Healthcare Consulting Services
April 6, 2010
Cancer Chemotherapy Accidents
As we were doing some research on safety issues dealing with cancer chemotherapy, we came across an interesting story Frantic 43 hours to fix chemo overdose (Khalik 2009). Its a news article from Singapore in November 2009 about the successful search for an antidote for a patient inadvertently given a massive overdose of 5-FU (5-fluorouracil). The patient, being treated for a nasopharyngeal carcinoma, was to receive the total 5-FU dose over 5 days but the IV pump had erroneously been programmed to administer the dose over 5 hours. The patients oncologist was notified very shortly after the dose had been administered and happened to recall a poster presentation at the American Society of Clinical Oncology (ASCO) the previous June that addressed a new drug (vistonuridine) developed as an antidote for 5-FU. A series of frantic phone calls ensued, complicated by time zone differences and occurrence on a weekend, as they tried to get the US company that developed the new antidote. They successfully procured the drug but then had to rush through bureaucratic red tape and health affairs authorities to use a drug that was not yet approved for use in Singapore. The patient apparently survived that potentially fatal overdose and the hospital apologized to the patient and family, covered the medical expenses, and investigated to implement steps to prevent similar future occurrences (Koh 2010). The Singapore Ministry of Health issued an alert to other hospitals to check their procedures for administering chemotherapy via pumps.
From the patient safety perspective, the key factor was a problem programming of the pumps. In fact, there were actually two cases and it was the first case (administering several days worth of a much less toxic agent to a different patient) that alerted the pharmacists that the above patient might have inadvertently received the overdose of 5-FU. The hospital was using pumps that looked very similar but some were programmed in milliliters per hour and others in milliliters per day. Despite a double check by two pharmacists, the error was not noticed until the first patient happened to call the hospital and tell them that her infusion had gone in over several hours rather than several days.
When we read this story, it sounded eerily familiar so we searched through our archive. We did not have to search far. In last weeks Patient Safety Tip of the Week Publicly Released RCAs: Everyone Learns from Them we made reference to one of the few good publicly available RCAs in the past, one we discussed in our September 11, 2007 Patient Safety Tip of the Week Root Cause Analysis of Chemotherapy Overdose. That was an RCA done by ISMP Canada on an almost identical event in 2006! The full RCA of that incident is available online (and is an excellent example of the way to do an RCA, utilizing both the Canadian Root Cause Analysis Framework and the Veterans Administration root cause analysis tools).
That case involved a 43 year old woman who was being treated for an advanced nasopharyngeal carcinoma with a chemotherapy protocol of high-dose fluorouracil and cisplatinum. The chemotherapy was to be given intravenously by an infusion pump over a 4-day period. However, the pump was inadvertently programmed to infuse the entire contents over a 4-hour period instead. The patient died as a result of the mishap.
The discussion on the causal chains leading to incorrect programming of the infusion rate is excellent and focuses on many of the individual issues we have mentioned in previous Tips of the Week. The bedside nurses had to perform an incredibly complex calculation and they did not have at hand all the information needed to make the calculation. And the double check process failed as well. The nurse doing the double check did not have a calculator readily available so did the complex calculation on paper and in her head. Much as we described in last weeks column, the independent double check should be done without knowing what or how the first individual did the calculation and should be done by someone who has the time and an undistracted environment in which to do the calculation and check. All too often the nurse (or pharmacist or even physician) doing the double check is called away in the midst of another task to do the double check and never ends up doing it correctly. One very important point is that neither the first nurse nor the one doing the double check did a mental approximation. Thats where you do a simple calculation in your head that would have said this infusion is going to be done in 4 hours, not in the 4 days that were intended.
The medication label printed in the pharmacy not only had several features not in keeping with good human factors design principles but also included unnecessary information that may have increased the opportunity for false confirmation of the infusion rate. The pharmacists also were not familiar with how the pumps are programmed. (Note also that this RCA was probably done before widespread adoption of smart pumps because todays smart pumps would likely also have a built-in drug library that included dose range limits). And the patient education process did not include review of pump data input, which might have been an additional opportunity to notice the mistake. There was also lack of feedback from the pump that further reduced the opportunity to notice the incorrect infusion rate. The description about how several advanced technologies were poorly integrated and actually led to increased cognitive workload is particularly informative. The RCA notes that use of checklists would help in this complex process and there should be ways to incorporate the formulas and calculations into the ordering process.
They also discussed issues with the chemotherapy protocol and the lack of standardization across multiple cancer centers in the system. The protocol lacked any section on what to do in the event of misadministration of the drug.
All the above occurred against a background where the potential toxicity of the regimen and the lack of an effective treatment for overdose did not appear to be fully appreciated by numerous members of the healthcare team. Much had to do with the dearth of published literature on fluorouracil overdosage. That is probably still largely the case and in the Singapore case it was only by chance that the oncologist had recalled the poster presentation about the possible antidote.
Many of the most useful comments pertain to the response to the incident. The recommendations expand upon some of the important points we included in our July 24, 2007 Patient Safety Tip of the Week Serious Incident Response Checklist. They also showed how multiple other individuals would have had similar difficulties programming the pump and nicely illustrated how a facility needs to assemble a representative group of end-users during the pre-purchase phase of any investment in new technology in order to identify potential usability and safety issues.
The recommendations made in the RCA are well thought out and do take into consideration possible unintended consequences. The recommendations extend well beyond the facility and include recommendations for manufacturers, regulators, safety organizations, etc. A followup to that RCA was also published in the August 20, 2007 ISMP Canada Safety Bulletin. And a summary also appears in the September 20, 2007 Medication Safety Alert from ISMP (US).
This is an excellent RCA and a model for doing a good RCA. In fact, our sole criticism has to do with their prioritization of causal statements. The treatment protocol design was ranked #15 (out of 16) on their list. We would have ranked it at or near the top of the list. A high-reliability organization would assume that something could go wrong with the infusion process and ensure that, if it did go wrong, irreparable harm would not take place. We see this as akin to the concentrated potassium chloride issue. We understand that convenience of the patient must have been important in development of the chemotherapy protocol but inclusion of 4 days worth of fluorouracil (plus a single high dose of cisplatinum) in a single IV bag enabled the fatal outcome when subsequent errors occurred. A safety culture would likely have said what is the highest dose that a patient could tolerate in one day (or less) if there was inadvertent administration of the infusion?. A safety culture would have designed the protocol with sublethal dosages that would have protected the patient in the event of what can go wrong will go wrong. It also would not have put the healthcare workers at the sharp end in a situation none of use would want to be.
There are incredibly valuable lessons in both the Singapore case and the Canadian case. Your organization can benefit from reviewing the issues and recommendations here regardless of whether you perform cancer chemotherapy or not.
Update: See also our April 2010 Whats New in the Patient Safety World column for new papers on medication incidents involving cancer chemotherapy.
Frantic 43 hours to fix chemo overdose.
By Salma Khalik
Tue, Nov 17, 2009
The Straits Times
Elroy Koh (medical student blog) Sunday, March 28, 2010
Chemotherapy mix-up - there is power in an apology
ISMP Canada. Fluorouracil Incident Root Cause Analysis: Follow-Up. ISMP Canada Safety Bulletin 2007; 7(4) 1-4. August 20, 2007.
ISMP Canada. Root Cause Analysis. Fluorouracil Incident Root Cause Analysis. May 22, 2007 (full RCA)
ISMP (US). Fluorouracil error ends tragically, but application of lessons learned will save lives. ISMP Medication Safety Alert. Acute Care Edition. September 20, 2007
April 13, 2010
Update on Handoffs
Weve written many columns highlighting issues related to handoffs in healthcare (see the listing and links at the end of todays column). But there have been several good new articles on handoffs recently that deserve mention.
Two systematic reviews on both nursing handoffs and physician handoffs (Riesenberg 2010; Riesenberg 2009) found a dearth of high quality research studies showing what features of handoffs are responsible for desirable outcomes. So well admit right up front that most of the recommendations on handoffs are largely based on anecdotal evidence. The Riesenberg paper on nursing handoffs nicely summarizes the barriers to effective handoffs identified in the literature, plus recommendations from the literature.
In the past few years there has been a movement to doing face-to-face nursing handoffs right at the patient bedside at change-of-shift. This gives patients (and families) both the opportunity to be updated on their plans of care but also to have input. From a patient satisfaction standpoint these handoffs have been very positive. But it is not yet known whether they result in better clinical outcomes. Again anecdotally, there are many examples where a patient or family member were able to change incorrect information or add additional information during these bedside handoffs that did impact on their care.
Among several articles on handoffs appearing in the February 2010 Joint Commission Journal on Quality and Patient Safety was one on measuring effectiveness of handoffs (Patterson & Wears 2010). Though the article gets somewhat ethereal at times, it does highlight the difficulties in assessing the effectiveness of handoffs. Perhaps most importantly it really makes you realize that there is more to a handoff than simply transmission of information. It also involves, in most cases, transfer of authority and responsibility and in most cases requires not only that the two parties directly involved understand what change of responsibility has occurred but also that all other pertinent parties understand that change. Moreover, they point out that the handoff also involves social aspects, and those may be interdisciplinary.
Several good articles on handoffs related to the emergency department (ED) appeared in the February 2010 issue of the Annals of Emergency Medicine. Cheung et al (Cheung et al 2010) discuss some of the same conceptual frameworks as in the above article (one of the authors participated in both publications) but also discuss concerns that are unique to the ED. They begin with the statistics about EDs as high risk areas and that communication issues commonly contribute to both adverse outcomes and delays in care. Up to 62% of delays in care related to communication issues are associated with shift changes. Up to 24% of ED malpractice claims involve faulty handoffs. They highlight the difficulty of communicating in an environment that is loud and disruptive with numerous interruptions, ongoing patient concerns, phone and radio calls, etc. They even note that poorly performed handoffs actually add to the distractions.
They note one particularly unique occurrence in the ED: the departing physician sometimes stays in the ED to complete charts, etc. Nurses and other staff often then go to that physician for decision making, often resulting in the receiving physician (who now officially is responsible and accountable for the patient) not knowing vital information.
Another problem that may occur in any situation where the care of a patient is temporary (so especially in the ED) is cognitive bias or diagnosis momentum where the receiving physician relies too heavily on the judgement of the departing physician.
Though the article admits that there is no standard ED handoff (and that there may in fact be no one size fits all handoff model for each setting), they discuss the various pros and cons of some handoff models such as single vs. multidisciplinary handoff, central vs. bedside handoff, verbal vs. written vs. computerized handoff, etc. Note that a previous study on nursing handoffs (Pothier et al 2005) showed that pure verbal handoffs and note-taking style handoffs had high rates of data loss but that when a typed sheet was included with the verbal handoff, data loss was minimal. Many programs have been utilizing computerized tools that extract data electronically from multiple computer sources to populate templates that can then be supplemented and used during physician handoffs (see Flanagan et al 2009).
Cheung et al have some good advice regarding strategies to improve ED handoffs. Firstly, reduce the number of unnecessary handoffs. That can often be done by scheduling overlapping shifts or protecting the departing physician from new patients toward the end of a shift (but beware of the unintended consequence of pushing the patient through the system too rapidly). Do the handoffs in a quiet, dedicated space to minimize distractions, leaving adequate time for discussion and questions. Balance completeness with succinctness in the handoff (if too much information is conveyed, the critical elements are often lost among the irrelevant ones). Prioritize patients who need to be seen first and communicate all outstanding issues (labs, radiology, consultations, etc.). Be sure to spell out authority issues (eg. when a consultant will be determining disposition of the patient) and let all the ED staff know that a transition of care has occurred.
The second paper (Apker et al 2010) used an assessment tool developed for the express purpose of evaluating handoffs and then used it to evaluate handoffs between ED physicians and hospitalists that were recorded. They found that most handoffs were predominantly one-way. The bulk of the handoffs were spent with the ED physician speaking and seldom did the hospitalists ask questions or seek verification. And in most cases the hospitalists acceptance of the admission was indirect. They did comment, however, on the use of silence, uh-huhs, and okays by hospitalists as communication tools.
Despite the trend toward using more standardized tools for handoffs using formats such as SBAR, we continue to see many incidents in which poorly done handoffs have played major roles. During the economic downturn we have seen many hospitals either cutting back on staff or cutting back on staff hours. The 7 hour day (shift) has appeared. And even where hospitals have been able to change scheduling to create overlapping shifts, that 7 hour shift inevitably results in fewer face-to-face handoffs. So even though most hospitals are now using structured handoff tools, the ability of the recipient of the handoff to ask questions and get clarifications is impaired.
Hospital cutbacks may have also created new, unique need for handoffs. For example, in some small hospitals nursing will now perform some respiratory therapy treatments during night or evening shifts that were formerly done by respiratory therapists. So there now needs to be a handoff from respiratory therapy to nursing (and then a handoff in the reverse direction in the morning).
The biggest problem we see with handoffs is failure to allow adequate time. One party is often delayed in arriving at the site where the handoff will take place and there is often pressure on the oncoming party to cut the handoff short to attend to some urgent need. Ensuring adequate time for exchange of information is critical to effective handoffs. Yet we wonder if our failure to ensure adequate time may be a reflection that our safety culture is not yet mature enough to give the handoff the priority it is due.
Part of the problem in ensuring adequate time is that interruptions remain a major barrier to effective handoffs. Back to our aviation analogies, the handoff should be done under sterile cockpit conditions where all parties must be focused on the task at hand. So the handoff should be done in an environment where nothing but the most serious emergencies should be allowed to interrupt.
All too often we realize that our handoffs are suboptimal only after we review an incident that has already occurred. We believe that recording handoffs can be a valuable educational and performance improvement tool that may help your organization identify problematic communication before adverse events occur. Video recording is preferable to audio since so much communication is nonverbal. When you play back the handoffs to those staff members who were involved, they usually readily recognize opportunities for improvement. As long as this is done in a constructive, nonpunative and nonderogatory fashion it helps staff at all levels of the organization improve their communication skills.
Read about many other handoff issues (in both healthcare and other industries) in some of our previous columns:
August 28, 2007
December 11, 2007
February 26, 2008
September 30, 2008
November 18, 2008
June 30, 2009
April 25, 2009
Riesenberg LA, Leisch J, Cunningham JM. Nursing Handoffs: A Systematic Review of the Literature. AJN The American Journal of Nursing. 110(4):24-34, April 2010.
Riesenberg LA, Leitzsch J, Massucci JL et al. Residents' and Attending Physicians' Handoffs: A Systematic Review of the Literature. Academic Medicine 2009; 84(12): 1775-1787, December 2009.
Patterson ES, Wears RL. Patient Handoffs: Standardized and Reliable Measurement Tools Remain Elusive. Joint Commission Journal on Quality and Patient Safety 2010;
36(2): 52-61 February 2010
Cheung DS, Kelly JJ, Beach C, et al for the American College of Emergency Physicians Section of Quality Improvement and Patient Safety. Improving Handoffs in the Emergency Department. Annals of Emergency Medicine 2010; 55(2): 171-180 February 2010
Pothier D, Monteiro P, Mooktiar M, Shaw A. Pilot study to show the loss of important data in nursing handover. British Journal of Nursing 2005; 14(20): 1090 - 1093
Mindy E. Flanagan, Emily S. Patterson, Richard M. Frankel, and Bradley N. Doebbeling
Evaluation of a Physician Informatics Tool to Improve Patient Handoffs
J Am Med Inform Assoc 2009; 16: 509-515.
Apker J, Mallak LA, Applegate EB, et al. Street. Exploring Emergency PhysicianHospitalist Handoff Interactions: Development of the Handoff Communication Assessment. Annals of Emergency Medicine 2010; 55(2):161-170 February 2010
Print Update on Handoffs
April 20, 2010
HIT's Limited Impact on Quality To Date
For months now, we have heard complaints from hospitals and physician practices that it will be difficult to get to meaningful use to be eligible to receive the financial incentives for adoption of healthcare information technology (HIT) that are part of the American Recovery and Reinvestment Act (ARRA) of 2009. But it is very clear to us that simply adopting HIT is not enough. There is ample evidence that, unless you specifically use systems with clinical decision support tools, you are unlikely to improve quality and patient safety and unlikely to achieve overall reductions in healthcare costs. In fact, the unintended consequences of HIT may even result in adverse events. See our October 2009 Whats New in the Patient Safety World column A Cautious View on CPOE and our November 24, 2009 Patient Safety Tip of the Week Another Rough Month for Healthcare IT.
The theme of this months journal Health Affairs is healthcare information technology. The issue addresses multiple aspects of HIT, including the impact of HIT on quality and cost, the meaningful use criteria, the use of HIT in the medical home concept, and the trials and tribulations of adopting HIT in both hospitals and various practice settings. The section on the relationship between HIT and quality has 3 articles that conclude the impact of HIT on quality is lukewarm at best. DesRoches et al used data from the Hospital Quality Alliance for measures on the care of acute MI, CHF, pneumonia, and a number of surgical care measures and correlated these with levels of HIT adoption from various hospital surveys and other sources. They found, in general, little improvement in most quality measures related to use of electronic health records. Nor was there significant improvement in length of stay or readmission rates or inpatient costs. They did see some marginal improvement in several measures in those hospitals using computerized physician order entry for medications and specific clinical decision support tools (alerts and reminders).
A second study (McCullough et al) found some improvements in hospital quality but many of the outcomes were not statistically or clinically significant. Most of the improvements were seen at academic facilities compared to nonacademic ones.
A third study (Byrne et al) reported on some significant quality and cost improvements seen in the VA healthcare system related to its longstanding and significant investment in HIT. They estimated cumulative savings due to HIT to be on the order of $3 billion. Most of the cost savings was due to avoiding hospital admission and unnecessary tests plus efficiencies in workloads and workflows.
A fourth study (Metzger et al) was a multicenter simulation study that looked at the impact of clinical decision support tools for computerized physician order entry of medications. The simulation detected only 53% of the medication orders that could have led to fatalities and 10-82% of the orders that could have led to serious adverse drug events. Note that this is similar to what we have seen in general with CPOE implementations nationally to date, i.e. CPOE may reduce overall medication errors but has had little impact on serious adverse drug events.
Key to all the studies that do show quality or safety improvements with HIT is the use of timely clinical decision support (CDS) tools. These are evidence-based tools that come in a variety of formats: real-time alerts and reminders, forms, templates, standardized order sets, etc. They all are designed to provide the clinician with knowledge that is specific to that patient at an appropriate time and point of care. But this has been easier said than done. Those organizations that have been successful with CDS have largely used home-grown systems that they have tweaked over many years. Perhaps the most important lesson learned to date has been that one must carefully balance the frequency, utility and importance of such interventions against the detrimental effect they may have on workflow. Alert fatigue is a well-known phenomenon in which clinicians begin to ignore the majority of alerts simply because they are continuously bombarded with them. A better strategy appears to be minimizing at least the intrusive alerts to those critically important issues that may lead to patient harm.
AHRQ (the Agency for Healthcare Research and Quality) has been funding many HIT projects over the years. They have taken a keen interest in CDS research and have recently funded two significant CDS research projects. This month they released a report describing some of the significant challenges and barriers that those two projects have been encountering (Eichner and Das 2010).
One of those projects is developing clinical decision support tools for aiding the management of several chronic conditions. It is being led by an experienced team from Brigham and Womens/Partners Healthcare in Boston but has multiple collaborating organizations across the country. The concept is to develop open-architecture tools such that information during order entry would be sent to a web-based resource where the rules would be applied and then sent back to the source regardless of the computer system or HIT vendor involved. Some of the challenges they have encounted have been (1) the organizational structure is large and complex (2) the projected funding, time and personnel needed were underestimated (3) managing a large project across multiple organizations is difficult (4) vendor buy-in has been hesitant. They also encountered something we frequently see at all organizations implementing CPOE with CDS: difficulty keeping track of versions and authors (or responsible parties) for various rules.
Another significant challenge has been establishing consensus about the clinical decision support. Their best quote: If you came up with a guideline everyone agreed with, it would be mushy. Some clinicians inevitably disagree with a rule or the evidence behind it. So theyve had to establish a Content Governance Committee to intervene in such cases. And thats just internally. They have concerns about the willingness to adopt rules at the collaborating organizations. Technical issues such as translating the guidelines into executable code have also surfaced and many staff needed to be trained in use of other programming languages and techniques. Additional barriers have included standards for data format and exchange, mapping, terminologies, interfaces, proprietary or locally developed codes, and information in free text fields. A big problem is that data entry into an EMR is not always complete and often there is failure to update key things like problem lists and medication lists. Some rules cannot be triggered if a diagnosis or a medication is missing from those lists. So training clinicians in the proper ways to input data into the EMR can be a big project.
The second AHRQ-sponsored project is at Yale. Their GLIDES (GuideLines Into DEcision Support) project is focusing on a pediatric ambulatory setting to aid with the management of asthma and prevention of obesity. Their project had a short design period followed by a planned 18-month implementation period. They encountered numerous workflow issues and differences between primary care physicians and specialists. They felt many of these issues might have been avoided had the preimplementation planning been longer. The CDS project goals did not align with the priorities of all parties. They did offer small financial incentives for participation in the project, probably too small to directly influence CDS use but felt to be symbolically important. Getting agreement at each implementation site as to how to integrate the CDS into workflows and how to present the interventions was also a challenge. Decisions about continuing current workflows vs. redesigning workflow was a big issue. As the Partners group had found, the Yale group also found issues with the written guidelines and problems integrating guidelines that were written for individual problems to patients having multiple clinical comorbidities. And they also found issues with code, standardization, and differences in vendor applications at multiple sites.
During the implementation phase, they were disappointed that some clinicians were not using the CDS tools. Specialists often felt they were already delivering optimal care and found the tools to be intrusive and time-consuming. Perhaps the most surprising revelation is that the very clinicians who were involved in the development of the CDS tools were unlikely to use them! Interestingly, the specialists often thought that their patients were too complicated for the CDS tools and that the tools were meant for those cared for by the primary care physicians. Their CDS also relied on how the clinicians used the EMR system and they found that some were only using the EMR after the patient encounter, losing the opportunity to see the CDS intervention in real-time. And heres one we could have predicted: training residents and fellows in use of the CDS was important but attending physicians were not the best role models! And though they tried to do group training sessions for clinicians to help generate buy-in, scheduling those was difficult. They did find that, when they had to do one-on-one training, having a clinician leader lead the training helped generate buy-in.
The AHRQ publication goes on to summarize the challenges and barriers that were common to both the Partners and the Yale CDS projects and makes a set of recommendations about planning and implementing CDS projects. We find the lessons learned in these projects to be incredibly valuable. Our general rule when we discuss a CPOE implementation with an organization is to allow 6-12 months beyond whatever they had planned for a CPOE implementation. Now we are going to tell them that if they are incorporating CDS into that implementation (which they must do!) they should really add at least 12-18 months beyond whatever they had planned for.
We also like to point out that there are different types of CDS alerts: (1) those that need to be delivered at the time of order entry by the physician and (2) those that are not as time-critical and could be delivered to another healthcare worker. An example of the first would be an alert that tells the physician writing a prescription that the drug is not on the formulary of his patients payor. That real-time alert is ultimately going to save the physician, patient and pharmacist a lot of time and angst. On the other hand, when a physician writes for an antidiarrheal medication in an inpatient who is on antibiotics, an alert to check for C. diff could go to the infection control nurse rather than the physician. That could help eliminate alert fatigue.
We have always assumed that physician order entry was the only way to go. After all, how would you get the messages to them otherwise? Well, an interesting study just came out that challenges that concept. A study (Kazemi et al 2010) on a neonatal unit at an Iranian teaching hospital (where there apparently was some physician resistance to CPOE to start with) did a study where they had physician order entry (POE) for 4 months, then nurse order entry (NOE) for 4 months. They found that the rate of non-intercepted medication errors was 40% less during the NOE period! Though there may be some methodological issues here (a better study would have used two groups and flip-flopped the order of POE and NOE to minimize the chance of a learning bias) this finding is one that cannot be ignored. This study needs to be replicated in more diverse settings. It certainly would turn some of our assumptions upside down! But then wed need to make very certain that we are not overburdening our nursing staffs who are already being deluged with too many activities. Those of you who have not yet implemented CPOE will be surprised at how much tension often develops between nursing, pharmacy and physician staffs during such implementations. But the bottom line is that the whole purpose of CPOE and CDS is meaningful use, i.e. we are doing this to improve patient outcomes and patient safety. There is a ton of learning we have to do to find out what are the best practices in implementing these systems. There is a danger in the timelines put forth in the ARRA incentives for HIT. Since we are moving forward blindly in some cases, the danger is we may try to implement systems and procedures that are not the best possible ones to achieve these lofty goals.
Some of our other columns on healthcare IT issues:
DesRoches CM, Campbell EG, Vogeli C, et al. Electronic Health Records' Limited Successes Suggest More Targeted Uses. Health Affairs 2010; 29(4): 639-646 http://content.healthaffairs.org/cgi/content/abstract/29/4/639
McCullough JS, Casey M, Moscovice I, Prasad S. The Effect Of Health Information Technology On Quality In U.S. Hospitals. Health Affairs 2010; 29(4): 647-654
Metzger J, Welebob E, Bates DW, Lipsitz S, Classen DC. Mixed Results In The Safety Performance Of Computerized Physician Order Entry. Health Affairs 2010; 29(4): 655-663
Byrne CM, Mercincavage LM, Pan EC, et al. The Value From Investments In Health Information Technology At The U.S. Department Of Veterans Affairs. Health Affairs 2010; 29(4): 629-638
Eichner J, Das M. Challenges and Barriers to Clinical Decision Support (CDS) Design and Implementation Experienced in the Agency for Healthcare Research and Quality CDS Demonstrations. AHRQ Publication No. 10-0064-EF. March 2010
Kazemi A, Fors UGH, Tofighi S, et al. Physician Order Entry Or Nurse Order Entry? Comparison of Two Implementation Strategies for a Computerized Order Entry System Aimed at Reducing Dosing Medication Errors. J Med Internet Res. 2010; 12(1): e5.
Published online 2010 February 26. doi: 10.2196/jmir.1284.
April 27, 2010
Infusion Pump Safety
In our April 6, 2010 Patient Safety Tip of the Week Cancer Chemotherapy Accidents we described several cases where patients received potentially lethal doses of chemotherapy when infusion pumps were inadvertently programmed to infuse the entire contents over several hours rather than over several days. That got us thinking again about infusion pump safety. Infusion pumps have been a wonderful addition to clinical care. They allow infusion of some medications that previously required a nurse or physician to physically administer over long periods. They allow infusion of large or small volumes of fluids to be administered in a controlled fashion. And they theoretically reduce the likelihood of overdose due to a wide open or free-flow infusion from a conventional IV setup. And smart pumps allow for safer and more accurate dosing. But we can expect unintended consequences with the introduction of any new technology and infusion pumps are no exception. And perhaps the problem is magnified because infusion pumps are often used for administration of high-risk medications such as chemotherapy agents, anticoagulants, and narcotic analgesics. And even the advantage of relieving clinical staff of physically doing the infusion themselves could become a disadvantage because those staff were also doing bedside monitoring of the infusion.
Just looking back through our Archives, we found several columns identifying patient safety issues related to infusion pumps. And, of course, infusion pumps are not just used for IV fluids and medications. They may also used for enteral feedings, epidural anesthesia and other procedures. These other uses also raise problems related to catheter misconnections. We wont talk further about catheter misconnections in todays column but those interested can go to our July 10, 2007 Tip of the Week Catheter Connection Errors/Wrong Route Errors and our Whats New in the Patient Safety World columns November 2007 Whats New in the Patient Safety World, August 2009 Catheter Misconnections Continue to Occur, and April 2010 RCA: Epidural Solution Infused Intravenously.
In our March 12, 2007 Patient Safety Tip of the Week 10x Overdoses we noted that a data entry person may double press a key (or the key may become stuck) resulting in, for example, 88 instead of 8. Also, during data entry it is possible to think one hit a decimal point but it fails to print out. Such data entry errors have recently been noted in programmable intravenous infusion pumps and there have been several occurrences of 10x overdoses with those pumps. Therefore, a policy of having a second independent observer verify the dosage or rate on such pumps makes sense (however, keep in mind that error rates from other industries tell us that one who oversees someone elses work typically does so in error up to 10% of the time!).
In our September 9, 2008 Patient Safety Tip of the Week Less is More.and Do You Really Need that Decimal? we discussed 2 issues related to programming infusion pumps. The first was a significant and somewhat paradoxical problem with PCA pump programming outlined in an ISMP Safe Medication Alert Misprogramming PCA concentration leads to dosing errors. If one programs in too high of a concentration, the patient tends to get underdosed (so may suffer continued pain). If one programs in too low a concentration, the patient actually gets overdosed! This seems counterintuitive. But think about it the patient asks for a certain dose of the narcotic and the pump delivers the volume it is programmed for to meet that request. If the concentration was erroneously too low, the pump has now given a higher volume and, hence, a higher actual narcotic dose. And often a warning on the pump that the concentration is too low may be overridden because the nurse or physician feels less concerned about too low than too high. ISMP makes some specific recommendations to reduce the risk of such errors. One is to make the too low concentration warning a hard warning that must be acknowledged and reprogrammed rather than simply being overridden. They strongly suggest organizations assess their current vulnerabilities to mistakes of this sort (perhaps do a FMEA on PCA pumps) and increase staff awareness of the results. Limiting stock to a single standard concentration of each of the PCA drugs may also help. They discuss numerous aspects of proper labeling and stress that there must be a very distinctive label for any nonstandard concentrations. They also recommend use of double checks and bar-coding and smart pump technology.
The second issue we raised in that September 9, 2008 Patient Safety Tip of the Week Less is More.and Do You Really Need that Decimal? was that when we do calculations we often include several digits after a decimal point that may be largely irrelevant yet expose our patients to a significant safety risk if the decimal point happens to be overlooked. You all know you should never use a trailing zero, i.e. a zero following a decimal point, because if the decimal point is not seen there is a risk of a 10-fold (or higher) overdose. But what about other numbers following a decimal point? They are important in certain circumstances (eg. a dose of 0.3 mg or 2.7 mg). However, at higher doses they become much less relevant. For example, lets say you performed a calculation and the result was a recommended dose of a drug is 72.2 mg. Is there really a difference if the patient gets 72 mg. or 72.2 mg of most drugs? Yet ordering the latter dosage increases the risk that the decimal point may not be seen or not input into a computer or missed in a faxed order and the patient gets a 10x overdose. So we strongly recommend that in writing medication orders one specifically decides whether such fractional doses are important or merely place the patient at increased risk of an error.
Our May 12, 2009 Patient Safety Tip of the Week Errors With PCA Pumps dealt with a number of errors that may occur during use of patient controlled analgesia (PCA). That column dealt with a whole host of problems related to IV infusion of narcotic analgesics, including PCA by proxy, in which a family member or other caregiver pushes the button allowing narcotic administration, thereby bypassing the built-in safety mechanism where a patient becoming drowsy cannot self-administer more opioids. It is also critical that you have a good system for monitoring the level of sedation (using a sedation scale) in your patients on PCA.
Smart pumps are pumps having software programs that allow dosages ranges to be set up in attempt to prevent high doses being inadvertently programmed in. However, even with smart pumps one has to be careful. An erroneous drug library can cause an error to be propagated to multiple patients. Also, in the ISMP article Smart Pumps Are Not Smart On Their Own it is emphasized that the warnings on smart pumps can be bypassed by nurses and this may become a normalized deviance in some cultures. So periodically you need to monitor the actual use of your smart pumps.
One big problem we see is lack of standardization of pumps. If you are like most organizations, you probably dont replace your current stock of IV pumps all at once. That results in having multiple different models and styles and manufacturers of pumps in your facilities at any time. This can be very confusing for your staff since the programming and use of one pump may be different from other pumps. Sometimes those differences are subtle but may have significant impacts. As with any equipment purchases, it is critical that you include on your purchase decision team many clinical members who will be end users of the equipment so that they can help identify features that may become a concern if standardization is not maintained.
Now the FDA is beginning to take a hard look at safety of infusion pumps. They have recently announced a new initiative collaborating with industry to make infusion pumps safer. The FDA has received 56,000 reports of adverse events related to infusion pumps between 2005 and 2009 and there have been 87 infusion pump recalls, many of which have been for serious safety problems. The main part of this new initiative will be working with manufacturers to improve design and engineering issues that have been identified as problematic. But many problems also occur at the user end. Their website has several excellent resources including examples of infusion pump problems (including software problems, alarm errors, user interface design issues, battery problems, fire risk, etc.) and risk reduction strategies for staff at several levels of your healthcare organizations, including home care nurses and even patients themselves. Theres even a brochure for patients on getting the most out of their pump. This is an excellent resource that every healthcare organization should become familiar with.
Below are some of the recommendations that we have plus many from the FDA:
ISMP. Misprogramming PCA concentration leads to dosing errors. Medication Safety Alert Newsletter (Acute Care Edition). August 28, 2008http://www.ismp.org/Newsletters/acutecare/articles/20080828.asp
ISMP. Smart Pumps Are Not Smart On Their Own. ISMP Medication Safety Alert. Acute Care Edition. April 19, 2007
New FDA initiative on infusion pump safety
FDA infusion pump risk reduction strategies
Print Infusion Pump Safety
May 4, 2010
More on the Impact of Interruptions
There is ample evidence from research in other industries and from studies in cognitive psychology that interruptions cause errors in both cognitive and executive functions. So avoiding interruptions ought to be a good patient safety strategy. On numerous occasions we have used the aviation analogy of the sterile cockpit. That is a concept in which interruptions and distractions are avoided during certain critical procedures such as takeoff and landing in aviation or in medication preparation or administration in healthcare.
Our August 25, 2009 Patient Safety Tip of the Week Interruptions, Distractions, InattentionOops! highlighted some excellent studies on interruptions and distractions in healthcare. In that we provided references to some good statistics about the frequency and nature of interruptions and distractions and listed some recommendations about how to avoid them. We also discussed some of the cognitive research on how memory works and how interruptions affect what stays in your working memory, a key concept in error occurrence. Our November 3, 2009 Patient Safety Tip of the Week Medication Safety: Frontline to the Rescue Again! highlighted two studies showing how frontline nursing staff are still critical in avoiding medication errors. Both discussed the importance of avoiding interruptions and distractions.
Our December 15, 2009 Patient Safety Tip of the Week The Weekend Effect noted how the lack of non-nursing staff on weekends actually adds both considerable workload and interruptions to nursing staff. We have also seen that clerical staff have often been reduced or eliminated in the recent economic downturn, further accentuating the problem of interruptions for nursing staff.
Now two new papers have been published that quantify the impact that interruptions have on clinical care. The first (Kalisch 2010) observed 35 nurses over 4-hour periods at two Midwestern hospitals. They found an average of 10 interruptions per hour (one interruption every 6 minutes) but at some hospitals the interruption rate was as high as an interruption every 4.5 minutes. Those rates are comparable to those in several studies noted in our August 25, 2009 Patient Safety Tip of the Week Interruptions, Distractions, InattentionOops!. Interruptions were also significantly more frequent in ICU settings than on medical/surgical units. It was also not uncommon to have multiple interruptions (eg. one interruption interrupting another). The study also looked at multitasking by nurses and found they were multitasking on average 34% of the time.
Interruptions by patients were most common (28%), followed closely by other nurses (25%). Assistive personnel and physicians accounted for 10% and 9% of interruptions. The interruptions occurred during a whole host of nursing activities but nurses were interrupted during medication administration 57% of the time at one hospital. While most interruptions were initiated by others, 36% of the interruptions were self-initiated.
The second paper (Westbrook 2010) correlated the effect of nursing interruptions on medication administration errors in 2 teaching hospitals in Australia. Overall, interruptions occurred in over half of all medication administrations and they demonstrated a clearcut relationship between number of interruptions and both procedural failures and clinical errors. Every interruption was associated with an increase of 12.1% in mean procedural failures. And each interruption was associated with an increase of 12.7% in mean clinical errors per drug administration.
Strikingly, if there were 5 interruptions during a medication round with a single patient it was virtually certain that at least one procedural failure would occur and there was a 61% chance of a clinical error occurring. And the risk of a major clinical error doubled with 4 interruptions.
Perhaps the most interesting finding in the Australian study was that part-time and less experienced nurses had lower rates of procedural failures. Some of that may have been explained by the fact that the most common procedural error in that study was failure to check the patient identification prior to administration of medication. The authors felt that experienced nurses may have been more likely to believe they could easily identify patients visibly. But, more importantly, after controlling for multiple variables they found that nurses experience and work status did not reduce the risk of making a clinical error. That strongly suggests external factors are major contributors to medication administration errors and that focusing on those is likely to make an impact on reducing such errors. Thats actually good news! Those who work in quality improvement and patient safety circles know that it is usually much easier to change the system than to change individual behavior.
One currently popular method of minimizing interruptions is use of a brightly colored flag of some sort to indicate a nurse should not be interrupted. In John Nances fictitious hospital (see our June 2, 2009 Patient Safety Tip of the Week Why Hospitals Should FlyJohn Nance Nails It!) it was a red towel draped over a nurses left shoulder that told staff do not interrupt me. In others, nurses don brightly colored vests,sometimes called interruption vests.
It is also possible for some activities to cordon off an area and make it a no-interruptions zone when a nurse is preparing, dispensing, administering, or otherwise handling medications.
Interruptions are often done because of important events or activities. These are relevant interruptions. However, many interruptions are for activities that are irrelevant for patient care. One example is the nurse being interrupted to give directions to a family to get to the cafeteria. So you could use well-placed signage or good hospital services brochures to minimize such interruptions.
Another very common interruption is by another nurse or a physician asking about a piece of clinical information they could also get by looking at the patients chart. It may save them time but it interrupts you from an important task, increasing the chance of you making a mistake. Sometimes its as simple a question as Where did Mr. Jones go?, which might be easily handled by use of a whiteboard.
Using checklists can be very helpful in avoiding errors, as we have seen in multiple areas of healthcare. However, using another analogy from aviation, interruptions often cause items in checklists to be overlooked or bypassed. So if you do get interrupted, you need to go back over your checklist from its beginning.
One technique that has been steadily gaining acceptance in recent years is doing hourly rounds (Studer Group 2006). While these are often promoted as a means of improving patient satisfaction (which they clearly do), they also appear to be a tremendous time saver. That is because patients, knowing their nurse will be in to see them on the hour, are much less likely to press their call button. That results in fewer interruptions to nursing staff. As another bonus of hourly rounds, fall rates typically drop substantially (Meade 2006) (primarily because toileting activities can be ensured during the hourly rounds).
You dont realize the number of interruptions until you actually count them. Your own personal productivity is clearly impacted by interruptions. Some day when you are working keep a log of interruptions. Then assign a severity score to them to tell you how many were important interruptions and how many were to answer things that could have been handled in a different manner. You will be amazed at the frequency of the interruptions and you can usually then rearrange your work environment to minimize the less important interruptions and make your workday more productive.
The same obviously applies to most areas of clinical care. So it is not just interruptions medication administration that are important. Weve previously highlighted several other clinical settings where interruptions have a negative impact. During handoffs it is critical that you have enough time to allow a two-way dialog where the recipient has ample opportunity to ask questions. In the OR, it is clear that OR traffic (often in the form of interruptions) is a factor in increasing nosocomial infections and, we suspect, other medical errors. And we know that increased bed occupancy (either in the ER or hospital as a whole) is associated with increased risk of clinical incidents and errors. While the latter is usually associated with increased workloads, it is also likely associated with increased frequency of interruptions.
Redesigning workspaces or workflows may be very useful. A recent survery of over 1600 hospital nurses by Jackson Healthcare showed that almost three quarters of respondents spent over a quarter of their shifts on indirect patient activities. While much of that time is doing paperwork or documentation, many noted time spent walking to equipment/supply areas, utility rooms, etc. In our August 25, 2009 Patient Safety Tip of the Week Interruptions, Distractions, InattentionOops! we noted an article by Redding & Robinson that also noted disjointed traffic patterns often led to more interruptions, such as questions from families or caregivers, as nurses had to walk from a patients room to a different supply area. So one can redesign to ensure necessary supplies and equipment are kept within the patient room. Note that there may also be infection control benefits from avoiding long walks for supplies and equipment.
Sometimes simply taking the time to stand back and examine your workflows is a great patient safety exercise. If you work on reducing interruptions and distractions in your environment, we guarantee you will see not only gains in productivity and both patient and staff satisfaction but you will also see error rates decline and patient outcomes improve.
Kalisch, Beatrice J.; Aebersold, Michelle
Interruptions and Multitasking in Nursing Care. Joint Commission Journal on Quality and Patient Safety 2010; 36(3): 126-132 March 2010
Westbrook JI, Woods A, Rob MI, Dunsmuir WTM, Day RO.
Association of Interruptions With an Increased Risk and Severity of Medication Administration Errors
Arch Intern Med.2010;170(8):683-690
Jackson Healthcare. Hospital Nurses Study 2010. Summary of Findings.
Redding D, Robinson S. Interruptions and Geographic Challenges to Nurses' Cognitive Workload. J Nurs Care Qual 2009; 24: 194-200
Studer Group. You Called? Hourly Rounding Cuts Call Lights. November 20, 2006.
Meade CM, Bursell AL, Ketelsen L. Effects of Nursing Rounds: on Patients' Call Light Use, Satisfaction, and Safety. AJN The American Journal of Nursing. 106(9):58-70, September 2006.
May 11, 2010
Delayed Diagnosis of Cancer
Weve done several columns on test results slipping through the cracks to result in delayed diagnosis of cancer (see links at the end of this article). But until now, we knew of no comprehensive review of events across the entire continuum of care that lead to delayed diagnosis of cancer. Now the NPSA (UK) has issued a report Delayed Diagnosis of Cancer: Thematic Review that does just that. And while there are differences in the health care delivery systems between the US and the UK, most of the lessons in that report are applicable to our health care system.
The NPSA report was put together based upon a literature review, analysis of reports in their incident reporting system(s), and focus groups of stakeholders. They basically break down the delays into (1) patient delays (2) doctor delays (3) system delays.
Under patient delays the overwhelming influence leading to delays in diagnosis is symptom recognition and interpretation. Particularly when initial symptoms are vague patients are likely to dismiss them or attribute them to everyday explanations. For instance, symptoms of oral cancer are often attributed to dental problems or infection or symptoms of pharyngeal cancer are often attributed to the common cold or infection. Other contributing patient-related factors are fear and anxiety. Fear of cancer and fear of embarrassment are often noted in the literature. Even guilt may cause delays (eg. a patient feels guilty that one of their behaviors may have predisposed them to cancer). Lastly, socio-demographic factors and ethnicity may play roles. Older age has been identified as a risk factor and that may be due, in part, to the fact that older individuals have been less likely to speak up and challenge their physicians. Some cultures also do not allow male physicians to fully examine female patients, another factor that may delay diagnosis.
On the physician side, misattribution of symptoms is a common cause for delayed diagnosis. Many of the early symptoms of cancer may be quite vague and patients may have several comorbidities that could explain such symptoms. However, the study identified a change in the pattern of visits as a common presentation of cancer. This means that a patient who usually is seen infrequently now has an increase in visits for the same symptoms. Communication problems (between doctor and patient) are also frequently noted in cases of delayed diagnosis. Particularly with pediatric cases, physicians often minimized or discounted concerns that the parents had about their child. And lack of good systems for tracking tests and referrals remain a significant problem (which well discuss under system issues).
The report notes that relatively little is actually known about delays occurring on the primary care side because there is very limited reporting from primary care into their incident reporting systems. That, in fact, was recognized as one of their lessons learned.
System issues were readily uncovered in their review of incident reports. For pathology, they noted pre-lab problems and in-lab problems each accounting for about 45% of cases, with less than 10% of incidents being related to post-lab problems. Pre-lab problems included mistakes in labeling of specimens, getting specimens to the lab, and getting them to the lab in a timely fashion while they were still able to be properly evaluated. In-lab problems included delays in getting reports out or reports where malignancies were erroneously reported as benign. Examples included cases where a pathologist confused a specimen with that of a different patient. Post-lab issues were primarily those related to the reports being lost, misfiled, or otherwise never acted upon.
For radiology, where risk of delay was high, failure to communicate abnormal test results was the primary concern. These are the same issues we have discussed in detail in our prior columns (). But they did have a couple new ones that are really unintended consequences of technology. Both pertained to PACS (the picture archives and communications systems). A real value of PACS is the ability to easily call up old images for comparison. However, in one example provided, the radiologist reported an earlier examination rather than the current one. In another, a patient came for a CT-guided biopsy and the relevant images had not been placed on PACS. We have also mentioned previously that when you are looking at anything on the computer screen, PACS included, it is very easy to think you are looking at one patient when, in fact, information about a different patient is being displayed. That is why you always want the name of the patient and other identifiers displayed at the top of every screen. Actually, a radiologist should do a mini-timeout before every report (asking himself questions like Is this the correct patient?, Is this the correct study?, Is this the correct date? etc.).
But about a fifth of their incidents were related to failures of communication. This could be failure of the pathologist or radiologist to be sure the ordering physician actually received the report of the abnormal finding, or miscommunications when several physicians within a practice were seeing the patient on different visits, or miscommunications between primary care physicians and specialists, or cancellations of visits (whether patient-related or provider-related).
From their focus groups and workshops, which included patients as well as providers and other stakeholders, communication arose as the overriding theme. Patients especially felt that their primary care providers often failed to listen to them or failed to spend sufficient time with them. They often felt that the physician (or nurse practitioner) was too quick to dismiss their symptoms or label the patient as menopausal or neurotic. Such patient labeling is an issue we will probably discuss in an upcoming Tip of the Week since we have seen numerous serious incidents in which labels applied to patients likely biased their care and led multiple healthcare workers to overlook important aspects of care.
The focus groups also discussed in detail the passive patient issue. That is the patient who returns over and over with symptoms that have continued yet fails to complain or request a second opinion. They pointed out that the physician often reinforces the passive patient role rather than empowering the patient to speak up.
The report stresses non-verbal aspects of communication. We already mentioned the critical change in pattern of visits. That is when a patient suddenly starts making more visits than he/she usually makes and should be a sign that certain symptoms are not being adequately addressed. This could especially be a problem in those settings where multiple caregivers provide care for the patient (though sometimes the new provider was a set of fresh eyes that saw a diagnosis previously overlooked). Maybe there are ways we can flag such changes in visit patterns electronically to alert the provider in some fashion that this might be a higher risk scenario.
But communication across transitions of care may be even more of an issue. Weve noted that the emergency department is a particularly vulnerable area because both the patient and the physician may be long gone by the time the results come back. That problem is accentuated when you cannot track the patient down because the phone number given was incorrect. A recent MSNBC story on inaccurate patient phone numbers for patients seen in ERs noted a combination of delayed test results and bad contact information sometimes from fearful patients who deliberately give fake names and numbers is forcing some emergency room officials to resort to people-finders, registered letters and law enforcement visits to deliver their diagnoses.
It may be just as difficult for hospitalists, who may never see a patient again after discharge. You have heard us harp on the need to include a section in every discharge summary for test results pending. We still think that should be included in every case. However, identifying the pending test results is not an easy task. We tried it one day. We pulled charts of several patients whom a hospitalist was discharging and tried to identify what tests had been done and match them with final reports. It took forever! So how is a busy hospitalist (or housestaff member) who is taking care of 10-15 inpatients going to complete this task? The only way is likely to be writing a computer script that does the search for you. But even that may prove difficult because it is very likely to show lots of erroneous instances, in which case alert fatigue will likely cause the hospitalist to ignore all instances.
Note also that your good hospitalist programs have the hospitalist call the patient by phone 2-3 days after discharge to see how they are doing and whether they have any problems or questions. That may also be a good time to followup on pending test results.
And remember that Singh et al found that the well-intentioned process of sending test results to both the ordering physician and another physician (such a the primary care physician) actually increased the likelihood that no one would follow up on the abnormal results (see our Patient Safety Tip of the Week October 13, 2009 Slipping Through the Cracks).
The NPSA review makes the following five recommendations (our paraphrasing):
If you are like us, you looked at those recommendations and said Wheres the beef?! Too much fluff and no good action items. So well have to look elsewhere. We shouldnt say it had no action items. They did note a few. One is to give the patient an information card when tests are done. It should outline what tests have been performed, when to expect the results will be available, who to contact if a result has not been conveyed to them within a specified period of time, and what to do if the test result is negative but the symptoms persist. We like that! We have always recommended that the physician verbally tell the patient those things. But it actually should be very easy to deploy word processing templates that would fill in the dates based on the date the test is done and allow you to give the patient a printout for each test ordered.
But for some more specific action items, the Singh group comes to the rescue again! They have Eight Recommendations for Policies for Communicating Abnormal Test Results in an article in this months Joint Commission Journal on Quality and Patient Safety (Singh and Vij 2010). While their article talks about compliance with the Joint Commissions national patient safety goal NPSG.02.03.01 (reporting critical results of tests and diagnostic procedures on a timely basis), it includes not only panic values but also abnormal but not immediately life-threatening results such as the suspected tumor on chest radiographs. They discuss the key elements put together over several years in their VA system for communicating abnormal results
The first recommendation is to clearly define terms in your policy such as what are the specific test abnormalities that require either immediate notification or urgent notification (they provide good examples in the article). Secondly, the policy needs to clearly spell out the responsibilities of each provider (remember their key lesson learned previously that ambiguous responsibilities, as seen when dual notification takes place, actually increases the likelihood that no action will be taken).
Thirdly, they call for fail-safe methods for communication of abnormal results. While that could be a verbal communication, they also allow for a computer notification that includes a mandatory response (i.e. that the recipient cannot dismiss that alert without acknowledging its receipt and contents). They do have contingencies for alerting other responsible parties (eg. the responsible attending physician when a resident ordered the test). Particularly good are their recommendations about documentation of the communication that takes place, including verbal read-back, and an algorithm with escalation to supervisory level for after-hours situations.
Fourthly, policies should define reporting procedures for both critical and significantly abnormal test values. For any potentially life-threatening abnormal result, a verbal communication should take place. For the significantly abnormal (but not immediately critical) results they do allow a variety of electronic communications. Note that they also discuss that such notifications may not be always necessary on subsequent tests once the initial abnormality has been communicated. For imaging studies, they have specific codes for various findings and provide a table that outlines what verbal and/or electronic notifications must take place for each finding.
The fifth recommendation is specifying the timelines for notification of the results. The sixth deals with timelines for patient notification and discusses the various means of patient communication that should be specified in your policy. The seventh recommendation is that your policy should incorporate feedback from key stakeholders in your organization. For instance, they found that reporting abnormal (but not critical) results to the on-call resident after hours may be counterproductive. And, lastly, the policy should include responsibilities for monitoring the compliance with and effectiveness of the communications.
The recommendations are excellent and you can learn a lot from this article. They should work especially well in an integrated system. However, some barriers still exist. We still have to deal with fragmentation of care and poor communication between disparate providers. In real life, it is still common for patients to seek their cancer care at tertiary cancer centers. So if you are the radiologist at the small community hospital who noted the suspicious lesion on chest films, you may be unable to confirm that anyone actually took action because you (and, all too often, the primary care physician) may lack access to those records from the tertiary care cancer center. In fact, HIPAA might even preclude you from seeking that followup once your relationship with that patient has ended. So you may have to be satisfied with verbally notifying the ordering physician of your findings and hoping that the patient ultimately gets the appropriate management.
See also our other columns on communicating significant results:
National Patient Safety Agency (UK). Delayed Diagnosis of Cancer: Thematic Review. March 2010
Aleccia J. Wrong patient phone numbers trip up ER docs. Fake or inaccurate contacts raise risk when sick patients can't be found. msnbc.com April 26, 2010
Singh H, Thomas EJ, Mani S, et al. Timely Follow-up of Abnormal Diagnostic Imaging Test Results in an Outpatient Setting. Arch Intern Med.2009; 169(17): 1578-1586.
Singh H; Vij MS. Eight recommendations for policies for communicating abnormal test results. Jt Comm J Qual Patient Saf. 2010;36:226-232
May 18, 2010
Real-Time Random Safety Audits
All too many of our patient safety activities are after-the-fact. Much of what we monitor is time-consuming, labor-intensive and costly and often reactive in nature. Because it is after-the-fact, staff often feel that it is punitive rather than constructive. We are big fans of those patient safety activities that are more proactive and can help capture vulnerabilities before they give rise to adverse patient outcomes. That is why we like activities such as FMEA (failure mode and effects analysis), ICU daily goals, and patient safety walk rounds.
A somewhat lesser known proactive patient safety activity is the real-time random safety audit (RSA). An excellent article appears in the March 2010 Clinics in Perinatology (Ursprung 2010) by authors who have pioneered this technique in neonatal intensive care unit (NICU) settings. The same authors had published the impressive outcomes of RSA in the NICU setting in 2005 (Ursprung 2005).
Other industries (eg. banking, pharmaceuticals, steel making, etc.) have used such random audit techniques successfully for many years. Weve previously talked about the line operations safety audits (LOSA) audits in aviation where an independent observer sits in the cockpit and monitors and assesses multiple operations and procedures, then critiques the crew. But the LOSA is resource-intense, requires a well-trained auditor, and behavior may be quite different when a known audit is being undertaken. So many industries have adopted the simple real-time random safety audit. Ursprung and colleagues used trained research nurses to do the audits in their 2005 study but now use frontline staff for day-to-day RSAs.
The concept is simple. Each day you randomly choose (from a list of patient safety items your organization has deemed to be important) some process or condition or piece of equipment for auditing. Your list should be developed by a broad interdisciplinary team to reach consensus on prioritizing areas of importance for the unit in question. You then do your audit and provide immediate feedback to frontline staff. The person performing the audit could be a nurse, pharmacist, physician, respiratory therapist, or other appropriate individual. The important concept is to involve as many different disciplines as are relevant to that unit. That is very helpful in fostering a culture of patient safety on the unit.
One of the keys is keeping the number of questions and items to a manageable level, at least at the start. Ursprung and colleagues suggest 5-15 questions to start with. They also recommend making a deck of printed cards, each containing a single question. There are multiple copies of each question in the deck. You shuffle the deck so that you get the questions in a randomized fashion. For items considered to be of higher priority, you can include more cards with that particular item so that you are more likely to address it during the random process.
Each day one card is selected and then all relevant patients (or equipment, etc.) are audited for the question on that card. For example, you might look at procedures done on patients and have several cards with questions like If a procedure was done on this patient in the past 48 hours (remember one question per card):
A real value of the RSA is the ability to give timely feedback to frontline staff. That is why the RSA is a good method for improving compliance with things like your dangerous abbreviations list. All too often we audit our dangerous abbreviations retrospectively, then give providers several weeks later notice of the times they used those abbreviations. They often feel offended and we hear comments like So shoot me.. Instead, when you look at dangerous abbreviations during an RSA you can give immediate feedback and are often in a better position to point out how use of that abbreviation might be confusing to nursing or pharmacy.
Other considerations for the RSA are communication issues, in-house transport issues, timeliness of reports or consultations, delays in care, medication reconciliation, hand hygiene, use of catheters and other indwelling objects, care bundle compliance, alarms, device settings, pain management, oxygen use, and many others.
Of course, you also need to aggregate your results and report back on a regular basis at staff meetings, QI committee meetings, etc. But make sure that your use of audit findings is applied in a constructive fashion and avoid any semblance of punition or you may destroy the positive changes in safety culture.
The 2005 study (Ursprung 2005) identified numerous problems related to patient identification bands as well as problems related to delays in care, equipment issues, and others. Not only did their audit result in some immediate feedback to correct problems, but their project also resulted in a change in the patient identification process and revision of guidelines for pulse oximetry alarms. Their original study was done using a research nurse and they asked 5-7 questions per patient, which proved to be quite time-consuming. Therefore, the audit changed to the currently recommended format of one question per patient.
The 2010 article has a great appendix with numerous examples of questions that were addressed in RSAs in the NICU setting. However, most of them are easily adaptable to other settings. You should also keep in mind that things in many healthcare settings differ by day of the week or time of day. So consider doing your RSA on evenings and weekends as well. That also helps foster involvement of all frontline staff in the patient safety process.
The authors also suggest adding a little levity to the process. For example, include a trivia question on the back of some cards.
We really like the concept of the real-time random safety audit. Though we might by chance pick up some of the issues during patient safety walk rounds, the RSA is a method that is more focused and much more likely to encourage staff buy-in and foster development of a culture of safety. Look for more use of the RSA in the future.
Ursprung R, Gray J. Random Safety Auditing, Root Cause Analysis, Failure Mode and Effects Analysis. Clinics in Perinatology 2010; 37(1): 141-165
Ursprung R, Gray JE, Edwards WH, et al. Real time patient safety audits: improving safety every day. Qual Saf Health Care 2005;14: 284-289
May 25, 2010
Propofol, of course, recently hit the headlines for its likely role in the death of pop star Michael Jackson in 2009. But it has also been generating controversy off the front pages of standard media.
Propofol has several characteristics that make it attractive as a sedating agent for procedures. It has a rapid onset of action and short duration of action so patients wake up sooner and can resume normal activities faster compared to most other sedating agents. It also reduces the need for adjunctive opioids. And the ability to control the level of sedation also makes it attractive for use in procedures.
But numerous safety issuees have surrounded propofol use. Propofol has long been on ISMPs list of high alert medications and ISMP has published medication safety alerts about propofol. They include multiple examples of patients developing respiratory arrest or hypotension during propofol sedation for procedures. A sense of complacency or lack of fear because we use it all the time in the ICU may be factors predisposing to dangerous practices. But they also noted the sometime unpredictable and profound effects of propofol (noting that a patient can go from breathing normally to full respiratory arrest in seconds, even at low doses). Importantly, there is no reversal agent available like there is for other sedating agents or opioids.
Yet propofol has quietly become the procedural sedating agent of choice in many venues, particularly when dealing with pediatric patients. In fact, at the recent Pediatric Academic Societies meeting research was presented on over 25, 000 cases using propofol sedation in areas outside the OR by emergency physicians. That abstract (Mallory et al 2010) presented data from the Pediatric Sedation Research Consortium. The vast majority of these (22,068) were performed in radiology.
Controversy really erupted when CMS issued new interpretive guidelines regarding anesthesia services, which must be followed by hospitals who accept Medicare or Medicaid patients. The revised CMS guidelines point out that propofol is only indicated for general anesthesia, MAC (monitored anesthesia care) and for the sedation of the mechanically-ventilated patient. The guidelines essentially mean that propofol can only be administered by those with credentials to provide deep sedation or general anesthesia and many or most emergency physicians only possess privileges for moderate sedation (Klauer 2010). The CMS guidelines do not preclude emergency physicians from administering propofol. Rather they clearly specify that the Department of Anesthesiology has responsibility to oversee performance of anesthesia or deep sedation throughout the hospital (or healthcare organization). They would be responsible for ensuring that all clinicians administering propofol are appropriately trained and credentialed and oversee the quality improvement monitoring of such use. A key point of contention is the issue of having one physician vs. two during the administration of propofol. In most cases where an anesthesiologist is involved, the is one person (the anesthesiologist or CRNA) overseeing the anesthesia or deep sedation and the second who is performing the procedure. In the ER (or other venue where the emergency physician is involved), there might be only one physician who is attempting to do both.
As youd expect, specialty societies representing ER personnel have been active in opposing the new CMS guidelines. The American College of Emergency Physicians (ACEP), the Emergency Nurses Association (ENA), and the American Association of Emergency Medicine (AAEM) sent a joint letter to CMS on anesthesia issues in March and met with CMS officials in April to express their concerns. There are numerous position papers on use of sedating agents by emergency physicians as well (see Mace 2008 and Goodwin 2005)
The abstract presented by Mallory et al documented airway and respiratory adverse events in 3.9% of cases of the pediatric cases. Cases included two aspirations and one cardiac arrest but there were no deaths. In 2.4% of cases interventions beyond simple airway repositioning were required. They performed regression analysis and found the following variables to be independently associated with complications: age less than 2 months, ASA class greater than 2, use of adjunctive opioids or midazolam, or adjunctive use of anticholinergics.
Another recent study (Larsen 2009) looked at the safety of propofol administration by pediatric intensivists for pediatric outpatient procedures in a single institution over a 6-year period. In over 4700 cases, major complications occurred in only 0.1% of cases, though minor complications were noted in 15% of cases.
Frequencies of complications in adults undergoing procedures with propofol sedation are a bit harder to come by because of varying types of procedure, varying personnel administering and monitoring the sedation, varying depth of sedation, and varying concomitant use of opioids or other sedating agents. For routine endoscopic procedures (colonoscopies and upper endoscopies), the safety of nurse-administered propofol sedation has generally been accepted and position papers from most endoscopy-oriented specialty societies support nurse-administered propofol procedural sedation. However, studies from more advanced endoscopic procedures, where deep sedation or anesthesia are often produced, provide some insight into the risks of propofol sedation. A recent study (Cote et al 2010) looked at propofol sedation administered by CRNAs under the supervision of an anesthesiologist for patients undergoing advanced endoscopic procedures such as ERCP. Of these, 87.2% showed no response to endoscopic intubation, an indication they were probably in deep sedation or frank anesthesia. Of the 799 patients, hypoxemia developed in 12.8%, hypotension in 0.5%, and procedures were terminated prematurely in 0.5%. Airway modifications had to be performed in 14.4% (mostly chin lifts but sometimes modified face mask ventilation or nasal airways). Independent predictors of the need for airway modifications were male sex, ASA class 3 or higher, and high BMI (Mallampati score of 4 or higher was also more frequently associated with need for airway modifications but the small number precluded reaching statistical significance). Though the authors conclude that propofol can be used safely for advanced endoscopic procedures, they stress that this was done under the supervision of very well qualified professionals.
The accompanying editorial (Vargo 2010) stresses the importance that the sedation team maintain constant vigilance during the procedure. Vargo also makes the case for using capnography as a key component of such vigilance, at least in that setting. In our March 2, 2010 Patient Safety Tip of the Week Alarm Sensitivity: Early Detection vs. Alarm Fatigue we discussed an article (Deitch et al 2010) which looked at use of capnography during procedural sedation in the emergency department. Monitoring end-tidal CO2 during procedures in which IV sedation or IV opioids are used is theoretically very attractive since it is a better indicator of respiratory depression in such cases and should identify patients at risk before they develop oxygen desaturation. Their randomized controlled trial in adults undergoing propofol sedation showed significantly fewer patients with hypoxia in the group monitored by capnography. The 17% absolute risk reduction translates to a number needed to treat (NNT) of 6 cases to prevent one episode of hypoxia. Capnography recognized 100% of the patients who developed hypoxia and did so a median time of 60 seconds before hypoxia developed. That delay meant the physicians usually had adequate time to intervene.
We have previously pointed out that it is extremely difficult to identify respiratory depression just by watching a patient. We have had medical students, residents, and attendings all observe patients on whom we had arterial blood gases and they did little better than chance at picking out which patients had respiratory depression. So the ability to identify patients with respiratory depression before they become hypoxic is a major potential advantage.
The editorial (Green & Pershad 2010) accompanying the Deitch study describes the pros and cons of adopting capnography routinely for such procedural sedation. The editorial notes that capnography clearly identifies respiratory failure before it is apparent by either clinical examination or pulse oximetry. And it acknowledges the significant contribution of the Deitch study, though it points out that some methodological issues (eg. using O2 at a flow rate of only 3L/minute and using an O2 saturation of 93% as the definition of hypoxia) may have overestimated the frequency of hypoxic events. And many episodes of hypoxia are self-limited and resolve without any intervention. In fact, 41% of the episodes in the Deitch study resolved without any intervention.
Recent court cases have also involved propofol. A suit in one case alleges that a patient with sleep apnea died during routine colonoscopy when the CRNA was unable to intubate the patient when he deteriorated after a reduced dose of propofol was administered.
In another court case a jury found that the makers of propofol products failed to adequately warn not to reuse 50 ml vials of propofol on multiple patients. Use of such vials was found in an outbreak of hepatitis C linked to 2 Las Vegas endoscopy centers. Apparently such use of vials for multiple patients has occurred because of the nationwide shortage of propofol. The FDA has been cautioning against such usage and addresses a variety of issues related to the propofol shortage on its website.
And propofol is one of those drugs that often goes unlabeled in syringes in ORs or other sites because staff think it is the only cloudy or milky drug likely to be in the field. Remember: all drugs in syringes must be labeled.
So there remain many unanswered questions about the safety of propofol for procedural sedation and the best ways to minimize risk of adverse events if it is used. Until we have more complete answers we recommend:
Note that todays article does not address use of propofol sedation in the intubated, mechanically ventilated patient in the ICU setting. However, even there we know that propofol sedation is likely overused (see our Whats New in the Patient Safety World column March 2010 If Sedation Vacations Work, Why Not Eliminate Sedation All Together?). Every attempt should be made to assess the continued need for such sedation. Daily sedation vacations are a key component of the IHI VAP Bundle and other bundles designed to prevent ventilator-associated pneumonia. Minimizing sedation also helps reduce the incidence of delirium in the intubated, mechanically-ventilated patient. But the article by Strem 2010 found that patients who received no sedation had significantly fewer days on ventilators, shorter ICU stays, and shorter total hospital LOS. There was no difference in accidental extubations or VAP, though more patients in the no sedation group had agitated delirium. Those results are actually quite encouraging and the practice of eliminating sedation all together may become more widely accepted if these results can be replicated in other settings.
Propofol can be a very useful drug in a variety of settings. But it may have a small margin for error and there are safety issues lurking whenever it is used. Treat it with respect.
ISMPs list of high alert medications
ISMP. Propofol sedation: Who should administer? ISMP Medication Safety Alert (Acute Care Edition). November 3, 2005
Smith M. PAS: Propofol Widely Used to Sedate Children. MedPageToday.com. May 3, 2010
Mallory MD, Baxter AL, Yanosky DJ, Cravero. JP. Use of Propofol for Sedation of Pediatric Patients by Emergency Physicians: A Report from the Pediatric Sedation Research Consortium (abstract). Pediatric Academic Societies meeting May 1, 2010
Phillion M. New CMS Anesthesia Guidelines Completely Rewrite Former Standard. HealthLeaders Media, April 13, 2010
CMS. Revised Hospital Anesthesia Services Interpretive Guidelines State Operations Manual (SOM) Appendix A. Revision 2/05/2010
Klauer K. Is Propofol Gone? CMS Releases New Guidelines. Emergency Physicians Monthly March 24, 2010
Mace SE, Brown LA, Francis L, et al for the EMSC Panel (Writing Committee) on Critical Issues in the Sedation of Pediatric Patients in the Emergency
Department. Clinical Policy: Critical Issues in the Sedation of Pediatric Patients in the Emergency Department. Ann Emerg Med 2008; 51(4): 378-399
Goodwin SA, Caro DA, Wolf SJ, et al. from the American College of Emergency Physicians Clinical Policies Subcommittee (Writing Committee) on
Procedural Sedation and Analgesia. Clinical Policy: Procedural Sedation and Analgesia in the Emergency Department. Ann Emerg Med. 2005; 45:177-196
Joint Letter from the American College of Emergency Physicians (ACEP), the Emergency Nurses Association (ENA), and the American Association of Emergency Medicine (AAEM) to CMS on anesthesia issues. March 22, 2010
American College of Emergency Physicians. ACEP, Other EM Groups Meet With CMS About Anesthesia Interpretation. May 5, 2010 http://www.acep.org/acepnews.aspx?id=48402
Larsen R,Galloway D, Wadera S, et al. Safety of Propofol Sedation for Pediatric Outpatient Procedures. Clin Pediatr (Phila) 2009; 48: 819-823
Cot GA, Hovis RM, Ansstas MA et al. Incidence of Sedation-related Complications with Propofol Use during Advanced Endoscopic Procedures. Clin Gastroenterol Hepatol.2010; 8(2):137-142
Vargo JJ. Anesthesia-Mediated Sedation for Advanced Endoscopic Procedures and Cardiopulmonary Complications: Of Mountains and Molehills.Clin Gastroenterol Hepatol.2010; 8(2):103-104
Outpatient Surgery Magazine. After Death in the GI Suite, Patient's Family Sues CRNA. Outpatientsurgery.net May 19, 2010
Outpatient Surgery Magazine. Jury Finds Propofol Makers Liable in Las Vegas Hepatitis C Outbreak. Outpatientsurgery.net May 6, 2010
FDA. Questions and Answers on the Propofol Shortage.
Deitch K, Miner J, Chudnofsky CR, Dominici P, Latta P. Does End Tidal CO2 Monitoring During Emergency Department Procedural Sedation and Analgesia With Propofol Decrease the Incidence of Hypoxic Events? A Randomized, Controlled Trial. Annals of Emergency Medicine 2010; 55(3): 258-264
Green SM, Pershad J. Should Capnographic Monitoring Be Standard Practice During Emergency Department Procedural Sedation and Analgesia? Pro and Con. Annals of Emergency Medicine 2010; 55(3): 265-267
Strem T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. The Lancet 2010; 375: 475 - 480
Print Propofol Issues
June 1, 2010
A surgeon gets a newly autoclaved instrument that is too hot to use. He sets it down on the surgical drapes
A warm compress is ordered to help a diabetic foot ulcer heal
A patient undergoes MRI while wearing coiled electrodes for physiologic monitoring
A thermal blanket is used for a patient in the OR
A warming bottle for a neonate
Yes, you know the answers they all resulted in iatrogenic burns to patients. Could they occur in your hospital? We bet they could. Thats because with few exceptions, such as MRI suites and neonatal units, most patient care units lack protocols and systematic assessments to determine who might be at risk for burns.
When you look at the examples above examples you realize there are really 3 key conditions that predispose patients to burns. They are either insensitive to pain/temperature, unresponsive, or unable to communicate. There may be some additional predisposing factors, too, like impaired ability for the vasculature to help dissipate heat from the skin. And, of course, you need a heat source.
Patients who are obtunded or comatose or who are under anesthesia may not perceive heat or pain or be able to respond even if they could feel it. Patients who cannot communicate (infants, patients with aphasia, patients isolated in MRI suites, etc.) may perceive pain and temperature but may not be able to alert caregivers. And some patient cannot feel heat/pain because of local or regional anesthetic or certain neurological disorders (diabetic neuropathy, some other neuropathies, congenital insensitivity to pain, spinal cord problems, syringomyelia, certain CNS lesions, etc.).
The patient with the diabetic foot ulcer who suffered a burn due to a warm compress was obviously predisposed by a diabetic peripheral neuropathy a key factor in development of diabetic foot ulcers. But even patients with normal sensation may get burns under certain circumstances. Has the following ever occurred to you? You test the water temperature before you step into the shower and it feels too hot. You turn the hot water knob down (or turn the cold water knob up) and the water temperature is comfortable enough for you to begin showering. After a few minutes you increase the water temperature. The increased warmth may, in fact, feel good. But when you finish your shower you notice your skin is much redder than you usually experience. What happened? This was adaptation to heat (adaptation probably occurs at both the peripheral receptor level and a central level). You were no longer bothered by water at the same temperature that frightened you at the start. Yet that hot water was capable of burning your skin. The same sort of adaptation takes place to cold (ever dive in a 65 degree lake? You shout out Its freezing but after about a minute it becomes more tolerable).
So the point is this: even moderate heat applied for a long duration is capable of producing burns and patients may be surprisingly unaware that the burn is occurring. The potential damage to skin (or other organs) is a function of both temperature and duration.
The burn in the patient with the warm compress is interesting from another perspective. One of the first questions we always ask in a root cause analysis (RCA) after any adverse event is was the procedure indicated in the first place?. An AHRQ Web M&M (Cleland and Wasiak 2007) had an excellent discussion about warm compresses and burns. They point out that, though there is some basic science research suggesting that heat should improve wound healing, there is really a dearth of clinical evidence that heat therapy is efficacious for wounds. They also point out that wet heat (scalding) is more likely to cause a burn that dry heat.
Microwaved objects are particularly dangerous. Heating with microwaves is not uniform (ever sample safely the periphery of some food only to burn your tongue when you taste the middle?!). In addition, some of the warmth remedies for microwaving contain gels, or beans, or rice that retain heat for longer periods than the surface material.
Burns in the OR may occur when heat is applied over an area where drapes over or under the patients skin had been soaked with alcohol or any one of a number of other solutions used in the OR (this is also obviously a risk factor for surgical fires see our December 7, 2007 Patient Safety Tip of the Week on Surgical Fires,). In fact, some may develop chemical burns from these liquids.
Anesthesia, whether local or regional or general, may predispose patients to burns. Even under general anesthesia, where a patient cannot respond, we wonder if there are subtle signs such as changes in heart rate, perhaps mediated reflexly at lower levels, that could alert the surgical team to a potential burn.
There are special considerations in the neonatal period (Mhrenschlager 2004 and Mhrenschlager 2003). The neonate has a reduced thickness of the stratum corneum, thus less protection against thermal injuries. Thermal injuries in neonates have resulted from exposure to 1) transilluminating devides 2) infrared lamps placed too closely 3) other lights 4) tap water 5) warming bottles 6) even overheated plastic surfaces of disposable diapers.
Burns may be an issue during MRI scanning. A 2006 article by Lange and Nguyen became the subject of an FDA alert on burns caused by cables and electrodes in patients undergoing MRI. They stress that even with electrodes that have been approved for use with MRI, a serious burn can develop if the electrodes arent in complete contact with the skin surface (for example, if excess hair hasnt been removed or if there is an air gap between the electrode and the skin). Cables that are looped or coiled are especially likely to overheat during MRI so every attempt should be made to avoid looping or coiling and they should be kept off the patients skin by placing a blanket under them.
Transdermal drug patches may contain metal or ferromagnetic elements that may overheat during MRI scans and cause burns (see our March 2009 Whats New in the Patient Safety World column Risk of Burns during MRI Scans from Transdermal Drug Patches)
Our focus in this weeks Tip of the Week is primarily on burns to the skin. However, dont lose sight of the fact that thermal injuries can also occur internally during surgery. Such are well known to structures such as bowel and ureters. Such injuries are often not recognized and result in tissue necrosis and delayed manifestations of symptoms.
Lastly, burns may result from inadvertent radiation overdoses. In the recent spate of radiation overdoses from CT scanning (see our October 20, 2009 Patient Safety Tip of the Week Radiology AgainBut This Time Its Really Radiology!), skin burns and hair changes appeared after delay periods such that patients and their physicians did not even connect them to the CT scans.
So what should you do in your organization to minimize the risks of iatrogenic burns?
Cleland H, Wasiak J. Too Hot for Comfort. AHRQ WebM&M December 2007
[No authors listed] Iatrogenic burns: beware of microwaves! Prescrire Int. 2008 Aug;17(96):157-8.
Mhrenschlager M, Henkel V, Ring J. ABC of burns: Iatrogenic thermal injuries in the neonatal period BMJ 2004; bmj.com, 31 Aug 2004
Mhrenschlager M, Weigl LB, Haug S, et al. Iatrogenic Burns by Warming Bottles in the Neonatal Period: Report of Two Cases and Review of the Literature. Journal of Burn Care and Research 2003; 24: 52-55
Lange S, Nguyen QN. Cables and electrodes can burn patients during MRI. Nursing 2006; 36: 18
Print Iatrogenic Burns
June 8, 2010
Surgical Safety Checklist for Cataract Surgery
The UK National Patient Safety Agency (NPSA) has posted the new Surgical Safety Checklist: for Cataract Surgery ONLY, based upon the WHO Surgical Safety Checklist.
Cataract surgery has a special place in our patient safety journey. Our initial interest in surgical timeouts and checklists stemmed from a root cause analysis on an ophthalmology incident. That incident led to the development of one of the first formal surgical timeout policies, which later became a model for New York States first foray into surgical timeout policies (see the New York State Surgcal and Invasive Procedure Protocol (NYSSIPP). Also, during a lull at one of the meetings of the statewide NYPORTS (New York Patient Occurrence and Report Tracking System) committee we asked attendees if they had ever seen implantation of incorrect lenses during cataract surgery. One hand after another shot up! Probably a third of attendees had experienced this at their hospital. John Simon and his colleagues at Albany Medical College subsequently analyzed all such cases in the NYPORTS database and an ophthalmology malpractice claims database. His work and the references are summarized in our March 11, 2008 Patient Safety Tip of the Week Lessons from Ophthalmology.
Implantation of the wrong intraocular lens was the most common occurrence in both databases. Errors in both the preoperative period and operative period were found to lead to the incorrect implantation. In the preoperative period, contributory causes identified included faulty calibration of the A-scan equipment, transposition of records from the ophthalmologists office, transcription errors, switched patient identification stickers, and transposition of IOL power calculations while faxing records on two patients at the same time.
Intraoperative errors in almost all cases involved failure to identify the lens specifications properly before implantation. Multiple contributory factors were indentified, including changes in the OR schedule, changed staff assignments, staff changes during the procedure, poor lighting, multitasking and other distractions, and misreading the label on the implant box. In one case the surgeon had dropped multiple patient charts and they were out of order when reassembled. (Note in our June 5, 2007 Patient Safety Tip of the Week Patient Safety in Ambulatoy Surgery we discourage the practice of allowing the medical records of multiple patients to be in the operating room since it is too easy to mistakenly pick up the chart of the wrong patient during a procedure.) In 77% of the cases with adequate information the authors felt that adherence to Universal Protocol would have prevented the adverse event but most of the preoperative errors would not have been identified using Universal Protocol.
The new Surgical Safety Checklist: for Cataract Surgery ONLY is based upon the WHO Surgical Safety Checklist. Our July 1, 2008 Patient Safety Tip of the Week WHOs New Surgical Safety Checklist described the original tool and provided the link to download the checklist tool and instructions how to use it. We also discussed checklist design and use in our September 23, 2008 Patient Safety Tip of the Week Checklists and Wrong Site Surgery.
Like the prototype WHO Surgical Safety Checklist, there are 3 phases in the cataract checklist: sign in, timeout, and sign out.
The sign in phase (done before any anesthetic is administered) includes identification of the patient and the procedure to be performed and the consent for that procedure. It also includes whether site marking has been performed and a precheck of any anesthesiology equipment and whether VTE prophylaxis is indicated. It includes some questions important for anesthesiology (allergies, airway accessibility, special needs for draping or positioning). It then asks some questions important to the ophthalmologist: Is the Patient on warfarin? Is the patient on tamsulosin or other alpha blocker? The first question obviously raises the question of bleeding risk and the latter the risk of the intraoperative floppy iris syndrome (IFIS) and other complications (Bell et al 2009).
During the timeout phase, the team introduces itself and confirms the patient identification, the procedure to be performed, the correct eye, the intended refractive outcome, the power and model of the lens to be implanted, and whether that lens implant is physically present. Then any anticipated variations or critical events are discussed. For instance, the surgeon may discuss and planned variations in the surgery, need for special equipment, alternative lenses, etc. The anesthesiologist notes the ASA class, status of monitoring equipment, and any patient-specific problems. The scrub nurse notes whether sterility of the instruments has been confirmed and notes any other equipment issues.
The sign out phase included documentation of the name and side of the procedure, status and count of all instruments, swabs and other materials, identification of any equipment issues, and instructions for post-procedural care of the patient.
This checklist could be further modified at your individual sites.
Some other issues in our June 5, 2007 Patient Safety Tip of the Week Patient Safety in Ambulatoy Surgery are worth repeating. One factor is that a surgeon in ambulatory surgery will often be performing many cases of the same or similar procedures. Interestingly, very experienced surgeons may be more likely to be involved in wrong-site cases, perhaps because their experience allows them to schedule so many cases in one day. The quality of the medical records is often not as good in ambulatory settings. The facility medical record is often scant and the physician often brings in his/her office notes that are unofficial as far as the facility is concerned. Often critical information is in the physician office record and never appears in the facility medical record. It is therefore incumbent upon the facility and entire team to ensure the adequacy of the medical record and all documentation prior to the procedure. And there are certain production pressures unique to the ambulatory setting. When a surgeon is booked for many cases in one day, there is a higher likelihood of last-minute changes in the schedule. Also, weve seen cases in the ambulatory setting where one patient may demand a procedure earlier in the day, leading to last-minute alterations in the order on the schedule. And the pressure to get cases done promptly and stay on schedule are everpresent. Lastly, dont allow the medical records of multiple patients to be in the operating room at the same time since it is too easy to mistakenly pick up the chart of the wrong patient during a procedure.
The recommendations of the American Academy of Ophthalmology Wrong-Site Task Force are also quite valuable and include special attention to intraocular lens implants and a checklist to help. One good recommendation there is that the circulating nurse writes on the white board the patients name, operative eye, IOL style, and IOL power.
NHS NPSA. Surgical Safety Checklist: for Cataract Surgery ONLY
(adapted from the WHO Surgical Safety Checklist)
WHO Surgical Safety Cheklist
WHO Safe Surgery Saves Lives website (includes also an implementation manual and videos on how to use the checklist and how not to use it)
Chaim M. Bell CM, Hatch WV, Fischer HD et al. Association Between Tamsulosin and Serious Ophthalmic Adverse Events in Older Men Following Cataract Surgery.
JAMA.2009; 301(19): 1991-1996
American Academy of Ophthalmology. Recommendations of the American Academy of Ophthalmology Wrong-Site Task Force. November 2008.
June 15, 2010
Dysphagia in the Stroke Patient: the Scottish Guideline
Our June 26, 2007 Patient Safety Tip of the Week Pneumonia in the Stroke Patient focused on the evaluation of stroke patients for dysphagia prior to feeding them. Much of the morbidity and mortality in patients with acute stroke is related not just directly to the neurological deficit but rather to the complications such as pneumonia. The incidence of pneumonia in the acute stroke population varies considerably in the literature, largely because of stroke populations of varying severity and differences in definitions used. However, studies that have looked at stroke patients having at least some degree of paralysis present have noted incidences of pneumonia typically in the 12-13% range (Aslanyan 2004, Hinchey 2005). The human and financial impact of pneumonia in the acute stroke patient are substantial. The occurrence of pneumonia was associated with about $15,000 incremental cost per case (Katzan 2007) and pneumonia increased the risk of dying within 30 days threefold in patients with acute stroke, after correction for severity of the stroke (Katzan 2003).
Use of a formal dysphagia screening tool has been shown to reduce the risk of pneumonia in stroke patients by as much as half(Hinchey 2005) and there are reports showing that hospitals can increase their compliance with swallowing assessment by using preprinted order sets and by using written care protocols (Hinchey 2006, Book 2006).
We were very disappointed when NQF waffled in 2008 on including swallowing assessment in stroke patients as one of its quality measures (NQF presumably was concerned because the evidence base was not robust enough). Nevertheless, swallowing assessment has always remained part of the American Heart Association/American Stroke Association guidelines for management of the acute stroke patient and has been a quality standard for The Joint Commission accreditation of Stroke Centers.
There has not been a significant change in the evidence base for assessment and management of dysphagia in the stroke patient since then. However, this month the Scottish Intercollegiate Guidelines Network released its guideline Management of patients with stroke: identification and management of dysphagia.A national clinical guideline. This is the most comprehensive such guideline weve seen. It reviews the evidence base and makes recommendations not only for the assessment of dysphagia in the stroke patient but provides great recommendations about interventions in the dysphagic patient, nutritional status of the stroke patient, issues related to tube feedings, medication issues in the dysphagic patient, oral hygiene in the stroke patient, and training of both professional staff and lay caregivers in important issues. It also provides good advice about implementing and auditing the guideline and has a variety of useful tools in its appendix section. There is also a good quick reference guide with appropriate algorithms.
The Scottish guideline notes that there is videofluoroscopic evidence of dysphagia in 64-90% of conscious stroke patients acutely, with confirmed aspiration in 22-42%. Hence, assessing patients for dysphagia and aspiration risk is crucial. Note that seeing a patient cough on attempted swallowing is a good indicator of aspiration but the lack of coughing does not indicate safe swallowing. Factors associated with risk of aspiration are a wet, hoarse voice, a weak voluntary cough, any indication of reduced laryngeal function, and impaired level of consciousness. Factors that have not proven to be accurate predictors of aspiration are pharyngeal sensation and status of the gag reflex. The gag reflex is commonly reduced in the acute phase after stroke. However, some patients with bilateral lesions develop pseudobulbar palsy and may have a normal or even increased gag reflex when their swallowing is impaired.
The water swallow test is typically used as a first line tool to screen for aspiration risk. This screening test is administered by a healthcare professional trained in the procedure, usually a nurse. The Quick Referral Guide and Annex 2 of the full Scottish guideline provide an algorithm for the swallowing screen. If the patient can sit up and is alert and cooperative and has a clean mouth (or has received oral hygiene), the water swallow test can proceed. The patient is sat up and given a teaspoon of water times three. With each teaspoon, the observer watches for absent swallow, cough, delayed cough, and altered voice quality. It the patient shows any of those abnormalities, he/she is kept NPO and formal swallowing studies are ordered (usually done by speech therapy in most facilities). If the patient passes that initial screen, the patient is observed drinking a full glass of water, again looking for those same abnormalities. If none are witnessed, the patient may start feeding (soft options) cautiously and observation for coughing or evidence of chest infection are continued.
If the patient fails the initial swallowing screen, a formal assessment should be done by an individual appropriately trained in swallowing assessment, such as a speech therapist. A clinical bedside assessment (CBA) of swallowing can be done using a standardized tool such as the 28-item Logemann assessment (Annex 3 in the full Scottish guideline). Most may go on to either a modified barium swallow (MBS) or fiberoptic endoscopic evaluation of swallowing (FEES). The decision of which of these to perform is usually dependent upon individual circumstances (eg. test availability, whether the patient can be transported or not, risk of radiation exposure, etc.). Both tests allow for determination of penetration and aspiration. MBS may be better at determining the reason for dysphagia and aspiration and allow experimentation with various postures, maneuvers and food consistencies to see what might improve the effectiveness and safety of swallowing for each patient. Diet modification, compensatory techniques, texture modification, and approaches such as muscle strengthening exercises, electrical stimulation and biofeedback are discussed in detail in the guideline.
The initial assessment should include not only screening for dysphagia but also screening for risk of malnutrition and risk of dehydration. Because malnutrition and dehydration may impact on ultimate patient outcomes, they should be addressed by the multidisciplinary team and include a dietitian. For those patients who are unable to safely swallow and are at risk of malnutrition, tube feedings will need to be considered. The guideline has an excellent discussion of the pros and cons of nasogastric tubes and percutaneous gastrostomies (PEGs) and the timing for conversion from NG to PEG if needed. They also have a nice section on ethical and quality of life issues and feeding. And a short section on the need for pharmacists to be involved in looking at alternative formulations for necessary medications in those being tube fed.
Some of the most important sections deal with those things we tend to often overlook. One is one on the need for regular review of the patients status. Dysphagia in stroke patients often resolves within the first few weeks. Hence, there is a continuing need to reassess the patients swallowing ability and other risk factors for pneumonia and malnutrition. The guideline stresses that one professional should be identified who will be responsible for this ongoing assessment and reassessment, especially for any patient being tube fed or fed a modified diet. The second has to do with auditing. As you begin implementing the guideline you need to audit current practice to determine where your gaps in care and areas for improvement are. They provide a nice checklist to help you with that audit. But dont forget that audit and feedback are critical parts in the durability and sustainability of any quality improvement or patient safety activity.
The guideline also contains good advice on issues of communication, training of staff, and provision of information for staff, patients and their caregivers.
Implementing this guideline for all stroke patients is a pretty low cost patient safety intervention and, with a savings of $15,000 for each pneumonia prevented, one that has an excellent ROI. Again, this is another good example of how good patient safety programs can be very cost-effective for most hospitals.
Aslanyan S, Weir CJ, Diener H-C, Kaste M, Lees KR. Pneumonia and urinary tract infection after acute ischaemic stroke: a tertiary analysis of the GAIN international trial. Eur J Neurology 2004; 11: 49-53
Hinchey JA, Shephard T, Furie K, Smith D, Wang D, Tonn S. Formal Dysphagia Screening Protocols Prevent Pneumonia. Stroke 2005; 36: 1972-1976 http://stroke.ahajournals.org/cgi/content/abstract/36/9/1972?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=hinchey&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT
Katzan IL, Dawson NV, Thomas CL, Votruba ME Cebul RD. The cost of pneumonia after acute stroke. Neurology 2007; 68:1938-1943
Katzan IL, Cebul RD, Husak SH, Dawson NV, Baker DW. The effect of pneumonia on mortality among patients hospitalized for acute stroke. Neurology 2003; 60:620-625
Hinchey JA, Shephard TJ, Tonn S, Ruthazer R. Preprinted Orders Are Associated With High Adherence to Processes Required on Admission: P468. Stroke 2006; 37: 739
Book DS, Dostai J, Sama D. Compliance with Written Care Protocols Predicts Success in Achieving JCAHO Stroke Performance Measures: P469. Stroke 2006; 37: 739
Adams HP, del Zoppo G, Alberts MJ et al. Guidelines for the Early Management of Adults With Ischemic Stroke: A Guideline From the American Heart Association/ American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists.
Stroke 2007; 38;1655-1711; originally published online Apr 12, 2007;
The Joint Commission. Primary Stroke Center Certification.
Scottish Intercollegiate Guidelines Network. Management of patients with stroke: identification and management of dysphagia.A national clinical guideline. June 2010
Quick Reference Guideline
June 22, 2010
Disclosure and Apology:
How to Do It
Ever since we set up our first guidelines on responding to serious incidents in the early 1990s (see our July 24, 2007 Patient Safety Tip of the Week Serious Incident Response Checklist) we have always included a section for notifying the patient and/or family that errors had occurred in their care. The patient safety movement has adopted that approach and much has been written about the role of disclosure and apology after medical errors. Yet we continue to see hospitals struggle with how do we do it? even once they have bought into the basic concept. Fortunately, there is a wealth of resources available to help healthcare organizations learn how to do it.
Some of the best resources are the Canadian Patient Safety Institute Disclosure Guidelines (which well call the Canadian guidelines), When Things Go Wrong. Responding to Adverse Events. A Consensus Statement of the Harvard Hospitals (which well refer to as the Harvard guidelines), and the American College of Physician Executives toolkit (which well call the ACPE toolkit).
Why do we recommend disclosure and apology? Simply put: its the right thing to do. It is a moral imperative and it is the only way to maintain the physician-patient relationship and keep the patient at the center of the healthcare system. The fear that disclosure increases the risk of malpractice suits and settlements also was probably erroneous and it is becoming increasingly clear that failure to disclose is a much bigger risk when it comes to malpractice risk.
When to invoke the disclosure and apology process is usually a matter of common sense but most guidelines recommend each organization have its own policy that includes a threshold for disclosure. Most of the serious adverse events requiring disclosure are obvious but you may have to decide individually when to disclose things like near misses.
Following are some of the key issues you need to address in the disclosure and apology process. The Canadian guideline also has a nice checklist and algorithm to help you remember key things to do at each stage of the disclosure process.
When should you notify the patient and family?
Our recommendation is that you let the patient/family know about the incident as soon as possible. Obviously, you need to know enough about the event or incident to be able to discuss it with them. But sometimes you may not have all the details early on (for example, you may not yet have done your root cause analysis). It is okay to tell them that a serious incident did take place and that your investigation will be taking place within a few days and that you will keep them posted regularly on the status of that investigation. Let them know that you are doing this to help ensure that similar events will be prevented in the future. You need to show honesty, contrition, and empathy in order to build a trusting relationhip with that patient or family. If you wait to disclose that an incident occurred, the patient or family is likely to find out about it in other ways, your credibility will suffer and you will lose the opportunity to develop a rapport with them.
Who should notify the patient/family?
Generally this should be the person with direct responsibility for care of that patient, most often the attending physician. However, there are times when someone who has developed a special rapport with the patient/family may be more appropriate. And there are times when the medical director (or CMO or VPMA) is the most appropriate person. In most cases, since adverse outcomes are usually the result of a cascade of errors rather than the result of actions of a single individual, the attending physician should play a major role in the notification even regardless of whether he/she was part of that cascade of errors. The Harvard guidelines stress that the attending physician should assume responsibility even if he/she did not make the mistake(s) that caused the injury. Both the physician and the hospital need to take responsibility and accountability and show remorse to the patient/family. That is a critical part of the apology process and lets the patient/family understand that you are both human and truly sorry for what happened to the patient and not just sorry for what it might do to your reputation. If the involved physician is not present when the incident is disclosed, culpability or insensitivity or both are often implied by the patient/family. The Harvard guidelines also mentions joint apologies where the person who made a significant error may join with the attending physician at the time of disclosure and apology.
If the care team is different after the incident (eg. the patient has been transferred to the ICU), it may be wise to have attending physicians from both the new and old teams present.
If the attending physician is not comfortable or very inexperienced in dealing with patients/families under such circumstances, either an experienced person (eg. medical director or CMO) should accompany that physician or some coaching or other preparation should take place.
Both the Canadian and Harvard guidelines strongly suggest organizational training programs to prepare physicians for dealing with disclosure. Housestaff should also participate in any such training offered.
Where should the initial meeting take place?
Obviously, the meeting needs to take place in a quiet, comfortable setting where interruptions will not occur. The patient and family need to have the opportunity to ask questions and not feel intimidated. The Harvard Guidelines suggest a single patient room as a good setting or a private office for ambulatory communications. They caution against summoning the patient/family to the executive suite and note you should never use double rooms, open spaces of any sort, waiting rooms or hallways for such conversations.
What should be disclosed?
As above, you should disclose the facts as they become known. Sometimes early after an error and adverse outcome, the causes and root causes are not yet known. Be careful about speculating about those causes. Rumors can often run rampant after an adverse event and do not help either the injured patient, the family or the healthcare organization. If you tell a patient or family what you think might be the cause and that turns out not to be the case, your credibility may be damaged. So disclose what you know to be fact and emphasize to the patient/family that you will share with them all the other facts as they become known. And then follow up on that promise!
While lawyers will tell you never to use terms or phrases like mistake or erroror we screwed up, you do need to convey to the patient/family that you are both honest and sorry for what happened so sometimes you need to use language they understand. The Harvard guideline suggests ways like:
The Canadian Guideline specifically excludes the word error, citing our well-known concept that most cases of adverse patient outcomes are due to system issues. Keep in mind that, while we understand the systems nature of errors that give rise to adverse patient outcomes, patients and families and the public dont have the same level of understanding of those complex issues. Therefore, be very careful about blaming the system because patients/families may feel you are trying to divert responsibility. They are looking for someone to take individual responsibility. Both the Harvard and Canadian guidelines have excellent examples of some of the words used in effective communication with patients/families after an adverse event.
At the time of disclosure and apology, the attending physicians (and hospital administration or other leaders) need to make it clear to the patient family what will be done to deal with the clinical effects of the adverse event. It is especially important that the patient/family have an ongoing trust after an event since many of the same healthcare workers will still be involved in the care of the patient.
Very important is the manner in which disclosure and apology occur. You need to use language and terminology that the patient/family clearly understands, also taking into account cultural and language considerations. Make sure you listen carefully and allow adequate time for patients/families to ask questions and seek clarification. And never forget that body language may convey much more than verbal language.
In our November 2007 Whats New in the Patient Safety World column Snippets we discussed an article Guilty, Afraid, and Alone Struggling with Medical Error by Tom Delbanco and Sigall Bell in the October 25, 2007 issue of the New England Journal of Medicine that provides insights gleaned from interviews with patients and families that had been affected by medical error. Some of their findings were quite surprising. Patients and their families often feared further harm, even retribution, if they express their feelings too forcefully. Family members often have a profound sense of guilt, that they didnt watch carefully enough and were not able to prevent their loved one from suffering in an incident. That is why it is extremely important to do the disclosure in a manner that makes the patient and family feel comfortable speaking up and allowing both adequate time to ask questions and avoiding any semblance of intimidation.
Following up is critical and presents an opportunity to develop rapport and trust that may have been impossible at the first meeting. The main goal of the follow meetings is to keep the patient/family apprised of what the investigation has revealed and what actions are being implemented to prevent recurrences. The patient/family should be told at the initial meeting when they can expect a followup. If there are delays in that followup, the patient/family should be informed and an apology for the delay is appropriate.
As the findings of the incident investigation and root cause analysis become available, the patient/family should be made aware of the findings and the actions that will be taken to prevent similar incidents in the future. Followup does not end on discharge from the hospital. Communications should continue after discharge or transfer. All the while, patients should be supported in medical, social and psychological spheres. The Harvard guideline has good sections on such support and an excellent section on financial support for patients harmed in adverse events.
You should document when and where the meetings took place, who was there, what was said, the questions and issues raised, responses given, and what arrangements were made for followup (who, when, what).
The Canadian guideline also includes sections on disclosure of events involving children, those with impaired cognition or impaired capacity, those with language/cultural diversity, and those in research settings. There is also a section addressing disclosure involving multiple patients, a topic we have previously discussed (see our June 16, 2009 Patient Safety Tip of the Week Disclosing Errors That Affect Multiple Patients).
Pennsylvania has a law that requires hospitals to provide to the patient (or appropriate family member or other designee) a written notification of a serious event involving that patient within 7 days. A recent article (Cherry 2010) provides some step-by-step practical advice to help hospitals accomplish that. One very wise piece of advice they offer is not to have more hospital representatives at that meeting than the patient and family have. That is to help avoid creating an atmosphere that the patient/family might feel is intimidating. Also, this meeting is a time to show humililty and let them know that you have human feelings and its very difficult to convey those traits with opposing teams sitting across from each other at a board room table. So keep it small. Their recommendation is that the hospital have the physician responsible for the patients care, the chief medical officer (CMO or VPMA), the risk manager, and perhaps the Chief of Service of the involved department. Our own recommendation is to leave out the risk manager. You may include your head of quality improvement or patient safety director, especially if you feel they likely be serving as the key liaison for future meetings with the patient and family. Important: no lawyers (on either side)! Another important point is active listening. We have seen far too many such meetings where the hospital staff dominate the conversation. This is an opportunity for the patient and family to speak, express their concerns, and ask questions. They should feel they are encouraged to ask questions and expect that those questions will be answered honestly. They stress the value of apology, not only in humanizing the staff, but also in de-escalating tensions, creating a more level playing field, and leading to a more trusting relationship.
The Other Victims
While the patient is obviously the focus of the disclosure and apology process, the involved caregiver(s) are also victims in a sense and need support. Sadness, sense of failure, guilt, isolation, and loss of self-esteem may be overwhelming to some caregivers. Organizations need to recognize this and ensure support is available to caregivers involved in such incidents. We actually include this as an item in our Serious Incident Response Checklist. Such support may include various types of counseling, appropriate temporary adjustment of responsibilities (being careful to ensure that such adjustment is not mistaken as punitive or a sign of loss of confidence in the individual), and the general support that is a feature of the culture of safety. Participation in the root cause analysis and development of strategies to prevent future incidents may also have therapeutic value for the caregiver.
The article mentioned above Guilty, Afraid, and Alone Struggling with Medical Error (Delbanco 2007) provides excellent insight into how those emotions in clinicians may further compound the emotions the patient or family is going through. They note that physicians experience guilt after a medical error but also have fear after an incident fear about their reputation, job, license, career. That fear, often compounded by imprudent advice from attorneys and administrators, may lead to them becoming isolated and being perceived as cold and impersonal by the very patients and families looking for empathy and support.
Even caregivers not directly involved in the incident may experience similar emotions. We often do debriefing sessions after serious incidents even when no errors occurred. Staff generally feel much better after such sessions.
Susan Carr recently summarized findings at a forum on support for clinicians involved in adverse events, identifying numerous barriers that lead to underutilization of such support services.
Emotions Are Not Static
We have noticed that both patients/families and involved caregivers often go through stages after a serious incident in which a patient is injured that are very similar to the stages made famous by Kubler-Ross in On Death and Dying. Those stages include denial/isolation, anger, bargaining, depression, acceptance. You need to recognize that these emotional stages are part of a normal evolution and that anger may later convert a very positive emotion. Most in the patient safety movement know the story of the unfortunate death of Josie King at Johns Hopkins and how the anger initially shown by her parents later gave way to a profound understanding of the complex issues in patient safety and the emergence of her mother, Sorrel King, as one of the leading patient safety advocates in the world.
More than 30 states now have apology laws where statements made during apology to patients are not to be used in litigation. Most of these laws are too new for us to tell whether they will have a significant positive impact on the frequency of sincere apology.
Massachusetts Coalition for the Prevention of Medical Errors. When Things Go Wrong. Responding to Adverse Events. A Consensus Statement of the Harvard Hospitals. 2006
Canadian Patient Safety Institute. Canadian Disclosure Guidelines. May 2008
The American College of Physician Executives. Disclosure and Apology Toolkit.
Delbanco T, Bell SK. Guilty, Afraid, and Alone Struggling with Medical Error. NEJM 2007; 357:1682-1683
Cherry RA, Marcus L, Dorn B. Reporting Adverse Events to Patients: A Step-by-Step Approach. Physician Exec. 2010; 36: 4-9 MayJune 2010
The Josie King Foundation
Carr, Susan. Disclosure and Apology. Whats Missing? Advancing Programs that Support Clinicians. Patient Safety and Quality Healthcare. March/April 2010
June 29, 2010
Torsade de Pointes:
Are Your Patients At Risk?
For some time now we had planned to do a column on Torsade de Pointes and its relationship to a variety of commonly used medications. We kept putting it off because of a lack of consensus of how to best monitor for it and how to treat when the risk becomes obvious. But now the American Heart Association/American College of Cardiology Foundation) has published the AHA/ACCF statement on Torsade de Pointes (Drew et al 2010).
Torsade de Pointes is a form of ventricular tachycardia, often fatal, in which the QRS complexes become twisted (changing in amplitude and morphology) but is best known for its occurrence in patients with long QT intervals. Though cases of the long QT interval syndrome (LQTS) may be congenital, many are acquired and due to a variety of drugs that we prescribe. The syndrome is more common in females and many have a genetic predisposition. And there are a number of reasons why this syndrome is more likely to both occur and result in death in hospitalized patients. Hospitalized patients have a whole host of other factors that may help precipitate malignant arrhythmias in vulnerable patients. They tend to have underlying heart disease, electrolyte abnormalities (eg. hypokalemia, hypomagnesemia, hypocalcemia), renal or hepatic impairment, and bradycardia, all of which may be precipitating factors. More importantly they may have the sorts of conditions for which we prescribe the drugs that are primarily responsible for prolonging the QT interval (eg. haloperidol, antiarrhythmic agents, etc.). And many of those drugs are given intravenously and in high doses in the hospital as compared to the outpatient arena. Rapid intravenous infusion of such drugs may be more likely to precipitate Torsade de Pointes than slow infusion.
The drugs most commonly associated with Torsade de Pointes are haloperidol, methadone, thioridazine, amiodarone, quinidine, sotalol, procainamide, erythromycin, azithromycin, the antihistamine terfenadine and certain antifungals. Though the newer antipsychotic agents have been less often implicated in torsade de pointes, quetiapine has been reported to be associated with it occasionally (Vieweg 2005). For a full list of drugs that commonly cause prolongation of the QT interval and may lead to Torsade de Pointes, go to the Arizona CERT website. That site also has a list of drugs that prolong the QT interval and might possibly cause Torsade de Pointes and another list of drugs that have conditional risk (eg. only when combined with other drugs). Some drugs (eg. cisapride (Propulsid), a drug formerly used to promote GI motility) have actually been withdrawn from the market because of serious cardiac side effects, including prolongation of the QT interval and torsade de pointes.
One study of Torsade de Pointes associated with psychotropic drugs (Justo et al 2005) found that most patients had multiple risk factors for Torsade de Pointes before they were begun on the psychotropic drugs. 73% had 2 or more risk factors that were easily identifiable prior to initiation of the psychotropic drugs. While female sex is the most common risk factor (71%), 34% had advanced heart disease, 30% were on a second drug known to prolong the QT interval, and 27% had high doses of the offending psychotropic drugs. 18% had either a family history of LQTS, a prior episode of Torsade de Pointes, or prolonged QT on baseline EKG. 14% had hypokalemia. Most of these could have been determined by simple history, baseline EKG, and serum potassium levels. Thus, they made the recommendation that prior to initiating treatment with psychotropic agents, patients be assessed for these risk factors. Yet we see very few behavioral health units monitoring for QT prolongation when patients are begun on such agents.
One must keep in mind that the incidence of Torsade de Pointes is still quite low overall. The potential benefits of many of these psychotropic agents may outweigh the risks of Torsade. But identifying the risk factors should at least flag such patients for closer monitoring during treatment with psychotropic drugs.
When seeing patients in the ED who have overdosed on unknown medications, prompt performance of EKG may be important in case one or more of the ingested drugs prolongs the QT interval and predisposes to torsade de pointes.
There are numerous issues when the patient with a long QT interval must undergo anesthesia and surgery. A review on anesthesia in such cases (Booker 2003) focused primarily on patients with congenital long QT syndrome but most of the issues apply to any patient with QT prolongation irrespective of etiology. Most commonly used anesthetic agents (halothane, enflurane, isoflurane, and sevoflurane) can prolong the QT interval. A variety of drugs used in the OR may further prolong the QT and lead to torsade de pointes (Saussine 2006). These include ketamine, succinylcholine, pancuronium, droperidol, sufentanil, and neostigmine. They also note that adrenergic stimulation, such as occurs with anxiety or tracheal intubation/extubation or pain may precipitate arrhythmias in such patients. In addition, Saussine et al (Saussine 2006) described precipitation of ventricular arrhythmias by sevoflurane in a patient with congenital LQTS. These resolved promptly when the sevoflurane was discontinued and propofol was added. They note that propofol has been shown to shorten the QT interval in normal patients and suggested it might be wise to use in patients with prolonged QT syndromes.
Unfortunately, at this time, there is no validated scoring tool that can identify for you the magnitude of an individual patients risk for torsade de pointes. Therefore, the best you can do is look for the presence of the individual risk factors and monitor the QT interval more closely in those patients.
We refer you to the AHA/ACCF scientific statement for details on the nuances of measuring the QT interval and the QTc (corrected QT). Note that it is not as straight forward as youd expect. In fact, a study on a large group of patients diagnosed with congenital LQTS seen for second opinion at the Mayo clinic (Taggart 2007) noted almost 40% of patients erroneously diagnosed, often because of inaccurate measurement of the QTc. The AHA/ACCF statement also notes that the morphology of some EKGs may make it more difficult to measure the QT so alternative methods may need to be considered. Also, they provide advice about the EKG in the setting of conduction block, bradycardia, or atrial fibrillation. Perhaps most important are their comments about being consistent about which lead you use to measure the QT. They discuss manual measurement and monitoring, using electronic calipers, and doing fully automated monitoring.
So who should you monitor? Continuous monitoring might be personnel- and resource-intensive and you might consider that only in those at-risk patients who will be receiving one of the drugs known to be most likely to cause QT prolongation and torsade de pointes. Most hospitals may have to just periodically monitor the QT in at-risk patients. No one could be expected to remember all the drugs or drug-drug interactions that may potentially prolong the QT interval and all the other conditions that predispose to QT prolongation and torsade de pointes. Therefore, it is incumbent to develop and use computer algorithms that will prompt staff to do appropriate QT monitoring. You can usually build rules into most hospital computer systems that will check laboratory and other clinical data and pharmacy data and generate an alert to an appropriate caregiver to check the QT interval. If your system is actually capturing the QTc in a data field, your alert could even be triggered by a rule that says something like if the QTc increases by more than x% or x msec. over baseline or if the exceeds x msec., alert physician. Remember also that it is not only addition of new drugs you must be concerned about. Risk factors are not static. On admission a patient may have normal potassium and magnesium levels but both may become depleted after even several days of diuretic therapy so your algorithm must take such into account and look for the most current risk factor data. When you already have a prolonged QT you should have a second algorithm that triggers an alert when a physician attempts to order a drug known to prolong the QT or one that interacts with other drugs potentially prolonging the QT.
The AHA/ACCF scientific statement has a good section on management of patients who have drug-induced QT prolongation and/or torsade de pointes, including comments on cadioversion, use of intravenous magnesium sulfate, repletion of potassium, temporary pacing, etc.
A patient you have identified as at risk should be given an up-to-date list of the drugs that may prolong the QT either alone or in combination with other drugs and the patients should be told to avoid those drugs.
Remember also that the genetic predisposition to prolongation of the QT may be placing other family members at risk as well. So you need to consider when to recommend EKGs and even genetic testing on family members.
Is there a downside to such monitoring for patients at risk? The study by Taggart et al., which related to congenital LQTS, found many patients erroneously diagnosed also received unnecessary treatment (such as implantable defibrillators) or advice that significantly curtailed their activities or unnecessary anxiety. On the other hand, the editorial on that study (Vetter 2007) stresses the risks of failure to diagnose and the risk of sudden cardiac death.
So what should your healthcare organization be doing?
Torsade de pointes is a relatively uncommon cause of sudden unexpected death but one that is potentially preventable. Being aware of the risk factors and having systems that identify when potentially dangerous drugs are being given to at-risk patients may potentially save lives.
Drew BJ, Ackerman MJ, Funk M on behalf of the American Heart Association Acute Cardiac Care Committee of the Council on Clinical Cardiology, the Council on Cardiovascular Nursing, and the American College of Cardiology Foundation
Prevention of Torsade de Pointes in Hospital Settings: A Scientific Statement From the American Heart Association and the American College of Cardiology Foundation
Circulation 2010;121;1047-1060; originally published online Feb 8, 2010
Vieweg WVR, Schneider RK, Wood MA. Torsade de pointes in a patient with complex medical and psychiatric conditions receiving low-dose quetiapine. Acta Psychiatrica Scandinavica 2005; 112(4):318-322
Arizona Center for Education and Research on Therapeutics.
D. Justo, V. Prokhorov, K. Heller, D. Zeltser. Torsade de pointes induced by psychotropic drugs and the prevalence of its risk factors. Acta Psychiatr Scand 2005; 111: 171176
Taylor D. (Editorial) Psychotropic drugs, torsade de pointes and sudden death.
Acta Psychiatr Scand 2005; 111: 169170
Booker PD, Whyte SD, Ladusans EJ. Long QT syndrome and anaesthesia.
Br. J. Anaesth. 2003 90: 349-366
Saussine M, Massad I, Raczka F et al. Torsade de pointes during sevoflurane anesthesia in a child with congenital long QT syndrome. Pediatric Anesthesia 2006;16(1):63-65
Taggart NW, Haglund CM, Tester DJ, Ackerman MJ. Diagnostic Miscues in Congenital Long-QT Syndrome. Circulation. 2007;115:2613-2620
Vetter VL. Clues or Miscues?: How to Make the Right Interpretation and Correctly Diagnose Long-QT Syndrome. Circulation. 2007;115:2595-2598
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May 17, 2011
May 10, 2011
May 3, 2011
April 26, 2011
April 19, 2011
April 12, 2011
April 5, 2011
March 29, 2011
The Silent Treatment:A Dose of Reality
March 22, 2011
March 15, 2011
March 8, 2011
March 1, 2011
February 22, 2011
February 15, 2011
February 8, 2011
February 1, 2011
January 25, 2011
January 18, 2011
January 11, 2011
January 4, 2011
December 28, 2010
December 21, 2010
December 14, 2010
December 6, 2010
November 30, 2010
November 23, 2010
November 16, 2010
November 9, 2010
November 2, 2010
October 26, 2010
October 19, 2010
October 12, 2010
October 5, 2010
September 28, 2010
September 21, 2010
September 14, 2010
September 7, 2010
August 31, 2010
August 24, 2010
August 17, 2010
August 10, 2010
August 3, 2010
Tip of the Week on Vacation
July 27, 2010
July 20, 2010
July 13, 2010
July 6, 2010
June 29, 2010
June 22, 2010
June 15, 2010
June 8, 2010
June 1, 2010
May 25, 2010
May 18, 2010
May 11, 2010
May 4, 2010
April 27, 2010
April 20, 2010
April 13, 2010
April 6, 2010
March 30, 2010
March 23, 2010
March 16, 2010
March 9, 2010
March 2, 2010
February 23, 2010
February 16, 2010
February 9, 2010
February 2, 2010
January 26, 2010
January 19, 2010
January 12, 2010
January 5, 2010
December 29, 2009
December 22, 2009
December 15, 2009
December 8, 2009
December 1, 2009
November 24, 2009
November 17, 2009
November 10, 2009
November 3, 2009
October 27, 2009
October 20, 2009
October 13, 2009
October 6, 2009
September 29, 2009
September 22, 2009
September 15, 2009
September 8, 2009
September 1, 2009
August 25, 2009
August 18, 2009
August 11, 2009
August 4, 2009
July 28, 2009
July 21, 2009
July 14, 2009
July 7, 2009
June 30, 2009
June 23, 2009
June 16, 2009
June 9, 2009
June 2, 2009
May 26, 2009
May 19, 2009
May 12, 2009
May 5, 2009
April 28, 2009
April 21, 2009
April 14, 2009
April 7, 2009
March 31, 2009
March 24, 2009
March 17, 2009
March 10, 2009
March 3, 2009
February 24, 2009
February 17, 2009
February 10, 2009
February 3, 2009
January 27, 2009
January 20, 2009
January 13, 2009
January 6, 2009
December 30, 2008
December 23, 2008
December 16, 2008
December 9, 2008
December 2, 2008
November 25, 2008
November 18, 2008
November 11, 2008
November 4, 2008
October 28, 2008
October 21, 2008
October 14, 2008
October 7, 2008
September 30, 2008
September 23, 2008
September 16, 2008
September 9, 2008
September 2, 2008
August 26, 2008
August 19, 2008
August 12, 2008
August 5, 2008
July 29, 2008
July 22, 2008
July 15, 2008
July 8, 2008
July 1, 2008
June 24, 2008
June 17, 2008
June 10, 2008
June 3, 2008
May 6, 2008
April 29, 2008
April 22, 2008
April 15, 2008
April 8, 2008
April 1, 2008
March 25, 2008
March 18, 2008
March 11, 2008
March 4, 2008
February 26, 2008
February 19, 2008
February 12, 2008
February 5, 2008
January 29, 2008
January 22, 2008
January 15, 2008
January 8, 2008
January 1, 2008
December 25, 2007
December 18, 2007
December 11, 2007
December 4, 2007
November 20, 2007
November 13, 2007
November 6, 2007
October 30, 2007
October 23, 2007
October 16, 2007
October 9, 2007
October 2, 2007
September 25, 2007
September 18, 2007
September 11, 2007
September 4, 2007
August 28, 2007
August 21, 2007
August 14, 2007
August 7, 2007
July 31, 2007
July 24, 2007
July 17, 2007
July 10, 2007
July 3, 2007
June 26, 2007
June 19, 2007
June 12, 2007
June 5, 2007
May 29, 2007
May 22, 2007
May 15, 2007
May 8, 2007
May 1, 2007
April 23, 2007
April 16, 2007
April 9, 2007
April 2, 2007
March 26, 2007
March 19, 2007
March 12, 2007
March 5, 2007
February 26, 2007