First, do no harm

More and more patients are getting themselves exposed to grievous medical injuries as clinical establishments neglect to follow quality norms

First, do no harm

When aspiring doctors enter their clinical training years in medical college, one of the first lessons they are given is: Primum non nocere — “First, do no harm”. In the lengthy careers of doctors and other healthcare professionals, they are faced with many medical situations that are beyond their power to remedy. At the same time, they are expected to ensure that their actions do not leave the patient worse off than before.

Yet, this principle has been repeatedly violated in healthcare establishments across the world for the last several years. This is the reason why so much attention is being paid to healthcare quality and patient safety in every country, and the reason why the World Health Assembly has declared September 17 every year as Patient Safety Day. This would ensure that the day is observed in all 194 member countries of the World Health Organization (WHO). With this, all the countries make specific commitments to accord the highest priority to patient safety in their healthcare establishments.

MAEs: Huge toll

The true extent of Medical Adverse Effects (MAE) hit the headlines for the first time in 2001. That year, the US Institute of Medicine (IOM) published a report saying that 98,000 people in that country died or suffered grievous injury because of physician-induced errors. 

Last year, the IOM, which is now known as the National Academy of Science, Engineering and Medicine (NASEM), brought out a new report that painted an even more discouraging picture. The August 2018 report estimated that approximately 134 million people suffer from MAE (on account of poor quality healthcare) each year in Low and Middle Income Countries (LMIC) spread across Asia, Africa, Latin America and other continents. Of these, 2.5 million people die on an average every year! Studies from the US, UK and other countries reveal a similar situation.

India-specific figures are difficult to come by, says Girdhar Gyani, Director General of Association of Healthcare Providers of India (AHPI), which provides a lot of handholding and support to hospitals going through the process of accreditation. AHPI Institute of Quality has launched a series of training programmes to improve patient safety. It is also the first to design a training programme for Patient Safety Implementation Framework (2018-2022), initiated by the union health ministry. The first such such programme was conducted for government doctors in Gujarat. AHPI is also holding a series of programmes, such as those for Infection Prevention and Control for Nurses, Clinical Audit, etc.

India sees 5.2 million MAE (with 3 million deaths) per year, according to an estimate which was published three years ago. But Gyani says even that was an extrapolation from studies conducted in other countries. 

The founder and the first CEO of National Board of Accreditation for Hospitals (NABH), Gyani is a doyen of the healthcare quality movement in India.

Another report published by the WHO and World Bank in 2018 highlighted huge deficiencies in the standard of healthcare services in a number of LMIC. The report pointed out that adherence to clinical guidelines in maternity care in eight LMIC was less than 50 percent; diagnostic accuracy varied from 34 to 72.2 percent, while absenteeism of healthcare professionals could be as high as 44.3 percent in some places!

The JCI (Joint Commission International), which is the global wing of the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) of the US, has begun issuing accreditation to hospitals in other countries as well. At present, about 21 Indian hospitals have been accorded JCI accreditation, mostly with a view to enabling them to compete in the medical tourism market.

The JCAHO has also formulated a series of Sentinel Events, which are serious medical mishaps that accredited hospitals must report as and when they occur. These include wrong procedures, treatment to the wrong person, medication and radiation overdose, full-term infant death, peri-operative or post-operative death (within 72 hours), etc.

More prone to iatrogenic injuries?

Closer home, a recent report published by the National Health Systems Resource Centre (NHSRC) estimates that in Indian healthcare organizations, an average of 12.7 percent of hospital admitted patients suffer some kind of MAE. The NHSRC report also describes the commonest of these MAE: medication errors, hospital-acquired infections (HAI) and deep-vein thrombosis in lower limbs post-surgery or during prolonged convalescence. The report also mentions that public hospitals in the country have become more prone to these iatrogenic events after the launch of the NRHM (National Rural Health Mission) due to a substantial increase in patient load.

In the NHSRC’s view, patient safety has several components, including physical safety (of buildings, corridors, critical facilities and infrastructure), safety of engineering and support services, fire safety (obviously lacking in a number of hospitals in both the private and public sector), safe environment (proper cleaning and disinfection particularly of crucial areas such as operating rooms and ICU). In addition, there is the responsibility of ensuring the safety of clinical care (prevention of infections, medication safety – correct medicine to the correct patient in the correct dose and monitoring of vulnerable and high-risk patients). The last point deserves particular attention because patients falling off their bed or injuring themselves while in hospital is one of the knottiest problems faced by both clinicians and hospital administrators.

All this has prompted the Ministry of Health and Family Welfare (MOHFW) to launch the National Quality Assurance programme for Public Health Facilities. As a part of this programme, special steps are being taken keeping patient safety as a prime concern.

With these issues in mind, Quality Council of India (QCI), an autonomous body under the Government of India, spearheaded the formation of the NABH almost 13 years ago. The NABH has established Indian standards for healthcare quality because many Indian hospitals found JCI standards too difficult to implement. This was done in partnership with the Australian Quality Council and the ISQua (International Society for Quality).

Woefully low uptake

In recent years, the NABH has developed separate standards documents for nursing homes, small healthcare organizations, blood banks, eye care centres, etc to enable all of them to participate in the quality movement.

However even with all these efforts to reach out to more hospitals, it has managed to involve barely 2-3 percent of hospitals and nursing homes in the country, says Gyani. The government is more focused on affordability than patient safety and quality of care. Many hospitals and nursing homes are taking a cue from the ministry and claiming that in their struggle for financial viability, patient safety has to take a back seat!

Conversely, there are allegations that financial incentives are being offered to hospitals under government schemes such as CGHS and Ayushman Bharat to obtain NABH certification without any sustained effort towards better quality. However, leaders of the Quality movement believe that the system of surveillance and review that follows the first accreditation of any hospital would help expose anyone who manages to get the certificate but neglects to follow quality practices.  

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