Definisi dan Klasifikasi

Patient Safety

Iwan Dwiprahasto
MMR/CE&BU FK UGM
 Ruang Tunggu
Silakan menunggu sampai
batas waktu yang tidak
ditentukan
Putusan Pengadilan New York : Kasus-2 Medical Error
1. Baby's brain damage leads to [$40 million] record jury judgment
2. $23.8 million jury award in cerebral palsy childbirth lawsuit
3. $5.5 million settlement for baby's brain damage at hands of
midwife and labor nurse
4. $1.4 million settlement for mother of child with cerebral palsy
5. $2 million settlement in brain damage case resulting from failure
to respond to fetal distress
6. Prostate cancer case settled for $825,000
7. $1.8M settlement for undiagnosed lung cancer
8. Breast cancer diagnosis delay brings $1M settlement
9. Victim's family awarded $19.8 milion in malpractice suit
10. $4.5 million to be paid in girl's death
11. Dracut family wins $3.7million over errors at girl's birth
12. $4.5 million awarded for diagnosis error
13. Cost of a Mystery Ailment - $5.5 million, a family's pain
14. Breast cancer victim kin awarded $11 million
15. Cancer victim's kin gets $2.5 million for misdiagnosis
16. Jury says Docs must pay $2.5 million to girl, 7
17. Family wins $1.75 million in case against Beth Israel
18. Jury awards $30 million to assure care for child brain-
damaged at birth
19. Doctors ordered to pay $16 million
20. HMO to pay disabled girl $3 million over misdiagnosis
21. Jury awards $10 million to parents of brain-injured girl
22. Psych doc agrees to settlement, pay $1 million
23. Man wins $3.2 million for lost testicle
 TO ERR IS HUMAN:
BUILDING A SAFER HEALTH
SYSTEM

Institute of Medicine
Committee on Quality of
Health Care in America
 Adverse Event

setiap injury yang disebabkan oleh medical

management (bukan akibat penyakit yang
mendasari)

menyebabkan prolonged
hospitalization, menimbulkan kecacatan saat
discharge atau keduanya

19. Brennan, et al., 1991.

20. Leape, et al., 1991. See also; Brennan, et al., 1991.
 Contoh Adverse event
• pneumothorax from central venous catheter placement
• anaphylaxis to penicillin
• postoperative wound infection
• hospital-acquired delirium (or "sun downing") in elderly
patients

1. Identifying something as an adverse event does not imply "error,"

"negligence," or poor quality care. It simply indicates that an undesirable
clinical outcome resulted from some aspect of diagnosis or therapy, not an
underlying disease process.
 Error (IOM, 1999)

Error of planning Error of Execution

Menggunakan cara Gagal menyelesaikan

yang keliru untuk tindakan yang sudah
mencapai tujuan disiapkan

Errors dapat mencakup masalah dalam praktek,

produk, prosedur, dan sistem
 ERRO
R

Omission Commission

Tidak melakukan sesuatu Melakukan sesuatu

yang seharusnya yang seharusnya tidak
dilakukan dilakukan

• misdiagnosis • Tindakan keliru

• Terlambat bertindak • Obat salah
• Tidak melakukan • Tindakan/prosedur
pertolongan yang salah
“near miss”
Suatu kejadian atau situasi yang sebenarnya
dapat menimbulkan kecelakaan, trauma, atau
penyakit, tetapi belum terjadi karena secara
kebetulan diketahui atau upaya pencegahan
segera dilakukan.
 Near Mi sses
Death
1

Severe
0s

Minor – Moderate
00s

Prevented/No harm incidents

000s
 Clinical Negligence
(kelalaian klinik)

care that fell below the standard expected of

physicians in their community
(a relative standard not a “gold” standard)
 Jury Awards $38 Million To San Jose
Family In Malpractice Suit

01/01/02 - A San Jose family has won a 38

million dollar (342 Milyar) malpractice
award after a jury agreed that delayed
care for a newborn baby led to serious
brain damage.

The Santa Clara County Superior Court jury ruled against the San Jose
Medical Group, Doctor Ilene Newman and Regional Medical Center of San
Jose. Brandon Nunez is now three years old and lives at home with his
parents, Carmelo and Sonia Nunez.

Sonia Nunez was two weeks overdue when she went into labor on
September 27th, 1999. Her labor didn't progress normally and experts
testified that an immediate Caesarean section was called for. A C-section was
finally performed, but Fagel says that by that time the baby had already
suffered brain damage.
Percent of Injuries due to Negligence

California Medical Harvard Medical

Insurance Feasibility Practice Study
Study

17
28
%
%

AE’s AE’s
 Proportion of Adverse Events Involving Negligence
Type of Event Proportion of Events
Due to Negligence
Operative
Wound infection 12.5
Technical complication 17.6
Late complication 13.6
Non-technical complication 20.1
Surgical failure 36.4
All 17.0
Non-operative
Drug-related 17.7
Diagnostic mishap 75.2
Therapeutic mishap 76.8
Procedure-related 15.1
System and other 35.9
All 37.2
Source – Leape, 1991
 Rates of Adverse Events and Negligence by
Specialty
Specialty Rate of Rate of
Adverse Negligence
Events (%) (%)
Orthopedics 4.1 22.4
Urology 4.9 19.4
Neurosurgery 9.9 35.6
Thoracic and cardiac surgery 10.8 23.0
Vascular surgery 16.1 18.0
Obstetrics 1.5 38.3
Neonatology 0.6 25.8
General surgery 7.0 28.0
General medicine 3.6 30.9
Other 3.0 19.7
P value <0.0001 0.64

Source – Leape, 1991

How bad is negligent ?????????????

All Injuries
1000
All Negligent Injuries

280
36 Files a Claim
13% of Negligent Injuries Results in a
Claim
 System failure

A fault, breakdown or dysfunction within

an organisation’s operational
methods, processes or infrastructure.

Contoh:

salah operasi kasus

ortopedi

• Source: Australian Council for Safety and Quality in Healthcare, 2004

 • Keliru memutar knob
Slip pada suatu alat medik

• Tidak ingat/lupa
Lapses melakukan upaya medik

SLIP is observable anda LAPSE is not

 Adverse Drug Reaction

Efek samping akibat penggunaan obat pada

dosis yang direkomendasikan.

Efek bervariasi mulai dari yang sifatnya "nuisance effects"

(eg, dry mouth akibat anticholinergic medications) hingga
reaksi yang sangat berat sepertias anaphylaxis akibat
penicillin.
 Active error: An error
that occurs at the
level of the frontline
operator and whose
effects are felt almost
immediately.

Defining, Identifying, and Measuring Error in Emergency

Medicine
Latent error: Errors in the design organization, training,
or maintenance that lead to operator errors and whose
effects typically lie dormant in the system for lengthy
periods of time

Defining, Identifying, and Measuring Error in Emergency

Medicine
An international taxonomy for errors in general
practice
1.1. Errors in office administration

1.2. Investigation errors

1.3. Treatment errors

1. Process
Errors 1.4. Communication errors

1.5. Payment errors

1.6. Errors in healthcare workforce
management
2.1. Errors in the execution of a
clinical task
2. Knowledge
and Skills 2.2. Errors in diagnosis
Errors
2.3. Wrong treatment decision with
right diagnosis
 1. Process Errors
1.1. Errors in office administration 26 (20%) 55 (19%)
• 1.1.1. Filing system errors
• 1.1.2. Chart completeness errors
• 1.1.3. Patient flow (through the healthcare system)
• 1.1.4. Message handling errors
• 1.1.5. Appointments errors
• 1.1.6. Errors in maintenance of a safe physical environment

1.2. Investigation errors 17 (13%) 55 (19%)

• 1.2.1. Laboratory errors
• 1.2.2. Diagnostic imaging errors
• 1.2.3. Errors in the processes of other investigations

1.3. Treatment errors 38 (29%) 72 (24%)

• 1.3.1. Medication errors
• 1.3.2. Errors in other treatments

1.4. Communication errors 20 (15%) 42 (14%)

• 1.4.1. Errors in communication with patients
• 1.4.2. Errors in communication with other healthcare providers (non-medical)
• 1.4.3. Errors in communication with other doctors
• 1.4.4. Errors in communication amongst the whole healthcare team

1.5. Payment errors 1 (1%) 4 (1%)

• 1.5.1. Errors in processing insurance claims
• 1.5.2. Errors in electronic payments
• 1.5.3. Wrongly charged for care not received

1.6. Errors in healthcare workforce management 2 (2%) 8 (3%)

• 1.6.1. Absent staff not covered
• 1.6.2. Dysfunctional referral procedures
• 1.6.3. Errors in appointing after-hours workforce
2. Knowledge and Skills Errors
2.1. Errors in the execution of a clinical task

• 2.1.1. Non-clinical staff made the wrong clinical decision

• 2.1.2. Failed to follow standard practice
• 2.1.3. Lacked needed experience or expertise in a clinical task

2.2. Errors in diagnosis

• 2.2.1. Error in diagnosis by a nurse

• 2.2.2. Delay in diagnosis
• 2.2.3. Wrong or delayed diagnosis attributable to misinterpretation of
investigations
• 2.2.4. Wrong or delayed diagnosis attributable to misinterpretation of
examination
• 2.2.5. Wrong diagnosis by a pharmacist
• 2.2.6. Wrong diagnosis by a hospital-based doctor

2.3. Wrong treatment decision with right diagnosis

• 2.3.1. Wrong treatment decision, influenced by patient preferences

• 2.3.2. Wrong treatment decision by doctor
The 10 high level classes are
1. Incident Type
2. Patient Outcomes
3. Patient Characteristics
4. Incident Characteristics
5. Contributing Factors/Hazards
6. Organizational Outcomes
7. Detection
8. Mitigating Factors
9. Ameliorating Actions
10. Actions Taken to Reduce Risk
 Patient characteristics
• categorize patient • classify the information
demographics,
• the original reason for
seeking care &
• the primary diagnosis.
Incident characteristics
about the circumstances
surrounding the incident
such as where and
when, in the patient’s
journey through the
healthcare system, the
incident occurred, who
was involved, and who
reported.
 Contributing Factors/Hazards
circumstances, actions or influences which are thought to
have played a part in the origin or development of an
incident or to increase the risk of an incident.

human factors
• behavior, performance or
communication;

system factors • work environment;

external factors • natural environment or

(beyond the control
of the organization) legislative policy.
 patient safety incident

Umumnya melibatkan lebih dari satu

contributing factor dan/atau hazard single.
 Organizational outcomes

impact upon an organization which is wholly or

partially attributable to an incident.

indicate the
• an increased use of resources to
consequences care for the patient,
directly to the • media attention or
organization • legal ramifications
such as
as opposed to clinical or therapeutic
consequences, which are considered patient
outcomes.
 • tidak disebut sebagai clients, tenants atau
konsumen
Patients
• wanita hamil, anak yg diimunisasi juga
tidak disebut pasien

Healthcare • juga mencakup self-care.

Health • is the “state of complete physical, mental

and social well-being and not merely the
(WHO), absence of disease or infirmity”
 Safety
Penurunan risiko harm hingga tingkat acceptable minimum.

An acceptable minimum
Upaya kolektif melibatkan current knowledge, resources dan context dimana
pelayanan yang diberikan ditimbang dengan risiko jika diterapi atau tidak.

Hazard
keadaan, agent atau action yang berpotensi menimbulkan harm

A circumstance
Situasi atau faktor yang bisa berpengaruh untuk terjadinya event
 An event
Sesuatu yang terjadi atau menimpa pasien

agent
substance, object atau system untuk menghasilkan
perubahan

Patient safety
is the reduction of risk of unnecessary harm associated
with healthcare to an acceptable minimum.
 Healthcare-
associated harm
• harm arising from or
associated with plans or
actions taken during the
provision of healthcare, rather
than an underlying disease or
injury.
A patient safety
incident
• an event or circumstance that
could have resulted, or did
result, in unnecessary harm
to a patient. In the context of
the ICPS, a patient safety
incident will be referred to as
an incident.
 “unnecessary”
errors, violation, patient abuse and deliberately Certain forms of harm, however, such as an
unsafe acts occur in healthcare. These are incision for a laparotomy, are necessary. This is
considered incidents. not considered an incident.

Incidents
arise from either unintended or intended acts.

Errors
are, by definition, unintentional

violations
are usually intentional, though rarely malicious, and may
become routine and automatic in certain contexts.
An incident

• can be a reportable circumstance, near miss, no

harm incident or harmful incident (adverse event).

A reportable circumstance

• is a situation in which there was significant

potential for harm, but no incident occurred
• (i.e., a busy intensive care unit remaining grossly
understaffed for an entire shift, or taking a
defibrillator to an emergency and discovery it
does not work although it was not needed).
 A near miss
an incident which did not reach the patient

A no harm incident
is one in which an event reached a patient but no
discernable harm resulted

A harmful incident (adverse event)

is an incident that results in harm to a patient (e.g., the wrong unit of
blood was infused and the patient died from a haemolytic reaction).
 Harm
• Memburuknya fungsi dan struktur tubuh
dan/atau tiap efek yang merugikan termasuk
penyakit, injury, penderitaan, kecacatan, dan
kematian
• Dapat dalam bentuk fisik, sosial, atau
psikhososialis damage to tissues caused by an
agent or event and suffering is the experience
of anything subjectively unpleasant.
• implies impairment of • is damage to tissues
structure or function of the
body and/or any deleterious caused by an agent
effect arising there or event and
from, including suffering is the
disease, injury, suffering, dis
ability and death, and may experience of
be physical, social or anything subjectively
psychological. Disease is a unpleasant.
physiological or
psychological dysfunction.

Harm Injury
 Malpractice

In law, malpractice is type of tort in which the misfeasance, malfeasance or

nonfeasance of a professional, under a duty to act, fails to follow generally
accepted professional standards, and that breach of duty is the proximate
cause of injury to a plaintiff who suffers damages. It is committed by a
professional or her/his subordinates or agents on behalf of a client or patient
that causes damages to the client or patient. Perhaps the most publicized
forms are medical malpractice and legal malpractice by medical practitioners
and lawyers respectively, though malpractice suits against accountants (Arthur
Andersen) and investment advisors (Merrill Lynch) have been in the news
lately.
 Malpraktek

1. dokter yang benar bertugas memberi

pertolongan.
2. dokter telah melakukan tindakan medik
yang tidak sesuai dengan standar
medik.
3. tindakan dokter harus bisa dibuktikan
merugikan pasien.
 CONTOH TINDAK PIDANA
MALPRAKTEK
• KELALAIAN : 359-361 KUHP
• KETERANGAN PALSU : 267-268 KUHP
• ABORSI ILEGAL : 347-349 KUHP
• PENIPUAN : 382 BIS KUHP
• PERPAJAKAN : 209, 372 KUHP
• EUTHANASIA : 344 KUHP
• PENYERANGAN SEKS : 284-294 KUHP
The u
C l t ur e of Bl ame

Denial, distancing, displacement

Dishonesty with patients

Cover-up, non-reporting

Unwillingness to take responsibility for peer

misconduct