ADVERSE EVENT (kejadian tidak diharapkan) (KTD) Wirsma Arif Harahap Surgical Oncologist

(1)

ADVERSE EVENT

(kejadian tidak diharapkan)

(KTD)

Wirsma Arif Harahap

Surgical Oncologist

(2)

PRIMUM, NON NOCERE

FIRST, DO NO HARM

HIPPOCRATES’S TENET

(460-335 BC)

(3)

What I want to talk about

“

Freedom from accidental injury due to

medical care, or medical errors

”

–

(4)

What I want to talk

about



A story



How common is adverse event?



Why does it happen?



How should we think ?

(5)

“

Mistakes are a fact of life.

It

’

s the response

to the error that counts

”

(6)

Florida Annual Accidental Deaths,

2003

0

500 1000

1500

2000

2500

3000

3500

4000

4500

5000

Medical

Auto

Workplace

Air

(7)

5th leading cause

(8)

How hazardous is health care?

1

10

100 1,000

10,000

100,000

1

10

100 1,000

10,000

100,000

1,000,000

10,000,000

Number of encounters for each

fatality

T

ot

al liv

es

lo

st

p

er

y

ear

REGULATED

DANGEROUS

(>1/1000)

ULTRA-SAFE

(<1/100K)

Health Care

Mountain

Climbing

Bungee

Jumping

Driving

Chemical

Manufacturing

Chartered

Flights

Scheduled

Airlines

European

Railroads

Nuclear

Power

Note: both dimensions are logarithmic

scales

(9)

DATA KASUS DUGAAN MALPRAKTIK YANG SUDAH DILAPORKAN

1. 12 -02-04 Alm. Lucy Maywati RS Bersalin YPK Jkt Meninggal saat melahirkan caecar Polda Metro Jaya

Tgl Korban

Terlapor

Kasus

Lapor

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 Operasi caecar mengakibatkan Polda Metro Jaya

RS Hermina, Bekasi luka & cacat

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 Meninggal saat melahirkan Polda Metro Jaya 9. 07 -07-04 Robinson L. Tobing RS Kodam Bkt Barisan Vegetativ State akibat operasi/ Polda Sumatra

Medan cacat permanen Utara

10. 12-07-04 Anissa Safitri Yayasan Amal Beduli Perbuatan tdk menyenangkan Polda Metro Jaya Seribu, Jkt krn memulangkan pasien

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 Polda Metro Jaya

operasi kanker payudara

13. 18 -07-04 Dr Jane P PT Newmont Minahasa Pencemaran limbah B3 Mabes Polri Raya, Sulawesi Utara

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

(10)

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 SATGA OPS Polda

cacat permanen 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 Meninggal krn operasi usus Polda Metro Jaya

RSCM Jkt

27. 16-09-04 Leonardus W Pete RS Silom Gleaneglas Penyaderaan krn tdk mampu byr Polda Metro Jaya 28. 27-09-04 Wino Polres Sorong Papua Penganiayaan mengakibatkan Mabers Polri

Wiran mata dan dada rusak parah

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 RS Eva Sari Lalai mengakibtakan org lain Polda Metro Jaya

Sinurat Rawamangun Jkt meninggal

31. 05-10-04 Rizka Hudha RS Harapan Bunda Jkt Lalai mengakibatkan kematian Polda Metro Jaya 32. 05-10-04 Masita Ariani Klinik Bedah Plastik Kegagalan bedah plastik pd hidung Dit Reskrim Polda

(Annisa) Bandung Jawa Barat

33. 07-10-04 Tyava Putra Juliarty Klinik Dharma Bakti 2 Keracunan obat mengakibatkan Polda Metro Jaya RS harapan Kita Jkt Steven Johnson Syndrom

(11)

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 Dr. Siti Fadillah S Dugaan tindak pidana membuat Mabes Polri

Hasan Kesuma (Menkes RI) perasaan tdk menyenangkan

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 Polda Metro Jaya

belakang berakibat cacat

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 Polda Metro Jaya

RS Mitra Kemayoran Jkt

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 SIAGA OPS

mengambil ginjal korban Bandar Lampung 44. 12-05-05 Royke Bagalutu, SH Rosyid Rusdi Melarang membawa anak ke SATGAS OPS Jabar

Sandino Brata RS Hasan Sadikin Bandung (Asisten I Sukabumi)

45. 26-05-05 Royke Bagalatu, SH PT BIO FARMA Indo Pemberian vaksin polio yg tdk SATGAS OPS Jabar diakui WHO

46. 12-06-05 Nabila Ka Dinkes Jabar Anaknya kejang2, panas berak2 Polda Metro Jaya Dinkes Depok setelah imunisasi polio, kmd

Menkes RI meninggal PT Bio Farma Indonesia

47. 18 -06-05 Wagirin RS Pelabuhan Kelalaian Medis Polda Metro Jaya

Sumber : Dari berbagai sumber

(12)

(13)

Similar Vials: Cefazolin (antibiotic)

and Vecuronium (paralyzing agent)

(14)

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

(15)

Swiss Cheese Model of Accident Causation

Triggers

DEFENSES

Accident

Regulatory

Narrowness

Incomplete

Procedures

Mixed

Messages

Production

Pressures

Responsibility

Shifting

Inadequate

Training

Attention

Distractions

Deferred

Maintenance

Clumsy

Technology

LATENT

FAILURES

Goal Conflicts

and Double Binds

(16)

(17)

KESALAHAN MEDIS (Medical Error)



Kesalahan yang terjadi dalam

proses

asuhan medis

yang mengakibatkan atau

berpotensi

mengakibatkan cedera

pada

pasien.

(18)



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.

(19)

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

(20)

Defenition

Adverse effect

is a harmful and

undesired effect resulting from a

medication or other intervention

(21)

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).

(22)

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

(23)

Adverse effects of drugs



Drug interaction



Drug safety

(24)



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.

(25)

Side-effect" (when judged to be

secondary to a main or therapeutic

effect) and may result from an

unsuitable or incorrect dosage or

(26)



Complication

, in medicine, is an

unfavorable evolution of a disease, a

health condition or a medical

treatment.

(27)



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

(28)



A

near miss

is an unplanned event

that did not result in injury, illness, or

damage - but had the potential to do

so.

(29)

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

(30)

“

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)

(31)

Medical Error

Pasien

tidak cidera

Pasien

cidera

Near Miss

Adverse Event

(NM)

(AE)

Proses of Care

(Non Error)

Adverse Event

Pasien

cidera

(KTD=Kejadian Tdk Diharapkan)

Nico A. Lumenta/KKP-RS

- Dpt obat “c.i.”, tdk timbul

(chance)

- Plan, diket, dibatalkan

(prevention)

- Dpt obat “c.i.”, diket, beri anti-nya

(mitigation)

(32)

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

(33)

(34)

How to think of error?



An individual failing



Only the minority of cases amount from

negligence or misconduct; so it

’

s 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

(35)

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

(36)

The Pathway to Increased Patient

Safety

Performance

Improvement

Projects

Cultural &

Process

Change

Data

Analysis

Healthcare

Incident

Investigation Team

Event

Reporting

Tool

(37)

(38)