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Root Cause Analysis & Action (RCA2): Unintended Retained Foreign Objects

Student Name
NURS 452: Leadership & Management in Professional Nursing
Kathleen J. Griffith, MSN, RN, HACP
March 21, 2021

This RCA2 exemplar content may not be utilized, paraphrased, quoted, cited,
or referenced in student work.
Content in blue is provided for student guidance/instruction to complete the required elements
and suggest content integration from Module 3 Marquis & Huston (2021) assigned reading.
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Root Cause Analysis & Action (RCA2): Unintended Retained Foreign Objects

Introduction (No header). Succinct introduction to root cause analysis & action (RCA2).

Discuss the significance of conducting a RCA2 and the impact on a culture of safety and

prevention of future harm (1-2 paragraphs).

A 63-year-old male, Mr. R., was scheduled to undergo an open thoracotomy for right

upper lobectomy for primary lung cancer. Nurse M, Circulator RN, and Surgical Scrub

Technologist J are assigned to the case. The Surgical Scrub Technologist and Circulator RN

perform the initial count of sponges, needles/sharps, miscellaneous items, and surgical

instruments following established policy and procedure prior to the patient being brought into the

operating room (OR). Nurse M records the count on the White Board in the room following

established count policy and procedure. The patient undergoes the scheduled procedure as

scheduled; however, experienced unexpected significant bleeding during the procedure requiring

emergency measures be implemented. Counts were conducted during the procedure when new

items were added during the bleeding episode, when the surgical cavity closure began, and at

skin closure. All counts were correct, recorded, and announced as correct by the Nurse M. The

patient was transferred to the Surgical Intensive Care Unit (SICU) immediately following the

procedure, intubated, with a chest tube, central line, and multiple intravenous infusions including

propofol for sedation and ventilator synchronization. A postoperative chest x-ray performed in

SICU revealed a unintended retained foreign object (URFO)—a surgical sponge. The URFO was

disclosed to the Mr. R’s family. Informed consent was obtained. The patient was taken back to

the OR for removal of the URFO.

The Director of Risk Management, Chief Executive Officer, Chief Nursing Officer, and

Chief Medical Officer were notified immediately by the Director of Surgical Services. The
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Director of Risk Management initiated an investigation in preparation for the Root Cause

Analysis and Action (RCA2) and potential reporting to external regulatory and accrediting

agencies.

Background

URFO (e.g., sponges, needles/sharps, equipment/supply fragments, surgical instruments)

is a preventable serious safety event—a sentinel event. Surgical sponge, needles/sharps, and

instrument counts are the first line of defense in preventing URFO (Norton et al., 2012). In

operative and invasive procedures with pocket creation (e.g., permanent pacemaker procedures),

a count discrepancy may lead to URFO (Norton et al., 2012). In fact, URFO is 100 times more

likely when there is a count discrepancy (Norton et al., 2012). Risk factors for URFO include

emergency surgery, unexpected changes in procedure, higher body mass index, breakdown in

communication, multiple major procedures simultaneously, and incorrect sponge and instrument

count (Norton et al., 2012).

URFO is the most frequently reported sentinel event to The Joint Commission (TJC);

URFO events occur one in every 5,550 surgeries (Steelman et al., 2018). URFO cause patient

harm including return to surgery for reoperation, readmission, increase inpatient length of stay,

infection and sepsis, fistulas, bowel obstruction, visceral perforation, and death leading to an

increase in the cost of care (TJC, 2013; Steelman et al., 2018). According to TJC (2013), sponges

and towels, small miscellaneous items and device components or fragments, guidewires, needles

and other sharps and instruments are the most common URFO. The number one URFO is

retained cotton gauze sponges (48%-69%) and result in a more serious tissue reaction than metal

fragments (Steelman et al., 2018). By location, the majority of UFRO occur in the abdomen and
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pelvis (50.2%) followed by vagina (23.9%), chest or mediastinum (8.5%), and finally the breast

or pocket for pacemaker insertion (4.6%) (Steelman et al., 2018).

Human factors contribute to sentinel events such as URFO. Thiels et al. (2015) reported

predominant human factors contributing to surgical never events include unsafe actions (41%)

and precondition for actions (47%). Examples of unsafe conditions include bending or breaking

the rules, failure to follow a verification process, misunderstanding a situation, decision errors,

and confirmation bias (Thiels et al., 2015). Precondition for actions includes inadequate handoff,

poor surgical lighting, channeled attention on a single issue, overconfidence, inadequate

vigilance, and distractions (Thiels et al., 2015). Other studies confirm human factors as a

contributing factor to URFO. In one study of reported URFO cases, 90% included counts with

86.1% reported counts as correct (Steelman et al., 2018). In a small sample of cases employing

use of Radiofrequency identification (RFID) technology with a detection of a retained sponge,

the detection was ignored in 75% of cases because the count was correct (Steelman et al., 2018).

URFO is a reportable event to California Department of Public Health (CDPH). In the

California Health and Safety Code, Reportable Adverse Events, Section 1279.1 (b) (1),

reportable adverse events, includes surgical events including (D) 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 (CDPH,

2018). Reporting must be completed within 5 days of knowledge of the event. In this case, the

retained object, a surgical sponge, was reported within 24 hours of the event. CDPH requires

hospitals to conduct a root cause analysis for all sentinel events.

TJC (2021) considers URFO a sentinel event. Reporting of sentinel events is not

mandated; however, strongly encourages hospitals to report sentinel events. The hospital decided
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not to report the event to TJC; however, must conduct a root cause analysis and be prepared to

present the results during an onsite survey.

Root Cause Analysis Outline

I. Safety Assessment Code (SAC) is 2. A RCA2 event will be conducted.

A. Severity of the event was major.

B. The probability of future occurrence is occasional.

II. RCA Team Membership

A. Director of Risk Management. Subject matter expert root cause analysis, patient safety,

and reporting to external regulatory and accreditation agencies. Team leader.

B. Director, Cardiac Catheterization Lab. Leadership perspective in high-technology

procedural setting; un-involved in the case.

C. RN Clinical Informatacist. Subject matter expert.

D. Manager, Quality Management. Quality & regulatory perspective.

E. Director, Laboratory. Leadership perspective in highly regulated high-technology setting.

F. Emergency Department RN. Frontline RN experienced in bedside interventional

procedures; un-involved in the case.

III. Document Review

A. Operative record documented by the circulator RN.

B. Anesthesia records.

C. Operative reports.

D. Radiographic reports.

E. Policy and Procedure: Surgical Count

F. Policy and Procedure: Operative and Invasive Procedure Verification

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G. OR Orientation Plan

H. OR Competency Checklists

I. The Joint Commission Sentinel Event Alert: Unintended Retained Foreign Objects

J. Table of Evidence—prevention of unintended retained foreign objects

IV. Interviewees

A. Director, Surgical Services

B. Manager, Surgical Services

C. Circulator RN

D. Surgical Scrub Technologist

E. Surgeons, primary and assistant

F. CRNA

V. Interview Questions

Question 1. Describe the count policy and procedure.

Question 2. Describe the use of the counter bag.

Question 3. What education and training did you receive in the policy and procedure for

performing a count of sponges, needles/sharps, other items, and surgical instruments?

Question 4. Who performed the counts? If different individuals performed the counts, please

explain rationale.

Question 5. Was a count performed when sponges, needles/sharps, and instruments added to

the surgical field or table?

Question 6. Were all counts in this case conducted following the policy and procedure?

Question 7. What were the results of all surgical counts in this case?

Question 8. Were there any suspicions that the counts were not accurate?
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Question 9. Were there any interruptions or distractions during the counts such as but not

limited to anesthesia, noise, change in staff, or other interruptions?

Question 10. Were all three required verification procedures (pre-anesthesia briefing,

procedural timeout, and debriefing) conducted with all required team members?

Causes & Contributing Factors

Cause & Contributing Factor 1: Lack of Standardized Count Methodology (Sequencing)

The AORN Guideline for Prevention of Retained Surgical Items identified key actions to

prevent URFO: make all perioperative team members responsible for preventing URFO;

minimize distractions, noise, and interruptions during the surgical count; establish and adhere to

a consistent counting method for all surgical counts; when a discrepancy is detected, team

members should take action to locate the missing item; and finally use a systems approach for

performance improvement to prevent URFO (AORN, 2016; Fencl, 2016). The hospital policy

specifies who by role who will count and at what procedural milestones or events (e.g.,

permanent replacement of a team member); however, not a standardized sequenced methodology

for counting.

Action 1. Adopt the AORN Guideline for Prevention of Retained Surgical Items consistent

counting method. Re-write/update current policy and procedure to meet AORN guidelines and

mitigate threats of human factors (e.g., confirmation bias, distractions). Provide staff education

on the count policy and procedure. Education to include simulation and competency

documentation.

Action 2. Indoctrination (Marquis & Huston, 2021, pp. 399-402).

Cause & Contributing Factor 2: Staffing and Assignment

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Perioperative nursing requires training and onboarding to meet the challenges and

demands of the fast-paced, high-risk, and technologically laden OR environment. Recruiting

perioperative nurses is difficult due to nursing workforce trends include a decrease in inclusion

of perioperative nursing clinical rotations in undergraduate nursing education, aging workforce

nearing retirement, complexity of patient population and operative procedures, improved access

to care and aging population increasing demand and technological advances (Gorgone et al.,

2016). Nurse turnover, including recruitment, screening, and interviewing, hiring, and

onboarding, has been estimated to be $59,000 for a perioperative nurse (Gorgone et al., 2016).

The perioperative care setting is a difficult environment for novice nurses; mentoring and

precepting are significant interventions to ensure the successful transition to practice in the

perioperative setting (Gorgone et al., 2016). Gorgone et al. (2016) describe the successful

implementation of a new graduate perioperative nursing program based upon the AORN’s

Guidelines for Perioperative Practice. Outcomes included a cost-effective approach to staffing

and reducing vacancies from retirement and attrition with new graduates (Gorgone et al., 2016).

Action 1. New graduate perioperative nursing program. Design, develop, and adopt a new

graduate perioperative nursing program based upon AORN Guidelines for Perioperative

Practice.

Action 2. Selection (Marquis & Huston, 2021, pp. 392-396).

Action 3. Indoctrination (Marquis & Huston, p. 399-402).

Action 4. Educating (Marquis & Huston, 2021, p. 410-419)

Cause & Contributing Factor 3: Human Factors

Unsafe conditions, a human factor that leads to URFO, include bending or breaking the

rules, failure to follow a verification process, and confirmation bias (Thiels et al., 2015). Each of
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these unsafe conditions all apply to the process of the surgical count. Precondition for actions

includes inadequate handoff, poor surgical lighting, channeled attention on a single issue,

overconfidence, inadequate vigilance, and distractions (Thiels et al., 2015). These preconditions

also apply to the process of surgical counts. Surgical teams feel confident in the process and

accuracy of the count; however, UFRO still occurs in the presence of a correct surgical count.

Radiofrequency identification (RFID) sponge detection technology utilizes a RF chip or

radiopaque marker to detect the presence and location of retained sponges (Steelman et al.,

2018). Use of RFID, when used correctly with vigilance against confirmation bias of correct

counts, will prevent unintended retained sponges. Radiographic images are effective in detecting

URFO when there is a suspicion of a retained object in the face of an incorrect count. Imaging;

therefore, is reactive rather than proactive. RFID is a proactive method to detect a retained

sponge.

Action 1. Adoption of Radiofrequency identification (RFID) sponge detection technology. Re-

write/update current policy and procedure to integrate RFID technology and mitigate threats of

human factors (e.g., confirmation bias, distractions). Provide staff education on the count policy

and procedure and use of RFID technology. Education to include simulation and competency

validation.

Action 2. Operating budget (Marquis & Huston, 2021, p. 247)

Action 3. Capital budget (Marquis & Huston, 2021, pp. 247-248)

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References

Association of Perioperative Registered Nurses. (2016, June 25). Guideline summary: Prevention

of retained surgical items. AORN Journal, 104(1), 49-53.

https://doi.org/10.1016/j.aorn.2016.04.011.

California Department of Public Health. (2018, July 25). Reportable adverse events.

https://www.cdph.ca.gov/Programs/CHCQ/LCP/Pages/Reportable-Adverse-Events.aspx

Fencl, J. L. (2016, July). Guideline implementation: Prevention of retained surgical items. AORN

Journal, 104(1), 37-48. http://dx.doi.org/10.1016/j.aorn.2016.05.005

Gorgone, P. D., Arsenault, L., Milliman-Richard, Y. J., & Lajoie, D. L. (2016, July).

Development of a new graduate perioperative nursing program at an urban pediatric

institution. AORN Journal, 104, 23-29. http//dx.doi.org/10.1016/j.aorn.2016.05.006.

Marquis, B. L. & Huston, C. J. (2021). Leadership roles and management functions in nursing:

Theory and application (10th ed.). Wolters Kluwer.

Norton, E. K., Martin, C., & Micheli, A. J. (2012). Patients count on it: An initiative to reduce

incorrect counts and prevent retained surgical items. AORN Journal, 95(1), 109-121.

https://doi.org/10.1016/j.aorn.2011.06.007

Steelman, V. M., Shaw, C., Shine, L., & Hardy-Fairbanks, A. J. (2018). Retained surgical

sponges: A descriptive study of 319 occurrences and contributing factors from 2012 to

2017. Patient Safety in Surgery, 12, 20. https://doi.org/10.1186/s13037-018-0166-0

The Joint Commission. (2013, October 17). Sentinel Event Alert preventing unintended retained

foreign objects.

https://www.jointcommission.org/-/media/tjc/documents/resources/patient-safety-

topics/sentinel-event/sea_51_urfos_10_17_13_final.pdf
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The Joint Commission. (2021, January). Sentinel events. Retrieved March 9, 2021, from

https://www.jointcommission.org/-/media/tjc/documents/resources/patient-safety-

topics/sentinel-event/camh_se-chapter.pdf

Thiels, C. A., Lai, T. M., Nienow, J. M., Pasupathy, K. S., Blocker, R. C., Aho, J. M.,

Morgenthaler, T. I., Cima, R. R., Hallbeck, S., & Bingener, J. (2015). Surgical never

events and contributing human factors. Surgery, 158(2), 515-521.