Herkutanto - Informed Consent Sebagai Pencegahan Tuntutan 2015

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    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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    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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    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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