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

 

 

 

You my either scroll down through the entire Patient Safety Tip of the Week Archive or click on the headings at the right to go directly to the tip in a printer-ready format. Or click here to search the entire site.

 

 

 July 3, 2007   

Tip of the Week is on Vacation

    

Tip of the Week is on vacation this week as we celebrate Independence Day in the US and our neighbors celebrate Canada Day. Enjoy the holidays!

 

 

 

 

July 10, 2007

Catheter Connection Errors/Wrong Route Errors  

 

 

 

While statistics are important in patient safety, it is stories that get people’s attention. Perhaps the most dramatic story I ever heard was from a nurse involved in an incident where a child was given Bicillin intravascularly, causing a death. That nurse’s world was turned upside down by that event. The irony is that our system failed her. Our system put her and many other nurses and doctors and patients in a position where a substance could be inadvertently given via the wrong catheter/route.

 

 

 

 

 

 

It has been over a year since Joint Commission issued a Sentinel Event Alert  about catheter misconnections and administering substances via routes they were not intended to be administered. Recently, the issue has received considerable attention again.

 

 

 

 

 

 

Last month, the Wisconsin State Journal had a multipart series on medical errors and incidents and focused especially on cases of catheter misconnections or administering substances via the wrong route. That followed a fatal case last year in which a nurse had criminal charges filed after giving a drug intended for epidural anesthesia intravascularly. And there are previous similar cases where criminal charges were filed against nurses in cases where the system made them vulnerable to be at the “sharp” end of an unfortunate incident.

 

 

 

 

 

 

The Joint Commission’s Sentinel Event Database had nine cases at the time it issued its Sentinel Event Alert in April 2006. But the problem of catheter misconnections and wrong route drug/fluid administration is much more common. The US Pharmacopoeia reporting system (a voluntary reporting system) has over 1200 reports of cases in the past nine years in which a substance intended for one catheter was inadvertently administered into another catheter. The cases involve almost any catheter you can think of (substances intended for feeding tubes being given intravenously or via dialysis catheter, intravenous medications being given intrathecally, hypertonic intravenous contrast agents being given intrathecally for myelography, bladder irrigation solutions being given intravenously, intramuscular medications like Bicillin being given intravascularly, IV fluid being injected into a tracheostomy cuff, blood pressure cuffs being hooked up to IV lines, and many more examples).

 

 

ISMP/FDA Medication Safety Alerts have been issued at least as early as 2001, some of which include video presentations .

 

 

 

 

 

 

One of the salient problems, of course, is that the design of the systems allows 2 things to be connected that were never intended to be connected. The most successful safety interventions in any industry are forcing functions, that is designs that force someone to do something or not to do something. This particular issue is one that should be amenable to use of such forcing function solutions.

 

 

 

 

 

 

A major problem is use of the luer connections in the various types of tubing, catheters, or syringes. Good design would prevent a feeding tube or syringe with feeding solution from being physically connected to an IV catheter. Many facilities have moved away from purchasing any feeding systems that utilize luer connections. One of the biggest barriers has been getting the device manufacturing industry to come up with standards for connections on the various devices.

 

 

European healthcare organizations seem to be a little farther along in addressing the issues. In fact, the National Patient Safety Agency in the UK just issued a Patient Safety Alert on March 28, 2007 on “Promoting safer measurement and administration of liquid medicines via oral and other enteral routes” . This addresses design of equipment and labeling of tubes and syringes.

 

 

 

 

 

 

But there are multiple other contributing factors noted by both Joint Commission and ISMP. One of the biggest problems is that the various catheters and tubes may be in close proximity to each other, without clearcut labeling or other identification. Color coding of various lines/devices has been suggested but without a standard across facilities use of color coding could lead to unintended consequences. When color coding is not feasible, it may be possible to flag high risk medications by other means, such as wrapping them in foil. It is imperative that one always trace a tube or catheter or line from the patient to the point of origin before connecting any new device, line, infusion or other substance. This should always be done in proper lighting (many times a caregiver does not want to wake a sleeping patient so makes the connection in a dimly lit room).

 

 

 

 

 

 

The issue needs prominent attention in education and training sessions and should be part of annual competency inservices/evaluations. Including “lines and connections” may be an important part of change of shift communications or other handoffs. 

 

 

 

 

Importantly, facilities should make monitoring of these systems a priority. It would be a good process to add to your “patient safety walk rounds” and is an excellent process to conduct FMEA (failure mode and effects analysis) around.

 

 

 

 

 

 

Keep your eyes and ears open. We will likely see and hear more about this issue over the next year.

 

 

 

 

 

 

 

 

Print  Catheter Connection Errors/Wrong Route Errors

 

 

 

 

July 17, 2007    

Falls in Patients on Coumadin or Heparin or Other Anticoagulants

 

 

 

 

In our April 16, 2007 Tip of the Week we discussed falls with injury, with particular emphasis on what the first responder to a fall needs to do. We pointed out that the responder needs not only to assess the patient for injuries but also to do an assessment of the reason for the fall. Having a checklist to help the medical responder is a good way to ensure that the injuries are attended to and the cause of the fall is considered.

 

 

 

 

In response to the fall, there are a number of other tools that can be useful in the assessment of potential injuries. Many of these are already used in your emergency rooms. Good examples are the Canadian CT Head Rule, the New Orleans Criteria (for head injury), or the Ottawa C-spine Rule. Most of these rules and their algorithms can be downloaded for use on a PC (such as the Medical Algorithms Project) or handheld PDA (such as EM Rules).

 

 

 

 

The Canadian CT Head Rule is an excellent rule for determining which patients should get a CT scan of the head after minor trauma. However, it does not apply to patients who have a bleeding disorder or who are on anticoagulants. The following case is a good example of some of the unique considerations in anticoagulated patients.

 

 

 

 

An elderly patient with a cardiac condition was on full-dose heparinization while an inpatient and had an unwitnessed fall in the hospital one evening. He did not lose consciousness and was alert and fully oriented when the medical resident examined him after the fall. He had a mild ecchymosis on his right forehead but no focal neurological signs and no evidence of trauma elsewhere on the body. Because the patient was fully anticoagulated, the resident ordered an emergency head CT scan, which was normal. No changes were made in his heparin regimen. The following morning the patient was more somnolent than usual and a repeat CT scan showed a sizeable subdural hematoma that required surgical evacuation.

 

 

 

 

We’ve included this case because it shows that the timing of a CT scan may be important in the patient who is anticoagulated. The accumulation of a subdural hematoma after minor head trauma may be slow in a patient on anticoagulants. So particularly in a patient who is already hospitalized and being monitored regularly, one might consider delaying the head CT for several hours if the initial neurological examination is normal. However, that implies that the “neuro checks” will indeed be carried out as ordered. We’ve often seen in that past that there is a tendency for “neuro checks” to be overlooked when the patient is asleep – which is exactly when neuro checks are most important!

 

 

 

 

The same may apply to bleeding in other spaces in patients fully anticoagulated. A good example is retroperitoneal bleeding, which may present with no signs until a drop in hemoglobin is found or flank ecchymoses are noted.

 

 

 

 

Heparin, coumadin, and other anticoagulants are all high risk medications and your organizations should have comprehensive guidelines and protocols for their use. Joint Commission’s 2008 National Patient Safety Goals include taking steps to reduce the risk of harm in patients on anticoagulants. While the focus of that goal is to help ensure that patients are adequately and safely anticoagulated and avoid the frequent adverse drug events often associated with coumadin or other anticoagulants, a comprehensive policy should include recommendations about minor trauma in the anticoagulated patient as well.

 

 

 

 

 

 

Print  Falls in Patients on Coumadin or Other Anticoagulants

 

 

 

 

July 24, 2007    

Serious Incident Response Checklist

  

Many hospitals are still struggling with their root cause analyses of serious adverse events. One of the problems is just getting started promptly. One of the keys to good incident investigation is obtaining all the factual evidence as soon as possible. Particularly when it comes to interviewing witnesses, it is important to remember that memory of the event becomes less clear with passage of time and those memories may even be changed by other events, conversations, etc. It is extremely important that we understand how the participants in the incident perceived the unfolding situation and events as they occurred, rather than reinterpreting them after knowledge that the outcome was adverse.

 

 

Therefore, each hospital should have a Serious Incident Response policy and checklist to help guide them in their response to a serious incident. A link to a sample serious incident response checklist is at the end of this tip of the week.

 

 

Obviously, the individual assigned responsibility for each task may vary from organization to organization. But having the task listed on a checklist and and individual designated helps everyone remember what needs to be done.

 

 

The “serious incident” might meet the Joint Commission definition of a Sentinel Event or the state health department definition of a serious reportable event but you should also consider even near-misses as meeting the definition if there was potential for a serious adverse patient outcome. On receiving the incident report, the designated individual (usually a risk manager) should immediately discuss the incident with the medical director, director of nursing and director of quality improvement to decide whether the Serious Incident Investigation Team/RCA Team should be convened. The risk manager (or other designated person) should contact the supervisor of the area where the incident occurred to ensure that all potential witnesses are identified and then schedule a meeting of the Team as soon as possible (usually within one day). In those cases where a witness will be unavailable to be interviewed in person, arrangements can usually be made for that person to be interviewed by phone.

 

 

The chart of the patient should be secured and working copies made for use by the Team. Similarly, any equipment or devices involved should be sequestered. That is to ensure that the equipment is available for the investigation and also to ensure that any potentially faulty equipment is not used for another patient.

 

 

We believe that the patient and/or family should be notified early that errors may have occurred and that the incident is being investigated. We’ve long been believers in being very forthright with patients/families and telling them when there were mistakes made in their care. Subsequent research and other experience certainly seems to bear out that such an approach and an apology are important when mistakes or errors did impact on the outcome. The details and the apology, of course, cannot be given until the RCA is complete and all contributing factors known. However, our experience is that patients and families appreciate candor and should be told that an investigation is ongoing and that they will be made aware at some point of at least the general outcome of that investigation. It should be made clear to them that the investigation is being done to help ensure that similar events do not occur in the future. The individual who speaks to the patient or family should usually be the one with the best pre-existing rapport. That is usually the attending physician but may under some circumstances be someone else in the organization. If it is awkward for the attending physician to speak to the family, then the medical director is an appropriate individual to speak to them.

 

 

Most of the other items in the check list are self-explanatory (mostly notification to various agencies and bodies of the incident occurrence). Some state Department of Health offices require notification of certain events within 24 hours. Even if that is not a formal requirement, a good general rule is to notify them of any event that is likely to attract press attention. That way the state department is not taken by surprise if an inquiry is made and they are able to respond that they are aware of the incident and the ongoing investigation.

 

 

The last item is very important and often overlooked. Caregivers undergo a variety of deep emotions when one of their patients is harmed, particularly when they feel they may have contributed in some way to that adverse outcome. So each organization should have some mechanism for providing needed support and assistance to any physicians, nurses, pharmacists, etc. that may have been directly involved in the incident or had been actively involved in the care of the patient.

 

 

 

See a sample Serious Incident Response Checklist.

 

 

Print   Serious Incident Response Checklist

 

 

July 31, 2007    

Dangers of Neuromuscular Blocking Agents

  

 

A patient is in need of an emergency CT scan one night. There is no nurse available in the radiology suite so the ER resident accompanies the patient for the CT scan. The patient is in need of sedation for the scan and the resident inadvertently administers vecuronium IV to the patient, resulting in respiratory arrest necessitating rescuscitation.

 

 

A patient is undergoing a surgical procedure in the OR and the surgeon asks the anesthesiologist to give IV antibiotic. The anesthesiologist reaches into the anesthesia medicine drawer, where all the medications are kept, and pulls out a vial of vecuronium thinking it was the antibiotic and adds it to the IV bag. On arrival to the post-operative recovery area it is noted that the patient is not breathing well and she requires intubation.

 

 

We also previously mentioned a case (June 19, 2007 Tip of the Week) where an unintended consequence of CPOE led to inadvertent administration of a neuromuscular blocking agent to a patient.

 

 

Though these three cases were near-misses that did not result in patient harm, they illustrate the potential life-threatening dangers of medication errors with neuromuscular blocking agents. Neuromuscular blocking agents (NMBA’s) are high-alert medications in that permanent injury or death may occur as a result of inappropriate usage. An outstanding review of NMBA safety issues, contributing factors, and potential solutions issued by the ISMP Canada appeared in the Spring 2007 publication of the Canadian Association of Critical Care Nurses (CACCN). The article provides numerous case reports of individual NMBA incidents and points out many of the key contributing factors. It draws heavily on observations and recommendations from the September 22, 2005 ISMP (US) Medication Safety Alert. If you facility/organization is looking for a good place to begin doing Failure Mode and Effects Analysis (FMEA), the NMBA safety issue would be a great place to start, using the key points elucidated in these two articles.

 

 

NMBA incidents turn up in all areas of the hospital, not just ICU’s and OR’s where you might anticipate their occurrence. Sometimes a major contributing factor is continued use of an NMBA after ventilation is discontinued. Other times it might be continuation of an order for an NMBA when a patient is transferred to another level of care (good medication reconciliation should help avoid this). But look-alike/sound-alike names can be a major contributing factor. Norcuron (vecuronium) has been mistaken for Narcan, vecuronium for vancomycin, atracurium for Ativan, etc. In other cases, look-alike packaging has been a major contributing factor. In other cases, the NMBA has been in unlabelled syringes or unlabelled vials. And lack of understanding of the nature of NMBA’s and their life-threatening potential is often a contributing factor.

 

 

There are multiple measures that may be taken to minimize the risk of an NMBA-related incident in your organization. Restricted access to NMBA’s is very important. Restricting their floor stock to areas where mechanical ventilation is easily available, such as ICU’s and OR’s and ER’s, is one step. However, in reading the CACCN/ ISMP Canada review, it is striking at how supplies of NMBA’s turn up in the most unexpected places (eg. an anesthesiologist from a nearby OR, for convenience, had placed a vial of an NMBA in a refrigerator of a neonatal nursery where it was confused with vials of vaccine). So while restricting access is important, there clearly must be other safety measures taken.

 

 

In those areas where there must be stores of NMBA’s, they should be segregated from other medications. That would, for instance, prevent someone from reaching into an anesthesia medication cart for an antibiotic and inadvertently pulling out an NMBA. And you should already be avoiding unlabeled syringes/vials/etc. as part of your Joint Commission patient safety activities. The ISMP Canada article also stresses the importance of prompt disposal of any unused NMBA from an patient room as soon as they are discontinued.

 

 

Appropriate warning labels are an extremely important safety measure for NMBA’s. The ISMP Canada article lists several potential warning labels and color coding. A very good article on ways to optimize the effectiveness of warnings is in the August 2006 ISMP Newsletter.

 

 

Storage of NMBA’s in automated dispensing machines can be especially problematic. Probably most important is only storing them in areas where they are clearly needed. Where needed, they should be kept in single access drawers. But there needs to be a special warning that the NMBA should not be used in patients who are not intubated/mechanically ventilated. Such a message could be delivered in those automated systems having the capability of messaging when an NMBA is selected for removal from a drawer. Similarly, the type of CPOE error noted earlier might be avoided by programming in an alert ensuring the patient is intubated/ventilated when the physician enters an order for an NMBA.

 

 

Other measures that might be used include standardized order sets, protocols for use, independent double checks before administration, use of bar-coding, education/training, and availability of point-of-service informational resources.

 

 

Of course, one needs to consider the unintended consequences of all these solutions as well. The most important one would be inavailability of an NMBA at a time it is needed for an emergency intubation. One suggestion in the ISMP Canada article for outside the OR was sealing the NMBA in intubation kits or anesthesia kits so access in only available once the intubation kit is opened.

 

 

Lastly, one of the AHRQ M&M Conference cases from a few years ago happened to be on an NMBA incident and it had 2 terrific downloadable videos addressing some of the communications issues in that case. It is well worth reading and watching the videos.

 

 

Again, consider adding NMBA Safety to your list of things you look for in your Patient Safety Walk Rounds and consider doing a FMEA on NMBA use in your organization.

 

 

 

Update from our November 2007 What’s New in the Patient Safety World:

FMEA Related to Neuromuscular Blocking Agents

 

In our July 31, 2007 Tip of the Week dedicated to errors in use of neuromuscular blocking agents (MNBA’s), we recommended this is a good issue to address in FMEA (Failure Mode and Effects Analysis) in your organization. Susan Paparella, from ISMP, did exactly that in a recent issue of Journal of Emergency Nursing. The ED staff had recognized NMBA’s as high-alert drugs and were contemplating their removal from ED stores, to be replaced in kits prepared for rapid-sequence intubation. FMEA is especially useful in such situations where change is to take place, because it helps identify potential unintended consequences. The article nicely describes how you do a FMEA exercise and provides examples for scoring probability and severity and use of a hazard scoring matrix. She also lists 10 other problems commonly encountered in emergency rooms that could be candidates for FMEA.

 

Paparella, Susan RN, MSN Failure Mode and Effects Analysis: A Useful Tool for Risk Identification and Injury Prevention. Journal of Emergency Nursing. 33(4):367-371, August 2007 

 

 

 

Print  Dangers of Neuromuscular Blocking Agents

 

 

 

 

August 7, 2007    

Role of Maintenance in Incidents

 

 

Many of the most famous disasters in industry history have followed equipment or facilities maintenance activities, whether planned, routine, or problem-oriented. Well-known examples include Chernobyl, Three-Mile Island, the Bhopal chemical release, and a variety of airline incidents and oil/gas explosions. It is unknown how often maintenance activities contribute to medical incidents but, given the similarity of systems in medicine to those in other high-risk industries, it is likely that there are many cases in which maintenance errors contribute to adverse patient outcomes.

 

 

James Reason and Alan Hobbs in their 2003 book “Managing Maintenance Error. A Practical Guide” do an outstanding job of describing the types of errors encountered in maintenance activities, where and under what circumstances the various types of error are likely to occur, and steps to minimize the risks.

 

 

Omissions are the single largest category of maintenance errors. Omissions are especially likely to occur after interruptions or distractions. We frequently “lose our place” when performing a series of actions and then either unnecessarily repeat a step or omit a step or steps altogether. Omissions are also especially prone to occur near the end of a sequence of steps. This may be part of the “premature exit” phenomenon where one is already thinking about the next activity and leaves out a step in the current activity.

 

 

The book has an excellent discussion of error-provoking factors that come into play at both the individual level and the team level, including how to recognize them and how to deal with them. It has a particularly good discussion of violations (which are intentional deviations from standards) and the reasons for them and a useful approach that one company took to reduce them.

 

Don Norman’s work on design of systems is cited and the importance of involving end-users in the equipment purchasing phase is emphasized. This, of course, helps the organization help identify some of the safety issues that will arise with such new equipment. Hospitals and healthcare facilities need to adhere to that principle more often. They especially stress the end-user role in understanding equipment having multiple modes (that is, controls do different things depending upon what “mode” the machine is in), another issue frequently lacking in healthcare settings. “Automation surprises” (such as this mode confusion issue) are frequently mentioned as root causes in the aviation safety literature but probably occur as often in healthcare.

 

 

A section on omission-provoking features more than justifies buying this book. It includes an annotated “task step checklist” that will help your organization identify omission-prone tasks and better manage them. It also includes a discussion of the characteristics of a good reminder (many of these characteristics are incorporated into the ISMP guideline on good lablels for high-alert drugs that we discussed in last week’s Tip of the Week).

 

 

In healthcare, we talk about the importance of reporting near-misses and other issues proactively to help prevent errors and adverse outcomes. We usually stress the importance of developing anonymous reporting systems or error-reporting hotlines. This book describes and interesting method probably not widely used in healthcare. It describes the MESH (Managing Engineering Safety Health) system. MESH is a sampling tool given to randomly selected frontline workers to rate weekly (or monthly) a number of factors affecting the local workplace environment of the more general organizational environment. The resulting cumulated local factor profile allows identification of those factors occurring with sufficient frequency to help direct limited resources to areas in which ROI is likely to be high and help prioritize safety and quality goals. This book also has a good description of “just culture” (encouraging that the vast majority of errors reported are not punished but continuing to take action in the rare cases where reckless behavior occurred) and a very good description of the attributes of a successful reporting system. And it ends with a great discussion about the nature of “safety culture” and the “resilient” organization..

 

 

The book also has the overview of human factors, description of various human error types, and models of organizational accidents that you’d expect of any James Reason book. It gives real-life examples of incidents from several industries. Many of our “big three” issues (failed handoffs or other communication failures, failure to buck the authority gradient, and failure to heed alarms) are contributing factors in those examples. But they really emphasize some other aspects that we think about less often in healthcare but clearly need to integrate into our thinking.

 

 

Quite frankly, most of the lessons in this book apply not just to maintenance activities but to any process or procedure involving multiple steps. The caveat that steps near the end of a maintenance procedure are most likely to be omitted (“premature exit”) or that violations tend to occur frequently when under time pressure to complete a task certainly applies to many things we do in healthcare, not just equipment maintenance. The same issues could just as easily apply to a surgical case in the operating room or the delivery of chemotherapy on a medical unit.

 

 

 

Print  Role of Maintenance in Incidents

 

 

August 14, 2007    

More Medication-Related Issues in Ambulatory Surgery

  

 

In our June 5, 2007 and June 12, 2007 Tip of the Week columns we discussed medication-related patient safety issues in ambulatory surgery settings. Joint Commission is finding less than full compliance in ambulatory surgery on several medication-related goals (eg. medication reconciliation, labeling medications and solutions, “do not use” abbreviations, and look-alike/sound-alike drugs).

 

 

The April 2007 issue of USP Patient Safety CAPSLink™ examined medication errors in outpatient surgery, based on data collected from the MEDMARX reporting system. For adult patients, nearly 70% of the medication errors in ambulatory surgery were in the administration phase. They point out that many of the drugs in ambulatory surgery units are not prepared or reviewed by pharmacists, thereby omitting a potential patient safety defense. They also note, as we previously did, some of the issues around inadequate medical records, time pressures, etc. that are more frequent in the ambulatory surgery setting. Computerized physician order entry (CPOE), a tool with great potential for reducing medication errors, is seldom available to or used by physicians in the ambulatory surgery setting. The article provides several recommendations for reducing outpatient surgery medication errors.

 

 

Look-alike/sound-alike (LASA) medication errors continue to be a problem in all healthcare settings and ambulatory surgery is no exception. Lists of problem-prone LASA drug name pairs are available through Joint Commission  and ISMP . ISMP’s August 9, 2007 Acute Care Newsletter has a good discussion about name confusion errors. It highlights some of the actitivies ongoing to reduce problems related to drug name confusion and notes an upcoming summit on the issue. It provides several practical steps that healthcare facilities may take to minimize the risk of LASA medication errors. The FDA also has had a Name Differentiation Project that encouraged drug manufacturers to use “tall man” letters in their labeling of certain drugs. And one of the 9 Patient Safety Solutions recently published by the WHO Collaborating Centre for Patient Safety focuses on LASA Medication names. The latter is well-referenced and highlights barriers and possible uninteneded consequences along with many practical recommendations.

 

 

 

Each facility should have a list of targeted name pairs it will focus on and have a mechanism by which it will revise/update the list and disseminate the information and education to all members involved in ambulatory surgery activities. Examples of drug name pairs that might be encountered more frequently in ambulatory surgery might be: Amicar/Omacor, Darvon/Diovan, Anzemet/Avandamet, Celebrex/Celexa, Diprivan/Ditropan, ephedrine/epinephrine, fentanyl/sufentanil, Foradil/Toradol, heparin/Hespan, hydromorphone/morphine, Inderal/Adderal, Ketalar/ketorolac, Lasix/Luvox, MS Contin/oxycontin, Narcan/Norcuron, Paxil/Plavix, tizanidine/tiagabine, Zantac/Zyrtec.

 

 

Use of CPOE (with special alerts for potential LASA issues) or preprinted orders may be helpful. Requiring use of  both the brand name and generic name when prescribing may also be helpful but is difficult to implement and sometimes has the unintended consequence of introducing additional errors.

 

Requiring the indication for any ordered medication may help prevent a LASA error. In addition to the dosage form, drug strength, route of administration, and complete directions, knowing what use the drug is intended for may help a nurse or pharmacist avoid a LASA error.

 

 

Use of “Tall Man” letters for LASA pairs on labels or on computer screens, etc., has been suggested as a solution. Examples of “Tall Man” lettering are: VinBLAStine/VinCRIStine or HydrALAZINE/HydrOXYzine. USP is conducting a survey of provider organizations to see the impact of “Tall Man” lettering on medication safety. Other techniques to highlight potential LASA-risk might include flagging with color, boldface, “name alert” stickers, etc. (but beware there is no current color standard for LASA drugs). Separate storage of one of a LASA drug pair in a different part of the pharmacy/facility may be useful (but beware of unintended consequences). Automated dispensing devices may be especially problematic when it comes to LASA drug pairs, particularly when more than one drug is stored in the same compartment. Some of the newer devices allow for programming alerts that might alert a nurse of a potential LASA drug.

 

 

Involving a pharmacist in the process is a very important step that few ambulatory surgery sites currently utilize. And other more general practices, such as avoiding verbal orders, remain very important in avoiding LASA errors.

 

 

And formulary management is important. LASA issues should be considered any time a new drug is being considered for addition to the formulary. Another consideration is stocking different strengths of a potential LASA pair (eg. don’t stock 2 mg/ml strengths for both drugs).

 

 

Most importantly, monitor the practices in your facility as part of your QI activities. Just as you monitor for unacceptable abbreviations, or use of high-alert medications, you should monitor for use of the LASA risk drug pairs you’ve chosen on your list. And, obviously, encourage reporting of any new events or drug pairs that arise.

 

 

By the way, ISMP has updated its list of high-alert medications so as you put together your LASA list, you might review/revise your high-alert medication list, too.

 

 

 

Print  More Medication-Related Issues in Ambulatory Surgery

 

 

 

 

August 21, 2007    

Costly Complications About To Become Costlier

  

 

We’ve talked previously about the costs associated with various complications, such as urinary tract infections, post-stroke pneumonia, etc. Average costs for such complications have been estimated as below:

 

  Urinary Tract Infection            $ 3,000

  Pneumonia after Stroke           $15,000

  Adverse Drug Event                $ 6,000

  DVT dx and rx                        $13,000

  Fall with Injury                        $34,000

  Ventilator-assoc. Pneumonia   $40,000

  Decubitus                                $500 to $40,000

  MRSA infection                       $27,000

  C. diff infection                        $40,000

  Surgical site infection                $13,000

 

 

Some of those costs have been offset in the past by higher reimbursements to hospitals for cases “with complications”. Well, that is also about to end. CMS has announced that it plans in 2008 to stop Medicare reimbursement for cases in which certain preventable complications have occurred . Almost all the above complications make the CMS list. Thus, the financial incentive to provide high quality care and enhance patient safety will increase dramatically. And you can expect private third party payors to follow CMS in this change in reimbursement. While we expect that the list will be refined before actual implementation, the message is clear: Medicare will no longer pay for preventable complications.

 

 

It behooves all facilities to ensure they have appropriate patient safety/quality improvement programs in place to minimize the risk of these complications.

 

 

CFO’s have traditionally focused much more on the revenue side of the balance sheet than the cost avoidance side. Justifying patient safety initiatives to CFO’s should no longer be difficult when you put together a spreadsheet with the above averages times the number of occurrences at your facility.

 

 

 

Update from out November 2007 What’s New in the Patient Safety World:

Cost of adverse events in intensive care units

 

Add to the above the costs of adverse events in ICU’s. Kaushal et al published a study of the cost for adverse events in ICU’s. The average cost per adverse event for patients in the MICU was $3961 and the attributable increase in LOS was 0.77 days. Corresponding numbers for patients in the CCU were $3857 and 1.08 days. The extrapolated annual cost for adverse events in these two 10-bed ICU’s was nearly $1.5 million. Clearly, there is significant opportunity for costs savings in prevention of adverse events in this setting. Organizations looking for a good ROI (return on investment) in their patient safety programs may want to focus on ICU’s.

 

Kaushal R, Bates DW, Franz C, Soukup JR, Rothschild JM. Cost of adverse events in intensive care units. Critical Care Med 2007; 35: 2479–2483

 

 

 

 

 

Print  Costly Complications About To Become Costlier

August 28, 2007    

Lessons Learned from Transportation Accidents

  

We pointed out in our May 15, 2007 Tip of the Week that important lessons from other industries can be applied in healthcare regarding patient safety. Accidents in the airline and transportation industries have many analogies to adverse incidents in healthcare. Another good example is the 1996 ValuJet fire and crash in the Everglades (NTSB report).

 

 

Basically, the fatal crash followed a fire in the cargo compartment that was triggered by unexpended chemical oxygen generator canisters. Such canisters were known to be capable of producing fires, both because they generate large amounts of heat and then supply oxygen capable of feeding the fire. Procedures called for not shipping such canisters unless they had locking caps or their contents had been completely expended.

 

 

The major issues had to do with the nature of the maintencance of planes and problems with communications. ValuJet was a relatively new airline that was expanding rapidly. One of its cost control strategies was to outsource some of its plane maintenance, a practice allowed by the FAA as long as the same policies and procedures were followed by the subcontractor that would apply to in-house maintenance. The airline outsourcing is also responsible for oversight and supervision of the subcontractor’s work. The company doing the outsourced maintenance, SabreTech, also had both its own full-time maintenance personnel and hired other temporary personnel. The latter did not receive the same inservice/training on various policies & procedures that the full-time personnel received. SabreTech also apparently did not have in stock the locking caps that were required to disable the canisters.

 

 

In addition to the financial pressures that led the airline and the maintenance organization to use subcontractors and temporary personnel, there was an additional pressure created by the contractual obligation of the subcontract to turn the airplane over in a specified time period or face a financial penalty. So some of the technicians were working extensive overtime in attempt to meet the time constraints.

 

 

They were also functioning in “multi-operator’ teams, where work begun by one technician might be eventually completed by another technician. Hence, communication during handoffs was a problem. In some cases, the “work cards” were signed as though a step (the expending of the contents) was completed, assuming that someone else had or would complete that task. And color-coded labels that should have identified the canisters as hazardous were inappropriately used, resulting in personnel in shipping/receiving to be unaware they had materials that should not be placed aboard a plane. And in some cases the only communication that took place with the shipping/receiving personnel was via those labels. The latter eventually cleared the canisters to be loaded on the ill-fated airplane.

 

 

Additionally, the parent airline did have supervisory personnel assigned to the subcontractor but they worked only in the daytime whereas much of the maintenance activities were done at night.

 

 

Sound familiar? Most of these issues are faced by healthcare facilities on a regular basis. Financial pressures often lead to use of part-time or temporary personnel rather than full-time personnel. So one needs to be concerned about proper training/inservicing of those personnel and ensure that the communications during the resulting increased number of handoffs will be appropriately managed. In some cases, the “savings” achieved by use of part-time or temporary personnel may be short-sighted. Additionally, it is difficult for such temporary personnel to become part of a “culture of safety” one needs to develop in a healthcare facility. But if and when you do need to use temporary or part-time personnel, make sure that they have been appropriately trained for all the procedures in their area of work.

 

 

Teaching facilities also need to take this into account when housestaff are rotating from one hospital to another because they are similar to the temporary personnel in that regard.

 

 

The color tag issue is also an important one. In healthcare we often use color coding as a useful patient safety measure. Nevertheless, everyone needs to understand what the color coding means. When a facility uses a color code that is not an industry-wide accepted standard, the “temporary” personnel may not be familiar with it and may misinterpret its significance.

 

 

And the communications/handoffs/multi-operator team issues abound in healthcare facilities. And if you are auditing the quality of handoffs in some fashion, make sure you audit a sample of all handoffs, not just the daytime ones (particularly since more handoffs probably occur during the evening and night hours).

 

 

Once again, lessons learned from other industries may be extremely valuable in patient safety activities. We’ll have some other examples in future Tips of the Week.

Print  Lessons Learned from Transportation Accidents

September 4, 2007    

Workarounds as a Safety Issue

  

 

In our August 7, 2007 Tip of the Week we mentioned the book by James Reason and Alan Hobbs “Managing Maintenance Error. A Practical Guide” has a particularly good discussion of violations (which are intentional deviations from standards) and the reasons for them and a useful approach that one company took to reduce them. Violations, of course, are not always bad and are often a sign that the underlying process or system was flawed in the first place. Violations and “workarounds” are very common in healthcare. In fact, we often reward people for their innovation in finding solutions to organizational barriers. However, the problem is that workarounds and other violations in the aggregate tend to promote errors and, just as importantly, a “good” workaround that solves a system problem needs to be uniformly applied wherever the flawed system is in effect rather than having multiple different workarounds ongoing in different parts of the organization.

 

 

The December 2005 Advisory from the Pennsylvania Patient Safety Authority has a good article on workarounds. That article includes a list of over 70 “at-risk behaviors” compiled by ISMP relating to medication safety. Many of the at-risk behaviors involve workarounds and apply to multiple activities besides medication safety. The list is a good place to begin your look at potential error-producing behaviors that may be amenable to change.

 

 

We recommend that during Patient Safety Walk Rounds frontline staff be asked (in a non-threatening, non-punitive manner) what workarounds they see or do themselves. Then one needs to determine the underlying reason for the workaround and attempt to develop an optimal solution that may be applied system-wide.

 

 

A second approach is the one noted in the Reason & Hobbs book in which a Swedish company tried to modify the behavior of its drivers. They assembled their drivers in small groups with a facilitator. At the first meeting they discussed general safety and quality issues and assembled a list of issues. At a second meeting they broke the list into things they had to send to management to fix and things they thought they could fix themselves. At the third and final meeting they collectively discuss the issues they felt they could deal with themselves. At the end, they write down for themselves a reminder of what they will do individually to solve the issue. The group that participated in this activity had a 50% reduction in driving accidents compared to a control group that did not participate. Interestingly, most of the group participants did not feel that the group discussions had affected their behavior. However, it is hard to deny the results demonstrated.

 

 

We therefore recommend that groups with a natural affinity (eg. those working in an ICU, or dialysis unit, or radiology department) get together to do this sort of group exercise in which workarounds and other at-risk behaviors are discussed. Your frontline workers not only know most problems better than you do – they also probably know better how to solve them!

 

 

 

 

Print  Workarounds as a Safety Issue

 

 

September 11, 2007    

Root Cause Analysis of Chemotherapy Overdose

  

A root cause analysis has been published on an unintentional chemotherapy overdose that gained the attention of the Canadian media a year ago. This is an extremely well done RCA that has numerous lessons learned and should be read by anyone involved in patient safety, whether your facility is involved in cancer chemotherapy or not.

 

 

The RCA was coordinated by the Institute for Safe Medication Practices Canada and utilized the Canadian Root Cause Analysis Framework developed by the Canadian Patient Safety Institute, ISMP Canada, and Saskatchewan Health. For those unfamiliar with that RCA framework, it is an excellent comprehensive overview of the elements of a thorough RCA. It incorporates most of the important elements of the more widely known Veteran’s Administration root cause analysis tools and adds elements from a variety of other resources.

 

 

The 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 RCA clearly developed a timeline and an understanding of what happened, then did a cause-and-effect analysis, resulting in three causal chains and multiple associated findings or incidental findings that are equally important in identifying opportunities to improve patient safety.

 

 

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 formula the bedside nurses had to use was incredibly complex and they did not have at hand all the information needed to make the calculation. The medication label 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 double check process did not catch the programming error and there was a 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.

 

 

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.

 

 

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 Tip of the Week on an 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 .

 

 

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 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 us would want to be in.

 

 

All the people who contributed to this excellent RCA are to be congratulated. This is clearly the type of incident that could occur today at multiple healthcare facilities and provides numerous useful lessons you all can use. You need to read it because many of the same issues occur in processes your facility uses today. It’s also a great teaching tool to use with your RCA Team or any multidisciplinary team involved in patient safety.

 

Addendum: The September 20, 2007 Medication Safety Alert from ISMP also includes a summary of this case. 

 

 

Print  Root Cause Analysis of Chemotherapy Overdose

 

 

 

 

 

September 18, 2007    

Wristbands: The Color-Coded Conundrum

  

In several of our Tips of the Week we have mentioned issues related to the use of colored-coded labels or identifiers to alert staff to a number of issues (high alert medications, flag catheters, flag orders, etc.). Visual cues are a time-honored way of communicating information of extreme importance. However, lack of standardization of colors and their meanings can lead to dangerous circumstances and produce undesired outcomes.

 

 

An advisory by the Pennsylvania Patient Safety Authority in December 2005 was inspired by a near-miss incident in which a patient incorrectly had a yellow-colored wrist band placed that meant “Do Not Rescuscitate”. The nurse who placed the yellow wrist band usually worked in another facility where a yellow wristband meant “restricted extremity”. The advisory gave several other examples of incidents arising from color-coded wrist bands and also noted that wristbands are often temporarily removed for procedures or may be covered up by the patient or a caregiver and that some patients may come into a hospital wearing a colored wristband that has nothing to do with their health status (eg. social cause wristbands). The PSA then did a statewide survey and found that most facilities used color-coded wrist bands to indicate at least some condition or alert but that lack of standardization across facilities (for both the colors used and the conditions for which they are used) was a major problem. They made several recommendations:

·         Limit the number of different colors used

·         Standardize the meanings of specific colors across healthcare facilities

·         Use only primary and secondary colors and avoid different shades of the same color to convey different messages

·         Use brief, pre-printed text on the wristbands to further clarify and always emboss or prepint text rather than ever using handwriting

·         Beware of other color-coding schemes that may be in place at the facility (such as the Broselow system for pediatric rescuscitation carts, or certain blood bank systems)

 

 

They also recommended addressing the issue of wristbands that patients bring with them on admission, patient/family/staff education, policies and procedures, etc.

 

 

The issue of standardization remains the most significant barrier to use of color-coded wristbands as a patient safety tool. Several states and regions have done collaboratives to adopt standardized practices on this issue. The Missouri Center for Patient Safety recently put out an excellent toolkit "Banding Together - for patient safety" Standardization and Implementation Toolkit”.

 

 

They adopted most of the recommendations from the Pennsylvania PSA and recommended only three colored wrist bands: red to denote allergies, yellow to denote high fall risk, and purple to denote DNR. They chose red for allergy because red signals “Stop!” in most industries and other environments. Yellow was chosen for fall prone patients since it denotes “Caution!”. Purple was chosen to denote that a patient has “Do Not Rescuscitate” status, largely because blue (currently used at many hospitals) might lead to confusion. Since “Code Blue” is used by many hospitals to summon the rescuscitation team, a blue wristband might confuse people as to whether blue means “do I code or not code here?”. They also recommend pre-printing text on the bands to help reinforce the color-coding system for new staff and to help avoid confusion in dim light or for color blind individuals.

 

 

They recommend removal of any “social cause” or other colored wristbands on admission (with appropriate education of patients and families of the reasons) and, if that is not possible, covering those wristbands with bandages or medical tape. And wristbands from other facilities should be removed.

 

The Missouri toolkit has excellent resources for implementation, including good tips about development of policy and procedure, a sample workplan, FAQ’s, staff education, patient/family education, community education, brochures, PowerPoint slides, and even references on makers and designs of wristbands.

 

 

We highly recommend use of color-coded wristbands for the above indications, but only when you can be reasonably sure that all healthcare workers who might be working in your facility fully understand their meaning and use. That usually means that there has been a regional or state-wide collaborative to standardize the colors and their meanings across healthcare sites. We see many such regional organizations looking for a good project to collaborate on. This is a good one and most of the leg work has already been done for you!

 

 

Addenda:

 

 

 

The Colorado Foundation for Medical Care also provides a Wristband Color Standardization Project Implementation Toolkit. They add the color green to denote latex allergy and the color pink to denote restricted extremity. They also thoughtfully recommend that the color designation should apply not only to wristbands but any form of designation of the 5 conditions (eg. stickers or placards).

 

 

 

 

The Minnesota Hospital Association also has a Wristband Implementation Toolkit.  It also adopts green to denote latex allergy and pink to denote restricted extremity. They also provide a Power Point presentation on the color-coded wristbands and a sample policy.

 

 

 

 

Print  Wristbands: The Color-Coded Conundrum

September 25, 2007    

Lessons from the National Football League

  

A couple of weeks ago Buffalo Bills’ tight end Kevin Everett suffered a life-threatening spinal cord injury during a football game. Though his ultimate prognosis remains unknown, he has demonstrated some early neurological improvement that may be due at least in part to the rapid response of the emergency medical personnel and team physicians, including use of induced hypothermia which apparently had never been used this early in a human spinal cord injury. The ambulance/emergency medical technician team at the stadium had, in fact, met with team physicians Drs. John Marzo and Andrew Cappuccino a week before the first home game to go over procedures to be followed in the event of a suspected spinal injury. That training included the possible use of induced hypothermia by intravenous infusion of cold saline. The ambulance was also specially equipped with a backboard designed to accommodate a player's helmet and pads. At other NFL stadiums, physicians and emergency medical response teams simulated how they would respond to similar incidents.

 

 

Use of simulation in healthcare has become popular as a tool to help promote teamwork. Its roots are from Cockpit Resource Management training (also known as Crew Resource Management training) in the aviation industry (see our May 15, 2007 Tip of the Week). It’s most often used for teams, such as operating room teams, to improve communication skills and decision-making capabilities. Some simulators involve expensive hardware and software that allows life-like clinical situations and allows for “complications” or “unexpected circumstances” to be programmed into the simulation scenarios.

 

 

But simulation does not have to use expensive laboratories and equipment. Simulation could and should be part of your FMEA (Failure Mode and Effects Analysis) activities. Our September 11, 2007 Tip of the Week discussed the RCA on an unintentional chemotherapy overdose. Some of the issues addressed in the RCA dealt with the response and management of the patient after the patient had received the high dose of chemotherapy much more rapidly than planned. We wonder how many organizations that utilize such chemotherapy protocols (or a variety of other protocols, for that matter) have ever simulated such an unintended incident. Most often in a FMEA, one might simply note that someone would have to look up the effects of the chemotherapy toxicity and the clinical management of the patient. But an actual simulation in the above case may have surprised people when the paucity of published information on fluorouracil overdosage was discovered. Findings from such a simulation could certainly lead to a refinement of the protocol.

 

 

So a good simulation activity should include not only what steps are expected to be taken under certain circumstances but also anticipate what things might go wrong and how you would respond under those additional circumstances. Actually acting out the situation can sometimes produce surprises that lead to constructive changes. Think about adding that step when you do your next FMEA activity.

 

Print  Lessons from the National Football League

 

 

 

 

 

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