Protocol for the Prevention of Unintentionally Retained Foreign Objects During Vaginal Deliveries April 30, 2008 MHA Call to Action

Presenters n Carol Clark, MSN, RN l Protocol work group member l Nurse Manager Labor & Delivery, Fairview Health Services n Stephanie Lach, MSN, MBA, RN l Protocol work group leader l Patient Safety Director at Regions Hospital

Protocol Principles Patient safety is at the top of every hospital’s priority list. Any one of us can make a mistake that could lead to an undesirable patient outcome. Establish best practice. Collaborate rather than compete. Every process when implemented will achieve a result - good or bad.

Protocol Objectives Create a best practice for prevention of unintentionally retained items that can be used in any hospital. Provide concrete guidance on how to implement and measure the protocol. Address the high number of retained sponges reported to the Minnesota AHE registry.

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.

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 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

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 c- section and labor rooms.

Protocol Scope n To develop a step by step process designed to prevent the unintentional retention of a foreign object in a patient undergoing a vaginal delivery. n Key protocol steps include: Counting Reconciling counts Using radiographic imaging

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.

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.

Countable Items All sponges/soft goods All sharps Miscellaneous items that are not radiopaque and/or are small enough to be retained

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 : 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

Imaging n A radiographic image must be obtained when: 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

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.

Implementation Strategies n Use a standard count sheet. n Only drop sponges you want to count (i.e. don’t use sponges for wiping the perineum). n Identify a basin to hold used radiopaque sponges/soft goods. n Counting is done by two people – together and out loud. One must be an RN.

Implementation Strategies n Create a mechanism for educating staff, providers and residents, if applicable. n Ensure you have full support from the hospital and department leadership. n Establish, teach and enforce RED RULES.

Definition of a Red Rule n RED RULES are created to enforce key steps in a process that are to be followed every time except in very rare situations. n 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.

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.

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.

Measurements of Success n Outcome Measure l Rate or number of unintentionally retained foreign objects during a vaginal delivery. n Process Measures l Percentage of vaginal deliveries during which an adequate baseline count was conducted. l Percentage of cases where counts could not be reconciled and imaging was/was not performed.

Protocol Next Steps Protocol is up for review and revision later this month. Suggestions for improvement, additions, and/or changes? Contact Cally Vinz with ICSI at: Office Telephone #

Questions?