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7/24/2019 Herkutanto - Informed Consent Sebagai Pencegahan Tuntutan 2015
1/8
03/11/2015
HERKUTANTO, 2015 1
INFORMED CONSENTBENTENG PENCEGAH TUNTUTAN PASIEN
HERKUTANTO
HerkutantoKetua Komite Nasional Keselamatan Pasien Rumah Sakit,
Kementerian Kesehatan RI
Doktor (S3), Dokter, SpesialisForensik-Universitas Indonesia
Grad. Dip. Forens.Med. - MonashUniversity, Australia
SarjanaHukum(SH)UniversitasIndonesia, Fakultas Hukum
Master of Laws (LL.M) La TrobeUniversity, Australia School of Law
Pendidikan dibidang HukumPendidikandibidangKedokteran
Ketua Konsil Kedokteran, Konsil Kedokteran Indonesia
PENGANTAR
Intervensi hukum terhadap dunia kedokterandirasakan semakin intens
Jenis intervensi dan prosedur tindakan medis dan
risikonya semakin banyak Persepsi terhadap informed consent masih sangat
beragam
(Schellekens, W : Pati ent Safety Confer ence,
European Union Presidency Luxembourg , 4 5 April 2005 )
ALASAN UTAMA MELAKUKAN
REGULASI
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HERKUTANTO, 2015 2
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 informedconsent
Mendiskusikan implementasi informed consentdalam berbagai situasi klinis dan konsekuensihukumnya
SISTIMATIKA PAPARAN
1. Konsep Akuntabilitas Profesi danTanggungjawab hukum Tenaga Kesehatandalam rumah sakit
2. Regulasi tentang Informed Consent
3. Konsep informed consent danimplementasinya dalam rumah sakit
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HERKUTANTO, 2015 3
KONSEP TANGGUNGJAWAB HUKUM
1
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 PidanaHerkutanto, Dinas Kesehatan DKI 2013
STATEMENT ON MEDICAL MALPRACTICE44thWorld Medical Assembly, Marbella, Spain, September 1992
A distinction must be made between medical malpracticeand anuntoward resultoccurring in the medicaltreatment that isnotthe fault of the physician
An injury occurring in the course of medical treatment
which could not be foreseen.. is an untoward result In anuntoward result, physician should notbear any
liability
What is foreseeable is what the defendant will pay for
I.Kennedy, A.Grubb, Principles of Medical Law, Oxford Univ.Press, London, 1998, p.41511/3/ 2015 Herkutanto, 200112
UNWANTED RESULT IN
MEDICINE
NEGLIGENCE
RISK
?
?
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HERKUTANTO, 2015 4
03/11/2015Herkutanto, 200113
LIABILITYIN MEDICINE
RISK NEGLIGENCE
DAMAGE
liableNot liable
Consent
obtained
No Consent
obtained
11/3/ 2015 Herkutanto, 200114
MEDICAL MISHAPSFORESEEN UNFORESEEN
Prevention
performed
Prevention
not performed
liable Not liable
AKUNTABILITAS PROFESIDAN KESELAMATAN PASIEN
CMPA, Medical Liability System in Canada: toward the right balance, 2005
POTENTIAL
COMPENSATED
EVENTS
RISK
REGULASI INFORMED CONSENT
2
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HERKUTANTO, 2015 5
REGULASI INFORMED CONSENT DIINDONESIA
UU No. 29/ 2004 tentang Praktik Kedokteran
UU No. 44/ 2009 tentang Rumah Sakit UU No. 36/ 2009 tentang Kesehatan
PERATURAN MENTERI KESEHATAN REPUBLIKINDONESIA NOMOR290/ MENKES/ PER/ III/ 2008TENTANG PERSETUJUAN TINDAKAN KEDOKTERAN
UU No. 29/2004 tentang Praktik Kedokteran
UU No. 29/2004 tentang Praktik KedokteranPenjelasan Pasal 45 ayat (1)
UU No. 29/2004 tentang Praktik Kedokteran
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Pasal 45 dan Penjelasan Persetujuan TertulisUU No. 29/ 2004 tentang Praktik Kedokteran
Pasal 32 Tentang Hak Pasien RUU No. 44/2009 tentang Rumah Sakit
UU No. 36/2009 tentang Kesehatan
Persetujuan pengakhiran kehamilan, SubyekPenelitian, Donor Transplantasi Organ, BedahMayat Klinis
KONSEP INFORMED CONSENT
3
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HERKUTANTO, 2015 7
?
RISK ARISE FROM
MEDICAL PROCEDURES
RISK ARISE FROM
THE DISSEASE
let the patient
CHOOSE THE RISK
INFORMATIONFROM 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 WAIVERagainst malpractice
NOTAN AGREEMENTbetween Dr vsPatient
It is a PROCEDURE(Protocol)
It is aWAIFERagainstRisk Liabilities
PATIENT CONSENT tomedical procesures
Informed Consent is NOT Informed Consent is ...
ELEMEN ESENSIAL DALAM INFORMEDCONSENT
1. Persetujuan atau Penolakan diberikan untuk tindakan kedokteran yangdinyatakan secara spesifik tindakan tersebut(The Consent must be for whatwill be actually perf ormed)
2. Persetujuan atau Penolakan Tindakan Kedokteran diberikan ataspengambilan keputusan yang bebas / sukarela(Voluntary)
3. pengambilan keputusan Persetujuan dan Penolakan Tindakan Kedokterandiberikan setelah diberikan informasi yang cukup(adekuat) tentangperlunya tindakan kedokteran dilakukan, alternatif dan risikonya.
4. Persetujuan atau Penolakan diberikan oleh pasien yang mampu mengambilputusansecara sehat, atau yang berhaksecara hukum
PERAN RUMAH SAKIT DALAMIMPLEMENTASI INFORMED CONSENT
Menyusun Kebijakan tentang Informed Consent
Implementasi informed consent dalam situasi spesifik
Bukti2 informed consent, penggunaan meterai, dll
Monitoring dan Evaluasi Pelaksaaan InformedConsent
Kerjasama dengan Komite Medik
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KESIMPULAN
Informed consent telah diatur secara tegas dan rinci
dalam peraturan perundang-undangan Informed consent memproteksi tenaga kesehatan
dan RS atas risiko yang telah disetujui pasien
Berbagai mispersepsi tentang Informed consentperlu diluruskan
Herkutanto 2009
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