Legal Review & Commentary: Medication error case settles for $8.25 million prior to trial
Legal Review & Commentary
Medication error case settles for $8.25 million prior to trial
By Jonathan D. Rubin, Esq.
Partner
Kaufman Borgeest & Ryan
New York, NY
Philip Nash
Law Clerk
Kaufman Borgeest & Ryan
Garden City, NY
Alvin Safran
Director of Risk and Claims
Management
The New York Hospital Medical
Center of Queens
Flushing, NY
News: A baby boy, born prematurely at 24 weeks, and weighing less than 2 pounds, was in the hospital’s neonatal intensive care unit. After successful heart surgery, the hospital’s pharmacy technician incorrectly transcribed a physician’s order for a sodium chloride intravenous bag into the compounding machine. A sodium chloride solution containing 60 times the amount ordered was formulated and administered. The baby went into cardiac arrest and died. The hospital settled with the boy’s parents for $8.25 million.
Background: A baby boy was born prematurely at 24 weeks on Sept. 6, 2010. He weighed less than 2 pounds at birth and was being treated in the hospital’s neonatal intensive care unit. His condition improved after 40 days of treatment. On Oct. 15, 2010, the baby successfully underwent heart surgery. Following the surgery, a physician ordered a sodium chloride IV. According to the complaint, a pharmacy technician incorrectly transcribed the order into the hospital’s IV compounding machine. The machine created a customized IV bag containing 60 times the sodium chloride than originally was ordered. This faulty bag was administered to the baby. After administering the IV, a blood test on the baby was performed. The test reported abnormally high sodium levels. However, the resident reading the blood test results assumed the numbers were a mistake. Another blood test was ordered, but it was not ordered to be done immediately. Eight hours elapsed, and the second blood test was not completed. The baby went into cardiac arrest from the overdose of sodium chloride and died.
Immediately following the baby’s death, the hospital launched an investigation. Several factors were found to have contributed to the administering of a lethal dose of sodium chloride. Physicians primarily transmitted their medication orders electronically to the pharmacy’s drug dispensing system. However, the automated compounding system used to prepare the custom IV bag in this case was not connected to this electronic system.
The physician’s order was manually input into the compounding machine by a pharmacy technician. This input resulted in the transcribing error. Additionally, when the technician initially input the incorrect order into the compounding machine, the machine’s automated alerts were not activated to warn about the lethal dosage. Furthermore, the original label affixed to the bag of custommade solution correctly identified the solution’s composition, but a second label was placed over that original label. This second label only indicated the physician’s original order.
Several hospital policies were changed as a result of this incident. Pharmacists must now double check IV bags before they leave the pharmacy to guarantee the solution correctly matches the label affixed to the bag. Alerts on IV compounding machines also have been activated. In addition, blood tests ordered after a physician suspects a mistake or faulty test reading must be completed immediately.
Hospital officials informed the baby’s parents about the errors and apologized. A medical malpractice suit against the hospital alleging wrongful death was filed in April 2011. The case settled for $8.25 million before going to trial.
What this means to you: This case represents a true system failure in which all checks and balances on several levels failed. The transcribing error was the first in a series of errors.
Sometimes the way in which one reacts to an error is more important than the actual error. It was reported that a second label was placed over the original label on the IV solution. The placement of the second label over the original label would have made it that more difficult for the nurse administering the drug to detect the error because the second label was consistent with the order, not what was actually in the IV bag. The dispensing of drugs with two labels needs to be a major part of any analysis concerning this incident. The receipt of any drug with two labels on a care unit, whether side by side or one over another, should prompt the highest degree of scrutiny. The care unit should not try to figure it out. It would not be unreasonable for the care unit to return such an IV bag to the pharmacy. At that point, all stages of the medication process for that order should be rechecked. This case represents an instance in which an opportunity to rectify the error was missed.
In this instance, the fatal overdose was administered in an intensive care unit (ICU). Lab results came back indicating the abnormal sodium level. The physician ordered retesting but did not order it stat, and some eight hours transpired in the interim. Another opportunity to possibly rectify the error was missed. This situation raises some concerns over the level of supervision in the ICU.
There appears to be a large degree of human error here, but it is still most important that the analysis of the incident focus on what happened and why the system(s) failed. Those who are responsible for putting the correction plan together must tread the fine line between blame and accountability. Conducting a root cause analysis (RCA) when human error played a significant role in the incident can be awkward. The person conducting the RCA needs to give much thought as to who should be invited to the RCA. More specifically, should the person(s) who made the error(s) be invited to participate? Some believe that the only way to analyze exactly what happened is to have all of the players directly involved in the incident participate in the RCA. While the obvious benefit is that those who were directly involved can best explain what happened, the disadvantage is that having the persons who committed the error participate in the RCA can have a chilling effect on the process. It can make the participants feel uncomfortable about asking probing questions. It also can be traumatic for the person who committed the error to relive it. Another factor to take into consideration is your state’s discoverability laws. In some states, all statements (written or verbal) by defendants are discoverable, even if made during the peer review process. Under these circumstances, careful consideration must be given with respect to having potential defendants participate directly in the RCA.
Another difficult issue that needs to be considered is what corrective action, if any, should be taken against the individual(s) who made the error. The current risk management philosophy says a non-punitive culture is the best way to establish a culture of safety. A just culture strives for a system approach to analyzing an error rather than a punitive approach. The analysis should focus on what happened rather than who made the error. Nevertheless, a just culture does not preclude accountability for one’s actions. (Editor’s note: For more information on a just culture, see “Hospital shows just culture can work,” Healthcare Risk Management, March 2006.)
In its correction plan, the hospital stated it would institute a double-check system in the pharmacy. While this system sounds good on paper, a great deal of thought needs to go into any double-check system. Each healthcare facility should describe how a double check or a double review is to take place. The danger in a double review is that the second review becomes a “rubber stamp” of the initial review. The double check needs to be devised in a manner that ensures a second review is as independent as possible.
Electronic medical records and electronic order entry can prevent many errors. On the other hand, we are learning that electronic records create their own unique problems. In this case, the pharmacy’s system did not send out any alert over the discrepancy between the physician’s order and the pharmacist’s incorrect transcription. Hospitals are struggling with the major challenges of standardizing electronic systems, or at least having electronic systems that communicate critical information to each other.
The decision to settle this case rather than to take it to verdict appears to be a reasonable one. The fact that human error caused the incident and the systems in place failed to detect the error would have made this case difficult to defend. Of course, the decision to settle rather than defend takes into account sustainable jury verdicts in each state. There can be a large disparity in sustainable verdicts from state to state.
Another interesting risk management issue in this case involves the disclosure and apology. The hospital seems to have followed the textbook manner in apologizing and disclosing quickly and transparently. Once again, state laws regarding discovery of disclosures and apologies can play a significant role in determining how the disclosure is conducted. While it was unquestionably the right thing to do ethically and morally, one cannot help but notice that it did not result in any appreciable savings to the hospital.
It is hoped that other healthcare providers can learn lessons from this tragic event.
Reference
Circuit Court of Illinois, Law Division, Cook Co. Case No. 2011-L-003535.
News: A baby boy, born prematurely at 24 weeks, and weighing less than 2 pounds, was in the hospitals neonatal intensive care unit.Subscribe Now for Access
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