The universal protocol for correct patient, site and procedure

The universal protocol for correct patient, site and procedure

  • Jul 09, 2016

The Universal Protocol for Correct Patient, Site and Procedure
Reports of surgery at wrong site in a leading hospital having NABH Accreditation are hogging media and social site space. While the affected hospital and its surgical team face possibility of filing of medical negligence case against them, this incidence should act as a stimulus for all hospitals and care givers to review their safety protocols and adopt The Universal Protocol laid down by World Health Organisation to avoid similar error.

The Universal Protocol is a three-step process in which each step is complementary and adds redundancy to the practice of confirming the correct patient, site and procedure.
Step 1. Verification: This consists of verifying the correct patient, site and procedure at every stage from the time a decision is made to operate to the time the patient undergoes the operation. This should be done:

  • When the procedure is scheduled;
  • At the time of admission or entry to the operating theatre;
  • Any time the responsibility for care of the patient is transferred to another person; and
  • Before the patient leaves the preoperative area or enters the procedure or surgical room.
The step is undertaken insofar as possible with the patient involved, awake and aware. Verification is done by labelling and identifying the patient and during the consent process; the site, laterality and procedure are confirmed by checking the patient’s records and radiographs. This is an active process that must include all members of the team involved in the patient’s care. When many team members are involved in verification, each check should be performed independently. Team members must also be aware, however, that the involvement of multiple caregivers in verification can make the task appear onerous and could lead to violations of the protocol. Adherence to the verification procedure can be facilitated by the use of reminders in the form of checklists or systematic protocols
Step 2. Marking: The Universal Protocol states that the site or sites to be operated on must be marked. This is particularly important in case of laterality, multiple structures (e.g. fingers, toes, ribs) and multiple levels (e.g. vertebral column). The protocol stipulates that marking must be:

  • At or next to the operative site; non-operative sites should not be marked;
  • Unambiguous, clearly visible and made with a permanent marker so that the mark is not removed during site preparation (Health-care organizations may choose different methods of marking, but the protocol should be consistent in order to prevent any ambiguity.  The guidelines of the National Patient Safety Agency in England recommend use of an arrow drawn on the skin and pointing to the site, as a cross could denote a site that should not be operated and introduces an element of ambiguity. The American Academy of Orthopaedic Surgeons endorses a ‘sign your site’ protocol in which surgeons write their initials or name on the operative site 
  • Made by the surgeon performing the procedure (To make the recommendations practicable, however, this task may be delegated, as long as the person doing the marking is also present during surgery, particularly at the time of incision; and
  • Completed, to the extent possible, while the patient is alert and awake, as the patient’s involvement is important.
The verification and marking processes are complementary. They are intended to introduce redundancy into the system, which is an important aspect of safety. Either one used alone is unlikely to reduce the incidence of wrong-site surgery.
Patients or their caregivers should participate actively in verification. The Joint Commission views failure to engage the patient (or his or her caregiver) as one of the causes of wrong-site surgery. The Joint Commission has published information leaflets for patients to inform them of their important role in preventing wrong-site surgery; patient awareness initiatives have also been adopted by the National Patient Safety Agency in the United Kingdom and the Australian Commission of Safety and Quality in Healthcare.
Step 3. ‘Time out’:  The ‘time out or ‘surgical pause’ is a brief pause before the incision to confirm the patient, the procedure and the site of operation. It is also an opportunity to ensure that the patient is correctly positioned and that any necessary implants or special equipment are available. The Joint Commission stipulates that all team members be actively involved in this process. Any concerns or inconsistencies must be clarified at this stage. The checks during the ‘time out’ must be documented, potentially in the form of a checklist, but the Universal Protocol leaves the design and delivery to individual organizations. The ‘time out’ also serves to foster communication among team members.
The Australian Commission on Safety and Quality in Healthcare uses a five-step process similar to the Universal Protocol to prevent wrong-site surgery):
Step 1: Check that the consent form or procedure request form is correct. 

Step 2: Mark the site for the surgery or other invasive procedure.

Step 3: Confirm identification with the patient.

Step 4: Take a ‘team time out’ in the operating theatre, treatment or examination area.
Step 5: Ensure appropriate and available diagnostic images.
Consent is part of both protocols. It is the first step in the Australian protocol and is included as critical documentation in the Universal Protocol in the United States. While consent is being obtained, the patient must be awake and alert and have the capacity to understand the details and implications of the procedure. Consent must be obtained in a language that the patient understands or through an interpreter. It should include a clear statement of the procedure to be performed and the site of operation, including laterality or level. The consent protocol can, however, be waived in emergency cases with threat to life or limb.
(WHO Guidelines for Safe Surgery 2009)


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