Healthcare Consulting Services
October 4, 2011
Radiology Report Errors
and Speech Recognition
All of you have probably had fun at one time or another uttering short phrases or paragraphs into speech recognition software and chuckling at the bizarre things that pop up on your screen. But suppose those bizarre things were popping up in medical reports you were sending out to others.
Many different venues in medicine have adopted speech recognition software to improve efficiencies and reduce costs. It can be especially useful in those areas where timeliness of reports is important. For example, an emergency department physician can dictate via speech recognition software and have immediate access to a typed note that he/she can edit and sign before the end of his/her shift. That also means the note will be immediately available to all others with access to the computer system (with conventional dictation transcription services the typed note may not be available for 24 hours).
Radiology is another area where timely reports may be useful and radiology is typically the service that adopted speech recognition software longest ago. Radiology reports, whether normal or abnormal are very structured and one may develop templates that nicely meet many aspects needed in a report. For example, one could state load normal chest x-ray template, then make any minor editing changes needed for the actual chest x-ray you are reading. That can save considerable time compared to dictating the whole report from scratch. Indeed, use of speech recognition software systems has improved radiology report turn-around times (TATs) considerably.
However, as reports get more complex templates become less useful and dictation process becomes more complicated. This substantially increases the chance that errors may appear in the reports.
A study just published (Basma 2011) found that error rates in breast imaging reports were substantially higher in those done by speech recognition software compared to traditional dictation transcription. In fact, at least one major error was found in 23% of reports dictated by automated speech recognition compared to 4% by traditional dictation transcription, an error rate almost 8 times higher! They found that there was no difference in error rate whether the report was dictated by a resident/fellow vs. attending radiologist nor whether the person dictating had English as his/her first language. The modality for which the report was being done did influence the error frequency, with those requiring more complicated reports (eg. breast MRI) having more frequent errors.
The types of errors were similar in the reports generated by speech recognition software and traditional dictation. The most common error was addition of a word but word omission, word substitution, and punctuation errors were common. Incorrect measurements or incorrect units of measurement were also seen. Errors were most common in the Findings section of the imaging reports but could be found in most sections.
Because the above study was done at a single academic teaching organization and most cases were discussed at a multidisciplinary case conference before interventions were done, the authors did not feel any patient was adversely impacted by these errors. However, one can readily anticipate how such errors could adversely impact patient care, particularly if the physician receiving the report is outside the hospital system and does not have access to the images themselves. Imagine the impact of omission of no before evidence of cancer or, conversely, erroneous addition of no before evidence of cancer!
There are reasons other than faulty software that also come into play whether you are using speech recognition software or other dictation systems. Background noise, the type of microphone you are using, etc. may influence the output. Similarly, systems may not pick up voice inflections where you are trying to emphasize something. So dont just blame your system. Make sure you appropriately review and edit your reports or notes.
Radiologists themselves are unaware of the frequency of errors in reports generated by speech recognition software. One study (Quint 2008) found errors in 22% of radiology reports where radiologists estimated the error rates would be well less than 10% for the radiology department as a whole and even less frequent for themselves. These were errors that could convey incorrect or confusion information. Examples included incorrect words, omitted words, nonsense phrases, added words, right-left substitutions, incorrect measurements or units of measurement. Incorrect image numbers or errors related to templates were also seen. A large number of nonsense errors with speech recognition technology was also seen in a recent study from Australia (Chang 2011).
When speech recognition software first became available, accuracy rates around 95% were often quoted. Such was hardly acceptable because it took more time to edit the reports that to just use traditional dictation systems. But as the accuracy of speech recognition systems has improved, they have become much more efficient and save time and costs. But no system is perfect and it is imperative that careful review and editing of each report be done before it is signed. Also keep in mind that some systems may allow pending (not yet reviewed or signed by the radiologist) reports to be seen.
Even when your errors do not impact patient care directly, they can be a reflection of your professionalism. If we see a report or note that is replete with grammatical or punctuation errors, we may imply some degree of sloppiness or disorganization and assume, incorrectly or not, a similar sloppiness in the thinking processes of the author.
And then there are always automation surprises (see our November 6, 2007 Patient Safety Tips of the Week Don Norman Does It Again! and May 19, 2009 Learning from Tragedies). Our favorite example is when we try to type EHR (for electronic health record) and our word processors spell checker automatically changes it to HER (try it yours probably does this too!).
Even as we do this column each week and review it twice after running it through a spell checker and a grammar checker, we are sometimes aghast when we see obvious mistakes in the online posting that we missed.
So how do mistakes get overlooked when we review and edit our reports? The number one contributory factor is usually time pressure. In our haste to get the report done and the big queue of other reports to review, we simply dont review and edit thoroughly. One of the early studies on report errors related to speech recognition systems (McGurk 2007) noted that such errors were more common in busy areas with high background noise or high workload environments. Though not statistically significant, there was a trend toward lower error rates with more junior staff (note that Basma et al had also noted fewer minor errors in reports where junior staff were involved).
But a second phenomenon happens as well. Our mind plays tricks on us and we often see what we think we should see. We show many examples during some of our presentations of orders or chart notes that have obvious omissions where the audience unconsciously fills in the gaps and thinks they saw something that wasnt there (of course they meant milligrams). It is easy for us to do the same thing when we are reading our own reports. In addition, the recency phenomenon probably comes into play, where the radiologist perceives he/she sees what he/she just dictated. The Quint paper suggests that mistakes like this may actually be more frequent the sooner you are reviewing your report. They even suggest that reviewing your report 6-24 hours after dictation rather than immediately may reduce the error rate.
Dictating in an environment with minimal background noise can help reduce errors. And McGurk et al note that use of macros for common standard phrases also reduces the error rates.
Were willing to bet that most of you have no idea what your error rate is, regardless of whether you are using automated speech recognition software or traditional dictation transcription services.
Obviously, you need to include an audit of report errors as part of your QI process, not only for radiology but for any service that does reports of any kind, whether done by speech recognition software or more traditional transcription. While random selection of reports to review is a logical approach, there are other approaches that may make more sense. Part of the peer review process in radiology is to have radiologists review the images that a colleague had reported and see if the findings concur. One could certainly add checking for report errors as part of that process. In the Quint paper, the reports were analyzed as they came up as part of their weekly multidisciplinary cancer conference. Reviewing them is a fashion like this makes the review more convenient but also adds context to the review. One gets to see how the errors could potentially impact patient care adversely. We like that approach where such multidisciplinary conferences take place. It also tends to raise the awareness of the existence and scope of report errors among not only the people generating the reports, but also those reading the reports.
Your radiology report is really your interface with the rest of the healthcare system (Kanne 2011) so you want to make sure you get it right. Integrating evaluation of your reports into your QI program thus is critical.
So make sure you are determining your error rates in all your dictated reports (whether traditional or speech recognition format) and feeding back those error rates to the providers doing the reports. Such feedback to the providers doing the reports was important in reducing the error rates in the study by McGurk et al.
Basma S, Lord B, Jacks LM, et al. Error Rates in Breast Imaging Reports: Comparison of Automatic Speech Recognition and Dictation Transcription. AJR 2011; 197: 923-927
Quint LE, Quint DJ, Myles JD. Frequency and Spectrum of Errors in Final Radiology Reports Generated With Automatic Speech Recognition Technology. Journal of the American College of Radiology 2008; 5(12): 1196-1199
Chang CA, Strahan R, Jolley D. Non-Clinical Errors Using Voice Recognition Dictation Software for Radiology Reports: A Retrospective Audit. Journal of Digital Imaging 2011; 24(4): 724-728
McGurk S, Brauer K, MacFarlane TV, Duncan KA. The effect of voice recognition software on comparative error rates in radiology reports. Br. J. Radiol. 2008; 81: 767-770
Kanne JP. Quality Management in Cardiopulmonary Imaging. Journal of Thoracic Imaging 2011; 26(1): 10-17
October 11, 2011
LEAN in the Lab
In our November 16, 2010 Patient Safety Tip of the Week Lost Lab Specimens we discussed performing a FMEA (Failure Mode and Effects Analysis) related to the whole process of handling lab specimens. While youre doing a FMEA on such an issue you probably should integrate it with redesigning the overall process with LEAN (Toyota Production System) principles. One lab successfully used LEAN principles to redesign processes and improve quality, patient safety and workflow in histology and anatomic pathology (Serrano 2010) at Avera McKennan Hospital in South Dakota.
The Serrano article begins by describing the concepts and tools used in their LEAN redesign project. We usually begin a FMEA by mapping out the entire workflow from beginning to end. In LEAN we develop a value stream map that similarly identifies all the steps involved. However, the key to the working with value stream mapping is looking at it through the eyes of the customer(s) and identifying those steps that add no value or are considered waste. The voice of the customer (VOC) principle is that your processes should deliver what your customer(s) wants and needs and you need to eliminate those steps that are not of value to the customer(s). Keep in mind that a typical lab has multiple customers patients, physicians, hospital staff, regulators, and even the staff in the lab itself. Anything that does not add value to the customer(s) should be considered waste (muda in the vernacular of LEAN).
The Serrano article nicely describes the various types of waste. One type is defects or time spent doing something incorrectly or inspecting for errors. Overproduction includes not only producing too much but producing it sooner than needed. There is often waste in transportation, that is unnecessary movement of a product within a system. Similarly, there may be unnecessary motion or movement of employees in the system. Waiting for the next work or next activity is a form of waste. Inventory (excess inventory) and overprocessing (doing work not valued by the customer) are other forms of waste. Lastly, waste of human potential by not engaging employees is important.
The Serrano article then shows a spaghetti diagram, another LEAN tool, to show the paths taken by product and employees during processes. For example, this diagram might contain a map showing all the key places and items that workers interact with (eg. a reception bin, a refrigerator, accessing station, sterile equipment supply site, processors, etc.). This helps one visually understand the complex movements within the system that may be unnecessary and cause delays or bottlenecks. (Note that one could also borrow from another set of principles and tools in yet another quality improvement approach Theory of Constraints or TOC that is especially good at dealing with bottlenecks.)
LEAN then utilizes standardized work, basically best practices to provide guidance to proper performance and order of tasks. Serrano et al. however stress that this still allows professionals to use their own judgment to make certain decisions within that guidance.
Two somewhat related LEAN concepts are single piece flow and first in - first out. The former concept refers to the need (in a lab) to keep batches to as small a size as possible. The latter refers to making sure that the item which has been in inventory the longest is processed first.
One of the most well-known LEAN principles is 5 S (sort, straighten, shine, standardize, sustain). These basically say that you need to keep your workspace designed and maintained to promote efficient use. You sort out unneeded items and keep others based on frequency of use. You straighten your workspace to reduce the amount of wasted space. You shine it to keep it neat and clean daily and standardize it so workspaces are consistently organized for anyone who might use them. And you sustain the 4 other Ss. (Boy, could my desk use a healthy dose of LEANs 5 Ss!!!)
Double-binning is another LEAN concept where 2 identical bins are filled with enough supply for a typical 8-hour shift. When one bin becomes empty it serves as a visual cue for a designated person to refill that bin while work continues on the second bin. Another visual cue is shadowing where the exact location of equipment or supplies is highlighted so that one can immediately see missing or misplaced items.
And they stress two other LEAN concepts that occur after the redesign. A kaizen is a focused small-scale improvement project (timeframe usually 1-2 weeks) typically aimed at addressing bottlenecks or other problems that are seen after the bigger redesign has been implemented. The other is gembi gembutsu which means go and see. This means that you need to go out into the frontlines to actually observe what is going on and talk to the workers about what is going on. The latter, of course, is known to administrators as management by walking around (MBWA) though most of you doing quality improvement and patient safety activities would recognize this is part of your patient safety walk rounds.
Serrano et al. go on to describe what their lab looked like and how it functioned prior to their LEAN project. Not surprisingly, many things had been simply added on randomly without consideration of how they would impact workflows, movement, and efficiencies. (Sound familiar? Thats a problem with adding new technologies to almost every area of the hospital!)
They then describe how they implemented their LEAN project, beginning with the ways they reached out to hear the voice of the customer (surveys, questionnaires, interviews, etc.) and how they developed their value stream map (yellow sticky notes, videotaping, etc.). After analysis of all these items they were able to construct a future state process map. They then first addressed processes in the supply chain and then receipt of specimens and accessioning, including things like pickup and delivery of specimens, in such a way that they could minimize the need to batch items and facilitate the first in-first out principle.
They go into detail about the redesigned processes in each step. Ultimately, they facilitated a change from a rush/lull workflow to a steady workflow. Outcomes were significantly improved. Overall surgical specimen turn-around times (TATs) were reduced 67%, with over 80% of cases being signed out within 24 hours. Staff productivity improved significantly, stress levels were reduced, and satisfaction (both patient and medical staff) reached an all time high.
Mark Graban, in his excellent book Lean Hospitals (Graban 2008), also describes a similar dramatic improvement in lab outcomes after a LEAN redesign. St. Pauls Hospital in British Columbia was able to reduce average TAT by a full day, smooth out the workflow throughout the day for all workers (even transcriptionists now had an even workflow rather than receiving large numbers of batched dictations), improved their quality rating on a 5-point Lickert score from 3.5 to 4.5, and improved employee satisfaction.
One thing missing from these studies are measurements of hard patient outcomes. This tends to be a problem in much of the literature on LEAN in healthcare. A recent critical review of LEAN in emergency departments (Holden 2011) found that implementation of LEAN in emergency departments invariably was associated with improved measures of processes (eg. wait times, ER LOS, door-to-needle times, % of patients leaving without being seen, etc.). However, seldom were there reported formal measures of patient outcomes or employee outcomes. Holden also suggests the possibility that publication bias may be in play as well. Nevertheless, Holden also found little evidence of unexpected consequences nor harm from LEAN interventions. Though the employee outcomes were seldom formally measured, numerous studies did comment on the anecdotal increase in employee feeling of involvement and empowerment when LEAN was used.
For those of you new to the LEAN world, the Serrano article provides a great introduction to basic concepts and principles of LEAN. For those of you who are looking for more detail on LEAN in healthcare, wait about a month for the upcoming second edition of Mark Grabans book Lean Hospitals.
Serrano L, Hegge P, Sato B, et al. Using LEAN Principles to Improve Quality, Patient Safety, and Workflow in Histology and Anatomic Pathology. Advances in Anatomic Pathology 2010; 17(3): 215-221
Graban M. Lean Hospitals: Improving Quality, Patient Safety, and Employee Satisfaction. Productivity Press 2008
Holden RJ. Lean Thinking in Emergency Departments: A Critical Review. Ann Emerg Med 2011; 57(3): 265-278
Print LEAN in the Lab
October 18, 2011
High-Risk Surgical Patients
Whats the surgical mortality rate at your hospital? You probably dont know what it is. And if you do know what it is you probably dont know what it means. Is it good? Is it bad? It is extremely difficult to use surgical mortality rates across hospitals (or even within hospitals across time). Thats because we dont have any universally accepted methods of risk-adjusting surgical patients. Some methods of risk adjustment have been developed for specific surgical procedures (eg. coronary artery bypass, percutaneous coronary interventions, etc.) but these obviously apply to small subsets of the entire surgical population.
But there has been a renewed interest in identifying and improving on mortality rates in high-risk patients. An article earlier this year (Moonesinghe 2011) focused on the epidemiology and outcomes of high-risk surgical patients discussed many of the risk assessment tools that have been used in determining surgical risk and outlined the many methodological issues that have hampered more widespread use. Another article in that same issue (Lobo 2011) found that multiple organ failure was the main cause of death in high-risk patients undergoing non-cardiac surgery and identified some of the factors associated with death.
In our June 2010 Whats New in the Patient Safety World colum The Frailty Index and Surgical Outcomes we noted a study (Makary et al 2010) demonstrating use of the frailty index greatly improved the ability to predict post-surgical outcomes (post-op complications, LOS, and discharge to an SNF or assisted living setting) much better than existing methods. And in our August 9, 2011 Patient Safety Tip of the Week Frailty and the Surgical Patient we noted two studies by Robinson and colleagues (Robinson 2009, Robinson 2011) looked at outcomes in (mostly male) patients age 65 and older who were undergoing major elective surgical procedures in the VA medical system and correlated them with measures of frailty, disability, and comorbidity. Using a group of markers that were easy to use in a surgeons office setting they were able to predict 6-month postoperative mortality and post-discharge institutionalization.
A recently released report from the Royal College of Surgeons of England (Royal College 2011) is a call for action to address high rates of mortality and morbidity in high-risk general surgery patients, especially patients undergoing emergency or unscheduled general surgery procedures. Cardiac surgery, which is closely measured and audited and highly protocolized, typically has mortality rates of 2-3% in England. Compare high-risk general surgery to that and you find much higher rates of both mortality and complications. They note that 15% of surgical cases account for 80% of the deaths they see annually. And the frequent complications lead to long lengths of stay and considerable costs to the healthcare system.
And they are quick to point out that the problem is not just with surgeons and operating rooms. Rather all levels of the perioperative experience contribute to the excess mortality and morbidity in the high-risk patient. That includes making sure there is appropriate access to the operating room, appropriate staffing, accessible radiology and interventional services and adequate critical care. Though this work comes out of the UK, where critical care beds are far fewer than in the US, the importance of getting the high-risk patient to the appropriate level of care is important.
The report has 9 main recommendations:
Postoperative complications, in fact, account for most of the morbidity and mortality in general surgery but they readily identify opportunities for improvement before, during and after surgery.
They focus, in particular, on rapid identification of complications so that rescue interventions can be performed on a timely basis. There should be a special focus on identifying sepsis and recognizing severe sepsis and septic shock. For severe sepsis they note two important steps. First consists of early resuscitative measures (lactate levels and blood cultures followed by broad-spectrum antibiotics within the first hour and optimal fluid resuscitation). The second critical step is dealing with the source of sepsis, which often means a surgical procedure or interventional radiology procedure is needed. Timing of the source control is crucial.
The British system often relies on the MEWS early warning system to help identify sepsis and other complications early. They provide algorithms for escalation of response to the patient with developing sepsis that includes getting the most experienced personnel involved, getting the patient to the appropriate level of care, expediting imaging or other necessary diagnostic studies, initiating the sepsis protocol and doing source control. They note that delay in source control more than 12 hours after onset of hypotension raises the mortality rate from 25% to 60% compared to patients with delays of less than 3 hours. For patients with full-blown sepsis (evidence of end-organ damage) surgery or radiologic drainage should be carried out within 6 hours of onset of deterioration.
Healthcare facilities must therefore be capable of adjusting elective surgical schedules, prioritizing these patients as critical, and ensuring access to ORs that are appropriately staffed and equipped to facilitate source control.
Though they start the report focusing on the postoperative complications, they then go back and focus on the need to assess and identify the risk in all patients at several points in time. They make a case for objective assessment of risk and note several tools available to help assess that risk, such as the simple but validated P-POSSUM score or a scoring tool they developed in their report. Yet others use modifications of the ASA class or use data from the types of procedures being considered.
So the patient should have his risk identified prior to surgery. But they also recommend a second determination of risk should be undertaken near the end of the surgical procedure. The latter facilitates disposition on completion of the surgery and such decisions should be made jointly by the surgeon and anesthesiologist. They suggest use of the surgical Apgar score (Gawande 2007, Reynolds 2011) or the end of surgey bundle described in their report. Note that in addition to the more general risk assessment tools, some have developed risk prediction tools for specific procedures, such as one recently validated for emergency colon surgery in the very elderly (Kwok 2011). Those with predicted mortality risks equal to or above 10% should be admitted to high-capability post-anesthesia care units (PACUs) or critical care units.
Like everything we do in quality improvement, measurement and audit are critical activities. They make a case for such auditing on a national level but also identify those outcomes and process parameters that should be audited and measured on a local level, including:
The report appendices have some good algorithms and care pathways, and information about the MEWS scoring and the end of surgery bundle plus a comprehensive bibliography.
Expect to see a lot more in the coming year about managing high-risk general surgery patients.
Moonesinghe SR, Mythen MG, Grocott MPW. Review Article: High-Risk Surgery: Epidemiology and Outcomes. Anesth Analg 2011; 112: 891-901
Suzana M. Lobo SM, Rezende E, Knibel MF, et al. Early Determinants of Death Due to Multiple Organ Failure After Noncardiac Surgery in High-Risk Patients. Anesth Analg 2011; 112: 877-883
The Royal College of Surgeons of England / Department of Health. The Higher Risk General Surgical Patient: Towards Improved Care for a Forgotten Group. 2011
Gawande AA, Kwaan MR, Regenbogen SE. An Apgar Score for Surgery. J Am Coll Surg 2007; 204: 201208
Reynolds PQ, Sanders NW, Schildcrout JS, et al. Expansion of the Surgical Apgar Score across All Surgical Subspecialties as a Means to Predict Postoperative Mortality. Anesthesiology 2011; 114(6):1305-1312
Kwok AC, Lipsitz SR, Bader AM, Gawande AA. Are Targeted Preoperative Risk Prediction Tools More Powerful? A Test of Models for Emergency Colon Surgery in the Very Elderly. J Am Coll Surg 2011; 213(2): 220-225
Makary MA, Segeve DL, Pronovost PJ, et al. Frailty as a Predictor of Surgical Outcomes in Older Patients. Journal of the American College of Surgeons 2010;
Robinson TN, Eiseman B, Wallace JI, et al. Redefining Geriatric Preoperative Assessment Using Frailty, Disability and Co-Morbidity. Annals of Surgery 2009; 250(3): 449-455, September 2009
Robinson TN, Wallace JI, Wu DS, et al. Accumulated Frailty Characteristics Predict Postoperative Discharge Institutionalization in the Geriatric Patient. J Am Coll Surg 2011; 213(1): 37-42, July 2011
October 25, 2011
Renewed Focus on
Over the last 5 years we have done a number of columns on MRI safety (see the links at the end of todays column). But this week the FDA is conducting a workshop on MRI safety in response to ever-increasing adverse events related to MRI scanning. There has been an almost five-fold increase in MRI accidents from 2004 to 2009, from 40 reports to 193 reports in the FDAs MAUDE database (Forrest 2011). The Forrest article on the AuntMinnie.com website notes a recent review of the MAUDE incidents done by two of the most well-known researchers in the field of MRI safety, Tobias Gilk and Emanuel Kanal. They found the vast majority of incidents fell into one of three categories: (1) burns and thermal injuries (2) projectile events and (3) hearing loss, all potentially preventable events.
Weve discussed burns from MRI in several columns (see our Patient Safety Tips of the Week for June 1, 2010 Iatrogenic Burns and October 5, 2010 More Iatrogenic Burns and our March 2009 Whats New in the Patient Safety World column Risk of Burns during MRI Scans from Transdermal Drug Patches).
For many years we have also considered the presence of certain devices, like cardiac pacemakers or implantable cardioverter-defibrillator devices, to be absolute contraindications to MRI scanning. Over the years there has been a focus by device manufacturers to develop devices that are MRI-compatible. Also, a recent study (Nazarian 2011) demonstrated a very low incidence of harm when MRI is done with appropriate precautions in patients with some select cardiac devices. We concur with the editorial accompanying that article (Reynolds 2011) that it is critical to assess the potential benefits and risks in individual patients with such devices and if the decision is to procede with MRI, all the precautions taken in the Nazarian study should be followed.
The most feared incidents in the MRI unit are the projectile events. Just published online in Patient Safety and Quality Healthcare (which, by the way, is another great free patient safety resource) is the root cause analysis of the terrible accident 10 years ago in which young Michael Colombini was fatally injured in a projectile incident in an MRI suite (Gilk 2011). The video of that root cause analysis is also available at the PROACTFor Healthcare.com website. The video is 24 minutes long but we guarantee you it will probably be some of the best 24 minutes of your time invested. Gilk and his colleague Robert Latino have done a superb job in reconstructing all the facts in the Columbini accident from published accounts and publicly available testimony in the legal proceedings following that case.
The incident, like almost all other incidents we see with bad patient outcomes, was the result of a cascade of events, not a single error or event. And many (in fact most) of the contributory events were not temporally related to the accident but rather were related to the design, planning, and oversight of the MRI unit.
This RCA has some very valuable lessons learned. While most facilities have done a good job of inservicing their staffs about MRI dangers and safety, sometimes someone who has not been inserviced might gain access to the MRI suite. In this RCA, the two MRI technicians had gone to another room and temporarily lost auditory contact with the MRI suite, when a nurse happened to return to the MRI suite to pick something up from a prior patient encounter. That nurse heard the frantic pleas from the anesthesiologist attending the patient for oxygen. That nurse unwittingly picked up a ferromagnetic oxygen canister and handed it to the anesthesiologist. The magnet then wrested the canister from the anesthesiologist and it launched into the MRI unit, fatally injuring the patient. Apparently neither the nurse nor the anesthesiologist had ever been trained in MRI safety. The RCA goes on to discuss not only the training issues but also the fact that individuals lacking such training had relatively easy access to the MRI unit.
In our March 17, 2009 Patient Safety Tip of the Week More on MRI Safety we discussed many important issues related to role of the anesthesiologist in the MRI suite. We discussed the American Society of Anesthesiologists (ASA) report Practice Advisory on Anesthetic Care for Magnetic Resonance Imaging. In addition to all the training related to working in the MRI suite, the anesthesiologist needs to develop a plan for implementing anesthesia care before each individual case. Such a plan should be done in collaboration with other personnel who will be involved in the care of the patient, including the MRI technician, radiologist, radiology nurse, other clinical personnel accompanying the patient and even the facility biomedical engineer. They need to find the appropriate location of moveable equipment in relation to the gauss lines within the MRI suite. The plan should include where the optimal line of sight will be for both observing the patient and any monitors. The plan needs to have a contingency for emergencies. The latter would include how to summon assistance during an emergency, where emergency medications and equipment will be located, where the patient will be evacuated to (note that rescuscitation is begun as the patient is transported to the previously designated safe area outside Zone IV), and how emergency response personnel need to be prevented from entering Zone IV. The plan also needs to address the level of sedation or anesthesia anticipated and what to do if a higher level is needed or inadvertently achieved. The plan needs to specify how the intravenous drugs, oxygen, anesthetic gases, suction and waste management will be handled. In some cases where MRI-safe or MRI-conditional equipment is not available, special conduits called wave guides may have to be used for some of these management activities. When deep sedation is used or when direct observation of respiration cannot be performed during moderate sedation, monitoring of exhaled carbon dioxide should be considered (simply monitoring oxygen saturation by pulse oximetry is insufficient in such circumstances). It should also be remembered that the magnetic fields may interfere with interpretation of some monitoring tools, such as EKG, so some data must be interpreted with caution.
We suggested a few additions to this otherwise excellent ASA practice advisory. First is the importance of determining up front whether the MRI is truly indicated, whether the potential benefits of performing the MRI outweigh the potential risks, and whether alternative safer imaging modalities might suffice. In many of the incidents weve seen occurring in ICU patients transported to the MRI suite or radiology suite, weve been surprised at how often the scan being done was really of marginal value.
Second is the need for a huddle/timeout before the procedure is performed. We should approach doing MRI on these critically ill patients in the same manner in which we approach patients going to the OR. A huddle or whatever else youd like to call a pre-procedure briefing is very important in such cases. Not only do you need to know you have all the equipment needed, but you also need to know everyones role and have contingency plans for emergencies. This is where you ensure all parties know what to do if there is a fire or if there is a cardiopulmonary arrest or a quench. You discuss what location you will need to move the patient to in such events. You discuss the availability and location of equipment and medications you may need. You discuss the line of sight required and where the monitoring equipment will be deployed. You may need to discuss also how you will communicate (with both staff and patient) given the high noise levels associated with MRI scanning. You should probably even discuss the potential impact of the lighting levels in the various zones (and fact that you may not be able to wear your ferromagnetic glasses in Zones III and IV).
Third, really related to the above, is use of a checklist. To remember all the needs for the procedure (which vary be individual patient) and the contingencies you have to plan for is really too much to expect for any individual or group of individuals. Thats where the simple checklist comes in: it helps you to remember details you might otherwise overlook.
Fourth, you need to practice. We wonder how many MRI facilities, particularly hospital-based ones, actually simulate an emergency during MRI scanning.
There were, of course, also latent factors that contributed to the Columbini incident. One was the fact that the oxygen supply to the wall-mounted unit had no flow of oxygen at the time of the incident. Part of running an MRI or radiology unit should be regular checking of the availability of adequate oxygen supply (that should occur daily before the first patient is brought to the suite and again after every use of oxygen).
A second factor was that ferromagnetic oxygen canisters were easily accessible just outside the MRI room. Thats really an accident waiting to happen since it should be anticipated someone, in an emergent situation, might grab any available oxygen canister. In our April 8, 2008 Patient Safety Tip of the Week Print Oxygen as a Medication we noted a Patient Safety Advisory in 2005 Continuity of Oxygen Therapy During Intrahospital Transport found that as many as 55% of patients transported to radiology run out of oxygen at some time during their trip. That includes unavailability of oxygen at the destination site. If you use the Ticket to Ride concept for transports, ensuring adequate oxygen supply is one of the items that needs to be discussed. It is critical that if the destination is an MRI suite all staff are aware that ferromagnetic oxygen canisters cannot be taken into the MRI suite. Therefore the staff involved in the transport need to ensure that there will be adequate supply of oxygen on the receiving end (the MRI suite) either in the form of non-ferromagnetic canisters or oxygen delivered via wall outlet. Obviously in the latter the clinical staff involved in the transport should discuss with the MRI staff the status of oxygen via either of those two sources.
One of the key root causes identified was the fact that two separate entities were involved in the MRI operation and it was unclear who was providing all the safety oversight for the unit. That same issue undoubtedly still exists today where some MRI units are jointly owned by a hospital and a physician group or where a physician group owns the MRI and rents space for it from a hospital. In addition, we still see mobile MRI units. For the latter, nurses or other hospital staff typically accompany the patient to the mobile MRI unit. We wonder how many of those nurses and other staff have been inserviced on MRI safety (since the hospital itself technically does not have an MRI unit). We strongly recommend you review all aspects of safety if your staff does go on transports to such mobile MRI units.
And, of course, a major root cause was the lack of prior lessons learned. There had apparently been prior projectile events at that same facility, including one said to have been remarkably similar to the fatal accident. The hospital involved had not even been aware of those prior incidents (because technically the MRI unit was owned and operated by another entitiy). In addition, unlike incidents in a hospital-owned MRI unit, incidents from physician-owned MRI units were not reportable to the state health department. It is not known whether root cause analyses were done on those prior events, but clearly any potential lessons learned from those were not applied going forward. Similarly, all the valuable lessons in the current RCA had to wait until now to be revealed to all other sites having MRI units.
Weve touched on only a few points brought out in this outstanding RCA. We strongly encourage you to both read the RCA done by Gilk and Latino and watch the video. This is an incredibly useful RCA full of lessons learned that you will be able to take back to your own institution.
Our prior columns on MRI safety:
February 19, 2008 Patient Safety Tip of the Week MRI Safety
March 17, 2009 Patient Safety Tip of the Week More on MRI Safety
September 16, 2008 Patient Safety Tip of the Week More on Radiology as a High Risk Area
October 2008 Whats New in the Patient Safety World Preventing Infection in MRI
March 2009 Whats New in the Patient Safety World Risk of Burns during MRI Scans from Transdermal Drug Patches
February 1, 2011 Patient Safety Tip of the Week MRI Safety Audit
FDA. Public Workshop Magnetic Resonance Imaging Safety, October 25-26, 2011
Forest W. Rising number of MRI accidents prompts FDA workshop on safety. AuntMinnie.com Oct. 11, 2011
Nazarian S, Hansford R, Roguin A, et al. A Prospective Evaluation of a Protocol for Magnetic Resonance Imaging of Patients With Implanted Cardiac Devices. Ann Intern Med 2011; 155: 415-424
Reynolds MR, Zimetbaum P. Magnetic Resonance Imaging and Cardiac Devices: How Safe Is Safe Enough? (Editorial). Ann Intern Med 2011; 155: 470-472
Gilk T, Latino RJ. MRI Safety 10 Years Later. What can we learn from the accident that killed Michael Colombini? Patient Safety and Quality Healthcare 2011; online first Nov-Dec 2011
PROACTFor Healthcare.com. Gilk T, Latino RJ. Movie: Colombini MRI Case: Root Cause Analysis - 10 Years Later.
PROACTFor Healthcare.com. Michael Colombini MRI RCA - MRI Safety Week. 2011
American Society of Anesthesiologists. Practice Advisory on Anesthetic Care for Magnetic Resonance Imaging. A Report by the American Society of Anesthesiologists Task Force on Anesthetic Care for Magnetic Resonance Imaging. Anesthesiology 2009; 110(3): 459-479, March 2009
Pennsylvania Patient Safety Authority. Patient Safety Advisory.
Continuity of Oxygen Therapy During Intrahospital Transport. September 2005.
November 1, 2011
So What's the Big Deal
About Inserting an
So whats the big deal about inserting an NG tube? Thats a question we heard recently at a hospital. The questioner thought the answer would be simple. Its not. Nasogastric tube (NG tube) insertion is so common that we tend to forget its risks. But if youve ever seen a patient die because their enteral feeds were inadvertently given into their lungs or develop meningitis because the NG tube went through a basal skull fracture, you wont take this cavalier attitude toward NG tubes.
Indeed, the UKs NPSA issued 2 Patient Safety Alerts in 2005 (NPSA 2005a, NPSA 2005b) because of numerous reports of incidents and bad outcomes related to NG tubes. And because they have had 21 deaths and 79 cases of harm due to feeding into the lungs through misplaced NG tubes since that original alert, the NPSA reissued the alert in March 2011 (NPSA 2011). In 45 of the 79 cases of harm (and 12 of the deaths) the primary contributing factor was misinterpretation of x-rays.
The 2005 alert noted that while the most accurate method for confirming correct tube placement is radiography, there had been multiple reports of x-rays being misinterpreted by physicians not trained in radiology. Other problems noted with radiographic confirmation included increased exposure to radiation, loss of feeding time and increased handling of seriously ill patients. Plus, outside of the acute care setting, access to radiology is often difficult. Therefore, the recommendation in the UK was that radiography should not be used routinely for verification of tube placement and that the first line test to be used is determination of pH of the aspirate.
However, pH testing of the aspirate has its own limitations. A number of medications, such as proton pump inhibitors or H2 antagonists or antacids may affect the pH of gastric fluid. Secondly, the feeds themselves may affect pH of the fluid and it may even be difficult to obtain fluid on aspiration. In addition, the correct type of litmus testing paper must be used.
Just as importantly, they noted several other methods that should not be used for determining tube position. The whoosh test (auscultation while air is injected into the tube) is notoriously unreliable. Similarly, looking for air bubbles in the tube is also unreliable since air may be present in the stomach as well as the lungs. And simply observing the patient for respiratory distress is not reliable.
The new alert starts with some good common sense recommendations. First, before inserting an NG tube there should be an assessment as to whether NG feeding is appropriate for the patient and the rationale for that decision should be documented in the chart. Second, placement of the NG tube should be delayed (unless urgent) if there is not appropriate skill and expertise available to confirm tube placement (for example, at night). Third, the NG tube to be inserted should be radio-opaque throughout its length and have externally visible external length markings. Fourth, no feeds or flushing of the tube should take place until position is confirmed either by pH testing or x-ray.
They continue to recommend pH testing as their first line method, with a safe pH being between 1 and 5.5. They recommend x-ray confirmation when there is no aspirate or the pH is not in the target range.
When radiographic confirmation is needed they also have practical advice. First, the x-ray requisition should clearly state the x-ray is for determination of tube placement. All too often we still see x-ray requisitions filled out with something like the admission diagnosis rather than the real reason for the x-ray. And you need to make sure that the person doing the interpretation is appropriately credentialed to do so (for example, if someone other than the radiologist is doing the interpretation).
They provide some examples of radiographs prone to misinterpretation. One seems to show the tip of the catheter below the left hemidiaphragm but it is actually in the left lower lobe of the lung. Another shows the difficulty of determining tube position when artifacts, such as those do to EKG leads, are present. And they describe the responsibilities of both the radiology tech and the radiologist in the process. The former must ensure correct film exposure and that the bottom of the hemidiaphragms are adequately seen. The radiologist is responsible for documenting the position of the tube and its tip and noting whether it is safe to proceed with feedings.
The alert goes on to discuss repeat checks after the correct position has been initially confirmed. Its recommended position be rechecked before each feed, any time medication is to be given via the tube, and at least daily. Also, any time there is reason to believe the tube may have been misplaced (eg. after movement, retching, coughing, unexplained respiratory symptoms, etc.) position should be rechecked. The alert discusses how to appropriately assess for displacement also by visualizing the length markers.
Lastly, they recommend a full multidisciplinary assessment be done before a patient with an NG tube is discharged from acute care to other settings.
Another paper (Eveleigh 2011) describes a case of a patient in whom feeds were given via NG tube that was positioned in the lungs and the subsequent root cause analysis. The x-ray was misinterpreted in the middle of the night by a junior physician who had inadequate training in interpretation for NG tube placement. So the organization did a further audit on cases and found that there were 43 errors in interpretation of tube position in 192 position placement x-rays. Moreover, documentation of the interpretation was missing in 41% of the charts. Moreover, the mean time from ordering the x-ray to time actually performed was 4 hours.
Actions taken as a result of the RCA included a new educational/competency assessment program for all junior physicians, development of a standardized NG feeding tube care plan, avoiding placing NG tubes out-of-hours unless critical, re-prioritization of these cases in the radiology department, a standardized NG tube insertion sticker for documentation purposes, and switch to one standard NG tube type. In one year, they reduced the number of misinterpreted studies to one, cut the x-ray delay time in half, and significantly improved chart documentation.
There is also an excellent e-learning tool on the Merck Serono web site for interpreting x-rays for placement of NG tubes, including a nice flow chart of the questions to ask when viewing such radiographs. The module includes a case description of a patient inadvertently fed through a misplaced feeding tube and summarizes results of an RCA that identified root causes in the following areas: human factors, equipment factors, system factors, environmental factors, and communication factors. Identification of anatomical landmarks and taking into account rotational factors were stressed in x-ray interpretation. They provide some good sample x-rays to see correct and incorrect positioning.
The first line study in most US hospitals remains radiologic confirmation. In the US, radiologists are available more frequently. Even in those facilities where a radiologist is not present on site, they are often able to interpret films remotely via teleradiology. However, that does not mean you cant learn a lot from the above alerts and RCAs. Were willing to be that if you do an audit youll find considerable deficiencies in documentation of tube positioning before feedings are started. Particularly if you have physicians other than radiologists confirming the NG tube position (eg. at night) you want to make sure they have had the appropriate training and competencies to do so. And if you are having radiologists read the films remotely via teleradiology at night, take a hard look at the documentation of tube position, how that result gets communicated to everyone who needs to know, and how long it takes.
There are many other facets of NG feeding that we have not covered here. For example, the common practice of grinding up oral medications and giving them via NG tube may be dangerous in certain cases. The recently approved oral anticoagulant, dabigatran, may result in toxic levels if given that way. So there are a whole host of other patient safety issues surrounding NG feeding well beyond those related just to position.
So whats the big deal about inserting an NG tube? Its a lot bigger than you thought!
National Patient Safety Agency (UK). Patient Safety Alert. Reducing harm caused by the misplacement of nasogastric feeding tubes. February 21, 2005
National Patient Safety Agency (UK). Patient Safety Alert. Reducing the harm caused by misplaced naso and orogastric feeding tubes in babies under the care of neonatal units. September 18, 2005
National Patient Safety Agency (UK). Patient Safety Alert. Reducing the harm caused by misplaced nasogastric feeding tubes in adults, children and infants. March 10, 2011
the supporting information
the decision tree for adults
the decision tree for children and infants
Eveleigh M, Law R, Pullyblank A, Bennett J. Nasogastric feeding tube placement: changing culture. NursingTimes.net October 17, 2011
Merck Serono. Reducing the fisk of feeding through a misplaced nasogastric tube. E-Learning module. March 2011
flow diagram for interpreting x-rays for tube placement
November 8, 2011
Patient Safety Curriculum
The World Health Organization (WHO) has just released a curriculum guide for patient safety (WHO 2011). It is accompanied by a set of tools and resources (WHO 2011b), including slide presentations corresponding to key chapters of the guide. Though it is aimed primarily at education of students in the various healthcare professional schools, many of the principles and learning techniques are equally applicable to training in patient safety at any level.
Part A of the guide is aimed at the educators who will be teaching the patient safety curriculum. It includes many useful tips on best methods to teach to concepts of patient safety, including good use of stories and narratives, case studies and practical examples. They discuss various delivery methods such as a combination of lectures, small group discussions, project work, practical workshops, or simulation-based exercises. They also discuss how to integrate patient safety education into procedural skills training programs.
While doing the curriculum as a stand-alone is mentioned, they favor integrating the curriculum into the various other curricula. They provide examples of how patient safety concepts can be woven into other traditional medical or nursing school courses. However, they note that in doing so it is critical to keep track of what elements are covered in the various courses.
They stress the need to put the training in context and use examples that are realistic for the setting, of interest to the parties, and likely to be relevant to the student in the near future. While they discuss a variety of teaching styles, they stress the importance of being interactive. And they provide some good advice: Dont tell students when you can show them, and dont show them when they can do it themselves. They recommend lectures be limited to about 45 minutes as concentration falls after this time. And they recommend you aim for four or five key points at most. These recommendations, of course, are really applicable to almost any audience you are engaging. Of interest, while most of us are big advocates of simulation, they advocate simulation but with a word of caution. They note that the simulation needs to be realistic and practical and cite the example of a nursing student talking to a fake practice IV insertion arm as if it were a real patient can be embarrassing.
Part B deals with specific patient safety topics. Topic #1 is a general introduction to patient safety. They recommend practical examples such as the case of nurse, pharmacist or medical student being assertive and speaking up. Several of the sections do discuss the issue of hierarchy in healthcare. One section provides some practical examples of the old way vs. the new way. For example, in observing a senior clinician fail to wash his hands between patients, the old way was to say nothing and participate in the inadequate practice but the new way might be to seek clarification from the senior clinician as to the when and how of hand hygiene or to respectfully comment and continue to use good hand hygiene techniques.
When we discuss root cause analyses after an untoward event, one of the big three root causes we find in almost every case is failure to buck the authority gradient, i.e. someone recognized that an error or problem was occurring yet failed to speak up. The hierarchical structure of healthcare, whether formal or tacit, continues to be one of the biggest impediments to patient safety. Interesting in this vein was a recent survey presented at the American College of Clinical Pharmacy (ACCP) 2011 Annual Meeting (Kann 2011). Five hypothetical scenarios were presented to almost 600 pharmacists who responded to the survey. They found that large percentages of the pharmacists would fill inappropriate or potentially dangerous prescriptions after verifying the prescription with the prescriber. 43% of respondents actually recalled actually doing so in real-life situations and 74% of those deferred to the prescribing physician because they assumed that he/she knew more about a particular patient and situation than they did. Of the clinical scenarios presented, almost 20% would have filled inappropriate prescriptions for digoxin and methotrexate and almost 40% would have filled a prescription for a fentanyl patch in a patient who had taken other opiates for only 7 days.
And, of course, we previously discussed problems with the hierarchy of medicine in our March 29, 2011 Patient Safety Tip of the Week The Silent Treatment: A Dose of Reality and July 19, 2011 Patient Safety Tip of the Week Communication Across Professions.
But back to the WHO guide. Topic #2 is on the role of human factors and is very good. It discusses important principles like avoiding reliance on memory, making things visible, simplifying, standardizing, using checklists, and reduced reliance on vigilance. They provide case studies showing how contributing factors, such as fatigue, may impact patient safety. They point out that human beings make silly mistakes all the time, regardless of their level of experience. As part of the teaching techniques they recommend you discuss any silly mistakes you recently made outside work or study. We can think of lots of those!
Topic #3 deals with the concepts of systems thinking and complexity. It draws heavily on the work of James Reason and Charles Perrow.
Topic #4 is all about teamwork and being an effective team player. They focus on communication, handoffs, and conflict resolution. They note the stages of team development (forming, storming, norming, and performing) and the characteristics of successful teams (common purpose, measurable goals, effective leadership, effective communication, cohesion, mutual respect, flexibility, conflict resolution, etc.). Communication techniques such as ISBAR, callout, check-back, and handoff formats such as I PASS the BATON are discussed.
In our own work with housestaff or nursing staff we discuss ways in which you can usually get someones attention and force further review of a situation. Sometimes that can be as simple as Ive just got a funny feeling were missing something. In the WHO guide they describe multiple techniques that can be used. They describe the 2-challenge rule where all members of the team are empowered to stop an activity if they perceive an essential safety breach. It is 2-challenge because the first challenge is in the form of a question (eg. Im worried about Mrs. Jones. Can you take a look at her?) and the second challenge provides support for the team members concern (eg. Im very worried about Mrs. Jones. Her symptoms are worsening. I think you should see her now.). Key to the 2-challenge rule is that the concern has been heard, understood, and acknowledged.
Next they note the CUS approach:
I am Concerned
I am Uneasy
This is a Safety Issue
And then the DESC approach:
Describe the specific situation or behavior and provide concrete evidence or data.
Express how the situation makes you feel and what your concerns are.
Suggest other alternatives and seek agreement.
Consequences should be stated in terms of their effect on established team goals or patient safety.
Topic #5 is Learning from Errors. This begins with a description of the various types of error, acknowledgement that errors occur, and situations in which errors are more likely. They have good sections on root cause analysis (RCA), case studies, and failure mode and effects analysis (FMEA).
Topic #6 Understanding and Managing Clinical Risk discusses the variety of sources of information that helps identify patient safety risks in your organization, including RCAs, incident reports, sentinel events, patient complaints, and others. It discusses some of the factors that contribute to adverse events, such as fatigue, communication issues, and others.
Topic #7 is all about quality improvement. It relies heavily on the principles in The Improvement Guide (Langley 1996), including measurement, PDSA cycles, rapid change, and sustaining improvement. It has good discussions about tools such as flow charts, run charts, cause and effect diagrams, Pareto charts, root cause analysis (RCA), and failure mode and effects analysis (FMEA).
Topic #8 Engaging with Patients and Carers is about getting patients and their families involved in their own care and promoting their own safety. It has good discussions on disclosure and apology when adverse events occur. The latter is a topic weve discussed on several occasions (see our June 22, 2010 Patient Safety Tip of the Week Disclosure and Apology: How to Do It and our November 2010 Whats New in the Patient Safety World column IHI: Respectful Management of Serious Clinical Adverse Events). One of the resources we noted in the latter column, IHIs Respectful Management of Serious Clinical Adverse Events has recently been updated (Conway 2011). The WHO guide discusses the Harvard disclosure framework and a disclosure process from New Wales, Australia. They also provide a good discussion about the SPIKES (Setting, Perception, Information, Knowledge, Empathy, Strategy and Summary) communication tool that can help guide communication with patients and their caregivers over a wide range of topics and issues.
The last three topics deal with some specific clinical issues. Topic #9 Infection Prevention and Control focuses on healthcare-associated infections (HAIs) and especially on hand hygiene. Topic #10 Patient Safety and Invasive Procedures, as youd expect, deals with wrong site surgery and the WHO Surgical Safety Checklist, along with a host of issues arising in the perioperative period. Topic #11 Improving Medication Safety is an excellent chapter dealing with the gamut of problems in medication safety. The slide set accompanying the latter chapter is especially useful.
Whether you are and educator in academic medicine at a medical, nursing or pharmacy school or other healthcare professional school or a clinician in any healthcare setting, the new WHO Patient Safety Curriculum Guide is a very valuable resource for your patient safety programs.
WHO. Patient Safety Curriculum Guide: Multi-Professional Edition. 2011
WHO. Patient Safety Curriculum Guide Tools and Resources. 2011
Kann C, Hoehms J. American College of Clinical Pharmacy (ACCP) 2011 Annual Meeting; Abstract #173. Presented on October 18, 2011 as reported by Goodman A. Many Pharmacists Likely to Fill Dangerous Prescriptions. An Expert Interview With James Hoehns, PharmD. Medscape Medical News. October 25, 2011
Langley GJ, Nolan KM, Norman CL, Provost LP, Nolan TW. The Improvement Guide: A Practical Approach to Enhancing Organizational Performance. New York, NY; Jossey-Bass, 1996
Conway J, Federico F, Stewart K, Campbell MJ. Respectful Management of Serious Clinical Adverse Events. IHI Innovations Series 2010. Cambridge, Massachusetts: Institute for Healthcare Improvement; 2010
Conway J, Federico F, Stewart K, Campbell MJ. Respectful Management of Serious Clinical Adverse Events (Second Edition). IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement; 2011
November 15, 2011
A provocative new editorial in the Journal of the National Cancer Institute (Harris 2011) has challenged the colorectal cancer screening strategy currently dominant in the US. In the US, of course, almost all major medical organizations and societies recommend colonoscopy as the primary screening strategy for colorectal cancer. Harris and Kinsinger in the editorial point out that there are randomized controlled trials that demonstrate that screening for colorectal cancer with fecal occult blood tests (FOBT) and flexibile sigmoidoscopy reduces mortality from colorectal cancer but they point out that evidence of the magnitude of additional benefit from colonoscopy is much less robust.
The editorial should not really be considered provocative, given the recent US Preventive Services Task Force (USPSTF) recommendations regarding screening for prostate and breast cancer. In the case of the USPSTF recommendations and the JNCI editorial, the call is really to look at the net benefit of the screening programs. That is, it is not enough any longer to just look at how many cancers are detected by the screening methods and how many deaths due to those cancers are prevented, but to also look at the potential harms of such screening methods and ensure that those potential harms do not outweigh the potential benefits.
They point out in the editorial that harm may occur at both the individual level and the societal level. At the individual level they note potential harms such as anxiety related to what might be found, the discomfort associated with bowel preparation for the procedure, inconvenience of the preparation and the procedure, effects of procedural sedation, loss of productivity (at work or at home), the risk of overdiagnosis, having to remember that another colonoscopy is needed in the future, in addition to the traditional potential complications of the procedure itself (eg perforation, hemorrhage, etc.). They make a case for development of tables that could compare the potential risks and benefits for individual patients so that the potential net benefit might be better gleaned.
A few years ago we tried to find out what the rate was for complications of colonoscopy. That was not as straightforward as we expected. The rate depends on whether the colonoscopies are for screening vs. diagnostic, whether polypectomy was done, and also relates to the age of the population and associated comorbidities (Warren 2009). All these factors make it extremely difficult to compare rates of colonoscopy complications across facilities. Some of the same factors likely explain why rates at free standing ambulatory sites tend to be lower than at hospital-based endoscopy units.
Last month there were a couple timely reviews of colonoscopy complications. First is a guideline from the American Society of Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee (Fisher 2011). The guideline provides statistics from multiple different sources and prior studies and notes that the overall pooled rate of serious complications is on the order of 2.8 per 1000 colonoscopies. They note that over 85% of the serious complications occur in patients undergoing colonoscopy with polypectomy performed. Rates of colonic perforation are generally below 1 per 1000 procedures and are probably closer to 1 per 10,000 for purely screening colonoscopies. Hemorrhage, immediate or delayed, occurs in 1 to 6 cases per 1000 colonoscopies and is more common in diagnostic colonoscopies and those with polypectomy. Polyp size and type are risk factors and patient comorbidities increase the risk of hemorrhage. Its not clear whether the latter increases the risk or is just a marker for increased use of anticoagulants and antithrombotic agents. They note there is a guideline for management of antithrombotic therapy in patients undergoing endoscopy (Anderson 2009). Other more serious complications such as death, infection, and colonic gas explosions are relatively rare. They also mention the postpolypectomy electrocoagulation syndrome, where a transmural burn gives rise to signs of localized peritonitis but is usually treated medically rather than surgically. Among less serious complications, they note transient GI symptoms in as many as one third of all patients. Cardiopulmonary complications occur frequently, both during the procedure and up to 30 days following the procedure. However, in the Warren study (Warren 2009) the latter events were more likely related to the comorbidities in this patient population rather than to the procedure itself. And while many of the cardiopulmonary events during the procedure may be relatively minor (transient hypoxemia or transient hypotension), weve cautioned about the need for careful monitoring during procedural sedation, particularly in patients who may be at risk for undiagnosed conditions like obstructive sleep apnea. A review of procedural sedation in endoscopic procedures (McQuaid 2008) notes relatively few controlled studies involving colonoscopy but does note that the common practice of adding an opiate to a sedating agent for colonoscopy increases the likelihood of deep sedation and oxygen desaturation.
While infectious complications are uncommon with colonoscopies, dont forget the risks of mass cross contamination from inadequately reprocessed endoscopes. See the recent multisociety guideline on avoiding the latter (Petersen 2011).
A second study on complications of colonoscopy in the Medicare population (Day 2011) confirmed increased rates of complications with advancing age and especially in octogenarians. While some of the higher rates in octogenarians are due to more comorbidities (and, hence, more medications) and the likelihood that more of the colonoscopies in that group were diagnostic rather than screening, they noted some physiologic changes with aging that may make complications more likely. Those include things like more tortuous colons, higher prevalence of diverticula, greater probability of polyps, and more advanced cancers.
There is an excellent existing guideline on management of antithrombotic agents for endoscopic procdures (Anderson 2009). That guideline is quite comprehensive and, while it notes that agents may not need to be stopped in many diagnostic studies, it does provide good suggestions based upon both procedure and patient risk factors. It also provides good guidance about how to start and stop these agents, bridging therapy, etc. Obviously, those guidelines are going to need revision, given the recent introduction of multiple new oral anticoagulants.
Not surprisingly, the studies in the endoscopy literature do not mention overdiagnosis at all in their discussions of complications and harm. The recent JNCI editorial points out that overdiagnosis is a significant issue in colonoscopic screening, noting that the majority of findings at colonoscopy are small low-risk adenomas and non-adenomatous polyps, not cancers. Weve already noted above that removal of polyps is one of the factors that increases the risk of complications from colonoscopy.
And all weve said is based upon net benefit as it applies clinically. We have not even touched upon the cost implications. Most cost effectiveness analyses take into account primarily the costs of the procedures and the individual complications compared to the costs saved by early detection of cancers. Seldom do they take into account costs related to management of the non-cancerous findings. To truly quantify the incremental benefit of colonoscopy over other screening strategies you need to take all these factors into account.
Just as I, as a neurologist, need to know the procedural complication rate of the local surgeons before I recommend carotid endarterectomy to a patient, you should know the complication rates of your local endoscopists before you recommend colonoscopy to your patients. And those rates should be risk stratified (age, comorbidities, type of procedure, etc.). Were willing to bet you probably have no idea what those rates are at your local facility. So, in most cases, you really dont have a good handle on the potential net benefit when you recommend screening colonoscopy to your patients. Of course, we all know someone whose life was saved by a screening colonoscopy and, conversely, someone who died because they never had a screening colonoscopy. But the time has come to look at the bigger picture and really be able to advise our patients in a truly informed way.
Weve entered a new era in the way we look at screening tests. No longer is earlier detection is best the sole driving force. We need to take a balanced look at both sides of the equation for each individual patient.
Harris R, Kinsinger LS. Less is More: Not Going the Distance and Why.
JNCI 2011; 103(23): 1-3
Warren J.L., Klabunde C.N., Mariotto A.B., et al: Adverse events after outpatient colonoscopy in the Medicare population. Ann Intern Med 2009; 150: 849-857
Fisher DA, Maple JT, Ben-Menachem T, et al for the ASGE Standards of Practice Committee, Complications of colonoscopy. Gastrointestinal Endoscopy 2011; 74(4): 745-752
Anderson MA, Ben-Menachem T, Gan SI, et al: Management of antithrombotic agents for endoscopic procedures. Gastrointestinal Endoscopy 2009; 70: 1060-1070
McQuaid K.R., Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointestinal Endoscopy 2008; 67: 910-923
Petersen BT, Chennat J, Cohen J, et al for the ASGE Quality Assurance In Endoscopy Committee. Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011. Gastrointestinal Endoscopy 2011; 73(6): 1075-1084
Day LW, Kwon A, Inadomi JM, et al. Adverse events in older patients undergoing colonoscopy: a systematic review and meta-analysis. Gastrointestinal Endoscopy 2011; 74(4): 885-896
Print Rethinking Colonoscopy
November 22, 2011
Perioperative Management of Sleep Apnea Disappointing
Youve heard us talk on numerous occasions about identifying potential obstructive sleep apnea (OSA) as a risk factor for procedural sedation, surgery, postoperative care, and pain management (see the summary of our previous columns at the end of todays column). Obesity and sleep apnea, conditions that predispose further to opioid-induced respiratory depression, are also becoming more and more prevalent. See our July 2010 Whats New in the Patient Safety World column Obstructive Sleep Apnea in the General Inpatient Population for a study that found a potential 60% prevalence of obstructive sleep apnea in patients admitted to general medicine units in an urban academic hospital, most of whom had never been diagnosed with OSA.
Surgical patients probably have an even higher prevalence. We previously mentioned two clinical studies by the Toronto group headed by Frances Chung that emphasized the need to identify OSA patients using screening procedures prior to surgery. One study using either standard nocturnal polysomnograms or portable home sleep studies on over 800 patients prior to anticipated surgery found that 536 of the 819 patients enrolled had obstructive sleep apnea. Of those with severe sleep apnea, 85.5% were not diagnosed by surgeons and 47% were not diagnosed by anesthesiologists. Notably 84% of the patients overall had at least one symptom or sign of OSA such as snoring, excess daytime drowsiness, or observed sleep apnea.
In the second study the STOP-Bang questionnaire and a wristwatch pulse oximeter were used during the preoperative evaluation in 367 patients. Of these 61% were ranked at high risk for OSA using the STOP-Bang questionnaire. The accuracy of the data extracted from the pulse oximeter to detect moderate and severe sleep apnea was strong. The sensitivity to detect moderate and severe obstructive sleep apnea was 92.8 percent and 100 percent. The specificity to predict moderate and severe obstructive sleep apnea was 74.8 percent and 64.6 percent. There was a strong correlation between those scoring high risk on the STOP-Bang and those with an oxygen desaturation index greater than 10 on the wristwatch oximeter and having confirmed obstructive sleep apnea. The authors therefore suggest a screening process of administering the STOP-Bang, followed by the wristwatch pulse oximetry in those scoring as high risk.
Another group (Vasu 2010) found that 41.5% of 135 patients who scored high risk on the STOP-Bang questionnaire had higher rates of postoperative complications than those who scored low risk (19.6% vs. 1.3%). They did not confirm OSA with polysomnograms so the association here is with the STOP-Bang score rather than confirmed OSA. Nevertheless, the association was strong and applied across a wide range of types of surgery.
So it logically makes sense to consider identifying patients with potential OSA early so that appropriate preoperative assessment, intraoperative management, and postoperative management and monitoring can be undertaken. Of course, wed like to know that recommendations for the perioperative management of OSA or potential OSA actually improve patient outcomes. Surprisingly, while there are many practical, rational and consensus-based recommendations for perioperative management of OSA, few are actually evidence-based.
In 2006, the American Society of Anesthesiologists (ASA) published practice guidelines for the perioperative management of patients with OSA (ASA 2006). And good reviews of the perioperative management of patients with OSA have been done in 2008 (Chung 2008) and 2010 (Adesanya 2010). All 3 papers readily admit there is a paucity of evidence-based recommendations for care of surgical patients with suspected or known OSA.
And just last month one of the few randomized controlled studies of surgical patients deemed at high risk of OSA had disappointing results (OGorman 2011). That study, presented by Mayo Clinic researchers at the CHEST 2011: American College of Chest Physicians Annual Meeting, showed that autotitrating positive airway pressure (APAP) failed to prevent obstructive apnea in surgical patients deemed high risk for the disorder. They did find that patients deemed to be at high risk for OSA via the Flemons questionnaire (Flemons 1994) did have longer lengths of stay and more complications than those deemed to be at low risk. They randomized 85 patients deemed at high risk for OSA to either standard postoperative care or standard care plus APAP but found no significant difference in LOS or complications between the two groups. Admittedly, the number of patients studied was small and further research is needed. But it leaves one more gap of evidence-based recommendations.
So what are the recommendations for patients with suspected OSA who are to undergo surgery?
One is that the preoperative evaluation by anesthesiology should take place far enough in advance of the planned surgery so that there is adequate time for any further evaluation and time for the surgeon and anesthesiologist to jointly develop a management plan. The importance of involving family members in the evaluation is emphasized since much of the history suggestive of OSA may come from, for example, a spouse who notes the patient snores and has apneic spells. Assessments of common comorbidities in patients with OSA (hypertension, diabetes, CHF, etc.) should be done. The physical examination should take into account BMI, neck circumference, craniofacial abnormalities, tonsil size, tongue size, etc. Patients with OSA also may have airways that are difficult to manage so a good assessment of potential difficulties managing the airway is indicated.
Both the Chung and Adesanya reviews discuss the clinical screening tools, which include not only the STOP-Bang tool noted above, but also the Berlin questionnaire, the ASA checklist, and others.
The severity of the OSA risk and the nature of the surgical procedure should be discussed. The surgeon and anesthesiologist need to consider the urgency of the procedure and decide whether there is time to delay the surgery while further evaluations, such as polysomnography, are undertaken. Also, a discussion about ambulatory vs. inpatient surgery is beyond todays column but, while ambulatory surgery in OSA patients is generally felt to be relatively safe, there are special recommendations about monitoring, equipment, transfer agreements, etc. that should be followed.
Intraoperatively, it would make sense to use local or regional anesthesia in preference to general anesthesia, where possible. Agents used are preferred to be shorter-acting and one needs to consider drugs (anesthetics, analgesics, and sedatives) that are less likely to produce respiratory depression or neuromuscular weakness.
Post-operatively, the major discussion centers around monitoring and the use of opiates. Certainly, where opiates can be avoided, it makes sense to use drugs like acetaminophen or nonsteroidal anti-inflammatory agents or even non-pharmacological modalities for analgesia. In those who do use patient-controlled analgesia (PCA) avoiding a basal infusion may be wise. Patients with OSA are often found to require lower doses of opiates for analgesia. As weve noted in many prior columns, the risks of opiates probably apply equally to any means of use of opiates, not just PCA.
Patient positioning may be important, as patients with OSA are more likely to develop hypoxemic episodes when they are supine.
The issue of oxygenation is much debated. If a patient has known OSA and has been on CPAP at home, they should get CPAP post-operatively (preferably with their own CPAP equipment brought in from home). As above, the use of CPAP, NIPPV, BiPAP, or APAP are not currently evidence-based in those not previously on CPAP at home.
Monitoring is probably the most important aspect of care of the patient with suspected OSA. Most recommend continuous pulse oximetry (rather than periodic assessment of O2 saturation) but our previous columns have highlighted the problems associated with just using pulse oximetry and the false sense of security that one may develop. Very important in that light is the work of Lynn and Curry (Lynn 2011) who describe 3 patterns of unexpected in-hospital deaths and demonstrate the problems with threshold-based alarms (almost all currently used alarm systems use threshold-based principles) in detecting early deterioration. Indeed, they posit that threshold-based alarms themselves often cause us to miss signs of early deterioration. The second pattern of deterioration they note is the classic CO2 narcosis but they note many of these cases are complicated by the third pattern typical of sleep apnea. The important point is that there may be a huge difference when the patient is awake and when he/she is asleep and that has important implications for monitoring. In the third pattern one sees repetitive reductions in airflow and oxygen saturation during sleep followed by arousals. The arousals rescue the patient but eventually the capacity or reserve of the patient to recover with arousals becomes impaired (often in response to narcotics or sedatives) and the patient may experience sudden death during sleep. The authors discuss the inability of currently used oximeters to recognize this pattern. They even imply that this pattern may give rise to oximeters alarming and being interpreted as false alarms attributed to motion artifact, etc. because when staff respond to the alarm the patient is now awake, breathing normally and has a normal oxygen saturation. So even systems using continuous pulse oximetry and end-tidal CO2 monitoring may fail to adequately identify these patients.
In both the second and third patterns, use of supplemental oxygen may mask the deterioration, provide a false sense of security, and delay critical responses to a deteriorating clinical situation. Hence, its important not to use oxygen unless there is a legitimate indication for its use (see our January 4, 2011 Patient Safety Tip of the Week Safer Use of PCA). The authors go on to discuss the flaws in current threshold-based alarm systems and the need for true smart alarms that integrate multiple physiological parameters and respond to patterns of changes in these.
The timing of deterioration is discussed in several of the above reviews. While the first 12-hours post-operatively is a vulnerable period, they also note that REM rebound may be seen and that REM-associated hypoxemic events may increase 3-fold on the second and third postoperative nights, with associated risk of complications.
We were indeed surprised that so many of the recommendations for managing patients with suspected OSA in the perioperative period lack a solid evidence base. But lots of research is ongoing and hopefully well have more evidence-based interventions in the future. In the meantime, many of the practical recommendations made in the above reviews make sense.
Does your organization or facility have a formal approach to identifying patients at risk for OSA before surgery and putting in place common sense management guidelines?
See some of our prior columns on obstructive sleep apnea in the perioperative period:
Patient Safety Tips of the Week:
June 10, 2008 Monitoring the Postoperative COPD Patient
August 18, 2009 Obstructive Sleep Apnea in the Perioperative Period
August 17, 2010 Preoperative Consultation Time to Change
July 13, 2010 Postoperative Opioid-Induced Respiratory Depression
February 22, 2011 Rethinking Alarms
Whats New in the Patient Safety World columns:
American Society of Anesthesiologists. Studies Reveal a Need to Identify and Implement a Screening Procedure for Obstructive Sleep Apnea Prior to Surgery. Newswise 10/17/2010
Vasu TS, Doghramji K, Cavallazzi R, et al. Obstructive Sleep Apnea Syndrome and Postoperative Complications: Clinical Use of the STOP-BANG Questionnaire. Arch Otolaryngol Head Neck Surg. 2010; 136(10): 1020-1024
American Society of Anesthesiologists. Practice Guidelines for the Perioperative Management of Patients with Obstructive Sleep Apnea. A Report by the American Society of Anesthesiologists Task Force on Perioperative Management of Patients with Obstructive Sleep Apnea. Anesthesiology 2006; 104: 108193
Chung SA, Yuan H, Chung F. A Systemic Review of Obstructive Sleep Apnea and Its Implications for Anesthesiologists. Anesthesia & Analgesia 2008; 107(5): 1543-1563
Adesanya AO, Lee W, Greilich NB, Joshi GP. Perioperative Management of Obstructive Sleep Apnea. Chest December 2010; 138(6): 1489-1498
O'Gorman S, Horlocker T, Huddleston J, et al. Does Self-Titrating CPAP Therapy Improve Postoperative Outcome in Patients at Risk for Obstructive Sleep Apnea Syndrome? A Randomized Controlled Clinical Trial. Chest 2011; 140: 4 Meeting Abstracts 1071A; doi:10.1378/chest.1119434
also reported in: Harrison L. Postop APAP Fails in High-Risk Sleep Apnea Patients. Medscape Medical News. November 3, 2011
Flemons WW, Whitelaw WA, Brant R, Remmers JE. Am. J. Respir. Crit. Care Med. 1994; 150(5): 1279-1285.
Likelihood ratios for a sleep apnea clinical prediction rule
Lynn LA, Curry JP. Patterns of unexpected in-hospital deaths: a root cause analysis. Patient Safety in Surgery 2011, 5:3 (11 February 2011)
November 29, 2011
More on Diagnostic Error
A young woman presents to a busy hospital emergency room complaining of tingling in her fingers and toes. Her neurological exam is WNL. When asked if shes been having trouble with her boyfriend she replies yes. She is sent home with a diagnosis of anxiety and hyperventilation. She returns in 48 hours with quadriparesis and a vital capacity of 1000 cc. and needs urgent intubation. Its now apparent she has acute Guillain-Barre syndrome. (Ropper 1991)
A patient presents to a busy clinic complaining of abdominal pain and 3 days of constipation not responding to over-the-counter laxatives. Hes given a cursory examination and prescription for stronger laxatives. Later that evening he dies from a ruptured abdominal aortic aneurysm. (Croskerry 2010)
An overweight woman with diabetes presents to her primary care physicians office with an axillary rash. Shes diagnosed as having intertrigo and given a prescription for a cortisone/antifungal ointment. Shortly thereafter, while the PCP was away on vacation, the PCPs partner sees the patient for complaints about knee pain and other joint pain. That physician attributes the pain to arthritis related to obesity and prescribes ibuprofen. The patient later sees a rheumatologist who notes the rash was an erythematous ring with central clearing, typical of Lyme Disease. (Wellbery 2011)
These are but a few examples of diagnostic errors that illustrate some of the biases in our thinking and decision-making that can lead to erroneous diagnoses and care plans. The first example was a scenario we saw several times when putting together a monograph on Guillain-Barre syndrome (GBS). It is an example where we can be misled by normal findings on examination (or other tests). Early in the course of GBS, strength and gross sensory testing may indeed appear to be normal on examination. However, there are usually other clues present. Early loss of deep tendon reflexes and the presence of an unexplained sinus tachycardia are common. So the clinician looks for alternative diagnoses and might think about psychiatric diagnoses. When he/she hears about the trouble with the boyfriend, that may be taken as evidence supporting such a diagnosis (confirmation bias).
The second case is one unfortunately played out all too frequently. It illustrates a problem with framing. The clinician latches on to the constipation part of the history and frames the diagnostic thought process around that. Had the patient presented with just complaints about abdominal pain, the clinician might have considered abdominal aortic aneurysm in the differential diagnosis.
The third case also illustrates a problem with framing but also demonstrates availability bias. That is where something that comes to mind with ease or is familiar because it has recently been seen. In this scenario the clinician thought about what is probably the commonest cause of an axillary rash in an overweight diabetic patient.
Two of the more dangerous biases we are vulnerable to are anchoring and premature closure. Anchoring is where we latch on to one diagnosis and fail to consider others. Premature closure is accepting a diagnosis before it has been fully verified. In fact, Graber and colleagues (Graber 2005) noted premature closure to be the single most common cognitive process contributing to diagnostic error. It is obvious that with both these biases we may put in motion a management plan that is totally inappropriate and even make incorrect adjustments to that plan when the improvement we expected fails to occur.
Weve mentioned anchoring previously and noted it becomes a more significant problem once a diagnosis or other decision has been declared publicly. Many of you have done an exercise in executive training where a scenario is presented in which you must state a position publicly. You are then given a bit of disconfirming evidence and a chance to change your decision. Almost no one changes their decision! (The scenario is actually a poorly disguised parallel of the Challenger disaster). Another example is when we point out that a geriatric patient is on a drug on Beers list. The physician almost never takes that patient off the drug but may in the future be less likely to prescribe that drug in other geriatric patients.
Another cognitive error often encountered is the tendency to attribute all signs or symptoms to one condition. In the study by Graber and colleagues they cite an example of a patient presenting with retrosternal and upper epigastric pain who was found to have new Q waves on EKG and elevated troponin levels. All symptoms were ascribed to acute MI and a coexisting perforated ulcer was missed.
Our September 28, 2010 Patient Safety Tip of the Week Diagnostic Error highlighted a review article by the Pennsylvania Patient Safety Authority (PPSA 2010) discussing many cognitive biases, including the availability bias, confirmation bias (and its corollary dismissing contrary evidence), anchoring and others, such as premature closure, context errors, and satisficing (accepting any satisfactory solution rather than an optimal one). And it talks about communication issues across the continuum of care. But, importantly, it also emphasizes that system-related factors (remember: the system is usually much easier to change than the human factors) do commonly contribute to diagnostic errors and that strategies to minimize those may reduce diagnostic errors. Such system-related factors include things like specimen labeling, communication of abnormal results to physicians, communication of revised reports to physicians, physician followup with patients, and managing the patients across transitions of care.
We have also previously discussed the cognitive processes and decision making processes that healthcare workers use. We have discussed the work of people like Gary Klein (see our May 29, 2008 Patient Safety Tip of the Week If You Do RCAs or Design Healthcare ProcessesRead Gary Kleins Work) on pattern recognition and recognition-primed decision making that typically takes place in more acute scenarios. And Malcolm Gladwells Blink in our Patient Safety Library also focuses on how we typically use that more intuitive mode of decision-making for most of our decisions in life. And we discussed the work of Jerry Groopman (see our August 12, 2008 Patient Safety Tip of the Week Jerome Groopmans How Doctors Think) on the day-to-day thinking that takes place in interacting with patients. Both types of cognitive approaches have their upsides and downsides but both also tend to fall into similar cognitive error traps.
A terrific video on the pitfalls involved in diagnostic thinking and decision making was presented by Pat Croskerry at the Risky Business conference (Croskerry 2010). He utilizes multiple visual and written props to demonstrate how our cognitive thinking is influenced by the manner in which we see things. They are great ways of showing how we tend to fixate on the first things we see. He goes on to discuss intuitive vs. rational thinking and that, though there are some advantages to intuitive thinking there are more dangers and we actually probably spend 95% of our time in the intuitive sphere.
Croskerry in another paper (Croskerry 2009) nicely describes the two approaches most commonly taken in decision making and proposes a model of diagnostic reasoning. He points out that the more intuitive approach and the analytical approach are context-sensitive and that both approaches may be used under certain circumstances. Importantly, sometimes even the analytical approach may be overridden by the intuitive approach at times, increasing the likelihood of a diagnostic error. He points out that even when well-developed clinical decisions rules have been shown to outperform individual decision making, some physicians persist in an irrational belief that they still know whats best for the patient and that this overconfidence is a major source of diagnostic error. The PPSA article (PPSA 2010) actually speaks about the overconfidence that clinicians have in their diagnostic capabilities and attributes some of that overconfidence to the fact they often get no feedback about when their diagnoses are wrong.
Statistics from CRICO/RMF, which is the medical malpractice carrier/risk management organization for the Harvard hospitals and health systems, show that diagnostic error is the highest risk area for malpractice claims, accounting for 26% of all claims. Though the true incidence of diagnostic error is unknown, studies have estimated the rate to be approximately 15%, which is in keeping with the rate detected in many autopsy series (Graber 2005). But one pretty startling statistic is that in a study of autopsy reports from an ICU population 43% of patients died from causes not considered or addressed in the care teams treatment plan (Winters 2011).
Data from closed malpractice claims files may not be reflective of the types of diagnostic errors commonly made in practice. In the pediatric study done by Singh et al (Singh 2010) very different types of error were noted in practice compared to that published from claims databases in the pediatric literature. In a survey of academic and community physicians and housestaff, they found that 54% of respondents noted making diagnostic errors once or twice a month and 45% noted making errors that led to patient harm once or twice a year. Failure to gather available medical information from history, physical, and old records was cited as the most frequent process breakdown but failure to achieve timely followup by the patient or caregiver was a close second. The study also inquired about specific biases and found that being too focused on a diagnosis or treatment plan was the leading bias. Another bias was being misled by a normal result (history, physical, lab or imaging study). Of strategies mentioned to reduce diagnostic errors, the two most frequently mentioned were (1) closer followup of patients and (2) use of electronic health records and decision support.
Perhaps one of the reasons there has been a dearth of research on diagnostic error is that such are commonly considered to be purely cognitive errors. But the review by Graber and colleagues (Graber 2005) notes the interplay between cognitive factors and system-related factors in leading to diagnostic errors, typical of the cascade of events we usually see when we do a root cause analysis of cases where patient harm occurred. Faulty knowledge or skills was actually seldom a factor contributing to diagnostic error. Most common was faulty data gathering or flawed processing of gathered information.
The biggest problem with diagnostic error is that the provider often is unaware that an error occurred at all, i.e. there is little feedback. So how do we better identify diagnostic error so that we may provide feedback to all involved? Singh and colleagues (Singh 2007) applied the concept of the trigger tool to help identify instances of diagnostic error. The used 2 electronic screening algorithms to identify cases for further chart review. One algorithm identified primary care visits that were followed by a hospitalization within the next 10 days. The other identified primary care visits followed within 10 days by one or more primary care visits, urgent care visits, or emergency department visits. When the medical records were reviewed blindly evidence of diagnostic errors were found in 16.1% and 9.4% identified by the first and second algorithms, respectively. These compared to 4% diagnostic error rates found in randomly selected charts. In addition to diagnostic errors, the reviewers often found evidence of other management errors (eg. inappropriate antibiotic use, failure to adjust medication dose, failure to monitor lab values, etc.) in the above reviews. The positive predictive value for the first screen actually increased to 24.4% when adjusted for things like planned hospitalizations and to 33% to detect any error (diagnostic or management error). So these rates are as good or better than those in trigger tools looking for medication errors. While the spectrum of diagnostic errors was found, the most common errors were failure or delay in eliciting information and misinterpretation or suboptimal weighing of critical pieces of data from the history and physical examination. Other common errors were failure to order or delay in ordering needed tests or failure to follow up test results.
There is even less literature on interventions to prevent diagnostic errors. Weve often talked about asking yourself What is the worst thing this could be?. This may help you refocus and avoid anchoring, premature closure, and other cognitive biases. Most neurologists already do this. For example, when seeing a patient with a headache in the emergency room, we typically ask ourselves What is the worst thing this could be? and that usually would be a subarachnoid hemorrhage. Therefore, we are unlikely to send that patient home until we feel comfortable the patient does not have a subarachnoid hemorrhage.
But we need something more than just remembering to ask that question. Ely and colleagues (Ely 2011) have suggested use of checklists to help avoid diagnostic errors. They actually proposed 3 types of checklists. One is a general checklist to prompt physicians to optimize their cognitive approach (and avoid cognitive biases such as premature closure). Second is a differential diagnosis checklist based upon the presence of specific signs and symptoms, which helps to avoid one of the most common causes of diagnostic error failure to consider the diagnosis. The third is a forcing function checklist that helps physicians consider some of the common pitfalls in recognizing specific diseases. The accompanying editorial (Winters 2011) supports the concept of using checklists to prevent diagnostic errors but notes that the next step, formally testing these checklists in a rigorous manner, is the difficult step. They need to show not only that the checklists reduce such errors but also that they will actually be used by clinicians in routine practice. Schiff and Bates (Schiff 2010) proposed a number of ways that electronic health records might be used to improve diagnostic accuracy and prevent diagnostic error. They provide at least 15 examples of how EHRs might accomplish this. They especially talk about the way that the EHR might be used to visually present data in a more useful way (eg. trended data) to facilitate diagnostic thinking. They also note that there need to be changes in workflows and work layouts to facilitate having both the patient and physician involved interactively.
The PPSA review also provides a couple nice tools to help clinicians identify and avoid diagnostic errors. One is a chart audit tool to help identify errors adopted from the article by Schiff et al (Schiff 2009). The other is a simple checklist the clinician can use to help focus the things he/she needs to do to in each case avoid diagnostic errors.
The Singh pediatric study (Singh 2010) also notes the need for better use of simulation exercises in our training. We need more focus on diagnostic decision making in our medical schools and residency programs. Many of our medical schools already utilize simulations involving trained actors to improve our interviewing skills and diagnostic skills. Our August 10, 2010 Patient Safety Tip of the Week Its Not Always About The Evidence discussed contextual errors and provided examples of how simulation exercises can be used to point out how contextual red flags may be missed, resulting in erroneous care.
And our frequent focus on the need for better teamwork training has relevance to diagnostic error as well. The Croskerry video discusses how use of team thinking may improve diagnostic thinking. While admitting that occasionally a dominant team member who is in intuitive mode might get the group to come to wrong decisions, in general working in a team requires that you think out loud, which gets everyone to stop and think more in the rational or analytic mode. This is good since errors are much more frequent when we are functioning in the intuitive mode. The Winters et al. editorial (Winters 2011) also notes the generally positive influence of teams on decision making because of diverse input, and a balance of interdependent discussion with independent voting. Interestingly they note that honeybees use group decision making very successfully!
All our discussion on cognitive errors does not just apply to diagnostic errors. Keep in mind that we can make the same sorts of cognitive errors when doing our root cause analyses (RCAs). Anchoring, availability bias, confirmation bias, and others are common mistakes we make that may prevent us from coming up with the best solutions in RCAs.
And dont forget that the same cognitive biases that affect our healthcare lives may also impact our decision-making processes in our day-to-day lives!
Some of our prior Patient Safety Tips of the Week on diagnostic error:
Ropper AH, Wijdicks EFM, Truax BT: Guillain-Barre Syndrome. FA Davis: Philadelphia 1991; pp. 224-225
Wellbery C. Curbside Consultation. Flaws in Clinical Reasoning: A Common Cause of Diagnostic Error. American Family Physician 2011; November 1 2011 Vol. 84 No. 9 (online)
Croskerrry P. Clinical Decision Making and Diagnostic Error (video). Risky Business. 2010
Graber ML, Franklin N, Gordon R. Diagnostic Error in Internal Medicine. Arch Intern Med 2005; 165: 1493-1499
Pennsylvania Patient Safety Authority (PPSA). Diagnostic Error in Acute Care. Pa Patient Saf Advis 2010 Sep;7(3):76-86
Croskerry P. A Universal Model of Diagnostic Reasoning. Academic Medicine 2009; 84(8): 1022-1028
CRICO/RMF. High-Risk Areas.
Winters BD, Aswani MS, Pronovost PJ. Commentary: Reducing Diagnostic Errors: Another Role for Checklists? Academic Medicine 2011; 86(3): 279-281
Singh H, Thomas EJ, Wilson L, et al. Errors in Diagnosis in Pediatric Practice: A Multisite Survey. Pediatrics 2010; 126(1): 70-79
Singh H, Thomas EJ, Khan MM, Petersen LA. Identifying Diagnostic Errors in Primary Care Using an Electronic Screening Algorithm. Arch Intern Med 2007; 167: 302-308
Ely JW, Graber ML, Croskerry P. Checklists to Reduce Diagnostic Errors. Academic Medicine 2011; 86(3): 307-313
Schiff GD, Bates DW. Can Electronic Clinical Documentation Help Prevent
Diagnostic Errors? NEJM 2010; 362(12): 1066-1069
Pennsylvania Patient Safety Authority. A Physician Checklist for Diagnosis.
Schiff GD, Hasan O, Kim S; et al. Diagnostic Error in Medicine: Analysis of 583 Physician-Reported Errors. Arch Intern Med, Nov 2009; 169: 1881 1887
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December 6, 2011
Why You Need to Beware
of Oxygen Therapy
Our regular readers are probably tired of hearing us harp on the dangers of using oxygen in patients who are on PCA pumps or receiving intravenous opiates. But we by chance stumbled onto an old paper that illustrates the hazard much better than we could ever do.
Smyth and Egan (Smyth 1998) did a case report of a near miss in a patient on a PCA pump who was also receiving oxygen. The patient was in a neurosurgical critical care unit with acute spinal cord impingement and had been placed in tongs for cervical traction. He was receiving morphine via PCA pump. The original PCA order had been written by the Pain Management Service and was for 1 mg of morphine with a 10-minute lockout interval, later increased to 1.5 mg of morphine. Later, another physician ordered two 5 mg doses of diazepam for anxiety (two hours apart). After the second diazepam dose there was a brief period where oxygen saturation fell to the 85-88% range. His supplemental oxygen was increased from 3 L/min via nasal cannula to 10 L/min via face mask. About an hour later he was found unresponsive and apneic but oxygen saturations were in the 92-95% range. But arterial blood gases showed a pH 7.08 and pCO2 102 and pO2 90. He was treated with IV naloxone and bag-mask ventilation and after 10 minutes became alert with spontaneous respiration.
Obviously the pulse oximetry was not helpful in this case since his oxygen saturation did not fall to levels where an alarm would be triggered. Similarly, the other alarm systems in the critical care unit (EKG and automated BP monitors) were not helpful in alerting nursing that there was a problem with this patient.
The authors discuss the physiology of how oxygenation is maintained in someone who is apneic, hence the term apneic oxygenation. This comes as no surprise to those of us who are neurologists since we routinely use tracheal insufflation of oxygen during apnea testing as part of braindeath determinations. Very seldom do patients develop significant oxygen desaturation during braindeath apnea testing.
But the key lesson learned here regards the false sense of security one gets when using continuous pulse oximetry monitoring. Obviously it was of no benefit here. The other key lesson learned regards the additive effects of a benzodiazepine and morphine in producing respiratory depression.
But there are a few other unanswered questions. We were not told why the patient was put on oxygen in the first place (though he had a 70-pack year smoking history). Secondly, we dont know what sort of evaluaton took place when the patient initially had the brief episode of oxygen desaturation that led to increasing his supplemental oxygen. Unfortunately, a common response to oxygen desaturation is simply increasing the amount of supplemental oxygen without doing an assessment of why the desaturation occurred. In their excellent paper on patterns of unexpected death in hospitals Lynn and Curry (Lynn 2011) note that in pattern #2 (CO2 narcosis) it is not uncommon to see overlap with pattern #3 (a sleep apnea pattern). They also note that it is not at all uncommon for nurses to respond to frequent brief episodes of oxygen desaturation in such patients and consider them false alarms. Such episodes might, in fact, be sleep apneic episodes and the stimulation by nurses wakes the patient so their breathing and O2 saturations are restored and the episodes are thus considered false.
Weve noted several times the excellent article by Lynn and Curry (Lynn 2011) on alarms and their failure to identify deteriorating patients early, highlighted in our February 22, 2011 Patient Safety Tip of the Week Rethinking Alarms. That article and the APSF initiative on monitoring the postoperative patient have really challenged the current methods of monitoring we use and pointed out the weaknesses of threshold-based alarms.
The APSF (Anesthesia Patient Safety Foundation) summary of their Conclusions and Recommendations from June 08, 2011 Conference on Electronic Monitoring Strategies to Detect Drug-Induced Postoperative Respiratory Depression made a cogent argument for continuous physiological monitoring of all patients receiving post-op opiates, including continuous pulse oximetry (and capnography for all patients receiving supplemental oxygen). And though they note the importance of identifying patients with conditions that place them at higher risk of respiratory depression, they note that selective monitoring of these would miss respiratory depression in patients without these risk factors. They again make the case that threshold-based alarm systems remain problematic and stress the need for systems that allow for earlier recognition of respiratory depression.
Obviously the current case highlights the need for new monitoring and intervention tools such as the apnea prevention device (Zornow 2011) mentioned in our September 6, 2011 Patient Safety Tip of the Week More Tips on PCA Safety.
Sometimes we do things in medicine that superficially sound good like putting post-op patients on oxygen only to see unintended consequences that are patient safety hazards. This is one of the reasons we like checklists or similar formats when using PCA pumps or otherwise treating post-op patients with opiates. These can force the ordering clinician to think twice before ordering oxygen in such patients and to consider whether appropriate monitoring protocols are in place.
Prior Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression and PCA safety:
Prior columns pertaining to oxygen safety:
Smyth E, Egan TD. Apneic Oxygenation Associated with Patient-Controlled Analgesia. Journal of Clinical Anesthesia 1998; 10: 499-501
Lynn LA, Curry JP. Patterns of unexpected in-hospital deaths: a root cause analysis. Patient Safety in Surgery 2011, 5:3 (11 February 2011)
APSF (Anesthesia Patient Safety Foundation). Conclusions and Recommendations from June 08, 2011 Conference on Electronic Monitoring Strategies to Detect Drug-Induced Postoperative Respiratory Depression. 2011
Zornow MH. Clinical Testing of the Apnea Prevention Device: Proof of Concept Data. Anesth Analg 2011; 112:;582-586
December 13, 2011
Surgical Fires - Again
Barely a month after the FDA launched a new initiative aimed at preventing surgical fires (see our November 2011 Whats New in the Patient Safety World column November 2011 FDA Initiative on Preventing Surgical Fires) 2 new high-profile surgical fires were in the news.
A 29 y.o. Florida woman suffered serious face and neck burns during surgery to remove several cysts on her head (NineMSM News 2011). Medical and procedural details are not available. Less than a week later, a similar event occurred in Washington state involving a man having a lump removed from his head (Hopperstad 2011). The patient said he believes the cauterizing tool used in the surgery caused a spark and that, in turn, ignited the oxygen in his oxygen mask. These two cases graphically illustrate the devastating effects such surgical fires have on patients.
See our December 4, 2007 Patient Safety Tip of the Week Surgical Fires for a comprehensive description of the factors involved in surgical fires. The fire triangle has 3 elements: heat, fuel and oxydizer. In general, each member of the surgical team the surgeon, the anesthesiologist, and the nurses controls a specific side of the triangle. That is, the surgeon controls the heat source, the nurse the fuel source, and the anesthesiologist the oxidizer. The heat source is most often an electrocautery instrument or electrosurgical unit or a laser but drills, heated probes, and even fiberoptic light sources and others may be heat sources. In addition, sparks and embers may serve as potential igniters. Almost anything in the OR can burn and be a source of fuel. The closer the heat source is to the oxygen source, the greater the risk of fire. Hence, surgeries involving the head, neck or upper chest are most vulnerable. That column also had links to the many great resources available through the ECRI Institute, the most renowned authority on surgical fires.
In our November 2009 Whats New in the Patient Safety World column ECRI: Update to Surgical Fire Prevention we noted ECRIs New Clinical Guide to Surgical Fire Prevention. The 2009 key change in clinical practice was discontinuing the open delivery of 100% oxygen during procedures done under sedation. They discuss ways to minimize the concentration of oxygen being used in a variety of scenarios. But essentially it says that if significant oxygen is needed during a procedure being done under conscious sedation, it should be delivered via a secure airway (endotracheal tube or laryngeal mask). It is not clear whether those guidelines were followed in the 2 recent fires in the news.
Given the potentially devastating consequences of surgical fires, it is essential that all appropriate steps be taken to prevent them. This starts by identifying those cases at high risk for surgical fire. We recommend that a surgical fire risk assessment be done on every case. This can be done at either the pre-surgical huddle or the surgical timeout. We favor it be done at the huddle, but only if all the key players (surgeon, anesthesiologist, and nurse) are participating in that huddle (as they should be!). This is, of course, necessary because if the case is a high-risk case for surgical fire each of those participants must understand what their role is in the event a fire should occur. In addition, the surgeon and anesthesiologist must be on the same page and understand when oxygen flow must be minimized or ceased prior to use of a heat source. Coordination between the anesthesiologist and surgeon are critical when it comes to using lasers, electrocautery tools, electrosurgical tools, or other potential sources of ignition. The surgeon should give adequate notice that he/she is about to use such a device and then adequate time should be allowed to elapse to allow the anesthesiologist to take steps to minimize the oxygen in the area.
The tool we really like is the one used at the San Francisco VA system (see our January 2011 Whats New in the Patient Safety World column Surgical Fires Not Just in High-Risk Cases). As part of an effort to promote fire safety in the OR (Murphy 2010), the San Francisco VA developed a checklist The Surgical Fire Assessment Protocol. This checklist/protocol is actually printed on the reverse side of their larger preoperative checklist. The fire risk is assessed by a simple numerical scale. If the score is 3 (high risk) the rest of the form is filled out, which basically delineates the respective roles of all those participants. Thats a really good way to remind all about their responsibilities if a fire occurred.
An alternative tool was described in the video accompanying the new FDA initiative that we discussed in our November 2011 Whats New in the Patient Safety World column November 2011 FDA Initiative on Preventing Surgical Fires. That video on surgical fires focuses on an approach taken by one healthcare organization after it experienced two surgical fires within an 8-month period. They incorporated a fire risk assessment into their Universal Protocol so that it gets done on virtually all surgical cases. The risk assessment is based on 3 simple questions about the fire triangle: (1) is there an open oxygen source? (2) is there a heat source present? and (3) how close are they to each other? (Note they assume that the fuel leg of the fire triangle is everpresent in the OR.) They then tie various protocols to the risk assessment score. The video describes the steps taken to mitigate the fire risk and also deals with improving communication among all members present in the OR and changing safety culture.
The American Society of Anesthesiologists Practice Advisory for the Prevention and Management of Operating Room Fires stresses that all anesthesiologists should have fire safety education, specifically for OR fires, with an emphasis on the risk created by an oxidizer-enriched atmosphere (see our April 29, 2008 Patient Safety Tip of the Week ASA Practice Advisory on Operating Room Fires). OR fire drills should take place with the entire OR team. Very importantly, the advisory recommends that for each case, the OR team should formally (1) determine whether or not a high-risk situation exists and (2) have team discussion about strategy for prevention and management of a fire. And a protocol for prevention and management of fires should be placed visibly in each location where surgery/procedures might be done, along with all appropriate equipment for managing a fire. Each member of the team should be assigned a task and understand they should perform that task immediately without waiting for other team members to act. (Once they have completed their task, they can help other team members with other tasks). Though there is no evidence base to confirm that such a pre-case team discussion actually prevents or helps manage fires, its certainly good common sense. For those of you who like checklists, its a good item to add to your preoperative checklist.
The other critical consideration in surgical fires typically has to do with skin preparations used. Most modern skin preparations contain alcohol, which is flammable. Its therefore essential that adequate time be allowed for drying of areas prepped with alchohol-based solutions. And one must ensure that any alcohol vapors have disseminated as well. Here there are often subtleties. One of the most popular skin prep agents comes in varying sizes of applicators. The ratio of chlorhexidine to isopropyl alcohol is that same in both instances. What is different is the size of the applicator and, hence, the total amount of isopropyl alcohol. The larger applicator has a warning in small print on its package not to be used in surgery of the head and neck but otherwise the applicator packages look the same.
We suspect a certain level of complacency may play a role in many surgical fires. They are often is cases very similar to the 2 in the headlines recently considered relatively minor, routine procedures, often performed under conscious sedation. Such cases are often add-ons, cases added onto a surgical schedule when time permits following more complex cases. In such cases, we often let our guard down. Unless we are rigorous in formally including a fire risk assessment in each and every case, its easy to see how risk factors for fires may be overlooked.
Prevention of surgical fires requires an ever-present vigilance for risk factors, protocols to minimize those risks, and simulation training or drills so that all staff know what to do if a fire does occur. Surgical fires are uncommon enough for staff to be poorly trained at both prevention and response once one actually occurs. Yet they are frequent enough that most OR staff will encounter one or more in a lifetime. Only with meticulous steps to minimize fire risk, identification of fire risk for each individual case, training and drills will OR staff be prepared to do what it takes to prevent fires and know their roles in responding immediately if a fire occurs.
Lastly, dont forget the impact of surgical fires on all the staff in the operating room. They all went to the OR that day with the intention of helping patients, then witnessed these horrific incidents that they will never forget. Thats one reason we try to educate staff about this risk before an event occurs. When they watch a surgical fire video or see photographs of the victims of such fires or a charred, melted endotracheal tube they typically say Wow. I dont ever want one of those to happen here.
There are many great resources available now on surgical fires. In addition to the ECRI Surgical Fire Prevention website and the new FDA Surgical Fires website, there is the AORN Surgical Fire Tool Kit and the Anesthesia Patient Safety Foundation video on prevention and management of operating room fires.
Please also see our prior columns on surgical fires:
Patient Safety Tips of the Week:
Whats New in the Patient Safety World columns:
NineMSM News staff. Woman's face burned during routine surgery. NineMSM News 2011; December 3, 2011
Hopperstad J. Washington man's face catches fire during routine surgical procedure. Q13 FOX News December 5, 2011
ECRI. Surgical Fire Prevention. 2009 update.
Murphy J. A New Effort to Promote Fire Safety in the OR.
Topics In Patient Safety (TIPS) 2010; 10(6): 3
SF VAMC Surgical Fire Risk Assessment Protocol
Silverstein KL, Joseph S. FDA on Medscape: Surgical Fires: How They Start and How to Prevent Them. October 12, 2011
American Society of Anesthesiologists Task Force on Operating Room Fires. Practice Advisory for the Prevention and Management of Operating Room Fires. Anesthesiology 2008; 108: 786-801 http://www.asahq.org/publicationsAndServices/orFiresPA.pdf
FDA. Preventing Surgical Fires.
ECRI Institute. Surgical Fire Prevention.
AORN (Association of periOperative Registered Nurses). Fire Safety Tool Kit.
Anesthesia Patient Safety Foundation. Fire Safety Video.
PREVENTION AND MANAGEMENT OF OPERATING ROOM FIRES
Print Surgical Fires Again
December 20, 2011
In our November 17, 2009 Patient Safety Tip of the Week Switched Babies we noted that, for at least the last 10 years, most hospitals have had fairly sophisticated systems in place to avoid infant abductions and to respond promptly if one occurs. And most hospitals feel confident with those systems.
However, all it takes to shake that confidence is reviewing an infant abduction that takes place elsewhere. Youll find yourself saying Wow. I wonder if that could have happened here.
Every year about this time the California Department of Public Health releases a report on significant incidents that have taken place in California hospitals. We read them, not to see which hospitals have had such events, but rather to look at the root cause analyses (RCAs) that were done. There are so few publicly available RCAs yet the lessons learned from them can be very powerful and applicable at hundreds of other hospitals. In the group released this year, one dealing with an infant abduction really got out attention.
Briefly, an individual dressed in scrubs entered the room of a mother and newborn, identified herself as a student nurse and told the mother she needed to take the infant to be footprinted. The individual was able to completely exit the hospital with the abducted infant in a large handbag/tote.
When a real hospital nurse entered the room and found the bassinette empty except for the intact infant security band, a Code Pink was immediately initiated.
Authorities were able to reconstruct the movements of the abductor through review of various surveillance videos and the individual and the infant were eventually tracked down because the parking lot attendant wrote down the license plate number when she had no money to pay her parking fee.
But as you read through the health departments description of the incident and contributing factors and the hospitals plan of correction you will likely find yourself saying that could have been us.
The abductor had been seen on the mother infant unit (MIU) on at least 3 consecutive days prior to the abduction. Each time she was dressed in a nurses uniform or scrubs. When asked by staff what she was doing there her reply was visiting a friend but no one apparently ever questioned who the friend was. There was no security guard on the unit at the time and apparently no access control policy. The video surveillance system was not actively monitored but rather only used for retrospective viewing if the need arose. There were also apparently multiple points of potential entrance and egress to and from the MIU (including stairwells, elevators, etc.). The stairwells were not equipped with door alarms or one-way locks to restrict access to the MIU. And the only alarm system would be triggered by the infant security band (a tag transmitter band), which had been removed intact in this case. An alarm would also be triggered if this security band is broken but in this case the abductor was able to remove the security band from the infants ankle intact.
Apparently, nursing staff were expected to serve as the access control mechanism but there was apparently suboptimal training for that. Additionally, when all nurses were busy there would be no one accountable for access control. There was also no signage identifying the unit as having restricted access and requiring visitors or non-authorized personnel to check in at the nurses station. The facility did have a visitors hours policy but it was seldom enforced (the event took place outside of the visitors hours in that policy).
Nurses on the MIU wore the same uniform and standard hospital badge used by all other nurses in the hospital. There was no distinctive feature that identified them as belonging on the MIU. Similarly there were no distinctive features that would identify personnel who could transport an infant in the hospital.
The hospital did regularly conduct drills on their Code Pink. In fact, they did 4 in the two years prior to the incident. In each of those 4 drills, the abductor was able to successfully exit the facility. Numerous drill evaluations were either incomplete or identified items needing improvement but lacked verification that those items were corrected.
The hospitals Code Pink response began with notification of the switchboard by dialing 599 and giving a specific location. The switchboard operator would then send out a group page. This was apparently a silent page that would be delivered to designated cell phones as a text message. There apparently was no hospital-wide overhead page or alert given. If cell phones were not operational, no message would be delivered.
The Code Pink policy did have specific assignments for staff on the various units. Security would respond to the location, call 911 and notify the security manager and VP of facility management. Facilities management staff would meet at a designated location and be assigned to various posts throughout the facility. And although the policy stated that all possible suspects would be stopped and detained, there was no formal training on what to look for, what a possible suspect looked like, and what to do if they stopped someone.
In the actual event, the request did go to the switchboard operator to send out the silent alarm. However, several attempts failed to get out the specific message. Apparently prior discussions about scripting messages for the operators had never been followed up on.
The adjacent parking structure was operated by an independent company. None of the parking attendants, nor the valets who sometimes parked cars for patients and visitors, had ever been included in training for Code Pink events. Fortunately, the parking lots own procedures for dealing with patrons unable to pay included writing down the license plate number and that facilitated finding the abductor and infant.
There was also no documentation that parent awareness training (including infant security and safe transportation guidelines within the hospital) had taken place.
There were also apparently 26 hospital exits in all.
The hospital response included multiple interventions to control access. These included better signage restricting visitors and unauthorized persons, institution of greeters, more strategically located security guards, and visitor logs and visitor badges. They also added alarms and locking devices for stairway doors and redeployed surveillance video cameras. They educated staff, including warnings not to let others tailgate them as they exited elevators to restricted areas and educated the community about new security issues in the hospital. They issued unique identification badges to identify staff working on special units like the MIU.
They also instituted procedures to verify tight fit of the infant security bands and switched to a new security band that can be tightened if the infant loses weight.
They made their Code Pink policies more in keeping with the NCMEC (National Center for Missing and Exploited Children) guidelines for missing/abducted children, redid their messaging system and redid their lockdown procedures, including the parking facility in those lockdown requirements. The parking lot staff and valet parking staff were also included in Code Pink training and responses.
They standardized written education materials for parents on infant safety and included information on infant security in pre-natal materials to give to parents prior to their labor and delivery. They also developed ways to use the EMR for more detailed description of infants (birthmarks, eye color etc.) and developed policies on holding cord blood for DNA testing, if necessary.
Code Pink drills were also improved by adding specific observers and development of standardized forms to be filled out by observers.
So, do any of these factors apply to your facilities and organizations? We see many recurrent themes that occur at multiple hospitals:
The Joint Commission issued a Sentinel Event Alert in 1999 that identified root causes in cases of infant abductions from hospitals and made numerous recommendations for steps to prevent such. Among those recommendations were attaching secure identically numbered identification bands to the baby (wrist and ankle bands), mother, and father or significant other immediately after birth. In addition, the footprint of the infant and a color photograph of the infant are recommended. Some hospitals also use a fingerprint of the mother in the identification process. Prompt recording of the physical examination of the infant is also useful in the identification process (eg. recording of birthmarks may be very helpful in correct identification). Code Pink policies also include conspicuous identification badges for all staff members, good security/surveillance of all access and exit sites, and high tech infant security tags and alarm systems. Note also that you may wish to modify your Code Pink policy to also include patients who have eloped or are otherwise missing (see our July 28, 2009 Patient Safety Tip of the Week Wandering, Elopements, and Missing Patients).
Education of both staff and the family are important in preventing infant abductions but should also be extended to help prevent incorrect identification of infants. When providing such education to mothers and family, it is important to assess their level of understanding. It is wise to do that education twice with the mother, once in the days or weeks just prior to anticipated delivery and then again immediately after delivery when the ID tags are being placed. You need to keep in mind that the mothers cognition may be impaired by drugs used during labor and delivery and she may not fully comprehend what she is being told at that time. In any case, the identification process should be reinforced on every interaction between mother and baby and staff.
The hospitals plan of correction in the current incident also relied heavily on information and recommendations from the National Center for Missing and Exploited Children.
While we previously had thought that doing a FMEA (failure mode and effects analysis) on the possibility of switched babies was likely to be more fruitful than doing one on infant abduction, this incident raises so many questions about potential vulnerabilities that it is a great topic for a FMEA.
Are you really sure this couldnt happen at your facility?
California Department of Public Health. Event ID: XEH111 April 25, 2011
The Joint Commission. Sentinel Event Alert. Infant Abductions: Preventing Future Occurrences. Issue 9 April 9, 1999
National Center for Missing and Exploited Children
Print Infant Abduction
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