Special law to guard patient’s sensitive medical history

The Centre has proposed to bring in a National Patient Safety Implementation Framework that could ensure the safety of patients at all levels.

Published: 09th October 2017 04:04 AM  |   Last Updated: 09th October 2017 07:47 AM   |  A+A-

Express News Service

THIRUVANANTHAPURAM: The Centre has proposed to bring in a National Patient Safety Implementation Framework that could ensure the safety of patients at all levels such as injection, medication, blood, medical device, bio-waste management and infection.
Attributing the failure of safe health care to unsafe clinical practices, poor systems and processes, the Draft Patient Safety Implementation Framework published by the Health Ministry proposes to enact a special law for making sensitive healthcare data exempt from the public domain - which means a patient’s personal and medical history is protected.

When coming to blood safety, it has asked to incorporate pharmacovigilance, ensure implementation of surveillance of adverse blood reactions and develop/revise Standard Operational Procedure (SOP) for ensuring the safety of healthcare workers and disposal of discarded blood and consumables in accordance with Biomedical Waste (BMW) rules.
With respect to medical device safety, the draft proposes to bring medical devices other than syringes and plastic waste under the BMW rules. One of the highlights of the draft is that it calls for ensuring services of biomedical engineers in all healthcare facilities for continued maintenance of medical equipment from installation till the equipment is used.

Biomedical Engineers should be a full-time employee as most of the deaths in coronary care unit (CCU) occur due to machine failure which could be averted if the machines could be checked immediately, it said.The draft suggests patient safety processes are clearly communicated to patients and caregivers prior, during and after intervention and also establish web-based grievance system and toll-free helplines.
Patient groups

There is also a proposal to establish patient groups so that these groups get involved in policy development and implementation processes. Another suggestion is to develop Patient Safety incident surveillance system and a system of reporting and learning from all adverse events and near-misses at national, subnational and healthcare facility levels.

As part of delivering safety, the draft calls for strengthening education, training and professional performance inclusive of skills, competence and ethics of health-care personnel. It puts forth revision of licensing/certification and recertification standards of all categories of the health workforce and also to ensure a specific number of credit hours on patient safety.
A sustainable framework for ongoing education and capacity building of health care workers both in public and private sectors was needed, the draft said.

It points out to the importance of establishing special committees for the Infection Prevention and Control programme  (IPC) at institutional levels. Moreover, it also suggests improving the effectiveness of Hospital Infection Control Committees. Apart from this, the draft has asked to ensure incorporation of sufficient funds for implementation of IPC programmes in all relevant national programmes and institutional budgets.

In case of safe surgical care, the ministry has asked to uniformly adopt surgical safety check-list that covers elective and emergency surgeries at first referral units (FRU). It also calls for adopting appropriate anaesthetic and sterilisation practices within National Trauma Care and National Burns Programme. The MBBS course should incorporate injection safety module, it said.


Conduct baseline assessment of the overall burden of unsafe care in the country, including public and private sector
Constitute national level steering committee as a central coordinating mechanism for Patient Safety (on the basis of Patient Safety Expert Group)
Ensure all healthcare providers are vaccinated against Hepatitis B in addition to waste handlers against tetanus
Introduce hospital performance monitoring/ranking system based on number of indicators, including patient safety indicators
Develop SOPs for disposal of discarded/expired drugs as per standard guidelines

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