new handoutstjc sentinel event alert webinar - hospital council · 2019. 12. 19. · estimated that...
TRANSCRIPT
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What does it mean? What do they want? What should we do?
Verna C. Gibbs MD
Director, Nothing Left Behind® Clinical Professor of Surgery, UCSF
Staff Surgeon, SFVAMC www.nothingleftbehind.org
Sentinel Event Alert #51 Recent Release
http://www.jointcommission.org/sea_issue_51/
Some Points from TJC
• Didn’t move away from URFO but did “approve” RSI
• Doesn’t define when an item is retained – up to the hospital to define It’s retained if it’s after surgery; and after
surgery is out of OR/procedure room
• Standardized reliable practice • Multi-stakeholder • Use near miss data
Surgery 2012
NPDB Study 1990-2010
9,744 paid malpractice reports, 4,857 for RSI (49.8%) 410 -708 never events/yr; 205 – 354/yr RSI then estimated that an RSI occur 39 times a week!
Incident Reporting
As of December 31, 2009 6923
2009 2008
303
118
TJC Sentinel Events
8 years = 96.5 events per year ~ 100/year 50 states; 2 RSI events/year/state
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The California Story
CDPH reports from 10/25/2007 – 8/5/2013 (7 years) where hospitals received administrative penalties of $25,000 - $100,000
74 Retained Surgical Item cases ~ 10 events/year
43 cases involving Soft Goods
28 laps ; 12 raytex; 3 towels (1 ROT)
23 cases of Small Miscellaneous Items
8 cases of a retained Instrument
(50% are visceral retractors)
STILL > ZERO RSI are considered to be NEVER EVENTS and the Incidence is
Bottom Line
~250-500 events per year across the US
When is it retained?
http://www.jointcommission.org/sea_issue_51/
JCR website
http://www.jcrinc.com/foreign-objects-retained-after-surgery
Previously said after surgery was wound closure
NQF Required Reporting Serious Reportable Events (SRE) 2011 Update
Event
• Unintended retention of a foreign object in a patient after surgery or other invasive procedure
• Applicable Settings: – Hospitals – Outpatient/Office-
based Surgery Centers
– Ambulatory Practice Settings/Office-based Practices
– Long-term Care/Skilled Nursing Facilities
Additional Specifications • Includes medical or surgical
items intentionally placed by provider(s) that are unintentionally left in place
• Excludes:
a) objects present prior to surgery or other invasive procedure that are intentionally left in place;
b) objects intentionally implanted as part of a planned intervention and;
c) objects not present prior to surgery/procedure that are intentionally left in when the risk of removal exceeds the risk of retention (such as microneedles, broken screws)
Implementation Guidance This event is intended to capture:
– Occurrences of unintended retention of objects at any point after the surgery/ procedure ends regardless of setting (post anesthesia recovery unit, surgical suite, emergency department, patient bedside) and regardless of whether the object is to be removed after discovery
– Unintentionally retained objects (including such things as wound packing material, sponges, catheter tips, trocars, guide wires) in all applicable settings
After surgery is…..
• After all incisions have been closed in their entirety
• Devices have been removed • Final surgical counts have
concluded • Patient has been taken from the
operating/procedure room
http://www.qualityforum.org/projects/hacs_and_sres.aspx
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When is it Retained?
• After surgery • After surgery is NOT wound closure • After surgery is “out of OR”
• So everybody has to work together to make sure we get any surgical tools not intended to remain out of the patient before leaving the OR
TJC Sentinel Events
• Voluntary Reporting to TJC • Consider RSI a reviewable sentinel
event
• Organizations are expected to respond to sentinel events as outlined in the standards and elements of performance (EP)
Requirements
• EP 5 Leaders create procedures to respond to system failures
• EP7 Leaders define sentinel event • EP8 Organization conducts RCAs • EP9 Leaders have support systems
for staff involved in event • EP21/22 Patient Disclosure happens
Disclosure vs. Reporting • Retained small item
but clinical decision NOT to remove
• Impossible to retrieve
• Unlikely to cause harm
• Disclose to the patient
• Discuss about reporting
NLB Vernacular
Three types of Retained Sponge Case:
1. No Count Retention Case
2. Correct Count Retention Case 3. Incorrect Count Retention Case
Correct Count Case
• Terminology relates to the count at the end of the case NOT what was the count looking back at the event
• So a CCRC is a case of an RSI where the counts were called “correct” at the final count
• This is the most common finding!
NLB Vernacular
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Incorrect Count Case
• At the final count for the case there was an incorrect count. Something was missing yet the patient left the OR with the item inside of them
• Involvement of other stakeholders • Usually acts of omission • Problems with knowledge and
communication NLB Vernacular
TJC Findings
7%
The California Story
Reports from 10/25/2007 – 8/5/2013
74 Retained Surgical Item cases
43 Soft Goods
27 laps; 12 raytex; 39 CCRC (91%)
1 lap; ICRC
3 towels NCRC
Findings from NLB series • 10% are NO COUNT cases
Usually vaginal births or pacemakers
• 70% of retained sponge cases occur in the setting of a CORRECT COUNT; Problems with OR practices e.g. variable
practices or having a fragile one that isn’t very reliable
• 20% occur in the setting of an INCORRECT COUNT Problems with knowledge and
communication usually with radiology
Have an action plan
• NCRC have to get a PRACTICE • CCRC have to change PRACTICE
Design ways to improve the process: SAS, RFAS • Decrease number of steps • Increase reliability of individual steps
Get a whole new process: SSS2;
• ICRC have to address COMMUNICATION Use an Incorrect FINAL count report ASSIGN RESPONSIBILITY for follow-up Move beyond the role of the RN circulator Engage radiology, surgery providers
TJC Improvements • High reliability = zero harm • Leadership must commit to goal • Culture supports reporting
• Implement systematic quality improvement approaches that measure magnitude, identify contributing factors and root causes
• Develop solutions for important causes
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TJC Recommendations
• Effective processes and procedures
Reliable Practice
Current Count Practices
0 0 0 0 0 0 0
1 1 1 1 1 1 1
2 2 2
4 4
Collect sponges and put some in hanging counter bags
Use the bar code device (Surgicount) with kick buckets
Use the bar code device (Surgicount) with kick buckets and counter bags
Use the wand system (RF Surgical) with one of the manual count practices above
Use the wand system (RF Surgical) with a manual count on every case
Use the wand system (RF Surgical) only on selected cases.
Use the RFID system (Clearcount) with counter bags
Collect in kick bucket and count 5 by hanging over fingers
Collect in kick bucket and count 5 by hanging blue tags over edge of bucket
Collect in kick bucket and count 10 by pointing with ring forceps
Lay sponges out on drape or flat surface and count with scrub
Collect sponges in groups of 10 and secure in clear plastic bag and put on floor
Collect sponges in groups of 5 and secure in clear plastic bag and put on floor
Use the RFID system (Clearcount)
In the unit of issue
All sponges only in multiples of 10
Collect in kick bucket and count 10 by hanging blue tags over edge of bucket
Use the hanging counter bags for laps by breaking center divider and count in 5’s
Use the hanging counter bags for raytex and count in 10’s
• Nurses use a standardized process to put sponges in hanging plastic holders and document the counts on a wall-mounted dry erase board in every OR • Surgeons perform a methodical wound exam in every case and before leaving the OR - verify with the nurses that all the sponges (used and unused) are in the holders.
SPONGE ACCOUNTING SYSTEM
50 lap pads accounted for
Trust but Verify In Count In count
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Issue of Risk
Emergency Cases • C-sxns are urgent/emergent BUT
they are known and expected
• OB/ORs teams “do these all the time” so NOT novel
• Expectation is that experienced personnel are available
• Rooms are set up and ready to go
Emergency Cases • The default is that you WILL BE able
to use the practice
• It takes on average 1 sec per sponge to count IN therefore it takes ~10-15 seconds to count in 10 sponges
• Move the sponges out of the kick buckets into the holders
• Even if there is a plan to get an xray continue to put the sponges in the holders throughout the case
All eggs in X-ray basket
Misread x-ray
Use it Anywhere
• Sponge ACCOUNTing should be in place ANYWHERE surgical sponges are used and there is an incision or wound Labor and Delivery Rooms OB Operating Rooms Cath labs Radiology suites
• The practice should be used in EVERY case
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• Initial confusion about actions at closing and final count
Failure modes • Before the procedure to establish a
baseline and identify manufacturing packaging errors
• When new items are added to the field • Before closure of a cavity within a cavity • When wound closure begins • At skin closure at the end of the procedure
or at the end of the procedure when counted items are no longer in use (ie, final count
• Time of permanent relief of either the scrub or circ although direct visualization of all items may not be possible
AORN is confusing
Closing Count • Surgeon performs a methodical wound
exam to get all the sponges out • Nurses perform two person accounting
practice between field, table and holders Give surgeon closing suture while
you continue count Respond back to surgeon “We think
the count is correct ; We think we’ve got all the sponges” (or NOT!)
• Keep on the field some sponges to use for closing. How many?
• All the sponges (used and unused) MUST be in the sponge holders
• Before MD leaves the OR they say “show me”; or you say “let me show you”
• Each pocket should be full - 10 sponges per holder.
• Team based verification
At the FINAL Count:
At the FINAL Count:
• The count is correct
• Look there are 10 laps
No Empty Pockets!
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“Let Me Show You”
• Anytime after the skin is closed the final count can be performed
• Who shows who doesn’t matter, it’s that it gets done
• “Here, let me show you that we have all the sponges, here in the holder”
• And the nurse and the surgeon can prove/verify that all the sponges are there and not in the patient
• Initial confusion about actions at closing and final count
• Not separating sponges at IN and OUT counts
Failure modes
Case S-E-P-A-R-A-T-I-O-N Togetherness is great, but S-E-P-A-R-A-T-I-O-N is better.
Verna C. Gibbs M.D. - NoThing Left Behind®
• The patient had a bilateral nephrectomy. There were no untoward events during the case. The surgeon did a “sweep” at the closing count and at the final count there were no empty pockets in the sponge holders. Two days post/op the patient “failed to progress” and an abdominal series revealed a retained lap pad in the posterior right renal fossa. The patient went back to the OR for removal.
• The case started with 20 lap pads and ended with 80 laps. At various times throughout the operation additional laps were added to the field. During one of those IN counts there were 11 laps not 10. The scrub and circ in just “counting” missed that extra sponge. In follow-up with staff involved in the case the circs and scrubs on the case were found to still be using the dangerous practice of “fanning” the sponges and not S-E-P-A-R-A-T-I-N-G them and this case served as yet another example of why the practice of “fanning” sponges MUST be stopped and surgeons need to perform a MWE.
• The ultimate mistake is in the thinking that the sponge packages are all “ok” and that mistakes in packaging don’t occur so fanning is good enough. This is a false assumption. There are mistakes in the number of sponges that are in these packs and it’s up to the scrub and circ to discover those errors. Having said that the problem is actually deeper.
• Did you know that the sponges have never been counted?
• They are WEIGHED before packaging
• SEPARATE the sponges Confirm how many
Look for tag or marker
r/o manufacturing errors
• Use audible and visual 2 person review, “see, separate and say”
At the IN Count:
You don’t know how many sponges are in a pack until you count them!
EACH UNOPENED PACK IS A BLACK BOX
Separate the sponges!
X
X
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S-E-P-A-R-A-T-I-O-N • Here is another case: • An open abdominal case had 20 lap pads and 10 raytex 4x4 used
during the case. At the closing count a MWE was performed and the counts were called “correct” however at the final count there was an empty pocket in the raytex holder. The staff looked for the raytex in the room trash and then in the holders. Two view xrays were taken which were read as negative. The missing raytex was then found mixed in with a lap pad in a pocket that contained another lap pad.
• The first point to consider is to use the incorrect count checklist that is supposed to be mounted on the wall in every OR to guide actions when looking for a missing sponge. The fourth checkbox on the poster in the nursing column is to look in the holders to see if two sponges are stuck together. This is before looking in the room, drapes, or in the trash because it is a common error not to S-E-P-A-R-A-T-E the sponges when taking them out of the kick buckets and there will be two stuck together and placed in one pocket.
Incorrect Count CheckList
• Visible in every OR • Levels the playing
field • Knowledge and
Communication so all team members can do the right thing
• It’s what is right not who is right… remember?
S-E-P-A-R-A-T-I-O-N • The second point is that it is important to look not only amongst
the raytex but also amongst the pockets of the laps. There have been other cases where the missing raytex was in the pocket of the raytex holders. This was also shown as an error trap in the training video. If the events keep occurring that suggests there isn’t any learning taking place. People keep making the same mistakes. Maybe not the same people or the same ORs. The foundational error in practice is not S-E-P-A-R-A-T-I-N-G the sponges.
• S-E-P-A-R-A-T-I-O-N of the sponges on the IN counts and on the OUT counts when they are put in the holders is a key, essential element. If the circs fail to S-E-P-A-R-A-T-E the sponges they are setting themselves up for failure.
S-E-P-A-R-A-T-I-O-N • Sponges are used to soak up blood and body fluids so they are
designed to be absorbent. The very characteristics we want in a good surgical sponge are characteristics that make them easy to stick together and difficult to S-E-P-A-R-A-T-E. If we want sponges that don’t stick together easily we most likely will trade their decreased absorbability. You can see this in telfa and in some of the dressing sponges that have a smooth shiny synthetic surface designed NOT TO STICK to the skin and guess what, those dressings don’t absorb very much either. So, we want sponges that soak up blood and fluid and the price we pay for that is that they tend to stick together. Knowing that fact and the fact that manufacturers and distributors make mistakes in the packaging of the sponges means that it’s up to the scrub and circs to S-E-P-A-R-A-T-E the sponges on the in and out to make sure they only have ONE.
S-E-P-A-R-A-T-I-O-N Here is one more case: • This case involved a vaginal birth in which there was
continued maternal hemorrhage after the birth. During the vaginal birth 10 raytex 4x4’s were used and accounted for in the pockets of a holder. The mother was transferred to the OR from the birthing room and prior to transfer the MD asked for a vaginal pack, which was placed in the vagina. On arrival in the OR an IN count of the lap pads was performed and there were 30 laps in the standard pack. The SAS was used throughout the case. There was a changeover in personnel from L&D folks to OR personnel who usually staff the OB OR cases. The patient required a hysterectomy. At the end of the case there were three holders full of lap pads AND an extra lap pad!
S-E-P-A-R-A-T-I-O-N • An xray was taken of the abdomen which was negative for any
additional laps and when the MD did the show me step and looked at the sponges he told the nurses that one of them was likely the vaginal pack that had been placed. Sure enough one of the “lap pads” in a pocket was really the 20ft long bloody vaginal pack that had been balled up and put in the pocket… that is it wasn’t opened up and S-E-P-A-R-A-T-E-D when it was taken out of the kick bucket.
• Again, the value of S-E-P-A-R-A-T-I-O-N is pointed out in this case. On taking the bloody sponges out of the kick buckets they have to be S-E-P-A-R-A-T-E-D in order to make sure there is only one and there is only one of an expected type.
• Also, on the handover from one team to another the placement of the vaginal pack was not communicated which might have helped the second team know that they had to account for it at the end of the case…. So a correct count at the end of this case was 30 laps and one vaginal pack not 31 laps!
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• The 3 most important things to do to prevent retained surgical sponges 1. SEPARATE the sponges – on the IN
and on the OUT
2. Surgeons have to actually look during the MWE
3. Get all the sponges in one place to make sure they are all ACCOUNTED for
TJC Recommendations
• Effective processes and procedures • Effective Communication
Incorrect Count CheckList
• Visible in every OR • Levels the playing
field • Knowledge and
Communication so all team members can do the right thing
• It’s what is right not who is right… remember?
MSI Imaging Guidelines
• Region of Interest specifics
• Instructions for radiology techs to take correct images
• Information to help get it right
Trust but Verify In Count In count
Incorrect Count Report
• Single most important element
• Communication tool
• Every OR should use them no matter what practice you adopt
• www.nothingleftbehind.org
NLB Vernacular
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Surgical Safety CheckList Surgical Checklist
HAVE BEEN ACCOUNTED FOR
✔
TJC Recommendations
• Effective processes and procedures • Effective Communication • Appropriate Documentation
Four Classes of Items
1. Soft Goods a) Sponges b) Towels
2. Miscellaneous Small Items and Device Fragments
3. Sharps/Needles 4. Instruments
Retained Surgical Items Documentation
Final Count CORRECT INCORRECT
Sponge X
Needle/Sharps X
Instruments X
Small Items X
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Cerner changes Cerner changes
Documentation also is.. Test conditions 2x2 box
Diagnostic test positive Cancer present
TRUE POSITIVE
Diagnostic test positive No Cancer
FALSE POSITIVE
Diagnostic test negative Cancer present
FALSE NEGATIVE
Diagnostic test negative No Cancer
TRUE NEGATIVE
TEST
TRUTH
Sponge “counts”
Sponge count incorrect Sponge in patient
TRUE POSITIVE
Sponge count incorrect No sponge in patient
FALSE POSITIVE
Sponge count correct Sponge in patient
FALSE NEGATIVE
Sponge count correct No sponge in patient
TRUE NEGATIVE
Miscount
Sponge count incorrect Sponge in patient
TRUE POSITIVE
Sponge count incorrect No sponge in patient
FALSE POSITIVE
Sponge count correct Sponge in patient
FALSE NEGATIVE
Sponge count correct No sponge in patient
TRUE NEGATIVE
CLOSE CALL EVENTS (found in trash)
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Retained Sponge
Sponge count incorrect Sponge in patient
TRUE POSITIVE
Sponge count incorrect No sponge in patient
FALSE POSITIVE
Sponge count correct Sponge in patient
FALSE NEGATIVE
Sponge count correct No sponge in patient
TRUE NEGATIVE
RETAINED SPONGE CCRC
Retained Sponge
Sponge count incorrect Sponge in patient
TRUE POSITIVE
Sponge count incorrect No sponge in patient
FALSE POSITIVE
Sponge count correct Sponge in patient
FALSE NEGATIVE
Sponge count correct No sponge in patient
TRUE NEGATIVE
RETAINED SPONGE ICRC
The Conundrum
Sponge count incorrect Sponge in patient
TRUE POSITIVE
Sponge count incorrect No sponge in patient
FALSE POSITIVE
Sponge count correct Sponge in patient
FALSE NEGATIVE
Sponge count correct No sponge in patient
TRUE NEGATIVE
RETAINED SPONGE ICRC
CLOSE CALL (ie + )
Some numbers
Sponge count incorrect Sponge in patient
TRUE POSITIVE 10% in patient = 100
Sponge count incorrect No sponge in patient
FALSE POSITIVE 10% miscount rate= 1000 90% in trash = 900
Sponge count correct Sponge in patient
FALSE NEGATIVE 1 retained sponge/10,000 cases/year (CCRC)
Sponge count correct No sponge in patient
TRUE NEGATIVE
Credibility
Sponge count incorrect Sponge in patient
TRUE POSITIVE 10% in patient = 100
Sponge count incorrect No sponge in patient
FALSE POSITIVE 10% miscount rate= 1000 90% in trash = 900
Sponge count correct Sponge in patient
FALSE NEGATIVE 1 retained sponge/10,000 cases/year (CCRC)
Sponge count correct No sponge in patient
TRUE NEGATIVE
Think you’re ok?
Sponge count incorrect Sponge in patient
TRUE POSITIVE 10% in patient = 100
Sponge count incorrect No sponge in patient
FALSE POSITIVE 10% miscount rate= 1000 90% in trash = 900
Sponge count correct Sponge in patient
FALSE NEGATIVE 1/10,000
Sponge count correct No sponge in patient
TRUE NEGATIVE 8,999 times usually are right
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A different story
Sponge count incorrect Sponge in patient
TRUE POSITIVE ~1/10,000 cases and always should be known
Sponge count incorrect No sponge in patient
FALSE POSITIVE 1% miscount rate
Sponge count correct Sponge in patient
FALSE NEGATIVE zero
Sponge count correct No sponge in patient
TRUE NEGATIVE 9,899 times are right
Truly Evaluate Practice
Sponge count correct No sponge in patient
TRUE POSITIVE 8,999 times usually are right
Sponge count incorrect No sponge in patient
FALSE POSITIVE 10% miscount rate= 1000 90% in trash = 900
Sponge count correct Sponge in patient
FALSE NEGATIVE 1/10,000
Sponge count incorrect Sponge in patient
TRUE NEGATIVE 10% in patient = 100
Sensitivity Specificity
PPV
NPV
Sponge count incorrect Sponge in patient
TRUE POSITIVE
Sponge count incorrect No sponge in patient
FALSE POSITIVE
Sponge count correct Sponge in patient
FALSE NEGATIVE
Sponge count correct No sponge in patient
TRUE NEGATIVE
Trust but Verify In Count In count
Close Calls
• If nothing else, start reporting near miss events
• Use this as an OR improvement opportunity
• Review them to change/improve practice
Miscounts by Case Type
66%
11%
23%
Miscounts n=161
Open Cases= 111
Laparoscopic Cases =18
Robo7c or Vaginal cases= 39
OR Miscounts
26%
52%
7%
9%
6%
0%
Where are the Sponges? Sponge found in wound
Sponges found in garbage,drapes, laundry or floor
No "IN" count performed
Sponges found in holder stuck with other sponges
Ended case with more sponges than started
n=110
53
5
52
1 1 Sponge Type
Raytec 4x4
Raytec 4x8
Laps
Peanuts
Baby Laps
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What the data tells us • In the majority of cases (61%) when a miscount has
occurred, the sponge has been found somewhere other than in the patient. • A trash receptacle, garbage bin, the drapes or on
the floor within the procedural area is the most common site
• Failure to S-E-P-A-R-A-T-E accounts for 9% of miscounts
• In 26% of the cases from the OR the sponge was discovered within the surgical wound
• The majority (52%) of the “lost” sponges were lap pads however in cases that use raytex they were the source of miscounts
What the data tells us
All procedural areas had miscounts
• Poor practice problems of nurses (sponge management practices) and surgeons (methodical wound exam practice) pose the greatest risk for retained sponges
• Miscounts provide valuable information about where errors occur in the management of surgical sponges.
• All sites should report miscounts and use the information to improve their practices
TJC Recommendations
• Effective processes and procedures • Effective Communication • Appropriate Documentation
• Safe Technology
Sponge Management
Policy
Process
Practice
Change Practice
• There have been retained sponges with the new technology adjuncts. Are these add-a step processes or a whole new practice?
• It’s people who interface with the devices not just the reliability or the functionality of the devices themselves
• Problem is with error prone, non-verifiable practices.
System Problems • Failure of leadership involvement
• Surgeon fears and lack of engagement • Everyone really wants to keep doing the same
thing and believe outcomes will be different
• Persistent belief in the superiority of “counting” and personal excellence, miss “systemness”
• Risky group behaviors trump safety, dysfunctional consensus building
• Failure of OR managers to train, perform audits and competency assessments and embrace reporting
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SMI
• Small Miscellaneous Items and Unretrieved Device Fragments (UDFs)
• Increasingly reported 70% of retained items in the Minnesota
Hospital Association reports 50% of items from the California Dept of Public
Health Majority of items from California Hospital
Patient Safety Organization voluntary reporting system
Probably the second most common item other places (e.g. Pennsylvania, VA reports) • have been “bundled” in the instrument category
Device Fragments
• Unretrieved Device Fragments (UDF) can lead to serious adverse events
• US FDA notification Jan 2008 • Local tissue reaction, infection,
perforation, obstruction, emboli • CDRH receives ~1000 adverse event
reports a year related to UDFs
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070187.htm
TJC Recommendations
• No comment
NQF Required Reporting Serious Reportable Events (SRE) 2011 Update
Event
• Unintended retention of a foreign object in a patient after surgery or other invasive procedure
• Applicable Settings: – Hospitals – Outpatient/Office-
based Surgery Centers
– Ambulatory Practice Settings/Office-based Practices
– Long-term Care/Skilled Nursing Facilities
Additional Specifications • Includes medical or surgical
items intentionally placed by provider(s) that are unintentionally left in place
• Excludes:
a) objects present prior to surgery or other invasive procedure that are intentionally left in place;
b) objects intentionally implanted as part of a planned intervention and;
c) objects not present prior to surgery/procedure that are intentionally left in when the risk of removal exceeds the risk of retention (such as microneedles, broken screws)
Implementation Guidance This event is intended to capture:
– Occurrences of unintended retention of objects at any point after the surgery/ procedure ends regardless of setting (post anesthesia recovery unit, surgical suite, emergency department, patient bedside) and regardless of whether the object is to be removed after discovery
– Unintentionally retained objects (including such things as wound packing material, sponges, catheter tips, trocars, guide wires) in all applicable settings
California Rules
Position Statement: Adverse Events Which Include Retained Foreign Objects – Retained Fragments From A Broken Needle Or Screw From Kathleen Billingsley, Deputy Director, Center for Health Care Quality, California Department of Public Health, Position Statement, March 30, 2010:
Adverse events which include retained foreign objects are defined in the Health and Safety Code (HSC). Specifically, HSC Section 1279.1 (b) (1) (D) states, “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 some surgical procedures, fragments from a broken needle or screw may be retained within the patient. The physician makes a clinical judgment at the time of surgery to leave the fragment within the patient as the relative risks outweigh the removal of the foreign object. The California Department of Public Health’s (CDPH) determines that this is a reportable adverse event. CDPH requires facilities to report even these types of retained objects wherein the physician makes a clinical decision to retain the object; however, the CDPH may not issue a deficient practice relative to an adverse event. Billingsley, Kathleen (CDPH-L&C)
Patient Disclosure 1. Advise patients of the existence and
nature of the UDF to include the following information: 1. material composition of the UDF, 2. the measurement/size of the fragment,
3. location, 4. x-rays findings with interpretation,
5. potential for injury e.g. migration, infection, embolization, thrombosis and
6. any procedures or treatments to be avoided or to be obtained
2. Report to MedSun
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Perspective
• The biggest resistance to change will come from within
• Everyone will tell you however it comes from without…
• And it does
SAFER SURGERY