PERTANGGUNGJAWABAN KEJADIAN TAK DIHARAPKAN DI

RUMAH SAKIT DI ERA JKN

BUDI SAMPURNAWorkshop, 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 / COMPLICATIO

N

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

PREVEN

TABLE

ADVER

SE

EVEN

TS

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 carethey 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% undeterminedMemakan biaya $ 324 juta

Bagaimana di SJSN?

Pembayaran Pelayanan Kesehatan di Fasilitas Kesehatan Lanjutan (Rumah Sakit) menggunakan Ina-CBGsPenyusunan 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 Events1. Surgery performed on the wrong body part2. Surgery performed on the wrong patient3. Wrong surgical procedure performed on a

patient4. Unintended retention of a foreign object in

a patient after surgery or other procedure5. Intraoperative or immediately post-

operative death in an ASA Class 1 patient

National Quality Forum, 2008

Preventable Adverse Events

Product or Device Events6. 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 EventsPatient Protection Events9. Infant discharged to the wrong

person10. 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 Events12. 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 EventsCare Management Events16. 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 Events20. 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 Events25. 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 age27. Sexual assault on a patient within or on the

grounds of the healthcare facility28. 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 errorSubstandard treatmentInadequate monitoringInadequate assessmentNecessary treatment not providedEvent rarely happensPoor communicationFlawed safety systemBreakdown in environment

Unpreventable

Poor or absent of documentationMedical care complexPatient’s condition complex

Unpreventable

• Proper procedure followed• Patient highly susceptible• Could not have anticipated• Patient’s 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