(Patient Safety)

Pipin Sumantrie. SKp., M.Kep

Kejadian 49:18

Aku Menanti-
nantikan
Keselamatan yang
dari padaMu ya
Tuhan.
 Pendahuluan
 Patient Safety adalah isu terkini, besar, penting, dalam
Pelayanan Rumah Sakit, praktis belum lama, dimulai sejak th
2000an
 Menteri Kesehatan mencanangkan Gerakan Moral Keselamatan
Pasien pada Seminar Nasional VII PERSI 21 Agustus 2005
 Dalam jangka panjang “tepat” utk kondisi di Indonesia dgn
maraknya tuduhan “Malpraktek” ( bias?)
 RS perlu melaksanakan Image Building meningkatkan
kepercayaan masyarakat
 Telah dibentuk KOMITE KESELAMATAN PASIEN RUMAH SAKIT
(KKP-RS) – PERSI, pd tgl 1 Juni 2005 :
 Dalam tahap membangun “Awareness” RS, Unit Yan Kes, Org.
Profesi, akan Keselamatan Pasien
 KP sdh dipresentasi ke Menteri Kesehatan, DirJen Bina YanMed,
KaDinasKes DKI Jkt, dipaparkan pd pertemuan nasional : Raker
MAKERSI Juli di Semarang, di Rakernas PELKESI Agustus di
Tomohon
 Keselamatan Pasien selain masih dalam kerangka Peningkatan
Mutu, juga merupakan pendekatan “Green Product” oleh
Rumah Sakit ke masyarakat
• Menurut Suprio (2008), Patient safety
merupakan salah satu isu utama dalam
pemberianmutu pelayanan kesehatan. Para
pengembilan kebijakan, memberi pelayanan
kesehatan, dankonsumen menempatkan
keamanan sebagai prioritas pertama mutu
pelayanan. Patientsafety merupakan sesuatu
yang jauh lebih penting daripada sekedar
efisiensi pelayanan.
•
• Sejak awal tahun 1900 Institusi rumah sakit selalu
meningkatkan mutu pada 3 (tiga) elemen yaitu
struktur, proses dan outcome dengan bermacam-
macam konsep dasar, program regulasi yang
berwenang, misalnya antara lain penerapan Standar
Pelayanan Rumah Sakit, penerapan Quality Assurance,
Total Quality Management, Countinuos Quality
Improvement, Perizinan, Akreditasi, Kredensialing,
Audit Medis, Indikator
• Klinis, Clinical Governance, ISO, dan lain sebagainya.
Harus diakui program-program tersebut
telahmeningkatkan mutu pelayanan rumah sakit baik
pada aspek struktur, proses maupun output dan
outcome.
• Namun harus diakui, pada pelayanan yang telah
berkualitas tersebut masih terjadi KTD yang tidak
jarang berakhir dengan tuntutan hukum. Oleh
sebab itu perlu program untuk lebih memperbaiki
proses pelayanan,karena KTD sebagian dapat
merupakan kesalahan dalam proses pelayanan
yang sebetulnya dapat dicegahmelalui rencana
pelayanan yang komprehensif dengan melibatkan
pasien berdasarkan hak-nya. Program
• tersebut yang kemudian dikenal dengan istilah
keselamatan pasien (patient safety).
TUJUAN PATIENT SAFETY

• Tujuan “Patient safety” adalah

– Terciptanya budaya keselamatan pasien di rumah
sakit
– Meningkatnya akutanbilitas rumah sakit terhadap
pasien dan masyarakat
– Menurunnya kejadian tidak diharapkan (KTD) di
rumah sakit.
– Terlaksananya program-program pencegahan
sehingga tidak terjadi pengulangan kejadian tidak.
Beberapa ciri penting RS
Rumah Sakit
1) Padat Modal
2) Padat Teknologi
3) Padat Karya
4) Padat Profesi *!*
5) Padat Sistem
6) Padat Mutu
7) Padat Risiko
8) Padat Keluhan/Masalah
9) Padat “Error “ ?
10)  RS = “Kompleks yg padat”
 Isu makro rumah sakit :

MUTU
ETIK
SAFE-
TY

Safety hadir
sendiri/explisit,
tetap terkait CQI
dgn Mutu
“Safety is a fundamental principle of patient care and a critical component
of quality management.” (World Alliance for Patient Safety, Forward Programme, WHO, 2004)
Patient safety
The prevention of harm caused by errors of commission
and omission. (IOM)

Patient safety
The process by which an organisation makes patient care
safer. This should involve: risk assessment; the
identification and management of patient-related risks; the
reporting and analysis of incidents; and the capacity to
learn from and follow-up on incidents and implement
solutions to minimise the risk of them recurring. (NHS-
NPSA)
Patient safety incident
Any unintended or unexpected incident which could have
or did lead to harm for one or more patients. (NHS-NPSA)
Medical errors
Mistakes made in the process of care that result in or have
the potential to result in harm to patients. Mistakes include
the failure of a planned action to be completed as intended
or the use of a wrong plan to achieve an aim. Can be the
result of an action that is taken (error of commission) or an
action that is not taken (error of omission).

Medical error
An adverse event or near miss that is preventable with the
current state of medical knowledge. (QuIC)
Dalam kenyataannya masalah medical error dalam
sistem pelayanan kesehatan mencerminkan
fenomena gunung es, karena yang terdeteksi
umumnya adalah adverse event yang ditemukan
secara kebetulan saja. Sebagian besar yang lain
cenderung tidak dilaporkan, tidak dicatat, atau
justru luput dari perhatian kita semua.
Adverse event
An event that results in unintended harm to the patient by an
act of commission or omission rather than by the underlying
disease or condition of the patient. (IOM)
Adverse event
An injury that was caused by medical management and that
results in measurable disability. (QuIC)
rent state of knowledge. (QuIC)
Near miss
An error of commission or omission that could have harmed
the patient, but serious harm did not occur as a result of (e.g.
Dokter menuliskan resep tambahan dosis bagi pasient namun
perawat tidak memperhatikan tulisan dokter sehingga tidak
mengorder obat sesuai dosis yang dianjurkan, setelah 2 hari
kemudian ps masuk ke ICU oleh karna koma)
Risk management
In the context of hospital operations, the term risk management
usually refers to self-protective activities meant to prevent real or
potential threats of financial loss due to accident, injury, or
medical malpractice. Kraman SS, Hamm G. Risk management:
extreme honesty may be the best policy. Ann Intern Med. 1999;
131(12):963-967.
 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
Medical Error (mitigation)

-Kesalahan proses
-Dpt dicegah
-Pelaks Plan action Pasien
tdk komplit
cidera Adverse Event (AE)
-Pakai Plan action yg
salah (KTD=Kejadian Tdk Diharapkan)
-Krn berbuat : commission
-Krn tidak berbuat : omission

Proses of Care Pasien

(Non Error) cidera Adverse Event
 Type of Errors
• Diagnostic
Error or delay in diagnosis
Failure to employ indicated tests
Use of outmoded tests or therapy
Failure to act on results of monitoring or testing
• Treatment
Error in the performance of an operation, procedure or test
Error in administering the treatment
Error in the close of method of using a drug
Avoidable delay in treatment or in responding to an abnormal test
Inappropriate (not indicated) care
• Preventive
Failure to provide prophylactic treatment
Inadequate monitoring or follow up of treatment
• Other
Failure of communication
Equipment failure
Other system failure
Leape, Lucian; Lawthers, Ann G.; Brennan, Troyen A., et al. Preventing Medical Injury.
Qual Rev Bull. 19(5):144–149, 1993.
 “First, do no harm” : Hippocrates (460-335 BC).
 Pelayanan Kesehatan pada dasarnya adalah untuk
“menyelamatkan” pasien
 Rumah Sakit :
Quality Quality Quality
Structure Process of care Outcome

 Sejak awal 1900 institusi RS selalu meningkatkan MUTU

pada ke-3 elemen tsb diatas : Standar Pelayanan,
Penerapan QA, TQM, CQI, Perizinan, Credentialing,
Akreditasi, ISO, Baldridge Award, Performance
measurement, Benchmarking, Hospital/Clinical
Governance, Clinical Indicator, EBM/P, Etik Profesi / RS,
Risk Management. . .

 Namun : . . . . .
 Quality Quality Quality
RS: Structure Process of care Outcome

 Near Miss : Everyday, tens if not hundred

thousands of error occur in the US health care system
….these errors not in serious harm but in Near Miss
(Aspden P, Corrigan JM, Wolcott J, Erickson SM, eds. Patient Safety:
achieving a new standard for care. Washington, D.C.: National Academy Press, 2004.)

 Adverse Event : 3.2 – 16.6 % !!!

(WHO, 2004)

“Sektor Yan Kesehatan selama ini tidak rutin mendata informasi tentang error”
(Aspden P, Corrigan JM, Wolcott J, Erickson SM, eds. Patient Safety: achieving a new standard for care.
Washington, D.C.: National Academy Press, 2004.)
 Di INDONESIA

KEKERAPAN TUNTUTAN
• DI INGGRIS
– TIAP HARI TERJADI KELALAIAN MEDIS
• DI AUSTRALIA
– KLAIM DITUJUKAN PADA 11,8 / 1000 PESERTA
ASURANSI PROFESI
• DI SINGAPURA
– KLAIM DITUJUKAN PADA 10,7 / 1000 PESERTA
ASURANSI PROFESI
• DI JAKARTA
– PIDANA: 48 KASUS DI POLDA METRO
– PERDATA: 160 KASUS DIAJUKAN LBH
KESEHATAN
*KaDinKes DKI Jkt (8Juli2005): setiap minggu ada 2 – 3 pengaduan pasien
(Budi Sampurna, Seminar Perumahsakitan, Surabaya, 24 Maret 2005)
 KEKERAPAN ERRORS DI
RUMKIT
• DI A.S.:
– KESALAHAN PEMBERIAN OBAT DI 2 RUMKIT
DI AS: 56% DAN 34% (BATES, 1995)
– KESALAHAN BEDAH : 1:50 PASIEN RAWAT
(GAWANDE, 1999)

• DI INDONESIA:
Iwan Dwiprahasto MMedSc, PhD di Jogja:
– MEDICATION ERROR DI I.C.U. MENCAPAI 96%
(TAK SESUAI INDIKASI, TAK SESUAI DOSIS,
POLIFARMAKA TAK LOGIS, DLL)
– MEDICATION ERROR DI PUSKESMAS: 80-AN %

(Budi Sampurna, Seminar Perumahsakitan, Surabaya, 24 Maret 2005)

SASARAN PATIENT SAFETY

• Sasaran Internasional Keselamatan Pasien

(SIKP), sebagaimana disyaratkan untuk
diimplementasikan mulai tanggal 1 Januari
2011 di semua rumah sakit yang terakreditasi
oleh Joint Commission International (JCI) di
bawah Standar Internasional untuk Rumah
Sakit.
Tujuan SIKP adalah untuk menggiatkan
perbaikan-perbaikan tertentu dalam soal
keselamatan pasien Sasaran sasaran dalam
SIKP menyoroti bidang-bidang yang
bermasalah dalam perawatan kesehatan,
memberikan bukti dan solusi hasil
konsensus yang berdasarkan nasihat para
pakar.
• Berikut ini adalah daftar semua sasaran. Agar nyaman dibaca, daftar
ini tidak menyertakan persyaratan maksud dan tujuan, atau elemen
terukurnya. Informasi lebih lanjut tentang sasaran-sasaran ini, dapat
dilihat pada bagian berikutnya dalam bab ini, yakni Sasaran,
Persyaratan, Tujuan, dan Elemen Penilaian.

• SIKP.1 Mengidentifikasi Pasien Dengan Benar

• SIKP.2 Meningkatkan Komunikasi Yang Efektif
• SIKP.3 Meningkatkan Keamanan Obat-obatan Yang Harus
Diwaspadai
• SIKP.4 Memastikan Lokasi Pembedahan Yang Benar, Prosedur
Yang Benar, Pembedahan Pada Pasien Yang Benar
• SIKP.5 Mengurangi Resiko Infeksi Akibat Perawatan Kesehatan
• SIKP.6 Mengurangi Resiko Cedera Pasien Akibat Terjatuh
Seven steps to patient safety, An overview guide for
NHS staff. Second print April 2004
1 Build a safety culture : Create a culture that is open and fair
2 Lead and support your staff : Establish a clear and strong
focus on patient safety throughout your organisation
3 Integrate your risk management activity : Develop systems
and processes to manage your risks and identify and assess
things that could go wrong
4 Promote reporting : Ensure your staff can easily report
incidents locally and nationally
5 Involve and communicate with patients and the public :
Develop ways to communicate openly with and listen to patients
6 Learn and share safety lessons : Encourage staff to use root
cause analysis to learn how and why incidents happen
7 Implement solutions to prevent harm : Embed lessons
through changes to practice, processes or systems
(www.npsa.nhs.uk/sevensteps)
 (Seven steps to patient safety,
An overview guide for NHS staff
April 2004)

A major element of programmes to improve patient safety is having the capacity and capability to
capture comprehensive information on adverse events, errors and near-misses so that it can be used
as a source of learning and as the basis for preventive action in the future. (WHO : World Alliance for
Patient Safety, Forward Programme, 2004 )
NHS-NPSA :
Seven steps to patient safety,
An overview guide for NHS staff.
Step 1 Second print April 2004
Build a safety culture
Action points
For your organisation:
• ensure your policies state what staff should do following an incident,
how it should be investigated, and what support should be given to
patients, families and staff;
• ensure your policies describe individual roles and accountability for
when things go wrong;
• assess your organisation’s reporting and learning culture using a safety
assessment survey (see ‘Resources from the NPSA’ on page 10).
For your team:
• ensure your colleagues feel able to talk about their concerns and report
when things go wrong;
• demonstrate to your team the measures your organisation takes to
ensure reports are dealt with fairly and that the appropriate learning
and action takes place.
Step 2
Lead and support your staff
Action points
For your organisation:
• ensure there is an executive board member with responsibility for
patient safety;
• identify patient safety champions in each directorate, division or
department;
• put patient safety high on the agenda of board or management team
meetings;
• build patient safety into the training programmes for all your staff and
ensure this training is accessible and measure its effectiveness.
For your team:
• nominate your own champion or lead for patient safety;
• explain the relevance and importance of patient safety to your team,
and the benefits it brings;
• promote an ethos where all individuals within your team are respected
and feel able to challenge when they think something may be going
wrong.
Step 3
Integrate your risk management activity
Action points
For your organisation:
• review your structures and processes for managing clinical and nonclinical
risk, and ensure these are integrated with patient and staff
safety, complaints and clinical negligence, and financial and
environmental risk;
• develop performance indicators for your risk management system
which can be monitored by your board;
• use the information generated by your incident reporting system and
organisation-wide risk assessments to proactively improve patient care.
For your team:
• set up local forums to discuss risk management and patient safety
issues and provide feedback to the relevant management groups;
• assess the risk to individual patients in advance of treatment;
• have a regular process for assessing your risks, for defining the
acceptability of each risk and its likelihood, and take appropriate actions
to minimise them;
• ensure these risk assessments are fed into the organisation-wide risk
assessment process and risk register.
Step 4
Promote reporting
Action points
For your organisation:
• complete a local implementation plan (see below) which describes how
and when your organisation will begin reporting nationally to the NPSA.
For your team:
• encourage your colleagues to actively report patient safety incidents
that happen and those that have been prevented from happening but
that carry important lessons.
Step 5
Involve and communicate with patients and the public
Action points
For your organisation:
• develop a local policy covering open communication about incidents
with patients and their families;
• ensure patients and their families are informed when things have gone
wrong and they have been harmed as a result;
• provide your staff with the support, training and encouragement they
need to be open with patients and their families.
For your team:
• ensure your team respects and supports the active involvement of
patients and their families when something has gone wrong;
• prioritise the need to tell patients and their families when incidents
occur, and to provide them with clear, accurate and timely information;
• make sure patients and their families receive an immediate apology
where it is due, and are dealt with in a respectful and sympathetic way.
Step 6
Learn and share safety lessons
Action points
For your organisation:
• ensure relevant staff are trained to undertake appropriate incident
investigations that will identify the underlying causes;
• develop a local policy which describes the criteria for when your
organisation should undertake a Root Cause Analysis (RCA) or
Significant Event Audit (SEA). These criteria should include all incidents
that have lead to permanent harm or death.
For your team:
• share lessons from the analysis of patient safety incidents within your
team;
• identify which other departments might be affected in future, and share
your learning more widely.
Step 7
Implement solutions to prevent harm
Action points
For your organisation:
• use the information generated from incident reporting systems, risk
assessments, and incident investigation, audit and analysis to identify
local solutions. This could include re-designing systems and processes,
and adapting staff training or clinical practice;
• assess the risks for any changes you plan to make;
• measure the impact of your changes;
• draw on solutions developed externally. These could be solutions
developed at a national level by the NPSA or best practice identified
elsewhere in the NHS;
• provide staff with feedback on any actions taken as a result of reported
incidents.
For your team:
• involve your team in developing ways to make patient care better
and safer;
• review changes made with your team to ensure they are sustained;
• ensure your team receives feedback on any follow-up to reported
incidents.
 AHRQ : 20 Tips To Help Prevent Medical Errors
(untuk Pasien / Masyarakat)
1.The single most important way you can help to prevent errors is to
be an active member of your health care team.
2. Make sure that all of your doctors know about everything you are
taking. This includes prescription and over-the-counter medicines,
and dietary supplements such as vitamins and herbs.
3. Make sure your doctor knows about any allergies and adverse
reactions you have had to medicines.
4. When your doctor writes you a prescription, make sure you can
read it.
5. Ask for information about your medicines in terms you can
understand– both when your medicines are prescribed
and when you receive them
6. When you pick up your medicine from the pharmacy, ask: Is this
the medicine that my doctor prescribed?
Patient involvement : …..in general, patients (and their family & friends) are
a vastly underutilized resource for identifying things that go wrong in health
care. (Aspden P, Corrigan JM, Wolcott J, Erickson SM, eds. Patient Safety:
achieving a new standard for care. Washington, D.C.: National Academy
Press, 2004.)
7. If you have any questions about the directions on your
medicine labels, ask
8. Ask your pharmacist for the best device to measure your
liquid medicine. Also, ask questions if you’re not sure how
to use it.
9. Ask for written information about the side effects your
medicine could cause.
10. If you have a choice, choose a hospital at which many
patients have the procedure or surgery you need.
11. If you are in a hospital, consider asking all health care
workers who have direct contact with you whether they
have washed their hands.
12. When you are being discharged from the hospital, ask
your doctor to explain the treatment plan you will use at
home.
13. If you are having surgery, make sure that you, your
doctor, and your surgeon all agree and are clear on exactly
what will be done
14. Speak up if you have questions or concerns.
15. Make sure that someone, such as your personal doctor,
is in charge of your care.
16. Make sure that all health professionals involved in your
care have important health information about you.
17. Ask a family member or friend to be there with you and
to be your advocate (someone who can help get things done
and speak up for you if you can’t).
18. Know that “more” is not always better.
19. If you have a test, don’t assume that no news is good
news.
20. Learn about your condition and treatments by asking
your doctor and nurse and by using other reliable sources.

(www.ahrq.gov/errors.htm.)
 AHRQ : 30 Safe Practices for Better Health Care
(untuk Staff)
1. Create a health care culture of safety.
2. Elective surgical procedures-patients should be clearly
informed- treatment facilities superior outcomes -should be
referred to such facilities in accordance with the patient’s
stated preference.
3. Specify an explicit protocol to be used to ensure an adequate
level of nursing
4. All patients in general intensive care units should be managed
by physicians having specific training and certification in
critical care medicine (“critical care certified”).
5. Pharmacists should actively participate in the medication-use
process
6. Verbal orders should be recorded whenever possible and
immediately read back to the prescriber;
7. Use only standardized abbreviations and dose designations.
8. Patient care summaries or other similar records should not be
prepared from memory.
9. Care information, especially changes in orders and new diagnost
information, is transmitted in a timely and clearly understandable
form to all of the patient’s current health care
providers who need that information to provide care
10. Ask each patient or legal surrogate to recount what he or
she has been told during the informed consent discussion.
11. Ensure that written documentation of the patient’s
preference for life-sustaining treatments is prominently
displayed in his or her chart.
12. Implement a computerized prescriber-order entry system.
13. Implement a standardized protocol to prevent the mislabeling of
radiographs.
14. Implement standardized protocols to prevent the occurrence
of wrong-site or wrong-patient procedures.
25. Decontaminate hands with either a hygienic hand rub or by
washing with a disinfectant soap prior to, and after, direct
contact with the patient or objects immediately around the
patient.
26. Vaccinate health care workers against influenza to protect
both them and patients.
27. Keep workspaces where medications are prepared clean,
orderly, well lit, and free of clutter, distraction, and noise.
28. Standardize the methods for labeling, packaging, and storing
medications.
29. Identify all “high alert” drugs (for example, intravenous
adrenergic agonists and antagonists, chemotherapy agents,
anticoagulants and anti-thrombotics, concentrated parenteral
electrolytes, general anesthetics, neuromuscular blockers,
insulin and oral hypoglycemics, narcotics, and opiates).
30. Dispense medications in unit-dose or, when appropriate,
unit-of-use form, whenever possible.
(www.ahrq.gov/qual/nqfpract.htm.)
 Mengapa Patient Safety
Quality Quality Quality
RS: Structure Process of care Outcome : AE
Costly
Cost: Invsment

Patient Safety “Blaming”

-Culture
-Reporting
-Learning/Analysis/Research
-K&R-based Standard-Guideline
-Implementasi,Monitor
-Patient Involvement
Kepercayaan meningkat
-Pengaduan, Tuntutan
-Tuduhan “Malpraktek”(Pid/Perd)
-Proses Hukum:Polisi,Pengadilan
-Blow-up Mass Media, 90%
Publikasi-opini negatif
-“Pertahanan RS” :
-Pengacara
-RS/Dr : Asuransi
-Tuntutan balik
- Dsb
Kecurigaan meningkat
 Manfaat RS terapkan Keselamatan Pasien
 Kecenderungan “Green Product” -produk yang aman- di bidang industri
lain, al.menjadi persyaratan dlm berbagai proses transaksi, sehingga menjadi
makin laku/laris, makin dicari masyarakat
 RS yang menerapkan KP akan lebih ”dicari” oleh ”3rd Party Payer” :
Perusahaan-perusahaan dan Asuransi-asuransi akan mengutamakan
memakai RS-RS tsb sebagai provider kesehatan karyawan / klien mereka,
& kemudian akan diikuti oleh masyarakat yang akan lebih mencari RS
yang aman.
 Kegiatan RS di kawasan Blaming akan menurun krn fokus di kawasan
Patient Safety,

“ PATIENT
SAFETY ”

“ BLAMING ”

2005 2008 2010

 Kesimpulan

1) Di berbagai negara yang notabene adalah negara maju,

termasuk mutu pelayanan kesehatan dan teknologi
kesehatannya, tenyata Medical Error yang berakibat
“Adverse Event” (AE) tidak kecil jumlahnya. Apalagi “Near
Miss” ada 10-100 ribuan tiap hari di US
(Disamping : Overuse, Underuse, Variasi Pelayanan)

2) Di Indonesia data AE ini masih minim, tetapi diasumsikan

tidak kalah besarnya

3) AE meningkatkan biaya, proses2 “Blaming” merugikan

semua pihak, kecurigaan meningkat, “semua pihak rugi” :
“lose-lose outcome”
4) Patient Safety / Keselamatan Pasien adalah solusi yang
menguntungkan: “win-win situation”, kepercayaan
meningkat. Di banyak negara sejak th2000an Patient
Safety sudah diangkat menjadi fokus nasional,
partisipasi luas berbagai organisasi

5) Elemen pokok Sistem Keselamatan Pasien, yang

bertujuan menekan kejadian AE, terdiri dari :

I. Reporting
II.Analyzing /Learning, Research, Taxonomy
III.
Solution development
IV.Knowledge & Research based Standards-
Practices-Guidelines for Patient Safety
V. Patient involvement-empowerment
Terimakasih
Atas perhatiannya