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Root Cause Analysis: Turning a needless maternal death into better care for all

November 18th, 2010 by avatar

On the morning of July 5, 2006, a 16-year-old patient came to St. Mary’s Hospital in Madison, Wisconsin, to deliver her baby. During the process of her care, an infusion intended exclusively for the epidural route was connected to the patient’s peripheral IV line and infused by pump. Within minutes, the patient experienced cardiovascular collapse. A cesarean section resulted in the delivery of a healthy infant, but the medical team was unable to resuscitate the mother. The medication error and its consequences were devastating for the patient’s family, the nurse who made the error, and the medical team that labored to save the patient’s life.

This is the real story of a tragic and unnecessary maternal death that occurred not in a mud hut in a third world country, nor in a backwater rural health clinic—but in a fully licensed and accredited 440-bed community teaching hospital that delivers more than 3,500 babies annually and serves as a regional referral center for all of south-central Wisconsin. In a highly unusual and commendable move, senior management at St. Mary’s requested an outside independent investigation of this event and published their findings in an effort to share painful lessons learned with the medical community and the public.

What happens when an unanticipated maternal death occurs? If the event occurred in a hospital accredited by the Joint Commission on Accreditation of Healthcare Organizations (“Joint Commission”), the hospital must complete a root cause analysis (RCA) as a first step. Since 1996, a total of 84 cases of maternal death have been reported to The Joint Commission. The lessons learned from these most extreme patient care outcomes, also called “sentinel events,” have widespread implications for everyone involved in maternal and infant care. As William M. Callaghan, M.D., M.P.H., senior scientist in the Division of Reproductive Health at the Centers for Disease Control and Prevention remarked, “Maternal deaths are the tip of the iceberg, for they are a signal that there are likely bigger problems beneath – some of which are preventable,” says Dr. Callaghan. “It is important to consider the women who get very, very sick and do not die, because for every woman who dies, there are 50 who are very ill, suffering significant complications of pregnancy, labor and delivery.”


What is a root cause analysis?

Root cause analysis, or RCA, is “a process for identifying the basic or causal factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event.” The RCA seeks to answer these questions: What happened? Why did it happen? What will we do to prevent this from happening again? The RCA is not about assigning blame, but rather identifying the direct and indirect contributing factors –latent system errors—that create the “perfect storm” in which the event occurred.

The RCA process might seem deceptively simple. We may be tempted to approach the RCA in the following manner:

What happened? The patient mistakenly received an IV infusion of epidural medication.

Why did it happen? The nurse hung the wrong IV bag.

What we will do to prevent this from happening again? Fire the nurse.

Indeed, this overly simplistic and ineffective “shame and blame” approach is the one that many hospitals take in conducting internal investigations of adverse medical events. A more thorough and credible RCA digs at the underlying factors and causes by asking a series of “Why?” questions, which might look something like this:

What happened?

The patient mistakenly received an IV infusion of epidural medication.

Why did it happen?

The nurse hung the wrong IV bag.

Why did the nurse hang the wrong IV bag?

Because she confused the epidural bag with the IV penicillin bag which were next to each other on the counter.

Why were the bags next to each on the counter?

Because the work flow process included having epidural medications and supplies set up and ready in the room ahead of time.

Why did the work flow process include having analgesia medication in the room ahead of time?

Because anesthesia had in the past expressed dissatisfaction with nursing staff over patients’ state of readiness for epidurals.

And,

Why did the nurse hang the wrong IV bag?

Because she confused the epidural bag with the IV penicillin bag.

Why did the nurse get confused?

Because she was tired.

Why was the nurse tired?

Because she had worked two consecutive eight-hour shifts the day before, then slept in the hospital before coming on duty again the following morning.

Why did she work consecutive shifts?

Because she was covering for another colleague and her departure would have left the unit inadequately staffed.

As we repeatedly ask “Why?” we start to see groups of factors emerge, and these groups can help us to organize our thinking and later, to identify remedies. These groups might include: patient characteristics, task factors, individual staff factors, team factors, work environment, and organizational and management factors. We can map these factors and groups onto a fishbone diagram, a commonly used RCA visual aid:
(Click on graphic for improved viewing)

Now you try it!
Although root cause analyses are most commonly performed in cases of serious permanent physical or psychological harm, we can apply these same principles to “near-miss” events and instances of suboptimal, although not lethal, care. Read Rima Jolivet’s thought-provoking allegorical tale of two births. As you compare the two women’s stories, consider the factors that contributed to Karen’s negative birth experience. Even if the causes were not stated explicitly in the article, draw upon your own experience as a birthing professional and fill in the gaps. Think about:

  1. Patient characteristics: Are there pre-existing or co-morbid medical conditions, physical limitations, language and communication barriers, cultural issues, social support needs that play a role?
  2. Task factors: What protocols and procedures are in place for labor and delivery, for use of analgesia, for dystocia, for C-sections? Are they safe? Are they practical? Are they effective? Are they consistently applied?
  3. Individual staff: How did the knowledge, skills, training, motivation, and health of Karen’s providers affect her care?
  4. Team factors: How well do the various health care professionals involved in Karen’s care work together? What is the nature of the communication? Are there hierarchies? What is the responsiveness of nursing supervisors or attending physicians? How easily can a team member ask for help or clarification?
  5. Work environment: Is the labor and delivery unit adequately staffed? What is the workload? What happens when the census fluctuates unexpectedly? What is the staffing level of experience, functionality of the equipment, quality of administrative support?
  6. Organizational and management factors: How do the values of the hospital translate into clinical practice? Do their standards and policies focus more on patient safety and quality of care, or volume and speed? Are management’s priorities patient- or provider-centered? Does senior leadership foster a culture of teamwork and safety or blame and shame?

Add your comments below, and I will include them in a root cause analysis of Karen’s case in my next blog post.

References:

Jolivet, R. “Two Birth Stories: An Allegory to Compare Experiences in Current and Envisioned Maternity Care Systems.” Childbirth Connection, 2010. http://www.childbirthconnection.org/pdfs/allegory_illustrating_vision.pdf

“PS104: Root Cause and Systems Analysis.” Institute for Healthcare Improvement Open School for Health Professions. http://www.ihi.org/IHI/Programs/IHIOpenSchool/.

“Sentinel Event Alert: Preventing Maternal Death.” The Joint Commission. Issue 44, January 26, 2010. http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_44.htm

“Sentinel Event Policy and Procedures.” The Joint Commission. July 2007. http://www.jointcommission.org/NR/rdonlyres/F84F9DC6-A5DA-490F-A91F-A9FCE26347C4/0/SE_chapter_july07.pdf

Smetzer J, Baker C, Byrne FD, Cohen MR. “Shaping Systems for Better Behavioral Choices: Lessons Learned from a Fatal Medication Error.” Jt Comm J Qual Patient Saf. 2010 Apr; 36(4):152-63. http://psnet.ahrq.gov/public/Smetzer-JCJQPS-2010-s4.pdf

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The New GBS Cochrane Review: A Hot Mess!

July 30th, 2009 by avatar

The Cochrane CollaborationAdvocates for evidence based care feel our ears perk up when we hear about a new Cochrane systematic review. Cochrane Review = Evidence! Right? Indeed, systematic reviews represent the top of the “evidence pyramid” and Cochrane systematic reviews are the gold standard for their rigor and transparency. A Cochrane review can even conclusively settle important clinical controversies.

But sometimes Cochrane reviews leave us with more questions than answers.

Last week, the Cochrane Library released a systematic review evaluating the effectiveness of intrapartum antibiotics for known maternal group B streptococcal (GBS) colonization. And it’s a hot mess.

The four included trials that compared IV antibiotics with no treatment in labor collectively had only 500 participants, which we automatically know is far too small to find statistically significant differences in a condition that affects 1 in 2000 newborns, and results in death or long-term complications even less frequently. But small sample sizes were the least of the problems here. The reviewers noted several other problems with the trials:

  • In one study, researchers tracked their findings and halted the trial as soon as a significant difference was found (favoring treatment with antibiotics). This is a blatant form of bias – it is like flipping a penny until you get heads 5% more often than you got tails. If you keep flipping long enough (or stop flipping soon enough) you’ll be able to find that 5% difference simply by chance.
  • In the same study, researchers changed to a different statistical test that allowed them to achieve statistical significance with their data, when the originally planned (and more appropriate) test would have produced a nonsignificant finding.
  • None of the studies used placebos, so women, care providers, and hospital staff knew which women received antibiotics and which did not. This may have altered treatment of the women or the babies, possibly in ways that would make no antibiotics appear safer (for instance, avoiding or delaying membrane rupture in a woman who is GBS+ but not getting antibiotics).
  • One study excluded women who developed fevers in labor. GBS colonization can cause maternal fever and newborn sepsis, so excluding these cases makes no sense.
  • Some women included in the studies were likely GBS negative because methods used to determine GBS status were inadequate
  • Outcomes were poorly defined.
  • Data on a substantial proportion of women and babies were missing.
  • Groups were mysteriously differently sized.
  • Need I go on?

The Cochrane reviewers, in my opinion, did a respectable job with what they had, but what they had was garbage and as the saying goes, “Garbage in, garbage out.” You can’t make reliable conclusions out of a bunch of bad research, even if you’re a Cochrane reviewer.

So what were the findings?

Three trials, which were around 20 years old, compared ampicillin or penicillin to no treatment and found no clear differences in newborn deaths although the occurrence of early GBS infection in the newborn was reduced with antibiotics.

More, better research is needed, but the Cochrane reviewers are not optimistic:

Ideally the effectiveness of intrapartum antibiotics to GBS colonized women to reduce neonatal GBS infections should be studied in adequately sized double blind controlled trials. The opportunities to conduct such trials have likely been lost as practice guidelines have been introduced in many jurisdictions. (p. 11)

Source: Centers for Disease Control and Prevention. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5111a1.htm

Source: Centers for Disease Control and Prevention. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5111a1.htm

In the meantime, women should be aware that other evidence, albeit not from randomized controlled trials, suggests that antibiotic treatment reduces deaths from early onset GBS disease in newborns. According to the Centers for Disease Control and Prevention, a steady decline in GBS disease has been seen in individual institutions, in the whole U.S. population, and in other countries as antibiotic use has risen. But these population-level data cannot tell us whether antibiotics or some other factor  caused the decline.

What other advice can we share with women?

  1. Be aware that antibiotics are not harmless. Severe allergic reactions are possible, and antibiotic use in labor can result in thrush (candida infection) which causes painful breastfeeding and sometimes early weaning. We do not know other possible harmful effects because they have never been studied adequately or at all.
  2. No study confirms the effect of labor practices on GBS infection in newborns, but here we can use our common sense. Care providers should avoid or minimize sweeping/stripping membranes before labor, breaking the bag of waters, vaginal exams, and other internal procedures, especially those that break the baby’s skin and can be a route for infection. These include internal fetal scalp electrodes for fetal heart rate monitoring and fetal blood sampling.
  3. Keep mothers and babies skin-to-skin after birth. This exposes the baby to beneficial bacteria on the mother’s skin, facilitates early breastfeeding, and lowers the likelihood that the baby will exhibit signs or symptoms that mimic infection, such as low temperature or low blood sugar, which could cause the need for blood tests or spinal taps to rule out infection.

Citation: Ohlsson A, & Shah VS (2009). Intrapartum antibiotics for known maternal Group B streptococcal colonization. Cochrane database of systematic reviews (Online) (3) PMID: 19588432

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First, Do No Harm: Another Reason to Ditch Routine IVs in Labor

May 21st, 2009 by avatar

In the latest Listening to Mothers Survey 83% of women reported having intravenous (IV) lines in labor or birth. This number is probably not surprising to many of us – IV’s are part of the routine package of care in most settings, even for low-risk women. Their ubiquitous place in modern obstetrics renders them practically invisible. And although the American Society of Anesthesiologists revised its guidelines in 2007 to encourage clear fluids in labor – which would presumably eliminate the need for IVs in most cases – the practice of routine IVs appears to be continuing unabated. Why? Because the medical model presumption is that it’s nice to have that IV access just in case an urgent complication is lurking around the corner. And besides – IVs are relatively harmless, right?

Wrong. In 2007, I was part of a team that conducted a systematic review (PDF, see p. 34S – 36S) of the research on IV fluids in labor. We found that IVs can cause anemia and that they reduce colloid osmotic pressure – which can lead to swelling in the tissues or lungs (pulmonary edema) of both the laboring woman and her infant. In addition, not all IV fluids are created equal: IV fluids with glucose in them were associated with low blood sugar in newborns, and salt-free fluids increased the likelihood of potentially serious electrolyte imbalances. The body of research also confirmed common sense – that women find IVs uncomfortable and that IVs limit mobility. Finally, we failed to find a single study that supported the notion that IV access improves outcomes when urgent problems arise. Despite this nearly universal belief, no one has in fact studied the question.

This week I happened to see two different bits of news blip onto my radar that raise other troubling concerns about the rampant use of IVs on maternity wards. Both pieces looked at possible harmful effects of the chemicals that may leach out of the plastic IV bags and tubing. A recent NPR story reported on an ongoing study looking at sexual maturity in teenagers who were exposed to high levels of phthalates as infants in neonatal intensive care units. The phthalates came from intravenous lines, including those used for extracorporeal membrane oxygenation (ECMO). The Wall Street Journal posted a short blurb about an animal study showing that another chemical found in IV bags and tubing, cyclohexanone, can trigger health problems in the hearts and neurological systems of the rats that were exposed. We can not – and should not - extrapolate the findings of these studies to possible effects on laboring women and their newborns. But they add new fuel to an already compelling case to do away with IVs whenever safely possible. With no evidence that their routine use is beneficial, a small but consistent body of evidence that they can cause harm, and important questions unanswered, a change in practice is long overdue.

For more information about potentially harmful chemicals used in health care settings and ways to reduce the environmental impact of our health care system, visit Health Care Without Harm. Along with other great resources, HCWH published a booklet with the American College of Nurse-Midwives called Green Birthdays (PDF) in 2001.

Citation: Goer, H., Leslie, M. S., & Romano, A. (2007). The Coalition for Improving Maternity Services: Evidence basis for the ten steps of mother-friendly care: Step 6: Does not routinely employ practices, procedures unsupported by scientific evidence. Journal of Perinatal Education (16)1, 32S-64S.

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