15,200).
From April to November 2018, AMC made advanced practice nurses at its hematology, oncology, and pediatric hematology-oncology departments perform periosteal punctures to collect bone marrow samples. The oncology nurses observed doctors performing periosteal punctures for about a month and received training on how to perform the procedure and what to expect.
In 2018, the Korean Hospital Doctors Association received the report through the PA (Physician Assistant) Illegal Medical Practice Reporting Center and filed a report with the police against AMC and related medical staff.
Appeals court overturned the lower court’s not-guilty ruling
The prosecution filed a summary indictment with a fine of 30 million won, but the first trial court found no violation of the Medical Service Act.
The first trial court acquitted the doctor in August of last year, saying it could not be seen as illegal that a doctor orders or delegates periosteal punctures to collect bone marrow samples to oncology nurses.
The court also noted that nurse specialists are performing periosteal punctures overseas. The verdict was based on the medical societies’ opinion that periosteal punctures are unlikely to cause nerve damage or serious bleeding in patients and that it is difficult to consider it inappropriate for a nurse practitioner to perform them under the guidance and supervision of a doctor.
The prosecution appealed, and the appeals court ruled that a periosteal puncture performed by an oncology nurse practitioner is unlicensed medical practice.
Notably, the appeals court found that even if the Ministry of Health and Welfare revised the rules to define the scope of practice of nurse practitioners as "work performed under the guidance of a physician," periosteal puncture, an invasive medical procedure, is a medical procedure that a physician must perform.
"If a nurse performs a periosteal puncture, regardless of whether a doctor is present, it is not a medical assistance but a medical procedure itself," the appeals court said. "The nurse's act (periosteal puncture) is a medical procedure beyond the scope of her qualifications and constitutes unlicensed medical practice under Article 27 Paragraph of the Medical Service Act."
The court, noting that there had been cases of patients dying while undergoing periosteal puncture at other hospitals, pointed out that "depending on the patient's situation, there is a possibility that a risk to life or limb may occur due to bleeding and other risks.”
In AMC, nurses also performed them without the presence of doctors if doctors had requested bone marrow tests through the appointment program, the court said, noting that "it is difficult to say that there was direct guidance and supervision from doctors."
At the time, AMC set the number of periosteal puncture tests at 12 per day for each nurse, and if the number exceeded, a doctor would perform them.
"They are only recognized as nurses with expertise in the field of oncology," the court also said regarding the qualifications of oncology nurses. “Like other nurses, they cannot directly perform medical procedures that only doctors can perform even if they have a doctor's order.”
The court also rejected AMC’s allegations that oncology nurses are more skilled than doctors in performing periosteal punctures, thus reducing the risk of medical errors and that nurse practitioners perform periosteal punctures in foreign countries.
"Proficiency is only determined by how long a person has been practicing a particular medical practice," the appeals court said. “The mere fact that a case exists in a foreign country with a different medical law or medical system does not mean it should be handled the same in Korea."
It seems that the doctors ordered the nurse practitioner to perform the medical treatment in this case due to the overload of work, adding that "intent to practice medicine without a license is recognized."
However, considering that no risk or damage to the patient's health had occurred and that the doctor performed the periosteal puncture himself after the complaint was made, the court said it would impose a fine of 20 million won.
AMC has appealed the decision.
Hospital doctors’ group welcomes decision recognizing illegal PA
The Korean Hospital Doctors Association, which filed the case, welcomed the verdict.
"This ruling establishes a legal standard that reinforces the fact that unlicensed medical practice should not be allowed in any form for the health and safety of the public," the association said in a statement on Wednesday, adding that it is a clear recognition that illegal PA (physician assistant) practice is unlicensed medical practice.
"It is very important to be very careful when deciding who should perform certain medical procedures, and it takes a lot of validation, research, and the consent of the entire medical team and the patient before a medical procedure can be performed without a physician," the association said. "If a very invasive medical procedure like periosteal puncture becomes a medical procedure that a nurse can perform, it could change the role of many medical procedures that are less invasive than a periosteal puncture but are still required to be performed by a physician."
"The Supreme Court's ruling will not be much different from the appeals, as the logic of innocence in the first trial was all refuted in the appeals," the association said. "We will not ease our tension until the end and confirm the final ruling."