Another medical mishap: wrong foot operated
It’s a never event: Never events are situations where deficiency of service and or negligence is presumed and no trial of expert’s evidence is necessary. Following are examples rectified by various court judgements.
a. Removal of the wrong limb (1,6) or performance of an operation on the wrong patient (1,6)
b. “……The issues arising in the complaints in such cases can be speedily disposed of by the procedure that is being followed by the Consumer Disputes Redressal Agencies and there is no reason why complaints regarding deficiency in service in such cases should not be adjudicated by the Agencies under the Act.” (6)
1. IMA vs VP Shantha 1995 (6) SCC 651 (37)
2. SC/4119 of 1999 and 3126 of 2000, 14.05.2009, Nizam Institute of Medical Sciences vs. Prasanth S. Dhananka and Ors: B.N. Agrawal, Harjit Singh Bedi and G. S. Singhvi, JJ.
1. Definition: Near misses -- when surgeons started to operate on the wrong site or patient
2. Operations on the wrong site or the wrong patient should never happen
3. Surgeons shall mark the surgical site before going to the operating room.
4. One should also mark the site should not be touched.
5. Reasons for the errors include similar sounding names, failure to check patient names on medical records and reversing the sides of X-rays and scans placed on viewing boxes in the operating room.
6. In the operating room before starting surgery, all members of the surgical team should confirm that they have the correct patient, surgical site and procedure.
7. The operating room team should take ''a timeout'' to check medical records and X-rays, discuss among themselves what they are about to do, and corroborate information with the patient.
The Universal IMA Protocol based on JCI recommendations for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery
Conduct a pre-procedure verification process
1. Address missing information or discrepancies before starting the procedure.
2. Verify the correct procedure, for the correct patient, at the correct site.
3. Try to involve the patient in the verification process.
4. Identify the items that must be available for the procedure.
5. Use a standardized list to verify the availability of items for the procedure.
6. At a minimum, these items include: relevant documentation (history and physical, signed consent form, preanesthesia assessment); labeled diagnostic and radiology test results that are properly displayed and any required blood products, implants, devices, special equipment
7. Match the items that are to be available in the procedure area to the patient.
Mark the procedure site
1. Mark the site when there is more than one possible location for the procedure and when performing the procedure in a different location could harm the patient.
2. The site does not need to be marked for bilateral structures. Examples: tonsils, ovaries
3. For spinal procedures: Mark the general spinal region on the skin. Special intraoperative imaging techniques may be used to locate and mark the exact vertebral level.
4. Mark the site before the procedure is performed. Try to involve the patient in the site marking process.
5. The site is marked by the doctor who is ultimately accountable for the procedure and will be present when the procedure is performed.
6. In limited circumstances, site marking may be delegated to some medical residents
7. The mark is unambiguous and is used consistently throughout the organization.
8. The mark is made at or near the procedure site.
9. The mark is sufficiently permanent to be visible after skin preparation and draping.
10. Adhesive markers are not the sole means of marking the site.
11. For patients who refuse site marking or when it is technically or anatomically impossible or impractical to mark the site (see examples below): Use your organization’s written, alternative process to ensure that the correct site is operated on. Examples of situations that involve alternative processes: mucosal surfaces or perineum, minimal access procedures treating a lateralized internal organ, whether percutaneous or through a natural orifice, interventional procedure cases for which the catheter or instrument insertion site is not predetermined [Examples: cardiac catheterization, pacemaker insertion], teeth and premature infants, for whom the mark may cause a permanent tattoo.
Perform a time-out
1. The procedure is not started until all questions or concerns are resolved.
2. Conduct a time-out immediately before starting the invasive procedure or making the incision.
3. A designated member of the team starts the time-out.
4. The time-out is standardized.
5. The time-out involves the immediate members of the procedure team: the individual performing the procedure, anesthesia providers, circulating nurse, operating room technician, and other active participants who will be participating in the procedure from the beginning.
6. All relevant members of the procedure team actively communicate during the time-out.
7. During the time-out, the team members agree, at a minimum, on the following: correct patient identity, correct site, procedure to be done
8. When the same patient has two or more procedures: If the person performing the procedure changes, another time-out needs to be performed before starting each procedure.
9. Document the completion of the time-out. The organization determines the amount and type of documentation.