Note from the National Guideline Clearinghouse (NGC) and the Institute for Clinical Systems Improvement (ICSI): For a description of what has changed since the previous version of this protocol, refer to Summary of Changes Report– September 2008.

The recommendations for prevention of unintentionally retained foreign objects during vaginal deliveries are presented in the form of a protocol and an algorithm with 12 components, accompanied by detailed annotations. An algorithm is provided for Prevention of Unintentionally Retained Foreign Objects during Vaginal Deliveries. Clinical highlights and selected annotations (numbered to correspond with the algorithm) follow.

Class of evidence (A-D, M, R, X) definitions are provided at the end of the "Major Recommendations" field.

Clinical Highlights

• Sponges/soft goods, sharps and miscellaneous items will be counted for vaginal deliveries. (Annotation #2, Aim #1)
• Sponges/soft goods with radiopaque markers are the only soft goods that will be present on the delivery field. (Annotation #2, Aim #1)
• Establishing an accurate baseline count is the most critical step in the count process. If the baseline count is not accurately performed before using any countable items, all subsequent counts should be considered compromised. A radiograph shall be obtained prior to the conclusion of the procedure to ensure that a foreign object has not been unintentionally retained. (Annotation #2, Aim #1)
• Good communication is necessary before and during the procedure, when staff changes and/or at hand-offs (e.g., transitioning to the operating room). (Annotation #2, Aim #1)

Special Considerations

• Temporary Packing of the Genital Tract After a Vaginal Delivery and Beyond the Immediate Recovery Period – When the genital tract is packed post-delivery and the packing is intentionally kept in place beyond the immediate recovery period (one to two hours after delivery), the risk for an unintentionally retained foreign object increases. Strict adherence to the count process and documentation of all packed materials are important for the prevention of an unintentionally retained item. Imaging is recommended only when the final count cannot be reconciled.
• Equipment Components – It is important to conduct an examination of all equipment used during the procedure to ensure that the equipment is intact and no incidental pieces of equipment are retained.

Labor and Delivery Retained Foreign Objects Prevention Protocol Annotations

1. Open Applicable Pack in Anticipation of Vaginal Delivery

   Organizations may elect to have distinct delivery packs for routine versus precipitous deliveries considering the variation with respect to these presentations. Additionally, it is recommended that facilities consider the financial and logistical benefits of not including countable items in the delivery packs.

2. Baseline Count – Count and Document All Countable Items in the Applicable Pack

   The timing and frequency of the count process in Labor and Delivery are different from the process in the surgical suite. Frequently, countable items are not used during or after a delivery. Items that are not opened during the delivery do not need to be counted.

   The counting recommendations outlined in this protocol are based on consensus statements and guidelines of American College of Obstetricians and Gynecologists and the American Academy of Pediatrics. In addition, articles on communication, teamwork, multitasking and interruptions and their relationship to unanticipated events were referenced. This protocol has identified staff responsible for various steps based on their scope of practice and licensing requirements. Direct and explicit language (e.g., will, must) has been incorporated to reduce variation and to identify the steps of the protocol where variation could significantly increase the risk for an unintentionally retained object [C], [D], [R], [NA].

   Accurately accounting for all items that could potentially become unintentionally retained is a shared responsibility of the entire Labor and Delivery team. The ultimate responsibility for prevention of an unintentionally retained object lies with the provider performing the procedure.

   What Items Will Be Included in the Count Process:

   It is the work group's recommendation that all non-radiopaque items on the delivery tray or within the delivery field be counted. In addition, the following items will be counted:

   Sponges/soft goods: Sponges/soft goods will be counted for all procedures when they are used. Furthermore, only radiopaque sponges/soft goods will be present on the delivery tray or within the delivery field [R].

   RayTec/laparotomy sponges will not be cut into pieces [R].

   Best practice is that radiopaque sponges/soft goods when placed in the genital tract should have a detection "tail" that can be clipped to the patient's drapes [R].

   Sharps: Sharps will be counted for all procedures when they are used [R].

   Miscellaneous items: Miscellaneous items will be counted for all vaginal deliveries [R].

   When the Count Process Will Be Performed [R]:

   • The baseline count will be conducted immediately before the delivery tray is used [R].
   • At the end of the delivery:
     • For sharps, the final count will be performed at the end of the case by counting each sharp that is placed into a needle box by the provider.
     • For sponges/soft goods and miscellaneous items, the final count will be performed at the end of the procedure by counting each item that was placed into the designated basin [R]. Sponges/soft goods WILL NOT be placed in the container that is used to collect and manage body fluids during the delivery until after the final count has been performed and reconciled.
     • If the delivering provider is called away for an emergency but anticipates returning before the end of the immediate recovery period (one to two hours), the final counts can be completed when the delivering provider returns.
   • Anytime a member of the Labor and Delivery team has concerns about the accuracy of the count, even when the counts appear correct.
   • Whenever there is a permanent staff change of the Labor and Delivery nurse.
     • All visible items will be counted and all items in use in the delivery field will be accounted for.

   When a count is not required:

   • If there is a permanent change in a member of the Labor and Delivery team other than the nurse, a structured handoff is required but a count is not.
   • When the Labor and Delivery nurse change is for a short duration (e.g., lunch break), a structured handoff is required but a count is not.

   How the Count Process Will Be Performed:

   • Two individuals, one of whom will be a registered nurse (RN), will directly view and verbally count each item. These individuals must be trained in the counting process [R]. The second person may be another registered nurse, the provider, a Labor and Delivery technician, or a nursing assistant.
   • Distractions and interruptions should be minimized during the count process [R]. If the count process is interrupted, the count will start over.
   • Sponges/soft goods, and sharps, when opened, will be counted prior to entering the delivery field.
   • The Labor and Delivery nurse will document the number and type of sponges/soft goods, sharps, and miscellaneous items on the preformatted count sheet or whiteboard. The other person involved in the count process will confirm the number.

     The work group does NOT recommend keeping two concurrent count records.

   • Sponges/soft goods will be separated and counted individually [R].
   • Every sponge/soft good will be visually inspected to verify that the radiographic-detectible indicator is present [R].
     • If the indicator is not present, the entire package of sponges/soft goods will be removed from the room and given to the designated person for follow-up with the manufacturer [R].
   • Packages where the labeling on the package does not match the number of items in the package will be removed from the room and given to the designated person for follow-up with the manufacturer [R].
   • Sponges/soft goods used by anesthesia will not enter the delivery field or be mixed in with sponges/soft goods used and counted for the delivery process.
   • Used sharps will be counted at the end of the procedure by counting each sharp as it placed into a needle box by the provider. The count is verbally confirmed by the Labor and Delivery nurse and documented on the count sheet.
   • Used sponges/soft goods will be placed in the designated basin and NOT in the container that is used to collect and manage body fluids during Labor and Delivery until after the final counts have been performed and reconciled.
   • Used sponges/soft goods will be separated, unballed and/or pulled apart to aid the count process.
   • Sponges/soft goods will be counted at the end of the procedure [R]. The count will be verbally confirmed by the Labor and Delivery nurse and documented on the count sheet.
   • All sharps and miscellaneous items, such as fetal scalp electrodes, will be inspected for broken or missing pieces.
   • Any items dropped during the procedure will be retrieved, shown to the person responsible for counting, and isolated from the delivery field.
   • Any items intentionally left in a patient will be documented on the procedure record.

4. Obtain Radiographic Imaging for Potential Retained Foreign Object

   Radiographic imaging, whether a portable image obtained in the Labor and Delivery room or a post-delivery image obtained in a radiographic room, is not a substitute for performing an accurate count process and methodical genital tract exploration [R].

   Portable radiographic imaging can be used to exclude the possibility of a retained foreign object. Portable radiographic imaging has limitations that need to be considered.

   The highest quality radiographic imaging is obtained in a radiographic room with fixed radiographic equipment and moving grid.

   Portable Radiographic Imaging Considerations and Limitations

   • Patient condition
   • Size and type of retained item
   • Whether the item is radiopaque
   • Limited placement options of the radiographic film cassettes under the Labor and Delivery table limiting the field included on the radiographic image
   • Lower tube power with portable radiographic imaging equipment
   • Availability of portable radiographic imaging equipment and staff

   Portable radiographic imaging should be obtained when:

   • Counts cannot be reconciled
   • The patient's condition does not allow for the count process to be followed (rushed counts, incomplete counts)
   • A member of the Labor and Delivery team has a concern about the accuracy of the count

   Radiographic imaging requests include the following information:

   • Callback number and physician name
   • Location and status of patient (e.g., in post-delivery recovery, transferred to the Caesarean room)
   • Number and type of item missing
   • Details of the delivery, as appropriate

   If a nurse midwife is the delivering provider, a physician will be consulted to provide immediate interpretation of radiographic image.

   Before a radiologist interprets the radiographic images:

   • The radiology technologist will review the radiographic image for quality and repeat the imaging as necessary
   • The physician will review the radiographic image to check for adequate anatomic coverage of the genital tract, prior to the film being sent to the radiologist for interpretation

   If the physician is unable to verify adequate anatomic coverage on the portable image, a radiographic image in a radiographic room with fixed equipment and moving grid should be obtained as soon as the patient is stable enough to tolerate transfer.

   The work group recommends that the radiologist and physician simultaneously review the radiographic image both verbally and visually to correlate the anatomical coverage of the images as well as a description of the potentially retained foreign object.

   The films should be reviewed before the end of the immediate recovery period (one to two hours).

   If a radiologist is not immediately available, the preliminary interpretation of the radiographic images used to identify a potentially retained foreign object is the responsibility of the physician.

   Post-delivery radiographic imaging in a radiographic room with fixed equipment and moving grid should be obtained as soon as possible when there is a discrepancy in the counts and:

   • The patient's condition did not allow for a portable radiographic image to be obtained
   • The entire anatomic area could not be included on the portable radiographic image
   • The portable radiographic image failed to locate the potentially retained foreign object and the count could not be reconciled

   Final reporting of radiologic imaging results should be completed in accordance with appropriate state and federal requirements [R].

5. Were Additional Countable Items Added?

   Countable items: Any item that could be unintentionally left behind after a vaginal delivery and is subject to the count process. This includes:

   • Miscellaneous items: Includes fetal scalp electrodes, intrauterine pressure catheters, non-radiopaque items such as umbilical tapes, vacuum sponges and other small items.
   • Sharps: Items with edges or points capable of cutting or puncturing through other items. In the context of a vaginal delivery, sharps include, but are not limited to, suture needles and hypodermic needles.
   • Sponges: Soft goods such as gauze pads, vaginal packs or laparotomy sponges used to absorb fluids, protect tissues or apply pressure or traction.
   • Tucked sponge: Refers to any soft good that is used to stop bleeding or absorb liquid, or used in conjunction with an instrument or the practitioner's hand to obtain traction and that is left in location for a period of time.

6. Count and Document All Countable Items Added to the Delivery Field at the Time They Are Added

   If additional soft goods and/or sharps are needed, they will be opened and counted in the same manner as the original count prior to being placed on the delivery field. Additional counted items will be added to the original count sheet or white board. Final count will equal original counted items plus all added items.

8. Is Patient Moved Out of Labor Room?

   Emergency Transfer to Surgery During or Immediately After a Vaginal Delivery

   When a mother's and/or fetus's condition becomes critical during the delivery, or the mother's condition becomes critical immediately following a vaginal delivery and transfer to surgery is required, there may not be adequate time for staff to perform the final vaginal delivery count. In this situation, all counts are considered compromised and the mother is at increased risk for a retained foreign object. If the mother's condition allows, intra-operative imaging should be obtained to rule out the possibility of an unintentionally retained foreign object.

   Any countable items used during the vaginal delivery that accompany the patient to surgery will need to be documented in the patient's record and verbally communicated to the surgical team.

   Note: Not all transfers to surgery are emergent, and there may be ample time to perform and reconcile the vaginal delivery final count. The subsequent surgical procedure is considered separately from the vaginal delivery procedure and the count process recommended for surgery is to be used. Non-emergent transfers to the operating room from Labor and Delivery do not create an increased risk for the unintentional retention of a foreign object.

10. Final Count – Perform Final Count

    The final count should be performed before the provider leaves the room. If the delivering provider is called away for an emergency but anticipates returning before the end of the immediate recovery period (one to two hours), the final counts can be completed when the delivering provider returns. If the provider is not available for the final count, the count will be completed by two members of the Labor and Delivery team who have been trained in the counting process. One member of the final count team will be a Registered nurse. Refer to Annotation #2, "Baseline Count – Count and Document All Countable Items in the Applicable Pack" for additional counting information.

    • No sponges/soft goods, sharps or miscellaneous items will be removed from the Labor and Delivery area until all counts have been performed and reconciled [R].
    • Countable items that accompany the infant out of the Labor and Delivery area will be communicated to the Labor and Delivery nurse and documented on the count sheet [R].
    • After all counts have been reconciled, all delivery tray items will be removed from the Labor and Delivery area before setup begins for the next procedure.

11. Able to Reconcile Count?

    Reconciliation Process for a Count Discrepancy

    When a discrepancy is identified, the Labor and Delivery nurse reports the number and type of missing item to the provider. If the mother's condition permits, the delivery should not be considered finished until all steps to reconcile the counts are exhausted [R]. The reconciliation process needs to be completed before the end of the immediate recovery period (one to two hours).

    The work group recommends that organizations develop a process of communication that includes specific phrases for conveying to the other team members that there may be a potentially retained foreign object. This communication process should include phrases that indicate, and increase in, urgency as the reconciliation steps are followed. The reconciliation process needs to be performed before the provider leaves the room at the conclusion of the case and before the end of the immediate recovery period (one to two hours). If the provider is called away for an emergency but anticipates returning, the reconciliation process can be completed when the provider returns.

    The following steps should be performed if the mother's condition permits [R]:

    • A visual inspection of the Labor and Delivery suite, including a visual inspection of the area surrounding the delivery field, the floor, linens, and trash receptacles.
    • The count is repeated and verified. A discrepancy must never be resolved by using the number listed on opened packages.
    • Special attention should be paid to items that can stick together, such as sponges/soft goods. Sponges/soft goods will be unballed and separated for counting.
    • The genital tract should be explored, with special attention paid to the location of where that particular item may be retained [R].

    If the counts cannot be reconciled:

    • Post-delivery imaging should be obtained if counts cannot be reconciled [R].
      • The physician and/or radiologist should review the films before the end of the immediate recovery period (one to two hours). See Annotation # 4, "Obtain Radiographic Imaging for Potential Retained Foreign Object."

    Unreconciled count:

    • If the count cannot be reconciled after all the steps above are taken, all the measures taken and the outcomes of those steps will be documented per the organization's policy.

Definitions:

Classes of Research Reports:

1. Primary Reports of New Data Collection

   Class A:

   • Randomized, controlled trial

   Class B:

   • Cohort study

   Class C:

   • Non-randomized trial with concurrent or historical controls
   • Case-control study
   • Study of sensitivity and specificity of a diagnostic test
   • Population-based descriptive study

   Class D:

   • Cross-sectional study
   • Case series
   • Case report

2. Reports that Synthesize or Reflect upon Collections of Primary Reports

   Class M:

   • Meta-analysis
   • Systematic review
   • Decision analysis
   • Cost-effectiveness analysis

   Class R:

   • Consensus statement
   • Consensus report
   • Narrative review

   Class X:

   • Medical opinion

A detailed and annotated clinical algorithm is provided for Prevention of Unintentionally Retained Foreign Objects during Vaginal Deliveries.

ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675; e-mail: icsi.info@icsi.org; Web site: www.icsi.org.

ICSI's conflict of interest policy and procedures are available for review on ICSI's website at www.icsi.org.

Electronic copies: Available from the Institute for Clinical Systems Improvement (ICSI) Web site.

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675; Web site: www.icsi.org; e-mail: icsi.info@icsi.org.

• Development and revision process for guidelines, order sets, and protocols. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2007 Jun. 5 p. Electronic copies: Available from the Institute for Clinical Systems Improvement (ICSI) Web site.

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675; Web site: www.icsi.org; e-mail: icsi.info@icsi.org.

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