ADVERSE EVENT (kejadian tidak diharapkan)

(KTD)

Wirsma Arif Harahap Surgical Oncologist

PRIMUM, NON NOCERE FIRST, DO NO HARM

HIPPOCRATES’S 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. It’s the response

to the error that counts”

- Nikki Giovanni

Florida Annual Accidental Deaths,

2003

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

Medical Auto Workplace Air

Deaths

5th leading cause

9th leading cause

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

To

tal lives l

ost

per

year

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

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

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

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 BUHAROYAN NADAPDAP SH

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

Wasn’t always like that….

Swiss Cheese Model of Accident Causation

Modified from Reason, 1991 © 1991, James Reason

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

The World

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)

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)

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 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

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

Performance

Improvement

Projects

Cultural &

Process

Change

Data

Analysis

Healthcare

Incident

Investigation Team Event

Reporting

Tool

Questions?