REVISED UNIVERSAL PROTOCOL POLICY

RETURN to Teaching Plan to Implement the Universal Protocol

POLICY AND PROCEDURE

Subject: Universal Protocol Preventing Wrong-site, Wrong-side, Wrong-Procedure, Wrong-Patient Surgical and Invasive Procedures.

Policy: Pre-operative patient, procedure, site/side verification will be performed by the physician, all staff members involved, with the patient included when at all possible (or legally delegated agent), to consistently and effectively prevent wrong site/side/procedure/patient interventions/surgeries.

I. PERSONNEL: Physician, Scheduler, Nursing Personnel, Anesthesiologist/Sedation Nurse, Tech/Support Personnel

II. SUPPORTIVE DATA:

Universal Protocol is a Joint Commission requirement to prevent wrong site, wrong procedure, and wrong person surgery. The principal components of the protocol include 1) preoperative verification process; 2) marking of the operative site; 3) taking a “time out” immediately before starting the procedure; and 4) adaptation of the requirements to non-operating room settings, including bedside procedures.

Definitions:

• Site: The specific anatomical part upon which the procedure will take place.
• Side: The right side or left side of the patient’s body upon which the procedure will be performed.
• Level: The level(s) of vertebrae in spinal surgery
• Time Out: A “Time Out” is required on all invasive procedures, it is a pause by the entire team involved in the procedure before an incision is made or an anesthetic block is administered to verify important data including patient identification, procedure verification, site, side, and/or level, antibiotics the patient will receive and allergies the patient has. (In the case of an anesthetic block “the entire team” will be considered to be the nurse and anesthesiologist)

EXCEPTIONS: Site marking is not required, nor is it prohibited, for procedures in which the site of insertion is not predetermined. However, the other requirements of the universal protocol still apply. These procedures include but are not limited to:

1. Single midline organ cases (for example Cesarean sections, cardiac surgery) and endoscopies with intended laterality.

2. Mouth, perineum, Teeth—BUT, indicate operative tooth name(s) on documentation OR mark the operative tooth (teeth) on dental radiographs or dental diagram and document.

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

4. Interventional Procedures for which the site of insertion is not predetermined, i.e., cardiac catheterization procedures or other interventional procedures.

III. STANDARDS OF CARE:

A. All procedures will be documented on an Informed consent, the surgical consent, and in the completed History and Physical. All documentation must include laterality (right/left), level, and or multiple structures.

B. If the patient is non-English speaking, the consent and procedure will be translated for the patient. See Administrative Policy “Language and Communication Assistance to People with Limited English Proficiency and/or Visual and Hearing Impairments”.

C. Pre-procedure a time out is held (see The “Time Out” Process) to determine that the correct is receiving the correct procedure and the correct site/side and/or level has been marked.

D. In the event the patient is a minor the parent/guardian will be responsible for the appropriate side/site/level, in agreement with the surgeon.

IV. STANDARDS OF PRACTICE:

A. Equipment: Indelible marker. Use ball point pen, non-indelible, for infants less than 12 months to prevent permanent tattoo.

B. Scheduling:

• 1. The physician’s office will send a reservation to schedule the procedure and indicate the correct site/side/level if appropriate.
• 2. If there is a change in the site/side/level, the physician’s office will send a new reservation/order with the correct information and the scheduler will correct the schedule and send the information to all appropriate persons.

C. The Physician:

• 1. The physician will document the patient’s Informed Consent and History and Physical with the designated procedure including correct site/side/level in the medical record.
• 2. In the event of multiple procedures with different physicians, each physician must document the patient’s Informed Consent and make note of the correct site/side/level in the medical record.

D. Pre-operative Verification Process:

• 1. Verification of the correct person (armband and verbal verification), procedure, site/side/level should occur:
  

• At the time the surgery/procedure is scheduled

• Admission or entry to the facility

• Anytime the responsibility of the care of the patient is transferred to another caregiver

• Before the patient leaves the pre-operative area or enters the surgical/procedure room

• 2. A checklist will be used to ensure availability and review of the following, prior to the start of the procedure:
  

• Relevant documentation (i.e. H&P, Informed Consent Surgical Consent)

• Relevant images, properly labeled and displayed

• Any required implants, special equipment, blood products.

• The need to administer antibiotics or fluids for irrigation.

• Safety precautions based on patient history or medication use (i.e. allergies etc.)

E. Marking the Operative Site:

• 1. The person performing the procedure will do the site marking
• 2. The marking must take place with the patient involved, awake and aware, and before being moved to the location where the procedure will be performed.
• 3. The mark is made at or near the site of incision and must be visible after skin prep and draping of the patient.
• 4. The mark will be the word “YES".
• 5. Individual digits will be marked, not merely the correct limb
• 6. In the case of multiple lesions care will be taken to localize lesion involved in procedure.

F. The “Time Out” Process:

• 1. The person conducting the procedure or staff assigned to the patient must conduct a “time out” in the location where the procedure will be done and immediately before starting the procedure (in the case of an anesthetic block the nurse and anesthesiologist will perform a “time out” prior to the block).
  
• 2. The “time out” must involve the entire operative team, use active communication, be briefly documented, such as a checklist, and must at the least include the following:
  

• Correct patient identity

• Confirmation that the correct site and side are marked

• An accurate procedure consent form

• Agreement on the procedure to be done

• Correct patient position

• Relevant images and results are properly labeled and appropriately displayed

• The need to administer antibiotics or fluids for irrigation purposes. (See also NPSG .07.05.01, EP7)

• Safety precautions based on patient history or medication use.

The completed components of the Universal Protocol and time-out are clearly documented in the medical record and posted on a white erase board (in operating room) in clear view of all team members for review during time-out.

G. Procedures for non-OR settings including bedside procedures.

• Site marking must be done for all procedures that involves laterality, multiple structures or levels (even if the procedure takes place outside of an OR).

• Verification, site marking, and “time out” procedures will be as consistent as possible throughout the organization, including OR and other locations where invasive procedures are done.

• Exception: Cases in which the individual doing the procedure is in continuous attendance with the patient from the time of the decision to do the procedure and consent from the patient through to the conduct of the procedure may be exempted from the site marking requirement. The requirement for a “time out” final verification still applies.

H. Emergencies: None of the above precautions should interfere in the timely care of the patient in an emergency, although the “timeout” to verify the correct patient, procedure, and site would still be appropriate (unless it is such an emergency that even a time out would add more risk for the patient.

I. Patient Refusals: The patient always reserves the right to refuse. The patient should be informed of the reason for marking so they can make an informed decision. If they still refuse, then this should be clearly documented in the patient’s medical record and the person performing the procedure should be notified before sending the patient for the procedure.

J. Procedure Discrepancies: If a discrepancy is discovered, the process will stop and the person performing the procedure will be notified for clarification.

V. REFERENCES:

• Joint Commission of Accreditation of Healthcare Organizations, “Universal Protocol” UP 01.01.01.01.02.02, 01.03.01

• Association of Perioperative Registered Nurses (AORN)

• American Academy of Orthopedic Surgeons (AAOS), Advisory Statement: Wrong-Site Surgery; Document Number 1015: November 27, 2001

• VHA Perioperative Leadership Learning Network (PLLN); the 7 Absolutes to Avoid Surgical Site Error; January 2002

• National Patient Safety Goal 1

• Joint Commission Standards FAQ’s (accessed 06.18.09)