PATIENT SAFETY(ETHICAL AND LEGAL ASPECTS)

Prof. Dr. Moch. Istiadjid ES, dr., SpS, SpBS, M.Hum

Patient safety is a new healthcare discipline that emphasizes the reporting, analysis, and prevention of medical error that often lead to adverse health

care events. The frequency and magnitude of avoidable adverse patient events was not well known until the 1990s,

when multiple countries reported staggering numbers of patients harmed and killed by medical

errors.

Recognizing that healthcare errors impact 1 in every 10 patients around the world, the

World Health Organization calls patient safety an endemic concern. Indeed, patient safety has emerged as

a distinct healthcare discipline supported by an immature yet developing scientific framework. There is a significant

transdisciplinary body of theoretical and research literature that informs the science of patient safetyThe resulting patient safety knowledge continually

informs improvement efforts such as: applying lessons learned from business and industry, adopting innovative

technologies, educating providers and consumers, enhancing error reporting systems, and developing new

economic incentives.

Prevalence of Adverse Events

Millennia ago, Hippocrates recognized the potential for injuries that arise from the well

intentioned actions of healers. Greek healers in the 4th Century B.C., drafted the Hippocratic Oath and pledged to "prescribe regimens for the good of my patients according to my ability and my judgment

and never do harm to anyone”.Since then, the directive “primum non nocere”

(“first do no harm”) has become a central tenet for contemporary medicine.

In the United States, the public and the medical specialty of anesthesia were shocked in April 1982 by the ABC television program 20/20 entitled The

Deep Sleep. Presenting accounts of anesthetic accidents, the producers stated that, every year,

6,000 Americans die or suffer brain damage related to these mishaps.

In 1983, the British Royal Society of Medicine and the Harvard Medical School jointly sponsored a symposium on anesthesia deaths and injuries,

resulting in an agreement to share statistics and to conduct studies

By 1984 the American Society of Anesthesiologists had established the Anesthesia Patient Safety

Foundation. The APSF marked the first use of the term "patient safety" in the name of professional

reviewing organization. Although anesthesiologists comprise only about 5% of physicians in the

United States, anesthesiology became the leading medical specialty addressing issues of patient

safety.

Likewise in Australia, the Australian Patient Safety Foundation was founded

in 1989 for anesthesia error monitoring. Both organizations were soon expanded as the

magnitude of the medical error crisis became known.

Causes of healthcare error

The simplest definition of a health care error is a preventable adverse effect of care, whether or not

it is evident or harmful to the patient. A conservative average of both the

Institute of Medicine and Health Grades reports indicates that there have been between 400,000-

1.2 million error-induced deaths during 1996–2006 in the United States.

These casualties have been, in part, attributed to:

Human FactorsVariations in healthcare provider training &

experience, fatigue, depression and burnout.Diverse patients, unfamiliar settings, time pressures.

Failure to acknowledge the prevalence and seriousness of medical errors

Medical complexityComplicated technologies, powerful drugs.

Intensive care, prolonged hospital stay.

System failuresPoor communication, unclear lines of authority of

physicians, nurses, and other care providers.Complications increase as patient to nurse staffing ratio

increases.Disconnected reporting systems within a hospital:

fragmented systems in which numerous hand-offs of patients results in lack of coordination and errors.

Drug names that look alike or sound alike.The impression that action is being taken by other

groups within the institution.Inadequate systems to share information about errors

Environment and design factors. In emergencies, patient care may be rendered in areas poorly

suited for safe monitoring. Infrastructure failure. According to the WHO, 50%

of medical equipment in developing countries is only partly usable due to lack of skilled operators

or parts. As a result, diagnostic procedures or treatments cannot be performed, leading to

substandard treatment

Common Misconceptions about Adverse Events :

"'Bad apples' or incompetent health care providers are a common cause." Many of the errors are normal human slips or lapses, and not the result of poor judgment or recklessness.

"High risk procedures or medical specialties are responsible for most avoidable adverse events". Although some mistakes, such as in surgery, are easier to notice, errors occur in all levels of care. Even though complex procedures entail more risk, adverse outcomes are not usually due to error, but to the severity of the condition being treated.

Clinical guidelines for disease management have a demonstrated benefit when accessible within the

electronic record during the process of treating the patient. Advances in health informatics and

widespread adoption of interoperable electronic health records promise access to a patient's

records at any health care site. Still, there may be a weak link because of physicians' deficiencies in understanding the patient safety features of e.g.

government approved software.

COMPONENTS

COMPETENCYEVIDENCE BASED MEDICINE

PROFESSIONALISMMEDICAL PROFESSIONAL STANDARD

STANDARD OPERATIONAL PROCEDUREINFORMED CONSENT

Competency areas:1. Effective communication2. Clinical Skill3. Scientific based medical sciences 4. Health problem management 5. Information management6. Self evaluation and development 7. Ethics, Moral, Medicolegal,

Proffesionalism and Patients safety

Indonesian Doctor’s Competence Standard

(Konsil Kedokteran Indonesia, 2007)

Evidence-based MedicineEvidence-based medicine (EBM) aims to apply the best available evidence gained from the scientific method to

medical decision making. It seeks to assess the quality of evidence of the risks and

benefits of treatments (including lack of treatment).EBM recognizes that many aspects of medical care depend on individual factors such as quality- and value-of-life judgments,

which are only partially subject to scientific methods. EBM, however, seeks to clarify those parts of medical practice

that are in principle subject to scientific methods and to apply these methods to ensure the best prediction of

outcomes in medical treatment, even as debate continues about which outcomes are desirable

ClassificationTwo types of evidence-based medicine have been

proposed.Evidence-based guidelines

Evidence-based guidelines (EBG) is the practice of evidence-based medicine at the organizational or institutional level.

This includes the production of guidelines, policy, and regulations. This approach has also been called evidence

based healthcare.Evidence-based individual decision making

Evidence-based individual decision (EBID) making is evidence-based medicine as practiced by the individual

health care provider. There is concern that current evidence-based medicine focuses excessively on EBID.

Process and ProgressUsing techniques from science, engineering, and

statistics, such as meta-analysis of medical literature, risk-benefit analysis, and

randomized controlled trials (RCTs), EBM aims for the ideal that healthcare professionals should

make "conscientious, explicit, and judicious use of current best evidence" in their everyday practice. Ex cathedra statements by the "medical expert"

are considered to be least valid form of evidence. All "experts" are now expected to reference their

pronouncements to scientific studies.

Three distinct, but interdependent, areas of EBMThe first is to treat individual patients with acute or chronic

pathologies by treatments supported in the most scientifically valid medical literature. Thus, medical practitioners would select treatment options for specific cases based on the best research for each patient

they treat. The second area is the systematic review of medical literature to

evaluate the best studies on specific topics. This process can be very human-centered, as in a journal club, or highly technical, using

computer programs and information techniques such as data mining. Increased use of information technology turns large volumes of

information into practical guides. Finally, evidence-based medicine can be understood as a medical

"movement" in which advocates work to popularize the method and usefulness of the practice in the public, patient communities,

educational institutions, and continuing education of practicing professionals

Ranking the quality of evidenceEvidence-based medicine categorizes different types of

clinical evidence and ranks them according to the strength of their freedom from the various biases that

beset medical research. For example, the strongest evidence for therapeutic interventions is provided by

systematic review of randomized, double-blind, placebo-controlled trials involving a homogeneous

patient population and medical condition. In contrast, patient testimonials, case reports, and even expert

opinion have little value as proof because of the placebo effect, the biases inherent in observation and reporting of cases, difficulties in ascertaining who is an

expert, and more.

Stratification of Evidence•Level I: Evidence obtained from at least one properly designed randomized controlled trial. •Level II-1: Evidence obtained from well-designed controlled trials without randomization. •Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group. •Level II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence. •Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

Categories of Recommendations•Level A: Good scientific evidence suggests that the benefits of the clinical service substantially outweighs the potential risks. Clinicians should discuss the service with eligible patients. •Level B: At least fair scientific evidence suggests that the benefits of the clinical service outweighs the potential risks. Clinicians should discuss the service with eligible patients. •Level C: At least fair scientific evidence suggests that there are benefits provided by the clinical service, but the balance between benefits and risks are too close for making general recommendations. Clinicians need not offer it unless there are individual considerations.

•Level D: At least fair scientific evidence suggests that the risks of the clinical service outweighs potential benefits. Clinicians should not routinely offer the service to asymptomatic patients. •Level E: Scientific evidence is lacking, of poor quality, or conflicting, such that the risk versus benefit balance cannot be assessed. Clinicians should help patients understand the uncertainty

Quality of Clinical Trials•Trial design considerations. High-quality studies have clearly-defined eligibility criteria, and have minimal missing data. •Generalizability considerations. Studies may only be applicable to narrowly-defined patient populations, and may not be generalizable to clinical practice. •Follow up. Sufficient time for defined outcomes to occur can influence the study outcomes and the statistical power of a study to detect differences between a treatment and control arm. •Power. A mathematical calculation can determine if the number of patients is sufficient to detect a difference between treatment arms. A negative study may reflect a lack of benefit, or simply a lack of sufficient quantities of patients to detect a difference.

PROFESSIONALISMThe Essential Elements

1. Altruism2. Accountability3. Excellences4. Duty to service5. Integrity

6. Respect7. Empathy8. Compassion9. Life-long learning10. The like

(George , Gousenhauser , andWhitehouse, 2010)

Internal Dynamic of Medical Professionalism Ten Aspects of Medical work /subsystem

1. Altruism2. Autonomy3. Interpersonal

Competence4. Personal Morality5. Professional Dominance

6. Technical competence

7. Social contract8. Social Justice9. Life style10. Commercialism

PANDANGAN UMUM TENTANG ETIK DAN HUKUM

• Etik dan hukum mengatur bidang yang sama, berupa aturan main antar individu dlm masyarakat, agar dicapai ketertiban dan kebaikan bersama

• Etik berkaitan dg moral, berdasar hati nurani untuk melakukan hal yg baik dan benar dalam segala aspek kehidupan

• Hukum mengatur etik dan moral secara tertulis secara garis besar, berlaku umum dlm negara,, dan memiliki sanksi hukum (perdata maupun pidana).

• Hukum negara dibuat dan diundangkan oleh pemerintah (PP), atau bersama-sama lembaga perwakilan rakyat (UU, KUHP)

ETIK, MORAL DAN HUKUM• Akar dari etik dan moral adalah hati nurani yang pertama-

tama akan menolak jika timbul keinginan untuk berbuat yang kurang baik

• Sumber dari etik dan moral adalah adat-istiadat suatu komunitas dalam suatu kurun waktu tertentu

• Diperkuat dengan faktor agama sebagai sumber keluhuran akhlak

• Sanksi : adat, administratif (etik, moral) dan hukum negara (moral, pelanggaran, kejahatan)

ETIK PROFESI

• Etik Profesi: etik terapan, pedoman moral yg bersifat intern dlm kelompok profesi tertentu untuk menjaga mutu, harkat dan martabat profesi.

Sanksi: teguran, skorsing, pemecatan

• Kode Etik Profesi: Etik profesi yang sudah dalam bentuk konkrit, tertulis sistematis

DASAR-DASAR ETIK PROFESIKEDOKTERAN

• 1. The Hippocratic Oath

• 2. Declaration of Geneva (The World Medical Association,1948; amended,1968)

• 3. Lafal Sumpah Kedokteran Indonesia (Depkes, 1981)

International Code of Medical Ethics

• A doctor must always maintain the highest standards of professional conduct.

• A doctor must practice his profession uninfluenced by motives of profit.

• A doctor is advised to use great caution in divulging discoveries or new techniques or treatment.

• A doctor should certify or testify only to that which he has personally verified.

LAFAL SUMPAH KEDOKTERAN INDONESIA(Mukernas Etik Kedokteran, Depkes, 1981)

Demi Allah saya bersumpah/berjanji, bahwa:

1. Saya akan membaktikan hidup saya guna kepentingan perikemanusiaan

2. Saya akan memelihara dengan sekuat tenaga martabat dan tradisi luhur jabatan kedokteran

3. Saya akan menjalankan tugas saya dengan cara yg terhormat dan bersusila, sesuai dg martabat pekerjaan saya sebagai dokter

4. Saya akan menjalankan tugas saya dengan mengutamakan kepentingan masyarakat

5. Saya akan merahasiakan segala sesuatu yang saya ketahui karena pekerjaan saya dan keilmuan saya sebagai dokter

6. Saya tidak akan mempergunakan pengetahuan kedokteran saya untuk sesuatu yg bertentangan dengan perikemanusiaan, sekalipun diancam

HUBUNGAN DOKTER - PASIEN

1. Komunikasi yang baik- mendengarkan keluhan, menggali informasi, menghormati

pandangan serta kepercayaan pasien yg berkaitan dengan keluhannya

- Memberikan informasi yg diminta tentang kondisi, diagnosis, terapi dan prognosis pasien serta rencana perawatannya

- Jika pasien meninggal, sesuai pengetahuannya, dokter hrs menjelaskan sebab dan keadaan berkaitan dg kematian tsb kpd keluarga terdekat, kecuali jika pasien berwasiat lain

HUBUNGAN DOKTER - PASIEN

2. Memperoleh Persetujuan• Dalam setiap tindakan yang akan dilakukan, dokter

harus mendapat persetujuan pasien, krn prinsipnya yang berhak memberikan persetujuan atau penolakan tindakan medis adalah pasien yang bersangkutan. Dokter hrs yakin bahwa pasien mengerti tetang apa yg disampaikan, shg dalam memberikan persetujuan tanpa adanya paksaan atau tekanan

HUBUNGAN DOKTER - PASIEN3. Menghormati Rahasia Kedokteran• Dokter wajib membuat dan menyimpan catatan medis pasien dan segala

sesuatu yang diketahuinya sebagai rahasia kedokteran. Rahasia itu hanya dapat dibuka untuk kepentingan kesehatan pasien, permintaan pasien sendiri maupun dlm penegakan etik, disiplin, dan hukum berdasar ketentuan yg berlaku

4. Mempertahankan Kepercayaan Pasien• bertindak sopan, hati-hati dan jujur• menghormati privasi dan harga diri pasien• menghormati hak pasien untuk menolak, dan mdpt opini kedua• selalu siap dihubungi para pasien atau sejawat berkaitan dg penyakit

pasiennya sesuai perjanjian

ETHICAL ASPECT

HIPPOCRATES OATH

“I will use treatment to help the sick according to my ability and judgment, but never with a view to injury and wrongdoing,neither will I administer a poison to anybody when asked to do so, not will I suggest such a course”.

1. SUMPAH HIPPOCRATES

2. KESEPAKATAN WMA (WORLD MEDICAL ASSOCIATION)

3. KODE ETIK KEDOKTERAN INDONESIA (KODEKI)

4. LAFAL SUMPAH DOKTER INDONESIA

Artikel 5 Deklarasi Universal HAM (Helsinki, 1947) yang juga ikut melandasi Lafal Sumpah Dokter disebutkan:

“No one shall be subjected to torture or to cruel, Inhuman or degrading treatment or punishment”.

Setiap manusia berhak untuk berperan serta dan menentukan dalam pengambilan keputusan yang menyangkut dirinya.

(“The right of self determination”)

World Medical Association (WMA)(2002):

“medical malpractice involves the physician’s failure to conform to the standard of care for

treatment of the patient’s condition, or lack of skill, or negligence in providing care to the patient,

which is the direct cause of an injury to the patient”

“An injury occurring in the course of medical treatment which could not be foreseen and was not the result of the lack of skill or knowledge on

the part of the treating physician is untoward result, for which the physician should not bear any

liability”.

Adverse events di bidang medik dapat diakibatkan oleh beberapa kemungkinan :

a. Hasil dari suatu perjalanan penyakitnya sendiri, tidak berhubungan dengan tindak medik yang dilakukan dokter.b. Hasil dari suatu risiko yang tak dapat dihindari, yaitu risiko yang tak dapat diketahui sebelumnya (unforeseeable); atau risiko yang meskipun telah diketahui sebelumnya (foreseeable) tetapi tidak dapat/tidak mungkin dihindari (unavoidable), karena tindak medik yang dilakukan adalah satu-satunya cara terapi. Risiko tersebut harus diinformasi-kan terlebih dahulu.c. Hasil dari suatu kelalaian medik.d. Hasil dari suatu kesengajaan.

PRINSIP UMUM ETIK KESEHATAN

1. RESPECT FOR PERSONS2. BENEFICENCE3. JUSTICE

4. NONMALEFICENCE5. VERACITY6. CONFIDENTIALITY

ASPEK HUKUMPozgar:

“Informed consent is a legal concept that provide that a participant has a right to know the potential risk, benefits, and alternatives of proposed procedure”.

Di Indonesia, dasar hukum untuk tindakan medis diatur dalam 1. Peraturan Menteri Kesehatan (PERMENKES)

Nomor 585 Tahun 1989 Tentang Persetujuan Tindakan Medis

2. Undang-Undang Nomor 29 Tahun 2004 Tentang Praktik Kedokteran (Pasal 39, 45)

3. Undang-undang Nomer 44 Tahun 2009 Tentang Rumah Sakit (Pasal 37)

Ketentuan pidana baik berupa tindak pidana kesengajaan (professional misconducts) ataupun tindak pidana culpa (kelalaian/ kealpaan) adalah:a. Menyebabkan mati atau luka karena kelalaian ( Pasal 359 KUHP, Pasal 360 KUHP, Pasal 361 KUHP ); b. Penganiayaan ( Pasal 351 KUHP ), untuk tindak medik tanpa persetujuan dari pasien ( Informed Consent ); c. Aborsi ( Pasal 341 KUHP, Pasal 342 KUHP, Pasal 346 KUHP, Pasal 347 KUHP, Pasal 348 KUHP , Pasal 349 KUHP );d. Euthanasia ( Pasal 344 KUHP, Pasal 345 KUHP);e. Keterangan palsu (Pasal 267-268 KUHP);

Hukum Perdata menganut prinsip “barang siapa merugikan orang lain harus memberikan ganti rugi”.

Dalam lingkup ini, hubungan kerja dokter-pasien dapat terjadi berdasarkan perjanjian (ius contracto)

dan berdasarkan hukum (ius delicto). Dari ius contracto terbentuklah apa yang disebut dengan kontrak terapeutik secara sukarela antara dokter

dan pasien. Kemungkinan perkara medik berdasarkan

KUHPerdata, antara lain wanprestasi (pasal 1239), perbuatan melawan hukum (pasal 1365),

melalaikan kewajiban (pasal 1367), dan kelalaian yang mengakibatkan kerugian (pasal 1366).

SYARAT SAH PERJANJIAN(Pasal 1320 KUHPerdata)

1.KesepakatanKesepakatan adalah adanya rasa ikhlas atau saling memberi dan menerima atau sukarela di antara pihak-pihak yang membuat perjanjian tersebut. Kesepakatan tidak ada apabila kontrak dibuat atas dasar paksaan, penipuan atau kekhilafan.

2. Kecakapan (Kompetensi)Para pihak yang membuat kontrak harus orang-orang yang oleh hukum dinyatakan sebagai subyek hukum.

a. Kompetensi subyek Pada dasarnya semua orang menurut hukum cakap

untuk membuat kontrak. Yang tidak cakap adalah orang-orang yang ditentukan

hukum, yaitu anak-anak, orang dewasa yang ditempatkan di bawah pengawasan (curatelle), orang sakit jiwa, orang tdk sadar

Anak-anak adalah mereka yang belum dewasa yang menurut Undang-undang Nomor 1 Tahun 1974 Tentang Perkawinan belum berumur 18 (delapan belas) tahun yg belum menikah.

b. Kompetensi Peneliti Menguasai substansi Menguasai metodologi Track record Integritas

c. Kompetensi Dokter Tujuh area kompetensi (KKI) STR, SIP SPM, SOP

3. Hal TertentuObjek yang diatur dalam perjanjian harus jelas, setidak-tidaknya dapat ditentukan, tidak boleh samar-samar.

Hal ini penting untuk memberikan jaminan atau kepastian kepada para pihak dan mencegah timbulnya perjanjian fiktif.

Semakin jelas semakin baik. Tidak boleh misalnya jual beli sebuah mobil saja, tanpa penjelasan lebih lanjut.

4. Sebab Yang Dibolehkan

Isi perjanjian tidak boleh bertentangan dengan aturan perundang-undangan yang sifatnya memaksa, ketertiban umum, dan atau norma kesusilaan.

Misalnya jual beli bayi adalah tidak sah karena bertentangan dengan norma-norma tersebut.

TERIMA KASIH