INFORMED CONSENT
ASPEK ETIK DAN MEDIKOLEGAL PROFESI BEDAH
Herkutanto
Ketua Komite Nasional Keselamatan Pasien Rumah Sakit, 2012 – 2015, Kementerian Kesehatan RI
Doktor (S3), Dokter, Spesialis
Forensik - Universitas Indonesia
Grad. Dip. Forens.Med. - Monash
University, Australia
• Sarjana Hukum (SH) Universitas
Indonesia, Fakultas Hukum
• Master of Laws (LL.M) La Trobe
University, Australia School of Law
Pendidikan dibidang Hukum
Pendidikan dibidang Kedokteran
PENGANTAR
Intervensi hukum terhadap dunia kedokteran
dirasakan semakin intens
Jenis intervensi dan prosedur tindakan medis dan
risikonya semakin banyak
Persepsi terhadap informed consent masih sangat
(Schellekens, W : Patient Safety Conference,
European Union Presidency Luxembourg, 4 – 5 April 2005)
ALASAN UTAMA MELAKUKAN REGULASI
5 HERKUTANTO, PERSI, 2015 risk risk risk risk D E F E N C E S D E F E N C E S INCIDENT ACCIDENT risk risk risk
INCIDENT ACCIDENT Tindakan Medis Tindakan Medis Tindakan Medis Tindakan Medis Clinical Privileges Clinical Privileges Clinical Privileges Clinical Privileges
TUJUAN DISKUSI
Menyamakani
persepsi
tentang informed
consent
Mendiskusikan
implementasi
informed consent
SISTIMATIKA PAPARAN
1.
Konsep Akuntabilitas Profesi dan
Tanggungjawab hukum Tenaga Kesehatan
2.
Konsep Risiko dan Informed Consent
3.
Implementasi Informed consent dalam
KONSEP TANGGUNGJAWAB MORAL DAN HUKUM
PRINSIP DASAR MORAL (ETIKA) KEDOKTERAN
AUTONOMY :
Self determination, Truth telling, Confidentiality, Privacy
BENEFICENCE
Providing benefit, Balancing the benefit and harms
NON MALEFICENCE
Primum non nocere
JUSTICE : fairness
PRINSIP AUTONOMY-2
PRINSIP AUTONOMY ADALAH DASAR DARI DOKTRIN
INFORMED CONSENT
TINDAKAN MEDIS TERHADAP PASIEN HARUS MENDAPAT
PERSETUJUAN (OTORISASI) DARI PASIEN TERSEBUT, SETELAH IA DIBERI INFORMASI DAN MEMAHAMINYA.
A PATIENT WITH SUBSTANTIAL UNDERSTANDING AND IN
SUBSTANTIAL ABSENCE OF CONTROL BY OTHERS,
INTENTIONALLY AUTHORIZES A PROFESSIONAL TO DO SOMETHING.
BENTUK KLAIM TERHADAP TENAGA MEDIS
DISIPLIN PROFESI Majelis Kehormatan Disiplin Kedokteran Indonesia
(MKDKI)
Peringatan – Suspensi STR
HUKUM PERDATA
Pengacara – Ganti Rugi
HUKUM PIDANA
Polisi – Jaksa – Sanksi Pidana
STATEMENT ON MEDICAL MALPRACTICE
44th World Medical Assembly, Marbella, Spain, September 1992
A distinction must be made between medical malpractice
and an untoward result occurring in the medical treatment that is not the fault of the physician
An injury occurring in the course of medical treatment
which could not be foreseen ….. is an untoward result
In an untoward result, physician should not bear any
liability
What is foreseeable – is what the defendant will pay for
5/6/2016 Herkutanto, 2001 16
UNWANTED RESULT IN
MEDICINE
NEGLIGENCE
RISK
?
?
06/05/2016 Herkutanto, 2001 17
LIABILITY IN MEDICINE
RISK
NEGLIGENCE
DAMAGEliable
Not liable Consent obtained No Consent obtained5/6/2016 Herkutanto, 2001 18
MEDICAL MISHAPS
FORESEEN UNFORESEEN Prevention performed Prevention not performedAKUNTABILITAS PROFESI DAN KESELAMATAN PASIEN
CMPA, Medical Liability System in Canada: toward the right balance, 2005
POTENTIAL COMPENSATED
EVENTS
KONSEP RISIKO DAN INFORMED CONSENT
?
RISK ARISE FROM MEDICAL PROCEDURES
RISK ARISE FROM THE DISSEASE
let the patient
CHOOSE THE RISK INFORMATION FROM PHYSICIAN INFORMED OPINION
I N F O R M E D D E C I S I O N
CONSENT TO
THE MEDICAL PROCEDURES
(accept risk arising from medical procedure )
REFUSE
THE MEDICAL PROCEDURES
(accept risk arising from the dissease)
INFORMED CONSENT
(What is it ... and what is it not) NOT just a FORM
(Formulier) NOT a WAIVER against malpractice NOT AN AGREEMENT between Dr vs Patient It is a PROCEDURE (Protocol) It is aWAIFER against
Liabilities of Med. Risks
PATIENT CONSENT to
medical procesures
TINDAKAN MEDIS
• Clinical Judgment
– Professional opinion following examination of the case
• Determination of Cause of “Dissease”
– Which cause of dissease affect the patient?
– Inductive and Deductive Approach (ex-post facto)
• Medicine is Science and Art
– The Science of Uncertainty
– The Art of Probability
1 penyakit -> beberapa gejala 1 gejala -> beberapa penyakit
time se v e rity o f d issea se mortality morbidity RISK IN MEDICINE
?
intervention intervention recognition recognition Diagnostic/time se v e rity o f d issea se mortality morbidity RISK IN MEDICINE
?
intervention intervention recognition recognition Tx/HAZARD vs RISK vs. COMPLICATIONS
1. A hazard is something that can cause harm, e.g. electricity, chemicals, working up a ladder, noise, a keyboard, a bully at work, stress, etc. [... tindakan medik ...??]
2. Complications are things that happen as a result of a disease or a treatment that you
prefer didn't happen [stroke from hypertension, or bleeding following surgery]
A complication may be described as an adverse event caused by pre-existing factors that were outside the doctor’s control. Patients are not the same in health, habits, immunity or healing power, and have varying susceptibility to complications
3. A risk is the chance, high or low, that any hazard will actually cause somebody harm.
Risk factors are things that make it more likely that you will develop a disease or
condition. They may be things you can't do anything about, like gender, family history, or race, or things you can control, like smoking and diet.
DIFFERENCES BETWEEN RISKS vs COMPLICATIONS Allergy Infection Bleeding Fragile tissues Anaphylactic Rx Sepsis Hypovolemic shock Tissue damage RISKS COMPLICATIONS
COMPLICATIONS HANDLING IN SURGERY
BEFORE COMPLICATIONS Foreseeability Preventive Measures Informed Consent AFTER COMPLICATIONS Awareness of Complications Complication Treatment Explain of what actually happenedMistake
Consequences
Are mistakes = risks
What should be informed ...
Consent to mistakes or Consent to risks ...
menyetujui tindakan medis
=
menyetujui akan risiko yang timbul
IMPLEMENTASI INFORMED CONSENT DALAM
pelayanan anestesi dan bedah
KONDISI DAN HAL2 APA SAJA YANG HARUS
DISAMPAIKAN DAN DISETUJUI OLEH PASIEN ...?
Semua risiko dan komplikasi sedetail-detailnya ...?
Kondisi pasien berbeda2 .... Tailor Made ....
Identifikasi Predictor dan Pitfall dalam tindakan
35
Masalah dan masalah-potensial
MASALAH
Perdarahan
MASALAH POTENSIAL
Gangguan faktor
:
Murphy’s law
If anything can go wrong, it will go wrong
(at the worst possible time)
...
Identify risk factors / predictors
Eliminate risk factors or minimize
36
37
Pre-op Durante-op Post-op
Initial target
38 Initial target Mortality PREDICT RISKS PREVENT DEVIATION MONITOR THE
39 Initial target PREDICT RISKS CONTROL MONITOR THE VITAL FUNCTION PREVENT DEVIATION
PERIOPERATIVE RISK ASSESSMENT
Patient’s co-morbid Patient’s Functional status
Surgical technique Surgeon’s skill
Complexity of procedures Anaesthetic & Post-op management
FORCIER -
LACERTE
Medicolegal Causal Analysis
ELEMEN ESENSIAL DALAM INFORMED
CONSENT
1. Persetujuan atau Penolakan diberikan untuk tindakan kedokteran yang
dinyatakan secara spesifik tindakan tersebut (The Consent must be for what
will be actually performed)
2. Persetujuan atau Penolakan Tindakan Kedokteran diberikan atas pengambilan keputusan yang bebas / sukarela (Voluntary)
3. pengambilan keputusan Persetujuan dan Penolakan Tindakan Kedokteran diberikan setelah diberikan informasi yang cukup (adekuat) tentang perlunya tindakan kedokteran dilakukan, alternatif dan risikonya.
4. Persetujuan atau Penolakan diberikan oleh pasien yang mampu mengambil
PERAN RUMAH SAKIT DALAM
IMPLEMENTASI INFORMED CONSENT
Menyusun Kebijakan tentang Informed Consent
Implementasi informed consent dalam situasi spesifik Bukti2 informed consent, penggunaan meterai, dll
Monitoring dan Evaluasi Pelaksaaan Informed
Consent
KESIMPULAN
Informed consent bukanlah sekedar dokumen atau
formulir isian
Pada tindakan anestesi dan bedah, pasien harus
menyetujui semua risiko dan komplikasi tindakan yang “foreseeable”
Informed consent memproteksi tenaga kesehatan dan RS
