Law nº 5905/73, which creates the Federal and Regional Nursing Councils, discipline that this body aims to discipline the exercise of the nursing profession.
There are, in this perspective, favorable precedents arising from the Federal Regional Court of the 1st Region, in a similar matter:
"ADMINISTRATIVE. REGIONAL COUNCIL OF NURSING. JUDICIAL MEASURE TO COMPEL HOSPITAL ESTABLISHMENT TO HIRE A NURSE TO MANAGE ITS NURSING TEAM. LACK OF LEGAL FORECAST. RESOLUTION WITHOUT BINDING FORCE. INADMISSIBILITY. ACTIVE ILLEGITIMITY AD CAUSAM RECOGNIZED. ATTORNEY FEES AS A PERCENTAGE OF THE VALUE OF CAUSE WHEN THERE IS NO CONVICTION. LEGITIMACY.
Since there is no legal provision to authorize the Regional Nursing Council to require that a hospital establishment hire a nurse to manage its nursing team, a simple Resolution could not do so because “”no one will be obliged to do or not do anything except by virtue of the law””. (Federal Constitution, art. 5, II.)” (AC No. 1989.0123269-3/MG)
“REGIONAL NURSING COUNCIL. RADIOLOGY CLINIC. REQUIRED REGISTRATION FOR ESTABLISHMENT REGISTRATION. DETERMINATION OF THE NURSE'S TECHNICAL RESPONSIBILITY NOTE. USURPATION OF POLICE POWER AND LACK OF LEGAL FORECAST. 1. The defendant's primary objective is to provide services in the field of radiological medicine, which is why it is registered with the Regional Council of Medicine in the region where it operates. 2. Article 1 of Law nº 6.839/80 prohibits the duplicity of registration in the Professional Council, by establishing that the registration will be made by the basic activity developed by the company. 3. Upon finding that the respondent is acting irregularly, the Nursing Council is responsible for prosecuting the establishment, and not forcing it to hire a nurse to assume the leadership of the nursing service and to record the technical responsibility of this professional. 4. It offends the principle of legality, enshrined in art. 5, II, of the Major Law, require, by means of a Resolution, that the respondent make a note of technical responsibility for nursing professionals, since only the law in the strict sense can impose limitations on the administrator5. Appeal and official shipment improvidas." (AC No. 1997.34.00.036102-7/DF)
There are even lawsuits that discuss the validity of this and other COFEN Resolutions, not yet judged by the Judiciary, which will be decisive for the solution of this type of conflict.
We found, in this sense, a decision in the provisional guardianship that determined that the Hospitals that lead the action would not need to comply with said determination:
Finally, we emphasize that the understanding of the Federal Council of Medicine, issued in opinion nº 16/12:
https://sistemas.cfm.org.br/normas/arquivos/pareceres/BR/2012/16_2012.pdf
Indeed, this legal advice agrees with the understanding that the doctor also has professional qualification and scientific technical knowledge to DIRECTLY perform all procedures related to radiodiagnostics.
Therefore, considering that COFEN does not have any interference in the medical profession and there is no provision in the current legislation that governs this issue, we understand that it would not be necessary to hire a nursing staff, either for the services provided, or, mainly, because the doctor himself is qualified to perform all procedures related to Medicine.
It is important to warn, however, that the issue raises some doubts that have not yet been settled by the jurisprudence of the country, which is why, in the event of a possible lawsuit, the final result may not be favorable.
The requirement presented by health plan operators regarding the request to send images and reports of patients is illegal - and unequivocally characterizes the violation of medical confidentiality, since sensitive information is demanded from the patient that only belongs to them.
Intimacy and private life are inviolable, under the terms of Article 5, X, of the Federal Constitution. The Code of Medical Ethics, in line with the provisions set forth in the Magna Carta, expressly establishes that the doctor must maintain the confidentiality of the information of his patients, being forbidden to communicate facts that he is aware of due to his professional practice, except for just cause, legal duty or express authorization from the patient.
Indeed, the requirements formulated by the operators, object of this article, absolutely do not fit the legal exceptions that allow the violation of medical secrecy. In this exact sense, CREMEC opinion No. 22/2013 and CFM Resolution No. 1.819/2007.
For me, more recently, with the enactment of the General Data Protection Law (LGPD), the processing and transfer of people's data was even more restricted, especially when it comes to sensitive data. In this way, the sharing of patient data with health operators is strictly prohibited, unless formally authorized by the latter and in compliance with all the requirements of the Law.
Thus, based on the arguments mentioned above, we understand that it constitutes an ethical infraction, subject to punishment by the Regional Councils of Medicine, the transmission of any sensitive patient data - eventually contained in images and reports made - to health plan operators/insurers, as well as as an illegal act, capable of subjecting the service to inspection and fine, in addition to being sued by the patient, with the possibility of condemnation in the civil sphere.
Despite the fact that there is no Resolution on this topic, the Federal Council of Medicine, through opinion 23/2019, defined the requirements on the delivery of exams to patients, the conclusion of which was as follows:
1 – Online: it can be done exclusively with the use of PACS, for internal use at the institution itself and on computers with direct access. In this case, the patient must be provided, when requested, with a copy on CD/DVD and/or printed.
2 – CD/DVD: In this case, all series acquired must be recorded, with full and wide capacity for reformatting the exam. Whenever indicated, multiplanar series (axial, coronal and sagittal) should be recorded with a reduction in the number of images, in order to facilitate the evaluation by the attending physician. An executable file must be attached to the disk that allows access to the exam, at least to computers with Windows and MacOS operating systems. Under these same conditions, the recording can be performed on a pen drive.
3 - Printout: printing images on film or transparency remains the ideal standard for documenting radiological exams. however, there are already techniques and equipment that reproduce images with good definition on paper. When printed, the scanned exams must be accompanied by the indication of the compression rate used and the metric scale.
There is an opinion on the website of the Federal Council of Medicine that addresses precisely this issue.
According to CFM Opinion nº 18/15, “In the aforementioned case, in which it is a spontaneous demand, the consultant can only perform the questioned examination, and others that configure a medical act, if he assumes responsibility for the request, for the procedure and for guiding the patient on the necessary care.”
That is, it is allowed to perform an examination on a patient who does not present a request from the attending physician, if the Radiologist assumes full responsibility for the act performed.
There is no defined rule regarding the recording of the exam by the patient's companion.
The recording may involve very personal rights of the doctor who performs the exam, such as his image and voice. In addition, it involves an issue related to professional autonomy, not needing to accept that the recording takes place.
Thus, they may refuse to be filmed or have the examination filmed by the patient, if they do not wish to do so, out of respect for their professional autonomy, and may even refuse to perform the examination in case of insistence.
On the other hand, if you feel comfortable with the recording, there is no reason to prevent it from being done.
In this way, and even as a protocol definition to more effectively justify to the patient, eventual refusal in the recording, it would be important that this type of situation was pre-defined by the direction of the service.
The radiological report is an integral part of the examination and it must mention the technique used and the possible intercurrences that occurred during the procedure, as well as the description of the findings, which must be written succinctly and completely, ending with the printout of the specialist doctor.
The Federal Council of Medicine has already ruled that it is the radiologist who is responsible for issuing the report on the radiological examination and diagnostic imaging, as seen in Opinion 12/97 of the CFM, according to which " (…) in radiology services, the responsibility for issuing the report rests with the radiologist.”
Likewise, the Regional Council of Medicine of Paraíba has already defined that the radiological examination is a medical act that includes the examination and the respective report, being the execution and interpretation attributions of the specialist in radiology.
By the way, a timely transcription of part of the content of the Opinion CRM PB No. 01/2007, to know: “(…) The radiological examination is a medical act that includes the preparation of the examination and the report, and is therefore the exclusive competence of the latter.
It must be remembered that the request for the exam can be made by any doctor, but its execution and interpretation are attributions of the doctor specialized in radiology.”
Furthermore, the urgency or emergency of the requested examination does not remove this specialist's competence and responsibility for the examination.
We can conclude, therefore, that for all radiological examinations there must be the respective report, as it is an inseparable part of it, in such a way that the radiodiagnosis service must always keep a radiologist available, even if at a distance.
Thus, if the radiologist is called to attend to an urgent or emergency situation, he must attend the service to prepare the respective report.
It is the duty of the radiologist to indicate, when deemed necessary, other tests to complement the diagnosis.
Certainly, the radiological report must contain all the findings seen in the images, as well as the physician's diagnostic impression and, if he so wishes, the recommendation that other tests be carried out for the correct diagnosis of the disease.
In cases of urgency/emergency, it is even recommended that you contact the patient's attending physician, alerting you to the indispensability of additional exams.
We recommend consulting CFM Opinion 29/2018 on this issue, which had the following conclusion:
“CFM Opinion nº 20/2003 says that the specialist doctor may suggest, in the report, the performance of other exams, leaving the decision to request them to the attending physician. This opinion mentions the summary of PC Cremesp nº 11920/2001, which says that suggestions in radiological and anatomopathological examinations may be made through reports, provided that they are technically justified, leaving the indication of the suggested examination at the discretion of the attending physician.”
Article 1 of Federal Law No. 6.839/80 provides: “Art. 1 - The registration of companies and the recording of the legally qualified professionals in charge of them will be mandatory in the competent authorities for the supervision of the exercise of the various professions due to the basic activity or in relation to that for which they provide services to third parties. " In the case of radiodiagnosis clinics and other establishments that, although employing radiological techniques, have the diagnosis of diseases as their core (basic) activity – a private activity of physicians –, therefore, only before the Regional Council of Medicine in the region where it operates.
It is true that each professional (individual) must be registered with the Council that oversees their profession, however, establishments (legal entities) must only be registered with the Professional Council that oversees their core (basic) activity.
The Superior Court of Justice has decided in this sense, that is, that the registration of the establishment must be made only before the Professional Council that supervises the core activity, as seen in the following judgments: REsp 232839/PE, REsp 262090/PE, and REsp 197757/DF.
Therefore, as long as the establishment is already duly enrolled/registered with the Regional Council of Medicine, it is not necessary to comply with requests made by other Professional Councils (CRTR, Coren, etc.) sending a letter/official informing him that the establishment is enrolled/registered and inspected by the region's CRM, pursuant to Federal Law No. 6,839/80.
Indeed, given the police power that the Professional Councils exercise to carry out the inspection of the respective professionals, the clinic/establishment must provide the relevant information, when requested, in relation to its employees and collaborators who are registered with these professional inspection bodies. .
The Specialist Qualification Registration (RQE) is the formality that allows the physician to disclose his specialty/area of activity after registering with the Regional Council of Medicine of his jurisdiction, in accordance with CFM Resolution No. 1.974/2011.
Decree Law 8516, of September 10, 2015, which created the National Register of Specialists, established that the title of specialist “[…] is that granted by specialist societies, through the Brazilian Medical Association (AMB), or by medical residency programs accredited by the National Medical Residency Commission (CNRM).
Thus, it appears that obtaining the specialty is contemplated in two ways: passing the exams promoted by medical associations/
AMB or official medical residency programs.
The regulation of medical specialties in Brazil is jointly established by the Federal Council of Medicine (CFM), the Brazilian Medical Association (AMB) and the National Medical Residency Commission (CNRM), with CFM Resolution No. of all medical specialties and respective areas of expertise currently recognized – a list that is updated with some frequency.
Finally, it should be stressed that the disclosure of a medical specialty that cannot be proven constitutes an ethical infraction, pursuant to article 114 of the current Code of Medical Ethics.
With the advent of RDC 330/2019, which replaced ordinance 453/98, many doubts arose as to who would be able to perform the role of Technical Manager of the radiological service, as the aforementioned norm did not make this clear.
For this reason, ANVISA stated that the interpretation of a legally qualified professional should be in the sense that only professionals who meet the legal requirements for carrying out the activity can be designated as technically responsible for the diagnostic and interventional radiology service.
In this sense, technical note No. 35/2020/SEI/GRECS/GGTES/DIRE1/ANVISA clarifies what should be understood by technical responsible under the terms of current legislation:
“Article 13 also defines that the technician in charge assumes responsibility for the radiological procedures performed in the health service, which includes, for example, the definition of medical conduct, the preparation of reports and the attendance to intercurrences, activities exclusive to doctors and dentists, according to the legislation current.
(…)
Therefore, according to the laws currently in force in the country, only the doctor and the dental surgeon can assume technical responsibility for the radiology service, in the case of dental services, who observe the specific determinations of the respective Council of Casse.”
It should be noted that ANVISA's understanding of current legislation and the competence to assume the role of technical manager is fully correct and in line with the understanding of Class Councils and representative bodies of medical and technical professionals.
It should be seen, therefore, that, based on the fact that all work in a radiology clinic must be supervised by a specialist physician, it is impossible to attribute to a radiology technician the quality of technical responsibility for the service, considering that this technician, under the terms of health and safety standards, must be supervised by a physician, and does not fit, under any circumstances, in the capacity of supervisor.
In addition, Article 5 of Law No. 12,842/2013
(Medical Act Law) establishes:
“Art. 5º The following are private to a doctor:
I - (VETOED);
II – medical expertise and auditing; coordination and supervision linked, immediately and directly, to the private activities of a physician;”
Therefore, either through the systematic interpretation of the Resolution, or through the interpretation in view of the other legal provisions in force, it appears that the role of responsible or technical supervisor must be the physician (or the dentist, in specific situations) and not other professions.
Report is the written instrument used by specialists in order to present their technical conclusions/opinions, in a reasoned manner, in relation to the analysis carried out on the object of the examination/expertise. Indeed, in the case of radiological exams and diagnostic imaging, the report must be issued after the specialist has interpreted it, binding the issuer with responsibility for what is presented therein.
RDC 302/2005 is not directly applicable to radiology and diagnostic imaging exams, since it regulates procedures related to exams of a clinical nature. However, the report rectification system contained in item 6.3.8.1 can be assimilated by analogy, since it confirms what is already allowed by the Code of Medical Ethics.
Thus, if the radiologist verifies that there is information that must be rectified in the report prepared by him, he must do so, rectifying the report as necessary, by means of a new report in which he makes reference to the rectified report, using the professional autonomy conferred by the Code of Medical Ethics (article 7), proceeding immediately with the communication to the attending physician to whom the examination and the report were sent.
However, the responsibility of the specialist doctor in relation to the technical conclusions that he/she enters in the report is inexcusable, even if he later rectifies it, in accordance with articles 31 and 32 of the Code of Medical Ethics.
In consultation formulated by CBR itself to CFM (CFM OPINION nº 27/14), here is the conclusion on the subject:
- a) Is it legal for a Radiology specialist to carry out a reassessment of radiological examinations performed by third parties?
- When requested by the patient or by his/her legal representative, the radiologist can evaluate, if he/she wishes to do so, radiological exams performed in another service and issue the respective report.
- b) If so:
b.1) what are the criteria that justify such a procedure, considering that the original examination already has a technical opinion issued by a physician?
- R. The patient's right to request a second opinion and the professional's autonomy, considering that the doctor is not obliged to provide the service if he or she does not wish to, as established in article 39 and item VII (Fundamental Principles) of the Code of Medical Ethics.
- b.2) Is there any specific rule regarding the precautions and procedures that must be adopted by the radiologist when performing the reassessment?
- R. The rules of conduct inherent to the practice of professional practice in the face of any medical act in the provision of radiological services.
b.3) should the physician expressly mention that it is a reassessment?
- R. The doctor has autonomy in the preparation of his report, which must contain expository and conclusive parts, describing what was observed and portraying the truth, in view of his technical judgment.
- Thus, it is perfectly possible for a second opinion to be issued by a radiologist from another service.
Indeed, ordering tests, diagnosing diseases and prescribing treatments are medical acts, which other professions cannot interfere with.
As is known, nurses were authorized by family health programs to request some restricted types of tests, as well as to prescribe medication, always based on a protocol determined by doctors.
However, even this Family Health Program finds resistance to this practice by non-medical professionals. Faced with the conflict regarding the legality of normative acts and the role of nurses in relation to diagnosis and prescription within the IMCI (Integrated Care Program for Prevalent Illnesses in Childhood, Ministry of Health), a lawsuit was filed at the Federal Regional Court of the 1st Region (AGI No. 200701.00.000126-2/DF), which decided as follows:
"CONSTITUTIONAL. ADMINISTRATIVE. ORDINANCE 648/GM OF THE MINISTRY OF HEALTH. NURSING PROFESSIONALS. EXTRAPOLATION OF ATTRIBUTIONS DELIMITED BY LAW 7,498/86. IMPOSSIBILITY.
- The governing legislation for nursing professionals – Law 7,498/86 does not authorize nurses to perform clinical diagnoses, prescribe medications (with the exception of the provisions of paragraph c, item II, of art. 11), perform medical treatments and request examinations, and it is not possible for the public authorities to extend the attributions of such professionals by means of an ordinance, authorizing them to practice private acts of medicine.
- Health professionals can only act within the narrow limits established by the respective legislation that governs each category.
- Despite the size and importance of the Family Health Program for public health in Brazil, it cannot be accepted that, in order to meet the population's demand for medical activity, the figure of one professional is replaced by another, especially regarding the inviolability of the right to life.
- Regimental grievance which is dismissed.”
In the same sense, the CFM manifested itself, on several occasions, establishing an understanding about the impossibility of requesting exams, diagnosis and prescription of treatments by nurses, regardless of whether or not they are included in social programs:
“Therefore, carrying out a prescription (with the exception of the provisions of paragraph c, item II, of art. 11, of Law 7,498/86, provided that it is supervised by a doctor), medical consultation or request for a complementary examination, for the purpose of diagnosis or therapy, constitutes an integral part of the act or medical treatment, being subject to the sanctions of the law who, without necessary qualification, does so”. (CRM/AC CONSULTATION PROCESS No. 07/2008)
Certainly, the Law of the Medical Act (Law nº 12.842/2013) clarified the issue of the physician being the professional responsible for presenting the patient's diagnosis. As the exams have a diagnostic purpose, it is up to a doctor and not to other professionals to indicate them.
There is a lawsuit, still pending, which had a favorable decision for nurses regarding the prescription of exams in the Health and Family Program (Federal Justice of the 1st Region, Process n. 1006566-69.2017.4.01.3400):
Initially granted. Dismissal judgment: "Furthermore, I review a previous position to recognize the absence of illegality in the administrative act now being challenged regarding the request for complementary and routine exams, since the contested Ordinance determines that these must be framed in the protocols and other technical standards of the manager, in line with the Public Health Programs and with the routines approved by the competent instances of the Unified Health System and that the interpretation of the result is forwarded to the responsible physician".
We understand, therefore, that only physicians can request examinations, and this authorization by the Health and Family Program must be observed with great caution, in accordance with the case law that exists on the subject.