Quaid Case Update: Whose Responsibility is Standardized Work?


If you're a regular reader, you might recall the Cedar-Sinai medical error that harmed Dennis Quad's twins (and others).

Quaid and his wife are now suing the maker of the drug, Baxter, claiming the company is negligent for not designing packaging with good visual distinctions between the two doses (photo there on the linked TMZ.com page).

This week, Baxter announced an initiative to redesign the packaging of their “high risk” medications.

Considering this problem has happened before, I'm sure that effort isn't just a direct response to the Cedar-Sinai incident. It sounds like Baxter tried to get some “voice of the customer” input:

Baxter conducted multiple interviews with more than 100 pharmacists, physicians and nurses to identify areas for improvement . The feedback received from health care professionals guided the design of the new vial packaging.

In research conducted after the three-phase development program, clinicians indicated that the new packaging design enhancements addressed the current clinical needs for safer injectable drug administration and could help reduce medication errors.

“Health care professionals played a vital role in the design of the new label and we look forward to their continued input to gain key insights that will help in the development of future design enhancements, ” said Bonderud.

Baxter had already done some redesign, but Cedar-Sinai may have tried to save a few bucks by using up the old medication (in the old packaging) first. Normally “FIFO” would be a good thing, but not if the old product leads to a greater patient safety risk. In hindsight, would have been cheaper to throw the old stuff out, right?

I'm also not impressed that Cedar-Sinai leadership is apparently throwing their employees under the bus. In a statement, they said:

The medical center's investigation found that preventable errors made by pharmacy and nursing staff caused the wrong concentration of heparin to be used.

A pharmacy technician failed to follow hospital policy of having another pharmacy technician verify the medication and concentration prior to removing it from main pharmacy inventory. As a result, the technician mistakenly retrieved a higher concentration of heparin (10,000 units per milliliter) instead of the lower-concentration heparin (10 units per milliliter) used for flushing IV catheters.

The higher concentration heparin was delivered to the satellite pharmacy that serves the pediatrics unit. A second pharmacy technician, working in the satellite pharmacy, did not verify the concentration of the delivery from the main pharmacy, as required by hospital policy.

As a result, the higher-concentration heparin was placed in a location in the pediatrics unit where the lower-concentration heparin is kept. The nurses who subsequently administered the heparin to the patients also did not follow hospital policy of verifying the correct medication and dose prior to flushing the intravenous site.

The error was identified later that day by Cedars-Sinai staff, who immediately performed blood tests on the patients to measure blood clotting function. In one of the three patients, the clotting tests returned quickly to normal. The other two patients were given protamine sulfate, a drug that reverses the effects of heparin and helps restore blood clotting function to normal. Additional medical tests and clinical evaluation conducted on the two patients found no adverse effects from the heparin or from the temporary abnormal clotting function.

“Although this was a rare event, and attributable to human error, it is also an important opportunity for the entire institution to explore any and all ways we can further improve medication safety,” said Michael L. Langberg, M.D., chief medical officer at Cedars-Sinai Medical Center.

“On behalf of the medical center, I extend my deepest apologies to the families who were affected by this situation, and we will continue to work with them on any concerns or questions they may have. This was a preventable error, involving a failure to follow our standard policies and procedures, and there is no excuse for that to occur at Cedars-Sinai,” Langberg said.

Whose responsibility is it for the Standardized Work to be followed? Doesn't management have a responsibility to be proactively checking and looking to see if policies and procedures are being followed? It's not enough to wait and react when an incident occurs. I'd guess those same policy violations were happening every day and it finally caught up to them. Are employees responsible for following processes? Sure, but it's also management's responsibility to manage the process and the people. Does Toyota say, “well, our policy says people don't build defective vehicles”? Of course not.

Does management taking responsibility mean that we constantly hound and watch employees? No, but we have a responsibility to check to see if there are violations of policies BEFORE an injury or death occurs. Proper training and re-training should happen BEFORE problems occur. The employees directly involved in the Quaid incident are suspended. What about the managers and leaders?

To be fair, Cedar-Sinai is making a number of systemic changes (including moving from using heparin to saline, which is much safer, they say). But, they've also added MORE double checks (adding more of a method, relying on inspection and “be careful,” that didn't work 100%).

I hope other hospitals, where the same risk factors exists, will be more proactive. We need to make “preventable” errors into “prevented” errors.

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Mark Graban
Mark Graban is an internationally-recognized consultant, author, and professional speaker, and podcaster with experience in healthcare, manufacturing, and startups. Mark's new book is The Mistakes That Make Us: Cultivating a Culture of Learning and Innovation. He is also the author of Measures of Success: React Less, Lead Better, Improve More, the Shingo Award-winning books Lean Hospitals and Healthcare Kaizen, and the anthology Practicing Lean. Mark is also a Senior Advisor to the technology company KaiNexus.


  1. In our December 2007 “What’s New in the Patient Safety World?” column (www.patientsafetysolutions.com), we discussed the recurrent problem with “heparin flush” inadvertent overdoses. There are a number of lessons learned:

    They serve as a good reminder that double checks remain weak solutions in any root cause analysis. Human error rates in many industries show error rates of 10% or higher when someone checks the work of someone else. So even though you should not abandon your double checks before medication administration, you must have other protections in place as well.

    Secondly, Joint Commission requires facilities to incorporate failure mode and effects analysis (FMEA) into their quality improvement activities. When we are asked what problems a facility might consider for a FMEA, hi-alert drugs are always at the top of our list. Doing FMEA for processes related to anticoagulants is important not only in helping to prevent errors but may also be very valuable in helping you to respond quickly and appropriately to prevent patient harm in the event that such an error actually occurs.

    Thirdly, Joint Commission also requires organizations systematically review look-alike/sound-alike medications as part of their medication safety program. Too many organizations spend most of their time on the “sound alike” portion and not enough time on the “look alike” side, especially looking at packaging and labeling.

    A fourth lesson is more philosophical. There are certain medications that clinical staff often don’t consider to be “medications”. Heparin flushes are probably one of those. IV solutions are another. We need to do a better job of reminding staff about all potentially dangerous things.

    Fifthly, automated dispensing machines have been a godsend for most organizations and have undoubtedly contributed to improvement in both efficiency and patient safety. However, they do bring their own set of potential problems. Organizations should be looking to ensure that they are tied to other technological patient safety initiatives such as barcoding and computerized physician order entry (CPOE). In the meantime, consider them as another topic for FMEA.

    Lastly, each organization needs to think about how it responds to alerts that are put out by critical incidents occurring anywhere. Don’t wait for something bad to happen at your facility. Make sure that part of your routine patient safety activities is responding to alerts put out by the FDA, ISMP, Joint Commission, your state Department of Health, or other reputable organizations that issue alerts. One item on your monthly quality improvement/patient safety agenda should be “Industry Alerts and Concerns” and someone should be charged with scanning the appropriate resources for such alerts.


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