Wise men learn by other men’s mistakes, fools by their own. H G Brown

Concerns about patients being harmed during treatment have been echoed since centuries in the aphorism “Primum Non Nocere” or ‘First do no harm’. Over the years there has been a dramatic change in the regulation of physician practices. While physicians were largely self- regulated and governed by the ethical codes defined by their respective Guilds, there are also examples of State-imposed legal penalties for incompetence.

For example, the legal code of Hammurabi, which was inscribed around 2000 BC in Babylon, describes penalties for medical malpractice, ranging from financial compensation to more draconian measures such as amputating a surgeon’s hand.

The role of regulation

In ancient India, Sushruta, the surgeon-teacher code of ethical and clinical conduct made medical students take an oath (not unlike the Hippocratic Oath), when they graduated from the School of Surgery. While self-regulation has been the norm over the centuries, regulatory shifts in health governance and increased accountability to patients is now gaining precedence. The watershed report published by the Institute of Medicine in the US in 1999- ‘To Err is Human”, highlighted the fact that on an annual basis, between 44,000 and 98,000 deaths occur in the US, from medical errors. This study catapulted patient safety concerns to the fore, and catalyzed governments into taking suitable action. In 2002, the 55th World Health Assembly adopted a resolution urging countries to strengthen their safety and monitoring systems.

This resolution urged the World Health Organization (WHO) to establish global norms and standards in support of countries’ efforts in developing patient safety norms, policies and practices. Along the same lines, the World Alliance for Patient Safety (WAPS) that was launched in May 2004 has worked with developed, developing and transitional economies on various patient safety programs.

The Danish Act on Patient Safety came into force on 1 January 2004, and is a model for other countries (http://patientsikkerhed.dk/in-english/act-on-patient-safety.aspx). The Danish Society for Patient Safety also provides a comprehensive tool kit for healthcare workers to refer to and measure their compliance with the law.

Regulation and accreditation are powerful tools to promote patient safety in that they can make certain safety practices compulsory - after all, if the carrot does not work, then why not use the stick? Regulation is vital in certain areas, particularly when doctors and hospitals fail to voluntarily adopt reasonable safety standards. A law or regulation can easily seem like the most straightforward way to fix an important safety problem, but real life is often too messy and complex, and a “one-size-fits-all” approach is never a panacea.

For example, doctors in India were brought under the purview of The Consumer Protection Act (CPA) in 1986. This was the first attempt at giving the consumer/patient the right to question the quality of medical service received. Since then, there has been a lot of debate about the CPA which has been censured for not factoring in all the complexities of our health care system.

The problem with the legal system

Sadly, judges are still not familiar with the modern systems approach towards analyzing medical errors. They are used to finding faults and assigning responsibility for crimes. They are too quick to criticize individual doctors, using the “name, blame and shame” approach, rather than seek system solutions. This often places the malpractice system in conflict with the goals of the patient safety movement because tort law is adversarial by nature, while a culture of safety is collaborative.

By refreshing contrast, several countries have adopted much healthier no-fault compensation systems for medical injuries. New Zealand, Sweden, and Denmark have replaced litigation with administrative compensation systems in which patients who sustain an avoidable medical injury can apply for compensation without engaging the services of a lawyer. A panel of medical experts reviews the case and decides on compensation. Such systems allow compensation to the injured parties without finding fault or negligence. This is a win-win, because it is much fairer and quicker for the patient; it doesn’t put the doctor and hospital on the defensive; it does not clog up the judicial system; it costs less; and it also helps society to eliminate medical errors.

This kind of system encourages openness, so that these errors can be analyzed and the lessons learned can be used to prevent errors in the future. The system is now designed to ask- not who caused the accident but what caused the accident? The single greatest impediment to error prevention in healthcare today is that we punish people for medical mistakes. In India, it is unfortunate that the police mindlessly applies criminal law statutes to cases where the patient suffers from medical complications. Judges, in their turn, blindly follow the letter of the law, and don’t differentiate between regular criminal offences and the injuries resulting from medical treatment. The law needs to be amended, so that what should be a matter of professional inquiry is not distorted into an adversarial argument in criminal courts by lay persons before judges, who are also lay persons.

It’s not that the law is an ass. The tragedy is that the two sections in the Indian Penal Code (Section 80 and 88, which relate to accidents in doing a lawful act) which are appropriate to medical negligence cases are usually ignored in daily practice. Medicine is a profession dealing with life-and-death situations, and criminalizing adverse outcomes of treatment would be a great disservice to society.

Accreditation

Accreditation is the external assessment of an organization to ensure they meet established standards. Recent efforts at standardization of healthcare include setting up of a national voluntary accreditation structure- the National Accreditation Board for Hospitals and Healthcare Providers (NABH). This was set up by the Quality Council of India (QCI) in 2006. NABH accreditation is voluntary and has to be renewed every 3 years.

These standards help hospitals to deliver quality medical care safely. In addition to scheduled audits, the NABH also conducts surprise checks to ensure that these facilities are obeying the set guidelines. Currently, the NABH accredits hospitals, medical laboratories, small healthcare organizations, primary and community healthcare centers, blood banks, dental facilities, as well as imaging facilities.

The Clinical Establishment (Registration and Regulation) Act was enacted by the Central Government in 2012. Since Health is a State subject, the States have been told to adopt the law through a resolution in their Assemblies, and Uttar Pradesh, Rajasthan and Jharkhand have done so. This Act aims to bring about the enforcement of uniform minimum standards across clinical establishments in the country.

The All India Institute of Medical Sciences (AIIMS) in Delhi launched the National Initiative on Patient Safety (NIPS) in 2009. NIPS resources have started to train and sensitize clinical professionals across the country on adverse events, reporting systems and patient safety practices. Several tertiary care hospitals in both the private and public sector have taken part in workshops that are held in Delhi, on a regular basis.

Meanwhile, the Directorate General of Health Services in collaboration with WHO conducts national-level workshops on patient safety concerns and strategies dealing with safer systems, documenting case studies and recording other innovative practices. However, a lot remains to be done, and this is both a challenge and an opportunity!