Tips, Tools, Techniques, and Resources You Can Use in Your Patient Safety and Quality Improvement Initiatives

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October 2, 2007    

Taking Off from the Wrong Runway

Again, we can learn a lot from RCA’s done in other high risk industries. In 2006 Comair Flight 5191 crashed in Lexington, Kentucky after taking off inadvertently from the wrong runway, which was too short for a commercial airliner (this runway was used by small general aviation planes). All passengers and all but one crew member died in the crash.

The NTSB analysis of the crash determined that pilot error was the primary reason for the crash. In particular, they felt that sufficient cues should have been available to the pilots to inform them they were on the wrong runway and that distractions, particularly a nonpertinent conversation between the captain and first officer during the taxi procedure and takeoff, were a primary cause of the crash. Moreover, a leisure-like atmosphere in the cockpit may have been a contributing factor. The concept of a “sterile cockpit”, in which all attention is focused on flight-related factors and no “nonpertinent” conversation is allowed, is applied during taxi and takeoff procedures.

Airlines do Line Operations Safety Audits (LOSA’s) that usually do include looking for “sterile cockpit” violations. But Comair apparently did not have a formal process for assessing for sterile cockpit violations.

The crew also did not cross check and confirm the plane’s position on the runway before takeoff and confirmation bias likely contributed to their thinking they were on the correct runway. Only after they had reached a point at which they could no longer abort the takeoff did they realize they were on the wrong runway.

The lone air traffic controller on duty at the time was engaged in an administrative task (that was of low priority) and did not notice that the plane was on the wrong runway.

NTSB recommendations (pardon some of the technical terms) included:

·         Establish procedures requiring all crewmembers on the flight deck to positively confirm and cross-check the airplane’s location at the assigned departure runway before crossing the hold short line for takeoff

·         Require that operators install on their aircraft cockpit moving map displays or an automatic system that alerts pilots when a takeoff is attempted on a taxiway or a runway other than the one intended

·         Require that all airports implement enhanced taxiway centerline markings and surface painted holding position signs at all runway entrances

·         Prohibit the issuance of a takeoff clearance during an airplane’s taxi to its departure runway until after the airplane has crossed all intersecting runways

·         Indicate that controllers should refrain from performing administrative tasks, such as the traffic count, when moving aircraft are in the controller’s area of responsibility that all runway crossings be authorized only by specific air traffic control clearance

·         Require that, when aircraft need to cross multiple runways, air traffic controllers issue an explicit crossing instruction for each runway after the previous runway has been crossed

·         Require that operators establish procedures requiring all crewmembers on the flight deck to positively confirm and cross-check the airplane’s location at the assigned departure runway before crossing the hold short line for takeoff.

·         Require operators provide specific guidance to pilots on the runway lighting requirements for takeoff operations at night

·         A number of recommendations to reduce the potential for air controller fatigue, develop a fatigue awareness and countermeasures training program, that will improve controller judgment, vigilance, and safety awareness.

One NTSB board member added her own comments aside from the formal report and felt that a substantial number of latent errors or conditions were contributory factors. In particular, she noted that there seemed to be no apprehension on the part of the crew in using abbreviated briefing procedures and engaging in nonpertinent conversation during the “sterile cockpit” period. She therefore wondered how abnormal those behaviors were, i.e. whether such behaviors had actually become the norm at this and other airlines. She also pointed out that this particular airline did not include a heading check (to ensure that the heading of the plane was aligned with the anticipated heading of the runway) in its pre-takeoff checklist, something that most other airlines had already incorporated.

Are there analogies to this case in healthcare facilities? Certainly sounds a lot like the sort of issues that led to development of the surgical timeout. The “sterile cockpit” concept also applies to the surgical timeout/final verification process. It also applies in those central pharmacies where the pharmacist is expected to do certain work without interruptions. And one could make a case that it should apply to any healthcare worker tasked with doing a double check or second “independent” verification (eg. for a blood product or a chemotherapy infusion rate). There are probably many other circumstances where the “sterile cockpit” concept applies.

How many healthcare organizations actually audit or monitor those processes to see how often the “sterile cockpit” process is indeed “sterile”? We recommend that periodic audits of at least the surgical timeout be done via a sampling methodology.

Of interest, the NTSB report mentioned that a LOSA Collaborative showed that flight crewmembers who intentionally deviated from standard operating procedures were three times more likely to commit other types of errors, mismanage more errors, and find themselves in more undesired aircraft situations compared with those flight crewmembers who did not intentionally deviate from procedures. We suspect the numbers in healthcare would be similar. So auditing as above might identify risk for other situations.

Certainly, there are lots of lessons to be learned from this aviation safety root cause analysis. However, one cannot help but wonder that they left out the most significant solution. The best fixes in any RCA are forcing functions or ones that prevent someone from doing by accident something that will have dire consequences. In healthcare, we use special connectors that prevent oxygen lines from being hooked up to nitrogen lines, or connectors that prevent a feeding tube from being hooked up to an IV line. We also remove the vials of concentrated KCl from floor stock so it cannot be inadvertently administered in fatal dosage. Even if fully barricading the entrance to that short runway is not feasible, I’ll bet healthcare safety personnel could easily come up with at least a dozen ways to make it physically impossible for a big airplane to get on a runway intended only for small airplanes. Just like healthcare inviting experts from other industries to help do RCA’s in healthcare, maybe the airline industry needs to invite patient safety experts to help in their RCA’s!

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October 9, 2007    

Errors in the Laboratory

Last week a 35 year old woman from Long Island, New York appeared on Good Morning America to discuss her tragic case that resulted from misidentification of a biopsy specimen. She had a double mastectomy after a tissue sample from a lab based in New York came back positive for breast cancer. Doctors later told her she did not have breast cancer and "never did", she said on the TV program. Apparently there was a "lab mixup".

The New York State health department reported that the biopsy sample had been mislabeled by a technician at a pathology laboratory, probably because the technician was handling more than one specimen at a time. The report said the technician admitted to his supervisors that he "occasionally cut corners by batching" and did not always verify patients' initials when labeling them.

A very similar case is noted in “Meeting the Joint Commission’s 2007 National Patient Safety Goals”¹.

And an article about the current case in Newsday² includes the description of a second recent case where a woman unnecessarily received radiation therapy for a cancer she did not really have. Undoubtedly there are many more comparable examples. We could not find any published error rates for misidentification of biopsy specimens but one study looking at surgery in an outpatient clinic or a hospital operating room found 4.3 surgical specimen identification errors in every 1000 cases (and about 60% of those errors were in biopsies) ³. Rates for incorrectly identifying hospitalized patients prior to collection of blood specimens have been found to be as high as 6.5%⁴.

The Joint Commission standard on patient identification requires use of at least 2 patient identifiers (neither of which is the patient’s location). In addition, all containers must be labeled in the presence of the patient. And for laboratories there must be a process in place to maintain the sample’s identity throughout the preanalytical, analytical, and postanalytical processes. However, laboratories should not automatically reject specimens lacking the 2 discrete identifiers because some samples may be irretrievable (such as biopsy specimens). In such cases the laboratory should have written guidelines on how to handle these specimens and the laboratory report should include a cautionary statement indicating the lack of complete identification. Importantly, prelabelling of collection containers is not to be done. Since specimen collection is often performed by personnel outside the laboratory, Joint Commission stresses education and inservicing of all personnel involved plus appropriate monitoring/auditing of the processes.

For Joint Commission-accredited hospitals the Joint Commission standards apply to the laboratory even if the laboratory is not specifically accredited by Joint Commission. However, a growing number of procedures with pathological specimens are being performed outside the hospital setting, not only in ambulatory surgery centers but in physician offices. The latter are often sending specimens to private or commercial laboratories that are not subject to the Joint Commission standards. Most such laboratories are otherwise accredited or certified (eg. by CAP or CLIA). When multiple organizations are involved the preanalytical, analytical and postanalytical phases, we suspect the likelihood of error is even higher.

While there is a lack of systematic reporting on such incidents, much can be gleaned from individual case reports. In one such case⁵, a pathologist noted a discrepancy among specimens submitted from several sites on the same patient. Specifically, the histological appearance suggested that specimens labeled “wrist” and “back” had been transposed and one of them showed a melanoma. When the pathologist contacted the physician who performed the biopsies, it turned out the patient was the physician’s spouse and that the procedures had been performed on a Sunday when the office was closed and no support staff were available. The specimens had been place in formalin-filled biopsy bottles, prelabeled with the biopsy sites and the requisition sheets were labeled only the following day by the nurse.

Another case⁶ involving transposition of prostate biopsy specimens from two patients used a detailed root cause analysis (RCA) that uncovered multiple contributing factors and suggested several improvements to processes. These included not only steps to ensure a “one-by-one” accessioning process but also improvements in dictation and transcription and what to do once such an error is identified. Note that this lab used molecular testing to confirm the transposition of specimens and correctly match up the specimens with the correct patient. See below for more on use of DNA techniques in laboratory identification of patients.

Some circumstances that may increase the likelihood of specimen mislabeling include:

·         Multiple specimens on the same patient

·         Multiple specimens on different patients being transported at the same time

·         Multiple specimens being accessioned at the laboratory at the same time

·         Specimens arriving near closing deadlines

·         “Rush” specimens

·         Procedures (eg. biopsies) being done outside of normal hours

·         Procedures being done in site other than hospital operating room

·         Specimens coming from a different physical location

Potential solutions include barcoding (of patient and biopsy bottles), ensuring adequate clinical information and descriptions accompany the specimens, strict one-by-one accessioning of specimens, and regular auditing of processes.

In cases where misidentification of specimens is suspected, some labs have used DNA testing to verify the correct match of patient to specimen. In fact, some have gone as far as to propose universal use of DNA polymorphic microsatellite analysis to confirm patient identification before invasive treatement in patients undergoing biopsies such as prostate biopsies⁷.

So what should a patient do?  You should ask such questions as: Where will my biopsy specimen be evaluated? Is that lab accredited? By whom? Will any other specimens be being sent along with mine? How and when will I be notified of the result? (And if the specimen is being sent to a lab other than a hospital-based lab, we recommend you also inquire about any financial arrangements between the physician and the lab.)

What should a physician do? He/she should ensure that all staff in his office/facility fully understand the processes involved in specimen collection, identification, and transport. The specimen handling should be done with the same diligence that one uses during surgical timeouts. He/she should have a good understanding of the steps that the laboratory takes to ensure patient identification is maintained throughout. He/she should always provide a good clinical description of the patient and what is being looked for on the specimen(s). When pathology reports note something unexpected, call the lab to discuss the possibility of misidentification and discuss whether a molecular/DNA technique to confirm correct identity should be considered.

Also remember that misidentification of a laboratory specimen may impacts two patients (in today’s index case, not only did the patient receive unnecessary treatment but there obviously was a second patient who did have cancer and we are not told if she received appropriate and timely treatment).  So it is imperative in such cases to double check to see whether two errors have occurred.

By the way, you’d be surprised at how often errors take place in cases where a physician is treating one of his/her own family members. The scenario above, where a procedure is done after-hours and without proper personnel present, is one we have seen on numerous occasions. The AMA has guidelines on physician treatment of family members and we feel strongly that the anecdotal evidence of errors in such circumstances is an even more cogent reason for physicians not to treat their own family members.

References:

1.      Makary MA, Epstein J, Pronovost PJ et al. Surgical specimen identification errors: A new measure of quality in surgical care. Surgery 2007; 141: 450-455

2.      Grayson A (ed.), Meeting the Joint Commission’s 2007 National Patient Safety Goals. Oakbrook Terrace, IL: Joint Commission Resources. 2006: pp. 13-14

3.      Epstein RJ. Lab mix-up leads to unnecessary double mastectomy. Newsday.com. October 3, 2007. http://www.newsday.com/news/local/longisland/ny-licanc1003,0,6442227.storyhttp://www.newsday.com/news/local/longisland/ny-licanc1003,0,6442227.story

4.      Howanitz PJ, Errors in laboratory medicine. Practical Lessons to improve patient safety. Arch Pathol Lab Med 2005; 129: 1252-1261 (http://arpa.allenpress.com/pdfserv/10.1043/1543-2165(2005)129[1252:EILMPL]2.0.CO;2)

5.      Jukic DM. Pathologist as the Final Quality Assurance Officer, or “The Buck Stops Here”. Pathology Case Reviews 2005; 10: 88-94

6.      Dhir R, Condel JL, Raab SS. Identification and Correction of Errors in the Anatomic Pathology Gross Room. Pathology Case Reviews 2005; 10: 79-81

7.      Suba EJ, Pfeifer JD, Raab SS. Patient Identification Error Among Prostate Needle Core Biopsy Specimens – Are We Ready for a DNA Time-Out? Journal of Urology 2007; 178: 1245-1248

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October 16, 2007    

Radiology as a Site at High Risk for Medication Errors

Earlier this year, United States Pharmacopeia (USP) came out with its MEDMARX® Data Report “A Chartbook of 2000–2004 Findings from Intensive Care Units and Radiological Services”, an analysis of records submitted to MEDMARX specifically capturing information on Intensive Care Units, including coronary, general, medical, and surgical ICU's; and Radiological Services focusing on cardiac catheterization labs, nuclear medicine, and radiology departments. The report analyzed records only on hospital inpatients.

Though the overall number of medication errors in radiology areas was small, USP pointed out that the percentage of cases resulting in patient harm was considerably higher than seen with medication errors elsewhere. 12% of the medication errors in these areas were considered harmful to patients, about 7 times higher than the percentage in the overall MEDMARX® database. Using the Pareto principle, almost 80% of the errors fell into 4 types of error: improper dose/quantity, unauthorized/wrong drug, omission error, and wrong administration technique.

The radiology community was prompt in condemning the report , pointing out the relatively low overall number of incidents, the lumping of cardiac cath labs with other radiology sites, the observational nature of the study, and the fact that many of the errors were attributable to problems outside the radiology department or had root causes outside the radiology department.

Rather than reacting defensively or indignantly, we need to recognize the real value of the USP report: it draws attention to a whole host of system issues that interplay to result in errors that happen to manifest themselves while a patient is in the radiology suite.

Our July 31, 2007 Tip of the Week gave an example of an incident where an emergency room resident inadvertently administered a neuromuscular blocking agent to a patient he had accompanied to the radiology suite for a CT scan. Obviously, that had little to do with “radiology” per se but does draw attention to potential high risk situations. Just as we have identified ER’s, OR’s, and ICU’s as areas in which patients are at high risk for errors, any other area where an inpatient might be transported for testing or treatment should be considered a high risk area.

Below are some of the issues, conditions, and circumstances pertaining to radiology areas that may predispose patients to suffer medication (or other) errors:

·     Patients often need to wait for tests or wait for transport back to their unit of origin.
We have seen numerous examples of patients deteriorating while waiting for a procedure or waiting to be transported back after a procedure.

·     Nursing care differs from ICU.
While most radiology departments in large hospitals do have nursing staff dedicated to the radiology area, they may not have the same expertise or skill set that a nurse from an ICU might have. The nurse:patient ratio is usually not what one would have in the ICU. And even when a nurse from the ICU accompanies the patient to the radiology suite, that nurse may be unfamiliar with where medications or equipment are stored in the radiology department.

·     Lack of access to current medication lists, allergy lists, etc.
While the patient’s chart usually accompanies him/her to the radiology suite, some important documents (eg. the MAR or medication administration record) may not.

·     The patient may be unable to give information and those who could answer questions are not available.
The patient may have impaired cognition or impaired level of consciousness. He/she may have been pre-medicated prior to coming to radiology or may have received conscious sedation for a procedure. Typically (at least for an inpatient) a family member or caregiver or the housestaff, individuals who could provide vital information about a patient, may not be present in the radiology suite or otherwise readily available.

·     The patients may be incredibly sick and have very complex medical problems, both of which are known to be associated with an increased likelihood of errors

·     Sedation of  patients for some procedures may have an additive effect to other medications (eg. narcotic analgesics) that a patient may be receiving.

·     Some of the hi-tech patient safety technologies available elsewhere in a hospital may be unavailable or underutilized in radiology.
This might include things like and electronic medical record (EMR), barcoding, electronic MAR, etc.

·     Patients may arrive with multiple lines and tubes.
Not only does this predispose to the rare occurrence of catheter misconnections, but often an IV must be temporarily discontinued and then there may be confusion as to how to restart that IV (especially for medications like anticoagulants).

·     Diabetic patients may represent specific problems.
Particularly when a patient needs to spend a prolonged time in radiology, there may be confusion about insulin administration, meals, etc.

·     Medications, supplies, equipment may have come from somewhere else.
Particularly when medications have been brought with the patient from some other area of the hospital, there is often suboptimal documentation of dosage, time given, etc.

·     Personnel in radiology may be unfamiliar with equipment.
This may apply to items like infusion pumps. Often a hospital has pumps made by different manufacturers or different models used in different units of the hospital. Personnel in the radiology suite may not have experience with that particular model.

·     Inadequate clinical information.
The bane of the radiologist’s existence is the requisition lacking sufficient clinical information. How often does a requisition for an X-ray of the hip come down with “stroke” as the only clinical information! The radiologist needs to know what specifically is being looked for and other clinical information so that he/she knows what is the most appropriate study and can better interpret the result of the study.

·     Key people to communicate results to may not be readily available.
The communication problem on the back end is as important as on the front end. We have talked in previous Tips of the Week about communication of critical reports back to physicians responsible for the care of the patient.

·     Time pressures.
The time pressures to move patients through the radiology suite and accommodate not only inpatients but also outpatients and unscheduled cases can be enormous. Add to this staffing issues, particularly around nights and weekends and holidays. And financial pressures (eg. cost issues that lead to use of less expensive contrast agents in many patients).

Medication reconciliation and communication issues are two of the most important issues giving rise to medication errors in any setting, and from the above you can see that the radiology suite is no different. An article in the April American College of Physicians Observer, “Imaging hand-offs: Tips to help prevent medication errors” describes what the internist (or any physician with primary patient responsibility) can do to reduce the likelihood of medication errors relating to the radiology suite. In particular, that article addresses some of the issues related to interactions between certain medications and contrast agents (either directly or indirectly through effects on renal function). The importance of communication and defining roles (eg. who is responsible for followup actions) is stressed.

There are, of course, issues specific to radiology as well. These often pertain to use of contrast agents. This is especially likely to occur when there is inadequate information about previous allergies or renal function. There have also been numerous cases where the wrong type or wrong dosage of a contrast agent has been injected during myelography with disastrous results, often because of inadequate labeling or storage. And the issue of unlabeled syringes or basins is as big an issue in radiology as it is in the OR. Many remember an unfortunate case a few years ago where a patient was inadvertently given the antiseptic skin prep solution, chlorhexidine, instead of contrast media intraarterially.

The radiology suite is a great place to include in your Patient Safety Walk Rounds and an excellent place to choose for doing a FMEA (Failure Mode and Effects Analysis) exercise.

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October 23, 2007    

Medication Reconciliation Tools

Medication reconciliation is one of the most important patient safety activities that should be undertaken at virtually all levels of the healthcare system. The current Joint Commission standards under National Patient Safety Goals are:

Goal 8 Accurately and completely reconcile medications across the continuum of care.

·        8A There is a process for comparing the patient’s current medications with those ordered for the patient while under the care of the organization.

·        8B A complete list of the patient’s medications is communicated to the next provider of service when a patient is referred or transferred to another setting, service, practitioner or level of care within or outside the organization. The complete list of medications is also provided to the patient on discharge from the facility.

But first quarter compliance data for 2007 show hospitals barely at 80% compliance.

On admission, unintended discrepancies between medications the patient had been taking prior to admission and those ordered on admission typically occur in the 50-60% of cases. And after discharge from the hospital, around 20% of patients suffer an adverse event, most often related to medication issues. Failures in communication and hand-offs are one of the primary reasons for such adverse events that are potentially preventable. And, though the exact frequency is not known, discrepancies during transitions and transfers between various hospital services or levels of care are common and potentially very harmful.

But success stories are becoming more numerous each day. Experiences in Massachusetts and Canada have demonstrated that such medication errors may be reduced 70-90% by the medication reconciliation process.

Not only are patients being spared the morbidity, mortality, and inconvenience due to such potentially preventable medication errors but healthcare systems are beginning to note a positive impact as well. While there is an upfront investment of time in the medication reconciliation process, successful programs have noted a significant reduction in rework and a net savings in time spent by nurses, surgeons and other physicians, and pharmacists. Well-designed forms, whether paper-based or electronic, seem to be particularly well-received by physicians because they save time and improve accuracy.

There is often an economic impact as well: hospitals, patients, and third party payors avoid the costs of medications that are no longer necessary. For example, one of the more frequent problems we see is that of patients being started on prophylactic proton pump inhibitors during a hospital stay and then being inadvertently continued on these long after the need has resolved. A good medication reconciliation process identifies this issue and corrects it in a timely fashion.

Some excellent tools for medication reconciliation programs are readily available. These include:

·          WHO Collaborative Centre for Patient Safety Solutions - Solution6

·          IHI 100,00 Lives Campaign and 5 Million Lives Campaign Toolkit

·         Massachusetts Coalition for The Prevention of Medical Errors, which includes both a toolkit  and a patient MedList

·         Canadian “Safer Healthcare Now! Campaign”

One of the most useful tools we have come across is the Getting Started Kit from the Canadian “Safer Healthcare Now! Campaign”. This toolkit was updated in 2007 after many participating Canadian hospitals had extensive experience with it. Not only does the toolkit have a wealth of sample forms for use at each transition of care, but it also has outstanding recommendations for implementation, auditing, and measurement, plus tips for improving the accuracy of information about medications the patient was taking prior to admission. It also has a great reference section, including links to sites of many other organizations having tools, forms, and educational presentations.

The key to the entire reconciliation process is getting the most accurate possible list of medications at admission. Getting a complete and accurate list of medications that a patient is taking is very difficult in our fragmented health care system. The primary care physician usually has the most comprehensive list, but even then, the PCP may not be aware of all medications prescribed, altered or discontinued by specialists.

Third party payors or pharmacy benefit managers (PBM’s) often actually have the most up-to-date data on which prescriptions are actually being filled by the patient. Because of formulary issues and adjudication issues, most pharmacy claims come in to managed care organizations very promptly. Thus, the managed care organizations have a virtual real-time snapshot of the medication profile. Several collaborative community projects are attempting to share such information through their regional health information organizations (RHIO’s). Even if your community has not developed such a RHIO, your organization should be insisting in its contracts with managed care organizations that they provide electronic access to those real-time databases to facilitate the medication reconciliation process. After all, helping to ensure accurate reconciliation benefits the managed care organizations in the long run. But even then, over-the-counter medications and free samples usually are not listed in such databases and the databases often do not contain (at least promptly) claims related to medications administered in physician offices, such as biological drugs.

And patients themselves may not be the most reliable source of information about medications. A study in this month’s Journal of General Internal Medicine found that over 30% patients thought to have good health literacy and almost 60% of those thought to have poor health literacy could not name any of their antihypertensive medications¹. Involving the family or caregiver and actually bringing in the medications from home may be very helpful in the medication reconciliation process.

The bottom line is that whatever process you develop to create your Best Possible Medication History (BPMH) should rely upon multiple data sources and require diligent cross-checking.

And a last comment is that many of the available medication reconciliation forms that are currently in use lack a field to clarify the indication for which the medication was prescribed. Knowing the indication is extremely important in avoiding look-alike/sound-alike medication errors. Many medications (eg. beta-blockers) also may have several indications and you need to know which one applies to your patient. And the dosage of the medication may vary depending upon the indication for use. Similarly, most medication forms and lists fail to include reason for discontinuation. It is important to know if a medication was discontinued because of lack of efficacy, side effect, allergy, or formulary or economic reasons.

1. Persell SD, Osborn CY, Richard R, Skripkauskas S, Wolf MS. Limited Health Literacy is a Barrier to Medication Reconciliation in Ambulatory Care. Journal of General Internal Medicine 2007; 22: 1523-1526

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October 30, 2007    

Using IHI's Global Trigger Tool

Those of us who have been involved with mandatory incident reporting systems know that underreporting has been a significant problem. Voluntary reporting systems typically identify more opportunities for improvement by identifying near-miss events in addition to adverse events where harm has occurred. Yet voluntary systems still miss significant numbers of adverse outcomes, too. One of our biggest issues, then, is knowing whether we are getting any better at reducing adverse outcomes over time. Quite frankly, over the years we have seen the numbers of reported incidents in both types of system increase. Rather than being of sign of worsening care, that usually means that hospitals and other facilities have actually been doing a much better job at identifying incidents and adverse events. That’s where IHI’s Global Trigger Tool for Measuring Adverse Events comes in. It provides a mechanism that can help us both measure performance over time and help us identify those system issues that need the most attention in our organizations.

The concept of the IHI Global Trigger Tool is that there are certain events or items that can be gleaned from chart review that are often associated with adverse events (with adverse events being defined as harm being caused). Those events/items are looked for in the charts and, if found, the chart is further reviewed to determine if an adverse event did occur. Again, there is a big difference between a trigger and an adverse event: a trigger simply raises a flag that there might be an associated adverse event. The adverse events are recorded. The charts are chosen for review in a truly random fashion and a finite number of charts are reviewed periodically, typically 10 charts reviewed every two weeks. This sampling methodology allows calculation of a crude rate of adverse events that can be charted and compared (within the same organization) over the long run to determine whether the organization is seeing improvement. Just as important, however, is that the pattern of adverse events identified allows the organization to prioritize where it will spend more of performance improvement and patient safety resources.

The triggers themselves have been carefully selected (and refined) to reflect both the frequency and severity of adverse events encountered in a typical hospital. Though the triggers are extensive, they do not uncover all the types of adverse events found in a healthcare system. And keeping the tool and its definitions consistent is what allows the organization to track performance over time.

The process, as adopted by most organizations, typically involves having two clinical reviewers (nurses, pharmacists, etc.) each review 10 charts every two weeks. Review of each chart is limited to 20 minutes. The reviewers then meet with a designated physician, who reviews the summary sheets assembled by the clinical reviewers and confirms whether an adverse event occurred and adds his/her expertise to answer any questions that may have arisen about the case. Some organizations have chosen to review more charts or do the reviews less often, but the model of 10 charts every two weeks lends itself to some nice run charts. The real key is consistency of the reviews. IHI strongly recommends that the two clinical reviewers and the physician reviewer of the team be the same reviewers for extended periods of time (eg. for one full year or more). Obviously the reviewers need to be experienced clinicians and their time needs to be freed up so they can do these chart reviews. The other key is maintaining consistency in the chart selection. IHI provides guidelines for the criteria to be used in chart selection. Some hospital charts are contained in several volumes but don’t worry – the 20-minute rule means you just go through that chart for a maximum of 20 minutes. You need not identify all the adverse events that occurred in every case.

IHI provides good guidelines on how to best review the charts and actually provides sample charts for training. They give good guidelines on how the training should be done (typically as a team).

Some issues have arisen about use of the Global Trigger Tool. Since it requires by definition that “harm” occurred, it does not identify near-misses that may be important sources of learning. Similarly, it does not include acts of omission in defining adverse events, only events arising from commission. But remember, this is only one tool of many your organization will be using in its patient safety/quality improvement activities. You should have many other mechanisms for identifying those sorts of events.

Some have noted that the tool has never been scientifically “validated”, such as one would require in a tool being used for screening a population for a certain condition. That’s probably true but multiple diverse organizations have now used this tool over the years and found it to be very helpful in the two primary purposes: identifying trends over time and helping to prioritize areas for improvement. Issues about consistency and inter-rater reliability are minimized by using the same reviewers and training as a team.

Others have developed tools that use electronic triggers. Such tools have been used now for many years to identify adverse drug events¹. Szekendi et al² developed such a system at Northwestern University using certain abnormal laboratory results and pharmacy data as triggers and demonstrated the system can such a identify many adverse events that might have otherwise gone unreported. In addition, it has the more important feature of being able to identify issues in real-time or near-real-time. That allows for reviewers to speak to clinicians involved in the patient’s care to get more accurate details and context about the case. Is also can lead to an intervention to prevent harm. That makes electronic trigger surveillance a powerful tool of the present for some and the near future for others³. But for most, electronic surveillance will be only one prong of a multi-pronged strategy to identify opportunities to intervene.

IHI also provides several other excellent trigger tools (eg. for adverse events related to drugs, ICU’s, perioperative, neonatal and outpatient settings). But we think you’ll find the IHI Global Trigger Tool for Measuring Adverse Events an excellent addition to your patient safety program. Remember, this is only one of several mechanisms you need to employ to identify patient safety areas that need improvement. Use it as one source of data to help identify and prioritize areas for investment of resources and use it as a rough gauge of  progress over time.

1. Classen DC, Pestotnik SL, Evans RS, et al. Computerized surveillance of adverse drug events in hospital patients. JAMA 1991; 266: 2847-51

1. Szekendi, M K; Sullivan, C; Bobb, A; Feinglass, J; Rooney, D; Barnard, C; Noskin, G A Active surveillance using electronic triggers to detect adverse events in hospitalized patients. Quality & Safety in Health Care. 15(3):184-190, June 2006

1. Kilbridge, P M 1; Classen, D C 2 Automated surveillance for adverse events in hospitalized patients: back to the future.Quality & Safety in Health Care. 15(3):148-149, June 2006

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November 6, 2007

Don Norman Does It Again!

Don Norman, author of the classic “The Design of Everyday Things” has done it again with his newest book “The Design of Future Things”.

His learnings add considerably to our understanding of how people interact with machines and technology, especially when it comes to alarms. Several of our prior Tips of the Week have talked about how often alarms are intentionally disabled, ignored, or inappropriately responded to. Don Norman talks about the striking increase in the number of alerts and alarms we deal with in the healthcare industry. He notes “So, although each single signal may be informative and useful, the cacophony of the many is distracting, irritating, and, as a result, potentially dangerous.” He makes a case, instead, for more natural interactions that are more effective and less annoying.

He talks about the need for natural, deliberate signals as a key concept. These are signals that are easily understood without instruction. An example is a driver maneuvering into a tight space, where a helper visibly guides him using hand signals to indicate how much space is left. He describes how that concept is used in newer automobiles that assist in parking. These uses beeps whose rate increases as you get closer to an obstacle.

And feedback is crucial. Signals must offer just enough information to remain at the “periphery” of our attention, so that they can rapidly move to the “center” of our attention when needed. An example he provides is the background noise of a car engine. We don’t pay close attention to it, but when it makes a funny noise, we do shift our attention to it.  How many of you have driven in one of the new hybrid cars and had trouble telling whether it was running or not when you were stopped at a traffic light?

We’ve talked about “automation surprises” where a task is being largely done in an automated mode by a machine and we are unaware that trouble is brewing. People become “out of the loop” and uninformed about what the machine/technology is doing and exactly where it is in its processes. That may work fine when all is going as planned but when something goes wrong, people cannot jump in and do the correct response required immediately. That has certainly led to plane crashes and shipwrecks in the past. Most of us have even experienced our automobile, being on cruise control, suddenly accelerate when we had anticipated slowing down.

Therefore, feedback from machines/technology is crucial and a system is needed to allow people to understand what strategy the machine/technology is following and how far along it is in its actions.

Overautomation remains a significant issue. Sometimes machines or technological solutions are so reliable that we lose vigilance and come to put too much trust in the technology. Norman tells of a research team flying over the ocean for several hours who went to tell the pilots they had finished the research, only to find the pilots asleep. Amazingly, last week’s headlines had a story about two pilots on an overnight flight who fell asleep at the controls of an airline carrying 100 passengers, only to be woken 20 minutes from landing by frantic calls from an air traffic controller who noticed they were travelling too fast and too high. This sort of over-reliance on technology abounds in healthcare today as well.

Our perception of safety is also a factor that can be misleading. Norman asks the question “Which airport has fewer accidents: an easy one (flat, good visibility, good weather) or a “dangerous” one (hills, wind, difficult approach, etc.)? The answer is the more dangerous ones – because the pilots become more attentive, focused and careful. He goes on to discuss the concept of “risk compensation” in which people who perceive an activity to be safer go on to take more risks, the net result being that the accident rate remains unchanged.

So maybe we should make things look more dangerous! He describes the interesting “Shared Space” project in which designers actually removed safety features to get drivers to be safer! They removed traffic lights, stop signs, pedestrian crossings, etc. and actually saw a 40% reduction in accidents!

He summarizes design rules for human designers of “smart” machines:

1. Provide rich, complex, and natural signals
2. Be predictable
3. Provide good conceptual models
4. Make the output understandable
5. Provide continual awareness without annoyance
6. Exploit natural mappings

And design rules developed by machines to improve their interactions with people:

1. Keep things simple
2. Give people a conceptual model
3. Give reasons
4. Make people think they are in control
5. Continually reassure
6. Never label human behavior as “error”

Wow! These are rules for design related to machines and technology. I’d apply them all to everything else we do! From the OR team to the Board room!

Norman, of course, goes on to describe many great things that will undoubtedly make our lives easier in the future (each, of course, also having a downside!). His writing is, as always, both informative and entertaining. This is a great addition to your library.

Norman DA. The Design of Future Things. New York: Basic Books; 2007

Norman DA. The Design of Everyday Things. New York: Basic Books; 2002

Print Don Norman Does It Again!

November 13, 2007       

AHRQ’s Free Patient Safety Tools DVD

Many healthcare organizations fail to avail themselves of the many patient safety tools that they can get for free. In our  May 22, 2007 Tip of the Week we talked about the TeamSTEPPS™ program, a great team training program developed by the Department of Defense (DoD) in collaboration with the Agency for Healthcare Research and Quality (AHRQ).

Another great free resource is the DVD “The Patient Safety Improvement Corps: Tools, Methods, and Techniques for Improving Patient Safety”, developed jointly by AHRQ, the Department of Veterans Affairs, and the VA National Center for Patient Safety (NCPS). The faculty for the DVD includes many well-known patient safety experts, including James Bagian, Carolyn Clancy, David Marx, John Grout, John Gosbee, among others.

The DVD is organized into modules, many of which also contain printable/downloadable tools use can use at your facility. Some of the highlights are:

Lessons from High Reliability Organizations are presented by James Bagian, M.D., who uses his past experience with NASA and the aviation industry to teach us valuable lessons for healthcare. Development of reporting systems are discussed, including the critically important need to report near-misses.

There are modules on the Culture of Safety, including Leadership, Creating a Culture of Safety, measuring safety culture, and David Marx’ always excellent presentation on Just Culture.

Modules on When and How to Do an RCA are excellent and based upon the well-known VA NCPS programs. The modules on Healthcare FMEA and other proactive tools include good discussions on decision trees, hazard scoring matrices, and other useful tools.

There are outstanding modules on Human Factors Engineering, Heuristics and Mistake Proofing, including practical advice on usability testing. These integrate very nicely with the sections on RCA and FMEA.

The module on mitigation of risk and risk management includes a very good section on disclosure, not only explaining why disclosure and apology are the right thing to do, but also giving useful “how to” tips.

There’s even a module on the Business Case for Patient Safety. This includes a whole host of downloadable worksheets into which you can plug your own data to demonstrate the ROI (return on investment) on various patient safety activities. Make sure your CFO, CEO, and Board of Trustees see this module! There’s also a module on how to use statistical tools and how you can use the AHRQ PSI’s (Patient Safety Indicators) in your organization.

How do I get it? Simply send an email to ahrqpubs@ahrq.hhs.gov and order AHRQ Publication No. 07-0035-DVD and tell them where to send it. That’s all! You can’t go wrong with this one.

Print AHRQ's Free Patient Safety Tools DVD

November 20, 2007

New Evidence Questions Perioperative Beta Blocker Use

The controversy about using beta blockers in the perioperative period for non-cardiac surgery just heated up again. Results of the POISE (Perioperative Ischemic Evaluation) trial (1) revealed this month at the American Heart Association 2007 Scientific Sessions, showed that perioperative beta blockers did reduce the frequency of perioperative MI but increased frequency of stroke and actually increased overall mortality.

Use of perioperative beta blockers to reduce morality in high risk patients undergoing noncardiac surgery has been in vogue for the past 10 years. A number of clinical studies had shown beneficial effect of beta-blockers in myocardial ischemia in other circumstances, and since most post-op cardiac events were felt to be likely mediated by myocardial ischemia, extension of their use to the perioperative setting was logical.

The actual clinical evidence for use of beta-blockers in the perioperative period was based upon results of only a few clinical trials, each having very few patients enrolled. Mangano et al. (2) randomized 200 high-risk patients undergoing major noncardiac surgery to either atenolol or placebo. They found a 50% reduction in perioperative ischemia detected by Holter in the atenolol group but no difference in in-hospital mortality or MI occurrence. Surprisingly, though, those in the atenolol group had a significant reduction in cardiac events 6-8 months later.

The Dutch DECREASE trial (3) looked at 112 vascular surgery patients who had evidence of ischemia on pre-op dobutamine stress echocardiography. This was a randomized controlled trial but was not blinded. Those randomized to bisoprolol had a 10-fold decrease in perioperative MI and cardiac death compared to placebo.

An AHRQ evidence report (4) in 2001 identified perioperative use of beta blockers as one of eleven evidence-based patient safety practices that should be more widely adopted. Many  have now extended the use of periperative beta blockers to those intermediate and high risk patients not previously on beta blockers.

The ACC/AHA Guidelines on Perioperative Beta Blocker Therapy (5) were updated late in 2006. They provide a class I indication for continuation of beta blockers in patients taking them for any class I indication (eg. angina, MI, CHF, arrhythmias, hypertension) or in any patient whose pre-op evaluation demonstrates ischemia. They add class IIa indications (probably recommended) for patients with known coronary artery disease or multiple risk factors and class IIb (“may be considered”) in patients with a single risk factor undergoing intermediate or high risk procedures. Class IIa evidence means there is conflicting evidence, weighted in favor, and class IIb means there is conflicting evidence, with efficacy less well established.

Several national quality improvement programs, including SCIP (the Surgical Care Improvement Project) (6) and the IHI’s 5 Million Lives Campaign (7), have included use of beta blockers in attempt to reduce perioperative mortality. However, their programs have focused only on those patients previously on beta blockers, for which there is class I evidence of efficacy.

But not everyone has been convinced of the benefit of perioperative beta blockers in patients not already on them. There has been considerable evidence on the negative side as well. The POBBLE randomized trial (8) published in 2005 showed no benefit of beta-blockade in patients undergoing noncardiac vascular surgery. However, it was a small study (only 100 patients total in the study). Likewise, the MaVS study (9) published in 2006 failed to show a statistically significant benefit of beta blockade in high risk patients undergoing vascular surgery.

A retrospective cohort study published in 2005 by Lindenauer et al (10) showed a reduction of in-hospital deaths on perioperative beta blockers in those patients deemed high risk but not in those deemed low risk. Though this was not a randomized controlled trial, it lent further impetus to the routine use of beta blockers perioperatively in high risk patients.

A sizeable multicenter randomized controlled trial of long-acting forms of metoprolol in diabetic patients undergoing major noncardiac surgery (DIPOM) (11)subsequently showed no improvement in overall mortality or cardiac morbidity in the treated group.

Several meta-analyses have subsequently been done. Devereaux et al. (12) analyzed data from 22 RCT’s (2437 patients) and concluded that beta blockers produced no statistically significant improvement in any single outcome measure but did produce a nominally significant improvement in a composite measure. Wiesbauer et al. (13) found no reduction in perioperative MI or mortality in patients on beta blockers.

Now the POISE trial seems to answer many of the controversial issues. POISE was a randomized, controlled multicenter trial in high-risk patients undergoing major noncardiac surgery who were not on beta blockers prior to their planned surgery. They were randomized to receive either the long-acting beta blocker metoprolol-CR or placebo before surgery and throughout the perioperative period. The primary outcome measure was a composite of cardiovascular death, nonfatal MI, and cardiac arrest at 30 days after randomization. There was a statistically significant reduction in the primary outcome in the metoprolol CR group, driven primarily by a reduction in nonfatal MI. However, overall mortality and frequency of stroke were increased in the metoprolol CR group. For every 1000 patients treated, 15 MI’s were prevented but there was an excess of 8 deaths in the metropolol group.

Some have criticized the POISE protocol for a number of reasons, including the dosage used and the lack of a titration period. The metoprolol group did have a higher incidence of significant hypotension and bradycardia. Others have criticized the degree of hypotension tolerated by the investigators before intervention. And the study has only been presented in abstract form so far. But the bottom line is that this is the highest level of evidence to date and it strongly suggests that we need to change our current approach.

So where does this all leave us? There is still general agreement that those patients previously on beta blockers should have them continued through the perioperative period. In fact, there is likely a detrimental effect from beta blocker withdrawal in such patients. It seems to us that this is the only group currently for which we can comfortably recommend perioperative beta blockers. For those not previously on beta blockers there is currently no clearcut answer at this time. The POISE trial certainly casts doubt on the benefit and safety of prophylactic beta blockers in the perioperative period. Undoubtedly, there will be analysis of subgroups in the POISE trial attempting to identify characteristics of those patients who might benefit. However, those will be post-hoc analyses and they serve only to raise hypotheses for further testing. Only randomized controlled trials are likely to provide the answer to this dilemma.

One very difficult issue is what to do with patients who were not previously on beta blockers but have a condition for which beta blockers are indicated long-term (eg. prior MI, CHF, etc.). This group would have been started on beta blockers in the perioperative period according to ACC/AHA guidelines. However, even though POISE excluded patients in whom physicians planned to start beta blockers within 30 days, we think that the results of the POISE trial even raise the question as to whether those patients would be better off having beta blockers started electively at a time well after the perioperative period. Some physicians will probably continue to consider use of perioperative beta blockers in patients in whom preoperative evaluation shows evidence of ischemia. But they will probably begin the beta blockers well prior to surgery and titrate the dosage gradually and be very careful to avoid hypotension. The results of future studies, such as the DECREASE V study currently being undertaken in the Netherlands, may clarify some of the remaining issues. But for now POISE should significantly reduce the number of patients receiving perioperative beta blockers.

Hospitals and ambulatory surgery facilities still need protocols and procedures in place to ensure that patients who should receive perioperative beta blockers do, in fact, receive them. Obviously, good medication reconciliation is required in ensuring those who have been on beta blockers are identified and appropriately continued on them through the perioperative period.

Sometimes things that make a lot of sense turn out to be wrong when subjected to the type of scientific scrutiny we need to apply to patient safety practices as well as therapeutic or diagnostic practices.

References:

1. Devereaux PJ, et al. Perioperative Ischemic Evaluation (POISE). (Abstract) Presented by Dr. P.J. Devereaux at the American Heart Association Annual Scientific Session, Orlando, FL, November 2007.
   http://www.theheart.org/article/826435.do http://www.theheart.org/article/826435.do 
2. Mangano DT, Layug EL, Wallace A, Tateo I. Effect of atenolol on mortality and cardiovascular morbidityafter noncardiac surgery. Multicenter Study of Perioperative Ischemia Research Group. N Engl J Med 1996; 335: 1713-20
3. Poldermans D, Boersma E, Bax JJ, et al. The effect of bisoprolol on perioperative mortality and myocardial infarction in high-risk patients undergoing vascular surgery. Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group. N Engl J Med 1999; 341: 1789-94
4. Auerbach AD. Ch. 25. Beta-Blockers and Reduction of Perioperative Cardiac Events. in Shojania KG, Duncan BW, McDonald MD, et al. Making Health Care Safer: A Critical Analysis of Patient Safety Practices. Evidence Report/Technology Assessment No. 43. AHRQ Publication No. 01-E058, Rockville, MD: Agency for Healthcare Research and Quality. July 2001
5. Fleischer LA, Beckman JA, Brown KA, et al. ACC/AHA 2006 Guideline Update on Perioperative Cardiovascular Evaluation for Noncardiac Surgery: Focused Update on Perioperative Beta-Blocker Therapy. J Am Coll Cardiol 2006; 47: 2343-2355 http://content.onlinejacc.org/cgi/reprint/47/11/2343 http://content.onlinejacc.org/cgi/reprint/47/11/2343 
6. SCIP Surgical Care Improvement Project http://www.medqic.org/dcs/ContentServer?cid=1122904930422&pagename=Medqic/Content/ParentShellTemplate&parentName=Topic&c=MQParents http://www.medqic.org/dcs/ContentServer?cid=1122904930422&pagename=Medqic/Content/ParentShellTemplate&parentName=Topic&c=MQParents 
7. IHI 5 Million Lives Campaign How-to Guide: Reduce Surgical Complications http://www.ihi.org/NR/rdonlyres/AC9AAEED-7516-4371-8810-8BF45B8CE9C2/0/SCIPHowtoGuide.doc http://www.ihi.org/NR/rdonlyres/AC9AAEED-7516-4371-8810-8BF45B8CE9C2/0/SCIPHowtoGuide.doc 
8. Brady AR Gibbs JS, Greenhalgh RM, Powell JT, Sydes MR, POBBLE trial investigators. Perioperative beta-blockade (POBBLE) for patients undergoing infrarenal vascular surgery: results of a randomized double-blind controlled trial. J Vasc Surg 2005; 41: 602-609
9. Yang H, Raymer K, Butler R, Parlow J, Roberts R. The effects of  perioperative beta-blockade: results of the Metoprolol after Vascular Surgery (MaVS) study, a randomized controlled trial. Am Heart J 2006; 152: 983-990
10. Lindenauer PK, Pekow P, Wang K, et al. Perioperative Beta-Blocker Theapy and Mortality after Major Noncardiac Surgery. N Engl J Med 2005; 353: 349-361
11. Juul AB, Wetterslev J, Gluud C, et al. Effect of perioperative β blockade in patients with diabetes undergoing major non-cardiac surgery: randomized placebo controlled, blinded multicentre trial. BMJ  2006; 332:1482
12. Devereaux PJ, Beattie WS, Choi PT, Badner NH, Guyatt GH, et al. How strong is the evidence for the use of perioperative _ blockers in non-cardiac surgery? Systematic review and meta-analysis of randomised controlled trials. BMJ 2005; 331: 313-321 http://www.bmj.com/cgi/content/abstract/331/7512/313?ijkey=bb50125e364f7a389cc409467ba3a23addaf9b77&keytype2=tf_ipsecsha http://www.bmj.com/cgi/content/abstract/331/7512/313?ijkey=bb50125e364f7a389cc409467ba3a23addaf9b77&keytype2=tf_ipsecsha 
13. Wiesbauer F, Schlager O, Domanovits H, et al. Perioperative [beta]-Blockers for Preventing Surgery-Related Mortality and Morbidity: A Systematic Review and Meta-Analysis. Anesthesia & Analgesia 2007; 104: 27-41

Update: See also our December 2008 What’s New in the Pateient Safety World column “Rapid Response Teams Don’t Live Up to Expectations”.

December 4, 2007

 

Surgical Fires

 

 

 

 

 

When the Pennsylvania Patient Safety Reporting System reported on 3 “never” complications of surgery that, in fact, occurred surprisingly frequently, many of us were not surprised by the frequency of wrong-site surgery or retained foreign bodies. However, most of us were quite surprised by the frequency of surgical fires. The PSRS had an average of 28 surgical fires per year in Pennsylvania and calculated the incidence to be 1 per 87,646 operations.

 

 

 

Two organizations, Joint Commission and ECRI, have really taken the lead on bringing this issue to the fore. Not only are most surgical fires preventable, but understanding the correct response to a surgical fire that does occur is essential since an improper response can actually result in more patient harm and even staff harm.

 

 

 

ECRI Institute has done many years of research on surgical fires and has published numerous alerts, tips and recommendations on their prevention and response to surgical fires. The ECRI publication “The Patient is on Fire! A Surgical Fires Primer” is a comprehensive document that all organizations or facilities performing surgery must read. ECRI also has a guideline “A clinican’s guide to surgical fires: how they occur, how to prevent them, how to put them out” available from the National Guideline Clearinghouse. After reading these, you won’t want to let anyone in the OR who has not been properly trained and prepared in surgical fire prevention and fire response! It’s actually quite frightening to think how easily fires can start and spread in the OR. While a fire theoretically could occur anywhere in the OR, such as at an oxygen source, in the real world almost all surgical fires occur on or around the patient.

 

 

 

Joint Commission issued a Sentinel Event Alert in 2003 addressing surgical fires. That alert contains many recommendations on how to prevent surgical fires. A subsequent document on FAQ’s for the 2007 National Patient Safety Goals makes numerous additional recommendations on steps to prevent surgical fires.

 

 

 

Joint Commission National Patient Safety Goals specifically require surgical fire prevention only for Ambulatory Care Accreditation and Office-Based Surgery Accreditation but Joint Commission strongly recommends that all hospitals adopt the recommendations. A 2005 article in the Joint Commission Journal of Quality and Patient Safety “Preventing Surgical Fires: Who Needs to be Educated?” from the University of Michigan and Ann Arbor VA Healthcare System provide an excellent discussion Another Joint Commission Resources article notes several examples of how vigilence by all staff in the OR can be important in reducing the likelihood of surgical fires.

 

 

 

The fire “triangle” has 3 elements: heat, fuel and oxydizer. In general, each member of the surgical team – the surgeon, the anesthesiologist, and the nurses – controls a specific side of the triangle. That is, the surgeon controls the heat source, the nurse the fuel source, and the anesthesiologist the oxidizer. The heat source is most often an electrocautery instrument or electrosurgical unit or a laser but drills, heated probes, and even fiberoptic light sources and others may be heat sources. In addition, sparks and embers may serve as potential igniters. Almost anything in the OR can burn and be a source of fuel. The ECRI primer noted above lists many of those items. However, certain especially volatile and flammable substances are implicated more often than others. For instance, many of the prepping solutions are alcohol-based and the liquid alcohol is volatile so its vapors may be trapped under drapes, etc., where they can become easily ignited. And the oxidizers include not only oxygen, but also nitrous oxide. Any area with an oxygen concentration higher than 21% is known as an oxygen enriched environment and fires in such are easier to ignite and burn faster.

 

 

 

Prepping and draping the patient are extremely important. Care must be taken to ensure that any volatile liquids have fully evaporated and drapes be properly placed to avoid collection of the vapors under the drapes.

 

 

 

Use of oxygen needs to be minimized and the drapes appropriately tented about the patient’s head to allow air circulation to dilute the oxygen.

 

 

 

Electrosurgical or electrocautery tools and lasers must be kept away from the patient and table when not in active use. Everyone in the OR needs to remain vigilant to ensure these heat sources are not inadvertently in proximity to a dangerous situation. Most have holsters or other devices that deactivate them when not in use. Many also have audible alerts that indicate when they activated.

 

 

 

The ECRI primer provides details on how to respond to fires in the OR. Having a fire plan and specifically running fire drills for surgical fires is crucial. Most hospitals conduct general fire drills several times a year. However, very few actually conduct drills to specifically prepare for a surgical fire. ECRI provides a useful poster “Only You Can Prevent Surgical Fires” and everyone who works in the OR needs specific training on surgical fires. However, given the seriousness of surgical fires and the speed with which the events unfold, there is no substitute for rehearsing for surgical fires in formal drills.

 

 

 

Airway fires are a special danger in the OR. The March 2007 Pennsylvania Patient Safety Authority Advisory shows shocking photographs of a trachea tube that had been ignited during a trachostomy and another showing a demonstration of a trachea tube turned into a blow torch after being ingited by a laser while 100% O2 was flowing. That advisory provides specific actions to minimize the risk of airway fires. Such fires are extremely hazardous to the patient, capable of causing severe harm and death. The advisory details the coordinated steps the OR team must take immediately in the event of airway fires, including stopping gas flow, removing the tracheal tube, maintaining airway patency, extinguishing the fire, and care and assessment of the patient, including bronchoscopic examination. Another poster “Airway Files during Surgery” is also available through the Pennsylvania PSA.

 

 

 

And keep in mind that burns may occur on patients even in the absence of a fire. An AHRQ Web M&M Case and Commentary describes how a laparoscope temporarily placed on a tray on the patient while the trocar was being repositioned resulted in a patient burn. The discussion provides excellent lessons about heat source and surgical fire potential in the laparoscopy setting.

 

 

 

ECRI and the Pennsylvania PSA also have several other articles on specific aspects of surgical fires, including excellent references and resources. These include “Risk of Fire from Alcohol-Based Solutions”, “Electrosurgical Units and the Risk of Surgical Fires”, and “Electrosurgery Safety Issues”. AORN also produces an excellent toolkit, the “Perioperative Fire Safety Tool Kit”.

 

 

 

Surgical fires are no laughing matter and they occur frequently enough that your facility may encounter one at some point. The consequent patient injury may be substantial, including the potential for death. You need to incorporate specific surgical fire training into your orientation programs and ensure that all staff coming to your OR’s have had that training. That includes housestaff and other people that may periodically rotate through your facilities. You should also perform specific surgical fire drills regularly so that staff know how to respond promptly and correctly should a surgical fire actually occur.

 

 

 

 

 

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December 11, 2007

 

Communication...Communication...Communication

 

 

 

 

This week we’ll discuss three recent articles highlighting issues with communication. We know that breakdowns in handoffs and a variety of communication are contributing events in almost 70% of sentinel events reported to Joint Commission and we know from doing many root cause analyses that we can find some sort of problem with communication among care providers almost every event with an adverse outcome.

 

In our October 23, 2007 Tip of the Week on Medication Reconciliation Tools, we mentioned that, while there are statistics on the error rates for medication reconciliation at admission and discharge, there have not been good statistics on errors in medication reconciliation at the time of internal transfers within hospitals. In the December 2007 Journal of Patient Safety, Grant and Larsen(1) report on a study on clinical information transfer and medication reconciliation in patients transferred from pediatric intensive care units at a pediatric tertiary care center. Overall, in 75% of the transfers there was at least one missed order (i.e. an order for either care or a medication) and 30% had 2 or more missed orders. They calculated a rate of 11.7 missed medication orders per 100 medication orders and 6.8 missed patient care orders per 100 patient care orders. That study was done before the hospital had implemented a formal medication reconciliation process that includes use of computer-generated reconciliation forms.

 

The second paper by Matheny et al. (2) was in the November 12, 2007 issue of the Archives of Internal Medicine entitled “Impact of an Automated Test Results Management System on Patients’ Satisfaction About Test Result Communication”. It describes an automated system at Partners Healthcare in Boston for generating letters to patients regarding laboratory test results. The physician sees a test results summary page and has the opportunity to acknowledge the test result and generate and document patient notification letters. They did a before and after comparison of patient satisfaction with results notification and had a control group that did not use the automated system. They demonstrated that there was an improvement in patient satisfaction with results notification in the group utilizing the automated sytem but no change in the control group. They also demonstrated that these patients were more likely to be satisfied with the amount of information given them about the conditions and treatments related to those test results.

 

And a report by Kate Madden Yee(3) on presentations at the 2007 Radiological Society of North America noted 3 presentations that used high-tech communications tools to improve patient care. That report, by the way, is from the AuntMinne.com website which is a very useful radiology site with up-to-date news on events related to radiology and loads of useful clinical information often related to patient safety. Ensuring that significant abnormal findings be communicated to referring physicians and subsequently to patients is often problematic (see our May 1, 2007 Tip of the Week The Missed Cancer). The Massachusetts General Hospital has developed a good solution. It integrated a communication tool with the existing IT infrastructure (we don’t know if it was part of the system referred to in the Matheny paper cited above). When a radiologist highlights important results with a specific phrase recongnized by the system, the system generates an e-mail alert to the referring physician. If the e-mail is not acknowledged, a fax with the information is sent to the referring physician’s office.

 

The Yee report also noted a presentation in which paper radiology request slips were scanned into the system so radiologists could read the request directly rather than just the information manually typed into the computer system. They found 62% of the reviewed cases had discrepancies between the written request and the computerized request, many of which included clinically important information. The third presentation in Yee’s report was about how a confidential web-based QA reporting system allowed non-radiology physicians to communicate radiology quality issues back to the radiology department. The hospital found this a very useful tool to drive some of their quality improvement processes.

 

 

 

 

1. Grant MJC, Larsen GY. Clinical Information Transfer and Medication Reconciliation in Patients Transferred from the Pediatric Intensive Care Unit. J Patient Saf 2007; 3” 195-199
2. Matheny ME, Gandhi TK, Orav EJ, et al. Impact of an Automated Test Results Management System on Patients’ Satisfaction About Test Result Commumication. Arch Internal Med 2007; 167: 2233-2239
3. Yee KM. High-tech communication tools improve patient care, studies find. Accessed from the AuntMinnie.com web site 12/6/2007. http://www.auntminnie.com/index.asp?Sec=sup&Sub=imc&Pag=dis&ItemId=79168

 

 

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December 18, 2007

 

Bed Rails

 

 

 

 

Anyone who has worked in hospital quality improvement for a substantial time period has probably seen or heard of at least one incident of bed rail entrapment with injury or a near-miss. Also, bed rails probably had some degree of “guilt by association” dating back to the late 1980’s and early 1990’s debates about use of “restraints”. (It should be clear in further discussion that we are not talking about bed rails as restraint devices. In those rare instances where your facility may be using them as restraints, make sure you include them as part of your restraint policy and procedures.) In 1995 the FDA issued a Safety Alert: Entrapment Hazards with Hospital Bed Side Rails about 102 bed rail entrapment incidents over a 5 year period. The report identified certain risk characteristics of patients involved and circumstances related to the beds and rails. The Veterans’ Administration issued a patient safety alert about bed rail entrapment in 2001. In 2002 Joint Commission issued a Sentinel Event Alert about 7 deaths or injuries related to bed rails over a 7-year period. They included many root causes and risk reduction strategies identified by reporting facilities. So many of us have had largely negative opinions of use of bed rails. But evidence-based medicine adds a dose of reality that makes us reconsider overly negative or overly positive opinions and arrive at rational approaches to the issue of when to use bed rails and when not to use them.

 

 

In fact, the discussion about use of bed rails must occur in a much bigger context, that is a discussion about why, how and how often hospitalized patients fall from bed and sustain injury. The purpose of bed rails is to reduce the risk of patients inadvertently slipping, sliding, falling or rolling out of bed. Certain characteristics of patients increase the likelihood that they might fall out of bed, including presence of dementia or delirium, visual or multiple sensory impairment, impaired balance, impaired mobility, or side effects from multiple medications. Bed rails do also serve some additional purposes, such as helping in turning or repositioning in bed, providing some support getting into and out of bed, and perhaps providing easy access to bed contols, call buttons, and personal care items (though there are alternatives for all of these).

 

 

Several organizations have actually now done systematic reviews on both the risks and the benefits of use of bed rails in hospitalized patients. However, the approaches on the two sides of the Atlantic appear to be somewhat different, though important lessons can be learned from both approaches.

 

 

The Hospital Bed Safety Workgroup in the United States had representatives from Joint Commission, the FDA, the National Patient Safety Foundation, ECRI, multiple clinical organizations, consumer advocacy groups, legal organizations, manufacturers, and others. They published their report in 2003 Clinical Guidance For the Assessment and Implementation of Bed Rails In Hospitals, Long Term Care Facilities, and Home Care Settings. An FDA 2007 update states “Between 1985 and 2005, FDA received 691 incidents of patients caught, trapped, entangled, or strangled in beds. The report included 413 deaths, 120 nonfatal injuries, and 158 cases where staff needed to intervene to prevent injuries. Most patients were frail, elderly or confused.”

 

 

Around the same time, the National Patient Safety Agency of the National Health Service in the UK was doing its own review and published a safer practice notice on “Using bedrails safely and effectively” in February 2007 and a companion literature review Bedrails – Reviewing the Evidence (Systematic Literature Review). Their review of incident reports showed that 44,000 hospitalized patients in the UK (1 in 200 inpatients, and about a fourth of all hospital falls) fell out of bed during a one-year period, including 90 patients who suffered fractured femurs, and 11 fatalities. They found that falls without bed rails were more frequent and more likely to be associated with injury, though there was no significant difference in moderate or severe injuries between those with and without bed rails. They also analyzed the hazards of bed rails and found 1250 patients injure themselves on bed rails each year, usually minor scrapes and bruises. They found reports of death due to bed rail entrapment to be rare (3 deaths in a six-year period in acute hospitals but a total of 21 bed rail entrapment deaths for all sites of care). Their work also showed that patients, in general, had a less negative view of bed rails than did healthcare workers. They also found that initiatives to reduce bed rail use too much actually sometimes led to an increase in falls. The evidence study is clearly worth reading. However, its primary value is that it points out the dearth of studies conducted in a scientifically designed manner and most studies on reduction of bed rail use did not stratify patients by risk. Much of what we currently know about bed rail use – both risks and benefits – remains largely anecdotal.

 

 

The statistics do make one thing very clear: the potential risks and benefits of using bedrails must be weighed individually in each case. It is clear that not everybody needs bed rails. In fact, most hospitalized patients do not need bed rails. There are several key questions to be asked:

• How likely is it that the patient will fall out of bed?
• How likely is it that he/she would injure himself/herself if they fell out of bed?
• Could the patient injure himself/herself on the bed rails?
• How likely is the patient to try to climb over the bed rails or to try to squeeze through them?
• Does the patient have characteristics that increase the likelihood of bed rail injury?

Ironically, many of the risk factors for falls are also risk factors for bed rail entrapment.

 

 

The Hospital Bed Safety Workgroup report notes numerous alternatives to bed rails:

• Use beds that can be raised or lowered closer to the floor
• Keep the bed in the lowest position with wheels locked
• Place mats next to the bed (but be careful they do not increase risk of a fall)
• Make use of other aids to mobility or transfer
• Monitor the patient frequently
• Anticipate the reasons a patient may want to get out of bed and alleviate those needs (eg. toileting, hunger, pain relief, etc.)

 

 

Frequent reassessment of both the risk of falling and the need for use of bed rails is needed. We’ve spoken in numerous Tip of the Week columns about the fact that a fall risk assessment is often done on admission and not repeated often enough during a hospitalization. The same applies to bed rail risk assessment.

 

 

A substantial number of patients who died from bed rail entrapment had a history of being found in a similar position previously (near-misses) so such should be used as a warning of the highest degree that the patient is high risk for entrapment.

 

 

The adequacy of bed rails and associated equipment must also be assessed, with particular attention to the size of “gaps” and use of nonstandard equipment. The FDA issued a guidance in 2006 “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment”. This contains many of the technical aspects of what facilities need to look for in their beds and other equipment in assessing the risk for bed rail entrapment. It talks about many of the mechanisms of entrapment and dimensional issues involved.

 

 

One issue is that the risk of entrapment involves more than just the bed rails themselves. It obviously involves a complex interaction between patient risk factors, the environment, the bed rails, and other parts of the bed. A substantial number of the deaths occur when the patient’s head becomes entrapped between the side of the mattress and the bed rail. This especially seems to be a problem with some of the pressure-relieving mattresses. Also, a key problem is that mattresses often wear out before beds or bed rails do. New mattresses purchased may not be appropriate for use with the bed rails. A Guide for Modifying Bed Systems and Using Accessories to Reduce the Risk of Entrapment also published by the Hospital Bed Safety Workgroup, gives excellent advice to facilities for conducting inventory of current hospital beds, assessing risk, guiding purchases, etc. There are also patients whose size or weight are inappropriate (too small) for bed size.

 

 

Good documentation in the medical record about the decision making process regarding use or non-use of bed rails is important. Where possible, this should be done in an interdisciplinary setting and seek input from all clinical services involved plus input from the patient and/or family. The record should also include documentation of monitoring of bed rail use and of the periodic reassessment of the need for bed rails.

 

 

Most importantly, the patient and family need to be brought into the loop on discussions about bed rail use. The potential benefits and risks need to be explained to them just as one would in performing informed consent for a surgical procedure.

 

 

And lastly, like any good patient safety or quality improvement initiative, there should be a process for auditing the use of bed rails, including incident reports related to both bed rail injuries and falls from bed. Bed rail use also is another good topic for a FMEA (Failure Mode and Effects Analysis) exercise.

 

 

 

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