# NCPS TIPS -- September/October 2004

### Contents: 1. Ensuring Correct Surgery and Invasive Procedures

> 2\. Reducing the Vulnerability of Retained Surgical Sponges

### 1. Ensuring Correct Surgery and Invasive Procedures

By Noel Eldridge, MS, NCPS executive officer

In June 2004, a new directive on Ensuring Correct Surgery and Invasive
Procedures (2004-028) was issued to update the initial, groundbreaking
directive that went into effect January 2003.

Visit the NCPS Web site to review the new directive:
*http://www.patientsafety.gov/CorrectSurg.html* or
*http://vaww.ncps.med.va.gov/CorrectSurg.html*. This article is just a
summary. The entire directive should be reviewed and understood by those
who implement relevant facility policies, or participate in performing
surgical or other invasive procedures.

In the new and old directive, NCPS worked with the VA National Director
of Surgery and a number of VA medical centers to develop a national
policy --- based on a straightforward, five-step process --- which
includes filling out a consent form, marking the site, identifying the
patient, holding a time-out, and checking pertinent images.

The initial directive was focused on surgical procedures conducted
within the operating room (OR). The new directive was developed to adapt
the five-step Ensuring Correct Surgery Directive to healthcare settings
outside the OR, such as at the bedside or in the intensive care unit.

The new directive also addresses JCAHO's requirements noted in the
Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong
Person Surgery^TM^, effective July 1, 2004, and available at
www.jcaho.org (click on "Universal Protocol").

To establish a procedure and policy for ensuring correct invasive
procedures outside the OR, we focused on two main requirements:

-   Modification of existing processes to recognize the variations in
    practice that are associated with out-of-OR invasive procedures

-   Development of a list of invasive procedures to which the directive
    applies

A list of procedures that apply to the directive appears below in figure
1, and a flowchart showing the process is provided in figure 2 below. In
general, the criteria for whether the processes must be followed are
simple: Is the procedure one that requires signature consent? If so, is
it invasive? If yes to both questions, then a form of the five steps
applies.

To meet the requirements of the JCAHO Universal Protocol, the practices
described in figures 1 and 2 must be followed.

The new directive includes one specific change to meet the requirements
of JCAHO's Universal Protocol for surgery performed within the OR:
During the time-out, the position of the patient must be checked and
confirmed in addition to the other requirements. In OR settings, the
initial directive that took effect in 2003 meets or exceeds all other
requirements of the universal protocol.

To address miscellaneous issues and questions that have come up since
the implementation of the initial directive, several adjustments or
additions were included in the new directive. The most important ones
are the following:

-   For surgery on the spine, a mark on the skin is sometimes inadequate
    to indicate the intervertebral space or other specific location to
    be operated upon. Because of this, the American Academy of
    Orthopaedic Surgeons developed additional guidance that is
    incorporated into the new directive as follows: In spine surgery, or
    when the bone or level is not identifiable visually, the surgeon
    takes an intraoperative X-ray using markers that do not move to
    confirm the site.

-   In some cases, procedures performed outside of the OR may be
    performed by an individual practitioner working alone. In these
    cases, the requirement for two practitioners to perform the step
    requiring an imaging check, as well as for a time-out, will not
    apply. The sole practitioner should pause to review the relevant
    information, as would be done in a time-out; the imaging data should
    be reviewed in the same manner as would be done were the sole
    practitioner with another practitioner.

-   In some cases, a special purpose wristband may be used instead of
    marking the site. JCAHO's FAQs state that an alternative method for
    visually identifying the correct side should be used (e.g., a
    temporary unique wristband or other similar device) when it is
    technically or anatomically impossible or impractical to mark a
    site. For example, JCAHO has OK\'d the use of a wristband instead of
    a mark for operative sites on the genitalia or perineum, but has
    also made it clear that an operative site that can be marked easily,
    such as a site on a breast, must be marked unless the patient
    refuses a mark. A wristband can also be used whenever a patient
    refuses a mark.

-   The requirement to mark the site is waived for endoscopic procedures
    performed through the mouth or anus. The requirement to mark the
    site is also waived for 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 (or teeth) planned for
    extraction should be marked and reviewed with the patient, and with
    any participating assistant (e.g., dental technician) prior to the
    procedure.

In summation, the biggest difference between the two directives is that
the 2004 update adds out-of-OR processes and allows for the use of a
wristband instead of a mark in limited situations. We have had multiple
reports of adverse events being prevented by the five-step procedure and
the results will be the subject of a future TIPS article.

*Figure 1: Definition of Surgical or Other Invasive Procedures*

Surgical or other invasive procedures are those involving a skin
incision or puncture including, but not limited to open surgical
procedures, and excluding venipuncture or intravenous therapy. To
clarify 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 are provided as
follows:

-   Injections of any substance into a joint space or body cavity

-   Percutaneous aspiration of body fluids through the skin

-   Biopsy

-   Cardiac procedures

-   Central vascular access device insertion

-   Electrocautery of skin lesion

-   Endoscopy

-   Laparoscopic surgical procedures

-   Invasive radiology procedures

-   Laser therapy

-   Dermatology Procedures

-   Invasive ophthalmic procedures, including miscellaneous procedures
    involving implants

-   Oral surgical procedures including tooth extraction and gingival
    biopsy

-   Podiatric invasive procedures

-   Skin or wound debridement performed in an operating room

NOTE: Procedures similar in scope to those listed above need to be
considered invasive procedures and subject to the requirements of this
directive. See Directive 2004-028, Attachment E, for examples.

# *Figure 2: Flowchart on Ensuring Correct Invasive Procedures in All Clinical Settings*

No

Yes

No

Yes

No Yes

No Yes No Yes

**2. Reducing the Vulnerability of Retained Surgical Sponges**

#### By Carol Samples, BGS, NCPS program analyst, and Ed Dunn, MD, MPH, director of policy and clinical affairs

Leaving sponges inside patients who undergo surgical procedures is a
serious and persistent problem in healthcare throughout the world. The
estimated incidence of retained sponges or instruments is one out of
every 1,500 operative procedures that involve an open abdomen or open
chest.^1,2^ Such incidents may result in major injury. The retention of
surgical sponges is avoidable and thus an important opportunity for
reducing harm to patients served by the VHA.

The Association of periOperative Registered Nurses, AORN, recommends
counting sponges on all procedures in which the likelihood exists that a
sponge or instrument could be retained in a body cavity. They advise
sponge counts to be taken:

-   before the procedure to establish a baseline,

-   before closure of a cavity within a cavity,

-   before wound closure begins,

-   at skin closure or end of the procedure, and

-   at the time of permanent relief of either the scrub person or the
    circulating nurse.^3^

####### Background RCA Data 

In our search of the NCPS SPOT database for surgical procedures
involving retained sponges, more than 70 cases were identified: 58
percent were adverse events; 42 percent were close calls. Our search
spanned 2000 to 2004. We defined "sponges" to include: peanut sponges,
various sizes of gauze pads (4x4 in., 2x3 in.), laparotomy pads,
surgical towels, and folded surgical drapes.

####### RCA Case Data

In cases of adverse events due to retained sponges, 41 percent of sponge
counts were reported as incorrect and 21 percent were reported as
correct. In 38 percent of these cases, no counts were documented.

Sponges were left in the neck, chest, peritoneum, knee, groin,
mediastinum, retroperitoneal cavity, and pelvis. Gauze sponges have been
discovered in a patient's airway after a tracheostomy, defecated
following use as a throat pack during a maxillectomy, and found visibly
extruding from an abdominal incision.

Retained sponges were discovered before and after wound closure and were
also found when searches were initiated after incorrect sponge counts
were reported. In some cases, evidence of a retained sponge was not
apparent until days, weeks or years later, when X-rays were taken of
patients with symptoms of pain, swelling, or signs of occult infection.
Radiologists also observed sponges in unrelated routine X-rays and
pathologists discovered them during autopsies.

The time elapsed from the original surgical procedure to reoperation for
removal of a retained sponge ranged from an immediate response to eight
years after the operation.

Radiographs are often inconclusive when they are done for incorrect
sponge counts. Radiopaque markers imbedded in sponges may be confused
for pacing wires and artificial cardiac valves or valve rings. Material
such as Surgicel® has been mistaken for a sponge. Sponges have been
obscured because of their proximity to bone or their position deep
within the recesses of the chest or abdominal cavities. The quality of
images from portable X-ray equipment in the OR is often suboptimal and
limited by a narrow range of possible views. To improve detection
skills, it has been suggested that radiology residents review films with
various foreign objects, including sponges, as part of their training.

####### Root Causes and Contributing Factors from RCA teams

Reports from RCA teams taken from our SPOT RCA database have suggested
possible root cause contributing factors in cases with retained surgical
sponges:

-   Incorrect sponge counts are commonplace and usually not associated
    with an actual retained sponge.

-   Radiopaque sponges were not used consistently; counts were not
    recorded.

-   Local norms may interfere with the adoption of AORN standards for
    counting surgical sponges --- i.e., "This isn't the way we've done
    things around here."

-   Suboptimal communication between members of the surgical team
    increases the likelihood of incorrect sponge counts.

-   Productivity pressures to increase throughput may compromise
    implementation of AORN standards (re: sponge counts).

-   Feelings that socialization, music and conversation are acceptable
    because the patient is asleep can contribute to lapses in
    concentration.

-   The stressful environment of the OR, with many people coming and
    going, requires multiple hand-offs of responsibility.

-   Urgency is experienced with changes or complications in surgical
    procedures.

-   Inconsistent policies and practices when sponge counts are
    incorrect, or when a missing sponge is not visualized on X-ray,
    leave staff without clear direction.

-   Lack of clarity in X-ray requests leads to incomplete interpretation
    by the radiologist reading the film.

-   Inability to obtain stat X-ray readings from the radiology
    department reduces the likelihood that incorrect counts are promptly
    validated.

-   Audits of the count process focus on count documentation rather than
    direct observation of the count process.

-   A surgeon's role in sponge and instrument counts is not clearly
    defined.

-   Varying levels of physician orientation to OR practices (especially
    residents who come and go on monthly rotations) contribute to
    practice violation of AORN standards. Attending physicians are often
    not completely familiar with the process.

####### NCPS Observations & Suggested Actions

Please note:

\* Indicates that "better than before" was documented in the outcome
measure table of the RCA. In all others, there was no indication of
follow-up.

-   \*Use AORN sponge and instrument count guidelines consistently.

-   Without exception, all sponges and towels should have radiopaque
    markers.

-   Sponge and instrument counts are critical regardless of the type and
    size of the incision.

-   A "throughput focus" for managing patient flow through the OR can
    hinder accurate and effective sponge and instrument counts.
    Designate an OR supervisor or team leader to control movement and
    flow of patients through the OR.

-   In collaboration with radiology, arrangements must be made for stat
    images whenever a surgical case is in progress.

-   Observational studies of the counting process in the OR should be
    done periodically for quality control. The actual counting process
    is more important than the documentation of that process.

-   Ensure that portable X-ray machines can provide adequate imaging
    data to meet needs for assisting with identification of retained
    items.

-   Recognition of retained foreign bodies after surgical procedures
    should be an integral part of residency training in radiology.

-   Consider routine intraoperative radiographic screening in selected,
    high-risk categories of surgical procedures (obese patients,
    closed-to-open procedures, emergent cases, and unexpected change in
    surgical procedures).^4^

-   Without exception, all attending surgeons should know and adhere to
    the institution's policies and practices for sponge and instrument
    counting.

-   Staff cannot rely on vigilance. They require physical reminders such
    as cognitive aids to ensure that they are conducting the correct
    procedure for sponge and instrument counting.

-   OR staff must be empowered to "speak up" during a surgical case if
    they are uncomfortable with the sponge or instrument count. The
    mindset should always be: "If you're not sure it's safe, it's not
    safe."

**Additional actions recommended by RCA teams included:**

-   Annually, assess staff competencies on the management of sharp
    instruments and sponges.

-   All medical and nursing staff should be educated and trained in the
    appropriate and standardized sponge and instrument count procedures.
    Without exception, all attending surgeons should know the
    institution count procedures.

-   \*Evaluate sponge-counting aids or devices such as plastic
    compartmented counting bags that could improve the accuracy and
    efficiency of the process.

-   Consider the elimination of small sponges (2x3 in. and 4x4 in.) from
    surgical cases when possible.

-   \*Purchase radiopaque towels for use in thoracic and abdominal
    cavities.

-   Use whiteboards in the OR suites to document counts.

-   \*Maintain continuity whenever possible by having the same team of
    OR staff start and complete a case. Whenever possible, lengthen
    assignments for consistency.

-   Conduct observational study of count process to learn
    vulnerabilities, identify specific distractions, and improve process
    design.

-   Enforce quiet or dedicated time during final counts so nurses
    performing them are not disturbed.

-   \*Requests for stat X-rays in the OR for surgical cases with an
    incorrect count should include: type of procedure, surgical site,
    surgeon, and nature of missing item. Stat intraoperative X-rays
    should be jointly or sequentially reviewed and discussed by the
    surgeon and the radiologist.

-   \*Check kick-buckets and trash before initiating sponge and
    instrument counts.

-   Sponge wrappers should not be discarded until the final count is
    complete and accurate to corroborate initial and final counts.

In the future, Electronic Article Surveillance (EAS) may play a role in
sponge and instrument counting. Radio Frequency Identification (RFID)
sensors are becoming increasingly miniaturized, some recently cited as
being the size of a grain of sand. This technology has the potential to
facilitate dramatic changes to the practice of sponge counting and
detection.

For additional information see:

Gawande, A. et al. Risk Factors for Retained Instruments and Sponges
after Surgery.

N Eng J Med 2003;348:229-235.

AORN web site: *www.aorn.org*

*References*

1 Gonzalez-Ojeda, A. et al. Retained foreign bodies following
intra-abdominal surgery. Hepatogastroenterolosy 1999; 46: 808-12.

2 Hyslop, J. Maulm i, K. Natural history of the retained surgical
sponge. South Med Journal 1982; 75:657-60.

3 AORN, Inc. (2004) Standards, Recommended Practices, and Guidelines.

4 Gawande, A. et al. Risk Factors for Retained Instruments and Sponges
after Surgery. N Eng J Med 2003;348:234.