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PERTANGGUNGJAWABAN

KEJADIAN TAK DIHARAPKAN DI


RUMAH SAKIT DI ERA JKN

BUDI SAMPURNA
Workshop, Hospex X,
Surabaya, 8 Mei 2014
SISTEMATIKA PEMBAHASAN
KEJADIAN TAK DIHARAPKAN DI RUMAH
SAKIT
PREVENTABILITAS DAN AVOIDABILITAS
KEJADIAN TAK DIHARAPKAN
PERTANGGUNGJAWABAN HUKUM
WACANA SISTEM PERTANGGUNGJAWABAN
HUKUM KEJADIAN TAK DIHARAPKAN DI
ERA JKN

KEJADIAN TAK DIHARAPKAN
DI RUMAH SAKT
ERRORS
NEAR MISS
ADVERSE
EVENTS
ACCEPTABLE
RISKS
VIOLATION
UNFORESEEABLE
RISKS
DISEASE /
COMPLICATION
Setiap cedera yang lebih disebabkan oleh
manajemen medis drpd akibat penyakitnya
Adalah tindakan yg dapat mencederai pasien,
tetapi tidak mengakibatkan cedera karena
faktor kebetulan, pencegahan atau mitigasi
UNPREVENTABLE
Adverse Outcome
Stuart Emslie :International Perspectives on Patient Safety,
National Audit Office, England, 2005
Study Year No
Hosp
No
Case
AE
%
Preventable
AE %
PrevAE
% of AE
California 1975 24 20864 4.6 0.78 16.9
NY State 1984 51 30121 3.8 0.95 25.0
Utah-Colo 1992 28 14700 2.9 0.93 32.1
Australia 1993 31 14179 16.6 8.4 38.5
UK 1999 2 1014 10.8 5.2 48.1
Denmark 2000 17 1097 9.0 3.6 40.0
New Zea 2000 3 1326 10.7 4.3 40.2
Canada 2002 20 3745 7.5 2.8 37.3
France 2002 7 778 14.5 4.0 27.6
Average 20 9758 8.9 3.4 38.2
Table 1 Results of retrospective case record reviews
(Revised)
Nico Lumenta
RISIKO TINDAKAN KEDOKTERAN
Risiko yg unforeseeable (tidak dapat
dibayangkan sebelumnya)
Risiko yang foreseeable:
Risiko yang akseptabel berdasarkan
keilmuan kedokteran pada situasi, waktu dan
tempat tertentu dan unpreventable.
Risiko yang tidak akseptabel karena dapat
dicegah (preventable) dengan tindakan
preventif, dihindari (avoidable), atau memiliki
alternatif yang setara efektivitasnya

Pemahaman hukum ttg KTD
Risiko yang unforeseeable dan
foreseeable yang akseptabel mengakibatkan
KTD (adverse events) yang unpreventable,
Bukan akibat kesalahan atau kelalaian (WMA:
untoward results)
Tidak dapat dipertanggungjawabkan kepada
tenaga kesehatan yang melakukan tindakan
medis tersebut, karena tidak terdapat
pelanggaran kewajiban (breach / derelection
of duty)
Pemahaman hukum ttg Risiko
Risiko yang foreseeable tapi akseptable:
Meskipun risiko tsb sudah dapat dibayangkan
namun tindakan pencegahan atau penghindaran
risiko tidak dapat menghilangkan risiko, atau bila
dibandingkan dengan benefit yang diharapkan
risiko tersebut dapat diabaikan. Risiko ini tetap
dianggap unpreventable
Risiko yang foreseeable dan tidak
akseptable
Baik dari segi risiko maupun segi benefit, tindakan
tsb tidak layak dilakukan (tidak sesuai indikasi,
tidak sesuai prosedur, kelalaian, kesalahan,
kesengajaan pidana). Risiko ini dianggap
preventable.

Venn Diagram
All Healthcare Encounters
All Errors
Near
Misses
All Adverse Events
Preventable
Adverse Events
Non-
Preventable
Adverse Events
Negligent
adverse events
Unforeseeable
Foreseeable but
Acceptable
ADVERSE EVENTS:
WHO IS GOING TO PAY?
Menggali sistem pembiayaan bagi adverse event?
Social Health Insurance
Insured persons pay a regular contribution
to a health insurance fund based usually on
income rather than reflecting their risk of
illness.
Clinical need and not ability to pay
determine access to treatments and health
care.
Contributions to the social insurance fund
are kept separate from other government
mandated taxes and charges.
Both employers and employees pay
contributions.
Centre for Health Economics University of York
Government support for those who are unable
to pay goes through the insurance fund.
There may be more than one social health
insurance fund and some choice may be available
to citizens.
Patients have at least some choice in the
doctor and other health care providers they use.
Social health insurance is compulsory for at least
some categories of citizens.
A basic package of health care benefits is
defined which may or may not vary across funds.
Health insurance funds may not turn away
applicants for membership.
Centre for Health Economics University of York
Mahalnya Yankes
Sejak lama Tuntutan Malpraktik dan
Defensive Medicine dianggap sebagai
penyebab tingginya biaya pelayanan
kesehatan
According to Public Citizen, even at the
highest point, actual malpractice payments
amounted to just a quarter of one percent
of overall health care costs.
From 2003 to 2012, medical malpractice
payments dropped by almost 29% while
national healthcare spending increased by
more than 58%
Medical Errors : Mahal
The Institute of Medicine memperkirakan
medical errors memakan biaya antara 17-
29 miliar dollar Amerika per-tahun.
Tetapi karena pada umumnya tanggung-
jawabnya dipindahkan ke pihak lain
(umumnya kepada payer: Medicare) maka
tidak ada usaha RS atas alasan finansial
untuk meningkatkan keselamatan pasien

Apakah KTD termasuk Paket Manfaat?
Paket Manfaat Jaminan Kesehatan adalah
semua penyakit atau gangguan kesehatan
sebagai risiko kesehatan dan
Prosedur/Tindakan untuk diagnostik/terapi.
KTD adalah adverse events, kejadian yang
merupakan risiko akibat tindakan
kedokteran, bukan risiko kesehatan
Sebagian KTD mungkin dapat dimasukkan
sebagai bagian paket manfaat
Pengkajian biaya di USA
Mello MM (Harvard, 2007): Dari 14.732
rekam medis di 24 RS di Utah dan Colorado
(1992) terdapat 465 adverse events akibat
medical management, termasuk 127
kelalaian.
Biaya mencapai $439 juta, dengan rata2 :
$58.766 untuk seluruh adverse events dan
$113.280 khusus untuk kelalaian.
Siapa yang membayar?
Peran Rumah Sakit (provider)?
Bila dilihat dari jumlah biaya yang didanai
oleh RS (premi asuransi dan biaya extra
perawatan) maka :
78% biaya seluruh injuries di-eksternalisasi
70% biaya injuries akibat kelalaian di-
eksternalisasi
(tidak ada perbedaan antara RS pendidikan
dengan bukan, RS di kota atau di pedesaan, dll
variabel)
Peran Payers?
Mereka berpendapat bahwa sudah waktunya
reformasi agar RS berinisiatif untuk
meningkatkan keselamatan pasien (dan
bertanggungjawab atas adverse events).
Medicare dan Medicaid :it will curtail
reimbursements for never events, identified by
the National Quality Forum as events that
should never happen, like surgery performed on
the wrong body part.
Mello: administrative compensation system
Peran Asosiasi RS ?
Medicare will start applying that logic to
American medicine on a broad scale when it
stops paying hospitals for the added cost of
treating patients who are injured in their care
they will not pay for as many as 28 never
events (so called because they are never
supposed to happen).
A number of state hospital associations,
including here in Minnesota, have brokered
voluntary agreements that members will not
bill for medical errors
Telaah Irjen DOHHS, 2010
13,5% (1:7) penerima Medicare yang dirawat
inap di RS merasakan KTD (setidaknya 1
kriteria dari 4 kriteria KTD)
1,5% penerima Medicare meninggal karena
KTD (dalam sebulan mencapai 15.000)
13,5% lainnya mengalami temporary harm
44% KTD : preventable, 51% unpreventable,
5% undetermined
Memakan biaya $ 324 juta
Bagaimana di SJSN?
Pembayaran Pelayanan Kesehatan di Fasilitas
Kesehatan Lanjutan (Rumah Sakit)
menggunakan Ina-CBGs
Penyusunan Ina-CBGs mungkin sudah
memperhitungkan adanya risiko adverse
event cost yang unpreventable, yang
dapat dimasukkan ke dalam severity level
3 tiap tarif Ina-CBGs.
Pernyataan tsb harus ditelaah dulu kebenarannya
Bagaimana dengan yg preventable?
Perpres 12/2013: penanganan KTD yang
preventable TIDAK termasuk pelayanan
kesehatan yang dijamin JKN..
Biaya medis 28 Preventable Adverse
Events harus ditanggung oleh Rumah
Sakit sebagai provider
Kompensasi bagi pasien harus
ditanggung oleh pembuat kesalahan,
bila dituntut
Masalahnya:
Bagaimana BPJS mendeteksi adanya
preventable adverse events (KTD)?
Menggunakan 28 kriteria KTD yg preventable
Menskrining dari setiap diagnosis dengan
severity level 3
(dapat digabungkan dengan upaya skrining adanya
fraud, abuse dan waste)
Mendayagunakan audit medis
Menerima informasi dari MKDKI, MKEK atau
Pengadilan (bagaimana dg kasus perdamaian)
Preventable Adverse Events
Surgical Events
1. Surgery performed on the wrong body part
2. Surgery performed on the wrong patient
3. Wrong surgical procedure performed on a
patient
4. Unintended retention of a foreign object in a
patient after surgery or other procedure
5. Intraoperative or immediately post-
operative death in an ASA Class 1 patient
National Quality Forum, 2008
Preventable Adverse Events
Product or Device Events
6. Patient death or serious disability associated with
the use of contaminated drugs, devices, or
biologics provided by the healthcare facility
7. Patient death or serious disability associated with
the use or function of a device in patient care, in
which the device is used or functions other than
as intended
8. Patient death or serious disability associated with
intravascular air embolism that occurs while
being cared for in a healthcare facility
National Quality Forum, 2008
Preventable Adverse Events
Patient Protection Events
9. Infant discharged to the wrong person
10. Patient death or serious disability
associated with patient elopement
(disappearance)
11. Patient suicide, or attempted suicide
resulting in serious disability, while being
cared for in a healthcare facility
National Quality Forum, 2008
Preventable Adverse Events
Care Management Events
12. Patient death or serious disability associated with a
medication error (e.g., errors involving the wrong drug,
wrong dose, wrong patient, wrong time, wrong rate, wrong
preparation, or wrong route of administration)
13. Patient death or serious disability associated with a
hemolytic reaction due to the administration of ABO/HLA-
incompatible blood or blood products
14. Maternal death or serious disability associated with labor or
delivery in a low-risk pregnancy while being cared for in a
healthcare facility
15. Patient death or serious disability associated with
hypoglycemia, the onset of which occurs while the
patient is being cared for in a healthcare facility
National Quality Forum, 2008
Preventable Adverse Events
Care Management Events
16. Death or serious disability associated with
failure to identify and treat
hyperbilirubinemia in neonates
17. Stage 3 or 4 pressure ulcers acquired after
admission to a healthcare facility
18. Patient death or serious disability due to
spinal manipulative therapy
19. Artificial insemination with the wrong donor
sperm or wrong egg
National Quality Forum, 2008
Preventable Adverse Events
Environmental Events
20. Patient death or serious disability associated with an
electric shock or elective cardioversion while being cared
for in a healthcare facility
21. Any incident in which a line designated for oxygen or
other gas to be delivered to a patient contains the wrong
gas or is contaminated by toxic substances
22. Patient death or serious disability associated with a burn
incurred from any source while being cared for in a
healthcare facility
23. Patient death or serious disability associated with a fall
while being cared for in a healthcare facility
24. Patient death or serious disability associated with the use
of restraints or bedrails while being cared for in a
healthcare facility
National Quality Forum, 2008
Preventable Adverse Events
Criminal Events
25. Any instance of care ordered by or provided by
someone impersonating a physician, nurse,
pharmacist, or other licensed healthcare provider
26. Abduction of a patient of any age
27. Sexual assault on a patient within or on the
grounds of the healthcare facility
28. Death or significant injury of a patient or staff
member resulting from a physical assault (i.e.,
battery) that occurs within or on the grounds of
the healthcare facility
National Quality Forum, 2008
Rationale to evaluate
Preventable:
Medical error
Substandard treatment
Inadequate monitoring
Inadequate assessment
Necessary treatment not
provided
Event rarely happens
Poor communication
Flawed safety system
Breakdown in environment
Unpreventable
Poor or absent of
documentation
Medical care complex
Patients condition complex
Unpreventable
Proper procedure followed
Patient highly susceptible
Could not have anticipated
Patients conditions complex
DOHHS, 2010
BENARKAH UNPREVENTABLE
ADVERSE EVENTs = KELALAIAN?
Dalam hukum Tort di Amerika, preventable
AE masuk ke dalam kelalaian medik.
Jangan lupa, kelalaian medik tsb bukan
hanya kelalaian profesi, melainkan juga
kelalaian institusional (rumah sakit)
Kesalahan sistem
Kesalahan komponen non SDM
Kelalaian dianggap ada pada pemburukan
yang terjadi under controlled *
*Low risk pregnancy, ASA 1, hipoglikemia, gas medik, perenteral th/, jatuh,
bayi hilang, kekerasan seksual/fisik, petugas palsu, dll
Who is going to pay?
Menurut Pasal 46 UU RS maka RS harus
bertanggungjawab atas seluruh ganti rugi
yang timbul akibat kelalaian yang
dilakukan oleh tenaga kesehatan yang
bekerja di RS
RS dapat mengatur:
Mengelola risiko (mengumpulkan dana)
Memperkecil risiko (patient safety)
Mengalihkan risiko (asuransi profesi)

Pendanaan
Insurance (risk transfer)
Membayar premi untuk asuransi indemnity
RS bisa membayari, atau berbagi, atau
mewajibkan dokter
Self Insured (risk retain)
Menyiapkan dana khusus untuk itu
Dana amanah: Kontribusi semua komponen secara
proporsional (% penghasilan)
Menganggarkan (RS Pemerintah: beli asuransi)
Mengatur tatacara penggunaannya
Penghindaran, pencegahan, pengurangan dampak tetap dilakukan
TANGGUNGJAWAB KTD (??)
KTD
KTD
preventable
KTD
unpreventable
Masuk CBGs
Provider
TAKE HOME MESSAGES
Biaya penanganan Unpreventable Adverse
Events dapat dimasukkan ke dalam tarif
Ina-CBGs, untuk itu perlu data dan
perhitungan simulasi
Biaya penanganan Preventable Adverse
Events tidak termasuk yg dijamin JKN
Perlu mekanisme dan aplikasi untuk
menemukan PAE, sekaligus deteksi fraud,
abuse dan waste