The Ambiguity of the Scope of Legal Liability of Japanese Nurse Practitioners with Regards to their Medical Practice: A Qualitative Research

Background : The role of nurse practitioners (NPs) is always expanding. The Japanese Nurse Practitioner (JNP) system was initiated in 2015 with the goal of shifting some aspects of doctors' work to various other healthcare professionals including nurses. Depending on the way in which JNPs fulfill their roles, a certain degree of efficacy has been exemplified with regard to patients and facility users. NPs are considered legally liable for their medical practice, because they ultimately perform that practice on behalf of a doctor; however, there is a degree of ambiguity in real life. It is necessary to clarify NPs' legal liability, to ensure the safety of medical practice and protect them in medical procedures performed on behalf of physicians. This study aimed to clarify how JNPs fulfill their own legal liability in medical practice. Methods : A qualitative, inductive research design was adopted to record participants’ opinions. The survey was conducted from October 2017 to February 2018. The participants were nurses working as JNPs at general hospitals in eastern Japan. We recruited participants via snowball sampling. Results : With regard to JNPs’ legal liability in their medical practice, three scopes of understanding were observed: “identify whether the JNP has the ability to perform the assigned medical procedure,” “anxiety when performing medical procedures in place of a doctor,” and “follow up medical practice through to the end.” Conclusions : We demonstrated that JNPs fulfilled their own legal liability in medical practice. They were legally responsible for the implementation of medical procedures and had to protect themselves, as their legal position was ambiguous. Moreover, even if JNPs performed legally ambiguous medical procedures, they fulfilled their responsibility as JNP through their actions. Furthermore, JNPs accepted that diagnosis and prescribing could be performed on behalf of doctors if trusting relationships were established with doctors.


Background
The role of nurse practitioners (NPs) is always expanding. The scope of the medical practice performed by practitioners varies somewhat from country to country and state to state. NPs are able to perform certain levels of diagnosis and treatment autonomously. Moreover, they compensate for a 3 shortage of doctors and provide medical care in areas in which there are few doctors [1]. For example, although there are some differences between countries, NPs in the United States [2], the United Kingdom [3], Canada [4] and Australia [5] are permitted to perform diagnoses, order tests, and prescribe medications. The Japanese Nurse Practitioner (JNP) system was initiated in 2015 with the goal of shifting some aspects of doctors' work to various other healthcare professionals including nurses. JNPs perform medical tasks within the bounds of comprehensive instructions compiled within procedural guidelines established by doctors, such as "the scope of a patient's condition, which permits medical support from a nurse" and "the scope of the medical support" [6]. JNPs are able to respond to patients faster using their own judgment because of the set scope of the written procedural guidelines.
Depending on how JNPs fulfill the requirements of a role, effectiveness measurements such as shortening the hospitalization period for patients and early response to emergencies have been observed for patients and institutional users.. For example, in cases involving NPs' involvement with adult patients with chronic renal failure, the effective management of blood pressure and cholesterol and blood sugar levels were found to be outstanding when compared to general care [7]. In addition, in nursing homes, NP intervention was shown to significantly reduce the number of times emergency transportation was used and shorten the duration of hospitalization for residents [8]. Moreover, when NPs and physicians were compared in emergency rooms, there was no significant difference in the number of tests ordered in triage, and the small difference observed did not affect the overall time that patients spent in emergency room beds [9]. NPs possess a high degree of knowledge, are able to make quick diagnoses and judgements, can respond to changes in patients' conditions, and provide patients with necessary medical care on behalf of doctors.
Moreover, NPs are considered legally liable for their medical practice, because they ultimately perform this practice on behalf of doctors, but in reality, there is some ambiguity regarding the exact situations in which NPs can be held liable. For example, in cases in which NPs and physicians work together, although NP activities are evaluated by the doctor, there is some overlap in their scope of practice, making the legal liability vague [10]. In addition, NPs are legally unable to perform advanced medical procedures independently [11]. Although NPs are an integral part of medical teams in emergency departments, they must have sufficient practical ability to ensure the safety of the practice and avoid litigation [12]. However, NPs hold a large amount of responsibility and as the number of patients to whom an NP responds daily increases, the number of medical malpractice insurance claims increases [13].
It is necessary to clarify NPs' legal liability, to ensure the safety of medical procedures and protect NPs in medical practice performed on behalf of physicians. This study aimed to determine how JNPs fulfill their own legal liability in medical practice. The results could provide suggestions regarding patient safety and the protection of NPs. In addition, knowledge could be accumulated to expand the role of JNPs.

Research design
A qualitative, inductive research design was adopted to explore participants' opinions. This design allows improvement of the understanding of the wholeness of a phenomenon and discovery of its inherent depth, richness, and complexity via its meaning [14]. The study aimed to clarify how Japanese Nurse Practitioners (JNP) fulfill their own legal liability in medical practice. Nursing practice is a fluid phenomenon that is influenced by contexts such as the human influences of nurses, patients, or medical professionals; environmental issues; and the situation surrounding the practice itself.
However, it is difficult to control such context in research. Therefore, we used a qualitative, inductive research design that could capture the phenomena of JNPs' thought processes and the surrounding context comprehensively. The study was conducted as a preliminary survey to examine nurses' responsibilities.

Setting and participants
The survey was conducted from October 2017 to February 2018. The participants were three nurses working as JNPs at general hospitals in the eastern region of Japan. The researchers explained the purpose of the study to six JNPs and invited them to participate in the study, and three consented to do so. These three JNPs belonged to the cardiac surgery, respiratory medicine, and emergency departments. Each JNP held between 9 and 22 years' experience as a nurse in addition to 2-5 years' experience as an NP. The JNP system, which facilitates the implementation of specific medical practices, was established in 2015. However, in certain hospitals, even if one has obtained the JNP qualification, the situation could arise in which working as a JNP at one's affiliated hospital is not permitted. The inclusion criterion for participation in the study was active employment as a JNP for more than 2 years. We recruited participants via snowball sampling.

Data collection
Data were collected via participant observation and interviews. Researchers initially observed JNPs while they practiced nursing and took field notes. The reason for this was that nurses are not always aware of their legal liability in practice, and it was easier to reconstruct these scenarios during subsequent interviews. The observed scenarios included handovers between nurses, confirmation of a doctor's instruction, conferences with medical staff, and patient-related practice. Observation was conducted for 2-3 days for each JNP. Individual interviews with JNPs were conducted once or twice for each JNP and took place in rooms in which privacy could be maintained. Each interview lasted approximately 1 hour. Based on the field notes, we asked JNPs to think about their own legal liability in terms of certain examples of medical practice. Each interview was recorded with the participant's permission.

Data analysis
We described JPNs' legal liability with regard to certain medical procedures comprehensively. The theme of the analysis was "how JNPs fulfill their own legal liability in medical practice." When analyzing data, it is possible that researcher bias could arise in data interpretation; therefore, we considered the appropriateness of the conclusion while returning to the data constantly. Further, to minimize such bias, we were supervised by researchers with experience in qualitative research and nurses with experience in nursing research. This ensured the credibility and validity of the study content and results.

Ethical considerations
The study was approved by the ethics committee at Tohoku University Graduate School of Medicine 6 (Approved July 24, 2017). We described the study in detail to the nursing department manager and participants at the facility at which the JNPs worked, both in writing and verbally. Thereafter, written informed consent was obtained from all participants. When necessary, the study documents were submitted to the ethics committee at the nurses' facility, and approval was obtained. We assured participants of anonymity, freedom, and their right to suspend or withdraw participation in the research at any time. We explained the benefits and disadvantages of participation in the research, how we would manage the collected data, and informed participants that the data would be used only for research purposes.

JNPs' fulfillment of legal liability in medical practice
The results of the analysis of JNPs' legal liability in their medical practice showed three scopes of understanding: "determination as to whether the JNP has the ability to perform the assigned medical procedure," "anxiety when performing medical procedures in place of a doctor," and "follow up medical practice through to the end." Determination as to whether the JNP has the ability to perform the assigned medical procedure With regards to the first scope of understanding, the data showed that even if a JNP was requested or permitted by a doctor to perform a medical procedure on behalf of that doctor, the JNP was responsible for assessing the patient's condition and the content of the procedure to be performed and determining whether to perform the medical procedure. Depending on the type of medical procedure involved, even if there was no problem with a JNP's ability to perform the procedure, it was possible that the patient's state could suddenly change to one that would require a doctor, because of the implementation of the procedure. Therefore, even if JNPs were permitted to perform a certain medical procedure by a doctor, they might not do so if they judged it to be dangerous.
When conducting medical practice, it cannot be said that accidents will definitely not occur.
Specifically, when performing invasive procedures instead of the doctor. The doctor has said, "I'll leave everything to you, so you can do anything." However, if any complications occur after medical procedures, the doctor may say, "You were the one who did this." In that case, it's tough, because I'm 7 forced to accept legal liability. When it comes to legal liability, I feel that I have to be careful when For the second scope of understanding, the data showed that when JNPs were tasked with performing medical procedures on behalf of a doctor, but they were not among their specified 38 performable medical tasks, they experienced anxiety about whether or not they should be performing the tasks and felt pressure to not make mistakes whilst doing so. By law, JNPs do not have the authority to diagnose and prescribe directly. However, if doctors had JNPs act as their substitutes, diagnoses and prescriptions were provided. Although these actions performed on behalf of a doctor were ultimately confirmed by the doctor, who remained responsible for determining the content of the orders, the JNPs were required to input their own ID numbers to implement medical procedures and therefore felt pressure to not make mistakes in diagnosis and prescription, and anxiety about their own legal liability in the case of mistakes occurring. I think that it's best to check and assess bed sores and debridement every day, but I can't follow up on this because I can only check and assess those conditions once a week. I have to leave it to the doctors or other nurses, but I feel some hesitation in leaving these tasks to others…The patient's condition may be alright when I'm looking after them, but infection, bleeding, or something else could set in later on. These things are real possibilities, so I feel I need to be somewhat cautious. If our hospital weren't so far from patients, we'd be able to respond to patients more quickly. (NP2)

Discussion
Ambiguity of JNPs' position in the legal system The results of the study indicated that JNPs were careful to determine whether they were able to perform certain medical procedures and assessed the difficulty of medical practice when they were asked to perform tasks on behalf of a doctor. The results of the current study were identical to those of a previous study showing that the law was a barrier to independent practice for NPs [11]. NPs 9 practice medical procedures in training; therefore, they are able to implement the procedures if they intend to do so. However, if complications result from the medical procedures performed, additional medical intervention is required to treat the complications. The medical procedures that NPs perform are carried out under the direction of a doctor. However, when additional medical care is required, it goes beyond the range of actions that can be performed under the direction of a physician or be determined according to NPs' judgment. JNPs also considered whether the medical procedures they performed caused complications and considered whether to perform further medical procedures to minimize risk to patients.
It is believed that JNPs' follow up of medical procedures that they have performed is an expression of their responsibility. In team-based medical care in cooperation with doctors and pharmacists, it is difficult to clarify the scope of responsibility and the role of JNPs in performing specific procedures [15]. Even in Japan, the existence of JNPs in medical practice is not widely implemented, and it has been shown that it is difficult to ascertain JNPs' role [16]. In the current study, the range of medical procedures performed by JNPs differed between facilities and medical departments. With respect to the unclear scope of JNPs' role, we considered this to be attributable to the fact that the recognition of the scope of the JNP's activity is inconsistent within each facility or department to which JNPs belong.
In situations in which the JNPs' role is unclear, it is assumed that societal reaction to the failure of a medical procedure will differ according to whether the actions that resulted in that failure were those of a doctor or a JNP. As it is recognized by law that doctors perform medical procedures, they are responsible for the procedures they perform. In contrast, JNPs' role is unclear within the law, despite their desire for the legal liability to be more clearly defined Therefore, the issue surrounding responsibility for medical procedures performed by JNPs under the instruction of physicians requires further consideration.

Relationship between JNPs and physicians
The results showed that JNPs felt pressured to perform medical procedures in place of doctors. In particular, JNPs felt pressured to diagnose and prescribe medication to patients on behalf of physicians. However, diagnosis and the prescription of medication on behalf of a physician is not listed among the 38 specific actions that JNPs perform. In such situations, it is assumed that the reason JNPs accepted and implemented diagnosis and medication prescription on behalf of doctors was that they wished to fulfill the doctors' expectations and avoid bothering superior doctors with misdiagnoses or incorrect prescriptions. It is thought that doctors had requested the performance of diagnosis and prescription in consideration of the JNPs' ability as their subordinates. JNPs managed the pressure of being a substitute for doctors through the establishment of trusting relationships with those doctors.
When a doctor instructs a JNP to prescribe a drug that is unknown to the JNP, the JNP will always check drug information, such as efficacy, side effects, and proper use, with a doctor or pharmacist.
The effects of comprehensive drug evaluations by NPs are effective for symptom management and have been found effective for the medical economy of the prescription of drugs tailored to patients' needs [17]. If JNPs were to be able to change the dosage of drugs or change the drug to be administered according to the patient's condition, it could lead to treatment and nursing tailored to the patient's condition.

Limitations of the study
The participants were three JPNs working in hospitals. It was difficult to recruit research participants because in Japanese hospitals, JNPs often work under the supervision of doctors, who tended to not grant permission for participation. Despite the fact that doctors were their immediate superiors, JNPs in fact belonged to the nursing department. In Japan, with its aging society and lack of physicians, further expansion of the role of JNPs is to be expected and JNPs will play an important role in improving medical care. We need to be clear on the exact limitations of JNPs' job role from a legal perspective. It is therefore necessary to accumulate knowledge regarding the role and actual working conditions of JNPs, and discuss their responsibilities through further research.

Conclusions
We clarified that JNPs accepted their own legal liability in medical practice. JNPs were legally responsible for the implementation of medical procedures as follows: 1) "identify whether the JNP has the ability to perform the assigned medical procedure," 2) "pressure to perform medical procedures 11 in place of a doctor," and 3) "follow up medical practice through to the end." JNPs were in a situation in which they had to protect themselves, as their legal position was vague. Even if JNPs performed legally ambiguous medical procedures, they fulfilled their responsibility as JNPs through their actions.
Moreover, JNPs accepted that diagnosis and prescribing were performed on behalf of doctors if trusting relationships were established with doctors. We surmise that if the scope of legal liability of JNPs were more clearly defined or if the role of JNPs were to be expanded, they would perhaps be able to fulfill their tasks without feeling anxious as to whether or not they were operating within the scope of their legal liability.
Abbreviations JNP = Japanese nurse practitioner NP = nurse practitioner

Ethics approval and consent to participate
The study was approved by the ethics committee at Tohoku University Graduate School of Medicine (Approved July 24, 2017).

Availability of data and material
Datasets generated and analyzed during the current study are not publicly available for preliminary study of the project, but are available from the corresponding author with reasonable requirements.

Competing interests
The authors declares there is no competing interest.