Universal Protocol for Correct Site Surgery/Procedures and Kaleida Health’s Protocols What is it? How does it apply to you? Who is responsible? When will it be used? Why will you use it?

What is it? Guidelines intended to prevent surgery/procedure errors Wrong Site Wrong Procedure Wrong Person Required by JCAHO Applicable to ALL procedures Not just surgery in an Operating Room This applies to procedures performed in other procedural areas and at the patient’s bedside Includes three major steps

How Does It Apply to You? As a staff member directly responsible for the patient You are the patient’s advocate You are responsible for making sure that the protocol is followed to protect your patient

Who is Responsible? The Kaleida Health’s policies and procedures specifically name who is responsible for each of the steps in the Universal Protocol Make sure to be aware of your role in the protocol

Why Will You Use It? Wrong site, wrong procedure, wrong person surgery can be prevented. The Universal Protocol is intended to achieve that goal.

When Will it be Used? The Universal Protocol will be used for all surgical procedures and minimally invasive procedures that may be performed at the bedside. The Universal Protocol will also be used for procedures done in other areas of the hospital Not just those done in the OR i.e., chest tubes, angiograms, etc.

Key points for Bedside procedures For the purpose of this policy, “invasive procedures” are defined as procedures that involve puncture or incision of the skin or insertion of an instrument or foreign material into the body and include: 1.Gastrointestinal endoscopy 2.Transesophageal Echocardiogram 3.Central line insertion involving primary entry into a major vessel. 4.Abdominal and/or intrathoracic biopsy/aspiration 5.Chest tube insertion 6.Skin and bone marrow biopsy 7.Bronchoscopy 8.Epidurals 9.Lumbar Puncture

Key points for Bedside procedures The following procedures are considered “minor” and are exempt for this policy: 1.Foley catheter insertion 2.Nasogastric tube insertion 3.Venipuncture 4.Peripheral IV line placement 5.Injection of contrast materials as part of diagnostic testing

Pre-procedural and Preoperative Areas In the pre-procedure/preoperative area and prior to the start of any invasive procedure, confirmation of correct site/side, procedure, and patient, will be completed and documented in a collaborative manner by the patient care team. A discrepancy at any point in time must stop the case from proceeding until resolved. The action taken and resolution of the discrepancy are to be documented by the operating physician and/or RN.

The Pre-operative Verification Process Includes… Verification of the correct person, procedure and site: At the time the procedure is scheduled At the time of admission of the patient At any time of care transfer With patient/family involvement Before entering the procedure/surgical room

The Three Steps Include.. The verification processes to confirm: Correct Patient Correct Procedure Correct Site (where applicable) The marking of the operative/procedure site A “time-out” immediately before starting the procedure

The Universal Protocol Form The Universal Protocol Form is divided into three Levels. Level One is the pre-procedural/pre- operative verification before the patient is sent to the operating room for a procedure, or before starting a procedure on a unit or floor. The preoperative checklist needs to be completed and sent with the patient to the operating room for Level 1 to be completed.

Pre-procedure / Preoperative Verification Verification Process a. The registered nurse will verify patient’s identity by asking the patient to state his or her full name, checking the medical number or the account number, and the procedure that will be performed. b. If the patient is a minor, incompetent, or sedated; has a language barrier; or is a trauma/emergency victim, accurate communication may be impeded. In such cases, the (patient’s family, physician/RN, interpreter or legal guardian) should complete the identifiers and verify site mark. c. The patient/family members will be involved in the process.

Level One of the Universal Protocol Form Please fill in the boxes by inserting your initials to complete the form. The date and procedure must be completed before transferring the patient to the surgical holding area. Please NOTE: Level One on the Universal Protocol Form needs to be completed by the nurse sending the patient to the surgical holding area. The nurse will be called to the operating room to complete the information in this section, if it is not completed when the patient is interviewed in the holding area. KH

Marking the Operative/Procedure Site Includes…  Mark ALL cases involving laterality  Mark ONLY the surgical site  The mark MUST be unambiguous  The mark MUST be visible after prepping and draping the patient  The mark MUST be removed at the end of the procedure.  EXCEPTION:Do not mark a premature infant whom the mark may cause a permanent tattoo.

Marking the Operative/Procedure Site Includes, Cont’d… The person performing the procedure should do the marking The marking MUST occur with patient/family involvement Involve family members or the caregiver if patient is not able to communicate The site MUST be verified during the final “time out”

Level 2 Universal Protocol Form Level 2 is completed in the surgical holding area prior to the patient entering the procedure room or completed prior to the start of the invasive procedure at the bedside by the physician/proceduralist or Registered Nurse. Preoperative verification and “time out” will be performed for all cases, including those not involving a site mark, except in an emergency if the risks outweigh the benefits.

The “Time Out” is performed in Level 3… MUST be done in the location where the procedure will be done, just prior to starting the procedure Must involve the entire operative team Must use active communication Must be documented on the Universal Protocol Form

The “Time Out”…Cont’d Must include verification of: Correct patient identity - you must use double identifiers to identify your patient Name, date of birth and medical record number are examples of patient identifiers. NOTE: You can not use the patient’s room number. Correct side and site Agreement on the procedure to be done Correct patient position Availability of correct implants and any special equipment or special requirements Agreement of the correct radiological exams for the patient’s procedure is being performed This is confirmation is documented on the Level 3 Time out area on the Universal Protocol Form

Level 3 –Universal Time Out Documentation is to be completed on the Universal Protocol Time Out form by the nurse, the anesthesia provider and the physician/proceduralist in the procedure area after the patient has been prepped and draped, and after the Universal Protocol Time Out has occurred.

Level 3 –Universal Time Out NOTE:The Physician/Proceduralist is responsible for calling the team together for the Time-Out process prior to making any incision. The physician/proceduralist, licensed anesthesia provider (Attending Anesthesiologist or CRNA), Circulating Nurse and Scrub Nurse/Tech must be in agreement that the Time-Out elements are correct. Instrumentation will not be passed until the Universal Protocol “Time Out” is completed.

Remember to… Review all relevant documents and studies Have them available Make sure the mark is visible after the prep and drape Involve the patient/family when marking the site Perform the “time out” for final verification Clarify all discrepancies prior to the start of the procedure

Remember that YOU are a Very Important part of the process in protecting your patient from wrong site procedures!