Universal Protocol

Abstract

The “Universal Protocol” dictates the minimum requirements that physicians must follow to help prevent basic surgical mistakes and that are required to be implemented by all accredited hospitals, ambulatory care, and office-based surgical facilities.

Appendix

1.1 Speak Up™

1.1.1 The Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery™

1.1.1.1 Guidance for Healthcare Professionals

1.1.1.1.1 Conduct a Preprocedure Verification Process

Address missing information or discrepancies before starting the procedure.

• Verify the correct procedure for the correct patient at the correct site.

• When possible, involve the patient in the verification process.

• Identify the items that must be available for the procedure.

• Use a standardized list to verify the availability of items for the procedure. (It is not necessary to document that the list was used for each patient.) At a minimum, these items include the following:

  • Relevant documentation (examples: history and physical, signed consent form, preanesthesia assessment)

  • Labeled diagnostic and radiology test results that are properly displayed (examples: radiology images and scans, pathology reports, biopsy reports)

  • Any required blood products, implants, devices, and special equipment

• Match the items that are to be available in the procedure area to the patient.

1.1.1.1.2 Mark the Procedure Site

At a minimum, 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.

• 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.

• Mark the site before the procedure is performed.

• If possible, involve the patient in the site-marking process.

• The site is marked by a licensed independent practitioner who is ultimately accountable for the procedure and will be present when the procedure is performed.

• In limited circumstances, site marking may be delegated to some medical residents, physician assistants (PAs), or advanced practice registered nurses (APRNs).

• Ultimately, the licensed independent practitioner is accountable for the procedure –even when delegating site marking.

• The mark is unambiguous and is used consistently throughout the organization.

• The mark is made at or near the procedure site.

• The mark is sufficiently permanent to be visible after skin preparation and draping.

• Adhesive markers are not the sole means of marking the site.

• 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 are as follows:

  • Mucosal surfaces or perineum

  • Minimal access procedures treating a lateralized internal organ, whether percutaneous or through a natural orifice

  • Teeth

  • Premature infants, for whom the mark may cause a permanent tattoo

1.1.1.1.3 Perform a Time-Out

The procedure is not started until all questions or concerns are resolved.

• Conduct a time-out immediately before starting the invasive procedure or making the incision.

• A designated member of the team starts the time-out.

• The time-out is standardized.

• The time-out involves the immediate members of the procedure team: the individual performing the procedure, anesthesia providers, a circulating nurse, an operating room technician, and other active participants who will be participating in the procedure from the beginning.

• All relevant members of the procedure team actively communicate during the time-out.

• During the time-out, the team members agree, at a minimum, on the following:

  • Correct patient identity

  • Correct site

  • Procedure to be done

• 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.

• Document the completion of the time-out. The organization determines the amount and type of documentation.

This document has been adapted from the full Universal Protocol . For specific requirements of the Universal Protocol, see The Joint Commission Standards.