ADVERSE EVENT

(kejadian tidak diharapkan)

(KTD)
Wirsma Arif Harahap
Surgical Oncologist

PRIMUM, NON NOCERE

FIRST, DO NO HARM

HIPPOCRATESS TENET
(460-335 BC)

What I want to talk about

Freedom from accidental injury due to

medical care, or medical errors
Institute of Medicine 1999

What I want to talk

about
A

story
How common is adverse event?
Why does it happen?
How should we think ?
How should we respond?

Mistakes are a fact of life.

Its the response

to the error that counts
- Nikki Giovanni

Florida Annual Accidental Deaths,

2003
5000
4500
4000
3500
3000
2500
2000
1500
1000
500
0

Deaths

Medical

Auto

Workplace

Air

5th leading cause

9th leading cause

How hazardous is health care?

REGULATED

DANGEROUS
(>1/1000)

Health Care

100,000

ULTRA-SAFE
(<1/100K)

Driving
Total lives lost per
year

10,000

1,000

Chartered
Flights

100

Mountain
Climbing

10

Bungee
Jumping

Scheduled
Airlines

Chemical
Manufacturing

European
Railroads
Nuclear
Power

1
1

10

100

1,000

10,000

100,000

1,000,000 10,000,000

Number of encounters for each

fatality
Note: both dimensions are logarithmic

DATA KASUS DUGAAN MALPRAKTIK YANG SUDAH DILAPORKAN

Tgl

Korban

Terlapor

Kasus

Lapor

1. 12 -02-04

Alm. Lucy Maywati RS Bersalin YPK Jkt

Meninggal saat melahirkan caecar

Polda Metro Jaya

2. 23-04-04

Wulan Yulianti

RSCM Jkt

Meninggal krn operasi pd usus

Polda Metro Jaya

3. 28 -04-04

Alm Lucy Maywati

RS Bersalin YPK Jkt

Penggelapan M/R

Polda Metro Jaya

4. 07-06-04

Jeremiah

RS Budi Lestari Bks

RS Hermina, Bekasi

Operasi caecar mengakibatkan

luka & cacat

Polda Metro Jaya

5. 11 -06-04

Mindo Sihombing

RS Persahabatan Jkt

Gagal operasi hernia

Polda Metro Jaya

6. 15-06-04

Anissa Safitri

RSCM Jkt

Hidrocepalus

Polda Metro Jaya

7. 24 -06-04

Alm. Jajang

RSUD Sukabumi Jabar Wabah malaria di Sukabumi

Polda Jawa Barat

8. 30-06-04

Alm. Lucy Maywati

RS Bersalin YPK Jkt

Polda Metro Jaya

9. 07 -07-04

Robinson L. Tobing RS Kodam Bkt Barisan Vegetativ State akibat operasi/

Medan
cacat permanen

Meninggal saat melahirkan

Polda Sumatra
Utara

10. 12-07-04

Anissa Safitri

Yayasan Amal Beduli

Seribu, Jkt

Perbuatan tdk menyenangkan

krn memulangkan pasien

Polda Metro Jaya

11. 08 -07-04

Ngatmi

RS Persahabatan Jkt

Operasi kanker payudara

Polda Metro Jaya

12. 14-07-04

Rohati

RS Darmais Jkt

Meninggal dunia akibat gagal

operasi kanker payudara

Polda Metro Jaya

13. 18 -07-04

Dr Jane P

PT Newmont Minahasa Pencemaran limbah B3

Raya, Sulawesi Utara

Mabes Polri

14. 18-07-04

Srifika Modeong

RS CM & RS MMC Jkt

Keracunan mercury & arsen

Mabes Polri

15. 18 -07-04

Rasyid Rahman

RS CM & RS MMC Jkt

Keracunan mercury & arsen

Mabes Polri

16. 18-07-04

Juhria Ratubahe

RS CM & RS MMC Jkt

Keracunan Mercury & arsen

Mabes Polri

17. 18 -07-04

Masna Stiman

RS CM & RS MMC Jkt

Keracunan mercury & arsen

Mabes Polri

18. 26-07-04

Revy Anastasia

RS Cikini Jkt

Keracunan Obat

Polda Metro Jaya

19. 09 -07-04

Revy Anastasia

Apotik RS Cikini Jkt

Keracunan Obat

Polda Metro Jaya

20. 12-08-04

Rasyid Rahman

Menkes Ahmad Sujudi Pencemaran nama baik dgn

Mabes Polri
Mentamben P Yusgiantoro menyatakan tdk ada pencemaran
Men LH Nabiel Makarim

21. 18 -08-04

Fellina Azzahra

RS Karya Medika Jkt

Meninggal krn salah operasi usus

Polda Metro Jaya

22. 31-08-04

Again Isna Nauli

RS Islam Bogor

Kelalaian medis yg berakibat

cacat permanen

SATGA OPS Polda

Jawa Barat

23. 03 -09-04

Anggi & Anggeli

RSCM Jkt

Membiarkan pasien yg hrs dirawat

Polda Metro Jaya

24. 03-09-04

Andreas

RS Pasar Rebo Jkt

Kelahiran yg mengakibatkan cacat

Polda Metro Jaya

25. 03 -09-04

Maena Nurrocmah RS Setia Mitra Jkt

Operasi usus

Polda Metro Jaya

26. 15-09-04

Fellina Azzahra

RS K Medika Cibitung
RSCM Jkt

Meninggal krn operasi usus

Polda Metro Jaya

27. 16-09-04

Leonardus W Pete

RS Silom Gleaneglas

Penyaderaan krn tdk mampu byr

Polda Metro Jaya

28. 27-09-04

Wino
Wiran

Polres Sorong Papua

Penganiayaan mengakibatkan
mata dan dada rusak parah

Mabers Polri

29. 28-09-04

Lexyano Hamsalim RS Medistra Jkt

Infeksi akibat operasi klip jantung

Polda Metro Jaya

30. 28-09-04

Parrel Davin H.A

Sinurat

RS Eva Sari
Rawamangun Jkt

Lalai mengakibtakan org lain

meninggal

Polda Metro Jaya

31. 05-10-04

Rizka Hudha

RS Harapan Bunda Jkt Lalai mengakibatkan kematian

Polda Metro Jaya

32. 05-10-04

Masita Ariani
(Annisa)

Klinik Bedah Plastik

Bandung

Kegagalan bedah plastik pd hidung

Dit Reskrim Polda

Jawa Barat

33. 07-10-04

Tyava Putra Juliarty Klinik Dharma Bakti 2

RS harapan Kita Jkt

Keracunan obat mengakibatkan

Steven Johnson Syndrom

Polda Metro Jaya

34. 20-10-04

Chealfiro M.P

RSCM Jkt

Operasi Hemia

Polda Metro Jaya

35. 20-10-04

Sahat Parulian

RS Cikini Jkt

Pencemaran nama baik

Polda Metro Jaya

36. 06-11-04

Fatimah

RSCM Jkt

Kelalaian mengakibatkan kematian

Polda Metro Jaya

37. 10-11-04

Panca Satriya
Hasan Kesuma

Dr. Siti Fadillah S

(Menkes RI)

Dugaan tindak pidana membuat

perasaan tdk menyenangkan

Mabes Polri

38. 14-01-05

Siti Zulaeha

RSUD Pasar Rebo Jkt

Kesalahan dlm operasi

Polda Metro Jaya

39. 16-02-05

Selli Wane Carolina RS Fatmawati Jkt

Kesalahan dlm operasi pd tulang

belakang berakibat cacat

Polda Metro Jaya

40. 24-02-05

Martha Manulang

RS St Carolus Jkt

Salah obat

Polda Metro Jaya

41. 11-03-05

Chris

RS Sumber Waras Jkt Kesalahan dlm operasi

RS Mitra Kemayoran Jkt

Polda Metro Jaya

42. 11-03-05

Tumi

RS Harun Jkt

Kesalahan dlm operasi

Polda Metro Jaya

43. 11-03-05

Erwin Said

dr. GW Sp.B

Pelaku tanpa seizin korban

mengambil ginjal korban

SIAGA OPS
Bandar Lampung

44. 12-05-05

Royke Bagalutu, SH Rosyid Rusdi

Sandino Brata
(Asisten I Sukabumi)

Melarang membawa anak ke

RS Hasan Sadikin Bandung

SATGAS OPS Jabar

45. 26-05-05

Royke Bagalatu, SH PT BIO FARMA Indo

Pemberian vaksin polio yg tdk

diakui WHO

SATGAS OPS Jabar

46. 12-06-05

Nabila

Ka Dinkes Jabar
Anaknya kejang2, panas berak2
Dinkes Depok
setelah imunisasi polio, kmd
Menkes RI
meninggal
PT Bio Farma Indonesia

Polda Metro Jaya

47. 18 -06-05

Wagirin

RS Pelabuhan

Polda Metro Jaya

BUHAROYAN NADAPDAP SH

Kelalaian Medis

Sumber : Dari berbagai sumber

Similar Vials: Cefazolin (antibiotic)

and Vecuronium (paralyzing agent)

Acceptable?
Health care is a highly complex, error
prone industry.
Medicine is not a hard science
combination of art and practice
Aviation and Nuclear arms = High
Reliability Organizations strong
safety record
Wasnt always like that.

Swiss Cheese Model of Accident Causation

Goal Conflicts
and Double Binds
Incomplete
Procedures

Mixed
Messages
Production
Pressures
Regulatory
Responsibility
Narrowness
Shifting

Inadequate
Training

Deferred
Maintenance
Attention
Distractions

Clumsy
Technology

LATENT
FAILURES

Triggers

The World

Accident
DEFENSES

Modified from Reason, 1991 1991, James Reason

KESALAHAN MEDIS (Medical Error)

Kesalahan yang terjadi dalam proses

asuhan medis yang mengakibatkan atau
berpotensi mengakibatkan cedera pada
pasien.
(KKP-RS)

Medical errors are associated with

inexperienced clinicians, new procedures,

extremes of age, complex care and urgent

care. Poor communication, improper
documentation, illegible handwriting,
inadequate nurse-to-patient ratios, and
similarly named medications are also
known to contribute to the problem.
Patient actions may also contribute

significantly to medical errors.

Example for M Error

Misdiagnosis
Giving the wrong drug or (wrong
patient, wrong chemical, wrong
dose, wrong time, wrong route)
Giving two or more drugs that
interact unfavorably or cause
poisonous metabolic byproducts
Wrong site surgery such as
amputating the wrong limb

Defenition
Adverse effect is a harmful and
undesired effect resulting from a
medication or other intervention

KEJADIAN TIDAK DIHARAPKAN (KTD)/ Adverse

Event

Suatu kejadian yang mengakibatkan

cedera yang tidak diharapkan pada
pasien karena suatu tindakan
(commission) atau karena tidak
bertindak (ommision), dan bukan
karena underlying disease atau kondisi
pasien (KKP-RS).

Adverse effects of medical

procedures

Surgery may have a number of

undesirable or harmful after effects,

such as infection, hemorrhage,

inflammation, scarring,

high intensity radiotherapy may cause

burns and alterations in the skin.

Adverse effects of drugs

Drug interaction

Drug safety

Dose

Iatrogenesis is almost exclusively

used to refer to a state of ill health or

adverse effect or complication caused
by or resulting from medical
treatment.

Side-effect" (when judged to be

secondary to a main or therapeutic
effect) and may result from an
unsuitable or incorrect dosage or
procedure

Complication, in medicine, is an

unfavorable evolution of a disease, a

health condition or a medical
treatment.

Medical malpractice is an act or

omission by a health care provider
which deviates from accepted
standards of practice in the medical
community and which causes injury
to the patient. Simply put, medical
malpractice is professional negligence
(by a healthcare provider) that causes
an injury.

A near miss is an unplanned event

that did not result in injury, illness, or

damage - but had the potential to do
so.

NYARIS CEDERA (NC)/ Near Miss

Suatu kejadian akibat melaksanakan suatu

tindakan (commission) atau tidak mengambil

tindakan yang seharusnya diambil (omission),
yang dapat mencederai pasien, tetapi cedera
serius tidak terjadi, karena :

keberuntungan(mis.,pasien terima suatu

obat kontra indikasi tetapi tidak timbul
reaksi obat)
pencegahan (suatu obat dengan overdosis
lethal akan diberikan, tetapi staf lain
mengetahui dan membatalkannya
sebelum obat diberikan)
peringanan (suatu obat dengan over dosis
lethal diberikan, diketahui secara dini lalu
diberikan antidotenya).(KKP-RS)

Pasien
tidak cidera

Near Miss (NM)

- Dpt obat c.i., tdk timbul (chance)
- Plan, diket, dibatalkan (prevention)
- Dpt obat c.i., diket, beri anti-nya
(mitigation)

Medical Error

Pasien
cidera

Adverse Event (AE)

(KTD=Kejadian Tdk Diharapkan)

Proses of Care
(Non Error)
Nico A. Lumenta/KKP-RS

Pasien
cidera

Adverse Event

Why do errors happen?

All humans make errors: indeed, the
ability to make mistakes allows
human beings to function
Most of medicine is complex and
uncertain
Most errors result from the system
Healthcare has not tried to make
itself safe

How to think of error?

An individual failing

Only the minority of cases amount from

negligence or misconduct; so its the
wrong diagnosis
Doctors will hide errors
May destroy many doctors inadvertently
(the second victim)

A systems failure

This is the starting point for redesigning

the system and reducing error

How to respond? Tactics

Reduce complexity

Optimise information processing

checklists, reminders, protocols
Automate wisely
Use constraints
for instance, with needle connections
Mitigate the unwanted side effects of change
with training, for example.

The Pathway to Increased Patient

Safety

Event
Reporting
Tool

Healthcare
Incident
Investigation Team

Data
Analysis
Cultural &
Process
Change

Performance
Improvement
Projects

Questions?