Root Cause

Shoulder Dystocia

By ThinkReliability Staff

Shoulder dystocia (SD) happens during childbirth when a baby’s shoulder gets stuck in the pelvic opening.  Shoulder dystocia can cause injury to or death of the baby and maternal injury.  These are impacts to the patient safety goals.

A very basic Cause Map shows that the potential for maternal and infant injury occurs from difficulty delivering the baby.  The difficulty is caused by a combination of shoulder dystocia (which occurs during vaginal delivery when the fetal shoulder width is greater than the pelvic opening) and improper management of the delivery.  Based on this very simplified Cause Map, two solutions are to plan for a cesarean section (C-section) when there is the potential for shoulder dystocia, and to define the process for delivery when shoulder dystocia occurs.

We can define a very basic process map for delivery management. First, the patient should be evaluated for the potential for shoulder dystocia.  Then, the labor team prepares for the potential for shoulder dystocia.  If shoulder dystocia is diagnosed, the team should perform the appropriate response, deliver the baby and then administer post-partum follow-up.  The key to this, of course, is to define the appropriate response.

We can add more detail to part of this process map.  Specifically, the additional detail outlines the “HELPERRZ” process used by some medical facilities for the management of  shoulder dystocia.  (To view the Outline, Cause Map and Process Map, click on “Download PDF” above).

Root Cause

Sponge Count Procedure

By ThinkReliability Staff

In last week’s healthcare root cause analysis blog we looked at an incident where a California hospital left a surgical lap band (sponge) inside a patient’s abdomen after a Cesarean section in a Cause Map.  This week we will look at the sponge counting procedures developed as a result of this incident.  (Since these procedures, as well as additional training and frequent audits, have been implemented, there have been no retained objects at the facility.

Based on the changes to procedure made by this facility, as well as the recommendations from The Journal of Family Practice and the Annals of Surgery, we can put together a sample procedure for sponge counts during an operative procedure which is shown on the downloadable PDF (click “Download PDF” above).

In our sample procedure, a sponge count is required before the surgical site is opened, each time sponges are added to the surgical field, an incision or body cavity is closed, and if a scrub or circulating nurse is replaced (such as at a shift change).   Once the procedure is complete, a sponge count, as well exploration of  the surgical area is performed before skin closure.  In addition, if the procedure indicates a high risk for retained sponge (examples are shown below), a radiograph of the surgical area is taken.  Because only sponges with radio-opaque markers are used, this creates another layer of assurance.

The procedure shown above may be more comprehensive than the sponge counting procedure used in some facilities.  As such, it requires more time, dedication and resources.  Is it really worth it?  The effort required to implement changes to a procedure have to be balanced with the risk of what the procedure attempts to prevent.  In this case, the sponge count procedure attempts to reduce the risk of object retention after surgery.  The risks of retaining an object after surgery include severe injury, possibly even death.  The retention of surgical sponges is a fairly common surgical complication, estimated to occur once for every thousand to five thousand surgeries.  Additionally, the financial and legal consequences for a facility and operating team for a retained foreign object can be severe.  Each organization must consider its own risks and available resources while determining the appropriate level of effort for a procedure.  However, because of the high level of risk of a retained foreign object, the procedure in this case should involve significant effort.

Root Cause

Retained Surgical Sponge

By ThinkReliability Staff

In May, the California Department of Public Health (CDPH) fined nine California hospitals for noncompliance which was likely to cause serious injury or death.  One of these hospitals was fined for leaving a surgical sponge inside a patient’s abdomen after a Cesarean section.  We can look at the issues leading to this unfortunate event in a Cause Map, or visual root cause analysis.

First we define the problem in an outline.  Within the outline we capture the basic information about the incident – the what, when and where.  We also capture the impacts to the organization’s goals.  In this case, there was a risk of death or serious injury to the patient, which is an impact to the patient services goal.  Two of the employees involved received disciplinary action, which impacts the employee impact goal.  The compliance goal was impacted because hospital policy/procedure was not followed.  The organization goal was impacted because of the $50,000 fine levied by the CDPH.   The patient services goal was impacted because the sponge was left inside the patient.  The property and labor goals were impacted due to the second surgery performed to remove the sponge.

Once we have defined the what, when, where and impact to the goals, we can look at the “why”.  First, we begin with the impacted goals and asking “why” questions, fill out the Cause Map to the right.  In this case, the risk of death or serious injury was caused by an intestinal obstruction caused by the sponge being left within the  patient’s abdomen post-surgery.  The sponge was used within the abdomen to aid in the Cesarean section.  The sponge could not be seen visually and the sponge count (used to prevent objects from being left within patients) was performed incorrectly.  There were 20 sponges opened in the operating room (OR).  The hospital’s procedures required that each sponge be placed in its own “easy count” bag.  Then, the OR staff could ensure that the number of bags matched the number of sponges used in the surgery.  Of the 15 sponges that were used in the surgery, 14 were placed into bags and counted.  Of the remaining sponges, 5 were not used, and were not placed in bags (but were counted), and one was left within the patient.  The staff believed that the sponge was within the surgical field and the surgeon did not report placing the sponge within the patient.

As a response to this incident, the hospital updated its procedures and re-trained its staff.  Frequent audits of surgeries were also implemented. Since the changes were updated, there have been no cases of objects retained after surgery.

Check back next week as we look at the sponge counting procedure developed by this facility in response to this incident.

Root Cause

Recreational Water Illnesses

By ThinkReliability Staff

Last year we wrote a blog about preventing pool injuries, specifically slipping and drowning.  However, there’s a lesser known risk from a pool – getting sick from swimming.  This is officially known as “recreational water illness” or RWI, and normally involves diarrhea. RWI is estimated to affect approximately 1,000 people a year (according to WebMD) and can cause death, especially in immune-compromised people.

We can perform a proactive root cause analysis to determine what causes these illnesses.  Essentially, a person consumes germs by ingesting pool water that contains germs.  Pool water becomes contaminated when germs enter the pool from fecal matter.  (Easier said than done. Did you know that the average person is wearing 0.14 grams of fecal matter?)  So please, keep fecal matter out of the pool.  Take a shower before you get in and make sure your kids are using the bathroom regularly elsewhere.  (Not surprisingly, kiddie pools are the ‘germiest’.)

Now, pools are treated to prevent these germs from proliferating.  However, some combinations of pool chemicals and germs take much too long to work to be effective.  (For example, cryptosporidium takes 7 days to be killed in chlorine.)  Some pools aren’t getting enough chemicals due to inadequate maintenance.  And, there’s some stuff you can put in the pool – namely urine, sunscreen, and sweat – that interacts with chlorine and reduces the effective volume in the pool. So, even though urine itself doesn’t contain germs, don’t pee in the pool.  And again, take a shower.

Our solutions to RWI – take a shower, don’t perform any bodily functions in the pool, and don’t swallow the pool water.  However, that works for you and your family, but what about the unwashed masses in the pool?  The CDC recommends you buy your own water testing kit and test the pool water before you get in.  Make sure there’s a pool treatment plan and that it’s being followed, and that all ‘accidents’ are reported immediately.  (Yep, even if   they’re your fault.)  Then lay back, relax, and enjoy your swim.

Root Cause

Over-the-counter Medications Recalled

By ThinkReliability Staff

On April 30, 2010, following a 10-day FDA inspection of a U.S. manufacturing facility, 43 name-brand over-the-counter (OTC) children’s’ liquid medications were voluntarily recalled.  Although there have not yet been any reported adverse events associated with the recalled medication, the impact of the issue has been far-reaching.

There is the potential (although believed to be remote) for an impact to consumer health, which is an impact to the safety goal.  Additionally, the drugs were recalled for not meeting required quality standards, which can also be  considered an impact to the safety goal.  The product recall, which encompassed 1,500 lots of 43 products, is an impact to both the customer service and property goal.  The cost of this recall has not yet been estimated.  The  manufacturing facility is on hold, which is an impact to the production goal.  Lastly, the time and costs associated with the investigation to determine what went wrong is an impact to the labor goal.  We can record these impacts to the goals in the outline (Step 1).

Once we’ve completed the first step, we move on to the root cause analysis, or Step 2.  We begin the analysis with the impacts to the goals and ask “Why” questions to complete the Cause Map.  Because the FDA’s investigation report has not yet been released, the Cause Map we have so far is very basic.  Essentially, the recalls occurred because unacceptable product was released to consumers.  It was released because the finished product met testing requirements.  However, it was unacceptable because it did not meet quality standards, because of contamination in the raw materials that were used.  At this point in the map, we run into more questions.  More detail can be added to this Cause Map as the analysis continues and more information is released. As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall goals.

A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that fits on one page.  View the investigation by clicking on “Download PDF” above.

Root Cause

Patient Death From Loss of Oxygen Supply

By ThinkReliability Staff

The California Department of Public Health recently announced that a California hospital will be fined $50,000 for a situation that led to the death of a patient.  On March 5, 2009, a patient died of cardiac arrest after his portable oxygen tank ran out.  The patient was not breathing adequately on his own, because he had pneumonia in both lungs.  A patient death is always an impact to the patient safety goals.  The fine is an impact to the organization and compliance goals.  Additionally, a patient’s oxygen tank running out of oxygen (regardless of whether it caused a death) is an impact to the patient services goal.  These impacts to the goals give us a starting point for our investigation.

The patient death was caused by cardiac arrest, caused by insufficient oxygen.  The patient had insufficient oxygen and insufficient supervision.  Had the patient been properly supervised (as required), a medical staffer should have noticed the issue before it came to this point.  The patient was unable to breath on his own because of the pneumonia and so was placed on oxygen.  The patient was placed on portable oxygen in order to be transported to the radiology department for an ultrasound.  Although there was the capability within the radiology department for the patient to be hooked up to the wall oxygen supply, there was no policy to do so, and the patient remained on the portable oxygen supply.

According to hospital procedures, when a patient is being transported, the responsibility for the safety of that patient lies with the transporter.  A hospital policy allows for patients to be transported by untrained personnel in the case that a patient is stable, and this is indicated on the Transport Communication Form.  This patient was transported by an untrained person; however, no Transport Communication Form was completed or signed.  Whether or not the patient was considered ‘stable’ is unknown.  For reasons that are unclear, the transport person left the patient in the radiology department and did not return.  Eventually, the Ultrasound Technician returned the patient to his room.   It was then realized that the patient was not breathing and the patient was connected to the wall supply.  However, it was too late and the patient was unable to be revived.  Although the Ultrasound Technician was trying to aid the patient, she did not verify that the patient was breathing, either because it was not her responsibility or she was unaware of the patient’s oxygen requirements.  The transport person was both not around, and not trained for this type of work.  Although the hospital policy required an RN or a Respiratory Therapist to regulate the oxygen flow rate, none were around.

Shortly after this incident, the hospital implemented new and clarified policies regarding patients on oxygen, and how they were to be transported.  These solutions, along with the rest of the information from the investigation, can be seen by clicking “Download PDF” above.

Information used for this investigation was found in the report by the California Department of Public Health.

Root Cause Analysis

Donated Blood Contaminated By Yellow Fever Vaccines

By ThinkReliability Staff

On March 27, 2009, 89 active duty military trainees donated blood at a local blood center.  Unfortunately, the trainees had received yellow fever vaccines (which contain live virus) only four days earlier.  The Red Cross blood donation eligibility criteria requires a two-week wait after a yellow fever vaccine.  The Red Cross does not test donated blood for yellow fever virus antibodies and the ineligible donations were not realized until the blood bank was preparing for another blood drive several weeks later.  The contaminated blood was immediately recalled, tracked down and destroyed, but only after six units had been transfused into five patients.

One of the five patients who received a transfusion died, but as he was in hospice care for terminal cancer, it’s unclear whether the contaminated transfusion was responsible.  Three of the four remaining patients had yellow fever antibodies in their system, but have not demonstrated any symptoms of yellow fever.  The potential transmission of yellow fever to these patients is an impact to the patient safety goal.  Additionally, the transfusion of contaminated blood impacts the compliance, organization, and patient services goals.   The cost of the disposal of 83 contaminated units of blood is an impact to the materials goal, and the required investigation is an impact to the labor goal.

The contaminated transfusions occurred because of the medical need for blood, and the use of contaminated donor blood.  The donor blood was contaminated because the recall did not occur for several weeks (although it happened immediately after the contamination became known) and because the blood contained yellow fever antibodies.  The yellow fever antibodies were present due to donors who had recently received vaccines, and donated, though ineligible.  Because of the large number of trainees who donated blood despite being ineligible, it’s apparent that there was a disconnect in providing the information of a required two-week deferral from donation after vaccination.

Although the Red Cross does make its eligibility criteria known, it’s clear from this incident that this was insufficient in this case.  The military has agreed to provide vaccination records for its members to ensure that blood is not donated during the deferral time after live virus vaccines.  Additionally, the Red Cross has added specific, individual questioning about recent vaccinations.  (The previous process used for screening with respect to recent vaccines was not discussed.)  A recommendation is being made to have healthcare providers discuss eligibility for blood donation after vaccines are provided, though this is not currently being specifically required.  These solutions should reduce the risk of providing contaminated blood.

To view the one-page PDF containing the outline, Cause Map, timeline and action items, please click “Download PDF” above.  The information for this investigation was provided by the Centers for Disease Control and Prevention (CDC)’s Morbidity and Mortality Weekly Report (MMWR).

Root Cause

Errors in Translated Medication Instructions

By ThinkReliability Staff

It’s well known that instructions on medication (both prescription and otherwise) can be confusing and lead to potentially lethal consequences.  (See our previous blog on the topic.)  Now imagine how much more danger there is if you don’t speak the language in which the instructions are printed.

A recent study published in the American Academy of Pediatrics Journal “evaluated the accuracy of translated Spanish-language medicine labels among pharmacies in a borough with a large Spanish-speaking population. ”  The study found significant issues with label accuracy with a popular language in an area with a large population of speakers of that language.  You can imagine how these results could get even worse for an area that had a smaller number of Spanish speakers, or for patients who speak a less common language.

One of the most striking examples was a man who received heart medication that was to be taken once daily.  The instructions were only partially translated and “once” (which means 11 in Spanish) was left on the instructions.  The patient took 11 pills (instead of 1) a day.

The study found an overall error rate of the prescription instructions that had been translated into Spanish by computer of 50%.  (86% of the pharmacies surveyed translated their prescriptions with a computer program.)  It is likely that patients with the incorrectly translated prescription instructions took the medicine incorrectly, resulting in the potential for serious harm, or even death.  This is an impact to the patient safety goal.  The rate of errors made by the computer means more work for pharmacists and translators due to the corrections that must be (or should be) made.  (Obviously this is not always happening.)  Patients receiving instructions they do not understand can be considered an impact to the patient services, compliance, and organizational goals.  (The study was performed in the Bronx, New York.  It is a law in New York City for pharmacy chains to provide translated labels for the top seven foreign languages in the area.)

Patients do not understand the directions because the patients do not speak English and the instructions are either not translated, or are translated incorrectly.  The instructions may be translated incorrectly because the computer program translates them incorrectly and there is an inadequate verification of the computer translation, because the pharmacist does not speak the language and/or there is no translator available (likely due to lack of funds or an uncommon language).   The instructions may not be translated if the pharmacy has no translating capabilities, also likely due to cost or an uncommon language.

An obvious suggestion is to improve the accuracy of the computer programs that do the translating, perhaps standardizing the translations among the different programs that do the job.  Pharmacists could also be provided with a guidebook of translations for standard pharmacy terms (such as take orally).  Additionally, translation software could be added to the computer programs currently used by pharmacists.

I have a simpler suggestion that I borrowed from the aviation industry.  I noticed the last time I flew that instead of having translations of the safety instructions in a dozen different languages, there were practically no words at all.  Instead, the airline used picture instructions.  I suggest doing something similar with medications.  (See my example of a picture for “take orally” on the PDF.  View the root cause analysis investigation and my picture by clicking “Download PDF” above.)

Because of the risk involved, it’s clear something needs to be done.  Prescription instructions are hard enough to understand in English, much less poorly translated into another language.  I’m sure suggestions will keep coming in, and surely some smart folks out there will come up with a way to reduce the potential for confusion and injury.

Root Cause

Therapy Equipment Delivers Radiation Overdoses for Years

By ThinkReliability Staff

In September of last year, a physicist at a healthcare facility was trained on use of the BrainLAB stereotactic radiation therapy system.  During this training, the physicist realized that the system had been incorrectly calibrated, as the wrong chamber had been inserted into the machine.  The facility realized that the chamber had been incorrectly inserted at installation in 2004, and that patients who used the portion of the machine calibrated by that chamber had received radiation overdoses over those five years.

The facility is working through the impacts of these errors, the causes of the error, and what needs to be done to keep an issue like this from ever happening again.

First let’s examine the impacts to the goals resulting from this error.  There’s an impact to the patient safety goal due to potential for deaths and injuries. (Because these patients  were already sick – sometimes very sick – the facility is still determining what impact the overdoses may have had.)  There has not yet been mention of an employee impact – the physicist who set up the machine is no longer at the facility – so we’ll just put a “?” after Employee Impact.  The event was reported to The Joint Commission (no reports were required by law), which can be considered an impact to the compliance goal.   The organizational goal was impacted due to potential lawsuits against the hospital.   The patient services goal was impacted because 76 patients received an average overdose of 50% (other patients received overdoses that were considered within the acceptable range for treatment).  Because radiation was involved, there is the potential for an environmental impact.  However, there is no evidence that any radiation leaked to the environment, we’ll put a “?” by the environmental goal as well.  Lastly, the property and labor/time goals were impacted because of the additional follow-up exams, testing, support, and treatment, which the facility will provide for all those affected by the issue.

Once we’ve determined the impact of the event, we can begin an analysis of how it happened.  Or, what were the causes?  The goals were impacted due to the overdose to several patients.  The overdose occurred because the radiation therapy machine was miscalibrated and the miscalibration was not discovered for five years.  The machine was miscalibrated because the incorrect chamber was installed and the chamber installation was not verified.  The physicist chose the wrong chamber and the equipment representative (who was on hand for the installation) did not notice the error.  At this point, it’s unclear why the physicist chose the wrong chamber and why the equipment representative did not notice the error.

The miscalibration was not noticed for five years because any re-calibration of the machine depended on the chamber which was incorrectly installed.  So although the machine was not delivering the correct amount of  radiation, the problem was with the calibration itself, resulting in a propagating error.  According to the facility, none of the patients showed any unusual side effects that would indicate they were getting too much radiation. However, some of the symptoms may take years to develop.  Additionally, no other staff members were trained on the equipment for five years.  It was a second staff member who was trained on the equipment who finally noticed the error.

Even though there are some questions still remaining in our Cause Map, we can develop some solutions, as the facility in question (as well as other stakeholders) is doing.   One suggestion is to do an external calibration of the machine – i.e., use a calibration method that is completely separate from the machine to determine if the correct amount of radiation is being delivered.  Also, have an independent verification that each piece of the equipment was installed correctly.   Require the equipment representative to sign off on the installation.  Last but not least, train other staff members to operate the equipment as backup.   The facility is working with the FDA to assist in its efforts to increase the safety of radiation use in healthcare settings.  (See our previous blog about this topic.)

Step 4 to avoid radiation therapy errors: verify HOW MUCH – how much radiation therapy is required, and how much is the patient actually getting.

Root Cause Analysis

Iris Scanners Used to Identify Patients

By ThinkReliability Staff

The Bronx, New York medical clinic had a potential problem.  It serves a large population (over 37,000 patients) that sometimes speaks limited English and has little identification.  Of the 37,000 patients served, the clinic had a high number of repeated names, including 103 Jose Rodriguezes.  The clinic was concerned that these issues would lead to potential safety issues if a patient was mistaken for another patient with the same or a similar name.

To address these concerns, the clinic has installed iris scanners to identify the patients.  The scanner pulls up a patient’s electronic medical records with an extremely low error rate.  An additional benefit is that an iris scanner does not require the patient to physically touch it, so it is much less likely to spread germs than a fingerprint or palm scanner.

The clinic has been extremely pleased with the iris scanner, noting that it has also helped fight benefits fraud and won the clinic recognition from the Healthcare Information and Management Systems Society.   The downside is that the system is expensive.  (The Bronx clinic purchased their scanner with a grant from the New York Department of Health.)  However, considering the high prevalence and cost of medical errors, it seems to be a worthwhile expense.