RISIKO, ADVERSE EVENTS,
MEDICAL ERROR, dan
KELALAIAN MEDIS
HERKUTANTO
KOMPARTEMEN HUKUM DAN PEMBELAAN ANGGOTA PENGURUS PUSAT PERSI
DISKUSI HARI INI
z
Situasi Klaim saat ini
z
Konsep Medical Error dan Adverse Events
zKaitan dengan Kelalaian dan
tangguingjawab hukum
z
Upaya penanggulangan
SITUASI SAAT INI
1. Asosiasi Penasihat Hukum dan HAM Indonesia (APHI),
2. Himpunan Advokad/Pengacara Indonesia (HAPI) cabang Jaktim,
3. Perhimpunan Bantuan Hukum dan HAM Indonesia (PBHI),
4. Lembaga Bantuan Hukum (LBH) Jakarta,
5. Serikat Pengacara Rakyat (SPR),
6. Yayasan Lembaga Konsumen Indonesia (YLKI),
7. Persatuan Pengacara Publik Indonesia (P3I),
8. Yayasan Perlindungan Konsumen Kesehatan Indonesia (YPKKI),
9. LBH perlindungan anak, 10.Kontras, 11.Imparsial, 12.Elsam, 13.ICW, 14.LBH Kesehatan, 15.PIRAC. z1999–2004: 126 Gugatan (2 gugatan / minggu) z60 kasus di RSCM z16 kasus di RSP zSiloam Gleneagles zRSIA Hermina zRS Budi Lestari zRSB YPK zRS.Bintaro zdll
KOALISI LSM YANG MENGGUGAT MALPRAKTEK MEDIS
TEMPO Interaktif, Jakarta, Juni 2004
FREKUENSI KLAIM MALPRAKTEK MEDIS
MODUS OPERANDI
zPanggilan dari Pengacara / LSM dengan
ancaman gugatan + publikasi
zGugatan Perdata zLaporan ke Polisi zPublikasi Media Cetak
zPemberitaan zArtikel
zMedia Elektronik
zDialog interaktif zFitur kriminal
KEKERAPAN
ADVERSE EVENTS
z STUDI DI COLORADO & UTAH (1992) DAN NEW YORK (1984)
z ADVERSE EVENTS : 2,9% DAN 3,7% RAWAT INAP z 53% : PREVENTABLE ec ERROR
z 29,2% : NEGLIGENT
z BERAKIBAT KEMATIAN: 6,6% DAN 13,6%, ATAU
44.000 – 98.000 KEMATIAN / TAHUN, LEBIH TINGGI DARI KLL (43.458) DAN CA MAMMA (42.297) z MEDICAL ERRORS: 3 JUMBO JET CRASHES
EVERYDAY (SHELDON F KURTZ, IOWA)
IOM, 2000
KEKERAPAN ERRORS DI RUMKIT
z DI A.S.:
z KESALAHAN PEMBERIAN OBAT DI 2 RUMKIT DI AS: 56% DAN 34% (BATES, 1995)
z KESALAHAN BEDAH : 1:50 PASIEN RAWAT (GAWANDE, 1999)
z DI INDONESIA:
Iwan Dwiprahasto MMedSc, PhD di Jogja:
z MEDICATION ERROR DI I.C.U. MENCAPAI 96% (TAK SESUAI INDIKASI, TAK SESUAI DOSIS, POLIFARMAKA TAK LOGIS, DLL)
KEKERAPAN KELALAIAN DI
MANCANEGARA
z DI INGGRIS
z TIAP HARI TERJADI KELALAIAN MEDIS
z DI AUSTRALIA
z KLAIM DITUJUKAN PADA 11,8 / 1000 PESERTA ASURANSI PROFESI
z DI SINGAPURA
z KLAIM DITUJUKAN PADA 10,7 / 1000 PESERTA ASURANSI PROFESI
z DI AMERIKA
z ADVERSE EVENTS :+ 2% PASIEN RAWAT INAP z 29% DIANTARANYA KELALAIAN MEDIS
15-20% KASUS YG DIADUKAN TERNYATA MEMANG KELALAIAN 18% serious adverse event 45.8% adverse event
Colorado Medical Practice Study, 1992
Lower extremity bypass graft 11% Abdominal aortic aneurysm 8,1% Colon resection CABG 4,7% TUR 3,9% Cholecystectomy 3,0% Hysterectomy 2,8% Appendectomy Iwan Dwiprahasto, 2004
Results of medical error
Di Australia • 18 000 unnecessary deaths • > 50.000 patients disabled tiap tahun Di United States • 44 000 - 98 000 unnecessary deaths • 1.000.000 excess injuries Iwan Dwiprahasto, 2004
Which patients are most at risk?
z
Pasien yang menjalani bedah cardiothorax,
bedah vascular, atau bedah saraf
z
Pasien-2 dengan complex conditions
zPasien-2 di unit gawat darurat
z
Pasienyang dirawat oleh inexperienced
doctor
z
Pasien usia lanjut
Iwan Dwiprahasto, 2004
KONSEP DAN DEFINISI
Medication Error
“setiap kejadian yang dapat menyebabkan kesalahan dalam penggunaan obat atau membahayakan keadaan pasien, dan sebenarnya dapat dicegah, mengingat obat berada di bawah kendali petugas kesehatan, pasien, atau masyarakat”.
• the failure of a planned action to be completed as intended (ERROR OF EXECUTION) or
• the use of a wrong plan to achieve an aim (ERROR OF PLANNING). (IOM, 1999)
DEFINISI ERROR
” A “near miss” is an event or situation that could have resulted in an accident, injury, or illness, but did not, either by chance or through timely intervention. Errors can include problems in practice, products, procedures, and systems.
Iwan Dwiprahasto, 2004 Defining, Identifying, and Measuring Error in Emergency Medicine
Latent error: Errors in the design organization, training, or
maintenance that lead to operator errors and whose effects typically lie dormant in the system for lengthy periods of time
Active error: An error that occurs at the level of the
frontline operator and whose effects are felt almost immediately.
TABLE 1. Recommended Definitions*
Accident: An event that involves damage to a defined
system that disrupts the ongoing or future output of the system
Iwan Dwiprahasto, 2004
CLINICAL ERRORS
DILIHAT DARI KONTRIBUSINYA
zLATENT ERRORS
zCENDERUNG BERADA DI LUAR KENDALI OPERATOR GARIS DEPAN; SEPERTI DESAIN BURUK, INSTALASI TAK TEPAT, PEMELIHARAAN BURUK, KESALAHAN KEPUTUSAN MANAJEMEN, STRUKTUR ORGANISASI YG BURUK
zACTIVE ERROR
zKESALAHAN PADA TINGKAT OPERATOR GARIS DEPAN
TIDAK SEMUA ERRORS MENGAKIBATKAN ADVERSE EVENTS
Table 1. Medication Error Index for Categorizing Errors Error Kategori Dampak dari Error
No error A Keadaan atau event yang potensial menimbulkan error Error,
no harm
Terdeteksi error, tetapi terapi belum sampai ke pasien B
Terjadi error tetapi tidak membahayakan 1 Terapi sudah terlanjur diberikan ke pasien 2 Obat sudah diterima tetapi belum diminum C
Terjadi error dan pasien meninggal Error,
death I
Terjadi error yang konsekuensinya harus melakukan monitoring ketat terhadap keadaan pasien Error,
harm D
Terjadi error yang hampir merenggut jiwa pasien (eg, anaphylaxis, cardiac arrest).
H
E Terjadi error yang memerlukan terapi ekstra dan memberi risiko yang merugikan
F Terjadi error yang memerlukan perawatan lebih panjang, risiko bersifat sementara
G Terjadi error yang mengakibatkan risiko menetap
Iwan Dwiprahasto, 2004
CLINICAL ERRORS
PENYEBAB PREVENTABLE ADVERSE EVENTS
z
KEGAGALAN MELAKSANAKAN SUATU
RENCANA TINDAKAN (error of execution;
lapses dan slips)
z
PENGGUNAAN RENCANA TINDAKAN YG
SALAH UNTUK MENCAPAI TUJUAN
TERTENTU (error of planning; mistakes).
Di dalam kedokteran, semua error dianggapserius karena dapat membahayakan pasien
AREA MEDICAL ERROR
• failure to order indicated tests • misplaced test results• incorrect conclusions from test results Diagnosis
• inadequate prep of patient for surgery • inappropriate technique
• surgery not indicated Surgery
• improper dosage • improper monitoring Anesthesia
Treatment
• delay in undertaking treatment • unnecessary treatment • failure to order indicated
treatment
Nutrition problem s
failure to consider food allergies
• wrong drug • wrong dosage • wrong delivery method Drugs
Iwan Dwiprahasto, 2004
19. Brennan, et al., 1991.
20. Leape, et al., 1991. See also; Brennan, et al., 1991.
an injury caused by medical
management (rather than the underlying
disease) and that prolonged the
hospitalization, produced a disability at
the time of discharge, or both.
Adverse Event
Iwan Dwiprahasto, 2004
ADVERSE EVENTS
z
SETIAP CEDERA YANG LEBIH
DISEBABKAN OLEH MANAJEMEN KLINIS
DARIPADA AKIBAT PENYAKITNYA
zSEBAGIAN DIANTARANYA PREVENTABLE, DISEBABKAN ERROR
zSEBAGIAN DIANTARANYA AKIBAT KELALAIAN MEDIS (BILA MEMENUHI KRITERIA HUKUM)
Iwan Dwiprahasto, 2004
SYSTEM FAILURES
z PADA PENELITIAN (LEAPPE, 1995) : 3 DARI 4 DRUG ADVERSE EVENTS DISEBABKAN “SYSTEM” FAILURES
z PROSEDUR, MEKANISME KONTROL, PELATIHAN, PERALATAN, REKRUTMEN, DLL
z “
ANY EFFORT TO REDUCE MEDICAL ERRORS
IN AN ORGANIZATION REQUIRES CHANGES TO
THE SYSTEM DESIGN, INCLUDING
REORGANIZATION OF RESOURCES
”KLAIM AKIBAT
KECELAKAAN MEDIS
risk risk risk risk D E F E N C E S D E F E N C E S INCIDENT ACCIDENT risk risk riskINCIDENT ACCIDENT patient’s dissatisfaction C L A I M P R O O F GUILTY NOT-GUILTY LIABLE CLAIM SETTLEMENT
UNWANTED RESULT IN
CLINICAL WORKS
NEGLIGENCE
RISK
?
?
CLINICAL MISHAPS
FORESEEN UNFORESEENAvoidable Unavoidable Avoidable Unavoidable
Prevention performed Prevention not performed Prevention performed Prevention not performed liable Not liable ACCEPTABLE RISKS UNFORESEEABLE RISKS ACTIVE ERRORS
(Error of planning & error of execution)
LATENT ERRORS
UNDERLYING DISEASE
DUTY + BREACH OF DUTY
PREVENTABLE ADVERSE EVENTS NEGLIGENT ADVERSE EVENTS + DAMAGE + CAUSAL ADVERSE EVENTS NO ERROR
KONSTRUKSI KLINIS DAN HUKUM
(KELALAIAN MEDIS) PREVENTABLE ADVERSE EVENTS PERJALANAN PENYAKIT DAN KOMPLIKASI
SO WHAT … ?
Faktor-2 yang mempengaruhi error
Equipment Procedures Operators Design Supplies & materials Environment Iwan Dwiprahasto, 2004
ERROR
KNOWLEDGE PERFORMANCE
DEFICIENCIES9no information available 9too busy to get information 9no development programs
9interruptions 9stress or Fatigue 9poor working condition
¾ bad lighting
¾ too cold / hot
¾ cramped work area
9carelessness 9 working too fast 9 inefficient
9 avoiding procedures
KOMPLEKS & INTERDEPENDEN
ORGANISASI DAN
MANAJEMEN RUMKITLINGKUNGAN KERJA PROTOKOL / PROSEDUR PERAWAT DAN TEKNISI PASIEN DOKTER PERALATAN (hardware) DOKTER KONSULTAN Stake holder General Manager Investor P en y ed ia a na n g g a ra n Bisnis P enj ualan Jasa Account Receivable Tag ihan Pembayaran Administrasi Hutang A cc o unt P a y a ble Pembelian Jasa
Laporan Keuangan, Neraca R/L Obat Alat Kesehatan
Material Kesehatan Logistik M a te ri a l U m u m Dokter Perawat Penunjang Medis Administ ra si Pasi en Catering Laundry H o u se ke ep in g Ambulance Lingkungan Peralatan Sarana PASIEN
The basic elements of an organizational accident
Goals Organise Manage Communicate Design Build Operate Maintain Regulate
Processes Conditions Unsafe acts Error-producing conditions Violation-producing conditions Errors Violations Organisation Environments Individual
Failed defences
Collective Mistakes : James Reason (1992)
Accident
Human Error (James Reason, 1990)
Decision makers Line Management Preconditions Unsafe Acts Defenses Latent failures Latent failures Latent failures Active failures Active & Latent Failures
ACCIDENT
How to respond? Tactics
Reduce complexityAutomate wisely
Optimise information processing
• checklists, • reminders, • protocols
Use constraints with needle connections
Mitigate the unwanted
side effects of change e.g. with training
patient’s
dissatisfaction
C L A I M
P R O O F
LIABLE
CLAIM SETTLEMENT
GUILTY Not -GUILTY Predisposing Factors •Unwanted effects • No consent • Poor communication Precipitating Factors •life style • demographic • expectation • need • want • perception on : - price - provider - quality
MANAJEMEN RISIKO
z
MANAJEMEN RISIKO ADALAH AKTIVITAS
KLINIK DAN ADMINISTRATIF YANG
DILAKUKAN OLEH RUMAH SAKIT (H.C.O)
UNTUK MELAKUKAN IDENTIFIKASI,
EVALUASI DAN PENGURANGAN RISIKO
TERJADINYA CEDERA ATAU KERUGIAN
PADA PASIEN, PERSONIL, PENGUNJUNG
DAN INSTITUSI RUMAH SAKIT
THE JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS
UPAYA
z
IDENTIFIKASI RISIKO
z
URUTKAN PRIORITAS RISIKO
z
TENTUKAN RESPONS RUMAH SAKIT
z
KELOLA KASUS RISIKO - MINIMALKAN
KERUGIAN (RISK CONTROL)
z
BANGUN UPAYA PENCEGAHAN
z
KELOLA PEMBIAYAAN RISIKO (RISK
FINANCING)
Balsamo RR and Brown MD. Risk Management. In: Sanbar SS, Gibofsky A, Firestone MH, LeBlang TR. (eds) Legal Medicine. Fourth ed, St Louis (Mosby), 1998
RISIKO MEDIS
z
INHEREN PADA SETIAP TINDAKAN MEDIS
z
SEBAGIAN DIANGGAP
ACCEPTABLE
:
1. TINGKAT PROBABILITAS DAN KEPARAHANNYA MINIMAL (UMUMNYA BERSIFAT FORESEEABLE BUT UNAVOIDABLE, CALCULATED,
CONTROLLABLE)
2. RISIKO “BERMAKNA” TETAPI HARUS DIAMBIL KARENA “THE ONLY WAY” (UNAVOIDABLE)
3. RISIKO YG UNFORESEEABLE = UNTOWARD
RESULTS
1 DAN 2 PERLU INFORMED CONSENT, SEHINGGA BILA TERJADI, DOKTER TIDAK BERTANGGUNGJAWAB SECARA HUKUM
RISK MANAGEMENT LOGIC
WHAT ARE THE HAZARDSPROBABILITY, SEVERITY, AND EXPOSURE ? LEVEL OF RISK ?
ACCEPTABLE ?
CAN IT BE ELIMINATED ? CAN IT BE REDUCED ? CANCEL THE MISSION NO ACCEPT THE RISK
YES ELIMINATE REDUCED
PENYELENGGARAAN
MANAJEMEN RISIKO
zPROAKTIF
z
CEGAH MASALAH DI KEMUDIAN HARI
z
PROSES SIKLIK YG TERUS MENERUS
z
MULAI DENGAN:
z
SELF-ASSESSMENT
z
INCIDENT REPORTING SYSTEM
z
CLINICAL AUDIT
TAHAPAN
z
RISK AWARENESS
zMENYELURUH: MEDIS & NON MEDIS, KE-4 FAKTOR TERKAIT
z
RISK CONTROL AND/OR RISK PREVENTION
zENGINEERING SOLUTION zCONTROL SOLUTION zKE-4 FAKTOR z
RISK CONTAINMENT
zMINIMALKAN KERUGIAN zRISK TRANSFER
zASURANSIRESOLUTION OF ERROR
NEGLECT / USED WRONG PROCEDUREDID NOT KNOW CORRECT PROCEDURE
KNEW CORRECT PROCEDURE
NEVER KNEW FORGOT
LACKED EXPERIENCE LACKED INFORMATION LACKED TRAINING OR PRACTICE LACKED TRAINING
MANAGEMENT ACTION TO CORRECT THE SYSTEM
DELIBERATE, INTENTIONAL TOLERATED PRESSURES LACKED DISCIPLINE PUNISHMENT SELF ASSESSMENT INCIDENT REPORT CLINICAL AUDIT ENGINEERING SOLUTION CONTROL SOLUTION PERSONNEL SOLUTION QUICK RESPONS EFFECTIVE COMMUNICATION PATIENT’S INTEREST INSURANCES
DEFENSE UNION RISK
AWARE NESS RISK CONTROL RISK CONTAIN MENT RISK TRANSFER RISK IDENTIFICATION:
