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Human Error or Criminal Conduct: How Did It Resolve?

March 13, 2007

At the time this article appeared in our Nov 2006 Health Law Vantage Point, the Madison nurse who mistakenly administered the wrong medication resulting in a patient fatality was facing a felony charge of Negligent Abuse of a Patient - Causing Great Bodily Harm under Wis. Stats. B'940.295(3)(a)3. This felony charge carried a potential penalty of up to six years in prison, a fine of up to $10,000 or both. The magnitude of the potential penalty facing the nurse was a very serious and potentially threatening outcome. As a result of negotiations, the criminal case has been resolved in Dane County Circuit Court with a plea to reduced criminal misdemeanor charges and the licensing sanction against the nurse in question has also been resolved before the Nursing Board at the Wisconsin Department of Regulation & Licensing.

As a follow-up to the last article on this topic, summarized below are the details of how the criminal case was resolved, what happened before the Department of Regulation and Licensing concerning the nursing license of the defendant in the case, and finally the stipulated facts to which the state and the nurse agreed. These facts present an opportunity to consider directly what may be the line between negligent and criminal conduct leading to a patient death.

Resolution of the Criminal Case
In the criminal case, the felony charge was reduced to two misdemeanor offenses: Nonpharmacist Dispensing of a Prescription under Wis. Stats. §450.11(3) and Possessing/Illegally Obtaining a Prescription under Wis. Stats. §450.11(7)(h). Upon the nurse's pleas of no contest, Judge Daniel Moeser withheld sentencing and placed the nurse on two years probation with conditions that the nurse not engage in critical care nursing, including OB/birthing units, intensive care ICU's, pediatric ICU's, neo-natal ICU's, cardiac care units, cardiac catheter labs, telemetry units, progressive care units, emergency departments and recovery rooms. No jail time or fines, other than standard court costs, were imposed.

Resolution of the Regulation & Licensing Case

As part of a stipulated disposition before the Department of Regulation & Licensing, the parties stipulated to a nine-month suspension of the nurse's license to practice nursing commencing July 6, 2006. Upon the end of the nine-month suspension of the nurse's license, her license is to be limited for two years. The details of the license limitations are available at the Department of Regulation & Licensing website (dept/decisions/docs/20061214Thao.htm).

Stipulated Factual Basis for Disciplinary Action
The parties also stipulated to the following facts in support of the suspension order, some of which may have had a mitigating effect on the final administrative disposition:

"The nurse's work history was as follows: On July 4, 2006, the nurse worked two consecutive 8-hour shifts and the second shift ended at midnight. The nurse had volunteered for the shifts some time prior to coming to work on July 4 and had arranged to sleep at the hospital following the shifts because she began another scheduled 8-hour shift on the Birthing Unit, at 7:00 a.m. on July 5th, the date of the fatal medication error.

The parties also stipulated that the unit secretary printed the patient identification wrist band and placed it in a pocket in her medical chart, which was taken to the patient's birthing room. Wrist bands are to be fastened to the patient's wrist as soon as possible. Prior to performing any treatment or providing any medication, a nurse is to check the wrist band to make certain it is the correct patient. It was the nurse's responsibility to fasten the wrist band on the patient's wrist, but the wrist band was never placed on the patient.

The nurse met with the patient and her family in the patient's birthing room and spent almost an hour explaining the process and answering questions. This was the patient's first pregnancy and she was anxious about delivering. The nurse says that much of her focus was on alleviating the patient's anxiety. At 10:49 a.m. the nurse performed an examination and determined that the patient's cervix was dilated 2 centimeters and effaced 80%. They had a discussion about the possibility of the patient receiving an epidural. The patient's mother recalls saying that the patient wanted an epidural only as a last resort. The nurse recalls that the patient and her mother seemed interested in her having an epidural as early as possible. The nurse said that no epidural would be given until the patient was dilated 3-5 centimeters.

11:00 a.m. - The obstetrics resident physician signed the order for the initiation of the initial prophylaxis dose of Penicillin G, 5 million units IV, may add 1ml Lidocaine 1% PRN. The nurse ordered the penicillin from the pharmacy, which is located in a different part of the hospital.

11:15 a.m. - The resident signed the labor admission orders, which included: starting a one liter IV bag of lactated ringers to provide water and electrolytes, oxytocin (brand name Pitocin) to be used during labor to initiate or improve contractions and oral and IV analgesics for pain as needed.

Approx. 11:30 a.m. - The obstetrician ruptured the patient's membranes to begin labor. The obstetrician did not order an epidural at that time. His practice was to wait and see if it was needed and then order it if it was required.

The nurse went across the hall on the Birthing Unit to the medication room where the Pyxis station was located which contained many of the medications used on the Birthing Unit. 1

1:36 a.m. - The nurse entered the patient's identification into the Pyxis machine and gained access to and removed the bag of IV fluid (lactated ringers) and several other medications which had been ordered, which might be needed for the mother or the newborn. At the same time, because she believed it likely that an epidural would be ordered for the patient, she removed the epidural medications (a combination of bupivacaine and fentanyl), which had not been ordered. She took all of the medications back across the hall and placed them on the counter in the anteroom to the patient's birthing room.

At about that same time, the penicillin was delivered to the Birthing Unit from the pharmacy and another nurse brought it to the anteroom to the patient's birthing room, placed it on the counter and told the nurse it was there.

The penicillin was in 250 cc of liquid in a clear plastic mini-bag. The epidural was also in 250 cc of liquid in a clear plastic mini-bag the same size and shape as the penicillin mini-bag. The penicillin mini-bag is to be administered intravenously and the epidural mini-bag is to be administered into the patient's spine, but the outlets and connections were the same. However, there were visible differences between the appearances of the two mini-bags:

a. The name of the drug contained in the liquid was printed on each mini-bag.

b. The front of the epidural bag had a bright pink label approximately three inches square which said "Epidural Medication" and the back had a smaller bright pink label which said "Epidural Medication." The penicillin bag did not have any colored labels.

c. Each bag had a portal adjacent to its outlet with the spike. The portal on the epidural bag had a large dark cap, which cannot be removed and does not allow any additional medications to be inserted in the bag. The portal on the penicillin bag had a smaller light colored removable cap, which would allow medications to be inserted.

Each bed on the Birthing Unit has a computer terminal with a monitor, keyboard and scanner which nurses and other providers use to make entries into the patient's electronic record. In addition, the terminal had Bridge Medical MedPoint point-of-care patient safety software which uses bar-code scanning to help nurses intercept potential clinical errors at the patient bedside.

a. St. Mary's had been integrating the Bridge Medical system into its units over a period of time and began using it on the Birthing Unit three weeks before July 5, 2006, after training was provided to the unit's staff.

b. Using that system, before giving any medication to a patient, the nurse scans the bar codes on: 1) the patient's wrist band to confirm the patient, 2) the nurse's ID card to identify who was administering the medication, and 3) the medication container to verify the medication, dose, route of administration and time of administration.

c. A screen then appears on the monitor which verifies that the drug, patient, dose, time and route of administration all match the medication order before the drug is administered. If the medication has not been ordered for the patient, the nurse must check a box on the screen to override the lack of an order.

Shortly before noon the nurse hung the IV bag of lactated ringers, inserted the needle into a vein in the patient's arm and began the flow of the IV fluid through the line into the patient's vein. The nurse then began the process of adding to the IV line the mini-bag of penicillin, which had been ordered. The nurse took what she thought was the mini-bag containing the penicillin and spiked it into the IV line into the patient's arm. However, it was actually the mini-bag containing the unordered epidural medication which is to be administered into a patient's spine and not intravenously.

Prior to starting the mini-bag to administer the medication to the patient, the nurse did not scan the barcodes on the patient's wrist band, her own ID card or the mini-bag. Had the nurse scanned the barcodes, the computer monitor screen would have shown her that this was epidural medication and that there was no order for the patient.

Prior to starting the mini-bag to administer the medication to the patient, the nurse did not follow basic nursing standards and read the label on the mini-bag to verify that she was giving the right medication to the right patient in the right dose at the right time by the right route of administration.

The order for the penicillin did not specify the rate at which it was to be infused. However, the hospital's pharmacy recommends 180 ml per hour as the rate of infusion. That recommendation is printed on the mini-bag containing the penicillin. The nurse infused what she thought to be the penicillin at a rate of 250 ml per hour. Infusion of the penicillin can sting the patient and the nurse usually infuses it at the faster rate so the stinging ends sooner. However, the order allowed for the addition of lidocaine to the solution and the appropriate way to lessen the stinging is by the use of lidocaine, not by increasing the rate of infusion.

Almost immediately upon the epidural entering the patient's veins, she began having a severe adverse reaction and appeared to be seizuring. The nurse assumed she was having a reaction to what the nurse thought to be penicillin and pulled the medication tube out of the IV line. A Code Blue was called and advanced cardiopulmonary life support was performed unsuccessfully on the patient. An emergency cesarean section was done and the baby was delivered at 12:20 p.m.

The nurse violated the minimum standards of the nursing profession necessary for the protection of the safety of the patient by:

a. Failing to place the wrist band on the patient's wrist.

b. Failing to scan the barcodes and use the Bridge Medical, which would have alerted her that she was about to administer the wrong medication.

c. Failing to read the label on the mini-bag containing the epidural medication, which would have alerted her that she was about to administer the wrong medication."

If you would like more information on professional care and negligence issues for health care providers, please contact Mark Frankel (608-284-2601 or mfrankel@gklaw.com) or another member of our Godfrey & Kahn Healthcare Team.

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