surgical procedures are safer in ca- don't be left behind!
TRANSCRIPT
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Verna C. Gibbs MD
Director, NoThing Left Behind® Professor of Surgery UCSF; Staff Surgeon, SFVAMC
Patient Safety First Hospitals Don’t Want to be
Left Behind Retained Surgical Sponges
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AHRQ PSI #5 and #21
Only Secondary diagnosis Denominator - All medical /surgical discharges
Patient Safety Indicator #21 Area Level Indicator Principal or secondary diagnosis) Denominator – Population of county of patient or hospital location
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Taxonomy for RSI
1. Soft Goods a) Surgical Sponges* b) Surgical Towels* c) Dressing sponges, Towels, Packs, Prep
Swabs, Gauze pledgets
2. Small Miscellaneous Items (SMI) includes parts of instruments
3. Sharps/Needles 4. Instruments (the whole instrument)
*cotton soft goods that contain a radiopaque marker for X-ray detection
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Retained Surgical Items
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Documentation
Final Count:
Four Classes
CORRECT INCORRECT
Sponge X
Needle/Sharps X
Instruments X
Small Misc Items X
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Unretrieved Device Fragments
• Unretrieved Device Fragments (UDFs)
• “Official” FDA nomenclature, not “bits and pieces”
• Broken parts or pieces of devices and surgical items
• These are the items where the “risk of retrieval > risk of retention” mantra is frequently invoked
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Device Fragments • can lead to serious adverse events • US FDA notification Jan 2008 • Local tissue reaction, infection,
thrombosis, perforation, obstruction, emboli
• Center for Devices and Radiological Health (CDRH) receives ~1000 adverse event reports a year related to UDFs
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070187.htm
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ECRI’s Top 10
• #7 Retained devices and unretrieved fragments
• Second most common RSI
www.ecri.org
Emergency Care Research Institute
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ADMINISTRATIVE PENALTIES
BECAUSE….. RSI are considered NEVER EVENTS and the CDPH still has
Tracking Sponges and Towels
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• As of April 1 2014 $75,000 for 1st IJ
• $100K for 2nd
• Up to $125K for the 3rd and every subsequent violation
• In 2015 all reports will become public, not just the AP cases
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The California Story
CDPH reports from 10/25/2007 – 10/24/2013 (7 years) where hospitals received administrative penalties of $25,000 - $100,000
75 Retained Surgical Item cases
43 cases involving Soft Goods
28 laps ; 12 raytex; 3 towels (1 ROT)
23 cases of Small Miscellaneous Items and UDFs
9 cases of a retained Instrument
(56% are visceral retractors)
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California AP events • 7 years of public reporting currently
includes cases from only 5 years - 2007 - 2011
• 75 reports = 15 cases/year 43 cases (57%) soft goods
• 11/43 (26%) Ob 7 > Gyn 4 cases • 28 laps; 12 raytex; 3 towels
23 cases (31%) SMI+UDFs 9 cases (12%) instruments 0 cases sharps
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CDPH 2011 • FOIA request by CHPSO • 114 releasable reports
52 (46%) no information
8 not RSI cases + no info = 53% 26 (23%) soft goods 19 (17%) UDFs
7 (6%)SMI + UDFs = 23% 2 retained sharps (1 needle/1 blade) 0 instruments
Freedom of Information Act
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CDPH 2011- drill down
• 23 cases 8 lap pads, 8 raytex, 1 towel, 2 vag
packs, 4 other types of sponges 11(48%) retained in abdomen/abd wall
9 (39%) retained in the vagina 3 other sites (pacemaker pocket, back) 13 cases (57%)were OB/GYN
procedures 2 cases involved Technology Adjuncts
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The California Story
Reports from 10/25/2007 – 10/24/2013
75 Retained Surgical Item cases
43 Soft Goods
27 laps; 12 raytex; 39 CCRC (91%)
1 lap; ICRC
3 towels NCRC
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Are We Getting Better?
CDPH reports from 2014 (May and July 2014)
4 Retained Surgical Item cases
3 cases involving Soft Goods
CCRC 2 laps 1 after C-sxn; 1 after cystectomy
NCRC 1 raytex after pacemaker insertion
1 case of Small Miscellaneous Item retained in the vagina
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When is it retained?
• A surgical item is considered to be retained if it is found in the patient AFTER SURGERY AFTER THE SURGERY/PROCEDURE
ENDS
• When is it after surgery?
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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
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UHC 2011 paper • 100 academic medical centers • 428 RSI* reports
171 (40%)UDFs
137 (32%) soft goods 77 (18%) Instruments (I doubt this!
more likely SMI’s + Instruments) + UDFs = 58%
43 (10%) sharps
*TJC interpretation of retained was used – which is wound closure
Williams, JACS Sept 2014
University Health Consortium
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UHC subset 2011 • 824 surgical sponge “events”
13 (1.57%) retained using NQF definition
• 811 (98%) are miscounts! • 40 hospitals in PSO
1/3 hospitals had issue with retention but every hospital has problems with miscounts
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Findings • Sponges are the most frequently retained
items that cause clinical patient harm The most common site is the abdomen then vagina
OB/GYN cases especially C-Sxns are important
• SMIs and UDFs are the second most commonly retained items
• Needles are most frequently miscounted item but infrequently retained
• Instruments are very uncommonly retained Most common is a visceral retractor
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When Reporting • State what the problem is
Retained Surgical Item (RSI), Unretrieved Device Fragment (UDF)
• Specify the Class of Item Soft Good, Sharp/Needle, Instrument,
Misc Item - includes parts of instruments
• Specify WHAT the item is Raytex 4x4 sponge, malleable retractor,
4x4 dressing sponge, 13 mm needle
• Details of the item and retention events
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Elements of Causation Applying Swiss Cheese Model of Sir James Reason BMJ, 2000;320:768
Exploration:SURGEONS
“Counts”:NURSES
Xray:RADIOLOGISTS
DEFENSES
LATENT FACTORS
OR PRACTICES
COMMUNICATION
Retained Surgical Sponge
MANUFACTURERS
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Error recognition
• Each slice of cheese represents a defense and a source of error
• If the defense of one fails then the hazard propagates to the next
• Nurses and Surgeons are the primary defenders
• The humans are the only ones that are going to be able to recognize the errors
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Communication
• Is not just talking • It’s the exchange of knowledge and
information • Patient safety problems frequently
have communication failures • How information is exchanged (or not) • Interested in the how not the who
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The Owl Syndrome
• Focusing on who • Anytime you see
initials it signals an emphasis on who
• Who did rather than how did
• Remnants of a blame and shame culture
Who?
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Communication
• It’s what is right not who is right Between nurses and surgeons
• “We’re missing a sponge” “Lets re-explore the wound!” • “Dr. Is this a good time for lunch relief?”
Between nurses and scrub techs • “Separate each raytex so we can make sure we have 10” • “Let’s verify the sponge holders before you take permanent
relief” Between surgeons
• “Make sure you check behind the heart for any raytex before you close”
• “Let’s do our wound exam and look for sponges”
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OR Practices
• What we do and how we manage our work We = Multiple Stakeholders
• Anesthesiologists: 4X4 management, coordinated reversal from anesthesia
• Surgeons: use only radiopaque items, perform a wound exploration
• Nurses: surgical item accounting process • Scrub Techs: organize field, know equipment
• Radiologists/Technicians: film quality, timely review, appropriate images
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Findings
• 80% of retained sponge cases occur in the setting of a CORRECT COUNT Problems with OR practices
• Very few reports specifically discuss THE PRACTICE but rather external factors around the practice
• If noise or distractions disrupt the practice of counting it’s not a very reliable practice
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Findings • 20% of cases occur in the setting of
an INCORRECT COUNT Problems with knowledge and
communication
• X-rays not called for, no radiologist input, wrong views, images called “negative”
• Incorrect count not reported, nurse manager never informed, no process for finding items or going to next step to make sure no harm
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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
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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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High impact Leadership involvement Simplify process and remove unnecessary steps Standardize equipment Evaluate forcing functions
Intermediate impact Checklist/cognitive aid Staffing workload Redundancy Enhanced documentation/communication/Readback Visual cueing
Low impact Education, training, form a committee to analyze, revise policy
Hierarchy of Actions
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High impact Leadership involvement Simplify process and remove unnecessary steps Standardize equipment Evaluate forcing functions
Intermediate impact Checklist/cognitive aid Staffing workload Redundancy Enhanced documentation/communication/Readback Visual cueing
Low impact Education, training, form a committee to analyze, revise policy
Hierarchy of Actions
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High impact Leadership involvement Simplify process and remove unnecessary steps Standardize equipment Evaluate forcing functions
Intermediate impact Checklist/cognitive aid Staffing workload Redundancy Enhanced documentation/communication/Readback Visual cueing
Low impact Education, training, form a committee to analyze, revise policy
Hierarchy of Actions
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1. Manual Standard – aka “Counting out of Kick Buckets”
2. Sponge ACCOUNTing System 3. Computer Assisted Sponge
Counting aka Bar-Code System 4. Count + Radiofrequency Detection 5. RFID Count and Detect
Sponge Mgmt Practices
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Pandora’s Box
The Practice of Counting
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Frights of Just Counting
HOPE
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A lot of Variation
0 0 0 0 0 0 0
1 1 1 1 1 1 1
2 2 2
4 4
0 1 2 3 4 5
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
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Sponge Management
CustomizedCare
WANDpatient +room
XRAY
Incorrect Count
Computer Assisted Sponge Counting2D matrix labeled spongeshandheld bar code reader
XRAY RF SystemRF tagged sponges
detector plastic wand
Incorrect Count
Sponge ACCOUNTing Systemplastic hanging sponge holderswall mounted dry erase boards
Incorrect Count
Smart Sponge SystemRFID chip labelled spongesbucket scanner and wand
Standardized Care
Safe Care
Policy
Process
Practice
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• 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
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Trust but Verify In Count
MWE
Standardized Practice
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• Only one system for staff to manage • Ten sponges no matter if laps or raytex • Running total count on board; easy math;
easily see how many are out • Ten pockets in holder means only one
sponge per pocket • Final count has no empty pockets, easy
visual • Show me step proves no sponges are in
the patient!
Always Multiples of 10
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Technologists Need To..
QUALITY
• Timely arrival in OR
• Bring adequate # of cassettes
• Take complete, high quality image of operative site - no “anatomical clipping”
• Obtain additional views if needed (lateral or oblique)
• Speak up if unsure
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Radiology Guidelines • Missing Surgical
Item (MSI) guidelines
• Region of Interest specified images
• Instructions for radiology techs to take correct images
• Information to help get it right
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Hospitals here….
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NLB Hospital Results YR I II III IV V VI VII VIII IX X XI XII XIII T
2005 4 4
2006 2 5 2 3 1 12
2007 1 2 2 2 3 1 1 1 13
2008 6 1 2 1 3 0 2 15
2009 3 0 1 0 4 1 2 3 14 1 29
2010 1 4 0 0 2 2 0 3 0 4 20 3 13 52
2011 1 4 0 0 2 1 0 0 0 0 1 5 9 23
2012 2 0 0 0 1 0 0 0 0 5 0 13 21
2013 2 0 0 0 0 0 1 0 0 2 1 6 12
2014 0 0 0 0 2 0 0 0 0 0 0 7 9
9 28 5 8 9 14 2 9 3 4 42 10 48 191
Year started using SAS # Retained Surgical Sponges
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0" 12" 24" 36" 48" 60" 72" 84" 96" 108"
BB"Y"F"Q"JJ"N"K"M"W"DD"EE"C"H"P"X"Z"
HH"B"E"G"O"V"FF"J"L"S"
KK"AA"GG"R"D"U"
Retained Surgical Sponges Ob/Gyn Cases: Pre/Post SAS 2006-2014 JAN
2006 2007 2008 2009 2010 2011 2012 2013 2014
1 3 1 0 2 2 ZERO ZERO ZERO V vcgibbsmd
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RETAINED SURGICAL SPONGES IN SURGERY
0" 12" 24" 36" 48" 60" 72" 84" 96" 108"
BB"Y"F"
CC"Q"JJ"N"K"M"W"DD"EE"A"C"H"I"P"X"Z"
HH"B"E"G"O"V"FF"II"J"L"S"T"
KK"AA"GG"R"D"U"
2006 2007 2008 2009 2010 2011 2012 2013 2014 5 2 6 3 4 4 2 2
Retained Surgical Sponges in Surgery: Pre/Post SAS 2006-2014 JAN
vcgibbsmd II
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Findings • ZERO is possible for at least a year,
ZERO for years is possible and 6 Sigma performance is possible too [1/300,000 cases]
• For these results everyone has to actually use the system as designed
• Takes a long time for “system” results
• Ongoing audits and training
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March headlines
Technology Will Solve This?
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Sponge Management
Policy
Process
Practice
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Two dimensional data matrix label. Sponges passed under reader and counted in at the beginning of case and then counted out at the end of case
Maintains “line of sight”, provides accuracy, all types of sponges, no ability to “read through” patient
[Safety Sponge System]
Count
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Detect
Reusable detecting wand, 9ft cord attaches to console. Can scan trash in any receptacles in room. Reads through tissue up to 24 inches Readout on console
[RF Assure]
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Count and Detect
Out scanner bucket
Inventory display and in count touch pad
WAND
Standalone RFID wand system
7mm RFID tag Complete count and detection system
[Smart Sponge System]
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Analogy
• Glucose • Sugar • Sweet & Low
(saccharine) • Equal (aspartame) • Splenda
(sucralose) • Stevia • ? What’s next
• Manual Practice (SpongeACCOUNTing System)
• Safety Sponge System (2D matrix counter)
• RF Assure System (RF tag detection)
• Smart Sponge System (RFID chip) ?? available
• OR Locate (RFID) • ? What’s next
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Change Practice
• There have been retained sponges with the new technology adjuncts.
• 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.
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Change Practice • Rewriting the policy or adding a step
to an existing policy is unlikely to prevent recurrence and actually decreases reliability
• This includes the addition of a new technology adjunct
• All the current devices are not new slices of cheese but just another hole in a slice of cheese
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Elements of Causation Applying Swiss Cheese Model of Sir James Reason BMJ, 2000;320:768
Exploration:SURGEONS
“Counts”:NURSES
Xray:RADIOLOGISTS
DEFENSES
LATENT FACTORS
OR PRACTICES
COMMUNICATION
Retained Surgical Sponge
MANUFACTURERS
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Where is your facility?
Look for at-risk behaviors • If you are using a manual practice
is it standardized?
• If you are using the SAS is it being used in all cases?
• If you are using a technological adjunct is it being used according to policy?
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• Have non-directive language • Have add-a-step actions • Unclear Small Miscellaneous Item part
• No specific practice for sponge mgmnt • Should use names for specific counts • Not multi-stakeholder; when they are • Surgeon actions not in surgeon domain • No Radiology or Anesthesiology
guidelines
Most “Count” Policies
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Non-directive language
• “Counts will be performed in all cases where there is a chance of retention” Who decides on the chance of
retention?
• Counts will be performed in all cases where surgical sponges are used and an incision is made or a wound exists
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AORN Practices • These are RECOMMENDED
practices - ultimately up to the hospital to decide
• Multi-disciplinary
Accountability beyond the RN Circulator
Guidelines for
• Surgeons, scrub techs, anesthesiologists, radiologists
• Addresses problems with device fragments and small misc items
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Count Confusion
Count
IN: initial, added IN 1st
OUT: Closing 2nd
OUT: FINAL 3rd
Using numbers, 1st, 2nd, 3rd is confusing and poor communication. What is the 4th or 5th count? Anyone can call for a count anytime so how do you “record” the 6th or other interim counts?
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1. Before the procedure to establish a baseline and identify manufacturing packaging errors and when new items are added to the field
2. Before closure of a cavity within a cavity 3. When wound closure begins 4. 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)
5. Time of permanent relief of either the scrub or circ although direct visualization of all items may not be possible
AORN Counts
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Better would be:
• Perform a count at skin closure
• Perform a count at the end of the procedure when counted items are no longer in use (ie. Final count)
This however changes a 5 count practice to a 6 count practice……. without demonstrable advantage
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Count Confusion
• No wonder there are problems with just counting!
• Nurse A’s 2nd count is Nurse B’s 1st final count or maybe not……
• This is a good example of where communication problems contribute to retention
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Sponge ACCOUNTing • Sponge ACCOUNTing uses words for
each of the 3 primary counts • The FINAL COUNT is defined:
at the FINAL COUNT all the sponges (the used and unused) must be in the sponge holders
• IN, CLOSING, FINAL counts each have defined actions so there is less ambiguity
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“separate sponges”
“box instructions”
“hard-coded”
“novice counters”
“film quality”
“custom packs”
“different names”
71
“sponges weighed”
SPONGE ACCOUNTing
Sponges are weighed so unknown how many are really in a pack
Instructions on box are different
Count record and x-ray requests are hard-coded and difficult to get changed
Whole area film to find RSI not in vernacular
Counting sponges Not part of usual practice In birthing rooms,
People set-up the custom packs Different names for each sponge all around the country
see, SEPARATE, say
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Just Culture
• Inadvertent Error Console and address system issues that set up
the humans to err
• At-Risk Behavior Coach and address group dynamics
• Reckless Behavior Counsel and provide warning/discipline around
improper choices
• Malicious Behavior Discipline
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For Example: • Unintentional Error
MD: mistaking raytex marker for wire or drain
• System response is having a radiologist interpret all images in real time
RN: In the heat of the battle loaded a holder from top down and had an empty pocket in the bottom pocket
• System response is having team based action of a “show me step”
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For Example
• At-Risk Behavior (usually accepted group norms)
MD: closing abdomen before x-ray obtained in face of known incorrect count
Scrub: “counting” the sponges e.g. holding two up and saying “count correct” but not throwing them off the field so all can go in the holders
Circ: Using clear-backed plastic sponge holders and hanging a blue “chux” behind them
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No Empty Pockets?
• Do you think they performed a show me step?
• What do you think they recorded in the perioperative report?
• Was this only one person?
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For Example
• Reckless Behavior (making a clear choice in face of training and knowledge) MD: grabbing a blue towel from back table and
inserting in patient
Scrub: fanning sponges on the IN count Circ: marking a count “correct” in the presence
of empty pockets
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Using the practice?
• Short case
• 10 raytex used
• No sponges placed in the sponge holders
• Do you think this was an accident?
• It was an error? Just forgot? Never got trained?
• Individual choice
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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 managers to train, perform audits and competency assessments and embrace reporting
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Thank You
For sharing lessons learned and having the courage to effect change
For taking the time in your day to attend this presentation
To the Patient Safety First Collaborative and
To our patients ……. who endure
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SAFER SURGERY
www.nothingleftbehind.org