Antonello Crisci                           Francesca Di Martino                              Stefano Russo
  Public, Clinical and Preventive                Public, Clinical and Preventive              Public, Clinical and Preventive
 Medicine Department - Forensic                  Medicine Department - Forensic               Medicine Department - Forensic
    Medicine Section - Second                      Medicine Section - Second                    Medicine Section - Second
University of the Studies of Naples.               University of the Studies of                 University of the Studies of
  L. Armanni 5 Street – Naples                               Naples.                                      Naples.
       +39-0815666016-17                          L. Armanni 5 Street – Naples                 L. Armanni 5 Street – Naples                          +39-0815666016-17                            +39-0815666016-17

Topic: Organization – Clinical risk management and medical performances

Introduction                                                           How confirmed also from the New Italian Medical Code of
Every time a patient, asking assistance that you improve its           Deontology of December 2006, the doctor should operate to
condition of health, to the opposite a damage from the health          guarantee the fitter conditions of safety of the patient and
action occurres, it is checked the failure, not only of the            should contribute to the prevention and management of the
individual service, but of the whole system that comes except          risk clinician also across the survey, report and evaluation of
for to its mission. The prevention of the unwanted events              the mistakes. That it is valid above all for the professionals
finds in the "Risk Management" one of the most effective               that operate in the field of the forensic medicine, that from
tools, even if, in its original representation, it is been             now onwards loses the descriptions of the Medicine of the
characterized above all from a "defensive" mailing , directed          "Day After" to take on those fundamental of the Medicine of
to reduce the frequency of the professional accidents and the          the "Day Before". One of the hinges of the management of
damages to the patients, the possible claims and the costs that        the risk clinician is represented from the Informed Consent,
can derive from them.                                                  not in the usual legal key of reading (validity of the approval
                                                                       in connection to the age, to the psychophysical conditions
                                                                       etc.), but as the fundamental trial of communication, in which
                                                                       an important part of the patient's trust is played by the

       Fig. 1: The Elements of the Risk Management

Really, according to a most correct and modern
interpretation, the Risk Management is a procedure directed
to the enhancement of the quality of the cares and the study                       Fig. 2: A Roger Radford’s Best Seller
of the unwanted events an useful tool to promote the
approach to the "litigation management". In this optics, the           A medical – surgical treatment, if finished according to the
Clinical Risk Management is presented like an approach to              rules of the medical art, but without the valid approval of the
the identification and to the control of the "unfavorable              patient, constitutes, unless itself is not in a necessity state, an
event", understood like such whatever damage, not                      illicit fact and a crime against the freedom. The informed
deliberate, or complication in the cares, that cause disability,       consent is, in practice, the tool across which is sought to
death or extension of the hospitalization and that is caused by        humanize and brighten the medical-patient relationship,
the cares (carried out or omitted) rather that from the illness        expression of the centrality of the man's value, which comes
of the patient.                                                        to acquire a new autonomy and a greater dignity. The
                                                                       informed consent, therefore, still before deontological hinge
                                                                       and inescapable legal obligation, should represent the not
Methodology                                                            legal but morale test of the requirement that every
                                                                       professional warns in the daily practice to inform and to

acquire the aware approval of the patient, so how sanctioned           of a worsening of the patient's health. For the configuration
in the title III of the New Italian Code of Deontology,                of a such responsibility of the doctor, it is indifferent if the
dedicated to the Relations with the Citizen. The medical one           treatment is been performed correctly or except for. We can
has the obligation to supply the most fit patient information          deduct that the informed consent expresses a choice of value
on the diagnosis, the prognosis, the perspectives and the              in the way to conceive the relation between doctor and
eventual diagnostic – therapeutic alternative sand, on the             patient, in the sense that this relation appears to be based
predictable results of the choices operated. The sanitary              above all on the rights of the patient and on its freedom of
should communicate with the patient, understanding its                 self-determination rather that on the sanitary duties. The
capacities of account, to promote its greatest participation and       informed consent has got, as correlated, the faculty not only
adherence to the diagnostic-therapeutic proposals.                     to choose between the different medical possibility of
                                                                       treatment, but also to refuse, eventually, the therapy and to
                                                                       decide aware to interrupt it, in all the phases of the life, also
                                                                       in terminal one. It appears obvious that the informed consent
                                                                       is becoming more a reflection of the so-called "new-
                                                                       contractualism" and of the more general "contractualization"
                                                                       of the medical service, that represents the walk of the
                                                                       assertion, also in health field, of the "fundamental rights of
                                                                       the people". It is also true, however, that the push to the
                                                                       extreme supremacy of the patient autonomy risks to
                                                                       transform the medical one in a technician, in a performer of
                                                                       the patient will. The "cultural" obstacle, that still remains in
                                                                       force, to a correct approach to the informed consent is
         Fig. 3: An Example of Informed Consent
                                                                       experienced by the little time that is reserved to the
                                                                       information and by the fact that the information and the
The diagnostic procedure and/or the therapeutic treatment,
                                                                       approval are for the most understood like a simple
that could allow serious risk for the safety of the people,
                                                                       bureaucratized formality with redeeming end, acquired
should be undertaken alone in case of extreme necessity and
                                                                       thanks to the acquisition of a signature on an arranged model.
upon information on the possible results, that should have an
                                                                       The "procedure" of the informed consent to the ends of the
adeguate documentation of the approval. At any rate, in
                                                                       single business accreditation is associated to that, that is of
presence of documented refusal of a capable person, the
                                                                       the satisfaction exclusively of the formal aspect. On the
medical one should desist from the consequent diagnostic
                                                                       forensic – medical side, in such picture, the falsity, for
and/or curative actions, because some medical treatment
                                                                       voluntary omission or voluntarily wrong communication of a
against the will of the person is not agreed. The main
                                                                       diagnosis or a prognosis and the error, productive of harmful
principal of information and approval, in the procedures of
                                                                       biological consequences for the patient count as title of guilt,
Risk Management, is constituted by the importance not only
                                                                       can have negative relief. The perimeter of the consent cannot
of obtaining a juridically valid approval, across a correct and
                                                                       be thought of unlimited dimensions, neither equal for all,
exhaustive information, but also of using this moment to
                                                                       because the information that it encloses must be personalized
create a feeling with the patient that doesn't have negligible
                                                                       to the psychological peculiarities of the patient, to its state of
probability to reduce sensitively eventual rivendicative
                                                                       disease and the possibilities of the therapy in a harmonic
pulsions. Also the Italian legislation has, in the course of the
                                                                       synthesis between the promotion in autonomy of its
years, more time confirmed that the legitimacy of the medical
                                                                       decisional processes and the respect of the ethical and legal
activity asks above all the show of the approval of the patient,
                                                                       principles of not slander.
which constitutes the premise of lawfulness of the medical-
surgical treatment. The approval affirms to the moral freedom
of the subject and to its self-determination, as well as to its
physical freedom, right to the respect of the actual bodily
                                                                       From how much said, it appears obvious as the informed
integrity, which are not other than a different profile of the
                                                                       consent is more and more becoming a "contract" between
personal freedom proclaimed inviolable from the article 13 of
                                                                       doctor and patient; but, it is stipulated between two
the Italian Constitution. The stocked information should have
                                                                       "contractors" who have not still caught up equal rights,
the requirements of the expository clarity, of the
                                                                       because the doctor, in particular the specialist, has a power
completeness and of the timeliness. Only after have supplied
                                                                       that is always greater of the patient one: the power of the
the most entire information, the medical one can ask for the
                                                                       acquaintance. Moreover, the will of the patient is, in any
patient approval to perform the treatment, holding in absolute
                                                                       case, influenced by the "content of the contract", which can
consideration any expression of dissent, relatively also to the
                                                                       discipline the consent, in relation to the expectation of the
same intervention or to its results. The phases of the
information and of the approval should develop themselves
already in the moment of the first visit and then in the
moment of the hospitalization, before the same intervention.
It's necessary, besides, that remains a written documentation
of this informed and aware approval, because of the
particularity of the therapeutic service and for the possible
results of it on the physical integrity of the subject. The
violation of the obligation of the approval informed
represents an illicit fact, as come down from an omissive
conduct of the doctor (and of reflection of the structure for
that he works) for unfulfilment of the obligation of
information about the predictable results of the treatment that                Fig. 4: The “Enemy” of Informed Consent:
the patient comes submitted and from the successive                                         The Doctor House
verification, in result of the execution of the same treatment,

Therefore, just for the particularity of the activity, it can be       performing the procedure may assign designated
thought that the strong-willed element of the patient remains          responsibilities.
however conditioned and such influence could go to affect              3. All operations and procedures carry the risk of
the validity of the same consent. This "problem", in particular        unsuccessful results, complications, injury or even death,
way, appears in those fields of the medicine, and still more of        from both known and unforeseen causes, and no warranty or
the surgery, in which the single individual must necessarily           guarantee is made as to result or cure. You have the right to
recover to the technical wisdom of the sanitary, or, to the            be informed of these complications:
stage of the specialistic cognitions of it, to the complete            a) The temporary or definitive lesion of the laryngeal nerves
professional modernizations, to the coldness and the                   that innervates the vocal cords, with consequent serious
temperance of its character and to the correctness of its              alterations of the voice. Respiratory difficulties can also be
behaviour.                                                             manifested, that could involve also the necessity of a
Conclusions                                                            b) The temporary or definitive lesion of the parathyroids
Various typologies of the written module of the informed               glands with consequent alteration of quantitative of calcium
consent have been proposed. In October 2007 the Association            and phosphorus in the blood.
of the Italian Units of Endocrinosurgery (U.E.C.) has                  c) Operating haemorrhages.
published the III review of the " Diagnostic – Therapeutic –           d) Infection of the surgical wound.
Assistential Managerial Protocols in Thyroid Surgery", which           e) Premature laryngeal oedema.
preview a Module of Information and Consent to the Medical             f) Tracheal collapse (tracheomalacia) also after some hours.
Action specific for the thyroidectomy, in which is indicated           g) Pneumothorax.
the type of surgical action, the complications and the eventual        Except in cases of emergency, operations or procedures are
adverse events.                                                        not performed until you have had the opportunity to receive
                                                                       this information and have given your consent.You have the
                                                                       right to give or refuse consent to any proposed operation or
                                                                       procedure at any time prior to its performance.
                                                                       4. By your signature below, you authorize the pathologist to
                                                                       use his or her discretion in disposition or use of any member,
                                                                       organ or tissue removed from your person during the
                                                                       operation or procedure set forth above.
                                                                       5. The practitioner who will perform your procedure is:
                                                                       6. If your doctor determines that there is a reasonable
                                                                       possibility that you may need a blood transfusion as a result
                                                                       of the surgery or procedure to which you are consenting, your
                  Fig. 5: Thyroid Anatomy                              doctor will inform you of this and will provide you with
                                                                       information concerning the benefits and risks of the various
After to have taken in examination the various modules of              options for blood transfusion, including predonation by
informed consent, proposals also from other societies of               yourself or others.
surgery, in this job, the Authors introduce a proposal for the         7. Your signature on this form indicates that: 1) you have
Module of Informed Consent specific for the Minimally                  read and understand the information provided in this form; 2)
Invasive Video-Assisted Thyroidectomy.                                 your doctor has adequately explained to you the operation or
                                                                       procedure set forth above, along with the risks, benefits, and
Informed Consent To Minimally Invasive Video-Assisted                  other information described above in this form; 3) you have
Thyroidectomy                                                          had a chance to ask your doctors questions; 4) you have
1. This form is called an “Informed Consent Form”. It is your          received all of the information you desire concerning the
doctor’s obligation to provide you with the information you            operation or procedure; and 5) you authorize and consent to
need in order to decide whether to consent to the surgery or           the performance of the operation or procedure.
special procedure that your doctors have recommended. The              Date:___________________ Time:_______________
purpose of this form is to verify that you have received this          Signature:____________________________________
information and have given your consent to the surgery or              Physician Signature: ___________________________
special procedure recommended to you. You should read this
form carefully and ask questions of your doctors so that you           References
understand the operation or procedure before you decide
whether or not to give your consent. If you have questions,                1)   Brennan TA. “The Institute of Medicine Report on
you are encouraged and expected to ask them before you sign                     Medical Errors – could it to harm?” N Engl J Med
this form.                                                                      2000;342:1123-5.
2. Your Doctors have recommended the following operation                   2)   Nightingale PG et al. “Implementation of rules
or procedure: MINIMALLY INVASIVE VIDEO-                                         based computerised bedside prescribing and
ASSISTED THYROIDECTOMY.                                                         administration:    intervention    study”.     BMJ
Upon your authorization and consent, this operation or                          2000;320:750-3.
procedure, together with any different or further procedures,              3)   Bates DW, Gawande AA. “Error in Medicine: what
which in the opinion of the doctor(s) performing the                            have we learned?” Ann Intern Med 2000;132:763-
procedure, may be indicated due to any emergency, will be                       7.
performed on you. The operations or procedures will be                     4)   Hebert PC et al. “Bioethics for physicians: 23.
performed by the doctor(s) named below (or in the event that                    Disclosure     of    medical     errors”.    CMAJ
one of these doctors is unable to perform or complete the                       2001;164:509-13.
procedure, a qualified substitute doctor), together with                   5)    “Risk Management in Sanità. Il problema degli
associates and assistants, including anesthesiologists,                         errori”.   Ministero     della   Salute    italiano,
pathologists and radiologists to whom the doctor(s)

Dipartimento della Qualità, Commissione Tecnica
sul Rischio Clinico. Marzo 2003.


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