Patient Safety Tip of the Week
August 19, 2014
Some More Lessons Learned on Retained Surgical Items
Just when you think you’ve learned everything about retained
surgical items/retained foreign objects you get surprised by some new lessons
learned.
Among the most recent CDPH (California Department of Public
Health) release of RCA’s and plans of correction were another 4 cases of
retained foreign objects. Three were in ob/gyn procedures. That should not be surprising since a
substantial proportion of retained surgical items have been reported in Ob/Gyn procedures and vaginal deliveries (Stiller
2010). The Minnesota
Hospital Association and ICSI
also have focused on Ob/Gyn procedures in their
efforts to prevent retained foreign objects. The fourth retained foreign object
case was related to a pacemaker insertion.
The cases (CDPH
CA00268068), (CDPH
CA0029845B), (CDPH
CA00309249),
(CDPH
CA00180867, CA00180956) had many of the factors previously identified as
contributing to retained surgical items (eg.
conversion to open procedure, transitioning of OR staff during the procedure,
etc.) and reinforced many of the important recommendations we’ve discussed in
our prior columns. The latter include fundamentals of the “count”, use of white
boards and “count bags”, ensuring attention of all and avoiding distractions during
the count, good communication between staff, the methodical wound exam, and the
importance of auditing to ensure all components of your policies are carried
out.
Three of the cases involved surgical sponges or lap packs,
which are the most commonly retained foreign objects. But what caught our eye
was a case with another unusual retained surgical item and the system
implications it had in its lessons learned. You’ll recall in our Patient Safety Tips of the Week for June 12,
2012 “Lessons
Learned from the CDPH: Retained Foreign Bodies” and November 5, 2013 “Joint
Commission Sentinel Event Alert: Unintended Retained Foreign Objects” we
noted several unusual items found as retained foreign bodies (a blue
towel, a cautery tip, a Kerlix bandage, a
piece of labeling tape from a surgical instrument, and a fish-shaped soft
flexible viscera retainer).
The case with the unusual retained surgical item (CDPH
CA00268068) began as a laparoscopic supracervical
hysterectomy. The surgical counts for sponges, instruments, sharps and needles
were “correct” as done by the scrub person and RN circulator. The patient was
discharged. Approximately a year and a half later examination because of
post-intercourse bleeding and pain revealed a circular piece of metal attached
to the patient’s cervix. This was removed by the physician and confirmed to be
a KOH Cup™. The KOH Cup™ is a device intended to improve safety during certain
procedures. Used in combination with a uterine manipulator, the KOH Cup™ enhances
traction capabilities, enabling greater access and visualization of
critical anatomic structures and helps prevent damage to such adjacent
structures.
Though the hospital at the time of the original surgery did
have a policy regarding what to do if an instrument was discovered to be
missing, apparently neither the surgical team nor sterile processing department
noted that the KOH Cup™ was missing and did not initiate attempts to find it.
At the time the KOH Cup™ was apparently not considered separately from the
uterine manipulator.
The hospital subsequently began attaching the KOH Cup™ to
the uterine manipulator with a suture. It also added the KOH Cup™ to its list
of surgical instruments separate from the uterine manipulator. The hospital
also added a “red rule” to ensure that all foreign objects placed into the
vaginal cavity have a “tail” that is visible from the outside and that all
items placed into the vaginal cavity are announced by the surgeon and entered
onto the instrument count white board. It also included discussion and
documentation during the post-case debriefing that the surgeon has examined the
patient for all items and removed them (see
also our July 22, 2014 Patient Safety Tip of the Week “More
on Operating Room Briefings and Debriefings”).
The hospital also developed a policy and procedure on
“Missing Instruments/Parts, Procedure for Locating”. They did inservicing of all appropriate staff and initiated an audit
program for surgical counts and specifically for KOH cups.
Though the KOH Cup™ was another unusual retained surgical
item, we were actually most interested in the role that SPD staff and central
supply might play in patient safety initiatives to prevent retained surgical
items. In fact, we found one such case where they actually did just that with a
missing KOH Cup™ (FDA
2014). That case was begun as a laparoscopic assisted vaginal hysterectomy,
using a KOH Cup™ and uterine manipulator. When the case was converted to an
open total abdominal hysterectomy the surgeon removed the uterine manipulator
and the laparoscopic instruments were passed on by staff and a new instrument
tray opened for the TAH. The case was completed without problems. The next day
the central supply supervisor called OR staff noting that the KOH Cup™ was
missing from the instrument set and another had been ordered. Staff were
confident the missing KOH Cup™ had not been discarded and subsequently
contacted the surgeon, who examined the patient and found and removed the
missing KOH Cup™.
We suspect that many facilities likely simply consider such
instances an inventory or logistical problem. We wonder how many would ask the
question “Could that missing item still be inside the patient?”. It’s another great example we can use when we go
department to department telling them “patient safety is everyone’s job”.
What does your facility do when an instrument or other
object is missing from a tray or set after a procedure?
We’ve already done several columns on retained surgical
items (listed below). We encourage you to read them because they contain a
wealth of information on the topic.
Our prior columns on retained surgical items/retained
foreign objects (RSI’s/RFO’s):
- June 12, 2012 “Lessons
Learned from the CDPH: Retained Foreign Bodies”
- November 2012 “More
on Retained Surgical Items”
- January 8, 2013 “More
Lessons Learned on Retained Surgical Items”
- November 5, 2013 “Joint
Commission Sentinel Event Alert: Unintended Retained Foreign Objects”
References:
Stiller RJ, Ivy MJ, Thompson T. Preventing retained foreign
objects in ob/gyn surgery.
Contemporary OB/GYN 2010; June 1, 2010
Minnesota Hospital Association. Eliminating Retained Foreign
Objects (Safe Count and Safe Account Programs).
ICSI (Institute for Clinical Systems Improvement).
Prevention of Unintentionally Retained Foreign Objects During
Vaginal Deliveries. Revision date: January 2012
CDPH (California Department of Public Health). Complaint
Intake Number CA00268068. CDPH 2014
http://cdph.ca.gov/certlic/facilities/Documents/2567KaiserFoundation_250010712_Riverside_MH3U11.pdf
CDPH (California Department of Public Health). Complaint
Intake Number CA0029845B. CDPH 2014
http://cdph.ca.gov/certlic/facilities/Documents/2567Southwest_250010718_Riverside_EKED11.pdf
CDPH (California Department of Public Health). Complaint
Intake Number CA00309249. CDPH 2014
http://cdph.ca.gov/certlic/facilities/Documents/2567Desert_Regional_250010729_Riverside_EGKN11.pdf
CDPH (California Department of Public Health). Complaint
Intake Number CA00180867, CA00180956. CDPH 2014
FDA. MAUDE Adverse Event Report: COOPER SURGICAL KOH CUP
VAGINAL FORNICES DELINEATORS UTERINE MANIPULATOR. Page Last Updated: 07/31/2014
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1298303
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