THE CASES
The first case involves a 34-year-old patient who had a vaginal delivery of her fifth child which was complicated by post delivery bleeding. The patient had an estimated blood loss of 1,000 ml and was noted to have tears in both the vaginal wall and the cervix. Bleeding was controlled by packing and repairs were performed. Post delivery the patient was transfused with two units of packed blood cells and carefully monitored. On post delivery day three, the patient was discharged home. On post delivery day ten the patient presented to the Emergency Department with complaints of abdominal pain and discharge. A pelvic examination revealed a retained absorbent pad and infection. The patient was given antibiotics and a follow-up appointment with her OB/GYN.
The second case involves a 29-year-old patient who had an uneventful vaginal delivery with a minor episiotomy repair. The postpartum progress notes stated the needle count was off with a 3-0 needle missing and post-delivery x-ray of the pelvis and perineum was interpreted as “no metallic foreign object, like a needle, seen in the pelvis”. The patient was discharged and began experiencing abdominal pain within six months. A “retained needle” was diagnosed by CT scan at another facility three years after the episiotomy repair.
The third case involves a 33-year-old who underwent her fourth Cesarean section in May 2007. The surgery was uneventful and nurses documented a first, second, and “final” count all as correct. Approximately four months later, the patient began experiencing abdominal pain. An ultrasound revealed nothing and still the pain persisted, so a CT scan was performed. The CT showed a collection of fluid, possible abscess and a retained foreign object. Six months after the Cesarean, the patient returned for an exploratory laparotomy due to an abdominal-pelvic mass. Surgery revealed a retained lap sponge which upon pathological review was described as “sponge with a blue tail weighing 108 grams and measuring 31 cm X 31 cm”. The patient was discharged home on post-op day two with pain medications and antibiotics.
Case Commentary
These cases from the CHI files are good examples of the vulnerability of obstetrical patients to Retained Foreign Objects (RFO). A RFO is one of the most commonly reported hospital adverse events, but what is surprising is that not only are most of these retentions occurring in our delivery units, but this is a problem that has been occurring for years.(4)
Other states with similar mandatory adverse health event reporting laws have demonstrated similar data. According to the Minnesota Adverse Health Events Reporting System, “a quarter of all retained foreign objects between 2003 and 2008 happened during obstetrical procedures, with nearly all of those cases involving vaginal deliveries.”(3)
THE SCOPE OF RFO IN VAGINAL DELIVERIES
According to the Institute for Clinical Systems Improvement, Prevention of Unintentionally Retained Foreign Objects During Vaginal Deliveries, November 2009: a RFO in a vaginally delivered patient is “an object unintentionally retained after the end of the immediate recovery period (one-two hours post-delivery) which does not include packing intentionally placed for the control of hemorrhage”.(4)
Why would there be such a high number of RFOs in obstetrics? In reviewing the guidelines from the Institute for Clinical Systems Improvement for prevention of RFO in vaginal deliveries, the following factors were extrapolated.
1) No agreed upon definition of “retained foreign object” and the associated items/process.
2) No standardized method for tracking baseline, ongoing and final counts.
3) No designated receptacle in the patient room for used sponges and soft goods.
4) Lack of training on who should count and how to count.
5) Inconsistency in what is counted.
6) Allowing other items besides radiopaque sponges/soft goods on the Labor and Delivery trays or entering the delivery field.
Add to these factors the weight of the patient, the arrangement of the room, the number of family members in the room, the amount of equipment in the room and the delivery activities, and you have a process with far less control than a surgical procedure.
The California Department of Public Health (CDPH), statistics from July 2007 – December 2009 show RFO accounted for 14% of the reported events in California; second only to Stage 3 or 4 decubitus ulcers acquired after hospital admission.(1)
Had we provided more details from the discovery phase of these cases, this article could focus on various topics identified such as communication, training, fatigue, scheduling, the environment, policies and cultural barriers.
However, our prevention and performance improvement strategies in this issue will focus on the regulations for reporting these events and recommendations to prevent RFO in obstetric patients with vaginal deliveries.
REGULATORY REQUIREMENTS
In 1995, The Joint Commission (TJC) began requiring accredited organizations to define “sentinel events” and establish mechanisms to identify, report, and manage these events. Part of the management includes conducting a timely, thorough, and credible root cause analysis (RCA). TJC established a minimum scope for analysis with each type of sentinel event and clarified in their FAQ’s that a retained sponge after a vaginal delivery is a reviewable sentinel event, thus requiring a root cause analysis.
RCA Focus for RFO
• Staffing levels
• Orientation and training of staff
• Competency assessment and credentialing
• Supervision of staff
• Communication among caregivers
From: The Joint Commission RCA Matrix
In 2002, the National Quality Forum (NQF) defined a list of patient safety events that pose serious harm to patients, but should be considered entirely preventable. This list of “Never 27 Events” was refined and expanded in 2006 to a list of 28.(8) The events were grouped into six categories; surgical, product or device, patient protection, care management, environmental and criminal; and again include the retained foreign object.
In October 2008, the Hospital Acquired Conditions (HAC) initiative for Centers for Medicare and Medicaid (CMS) listed eight preventable conditions for which CMS would no longer make payments to hospitals. Payments are denied for the increased cost of care that results when a patient is harmed and that has been determined to be reasonably preventable by following generally accepted guidelines. Hospitals are required to identify these cases on cost reports. Retained foreign object is included in this list.
Legislation-Mandatory Reporting
To date, 28 states require some type of mandatory reporting for “never events” as part of legislation to improve patient safety. California requires the reporting of unusual occurrences which threaten the welfare, safety, or health of patients. Legislation was enacted in 2006 to codify reporting of adverse events, beginning in July 2007. This legislation requires reported events and the outcome of investigations or inspections of substantiated adverse events to be made readily accessible to consumers by January 2009 and posted on the state Department of Health Services’ web site.
According to California law SB 1301, there are 28 adverse events defined by the Health and Safety Code, Section 1279.1 (b) (1) – (7) which include surgical events such as: “Retention of a foreign object in a patient after surgery or other procedure, excluding objects intentionally implanted as part of a planned intervention and objects present prior to surgery that are intentionally retained”. In California, a facility has five days after an adverse event is detected to report such an event to the CDPH.
In Nevada, the Nevada State Health Division is responsible for maintaining a Sentinel Events Registry through its Bureau of Health Planning and Statistics. Assembly Bill 1 (AB1) was passed during the 2002 18th Special Legislative Session and requires mandatory reporting of sentinel events. This was incorporated into the Nevada Revised Statute (NRS) 439,800-890 and Nevada Administrative Code (NAC) 439.900-920. According to Nevada law, each facility has 14 days after identifying a sentinel event to report to the Health Division of Nevada.
Adverse Event Reporting
California: http://www.nashp.org/pst-state-list/610
Nevada: http://www.nashp.org/pst-state-list/624
Patient Safety States: http://www.nashp.org/pst-state-list/622
Malpractice Statutes & Defense
According to Cal. Civ. Proc. Code § 340.5 (West 1992) a medical malpractice action for injury or death must be brought within one year from the date the claimant discovered the negligent act, but no more than three years from the date of injury. The statute is tolled until the claimant discovers or should have discovered the injury. The exception is retained foreign bodies. Ashworth v. Memorial Hospital of Long Beach, 206 Cal. App. 3d 1046, 254 Cal. Rptr. 104 (1988), rehearing denied, March 12, 1989.
In Nevada, action is required within four years from the date of injury, or two years from the date the injury was or should have been discovered, whichever was earlier. Nev. Rev. Stat. Ann. 41A,097 (Michie 1996).
As to defending the case with a RFO, the common law theory of res ipsa loquitor or “the thing speaks for itself” is applicable in cases involving the RFO, and renders them nearly indefensible.
Another doctrine often applicable to the RFO case is “captain of the ship” which deals with the surgeon’s responsibility for removal of sponges and devices at the end of the procedure versus that of the involved nurses.
GUIDELINES FOR PREVENTION
Rather than try to assess responsibility for liability, we recommend health care providers approach each case as a team. Dr. Atul Gawande recognized this several years ago and in collaboration with The World Health Organization launched the Safe Surgery Saves Lives campaign. This program involves implementation of a surgical safety checklist which includes complete sponge, instrument, and needle counts before the patient leaves the operating room.(8) The checklist can be found at www.who.int/patientsafety/safesurgery/en/.
The American College of Surgeons (ACS) issued a statement of policy in 2005 designed to prevent the retention of sponges, sharps, instruments and other items for all types of surgical patients.
In 2005, the Association of periOperative Registered Nurses (AORN) also updated practices which are intended as guidelines for sponge, sharp, and instrument counts which are adaptable to various practice settings.
ACS and AORN Recommendations can be found in the inserts.
Getting to Zero
In Minnesota, the hospital association has begun eliminating various types of health care events. Their Call to Action projects have addressed pressure ulcers, falls, wrong site, wrong patient, wrong procedures, and RFO. The 2008 “Safe Count” project was directed towards obstetrical vaginal deliveries and the 2009 “Safe Account” project addresses all other types of RFO.
The SAFE COUNT Tool Kit and some other tools are available from the Minnesota Hospital Association web site. The tools include:
--SAFE COUNT Training Video
--7 slide presentations covering best practices, human factors, physician perspective and implementation
--The tool kit, which includes:
• Staff education: PowerPoint and video
• Sample policies/procedures
• Communication considerations
• Counting sheets
• Audit tools
Details are available at the Minnesota Hospital Association Patient Safety: Safe Count Call to Action at www.mnhospitals.org/index/tools-app. Once you are at the web site, go to Priority Issues ? Patient Safety. In the far right green column is Calls to Action. Enter SAFE COUNT, then the “More” button to reach the tool kit.
By using process improvement methods and tools, outlining roadmaps for change, and bringing hospitals and surgical centers together, Minnesota is learning, sharing best practices and reducing RFO.
SUMMARY
All improvement efforts which ultimately reduce risk require communication, teamwork and leadership. CHI members are encouraged to use the resources mentioned in this article and in the inserts.
Each Labor and Delivery “team” will have to work together to implement a protocol, standardize methods for counting such as worksheets or whiteboards, dedicate receptacles to achieve count accuracy, and utilize ongoing training, measurement and feedback to enhance safety and reduce liability.
References:
1. Billingsley, K. California Center for Healthcare Quality, Adverse Event Reporting Presentation. January 2010.
2. Adverse Health Events in Minnesota, Sixth Annual Public Report. January 2010.
3. Spotlight on Patient Safety: Data Trends, and Learning from the Minnesota Adverse Health Events Reporting System. April, 2009.
4. Prevention of unintentionally retained foreign objects during vaginal deliveries. Health care protocol. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); Third Edition, November, 2009.
5. Gawande, A., Studdert, D., Orav, E., Brennan, T., and Zinner, M. Risk Factors for Retained Instruments and Sponges After Surgery. The New England Journal of Medicine. 348(3), 229-235; 2003.
6. Rosen, A, et al. “Evaluating the Patient Safety Indicators: How Well Do they Perform on Veterans Health Administration Data?” Medical Care 43:9; September 2005.
7. Pennsylvania Patient Safety Authority: 2008 Annual Report. April 30, 2008.
8. World Health Organization: Safe Surgery Saves Lives Campaign Tols & Resources Available: http://www.who.int/patientsafety/safesurgery/en/
INSERT #1 – Retained Foreign Objects- OB
RECOMMENDATIONS
Association of periOperative Registered Nurses (AORN)
• Sponges should be counted on all procedures in which the possibility exists that a sponge could be retained.
• Sharps and other miscellaneous items should be counted on all procedures.
• Instruments should be counted for all procedures in which the likelihood exists that an instrument could be retained.
• Additional measures for investigation, reconciliation, documentation, and prevention of retained surgical items should be taken.
• Sponge, sharp, and instrument counts should be documented on the patient’s intraoperative record by the registered nurse circulator.
• Policies and procedures for sponge, sharps, and instruments counts should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting.
“Recommended practices for Sponge, Sharp, and Instrument Counts,” 2009 Perioperative Standards and Recommended Practices (Denver: AORN, Inc., Last Revised: 2005) 405-413
American College of Surgeons (ACS)
• Consistent application and adherence to standardized counting procedures.
• Performance of a methodical wound exploration before closure of the surgical site.
• Use of x-ray detectable items in the surgical wound.
• Maintenance of an optimal OR environment to allow focused performance of operative tasks.
• Employment of x-ray or other technology (e.g., radiofrequency detection, bar coding) as indicated, to ensure there is no unintended item remaining in the operative field.
• Suspension of these measures as required in life-threatening situations.
From: Statement on the prevention of retained foreign bodies after surgery. Bulletin of the American College of Surgeons Vol. 90, No. 10, October 2005
The Institute for Clinical Systems Improvement (ICSI) has developed a protocol for the Prevention of Unintentionally Retained Foreign Objects During Vaginal Deliveries(4); this protocol provides aims, measures, implementation recommendations, resources and tools to aid health care in the elimination of RFO. Also included are “red rules” which are key rules to prevent or address specific actions which pose the high risk to patients and must be followed consistently and accurately each and every time.
INSERT #2 – Retained Foreign Objects - OB
Institute for Clinical Systems Improvement (ICSI)
An excellent publication on preventing unintentionally retained foreign objects during vaginal deliveries can be found at the website for the Institute for Clinical Systems Improvement, www.icsi.org. The following checklists summarize the ICSI’s recommendations. Red rules are used to address actions that pose the highest risk to the patient or staff. Red rules must be followed consistently and accurately each time. The reader is encouraged to go to the web site to obtain details on protocol.
Checklist for Implementation of Protocol
• Definitions have been standardized and agreed upon between nursing and the medical staff.
• Special considerations for the protocol and the steps to follow have been defined.
• A standardized method has been determined for tracking counts.
• The protocol requires baseline, ongoing and final counts.
• A dedicated receptacle/location is used for all used sponges/soft goods.
• Counting is completed by an RN and another person.
• Red rules include the following:
o All sharps and sponges will be counted for every vaginal delivery.
o Only radiopaque sponges/soft goods will be present on L&D trays or enter the delivery field.
o If the count cannot be reconciled, imaging must be done.
• Implementation of the protocol requires active support from administration and the medical staff.
• There are processes for ongoing training, measurement and feedback for all involved staff.
• Count practices are audited for performance improvement and trends are used for ongoing training, measurement and feedback.
Checklist for Protocol
• Open applicable pack in anticipation of vaginal delivery.
• Obtain baseline count by counting and documenting all countable items in the applicable pack.
• Count and document all countable items added to the delivery field at the time that they are added.
• For situations where patient is moved out of the delivery room, count is considered compromised. If there is no time to complete count process, obtain radiographic imaging for possible retention.
• Complete final count before provider leaves room.
• Items left intentionally in a patient will be documented on the procedure record.
• Items dropped during the procedure are retrieved, shown to the counter and kept away from the delivery field.
• No countable items are removed from the L&D area until all counts have been performed and reconciled.
• A reconciliation process is followed for count discrepancy.
• For unreconciled counts, the attempts to reconcile and outcome are documented according to policy.
Prevention of unintentionally retained foreign objects during vaginal deliveries. Health care protocol. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); Third Edition, November, 2009.
[
TOP ]
Contact Us