General Topics: Policy & Procedure

Policy and Procedure for Operative Site/Side Marking and Verification Stony Brook Medicine Ambulatory Surgery Center

POLICY:
Operative and Invasive procedures are performed on the correct patient and on the correct site/side by requiring a preoperative/pre-procedural marking that unambiguously identifies the site of an operative/pre-procedural location. This process will be a coordinated effort between the attending physician of record, resident/fellow who is on the service, nurses and the anesthesia care team (when applicable). All responsible personnel will confirm the appropriate site/side and never assume another individual has correctly performed the task. Routine “minor” procedures are not within the scope of this policy.

SCOPE: Hospital-Wide

KEYWORDS:
Operative and Invasive Procedures, Routine “minor” procedures, Anesthesia Procedures. “Time Out”, “Observer”, Additional Confirmatory “Time Out”, Medication “Time Out”.

FORMS:
Consent to Operation or Procedure and Anesthesia (OR2C251 12/06)
Consent for Pain Procedure or Regional Anesthesia (AS2C011 02/07)
Universal Protocol Sticker (UH13736/UHC022 P4/05)

POLICY CROSS REFERENCES:
Administrative Manual Policy RI: 0014: Consent for Treatment Policy
Administrative Manual Policy RI: 0015: Health Care Agent/Proxy
Administrative Manual Policy RI: 0002: Communication with Hearing Impaired Patients
Administrative Manual Policy RI: 0013: Interpreter Services
Administrative Manual Policy RI: 0035: Patient Identification Policy
Administrative Manual Policy MM: 0066 Management of Medication for the Sterile Field
High Alert Parenteral Medication List/Operating Room

DEFINITIONS:
Operative and Invasive Procedures: Procedures which expose patients to more than minimal risk, including procedures done in settings other than the operating room such as special procedure units, Endoscopy units or interventional radiology suites. Procedures that involve puncture or incision of the skin, or insertion of an instrument or foreign material into the body, including, but not limited to, percutaneous aspirations, biopsies, cardiac and vascular catherizations, and endoscopies are within the scope of this definition.

Anesthesia Procedures: Procedures performed either prior to a surgical procedure (e.g. regional nerve blocks-brachial plexus) or independently (e.g. spinal facet blocks).

Routine “Minor” Procedures: Venipuncture, peripheral Intravenous line placement, insertion of nasal gastric tube, or Foley catheter insertion.

“Time out”: All work should cease during a period of time when all members of the operative/procedural team, using active communication , confirms correct patient, correct procedure, correct site and side, medications on the sterile field and availability of all items anticipated for procedure to begin.

Additional Confirmatory “Time Out”: All work is to cease when a new surgeon arrives and assumes primary responsibility for the case, or if the patient/operative site is re-draped. The name of the patient and the correct site and side of the procedure is to be verified before proceeding.

Medication “Time Out”: Prior to the start of the case, the surgical/procedural team MUST verify ALL medications on the sterile field. This will include the drug name, strength and the maximum dose calculated for all injectables on the filed, as well as a discussion related to any cautions or contraindications for administration. For Pediatric patients, ALL dosages will be weight based and calculated in mg/kg. Any medication brought to the sterile field after the start of the case/procedure will require a subsequent “Time Out”.

Observer: A Registered Nurse, Licensed Independent Practitioner, PA, Resident or a Physician Assistant can perform in the role of an “Observer” as the second confirmatory party to “Time Out”.

Exemptions:

1. Single organ cases, which do not involve laterality (e.g., hysterectomy, appendectomy).
2. Spinal block for pain management or epidural does not require an intra-operative marker if fluoroscopy is used. However, it does require skin marking.
3. Interventional cases for which the catheter/instrument insertion site is not predetermined (e.g., cardiac catheterization).
4. Dental cases, where the operative tooth number or name(s) can be indicated on documentation or the operative tooth (teeth) including laterality can be marked on the dental radiographs or dental diagram.
5. Endoscopic or other procedures done through a midline orifice.
6. Situations in which the primary pathology itself is plainly visible (single laceration).
7. When the operative pathology has been identified by real time imaging in the immediate Pre-operative period such as for frameless stereo tactic neurosurgical procedures or micro calcifications in a breast biopsy.
8. Life threatening emergency when any delay in initiating the surgery would compromise the safety or outcome of the patient (e.g. ruptured aortic aneurysm).
9. When movement of a patient to create a marking would compromise the safety or outcome of the procedure (e.g. movement of a patient with an unstable spine fracture.)

NOTE: A practitioner is NOT exempt from the site-marking requirement when he or she is in continuous attendance with the patient (from the time of the decision to do the procedure through the conduct of the procedure). The requirement for "time out" applies as well. This is based on reports of wrong-sided procedures being done despite the continued presence of the person performing the procedure from time of decision, to completion of the procedure.

PROCEDURE:

1. The surgical and invasive procedure and site/side will be read back and verified during scheduling of surgical or invasive procedure.
2. Completeness of information for scheduling will include: NO abbreviations, ALL information on implants, special instructions, and site of harvest.
3. Correct site and side will be documented in History and Physical.
4. Correct site and side will be identified on informed consent, NO abbreviations.
5. Relevant images will be accessed via the Patient Access Computer System (PACS), by the surgeon, or assessed for proper labeling by surgeon if brought to hospital by the patient from another facility. When applicable, surgeon will display photographs, only with correct patient identifiers.
6. Relevant pathology and diagnostic reports when applicable, to assist in confirmation of correct patient, correct site and correct side.
7. When possible, active patient/family involvement and verbal verification with patient/family at all points of transfer of care.

1. Verification of Site/Side
   On the day of surgical/invasive procedure:
   
   1. The Pre-operative RN, the circulating nurse, the attending anesthesiologist (when applicable) and the attending physician of record will independently verbally confirm, with the patient’s participation (when possible); the patient’s identity (using name and date of birth: refer to Administrative policy: Patient Identification), the correct procedure, and the correct site/side. Each will confirm that the consent, H&P, radiological exams, and surgical or procedure schedule are in agreement with this verification. The anesthesiologist (when applicable) will confirm that he/she have identified the patient’s identity, correct operative site/side and will then sign the surgical site/side verification section of the consent form. As a third and final verification, the nurse will confirm that he/she has identified the patient’s identity and correct operative site and sign the surgical site/side verification section of the consent form. The nurse will only do this after the physician of record and anesthesiologist (when applicable) have signed the surgical site/side verification form with his/her signature and ID#, and, they have confirmed that there is an oral agreement amongst the operative team with regard to the operative procedure. The nurse will place his/her signature, ID#, date and time on the verification form.
   2. The physician of record will confirm the consent is correct & mark the correct operative/procedural site, with the patient’s participation (when possible) and using pertinent available data to reduce marking error, with a permanent marker. A mark will consist of, a minimum of the first and last initials of the surgeon, visible in the field of surgery. Do NOT mark any non-operative site(s). Site marking must be legible and unambiguous. All sites involving laterality (e.g. brain) and/or paired organs, multiple structures (fingers, toes, hernias, lesions) or multiply levels (spine) must be marked. A second time out must be performed when the intra-operative imaging is done to confirm the level. When site or level is not visible, the surgeon must get an intra-operative imaging film to confirm level. For hand and foot surgery, the surgeon must mark the surface(s) of the digit to be operated on, anterior, posterior or both. The appropriate site must be verified prior to splitting a cast. The skin/site must be marked immediately after cast/splint is removed. The physician of record will then sign the surgical site/side verification section of the consent form.
      
      “In the event of multiple surgical procedures by different surgeons, all relevant surgical sites must be marked prior to the first surgery. The Surgeon marking the site(s) must be present for and participate in the “time out” performed for each procedure he/she marks.”
   3. If there is an exemption or a situation that exists preventing the marking of the surgical site, the physician of record will document that an exemption exists and indicate this within the reason(s) section on the surgical site/side verification section of the consent form.
   4. If a patient lacks the capacity to verify the correct operative site/side all responsible personnel shall verify the correct operative site/side using all available documentation, as described above. For patients who lack capacity, discussion with the individual authorized to consent, if present, will verify the operative site/side.
   5. If a discrepancy is discovered between the consent, medical record, and marked operative site, then the team member discovering the discrepancy will STOP immediately, using the phrase “THIS IS A PATIENT SAFETY ISSUE, STOP!” The discrepancy MUST be reported to the attending physician of record. The case will STOP until the discrepancy between the consent, medical record, and the patient identified site is resolved.
2. In the OR/Procedure Areas:
   1. The physician of record or his/her designee selects for display the appropriate and relevant radiological films for the planned procedure (the attending physician of record determines what is appropriate and relevant).
   2. The circulating nurse/Registered Nurse (when applicable) will verify the site marking during skin/site preparation.
   3. After the patient is draped, immediately prior to beginning any operative or invasive procedure and prior to the first instrument being passed to the operative team, the physician of record will initiate, and all team members (anesthesia personnel (when applicable), physician of record, circulating nurse & scrub) will participate in a “time out”. The anesthesia personnel (when applicable) or Registered Nurse (when anesthesia personnel not applicable) will read the surgical consent out loud for confirmation of patient identity (using 2 patient identifiers, patient name and birth date), correct procedure, and correct site/side, which will be agreed upon by the attending physician of record, anesthesia personnel (when applicable), the scrub person, and the circulating nurse. The circulating nurse will confirm correct position, availability of implants, radiological review (if applicable) and any special equipment or requirements. ONLY WHEN all agree, surgery will begin.
      When the procedure is performed by one (1) individual, it is required to enlist an “Observer” during the “Time Out”. This “Observer” must be a Registered Nurse, Licensed Independent Practitioner, PA, Resident or Physician Assistant.
   4. Additional Confirmatory ‘Time Out” WILL be undertaken when a new surgeon arrives and is assuming primary responsibility for the case, or if the patient/operative site is re-draped. The name of the patient and the procedure should be verified during each subsequent “time out”.
   5. Medication “Time Out” will begin at the beginning of each case. Prior to that start of the case the surgical/procedural team shall verify ALL injectable medications TO BE PLACED on the sterile field. Appropriate medication cups and syringes WILL be labeled. This will include the drug name, strength and the maximum dose calculated, as well as a discussion related to any cautions or contraindications for administration. For pediatric patients all dosages will be weight based and calculated in mg/kg. Any medication brought to the sterile field after the start of the case will require a subsequent “time out”.
   6. Documentation Verification of operative/ invasive procedure, site/side verification, and time out will be documented in the Consent for Operative/Invasive Procedure/Anesthesia and either the Surginet OR Record, Procedural Note, or on the Universal Protocol Sticker (UH13736/UH2C022 P4/05).
   7. Compliance Monitoring and Reporting Compliance will be monitored by direct observation by the Unit Nurse Manager or his/her designee. Data will be collected monthly and reported via the Service Dash Boards. 100% compliance is the expectation of performance. Minimum Surgical “Time Out” participants will include; Anesthesia, Surgical Attending(s), Surgical Resident(s), Operating Room Surgical Technician, Operating Room Circulating Nurse. “Time Out” for invasive procedures will include the Attending, Resident or Licensed Independent Practitioner and Registered Nurse. Less than 100% will not be tolerated and will be reported to the Clinical Chairs/Associate Director of Nursing for corrective action.

RELEVANT STATUTE:
American Academy of Orthopedic Surgeons (AAOS) Advisory Statement, "Wrong Site Surgery", October 2003. Document number: 1015

Association of Peri Operative Registered Nurses (AORN), "Position Statement on Correct Site Surgery" April 2005

Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery, 2003

New York State Surgical and Invasive Procedure Protocol for Hospitals, Diagnostic and Treatment Centers, Ambulatory Surgery Centers, Individual Practitioners, September 2006