+-----------------------------------+-----------------------------------+
| # *                               | # **VHA DIRECTIVE 2004-028**      |
| *Department of Veterans Affairs** |                                   |
+-----------------------------------+-----------------------------------+
| ## Veterans Health Administration | ##                                |
+-----------------------------------+-----------------------------------+
| ## Washington, DC 20420           | **June 25, 2004**                 |
+-----------------------------------+-----------------------------------+

####### **ENSURING CORRECT SURGERY AND INVASIVE PROCEDURES**

**PURPOSE:** This Veterans Health Administration (VHA) Directive
provides specific information on what steps must be taken to ensure that
the indicated surgical or invasive procedure is performed on the correct
patient, at the correct site, and if applicable with the correct
implant. ***NOTE:** Correct site includes the correct side (i.e., left
or right) [and]{.underline} the precise anatomical part, such as a
specific finger.*

**2. BACKGROUND**

a\. Wrong site, wrong patient, and wrong implant procedures are
relatively uncommon adverse events in health care but are often
devastating when they occur. Specifically, this Directive provides
guidance on invasive procedures performed in settings such as patient
rooms and intensive care units.

b\. There are five steps used in the VHA to ensure correct surgery:

\(1\) The consent form is administered and executed properly,

\(2\) The operative site is marked,

\(3\) The patient is actively identified using required techniques,

\(4\) A "time-out" briefing is conducted in the operating room (OR)
prior to starting the procedure, and

\(5\) Two members of the OR team review pertinent radiological images
prior to commencing the surgical procedure.

c\. Attachments A, B, and C address the processes required to precede
surgical and invasive procedures performed in ORs, dedicated surgical
suites (inpatient or ambulatory), and other dedicated procedure rooms
such as endoscopy suites. ***NOTE:** Any reference to an "operating
room" or "OR" throughout this document should be understood to include
and pertain to similar dedicated inpatient or ambulatory procedure rooms
without regard to the name used locally to describe the room or suite.
The requirements for an OR in an ambulatory setting are described in
[VHA Handbook 1102.5: Criteria and Standards for Performance of
Ambulatory (Same-Day) Surgery Performed in Ambulatory or Dedicated
Surgical Suites (]{.underline}available at
http://vaww.va.gov/publ/direc/health/handbook/1102.5hb5-20-03.pdf).*

d\. Attachment D addresses the processes that are required to precede
invasive procedures that are performed in clinical settings other than
ORs, such as the inpatient bedside, intensive

**THIS VHA DIRECTIVE EXPIRES JUNE 30, 2009**

care units, emergency rooms, physician's offices, etc. ***NOTE:** These
settings are addressed separately because the assumptions underlying the
steps required in Attachments A, B and C do not always apply to non-OR
settings, for example, the assumptions that multiple practitioners and
staff will be involved and that the patient will be moved from a
location where the patient is prepared for surgery to a different
location where the surgery will be performed.*

e\. Attachment E describes the surgical and other invasive procedures
that are covered by this Directive.

f\. To facilitate the development of local procedures and policy
documents, Attachment F contains a sample facility policy.

> g\. Attachment G provides additional strategies, techniques, and tools
> that are not required by this Directive, but which merit consideration
> in the development and implementation of facility policies and
> procedures.

h\. Attachment H contains a flowchart for use in determining if a
procedure must follow the processes in Attachments A, B, and C, or if
the abbreviated processes in Attachment D apply.

**3. POLICY:** It is VHA policy that in VHA facilities where surgery and
invasive procedures are performed specific steps must be implemented in
order to reduce the likelihood of incorrect surgeries (see Att. A, Att.
B, and Att. C) and other incorrect invasive procedures (see Att. D and
Att. E).

**4. ACTION:** The Facility Director is responsible, for ensuring that,
no later than July 1, 2004:

a\. Except in cases of medical or surgical emergencies, or those rare
situations where certain steps are impossible to complete, the five
steps listed in preceding paragraph 2, and detailed in Attachments A, B,
and C, must be performed for those procedures performed in an OR
setting. Furthermore, if a step required by this Directive has not been
performed, the next step must be delayed until the previous step has
been completed. For surgical procedures, steps in Attachment C cannot
start until the steps in Attachment B are completed; and those steps in
Attachment B cannot start until the steps in Attachment A are completed.
For invasive procedures, the steps in Attachment D must be followed as
described. ***NOTE:** In the rare cases where the required steps are not
all followed, the justification for the deviation(s) must be
documented.*

b\. A facility policy document is put into effect that describes the
required specific steps (see Att. A, Att. B, Att. C, Att. E, and Att.
F.) that must be implemented in order to reduce the likelihood of
incorrect surgical and invasive procedures.

c\. The execution of these steps is documented in the patient's record
(see Att. A, Att. B, Att. C, Att. D, and Att. E).

d\. The implementation of the steps and conformance to the facility's
policy document(s) is monitored for compliance.

**5. REFERENCES**

a\. VHA Handbook 1004.1. VHA Informed Consent for Clinical Treatments
and Procedures. Available at:
[http://vaww.va.gov/publ/direc/health/handbooks/1004-1hk .]{.underline}

b\. VHA Handbook 1102.5. Criteria and Standards for Performance of
Ambulatory (Same Day) Surgery Performed in Ambulatory or Dedicated
Surgical Suites. Available at
[http://vaww.va.gov/publ/direc/health/handbook/1102.5hb5-20-03.pdf]{.underline}

c\. JCAHO Universal Protocol for Preventing Wrong Site, Wrong Procedure,
Wrong Person Surgery. Available at:
[http://www.jcaho.com/accredited+organizations/patient+safety/universal+protocol/wss_universal+protocol.htm]{.underline}

d\. JCAHO 2004 National Patient Safety Goals. Available at:
http://www.jcaho.com/accredited+organizations/patient+safety/04+npsg/index.htm
.

e\. American Academy of Orthopedic Surgeons Advisory Statement on Wrong
Site Surgery: Statement 1015, October 2003,
[http://www.aaos.org/wordhtml/papers/advistmt/1015.htm]{.underline} .

**6. FOLLOW-UP RESPONSIBILITIES:** 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 National
Center for Patient Safety at (734) 930-5890.

**7. RESCISSION:** VHA Directive 2002-070 is rescinded. This VHA
Directive expires

June 30, 2009.

  ------------------------------- ---------------------------------------
                                  

                                  Jonathan Perlin, MD, PhD, MSHA, FACP

                                  Acting Under Secretary for Health
  ------------------------------- ---------------------------------------

Attachments

  --------------- ------- ------------------------------------------------
  DISTRIBUTION:   CO:     E-mailed 6/28/04

                  FLD:    VISN, MA, DO, OC, OCRO, and 200 -- E-mailed
                          628/04
  --------------- ------- ------------------------------------------------

# **ATTACHMENT A**

# 

# **MINIMUM PRE-OPERATIVE PROCEDURES**

# ***(Days to approximately 1 hour before surgery)***

1\. The consent form to be signed by the patient (or the individual
legally authorized to consent on behalf of the patient) pre-operatively
must state the procedure site, including laterality if applicable; the
name and a brief description of the procedure; and the reason (condition
or diagnosis) for which the procedure is to be performed. More
information is available in VHA Handbook 1004.1, VHA Informed Consent
for Clinical Treatments and Procedures.

**ACTION:** The medical center Director, or designee, is responsible for
ensuring that facility consent forms facilitate providing the required
information on the:

a\. Site of the procedure (location on the body);

b\. Laterality of the procedure (side of the body), if applicable;

c\. Name and brief description of the procedure; and

d\. Reason (condition or diagnosis) for the procedure.

***Rationale:** To improve patient safety, documenting the preceding
information helps ensure that data critical to the proper identification
and verification of the patient and procedure is readily available. To
facilitate clear communication with the patient, this documentation
needs to be in language that the patient understands.*

***NOTE:** In order to give informed consent, the patient must have
decision-making capacity, be fully informed, and participate voluntarily
(see VHA Handbook 1004.1 - Informed Consent for Clinical Procedures and
Treatments).  A patient should be presumed to have decision-making
capacity unless an appropriate clinical evaluation determines that the
patient lacks decision-making capacity, or the patient is a minor, or
the patient has been ruled incompetent by a court of law. It should be
noted that patients who receive sedation or pain medication may still be
capable of giving informed consent. However, for routine procedures that
require the use of sedation or analgesia, signature consent should
normally be obtained before the patient is pre-medicated.  For
additional information about decision-making capacity, see the
VHA National Ethics Committee report on this topic:
[http://vaww1.va.gov/vhaethics/download/TenMythsReport.doc.
]{.underline}*

2\. The medical center Director, or designee, is responsible for putting
procedures and methods in place that specify pre-operative marking of
the operative site by a physician member of the operating team (surgeon,
resident, fellow), or other privileged provider, performing the invasive
procedure. The physician, or other privileged provider, who marks the
site must be a member of the operating team assigned to be present in
the operating room during the procedure. The purpose for marking the
site is to clearly indicate the procedure site and needs to be done with
the involvement of the patient whenever possible. Indicating the site
with appropriate precision needs to be the primary consideration when
placing the mark. For emergencies these procedures need to be applied to
the extent possible, and facilities must have policies and procedures in
place that specify when marking is not required. These policies must
include provisions for patients that consent for surgery but refuse to
have the surgical site marked, which allow the operation to proceed.

**ACTION:** The medical center Director, or designee, is responsible for
specifying exactly how physicians or other privileged providers are to
mark operative sites and document that the marking process has been
completed: a typical standard practice is to use an appropriate marking
pen and to mark the site with the physician's initials or an "X." The
method and type of mark to be made (initials, X, etc.) must be
consistent for the entire institution. The need for a different sized
mark or slightly different mark for some sites, such as a site on the
face for ophthalmic procedures is understood. The site needs to be
marked so that it is unambiguous; for example, for surgery on a finger,
the finger is to be marked rather than the palm or back of the hand.
Whenever possible the mark needs to be placed so that it will be visible
in the operative field after of the site is prepped and draped. Always
use ink that will withstand pre-surgical preparation of the operative
site. Do not use adhesive stickers to mark a site.

***Rationale:** Marking the site makes clear where the surgery is to be
performed. Having the surgeon or other designated member of the surgical
team mark the site will help ensure that the mark is placed at the
correct site. Although patients need to corroborate the site as the
surgeon marks it when it is possible to do so, patients are not to mark
the site.*

3\. To prevent confusion non-operative sites must not be marked, unless
required for another aspect of care.

**ACTION:** The medical center Director, or designee, is responsible for
ensuring that local policy explicitly states that the non-operative
sites must not be marked, unless required for another aspect of care.

***Rationale:** When non-operative sites are marked, these marks may
cause confusion and have the opposite of the intended effect. For
example, "X" may signify "operate here" to one person and "don't operate
here" to another.*

4\. Surgical procedures for which the requirement to mark the operative
site is waived in the OR setting are:

a\. Endoscopic or other procedures performed through the mouth or anus.
This does not include procedures performed on or near the anus such as
removal of an external hemorrhoid or repair of an anal fistula, or
procedures performed on adjacent anatomical locations such as the
perineum, buttocks, or lower back, which do require a mark.

b\. Oral surgery and other procedures where marking the site would
require marking a mucous membrane rather than skin.

5\. There is a requirement to mark virtually all operative sites,
including those on the midline, face, and groin (except as noted in
paragraph 4). However, in cases where there is a patient or practitioner
concern regarding marking a particular site, for example based on the
site being awkward or problematic to mark (such as the perineum), a
special-purpose wristband can substitute for a marked site. In practice,
this means that all patients (except as in paragraph 4) must have either
their operative site marked or be wearing a special-purpose wristband
prior to the steps described in Attachments B and C, and that if a
wristband is used that the wristband must be checked in the subsequent
steps rather than the marked site. When a special-purpose wristband is
substituted for a marked site, the anatomical site of the procedure and
the name of the procedure must be written on the wristband. A
special-purpose wristband with the name of the procedure and the site
(without indicating the side) can also be substituted for a mark for
cases when the side may be selected based on a real-time clinical
decision in the OR, such as the insertion of a cardiac catheter in the
left or right groin. This method should not be used for sites for which
the side is known and are easy to mark, but for which the precise site
of the incision(s) may be determined or adjusted in the OR, such as a
laparoscopic cholecystectomy. If a wristband is used in lieu of marking
a site, it must be affixed by the practitioner who will perform the
procedure, or be initialed by the practitioner after being affixed by
another member of the team. If a wristband is used instead of marking
the site, the wristband must be accessible to be checked when the
"timeout" step occurs; this may preclude final site preparation before
the timeout in some cases.

6\. For spinal surgery, marking the site to be operated on with a pen is
frequently inadequate to indicate the vertebral body or intervetebral
space that will be operated on. In these cases, procedures identified by
the American Academy of Orthopedic Surgeons (AAOS) should be followed:
"In spine surgery or when the bone or level is not identifiable
visually, surgeon takes an intraoperative X-ray using markers that do
not move to confirm the site." (AAOS Advisory Statement 1015, October
2003, available at
http://www.aaos.org/wordhtml/papers/advistmt/1015.htm)

# **ATTACHMENT B** 

# 

# **MINIMUM PROCEDURES BEFORE THE PATIENT ENTERS** 

# **THE OPERATING ROOM**

# ***(Usually an hour or less before surgery)***

1\. The staff must ask the patient to verbally state (not confirm): (a)
their name, (b) their full social security number (SSN) or birth date,
and (c) the location on their body at which they understand the
procedure will take place.

2\. These responses must be checked by staff against the completed
consent form, marked site, and patient identification band, as
applicable. This must occur in the immediate pre-operating room (OR)
environment before taking the patient into the OR, for example in the
hallway adjacent to the OR, etc., but not in the patient's room.
Whenever possible, in cases where patients cannot provide the correct
responses themselves, another person with knowledge of the patient, such
as a family member, should be asked to state the name of the patient and
the site to be operated on. 

3\. Once this active identification is performed, the staff member who
has performed the identification must stay with the patient until the
patient is transported into the OR. For emergencies these procedures
need to be applied to the extent possible.

**ACTION:** The medical center Director, or designee, is responsible for
establishing which personnel or job position(s) are to be assigned the
task of asking the patient to state the patient's identity and what the
patient understands to be the site of the upcoming procedure. In
addition, it must be established how the patient's answers are to be
documented and checked against local documents, including the consent
form.

***Rationale:** Asking the patient to state rather than confirm their
name helps prevent miscommunication and wrong-patient procedures.
Patients who are hard-of-hearing or distracted by illness or other
temporary or permanent disability may say "yes" to a name that is not
theirs, but it is very unlikely that they will misstate their name and
birth date or social security number when asked. Asking the patient to
state where the patient expects to be operated on is a final check prior
to the provision of anesthesia, after which the patient will likely be
unable to intervene on his or her own behalf. Verifying the information
physically and temporally close to the place and time of the procedure
helps prevent wrong patient procedures. Verifying the information in the
patient's room would be less effective in reducing the vulnerability to
an adverse outcome.*

# 

######## ATTACHMENT C

**MINIMUM OPERATING ROOM PROCEDURES**

***(Minutes to seconds before surgery or invasive procedure begins)***

1\. The medical center Director, or designee, is responsible for
ensuring that procedures are in place that require verification of the
correct patient, the correct procedure, the correct site, and the
correct implant (where applicable) by operating room personnel in the
Operating Room (OR) prior to the start of the operation, and at a time
when the patient and required OR personnel are present in the OR. In
most or many cases the patient will be under sedation or unconscious
when this verification occurs and is not expected to participate in this
process.

ACTION: The medical center Director, or designee, is responsible for
establishing a specific procedure by which members of the OR team verify
their agreement as to the intended surgery prior to the start of the
procedure. [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 location of the site (including laterality if
applicable), the required position of the patient (e.g., supine), and
the specifications of the implant to be used (if
applicable).]{.underline} After the statement, other members of the team
verbally state that they concur with this information before the
procedure begins. At minimum, this process must include the surgeon, the
circulating nurse, and the anesthesia provider. For procedures involving
special equipment or technology, the surgical technologist must also
participate in the time out. Successful completion of this process must
be documented. If a wristband is used instead of marking the site, the
wristband must be accessible to be checked when the "timeout" step
occurs; this may preclude final site preparation before the "time out"
in some cases.

***Rationale:** This makes sure everyone "is on the same page."*

2\. The medical center Director, or designee, is responsible for
ensuring that, when imaging data are used to determine or confirm the
operative site, procedures are in place that require two members of the
operating team to verify, prior to the start of a procedure, that the
relevant images for the correct patient are available, properly labeled,
and properly presented.

**ACTION:** For procedures during which physicians will refer to
pre-existing images, the medical center Director, or designee, is
responsible for ensuring that a method for documenting that two members
of the OR team have confirmed that the images are available, correct,
properly labeled, and properly presented. The surgeon performing the
operation bears the primary responsibility for making clinical and
technical decisions such as determining that available images are
correct for the situation. The role of the second check by another
member of the operating team is to confirm basic information, such as
the correct patient name and identification number. Because the second
check requires minimal technical expertise, it does not necessarily need
to be performed by another surgeon or physician qualified to perform the
operation.

***Rationale:** Errors in determining appropriate site due to lack of
availability or improper labeling of images is a real vulnerability and
methods to mitigate this vulnerability must be in place.*

**ATTACHMENT D**

**ENSURING CORRECT INVASIVE PROCEDURES IN CLINICAL SETTINGS OUTSIDE OF
THE OPERATING ROOM**

1\. When an invasive or surgical procedure is planned for a clinical
setting other than an operating room (OR), a condensed version of the
processes for OR settings (as described in Att. A, Att. B, and Att. C)
may be employed. Attachments A, B, and C provide specific information on
the five steps that must be taken in an OR setting to ensure that the
correct surgical procedure is performed on the correct patient, on the
correct site and with the correct implant, if applicable.

a\. Execution of the five steps can be summarized as follows:

\(1\) the consent form is executed properly,

\(2\) the operative site is marked,

\(3\) the patient is actively identified using required techniques,

\(4\) a "time-out" briefing is conducted in the OR prior to starting the
procedure, and

\(5\) two members of the OR team review pertinent imaging data prior to
commencing the surgical procedure. ***NOTE:** See Appendix H for a
flowchart that presents a summary version of the requirements to ensure
correct invasive procedures in all clinical settings.*

b\. A specific example of condensed version of the "five-step" process
for a procedure that would typically be performed in the patient's room
follows: "Thoracentesis performed at bedside in a hospital." \-- The
physician determines that the patient requires left-sided thoracentesis.
The physician discusses the procedure with the patient and secures
signature consent. At the time of the consent, the physician marks the
site. An hour later when the procedure is to be performed, another
member of the clinical staff, who will assist the physician, confirms
the patient's identity by asking the patient's name and birth date and
checking it against the identification (ID) band and consent form. The
physician reviews with the patient and other member of the clinical
staff: the patient's name, the name of the procedure and the correct
site and side on which it is to be performed. If the review of imaging
data is necessary, the physician and other member of the clinical staff
review the appropriate images together to ensure that they are for the
correct patient and correct side. The physician performs the
thoracentesis with assistance from the other member of the clinical
staff.

2\. [For surgical and other invasive procedures that require that a
practitioner obtain a patient's signature on a Department of Veterans
Affairs (VA) authorized consent form, as defined in Attachment E, the
basic requirements of the "five steps" of the VHA Ensuring Correct
Surgery Directive apply.]{.underline} As described in the preceding
paragraph, these may be incorporated into a condensed version as
appropriate.

3\. Invasive procedures for which the requirement to mark the operative
site is waived are:

a\. Endoscopic and other procedures performed through the mouth or anus
performed in a non-OR setting. This does not include procedures
performed on or near the anus, or procedures performed on adjacent
anatomical locations such as the perineum, buttocks, or lower back.

b\. Oral surgery, tooth extractions, and other procedures where marking
the site would require marking a mucous membrane rather than skin. For
dental extractions, a radiograph or diagram of the mouth showing the
tooth (teeth) planned for extraction should be marked and reviewed with
the patient.

c\. Procedures performed in non-OR settings where the practitioner is in
the physical presence of the patient from the time of signature consent,
through to the time when the procedure is performed.

d\. Two specific examples of these situations follow:

\(1\) Extraction of multiple teeth (ambulatory clinic or office setting)
-- One dentist sees the patient for an office visit and recommends
extraction of two teeth. At this appointment, the same dentist discusses
the procedures with the patient and obtains signature consent. The
signature consent should include the VA authorized consent form , and VA
Form 10-2570, Oral Examination Findings and Treatment Recommendations,
or local equivalent, which requires the dentist to specify the exact
teeth to be extracted using the required standard for numbering teeth.
The office clerk provides the patient with a follow-up appointment 10
days later with a different dentist. At the second appointment, the
dental assistant identifies the patient by asking the patient to state
their name and full SSN and confirms with the patient that two
extractions are to be performed and the location of the teeth. When the
dentist greets the patient in the dental chair, the dentist reviews with
the patient the planned procedures and a dental diagram or dental
radiograph that has the teeth planned for extraction marked. The
pertinent radiological images are also reviewed with the dental
assistant prior to the procedures (at this time or earlier); both the
dentist and assistant verbally confirm the planned extractions,
including tooth numbers, to assure consistency with the consent form. If
a dental implant is to be used, the planned site and availability of the
correct implant is also confirmed.

\(2\) Surgical removal of a superficial mole in an office or ambulatory
clinic setting. The physician greets the patient and confirms patient
identity by asking the patient to state their name and birth date or
social security number. They discuss the procedure in detail, and
signature consent is obtained. The procedure is performed and excised
tissue submitted to the Pathology Laboratory for evaluation. It was not
necessary to mark the site because the physician was in the presence of
the patient from the time of securing signature consent through the
start of the procedure. There were no relevant images to review so that
step did not apply in this case.

4\. There is a requirement to mark virtually all sites of invasive
procedures described in Attachment E, including those on the midline,
face, and groin (except as noted in paragraph 3 of this attachment).
However, in cases where there is a patient or practitioner concern
regarding marking a particular site, for example based on the site being
awkward or problematic to mark (such as the perineum), a special-purpose
wristband can substitute for a marked site. In practice, this means that
all patients (except as in paragraph 3 of this attachment) must have
either their operative site marked or be wearing a special-purpose
wristband, and that if a wristband is used that the wristband must be
checked in the subsequent steps rather than the marked site. When a
special-purpose wristband is substituted for a marked site, the
anatomical site of the procedure and the name of the procedure must be
written on the wristband. A special-purpose wristband with the name of
the procedure and the site (without indicating the side) can also be
substituted for a mark for cases when the side may be selected based on
a real-time clinical decision, such as the insertion of a central
vascular access device, e.g., a percutaneous intravascular catheter
(PIC) line, in the left or right arm. If a wristband is used instead of
marking a site, it must be affixed by the practitioner who will perform
the procedure, or be initialed by the practitioner after being affixed
by another member of the team.

5\. In non-OR settings, the requirements as to the specific individuals
(surgeon, circulating nurse, and anesthesia provider) that need to be
involved in the "time out" are waived. Individuals participating in
performing the procedure should participate in the timeout. The reality
that in non-OR settings a procedure will sometimes be performed by one
practitioner working alone is understood and there is no requirement to
find a second person just to do a timeout. For dental extractions, the
radiograph or a diagram of the mouth showing the tooth (teeth) planned
for extraction should be reviewed with the dental assistant.

6\. In non-OR settings, the requirement for two members of the team to
perform the "Review Imaging Data" check is waived in cases when one
practitioner will perform the procedure.

7\. In non-OR settings, the procedures performed to ensure correct
invasive procedures must be documented consistent with VHA-wide and
local requirements. Documenting and retaining the signature consent is a
VHA-wide requirement. The other steps need to be documented based on
local methods, for example a facility or Veterans Integrated Service
Network (VISN)- developed checklist may be used, or the fact that the
site was marked and the other steps performed may be recorded in the
progress notes according to standard processes at the facility.

**ATTACHMENT E**

### DEFINITION OF SURGICAL OR OTHER INVASIVE PROCEDURES

1\. Surgical or other invasive procedures are those involving a skin
incision or puncture including, but not limited to: open surgical
procedures, percutaneous aspiration, selected injections, biopsy,
percutaneous cardiac and vascular diagnostic or interventional
procedures, laparoscopies, endoscopies, and excluding venipuncture or
intravenous therapy.

2\. To provide clarity as to the types of procedures that are subject to
this Directive, in addition to open surgery and other unambiguously
surgical procedures, specific examples of other invasive procedures that
require the use the standard or a condensed version of the five steps
for ensuring correct surgery are provided as follows:

a\. Injections of any substance into a joint space or body cavity;

b\. Percutaneous aspiration of body fluids through the skin (e.g.,
arthrocentesis, bone marrow aspiration, lumbar puncture, paracentesis,
thoracentesis, suprapubic catheterization);

c\. Biopsy (e.g., breast, liver, muscle, kidney, genitourinary,
prostate, bladder, skin);

d\. Cardiac procedures (e.g., cardiac catheterization, cardiac pacemaker
implantation, angioplasty, stent implantation, intra-aortic balloon
catheter insertion);

e\. Central vascular access device insertion (e.g., Swan-Ganz catheter,
percutaneous intravascular catheter (PIC) line, Hickman catheter);

f\. Electrocautery of skin lesion;

g\. Endoscopy (e.g., colonoscopy, bronchoscopy, esophagogastric
endoscopy, cystoscopy, Percutaneous Endoscopic Gastrostomy (PEG), and
J-tube placements, nephrostomy tube placements);

h\. Laparoscopic surgical procedures (e.g., laparoscopic
cholecystectomy, laparoscopic nephrectomy);

i\. Invasive radiology procedures (e.g., angiography, angioplasty,
percutaneous biopsy);

j\. Laser therapy (e.g., eye, Ear, nose, and throat (ENT));

k\. Dermatology Procedures (biopsy, excision and deep cryotherapy for
malignant lesions - excluding cryotherapy for benign lesions);

l\. Invasive ophthalmic procedures, including miscellaneous procedures
involving implants;

m\. Oral surgical procedures including tooth extraction and gingival
biopsy, except as noted in Attachments A and D;

n\. Podiatric invasive procedures (removal of ingrown toenail, etc.);
and

o\. Skin or wound debridement performed in an operating room.

## *NOTE: Procedures similar in scope to those listed in the preceding need to be considered invasive procedures and subject to the requirements of this Directive.* 

## ATTACHMENT F

## 

## [SAMPLE FACILITY POLICY DIRECTIVE]{.underline} 

## CORRECT-SITE SURGERY PROCEDURES

# 

**1. PURPOSE:** This (Name) Department of Veterans Affairs (VA) Medical
Center Policy Directive establishes effective identification of the
correct site, patient, and implant for a surgical or invasive procedure.

**2. POLICY:** This VA Medical Center policy establishes a procedure to
significantly reduce the possibility of wrong-site, wrong-patient, or
wrong implant surgical or invasive procedures.

**3. ACTION**

a\. The physician or other privileged provider must:

\(1\) advise the patient or surrogate decision maker of the required
procedure and identify the body part directly involved. This information
must be recorded in the patient's medical record.

\(2\) review the following data after scheduling the patient for surgery
and prior to the surgery or invasive procedure:

\(a\) x-rays (and other imaging reports).

\(b\) pre-procedure history and physical (H&P), and other clinically
relevant material (i.e., consults, progress notes, laboratory values,
etc.) in the patient's medical record.

b\. Ensure that a VA authorized consent form is signed by the patient
(or the individual authorized by VA policy to consent on behalf of the
patient), and states the procedure site (location), including laterality
(side), if applicable; the name and a brief description of the
procedure; and the reason (condition or diagnosis) for which the
procedure is being performed. The explanation of the procedure should be
in terms that the patient understands. ***NOTE:** Abbreviations are not
to be used; "right," "left," "both," etc., need to be written out using
terminology intended to be understood by the patient.*

c\. Ensure that prior to the patient entering the Operating Room (OR), a
physician member of the patient's operating team (attending surgeon,
resident, or fellow) marks the correct site, side, and location of the
procedure with an appropriate marker. This must be done after asking a
competent patient to state their full name, full social security number,
and the location on the body where the patient understands the procedure
will take place.

\(1\) For invasive procedures performed outside the operating room, the
site must be marked prior to the procedure consistent with the
requirements of VHA national policy. This policy requires that most
sites of invasive procedures be marked, with the following exceptions:

\(a\) Endoscopic and other procedures performed through the mouth or
anus performed in a non-OR setting;

\(b\) Oral surgery, tooth extractions, and other procedures where
marking the site would require marking a mucous membrane rather than
skin; and

\(c\) Procedures performed in non-OR settings where the practitioner is
in the physical presence of the patient from the time of signature
consent through to the time when the procedures is performed.

\(2\) A special-purpose wristband can be substituted for a mark when the
side is uncertain at the time when the site would be marked. Examples
include cardiac catheters that may be placed in the left or right groin
or PIC lines that may be inserted in the left or right arm.

d\. Ensure that the site must be marked with the physician's initials,
except in special cases where a smaller mark is desired (for example,
near the eye).

e\. Ensure that the mark is placed on the patient's body in consultation
with the patient and after confirming the identity of the patient with
the patient. In a patient that lacks decision-making capacity, when
possible, the surgeon needs to ask the authorized surrogate to state the
name of the patient and confirm the operative site and side. The surgeon
then marks the correct site according to facility policy. For sites that
are awkward or potentially embarrassing to mark, such as the perineum, a
special purpose wristband can be substituted for a marked site to
indicate the site. In these cases the site and the procedure must be
written on the wristband.

f\. Ensure that whenever possible, the mark is placed so that it is
visible in the operative field after the site is prepped and draped. In
the case of multiple level surgeries, for example spine surgery, the
levels that are to be operated on need to be written next to the mark.

g\. Ensure that for spinal surgery, when marking a site with a pen is
frequently inadequate to indicate the vertebral body or intervetebral
space that will be operated on, procedures identified by the American
Academy of Orthopedic Surgeons (AAOS) are followed: "In spine surgery or
when the bone or level is not identifiable visually, surgeon takes an
intraoperative X-ray using markers that do not move to confirm the
site." (see AAOS Advisory Statement 1015, October 2003).

h\. Ensure that, to avoid confusion, non-operative sites or sides [are
not to be marked]{.underline}, unless required for another aspect of
care. Mucous membranes are not to be marked. Patients scheduled for
Gastrointestinal (GI) endoscopy do not have their site marked, but all
other steps described in this Directive apply.

\(1\) Outpatients and Same-day Admittance patients are to have the site
marked in the pre-care area prior to the procedure.

\(2\) Inpatients may have their site marked in their rooms.
Alternatively, after transportation by the OR team they may have the
site marked prior to the procedure in the pre-care area.

\(3\) Intensive Care Unit patients, including Emergency Care Service
patients, are to have the site marked in their respective units prior to
patient transport to the OR for the procedure.

\(4\) In the event of a life-threatening emergency, the site need not be
marked prior to transporting the patient to the OR; however, the
surgical team must concur about the correct operative site in the OR
prior to the initiation of surgery.

i\. Ensure that immediately before the patient enters the OR, a
physician, nurse, physician assistant or medical technician associated
with the care of the patient asks the patient to state the patient's
full name, full social security number or birth date, and to identify
the operative site. The responses must be checked against the VA
authorized consent form, the identification bands, and other documents.
This validation must be documented on the Pre-operative Checklist prior
to the patient's transfer to the OR; the staff member who performs this
check must stay with the patient until the patient is brought into the
OR. ***NOTE:** For procedures done outside an OR this step should be
performed shortly before the procedure at a time appropriately
integrated into the other preparatory steps.*

j\. Ensure that, prior to the start of the procedure, two members of the
OR team verify and document any imaging data that is used to confirm
that the site is correct, is properly labeled with the patient's name
and the correct side of the anatomy, and properly presented or oriented
(left or right and up and down). When a procedure is done outside an OR
by a single provider there is no requirement to seek out a second
provider to perform this confirmation -- the sole provider may verify
the imaging data alone.

k\. Ensure that, as a final check ("time out") prior to the start of the
procedure, at a time when the patient and the operating team are present
in the OR, the presence of the correct patient, the correctly marked
site, intended procedure, the required position of the patient (e.g.,
supine), and the correct implant (where applicable) must be verbally
confirmed by the members of the operating room team (at a minimum, the
surgeon, circulating nurse, and anesthesia provider). In cases involving
special equipment or technology, the surgical technician should also be
included in the time-out. The circulating nurse must document the
completion of the time out. When a procedure is done outside an OR by a
single provider, there is no requirement to seek out a second provider
to perform this the timeout; the sole provider must check and verify the
preceding patient data and identity alone. If a wristband is used
instead of marking the site, the wristband must be accessible to be
checked when the time out step occurs; this may preclude final site
preparation before the timeout in some cases.

l\. Ensure that except in cases of surgical or medical emergencies, or
those rare situations where certain steps are impossible to complete, if
any required action is found not to have been accomplished, the
procedure must be delayed until the discrepancy is corrected. ***NOTE:**
In the emergency or rare cases where the steps are not all followed, and
the decision is made to allow the procedure to proceed, the
justification for the deviation(s) must be documented.*

**4. REFERENCES**

a\. JCAHO Universal Protocol for Preventing Wrong Site, Wrong Procedure,
Wrong Person Surgery. Available at:
[http://www.jcaho.com/accredited+organizations/patient+safety/universal+protocol/wss_universal+protocol.htm
.](http://www.jcaho.com/accredited+organizations/patient+safety/universal+protocol/wss_universal+protocol.htm .)

b\. VHA Handbook 1004.1. VHA Informed Consent for Clinical Treatments
and Procedures. Available at:
[http://vaww.va.gov/publ/direc/health/handbook/1004-1hk
.](../%20http:/vaww.va.gov/publ/direc/health/handbook/1004-1hk%20.)

c\. VHA Directive 2004-028, Ensuring Corrective Surgery and Invasive
Procedures. Available at:
*[www.va.gov/publ/direc/health/publication](http://www.va.gov/publ/direc/health/publications.asp)[s]{.underline}
.*

**5. RESPONSIBLE OFFICE:** The Chief of Staff, or designee, is
responsible for the contents of this memorandum. Questions may be
addressed to (use telephone number).

**6. RECISSIONS:** The former facility directive ( use number and date
of rescinded policy) is rescinded. This (Name) VA Medical Center
Directive expires June 30, 2009.

John A. Doe, Director

VA Medical Center

######## ATTACHMENT G

**ADDITIONAL STRATEGIES, TECHNIQUES, AND TOOLS TO HELP ENSURE CORRECT
SURGERIES**

***(MORE MAY BE ADDED IN CONCERT WITH PILOT TEST SITES)***

***NOTE:** Any special steps taken to ensure a correct surgery, such as
the following suggestions, must be recorded in the patient's medical
record.*

# **1. Possible Enhancements to Minimum Pre-Operative Procedures (days to about an hour before surgery)**

a\. Confirm the site (including laterality if applicable) and the
procedure during the telephone call that is typically made to an
outpatient 24 to 48 hours before the scheduled procedure.

b\. Add to or create a guidebook for patients on what to expect related
to their role in ensuring correct surgeries. Or consistently distribute
the brochure developed by the VHA National Center for Patient Safety on
this topic.

c\. Standardize a check of the consent form against the Operating Room
(OR) schedule 24 hours in advance.

d\. Use no abbreviations or acronyms on the consent form or other
crucial documents.

e\. Do not accept illegible handwriting on the consent form or other
crucial documents.

[2. Possible Enhancements to Minimum Immediately Pre-Operative
Procedures (usually an hour or less before surgery).]{.underline} When
asking the patient to verbally state the site, ask the patient to
indicate the site by touching it too (as appropriate). This may be
especially helpful in cases where disease exists on both sides (e.g.,
two arthritic knees or two eyes with cataracts), but only one side is
scheduled for a procedure on that day.

[3. Possible Enhancements to Minimum OR Procedures (minutes to seconds
before surgery).]{.underline} Write the patient's name, the location of
the site (including laterality), the name of the procedure, and the
details of any implants that will be used (e.g., the diopter for an eye
implant, the size of femoral head and acetabular component for a hip
implant) on a white board or other easily visible place in the OR prior
to the start of surgery. Refer to this text in the confirmation process
before the start of surgery.

[4. Possible Checklist for Documenting Steps in Non-OR
Settings.]{.underline} A checklist may be developed.

ATTACHMENT H

# **FLOWCHART ON ENSURING CORRECT INVASIVE PROCEDURES**

# **IN ALL CLINICAL SETTINGS^1^**

No

Yes

No

Yes

No Yes

No Yes No Yes