India Ministry drafts law to improve patient safety


India’s health ministry has published a draft framework aimed at ensuring patient safety while undergoing any medical intervention and it proposes measures such as setting up of an online grievance system.

The draft National Patient Safety Implementation Framework (NPSIF) states that patient safety is a fundamental element of healthcare and is defined as freedom for a patient from unnecessary harm or potential harm associated with the provision of healthcare.

It is about safe drugs dispensing, surgical care, safe childbirth, injection safety, blood safety, medication safety, medical device safety, safe organ, tissue and cell transportation and donation. It is also about bio-medical waste management, prevention of healthcare associated infections and much more.

Failure to deliver safe care is attributed to unsafe clinical practices, unsafe processes and poor systems and processes.

The framework is based on six main pillars: health system strengthening, improvement in adverse events reporting, training of healthcare personnel, research, vertical campaigns which include injection safety, blood safety, surgical safety, maternal and child healthcare, and quality of healthcare services through accreditation.

The provision of healthcare services has significantly grown in the public sector over the past few years and there is a large unregulated private sector. Challenges in patient safety in India are numerous, ranging from unsafe injections and biological waste management to medication and medical device safety, high rates of healthcare associated infections, and anti-microbial resistance.

There are many initiatives in patient safety being implemented in India at different levels of care in both the public and private sectors.

The draft NPSIF proposes setting up of a web-based grievance system and toll-free helplines for patient safety in all healthcare facilities and introducing anonymous reporting system in healthcare facilities to be used by healthcare facility staff, students, patients and their families.

It also suggests setting up of a national steering committee as a central coordinating mechanism.

The draft proposes incorporating patient safety principles and concepts in the Public Health Act and streamlining patient safety in different insurance schemes.

To strengthen quality assurance mechanisms, including accreditation systems, the draft suggests incorporating selected patient safety indicators within the accreditation systems for hospitals and laboratories.

It also proposes the establishment of a culture of safety and improving communication, patient identification and handing over transfer protocols in healthcare facilities.

The draft calls for ensuring that patient safety processes are clearly communicated to patients and caregivers prior, during and after the medical intervention using different communication means such as videos, mobile apps, leaflets, brochures, and emails.



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