MHA Call to Action
Protocol for the Prevention of
Unintentionally Retained
Foreign Objects During
Vaginal Deliveries
April 30, 2008
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Presenters
 Carol Clark, MSN, RN
 Protocol work group member
 Nurse Manager Labor & Delivery,
Fairview Health Services
 Stephanie Lach, MSN, MBA, RN
 Protocol work group leader
 Patient Safety Director at Regions
Hospital
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ICSI Protocol Definition
A step-by-step statement of a
procedure routinely used in the care
of individual patients to assure that
the intended effect is reliably
achieved.
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Protocol Work Group
Stephanie Lach, MSN, MBA, RN
HealthPartners Regions Hospital
Sophia Anaya, RN
Hennepin County Medical Center
Carol Clark, RN, MSN
Fairview Health Services
Franklin Earnest IV, MD
Mayo Clinic
Letitia Fath, MS, RN
Mayo Clinic
Kathleen Harder, PhD
University of Minnesota
Dana Langness, RN, BSN, MA
HealthPartners Regions Hospital
Julie Thompson Larson, MS, RN
HealthPartners Regions Hospital
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Mary Matteson, RN, BA, CNOR
Gillette Children’s Specialty Healthcare
Cherida McCall, CNM
HealthPartners Medical Group
Peg McCoy, BSN, RN
Hennepin County Medical Center
Peggy Naas, MD
Aspen Medical Group
Louise Ou-Yang, MD
Fairview Health Services
Jeffrey Raines, MD
Columbia Park Medical Group
Carrie Trygstad, MBA, ICP
Gillette Children’s Specialty Healthcare
Becky Walkes, RN
Mayo Clinic
Development Process
 Multidisciplinary/multi-organizational
workgroup - ICSI members
 Literature review
 Review of reported events
 Creation of the protocol
 Review & comment by ICSI members
 Review & approval by Steering
Committee
 Posted on ICSI website
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Development Challenges
 Lack of peer-reviewed research.
 Literally starting from ground zero.
 Inconsistent or unclear definitions.
 Need to balance patient safety with
practicality, efficiency, resource
limitations and cost.
 Attempt to standardize practices in csection and labor rooms.
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Protocol Scope
 To develop a step by step process
designed to prevent the unintentional
retention of a foreign object in a patient
undergoing a vaginal delivery.
 Key protocol steps include:
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Counting
Reconciling counts
Using radiographic imaging
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Clinical Highlights
 Sponges/soft goods, sharps and
miscellaneous items will be counted.
 Sponges/soft goods with radiopaque
markers are the only soft goods that will
be present in the delivery field.
 Establishing an accurate baseline count
is the most critical step in the count
process.
 Used sponges are not to be placed in
the fluid/waste bucket.
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Clinical Highlights
 If an adequate baseline count can not
be performed, all subsequent counts are
to be considered compromised.
 When a count can not be reconciled,
has been inadequate, or has been
compromised a radiograph must be
taken.
 Thorough and detailed communication
during staff changes and hand-offs are
essential.
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Countable Items
 All sponges/soft goods
 All sharps
 Miscellaneous items that are not
radiopaque and/or are small enough to
be retained
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Counting Process
 Baseline count will be performed before
the delivery pack is used (if soft goods
or sharps are part of the pack).
 Additional count is performed when:
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Countable items are added to the surgical
field
Permanent relief of the L &D nurse
Whenever a member of the team has a
concern about the accuracy of the count
At the end of the delivery
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Imaging
 A radiographic image must be obtained
when:
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The count cannot be reconciled
The count is compromised
A member of the team is concerned about
the accuracy of the count
 The radiographic image must:
• Be of good image quality and resolution
• Include the entire anatomic area of the
patient
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Special Considerations
 If the mother is transferred to the c-
section room; any items that have been
placed in the genital tract must be
documented in the record and
communicated to the c-section team.
 When the genital tract is intentionally
packed post delivery; it is important to
document the number, type and location
of the packing.
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Implementation Strategies
 Use a standard count sheet.
 Only drop sponges you want to count
(i.e. don’t use sponges for wiping the
perineum).
 Identify a basin to hold used
radiopaque sponges/soft goods.
 Counting is done by two people –
together and out loud. One must be an
RN.
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Implementation Strategies
 Create a mechanism for educating
staff, providers and residents, if
applicable.
 Ensure you have full support from the
hospital and department leadership.
 Establish, teach and enforce RED
RULES.
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Definition of a Red Rule
 RED RULES are created to enforce key
steps in a process that are to be
followed every time except in very rare
situations.
 Failure to comply with a RED RULE has
been determined to be risky behavior
that can place the patient at high risk for
an undesirable outcome.
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Suggested Red Rules
 Sponges and sharps will be counted
for every vaginal delivery.
 Only radiopaque sponges/soft goods
will be in the delivery field.
 When the count can not be
reconciled, a radiographic image will
be obtained.
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Reporting RFOs
 An object is defined as retained (RFO),
and thereby reportable, if it is found
after the end of the immediate
recovery period (one to two hrs post
delivery).
 Any time an unintentionally retained
foreign object is recovered, it should
be reported to the organization that
performed the procedure.
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Measurements of Success
 Outcome Measure
 Rate or number of unintentionally retained
foreign objects during a vaginal delivery.
 Process Measures
 Percentage of vaginal deliveries during
which an adequate baseline count was
conducted.
 Percentage of cases where counts could
not be reconciled and imaging was/was not
performed.
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Protocol Next Steps
 Protocol is up for review and revision
later this month.
 Suggestions for improvement,
additions, and/or changes?
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Contact Cally Vinz with ICSI at:
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Cally.Vinz@ICSI.org
Office Telephone # 952-814-7068
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Questions?
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