Subject: Avoidance of Procedural Errors- Time Out and Site Marking Number: PC-12 Function: Provision of Care, Treatment and Services Includes former PC-12 and PC13 content Revised: 06-24-2014 Applies To: Corporate UHC MRC OBJECTIVE: 1. To ensure a final assessment and verification that the correct patient, site, and procedure are identified. 2. To ensure that all relevant documents and information are available, and proscribed, intentional communication is used to prevent wrong site, wrong person, and wrong invasive procedures. 3. To provide guidance in necessary documentation prior to surgical and other invasive procedures in both the outpatient and inpatient settings. Definition: Licensed independent practitioner (LIP) – for the purposes of this policy a licensed independent practioner will be any provider credentialed in the MU Healthcare system and approved for independently conducting procedures that are included in this policy. This may include physicians, oral surgeons, podiatrists for example. POLICY: 1. The institutional protocol at MUHC is to avoid wrong-person, wrong site, and wrongprocedure involves a preoperative/pre-procedural verification process, marking the procedure site, and a time-out immediately before the procedure. 2. This policy is applicable to all operative procedures, other invasive procedures, as well as situations requiring anesthesia or moderate/deep sedation, including procedures done in settings other than the operating room. 3. Such procedures include but are not limited to Peripherally Inserted Central Catheter, all central line insertions, and Chest tube insertion. 4. Procedures that are not included are: venipuncture, peripheral intravenous line placement, naso-gastric tube insertion, urinary bladder catheter, radiation oncology, lithotripsy, dialysis (excluding insertion of dialysis catheter), unless moderate or deep sedation or anesthesia are provided. 5. Procedures performed in the context of emergency treatment to save life or limb, are excluded from this policy, if optimal emergency care of the patient precludes adherence. 6. Requisite documentation and pre-processes must be completed prior to the start of all procedures (see General Information): 7. The pre-procedure verification process ensures that the procedure is what the patient needs and is performed on the right person. This is conducted in the patient holding area prior to the patient being taken to the OR or procedural suite. (see PC-13 Effective: 06/24/2014 Page 1 of 6 General Information) 8. Site Marking A. Site initialing will occur prior to the patient going to the procedural area and should only be done by a LIP, a licensed Advanced Practice Nurse (APRN), a licensed Physician Assistant (PA) or a resident physician at an appropriate level of training. The practitioner who marks the site must be familiar with the patient and the patient’s history and either be performing the procedure or acting as the first assistant in the procedure. B. The practitioner who marks the procedural site must participate in the “Time Out” process, be present during the procedure for which they mark the site and must participate actively in a hands-on manner for a significant portion of the procedure. C. To be allowed to mark the site, the APRN or PA must have a collaborative practice/supervising agreement with the physician or other LIP (whose procedure they are assisting ), allowing them to participate in site initialing and the procedure. D. The resident physician can only mark the site if they have sufficient experience to be allowed to perform part of the procedure. 9. It is the responsibility of the attending physician and the training program to ensure that the resident physician is at the appropriate level of training to warrant site initialing for the procedure. General Information: 1. Pre-procedural documentation requirements include: A. A history and physical completed within the last thirty (30) days. If there is not a current history and physical, the history and physical must be completed prior to the procedure. For inpatients, this may be the admission documentation or daily progress note B. A documented reevaluation (update) of the patients’ history and physical examination within 24 hours of the procedure C. Informed Consent to include any need for blood if anticipated D. Assessment for and plans for sedation 2. Pre –Procedural Verification The patient should be involved in the pre-procedure verification processes as the situation permits. The following are aspects of this process: A. Verify all documents and information related to the procedure and equipment are available before the start of the procedure. B. Identify the patient using two (2) patient identifiers. The identifiers are patient name and date of birth. C. Ascertain that the site is marked with a non-permanent hypoallergenic marker. D. Verify that the patient expectations and the team’s understanding are consistent with the intended patient, the scheduled procedure and site and if applicable, that any implants necessary are available. PC-13 Effective: 06/24/2014 Page 2 of 6 E. Determine if any missing information or discrepancies are addressed prior to entering procedure area and the start of the procedure. PROCEDURE: 1. Pre Procedure Verification Checklist A. Before the procedure, the health care team (admitting nurse) will use a periprocedural checklist (paper, white-board or electronic) to confirm that each requirement has been met. B. The checklist will confirm: 1. Patient identity 2. A compliant history & physical: is to be no more than 30 days old, and must be updated within 24 hours prior to the procedure. 3. A signed procedure consent or verification form 4. Correct and properly labeled diagnostic and radiology test results 5. Any required blood products, implants, devices or special equipment. 6. Site marking done 2. Site marking A. Initialing of the procedural site takes place in the pre-procedural area prior to the patient being transferred to the procedural room/area and is conducted with the patient involved, awake and aware, when possible. B. Before initialing the site, verification of correct patient will be done using two patient identifiers: patient name and birth date. C. Verification of the procedural site will be conducted by a representative of the procedural team with the participation and assent of the patient or caregiver. The verified procedural site will be marked with the Proceduralist initials using a marker that remains visible after completion of positioning, skin prep and draping. D. Once the site is marked and verified the patient may be transported to the procedural room. E. In circumstances where there is no pre-procedural area, such as a patient’s room, the procedural staff will verify site initialing. F. The procedural site will be verified from the “Consent” or “Verification of Informed Consent for Operative or Special Procedures and Blood Transfusions” form, the History and Physical examination and relevant imaging studies which identify the proper site . G. For all procedures involving incision or percutaneous puncture or insertion, the intended procedure site should be marked, unless excluded for specific reasons as noted in 2.M. below. H. The initialing takes into consideration laterality, the surface (flexor, extensor), the level (spine), or specific digit or lesion to be treated. I. For procedures that involve laterality of organs but the incision(s) or approaches may be from the mid-line or from a natural orifice, the site should be marked and laterality noted. J. For procedures involving anatomical laterality, the words right, left, or bilaterally will be written out fully on the procedural/operating room PC-13 Effective: 06/24/2014 Page 3 of 6 schedule and consent. K. Spine procedure(s) will involve a two-stage initialing process. The first includes marking the level in the same general area as the planned incision (cervical, thoracic or lumbar). Thus for an anterior cervical C4/5 surgery, the anterior portion of the neck is marked “C4/5” and for a posterior C4/5 surgery, the posterior portion of the neck is marked “C4/5”. Second, if the approach involves decompression of right versus left, this will be indicated. During surgery, the exact level(s) will be confirmed using intra-procedural radiographic techniques. L. For patient on which initialing the procedural site is technically or anatomically impossible or impractical, the correct procedure and site verification will be obtained from the “Informed Consent” or “Verification of Informed Consent for Operative or Special Procedures and Blood Transfusions” form, the history and physical, the patient or caregiver, and the proceduralist. M. Procedures for which site initialing may be unnecessary include, but are not limited to: 1. Midline, single-organ procedures, as well as endoscopies, without intended laterality do not require site initialing. 2. Mucosal surfaces (including peroral, pernasal or peranal endoscopy) 3. Perineum 4. Premature infants/neonates 5. Mangled limbs 6. Extensive burns 7. Intravenous and arterial access 8. Foley catheter insertion 9. Interventional a) cardiac and endovascular catheterization b) electrophysiology procedures N. Patient refusal of initialing the procedural site and the reason for refusal will be documented in the patient’s chart by the proceduralist. The procedural team will then verify correct procedure and site from documentation in the patient’s record to include the “Informed Consent” or “Verification of Informed Consent for Operative or Special Procedures and Blood Transfusions” form, the history and physical, the patient or caregiver, and the proceduralist. 3. Time Out Protocol: As a final verification for a procedure, the procedural team will perform a “Time Out” prior to the incision/insertion. The “Time-Out” is to be documented and performed as follows: A. A representative of the procedural team must be present for and initiate all time outs. This representative must be the proceduralist(s) of record (the proceduralist submitting the billing for the procedure), a licensed Advanced Practice Nurse (APRN), a licensed Physician Assistant (PA) or a resident physician at an appropriate level of training; and must participate actively in a PC-13 Effective: 06/24/2014 Page 4 of 6 B. C. D. E. F. hands-on manner at the beginning and for a significant portion of the procedure. For procedures in areas with oversight from the Operating Room Operations Committee (Main OR at UH, MOI OR, Missouri Center for Outpatient Surgery,, Women’s and Children’s OR; Cath Lab, Interventional Radiology, and GI Lab), or in Labor and Delivery, the surgeon or proceduralist of record should be present when the Time Out is being performed. For any instance that the proceduralist of record is not present for the pre-procedural time-out, a time out for patient, site and procedure verification must be reperformed immediately upon entry to the room of that procedualist of record. Other team members required for the Time Out, if participating in the procedure, are anesthesia providers, nurses, technicians, and all other participants who will participate in the procedure. The time out should be done immediately before starting the invasive procedure or making the incision. If desired, the team may perform a time-out before anesthesia and again immediately before the incision or start of the procedure. When two (2) or more procedures are being done on the same patient, a Time Out is performed to confirm the nature of each subsequent procedure before the initial procedure is initiated. When a new member joins the procedure team, a Time Out including elements appropriate for the stage of the procedure will be re-performed. During Time Out: 1. All activities are suspended and all team members and observers must be facing the patient. 2. All team members are to focus on the active confirmation of the correct patient, procedure, site and other critical elements of the procedure 3. All team members will use interactive verbal communication. 4. Any team member is empowered and encouraged to express concerns about the procedure verification. 5. For any discordant responses, the time-out and procedure is suspended until reconciliation is complete. G. Elements to be verified during the Time Out are: A. Correct patient identity using name and date of birth B. Confirmation of the correct side and site marked C. Agreement on the procedure(s) to be done with verification of an accurate procedure consent or verification form D. Relevant images and results are properly labeled and appropriately displayed. The proceduralist must verify agreement of the image study with the intended site. E. Correct patient position F. Availability of any special equipment, implants or special requirements G. Correct implant laterality and composition (porous/non-porous) H. The need to administer antibiotics I. Safety precautions based on patient history or medication use J. Specimens if applicable PC-13 Effective: 06/24/2014 Page 5 of 6 4. Verification prior to implantation of side-specific hardware (laterality) A. When implant is placed on the sterile field, there is to be a pause with suspension of other activities by the circulator and a representative of the procedural team as defined above, with visual verification of size and laterality of implant on implant and implant container. 6. Verification prior to surgical closure A. Circulating nurse and vendor representative will verify size, laterality and composition, as applicable. Key Content Expert: Chair Provision of Care, Treatment, and Services; OROC Approved: Signature available on original document _____________________________ Deborah Pasch Chief Nursing Officer MU Healthcare PC-13 Effective: 06/24/2014 06/24/2014 ________________ Date Page 6 of 6