The World Health Organization’s Safe Surgery Saves Lives initiative has released a Surgical Safety Checklist and an article on its preliminary use was published online in Lancet on June 25, 2008.

It is fitting that co-author Atul Gawande played a key role in rolling out this tool that undoubtedly will prove to be very useful in reducing adverse events related to surgery. Most of you are very familiar with Dr. Gawande’s published works in the peer-reviewed literature. But perhaps his best know publication was his treatise on “The Checklist” that appeared in The New Yorker. In that article, he eloquently expounded upon the simplicity and sophistication of Peter Pronovost’s success in introducing the concept of the checklist to improve medical care. Gawande and his colleagues have run with that concept and developed a tool that can be applied to surgery throughout the world. Piloting the checklist at 8 sites worldwide, they demonstrated that adherence to several standards of surgical care were improved from 36% to 68%. Some hospitals achieved almost 100% adherence. Their preliminary data (in 1000 patients) suggests that there will be significant reductions in surgical morbidity and mortality.

The checklist has 3 phases:

• Sign In
• Time Out
• Sign Out

At each phase, a designated Checklist coordinator must confirm that all steps/tasks have been completed before the patient moves on to the next phase. That coordinator could be any member of the team, though it is anticipated a circulating nurse may fulfill this role in many organizations.

During the Sign In phase (done before induction of anesthesia), the patient identity, site, procedure, and informed consent are confirmed. The site marking is confirmed and completion of the anesthesia safety check is done. The presence of a pulse oximeter on the patient and that it is functional are confirmed. Other issues addressed are allergies, airway risk, aspiration risk, risk of blood loss, and presence of proper equipment/assistance to help in these cases.

The Time Out phase is done before the skin incision. All team members introduce themselves by name and role. The team again confirms the identity of the patient, site, and procedure and discusses anticipated critical events. Also confirmed are antibiotic prophylaxis and timing and display of imaging studies.

The Sign Out phase is completed before the patient leaves the operating room. The Checklist coordinator verbally confirms the name of the procedure, the instrument and sponge counts, correct labeling of any specimens, any  equipment problems, and key concerns for postoperative care and recovery.

The Checklist and a short manual on how to best use it can both be downloaded from the WHO website. Facilities are encouraged to modify the Checklist and add safety steps that are important to their needs, though removal of any steps is discouraged. Modification of the Checklist for specific procedures is likely to occur, for instance confirmation of specific DVT prophylaxis for many specific procedures. Yet the beauty of the Checklist is its simplicity and the authors' caution against making it too complex.

Note that the importance of checklists has also made its way into the Joint Commission’s National Patient Safety Goals (see our July 2008 What’s New in the Patient Safety World column “Joint Commission 2009 National Patient Safety Goals”).

References:

WHO surgical safety checklist

http://www.who.int/entity/patientsafety/safesurgery/tools_resources/SSSL_Checklist_finalJun08.pdf

Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WF, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet 2008 (early online publication 25 June 2008)

http://www.thelancet.com/journals/lancet/article/PIIS0140673608608788/abstract?isEOP=true

Gawande Atul. The Checklist. If something so simple can transform intensive care, what else can it do? The New Yorker. December 10, 2007

http://www.newyorker.com/reporting/2007/12/10/071210fa_fact_gawande

Print “WHO’s New Surgical Safety Checklist”

We’ve already written about the dangers of heparin flushes three times since December 2007 and – guess what – they are back in the news again. This time there is a slightly different nuance but the end result is the same – multiple neonates were inadvertently exposed to dangerously high doses of heparin via heparin flushes. Somewhere between 14 and 17 neonates apparently were given heparin flushes with solutions containing about 100 times the expected concentration of heparin.

In our December 2007 and April 2008 What’s New in the Patient Safety World columns we pointed out many of the lessons learned from prior incidents in Indiana and California. ISMP (the Institute for Safe Medication Practices) has done a great service in its September 21, 2006 Newsletter and November 29, 2007 Newsletter disseminating useful tips on prevention of incidents related to heparin flushes and most of their recommendations are in the above columns. Then in our May 2008 What’s New in the Patient Safety World column we discussed the UK NPSA’s alert “Risks with Intravenous Heparin Flush Solutions”. Their recommendations were based not only on a thorough root cause analysis of several cases similar to those reported in the US, but also a thorough search into the evidence base on the utility (or lack thereof) of heparin flushes in many situations. The latter led to the conclusion that heparin flushes have no advantage over normal saline for maintaining peripheral intravenous catheters (evidence is less clear for arterial catheters or central venous catheters).

It is our opinion that one of the biggest problems is that heparin flushes are often not considered “drugs” or “medications”. They (along with oxygen and intravenous fluids) are not treated with the same “respect” that is used when dealing with a chemotherapy agent or insulin or other drugs. We clearly need to think of the heparin flush not only as a drug/medication but in fact as a high risk medication. Joint Commission’s 2009 National Patient Safety Goals would appear to exempt the heparin flush from its more rigourous standard (which does not apply to use of anticoagulants in a fashion not expected to significantly alter coagulation parameters). Well, these cases are good examples of what can happen even when you don’t expect the coagulation parameters to be altered. And inclusion of heparin in the flush solution also exposes patients to the risk of allergy and heparin-induced thrombocytopenia.

We don’t have enough details about the current Texas case to be certain, but we wonder whether the prior episodes may have actually made the current episode more likely. In all the prior cases, the person administering the heparin flush had drawn it up from a multidose vial. In the current case, multidose vials of heparin were not in floor stock. Rather, pharmacy was mixing up the heparin flush solutions and the error apparently happened during pharmacy’s mixing procedure and was not identified by a double check. We suspect they may have been doing this procedure with the good intention of removing this highly error-prone procedure from nursing staff. Unfortunately, it seems this just moved the “smoking gun” from one type of provider to another. If so, that is another lesson relearned: when you implement what you think is a good solution to a patient safety problem, you need to have some “measurement” or other methods of both demonstrating the solution leads to the desired outcome and some way of looking for undesirable unintended consequences.

The incident highlights another point we have made over and over – double checks are very weak safety interventions. From all industries we know that the error rate when a supervisor checks someone else’s work may be 10% or higher. Note that we don’t know what influence the double check has on the error rates of the original person. It is quite conceivable that the original person may make more errors if they feel that their errors will be intercepted by a second reviewer. We have certainly seen in some technology solutions that staff become so confident in the computer’s ability to capture errors that their own vigilance may wane. The UK NPSA study did acknowledge the controversy regarding double checks but notes that the literature supports a medication error reduction of about 30% when using a double check system.

In response to the current Texas incident, the Leapfrog Group released a statement again encouraging all hospitals to adopt CPOE and encouraging consumers to ask whether hospitals have CPOE before seeking care there. While we are, of course, huge advocates for CPOE, the Texas incident frankly would not likely have been prevented by CPOE. Note that we say “not likely”. The only way CPOE could have prevented this would be if heparin flushes required a specific physician order. Then, at the time of order entry, an alert could appear with links to the evidence base on use of heparin flushes in various settings.

This is clearly a situation where those who are ‘looking for blood” and someone to blame are way off base. Just look at some of the crude comments appearing about pharmacists and nurses and physicians and hospitals in many of the blogs in the LA Times and Wall Street Journal related to the heparin flush incidents. The two Texas pharmacists in the current episode are the two people in this entire country most likely to never have this happen again! Just as was the case with nurses getting fired after giving concentrated potassium solutions intravenously, looking at the role of individuals here takes away from getting to the root causes and coming up with viable solutions that need to be applied in all healthcare settings to prevent recurrence of these unfortunate events. Punishing those individuals would simply pave the way for a severely flawed system to be perpetuated.

So what are we to do? One solution is to use commercially available prefilled heparin flush syringes. However, those syringes must be clearly labeled in such a fashion that they are unlikely to be confused with or mistaken for similar-sized syringes filled with other medications. We have strong doubts that such a distinctive syringe can really be created. Using barcoding medication safety systems would improve that capability as long as the barcode on the prefilled syringe correctly matched the order in the system (which, in turn depends on the reliability of getting the correct concentration of heparin and correct barcode label at the factory).

Previous ISMP recommendations noted the hazards of stocking automated medication dispensing machines, especially on neonatal and pediatric units because they are especially high-risk patients. They noted that a double check of all medications as they leave the pharmacy is important but not fool-proof, as the current case demonstrates. They also made a renewed call for vigilance for look-alike/sound-alike (LASA) items and strongly recommended use of barcoding as a patient safety tool. They pointed out that even when bedside barcoding is not available, barcode systems are available for many of the automated dispensing machines to help ensure proper stocking of those machines. Previous NPSA recommendations on injectable medications included things such as only stocking low-dose heparin products in areas other than pharmacy, correctly labeling all syringes, and using double checking systems when preparing medication for injection and when administering such injections.

But perhaps the most important solution is to stop treating heparin flushes as something other than what they really are – drugs – and require a formal physician order for their use. Each institution clearly needs to look at their policies for use of heparin flushes and determine for which type of catheters and which type of patients is the evidence base solid enough to merit use of a heparin flush over a saline flush. Most facilities will find that they are currently using heparin flushes for many situations in which the evidence base is lacking. The UK NPSA alert recommends that heparin flushes should never be considered “routine” and should be used only when specifically prescribed.

And regarding the evidence base or lack thereof for some of the situations, this is where funding of multicenter randomized controlled trials by NIH or AHRQ should come in. No drug company is likely to sponsor such a study (since its conclusion could well be that the drug has no use in these situations) and many researchers will consider this too “mundane” an academic endeavor. However, this is exactly the kind of patient safety initiative that the Institute of Medicine (IOM) probably had in mind when it recommended legislation and creation of various methods of promoting clinical patient safety research.

We hope that the hospital in Texas will widely share the lessons learned from their root cause analysis on this incident. How many times have we already said “that could happen at almost any hospital today”? Let’s solve this vexing issue like the concentrated potassium solution issue was solved.

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July 22, 2008

Lots New in the Anticoagulation Literature

Patient-controlled analgesia (PCA) pumps have revolutionized pain management in the acute hospital as well as other sites. They allow analgesia to be delivered to a patient at a time when it is most needed – not on a nursing or pharmacy schedule but rather when the patient indicates he/she is still perceiving significant pain. And they minimize the need for guessing about how much analgesic will be needed by the patient. The overall safety record of patient-controlled analgesia is quite good and an improvement upon previous methods of administering patient analgesia. Nevertheless, there have been some significant concerns about certain aspects of patient safety with PCA.

ISMP published an outstanding monograph about patient safety issues involved in PCA in 2006. “PCA By Proxy” is perhaps the best know safety issue with PCA. This, of course, means the pressing of the infusion administration button by someone other than the patient. This is most often a friend or family member but could be a member of the healthcare team. In most cases, the person pressing the PCA button thinks they are helping the patient avoid pain. They may not recognize the problem of overdosage from the narcotics. One of the “built-in” safety features of PCA is that when a patient gets sedated from too much analgesic, they can no longer press the PCA button to get more analgesic. That safety measure is bypassed in “PCA by Proxy”. In fact, the occurrence of incidents involving “PCA by Proxy” was significant enough for Joint Commission to issue a Sentinel Event Alert in 2004.

A recent ISMP Safe Medication Alert “Misprogramming PCA concentration leads to dosing errors” points out another very significant and somewhat paradoxical problem with PCA pump programming. If one programs in too high of a concentration, the patient tends to get underdosed (so may suffer continued pain). If one programs in too low a concentration, the patient actually gets overdosed! This seems counterintuitive. But think about it – the patient asks for a certain dose of the narcotic and the pump delivers the volume it is programmed for to meet that request. If the concentration was erroneously too low, the pump has now given a higher volume and, hence, a higher actual narcotic dose. And often a warning on the pump that the concentration is too low may be overridden because the nurse or physician feels less concerned about “too low” than “too high”. ISMP makes some specific recommendations to reduce the risk of such errors. One is to make the “too low concentration” warning a “hard” warning that must be acknowledged and reprogrammed rather than simply being overridden. They strongly suggest organizations assess their current vulnerabilities to mistakes of this sort (perhaps do a FMEA on PCA pumps) and increase staff awareness of the results. Limiting stock to a single standard concentration of each of the PCA drugs may also help. They discuss numerous aspects of proper labeling and stress that there must be a very distinctive label for any nonstandard concentrations. They also recommend use of double checks and bar-coding and smart pump technology.

Our March 12, 2007 Patient Safety Tip of the Week “10x Overdoses” pointed out another potential problem with misprogramming PCA (or other infusion) pumps. The data entry person may double press a key (or the key may become stuck) resulting in, for example, “88” instead of “8”. Also, during data entry it is possible to think one hit a decimal point but it fails to print out. These types of data entry error have recently been noted in programmable intravenous infusion pumps and there have been several occurrences of 10x overdoses with those pumps. Therefore, a policy of having a second independent observer verify the dosage or rate on such pumps makes sense (however, keep in mind that error rates from other industries tell us that one who oversees someone else’s work typically does so in error up to 10% of the time!).

Speaking of decimal points, when do you really need them? You all know you should never use a “trailing zero”, i.e. a zero following a decimal point, because if the decimal point is not seen there is a risk of a 10-fold (or higher) overdose. But what about other numbers following a decimal point? They are important in certain circumstances (eg. a dose of 0.3 mg or 2.7 mg). However, at higher doses they become much less relevant. For example, let’s say you performed a calculation and the result was a recommended dose of a drug is 72.2  mg. Is there really a difference if the patient gets 72 mg. or 72.2 mg of most drugs? Yet ordering the latter dosage increases the risk that the decimal point may not be seen or not input into a computer or missed in a faxed order and the patient gets a 10x overdose. So we strongly recommend that in writing medication orders one specifically decides whether such fractional doses are important or merely place the patient at increased risk of an error.

The 2006 ISMP monograph also discusses other issues regarding misprogramming PCA pumps and several other issues, including selecting appropriate patients for PCA, monitoring patients, setting up quality indicators, and performing FMEA.

In our June 10, 2008 Patient Safety Tip of the Week “Monitoring the Postoperative COPD Patient” we also noted some important points about monitoring patients on PCA pumps. These included identifying high-risk patients, using sedation scales properly, and using capnography in addition to pulse oximetry in certain high-risk patients.

References:

Cohen MR, Weber RJ, Moss J (Institute for Safe Medication Practices). Patient-Controlled Analgesia: Making it Safer for Patients. A continuing education program for pharmacists and nurses. ISMP. April 2006 http://www.ismp.org/profdevelopment/PCAMonograph.pdf

http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_33.htm

ISMP. Misprogramming PCA concentration leads to dosing errors. Medication Safety Alert Newsletter (Acute Care Edition). August 28, 2008 http://www.ismp.org/Newsletters/acutecare/articles/20080828.asp

Print “Less is More….and Do You Really Need that Decimal?”

September 16, 2008

More on Radiology as a High Risk Area

Headlines continue to highlight cases of wrong site surgery. In the last few months, cases have even occurred at well-respected academic facilities such as the Beth Israel Hospital in Boston and the Miriam Hospital in Rhode Island. In the former case, a surgical timeout apparently did not take place. In the latter, the error occurred despite a surgical timeout. It is not clear whether either organization utilizes the checklist approach that we strongly advocate.

Joint Commission’s 2009 National Patient Safety Goals (see our July 2008 What’s New in the Patient Safety World column “Joint Commission 2009 National Patient Safety Goals”) have a requirement for use of a checklist during the pre-procedure verification process. The checklist can be paper or electronic or even on a wall-mounted white board and needs to include elements such as the H&P, anesthesia assessment, completed informed consent, appropriate diagnostic and imaging reports or images, and any required implants, devices, special equipment or blood products that will be needed.

WHO’s new Surgical Safety Checklist (see our July 2, 2008 Patient Safety Tip of the Week “WHO’s New Surgical Safety Checklist”) actually consists of 3 checklists, one for the period prior to induction of anesthesia, one for the timeout (prior to skin incision), and one before the patient leaves the OR. The Checklist and a short manual on how to best use it can both be downloaded from the WHO website. Facilities are encouraged to modify the Checklist and add safety steps that are important to their needs, though removal of any steps is discouraged. Modification of the Checklist for specific procedures is likely to occur, for instance confirmation of specific DVT prophylaxis for many specific procedures. Yet the beauty of the Checklist is its simplicity and the authors’ caution against making it too complex.

But even more comprehensive checklists have been developed for specific surgical settings. Use of a 28-item structured checklist (Verdaasdonk 2008) addressing problems with laparoscopic equipment resulted in a 53% reduction of incidents related to such equipment.

A few weeks ago, at one of our patient safety presentations, a surgeon expressed concern about the amount of time added to procedures by following Universal Protocol and doing the surgical timeout. The answer is that following the protocol in most cases adds no more than 1-2 minutes per case. Even in the busiest of OR’s that does not add a significant burden to the OR schedule. The beauty of checklists is that they are both simple and save time in the long run. Even the 28-item laparoscopic checklist in the Verdaasdonk article took only an average of 3.3 minutes to complete. Though they did not specifically measure it, we suspect that there was far more time savings on the back end, i.e. the time saved by avoiding equipment problems probably far exceeded the 3.3 minutes taken on the front end.

One important point to remember is that developing checklists is not enough. You must audit the use of and adherence to the checklists you develop. Some organizations do video monitoring of surgical procedures, including recording of the timeout procedure. That allows analysis of the completeness of the surgical timeout and can be a valuable tool in promoting a culture of safety and improving communication within the OR. Other organizations are too fearful of litigation to do video recording. Those organizations should at least perform sample audits of the timeout procedure (by having someone in the OR audit the timeout) but those need to be done in a manner in which the presence of the auditor does not bias the procedure. Walking into the OR and announcing  “I’m here to audit the timeout” almost guarantees that timeout will be done correctly. While we advocate openness and frankness in quality improvement activities, sometimes a “secret shopper” type audit needs to be done to get a true picture of how often the timeout is being done and being done properly and completely. The audit should be done for anything you develop a checklist for, not just a safe surgery checklist.

Atul Gawande, a coauthor of the WHO checklist may be best known for his treatise on “The Checklist” that appeared in The New Yorker. In that article, he eloquently expounded upon the simplicity and sophistication of Peter Pronovost’s success in introducing the concept of the checklist to improve medical care. We recommend use of checklists for multiple different types of processes in healthcare such as:

• Peter Pronovost-type checklist for ICU procedures like central line insertion
• WHO Safe Surgery Checklist
• Pre-procedure verification checklist
• Serious Incident Response checklist (see our July 24, 2007 Patient Safety Tip of the Week “Serious Incident Response Checklist”)
• Checklist for VAP prevention
• Checklist for any procedure (eg. thoracentesis)
• Checklist for equipment maintenance (see our March 5, 2007 Patient Safety Tip of the Week “Disabled Alarms”)
• Checklist for room decontamination

Checklists can also be a part of your own personal life. We have a little cabin on an island in northern Ontario. It takes 6-7 hours to get there so anything we overlook either when we are going there or coming back can lead to major problems. So we use checklists! We have one for all the things we need to make the trip up there and another for all the things we need to do when we are leaving the cabin. We even have a checklist for inventory of common items we keep at the cabin. Sometimes time pressures (there’s a thunderstorm coming in – let’s get going!) have caused us to shortcut the checklist. Almost invariably when we skip things on the checklist it comes back to haunt us. So we’ve learned the hard way – if you make a check list, use it correctly!

Checklists are some of the most valuable tools we have available in quality improvement and patient safety. They are also the least expensive of all tools. But the ROI on checklists is incredibly high, both in human terms and financial terms.

The Verdaasdonk article also references an excellent guidance from the UK Civil Aviation Authority on the proper design, presentation and use of checklists.

References:

Joint Commission. 2009 National Patient Safety Goals.

http://www.jointcommission.org/NR/rdonlyres/31666E86-E7F4-423E-9BE8-F05BD1CB0AA8/0/09_NPSG_HAP.pdf

WHO surgical safety checklist

http://www.who.int/entity/patientsafety/safesurgery/tools_resources/SSSL_Checklist_finalJun08.pdf

Verdaasdonk EG, Stassen LP, Hoffman WF, van der Elst M, Dankelman J. Can a structured checklist prevent problems with laparoscopic equipment. Surgical Edoscopy 2008; 22: 2238-2243 (accessed online 9/22/2008) http://www.springerlink.com/content/1845j684574501v2/

Gawande Atul. The Checklist. If something so simple can transform intensive care, what else can it do? The New Yorker. December 10, 2007

http://www.newyorker.com/reporting/2007/12/10/071210fa_fact_gawande

Civil Aviation Authority (UK). CAP 676: Guidance on the Design, Presentation and Use

of Emergency and Abnormal Checklists. January 2006.

http://www.avhf.com/html/Publications/Outside_Pubs/CAA CAP676.pdf

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September 30, 2008

Hot Topic: Handoffs