ENSURING CORRECT SURGERY

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ENSURING CORRECT SURGERY
Veterans Health Administration Directive 2002-070

• Training program created by the VA
  National Center for Patient Safety

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Purpose

• Ensure
• Correct site
• Correct patient
• Correct implant (if applicable)

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Background
Wrong patient and wrong site adverse events and
close calls are described in numerous VA Root
Cause Analyses as well as many other sources,
such as the New York Patient Occurrence Reporting
and Tracking System (NYPORTS).
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New Policy on Correct Surgery in VHA

• Pilot-tested at 10 VAMCs starting in June 2002
  
• Directive signed by the Under Secretary for
• Health (VHA Directive 2002-070) on 11/13/02
• Consistent with Joint Commission on
• Accreditation of Healthcare Organizations
  Patient
• Safety Goals for 2003

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New Policy

• All medical centers are required to comply with
  this Directive as of 1/1/03
• Data available from New York State rate of wrong
  site surgery was about 1 in 15,500 in 2001
• VA rate in 2001 was about 1 in 30,000
• Result approximately one wrong site surgery per
  month in VA

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The Problem

• Synopsis of reported cases of incorrect surgery
  in VA
• 44 left-right mix-ups on the correct patient
• 36 wrong patient
• 14 wrong implant or procedure on correct patient
• 7 wrong site (not left-right issue) on correct
  patient

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VHA Directive 2002-070

• Supplemental training materials provided with the
  Directive include
• Poster Resources
• Patient brochure Supporting literature
• FAQs Videotape

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Patient
Brochure
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Patient
Brochure
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Poster
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Days to Hours Before Surgery
1. The Consent Form

• The consent form to be signed by the patient
  pre-operatively must state in terms that are
  readily understood by the patient

• site of the procedure
• laterality (if applicable)
• name of the procedure
• reason for the procedure

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Days to Hours Before Surgery
2. Mark Site

• All facilities must specify exactly how
  physicians, or other privileged providers, are to
  mark operative sites a typical standard practice
  is to use a surgical marking pen and to mark the
  site with the physicians initials, an X or
  YES.

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Days to Hours Before Surgery
2. Mark Site (continued)

• Mark all sites, not just left/right
• The operative site must be marked by a physician
  or other privileged provider who is a member of
  the operating team and is scheduled to be
  scrubbed in for the procedure.
• Always use ink that will still be visible after
  pre-surgical preparation of the operative site.
  Do not use adhesive stickers to mark a site.

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Days to Hours Before Surgery
2. Mark Site (continued)

• The site should be marked so that it is
  unambiguous for example, for surgery on a
  finger, the finger should be marked rather than
  the palm or back of the hand.
• The mark needs to be placed so that it will be
  visible in the operative field after of the site
  is prepped and draped.

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Days to Hours Before Surgery
Do Not Mark Non-operative Site

• Local policy must explicitly state that the non
• operative sites must NOT be marked, unless
• required for another aspect of care.

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Just Before Entering the OR
3. Patient Identification

• Facilities must establish which personnel, or
  job position(s) are to be assigned the task of
  asking the patient to state the patients
  identity and what the patient understands to be
  the site of the upcoming procedure.

Your facilitys local policy specifies how
this must be accomplished
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Just Before Entering the OR
3. Patient Identification (continued)

• The patient must be asked to verbally state - not
  confirm
• his/her full name
• his/her social security number or birth date
• site of the procedure

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Just Before Entering the OR
3. Patient Identification (continued)

• Facilities must also establish how the
• patients answers will be documented and
• checked against the marked site, I.D. band,
• Consent form, and other documents.

Your facilitys local policy specifies how
this must be accomplished
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Immediately Prior to Surgery
4. Time Out
Facilities must establish a specific procedure
so that members of the OR team verify their
agreement as to the intended surgery prior to the
start of the procedure.
Your facilitys local policy specifies how
this must be accomplished
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Immediately Prior to Surgery
4. Time Out (continued)

• A standard method is a time out, during which a
  designated member of the OR team states
• the name of the patient
• the procedure to be performed
• the site of the procedure, including laterality
• the implant to be used (if applicable)

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Immediately Prior to Surgery
4. Time Out (continued)

• After the statement, other members of the team
  must verbally state that they concur with this
  information before the procedure begins
• This must be documented
• The patient need not be awake for the time out

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Immediately Prior to Surgery
5. Imaging Data
For procedures during which physicians will refer
to pre-existing images, facilities must establish
a method for documenting that two members of the
OR team have confirmed that the images are
available, correct, properly labeled, and
properly presented.
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Findings

• VA NCPS evaluated the Directive in light of
  events reported in VA RCAs and found that
• 45 of the incorrect surgery cases studied would
  have been prevented if the informed consent
  process included site (w/laterality), name, and
  reason for the procedure
• 65 of the incorrect surgery cases would have
  been prevented if the surgeon or other privileged
  provider marked the site in concert with the
  patient

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Findings (continued)

• 3. 75 of the cases would have been prevented
  by having staff ask the patient to say his name,
  social security number or birth date, and the
  site of the procedure and checking the given
  answers against the mark and records
• 4. 85 of the cases would have been prevented
  by taking the time-out in the OR

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Findings (continued)

• 5. 20 of the incorrect surgery cases would
  have been prevented by having two members of the
  OR team check the diagnostic images

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Conclusion

• Implementation of this Directive
• Is mandatory
• Will satisfy the JCAHO 2003 Patient Safety Goals
  for procedures conducted in an operating room
  environment

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Responsible Office
The VHA National Center for Patient Safety (10X)
and the Office of Patient Care Services (111B)
share responsibility for the development and
contents of this Directive.
Questions regarding this Directive may be
addressed to the Director, National Center for
Patient Safety at 734-930-5890.
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VHA Directive 2002-070
Other relevant information is available on-line
at http//vaww.ncps.med.va.gov (VHA intranet), or
www.patientsafety.gov (internet).
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Additional Material
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Guidance from Professional Societies and JCAHO
1. American Academy of Orthopedic Surgeons
Academy statement on wrong-site surgery. Accessed
9/6/2002. Available at http//www.aaos.org/wordh
tml/2000news/c9-16.htm 2. Association of
Perioperative Registered Nurses (AORN). AORN
Position Statement on Correct Site Surgery.
Accessed 9/6/2002. Available at
http//www.aorn.org/about/positions/correctsite.ht
m 3. American Academy of Ophthalmology
Eliminating Wrong Site Surgery. Patient Safety
Bulletin Number 1. Accessed 9/6/2002. Available
at http//www.aao.org/aao/education/library/safet
y_site.cfm 4. JCAHO Sentinel Event Alert, Issue
24 - December 5, 2001, A follow-up review of
wrong site surgery. Accessed 9/6/2002. Available
at http//www.jcaho.org/aboutus/newsletters/
sentineleventalert/sea_24.htm
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American Academy of Orthopedic Surgeons Academy
statement on wrong-site surgery

• Wrong-site surgeryresults from poor
  preoperative planning, lack of institutional
  controls, failure of the surgeon to exercise due
  care, or a simple mistake in communication
  between the patient and the surgeon.
• The American Academy of Orthopaedic Surgeons
  believes that a unified effort among surgeons,
  hospitals and other health care providers to
  initiate preoperative and other institutional
  regulations can effectively eliminate wrong-site
  surgery in the United States.
• Wrong-site surgery is preventable by having the
  surgeons initials placed on the operative site
  using a permanent marking pen and then operating
  through or adjacent to his or her initials.
  Spinal surgery done at the wrong level can be
  prevented with an intraoperative X-ray that marks
  the exact vertebral level (site) of surgery.
  Similarly, institutional protocols should include
  these recommendations and involve operating room
  nurses and technicians, hospital room committees,
  anesthesiologists, residents and other
  preoperative allied health personnel.
  \
• -September 1997

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Association of Perioperative Registered Nurses
(AORN) AORN Position Statement on Correct Site
Surgery

• A comprehensive approach is needed in each
  health care delivery system to prevent wrong site
  surgery. Procedures and protocols should be
  developed collaboratively by multidisciplinary
  teams, including surgeons, perioperative RNs,
  anesthesia care providers, risk managers, and
  other health care professionals.
• Risk-reduction strategies
• Involve the patient and/or family
  members/significant others in identifying the
  correct site.
• Use a specified, clear, unambiguous, indelible
  method for marking only the correct surgical
  site.
• Specify in individual facility policy and
  procedure how, when, and by whom the surgical
  site is to be marked.
• Use a verification checklist immediately before
  surgery -March 2001

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American Academy of Ophthalmology Eliminating
Wrong Site Surgery

• A Joint Statement of the American Academy of
  Ophthalmology, the American Society of Ophthalmic
  Registered Nurses and the American Association of
  Eye and Ear Hospitals.
• At a minimum, the following steps are suggested
  for ophthalmologists to minimize risks of
  wrong-site surgery, and to slow down and pay
  attention to the following
• Asking the patient and surgical team prior to
  surgery
• Reviewing the ophthalmic history and exam in the
  operating room
• Marking next to the operative eye
• Suggestions for a Checklist to Verify the
  Operative Eye
• (see detailed checklist specifically tailored
  for procedures on the eye)
• - March 2001

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JCAHO Sentinel Event Alert 24, December 5, 2001

• JCAHO suggests developing processes to assure
  the correct surgical site, patient and procedure
  by
• 1) marking the surgical site and involving the
  patient in the marking process
• 2) creating and using a verification checklist
  including appropriate documents, for example,
  medical records, X-rays and/or imaging studies
• 3) obtaining oral verification of the patient,
  surgical site, and procedure in the operating
  room by each member of the surgical team and
• 4) monitoring compliance with these procedures.
• Additionally, JCAHO recommends that
• 5) surgical teams consider taking a "time out" in
  the operating room to verify the correct patient,
  procedure and site, using active--not passive
  communication techniques.