Showing posts with label surgery. Show all posts
Showing posts with label surgery. Show all posts

Tuesday, April 24, 2018

Surgery performed on the wrong patient is a ‘never event’



A patient who was hospitalized in a dedicated Trauma Centre run by the Delhi government with head and face injuries that he sustained in an accident, instead underwent surgery under GA for a fractured leg, as reported in TOI. The surgeon mistook him for another patient admitted in the same ward who had a leg fracture. A small hole was drilled into the patient’s right leg to put a pin on Thursday morning. As the procedure had been done under general anesthesia, the patient could not realize or object to it. However, the pin was removed within hours following a corrective surgery after it was brought to the attention of the authoritis. A committee examined the case found merit in the allegations and a disciplinary action was initiated against the doctor, a senior resident, who has been barred from conducting surgeries without supervision with immediate effect.

Res ipsa loquitur is a Latin term, which literally translates as “the thing speaks for itself”. The doctrine of res ipsa loquitur is a rule of evidence in cases of medical negligence. It infers negligence from the very nature of an accident or injury in the absence of direct evidence on how any defendant behaved. Res ipsa loquitur is not applicable when determining the liability for criminal negligence; it applies only in cases of civil negligence.

To prove medical negligence, usually three components have to be established:

  • There was an element of duty to be performed
  • There was breach of duty
  • Resultant damage

If the patient is not harmed by the physician’s error, then the patient cannot recover damages arising out of the error. 

This case answers ‘yes’ to all the three components of medical negligence: there was a duty of care, there was a breach in the duty of care and the patient did suffer damage as a direct result of the breach.

In res ipsa loquitur, these three components of medical negligence elements are inferred from an injury that does not ordinarily occur without negligence i.e. negligence is evident and the complainant does not have to prove anything as the “thing proves itself” as also in this case.

This is a medical error and can be classified as a ‘never event’ i.e. event that should never occur under any circumstance. Never events are defined as adverse events that are serious, largely preventable, and of concern to both the public and health care providers for the purpose of public accountability. They are usually a direct result of a negligent action and no trial of expert’s evidence is necessary

The US National Quality Forum has defined 29 never events segregated into seven categories: surgical, product or device, patient protection, care management, environmental, radiologic, and criminal.

“Surgery or other invasive procedure performed on the wrong patient” is included in list of surgical never events along with “surgery or other invasive procedure performed on the wrong body part, wrong surgical or other invasive procedure performed on a patient, unintended retention of a foreign object in a patient after surgery or other procedure”.


The World Health Organization (WHO) has developed a Surgical Safety Checklist, to be read out loud, to decrease errors and adverse events for use in any operating theatre environment. The checklist has three phases as below:

“Sign In”: Before induction of anesthesia

  • Has the patient confirmed his/her identity, site, procedure and consent?
  • Is the surgical site marked?
  • Is the anaesthesia machine and medication check complete?
  • Does the patient have a: Known allergy, Difficult airway/aspiration risk or Risk of >500ml blood loss (7ml/kg in children)?

“Time Out”: Before start of surgical intervention

  • Have all team members introduced themselves by name and role?
  • Surgeon, Anesthetist and Registered Practitioner verbally confirm: What is the patient’s name? What procedure, site and position are planned?
  • Anticipated critical events (surgeon, nurse, anesthetist)
  • Has the surgical site infection (SSI) bundle been undertaken? Antibiotic prophylaxis within the last 60 minutes • Patient warming • Hair removal • Glycemic control
  • Has VTE prophylaxis been undertaken?
  • Is essential imaging displayed?

“Sign Out”: Before any member of the team leaves the OR

  • Registered Practitioner verbally confirms with the team:
o    Has the name of the procedure been recorded?
o    Has it been confirmed that instruments, swabs and sharps counts are complete (or not applicable)?
o    Have the specimens been labelled (including patient name)?
o    Have any equipment problems been identified that need to be addressed?

  • Surgeon, Anesthetist and Registered Practitioner: What are the key concerns for recovery and management of this patient?

However, when deciding the quantum of punishment, the mitigating circumstances need to be considered.

Does the hospital have a protocol in place to avoid such mistakes? Generally, a minimum of two ID marks are required to be checked at the time of surgery. More than one patient can have the same name; room numbers may not be reliable as an identification mark. Matching of HUID no. is important.

Being overworked, lack of resources and infrastructure, insufficient staff etc. is no excuse for not following such a checklist.

There should be guidelines and/or protocols in place, which should be strictly implemented. If there are no guidelines, then there is an urgent need to develop them as per requirements. The checklist must be completed for each patient who undergoes a surgery, including under LA. It also must be documented in the patient chart.

By following these few but crucial steps, such errors can be minimized. It also ensures effective team work.

This mistake is not just that of the doctor alone. It is also a result of system failure and administration error.

Dr KK Aggarwal
Padma Shri Awardee
Vice President CMAAO
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA

Monday, August 1, 2011

Ask Dr KK: When should one decide for carotid endarterectomy or removal of blockages with catheter?


It is indicated for selected medically stable patients with asymptomatic carotid stenosis of 60 to 99 % who have a life expectancy of at least five years, provided the perioperative risk of stroke and death is less than 3 percent. However, long-term outcomes for patients with carotid blockages managed by intensive medical therapy may be similar to surgical management. 

About the author: Dr K K Aggarwal is Padmashri and Dr B C Roy National Awardee, President Heart Care Foundation of India, Dean Board of Medical Education Moolchand Medcity, Sr. Physician & Cardiologist, Visiting professor Clinical Research DIPSAR, Past President Delhi Medical Association, Past Academic and Research Wing Head IMA, Chairman Ethics Committee Delhi Medical Council.  

Ask Dr KK:What are the medical interventions for carotid blockages?


The interventions are management of hypertension, smoking cessation, use of statin drugs and low-dose aspirin.

About the author: Dr K K Aggarwal is Padmashri and Dr B C Roy National Awardee, President Heart Care Foundation of India, Dean Board of Medical Education Moolchand Medcity, Sr. Physician & Cardiologist, Visiting professor Clinical Research DIPSAR, Past President Delhi Medical Association, Past Academic and Research Wing Head IMA, Chairman Ethics Committee Delhi Medical Council.  



Ask Dr KK: What is symptomatic carotid artery blockage?


Patients who have had a stroke or transient ischemic attack (mini paralysis) due to carotid stenosis are considered symptomatic and often benefit from carotid revascularization. Symptoms means transient or permanent focal neurologic symptoms related to the affected artery (same side loss of vision, opposite side weakness or numbness of an extremity or the face, difficulty in speech or loss of speech). Patients with nonspecific neurologic symptoms (dizziness or syncope/near syncope) are not considered in the definition of symptomatic carotid stenosis. 

About the author: Dr K K Aggarwal is Padmashri and Dr B C Roy National Awardee, President Heart Care Foundation of India, Dean Board of Medical Education Moolchand Medcity, Sr. Physician & Cardiologist, Visiting professor Clinical Research DIPSAR, Past President Delhi Medical Association, Past Academic and Research Wing Head IMA, Chairman Ethics Committee Delhi Medical Council.  

Ask Dr KK: When to screen for carotid blockages?


Carotid duplex ultrasonography is not recommended for routine screening of asymptomatic patients who have no clinical manifestations of or risk factors for atherosclerosis. However one should screen asymptomatic individuals who have:
  • Carotid bruit
  •  Peripheral arterial disease
  • Coronary disease
  • Aortic aneurysm
  •   Two or more risk factors for atherosclerotic disease.
About the author: Dr K K Aggarwal is Padmashri and Dr B C Roy National Awardee, President Heart Care Foundation of India, Dean Board of Medical Education Moolchand Medcity, Sr. Physician & Cardiologist, Visiting professor Clinical Research DIPSAR, Past President Delhi Medical Association, Past Academic and Research Wing Head IMA, Chairman Ethics Committee Delhi Medical Council.  

Ask Dr KK: At what prevalence is screening beneficial?


Only at prevalence rates of over 20 % significant benefits are seen with at best about 100 strokes prevented for every 10,000 screened at 20 percent prevalence. Clinical features cannot identify asymptomatic individuals likely to have carotid stenosis. The annual risk of stroke in patients with asymptomatic carotid artery stenosis is relatively low. 

About the author: Dr K K Aggarwal is Padmashri and Dr B C Roy National Awardee, President Heart Care Foundation of India, Dean Board of Medical Education Moolchand Medcity, Sr. Physician & Cardiologist, Visiting professor Clinical Research DIPSAR, Past President Delhi Medical Association, Past Academic and Research Wing Head IMA, Chairman Ethics Committee Delhi Medical Council.  

Ask Dr KK: How common is carotid artery blockages in general population?


The prevalence of carotid stenosis in general population is less than 1 %. Screening with resultant surgical procedures causes more strokes than it can prevent. For severe (≥70 %) carotid stenosis, the prevalence increases with age from approximately 0 to 3 %.

About the author: Dr K K Aggarwal is Padmashri and Dr B C Roy National Awardee, President Heart Care Foundation of India, Dean Board of Medical Education Moolchand Medcity, Sr. Physician & Cardiologist, Visiting professor Clinical Research DIPSAR, Past President Delhi Medical Association, Past Academic and Research Wing Head IMA, Chairman Ethics Committee Delhi Medical Council.  

Ask Dr KK: How risky is carotid stenting or surgery?


Both endarterectomy and carotid stenting are associated with an increased 30-day risk of stroke and death. These are in the range of 2.3 to 3.7 percent for endarterectomy.

About the author: Dr K K Aggarwal is Padmashri and Dr B C Roy National Awardee, President Heart Care Foundation of India, Dean Board of Medical Education Moolchand Medcity, Sr. Physician & Cardiologist, Visiting professor Clinical Research DIPSAR, Past President Delhi Medical Association, Past Academic and Research Wing Head IMA, Chairman Ethics Committee Delhi Medical Council.  


Ask Dr KK: How reliable is Doppler Carotid study for detecting blockages?


The reliability is variable and operator-dependent.

About the author: Dr K K Aggarwal is Padmashri and Dr B C Roy National Awardee, President Heart Care Foundation of India, Dean Board of Medical Education Moolchand Medcity, Sr. Physician & Cardiologist, Visiting professor Clinical Research DIPSAR, Past President Delhi Medical Association, Past Academic and Research Wing Head IMA, Chairman Ethics Committee Delhi Medical Council.  

Ask Dr KK: What are the screening methods available?



1.    Carotid ultrasound followed by catheter angiography
2.    Carotid ultrasound followed by MRA
3.    Ultrasound alone

About the author: Dr K K Aggarwal is Padmashri and Dr B C Roy National Awardee, President Heart Care Foundation of India, Dean Board of Medical Education Moolchand Medcity, Sr. Physician & Cardiologist, Visiting professor Clinical Research DIPSAR, Past President Delhi Medical Association, Past Academic and Research Wing Head IMA, Chairman Ethics Committee Delhi Medical Council.  

Ask Dr KK: Should I screen each patient for presence of carotid neck artery blockages?


The guideline says no. The potential harms include risks associated with the screening procedure itself like false positive findings leading to anxiety and the potential for unnecessary surgical procedures. Carotid angiography is associated with risk of neurological complications including stroke, with rates ranging from 0.1 to 1 %.

About the author: Dr K K Aggarwal is Padmashri and Dr B C Roy National Awardee, President Heart Care Foundation of India, Dean Board of Medical Education Moolchand Medcity, Sr. Physician & Cardiologist, Visiting professor Clinical Research DIPSAR, Past President Delhi Medical Association, Past Academic and Research Wing Head IMA, Chairman Ethics Committee Delhi Medical Council.