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Fmea Sponge Retention Mpb 041710
- 1. FMEA Sponge retentionMatt Bommarito HCA - Director performance improvement Lean six sigma Performance Improvement ASQ Workshop - April 17, 2010
- 2. Objectives Sponge Retention Background Causes Consequences Case Study Results FMEA Sponge Retention Process FMEA Example for Sponge Retention Sponge Retention Solutions/Results Sponge Retention FMEA Benefits 2
- 3. Background Foreign Objection Retention in a body cavity or incision after an operation includes sponges, whole instruments, needles, clamps, retractors hemostats and other broken or dislodged pieces of equipment – even a towel The projected rate of retained foreign bodies each year for inpatient surgical procedures is 1,500 out of 28 million patients (.00535%) with sponges being the most commonly retained foreign body. 3
- 4. Causes for Sponge Retentions Emergencies Unplanned changes in procedure Higher body-mass index Multiple major surgical procedures being performed at the same time and an incorrect instrument or sponge count Distractions Inadequate Training Not conforming to count procedure 4
- 5. Consequences – Sponge Retention Sepsis, infection, reoperation, increased length of hospitalization, hospital readmission, fistula formation, bowel obstruction, visceral perforation and death Adds four days to the average hospital stay (LOS) Readmission Source: The Agency for Healthcare Research and Quality, 5
- 6. Case Study 54 (out of 235) patients with a total of 61 retained foreign bodies (42 were sponges – 69%) Thirty-seven of the patients with retained foreign bodies (69 percent) required reoperation, and one died Source: NE Med Journal, April 24, 2003, Departments of Surgery, Brigham and Women's Hospital, Boston, MA 02115, USA. 6
- 7. Sponge Retention FMEA Process Identified Team (OR Surgery Director, RN, Tech, Surgeons, Suppliers, Facilitator) Mapped Current State Process Followed FMEA Procedure Process step Item/function potential failures Failure Modes Failure Effects Potential Causes Current Controls Assignment of RPN 7
- 8. 8a
- 9. 8b
- 10. 8c
- 11. Team Identified a list of 68 failure modes that could lead to a sponge retention RPN Summation ∑ 13408 Range RPN Score (24 to 576) 10 process steps RPN Score > 300 24 process steps RPN Score > 200 Mean Score = 197.1765 Std Deviation = 145.549 8 Sponge Retention FMEA Process
- 12. Develop Recommended Actions Identify Responsible Person Record Actions Taken Monitor Results Rescore – Revised RPN 9 Sponge Retention FMEA Process
- 13. FMEA Sponge Retention Solutions Ensure Standards are up-to-date Proper Counting and Documentation Procedures Effective Training (Counting, Standards, Procedures) Improved Sponge IDs - sponges have a number (eg, "1," "2," "3") sewn into the corner of the sponge RF Tagged Sponges “Clear Count” RFID Sponge Count System “Clear Count” RFID Wand for non-reconciled Sponges http://www.clearcount.com/?gclid=CNCbybaS0KACFR6kiQodtRQI0Q 10
- 14. PriorAfter RPN Summation ∑ 13408 3147 Mean RPN Score 197.2 46.3 Std Deviation RPN Score 145.5 29.7 Max RPN 576 192 Min RPN 3 24 RPN Score > 300 10 0 RPN Score > 200 25 0 11 Sponge Retention FMEA – RPN After
- 15. FMEA – important tool of Lean Healthcare FMEA – Failure Mode and Effects Analysis 15
- 19. Core Measures
- 20. Improved LOS
- 21. Hospital Reputation 13 All of these combined outcomes are based on error reduction / elimination
- 22. 17 How does that sound?
- 23. 15 Questions?
Editor's Notes
- Thank you Heather for the introduction. It is a pleasure to be here to speak to you today and I sincerely appreciate the invitation. As Heather stated, the majority of my career was spent in manufacturing and specifically within the automotive sector at the Ford Motor Company. I moved into healthcare a few years ago, and appreciate the similarities of both environments. There are processes, people and technology and our careers in Performance/ Process improvement lend themselves to meeting the ongoing requirements for continuous improvement. One major difference in healthcare, obviously, is the human element – where even a Six Sigma process capability may be substandard and unacceptable. This FMEA presentation for Sponge retention definitely falls in that category. The adverse effects of a failure in this case is plain unacceptable – yet the customer “or patient” pays severely for the mistake. Besides all kinds of adverse medical effects including infections, re-operations, longer hospital stays, the patients may even lose their lives – This is due to a mistake or a failure from someone on the surgery team. It could be nurse, the circulator, a tech or even the surgeon….the point is the patient suffers significantly. And, in today’s transparent world, the quality metrics, patient satisfaction scores and hospital reputations are at stake. Not to mention the cost effect of increase length of stays,hospital re-admissions and potential fines and lawsuits. The FMEA – Failure Mode Effects Analysis is a tool to help mitigate and more importantly, prevent medical errors. It is used throughout the healthcare universe and has become a Joint Commission requirement.
- So, the objectives for today are:Sponge Retention BackgroundCauses Consequences Case Study ResultsFMEA Sponge Retention ProcessFMEA Example for Sponge Retention Sponge Retention Solutions/Results Sponge Retention FMEA BenefitsResnar’s Swiss Cheese Model.
- As you can see, the types of foreign object retention is unbelievable. In addition, to sponges, there are numerous medical devices, equipment, supplies and even towels that can be left behind in a patient causing serious harm. Medical errors account for 98,000 deaths annually and can be associated with inaccurate or incomplete diagnosis, treatment of a disease, injury, syndrome, behavior or infection. The 98,000 deaths was published by the Institute of Medicine in 1999. So the question is what portion of the 98,000 deaths are due to foreign bodies being left in patients. I calculated the deaths attributed to sponges annually at 27 which I will explain more in the presentation. One thing we really do know for sure is the vast majority of the foreign objects left behind are sponges. Speaking of medical errors, I can attest to my own case recently. In February 2009, I had a stress test…..Has anybody witnessed or want to discuss medical errors?
- These are the majority of the consequences, and as I mentioned there are also the hospital impact including the poor quality (healthgrades scores), reputation and potential fines and lawsuits.
- In this particular study from the NE Medical Journal, 235 patients studied due to some condition that led them to believe there was a problem post surgery that may have involved a foreign object left in them. And, the positive hypothesis proved true for 54 out 235 patients. In fact, some of the patients had more than one foreign object left in them as you see by the total of 61 retained foreign objects or bodies. Not to make light of it, but those patients that had more than one foreign object left them, were truly having a “bad day”.And sponges accounted for 69% of the types of foreign bodies.(42/61)So, 37 of the 54 patients, or 69% as well, had foreign bodies left in them. So, as I stated earlier the death ratio is 1 out of 54 patients with a foreign body left in them or 1.85%. If we apply the same ratio to the 1500 people out of the 28 million people that have surgery annually, the death rate is approximately 27 patients per year. Now this is just the fatalities, not to mention the 1500 or so that go through excruating pain and suffering to combat the adverse effects and ultimately requiring a secondary surgery.
- Here are several potential solutions for improving the sponge retention process. Some of the solutions shown here were included in the FMEA we are reviewing. Ensuring up-to-date standards, proper counting procedures and a numbering system are some of the most common. Education is a common corrective action that you will see throughout this FMEA and it is consistent with many healthcare journals for process improvement. In this case, one specific improvement item is shown as item #5 on page 1 of the FMEA. This improvement item is to purge the supply process for sponges that had a certain color (blue) thread. The blue color thread indicated the sponge was not R/F (radio frequency) which means it would not have been detected by the r/f equipment that we identified in the process map. Although purchasing, is charged with ensuring the inventory change is occurring from blue threaded sponges to orange --- another check is the visual to ensure it occurs. Reporting a supplier error is another corrective action #13 --- in the case of a thread missing altogether. The supplier needs to know. Hospitals do not have an I/Q department to recheck suppliers.Much of the education surrounds proper procedure and ability to “tune out” distractions. In the end, proper counting is critical. There are some “hi tech” RF scanning and counting processes I would like to show you.
- I cannot emphasis enough how important The FMEA – Failure Mode Effects Analysis tool can lead a team to the correct improvement actions to help mitigate and more importantly, prevent medical errors. It is imperative the Lean Six Sigma Director / Black Belt recognize the type of performance improvement problem that an organization is experiencing and apply the right set of tools for success. Value Stream Maps, 5s, Six Sigma analysis and other tools just would not be applicable to this particular problem --- improving surgical success by eliminating sponge retentions. In my role, and what many of you do today or will do in the future, the ability to identify the right performance improvement tool and the team to solve the problem is far more critical than having the subject matter knowledge from the faciltatiors viewpoint. I’m sure you will all agree.
- In addition to the patient safety and satisfaction, hospital personnel and staffs absolutely want procedures to go well without an event. They are all professionals and I have the most respect for their dedication, knowledge and patient care responsibilities. Errors create numerous reports and explanations and can result in career ending situations. Core measures are critical quality measures like mortality, infection rates and other clinical outcomes. Having positive performance is key to surviving in competitive hospital markets. Patients will go down the street if the number look better. LOS decreases costs and therefore helps the overall healthcare cost structure .And, Hospital reputation is key.
- FMEA Joke?