PURPOSE  

To confirm correct patient, procedure, site, and other pertinent  information (implants, images, blood availability, etc.) prior to each surgery or invasive procedure.

To optimize communication between the procedure/surgical team.

To further patient safety in the organization

To garner patient input in the process

To standardize the pre-procedure verification, site marking, and time out practice in any setting where an invasive procedure may occur (OR  and non-OR sites).

POLICY

The Universal Protocol consists of three (3) relevant processes:   pre-procedural verification, site marking, and "time out".       

1. A pre-procedure verification of patient, procedure and pertinent safety information should occur (as applicable) when the procedure is scheduled, when care is transferred and prior to each surgical or invasive procedure. The process additionally ensures that all relevant studies and documents are present and have been reviewed, there is consistency in the patient and team's understanding of the procedure, and that all discrepancies have been resolved prior to the start of the procedure.        
2. A site marking process will be followed prior to any surgical or invasive  procedure involving a left or right side (such as limbs or face), levels  (such as spine), and multiple structures (such as fingers or toes).The physician or designated medical personnel, in conjunction  with the patient, will mark the intended surgical/procedure site using a  purple surgical marking pen. Mark all sites that involve multiple structures (such as  multiple toes).  The site will be marked in Ambulatory Surgery, Patient  Receiving, PACU, OR, procedure area, or bedside as appropriate.  If a patient refuses to have site markings, the attending  physician will be Notified to intervene and refusal will be noted in the medical record.       
3. A time out just prior to the surgical incision or procedure should occur  for one final verification.

EXCEPTIONS TO THE UNIVERSAL PROTOCOL:  Only minor procedures such as venipuncture.

EXCEPTIONS TO SITE MARKINGS

• Single organ cases (e.g., hysterectomy, liver biopsy).
• Interventional cases for which the catheter/instrument insertion site is  not predetermined (e.g., cardiac catheterization, lumbar puncture, bone  marrow aspiration).
• Teeth extractions – BUT, indicate operative tooth name(s) on  documentation OR mark the operative tooth teeth) on the dental radiographs or dental diagram. 
• Procedures done through or right next to a natural body orifice (e.g. tonsillectomies, gastrointestinal endoscopies).
• In the non-OR setting, when the practitioner performing the procedure  stays at the bedside from the consenting of the patient through to the  conduct of procedure.
• If the person performing the procedure leaves the presence of the patient for any amount of time from when the consent is obtained then  the site should be marked prior to leaving the patient.  The pre-verification and time out is still required.  Crash/emergent cases where delay of start could cause potential harm to  the patient. 

EXCEPTIONS TO PRE-VERIFICATION AND TIME OUT :  Crash/emergency cases where delay of start could cause potential  harm to the patient.  Patient identification is still necessary.  Team  communication is just as important in these intense situations and needs to occur even if modified from this procedure.

PROCEDURE

I. OR Settings

      A.  ASU, PATIENT RECEIVING OR PACU:

1. Patients who are awake and alert will be asked to verify their name and surgical site.  The nurse will mark the OR site with a purple  surgical pen. The mark must be positioned to be visible after the patient  is prepped and draped.   The mark should say "SITE."  (never mark the site  with an "X").
2. The pre-op RN and/or the OR RN Circulator caring for the patient  will verify accuracy with the operative consent.
3. Exceptions to "SITE" mark: a) Ophthalmology procedures will be  marked with a purple dot above the eyebrow.  b) Ear procedures will be   marked with a dot just in front of the ear on the jaw line. c) Genital  procedures will be marked in the inguinal area on correct side rather than  directly on the genitalia. d) Craniotomy will be marked "SITE" on upper R  or L forehead. 
4. Documentation will occur in the pre-op record, indicating that  the site was verified with the surgical consent and with the patient, and  that the site was appropriately marked with the identifying mark and   initials (when capable) – initials are not mandated. By checking the "yes"  box in the computer pre-op assessment, it will mean that the nurse has  complied with the above directive.
5. Surgical sites that are covered with a non-removable dressing or device will have the "SITE" marked on the dressing. 

      B. OPERATING ROOM

1. Final verification of the patient, procedure, site mark, and  other pertinent patient information  must take place during the "time out" and should be done by  the person performing the  procedure.
2. Upon the patient's arrival in the Operating Room and prior to  initiating the prep, the OR Circulator Nurse will verify the site by comparing the consent  to the marked site.  When the   OR Circulator meets the patient in the Pre-Op area, that nurse    should work with the ASU  nurse, in conjunction with the patient to get the site marked  if it has not already been done.
3. If PACU and Patient Receiving are full and patients are  being re-routed to the OR front desk,  then it is the responsibility of the OR Circulator Nurse to perform the verification and mark the site.
4. The OR Nurse will document this assessment in the OR Record  in the nursing notes.
5.  TIME OUT – Prior to the beginning of the surgical  procedure, the circulating RN, scrub personnel, anesthesia care provider and surgeon (resident or attending) verbally verify the  following:   

All surgical team members must be present for the PPV:

• Surgeon making incision:  Initiates the PPV
• The Anesthesia Provider, reads aloud to the surgical team: Patient's first and last name and hospital number  from the ID band to ensure patient's first and last name and hospital       number are identical on the ID band, addressograph plate, and Anesthesia record;  confirms with the Circulator whether or not the patient has any allergies; type, dose and the time the abx was administered
• The RN Circulating nurse: Opens the patient's chart to the surgical consent  form. Holds in view of the surgeon making the incision.  Obtains verbal confirmation from the surgeon by  asking the following open- ended questions to the surgeon:  "The patient's name is ________?"  "The procedure we are doing today is _______?" "Is the patient in the correct position?"
• The RN Circulator also announces to the surgical team:  Whether or not family is in the waiting room.   If blood products are available.  If all necessary equipment / supplies / implants are available
• The ST:  Must be in agreement that the PPV was performed  appropriately.  Will not make the scalpel available to the surgeon  until the PPV is performed with all surgical team members present.

7.  The circulator must also document that all the elements of the time out (final PPV) was completed per OR policy by checking the "yes" boxes on the OR  computerized record.  If charting on the paper record, the circulator will write that  the "PPV was completed per OR  policy" in the nursing comments section.

8.  Scrub personnel will not pass scalpel / instrumentation / equipment until final PPV is completed and missing information is completed and agreed upon by all team members.  If a disagreement is not resolved, follow the chain of command policy.

9.  If any part of the process is not completed per policy, and incident report should be completed in the online Patient Safety Net.

Quiz