When a ‘never event’ hits a patient

A young woman was left with an RFO, or retained foreign object, after surgery. A checklist could have avoided her death

Published - January 12, 2020 12:06 pm IST

We read in the news that a 24-year-old woman died tragically on January 1 after undergoing a lifesaving procedure to control abdominal sepsis (overwhelming infection). Five days prior to that, she was rushed to a hospital in labour pain and underwent a caesarean section. She was delivered of a baby girl.

Because of the mother’s worsening condition after surgery, she was transferred to a major referral hospital on December 31, where a large abdominal abscess was discovered and emergency surgery performed. Within the large pus cavity was found a cotton sponge, commonly used during surgery to mop up blood and fluid. Despite this damage-control operation, the woman died of severe sepsis.

Her husband and relatives picketed the hospital where the caesarean section was done, and lodged a complaint with the police. A team of police and revenue officials held peace talks with them.

The response from the health officials was: “We have issued a show-cause notice to the staff seeking an explanation. We will initiate departmental action based on their replies and finding of our inquiry.”

Great! But will it solve the problem? No.

Why do I make this statement? In the fields of healthcare quality and patient safety, such punitive measures of “naming and shaming” have not worked. Having moved back to India eight years ago with the key motive to improve accountability and safety in healthcare delivery, it is my humble observation that we have a long way to go in reducing “preventable harm” in hospitals and the health system in general. I have not styled myself to be a theory-based “arm-chair quarterback” (as we portray after-the-fact-punditry with no real-time action), but rather have worked to bring in accountability at the front lines. We need to move away from fixing blame, to creating a “blame-free culture” in healthcare, yet, with accountability. This requires both systems design for safe care and human factors engineering for slips and violations.

Zero data

Global surgical procedures modelling shows that among more than 234 million surgeries performed, the incidence of retained foreign object (RFO) is perhaps 1:3000 to 1:5000 procedures. (Do we have the data in India? No! We do not have a reporting system). The World Health Organization (WHO) launched a watershed campaign during 2007-08, known as “Safe Surgery Saves Lives” and validated a protocol called “WHO Safe Surgery Check List” in eight hospitals around the world, covering population disparities. This landmark study, published in the New England Journal of Medicine in January 2009, showed that the death rate following surgery was reduced from 1.5% to 0.8% and complication rate from 11% to 7% before and after checklist implementation.

A key element in this checklist is the accuracy of sponge/instrument count before surgery starts and after completion, to ensure that there is no RFO. The technical details need no elaboration here, but the principles need to be emphasised.

First, we have to mandate a robust checklist implementation (it may exist on paper, but not in practice). While the accreditation boards (such as the NABH) require it, it covers only a small segment, and that too, with compliance on paper. In the two institutes of eminence that I served during the past eight years, the WHO surgical check lists (or equivalent) were not used in practice routinely when I took over, and were implemented progressively.

Second, a reporting system for adverse events needs to be set up. A patch work of this exists (for instance, pharmacovigilance, for drug-related adverse events), but there is an urgent need to start with broader adverse events reporting. A nation-wide reporting of “never events” will be a good start.

“Never events” refer to shocking, egregious, unambiguous, measurable and preventable incidents that should never occur in health care (such as RFO). I had proposed a framework to enable this, without “blame to hospital or individual”, but rather to report, catalogue, analyse and learn from errors as a system, and reduce preventable harm.

Verifiable data

Third, we need verifiable accurate data. Most of what we talk about as incidence and statistics of improvement comes from studies in developed nations and some developing countries. For example, we do not have the data on RFO in India. Fourth, a quality and safety curriculum needs to be emphasised at all levels — medical students, postgraduates, practising doctors, nurses, allied health professionals and so on.

Providing safe care without harm is a “team sport”, and we need to work as teams and not in silos, with mutual respect and ability to speak up where we observe any deviation or non-compliance with rules. Basic quality tools (like the seven tools of quality) and root-cause analysis (such as the Ishikawa fish-bone chart) for adverse events must become routine. Weekly mortality/morbidity conferences are routine in many countries, but not a routine learning tool in India.

Let the death of Priya not go in vain, with a “Band-aid” of inquiry, departmental action and dismissal/suspension. After all, healthcare workers do not come to hospitals to commit a mistake.

Even with the best of intentions to provide care, the worst outcomes (harm with disability/ death) do happen.

We must learn from errors (analysis) and learn from others (industries such as aviation), and strive towards “absence of preventable harm to a patient during the process of health care and reduction of risk of unnecessary harm associated with health care to an acceptable minimum”, which is the WHO’s Definition of Patient Safety.

We can accelerate the recent initiative of the DGHS of the Government of India to implement a National Patient Safety Framework, and set up an analytical “never events” or sentinel events reporting structure.

The author is President, AIIMS Mangalagiri, Andhra Pradesh. He serves on the WHO Global Patient Safety Inter-Professional Curriculum Guide Committee


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