Tag Archives: infection

Root Cause Analysis

Family of Sepsis Victim Fights for Better Care

By ThinkReliability Staff

New York state has become a leader in identifying and treating sepsis. But it wasn’t always this way. On April 1, 2012, a twelve-year-old boy named Rory Staunton died from sepsis in a New York hospital (the subject of a previous blog). There were multiple opportunities that could have more quickly identified his sepsis, and potentially saved his life. After his death, Rory’s family founded the Rory Staunton Foundation For Sepsis Prevention. Part of the foundation’s mission is to improve diagnosis and treatment protocols for sepsis.

The foundation landed a success when New York state adopted what are known as “Rory’s Regulations” on December 31, 2013. These regulations require “health care providers to develop and implement protocols to rapidly diagnose and treat sepsis infections”. In addition, the state adopted hospital pediatric care regulations which specifically addressed many of the causes identified in Rory’s case. These include requirements to:

– Review of test results by a clinician familiar with the patient’s case: Blood tests ordered to be run immediately were not reviewed by the doctor who ordered them. Although initial tests showed abnormalities within an hour of Rory’s arrival, these results were not provided to the emergency department at all.

– Provide test results to the primary care provider: The test results were not provided to Rory’s primary care provider.

– Improve communications of test results to patients and parents: The test results were not provided to Rory’s parents

– Keeping patients in the hospital while awaiting critical test results: Rory had already left the hospital when the test results arrived. Because the results of the test were a matter of life or death, had his discharge been delayed while awaiting the results, the outcome may have been different.

Even with ensuring that test results make it into the right hands, diagnosing and treating sepsis is difficult. Rory’s Regulations also require developing protocols that will assist in sepsis detection and treatment. An international task force released updated definitions of sepsis and septic shock, as well as clinical guidance, in February 2016. The Centers for Medicare and Medicaid launched a new core measure for fiscal year 2016.

Another mission of the foundation is to increase public awareness and understanding of sepsis. The foundation requested the Centers for Disease Control and Prevention help them in this mission. The CDC launched its new sepsis website on May 29, 2014.

While New York’s regulations seem to have been a success (the state’s Department of Health estimates they will save at least 5,000 lives each year), the foundation isn’t stopping there. Their stated goal is to have similar regulations in place across the US by 2020.

To view the cause-and-effect relationships and the associated solutions laid out visually in a Cause Map, please click on “Download PDF” above. Click here to learn more about the Rory Staunton Foundation For Sepsis Prevention.

Root Cause

Infant Death Due to Infection from Water Birth

By ThinkReliability Staff

A recently-released study in the CDC’s Emerging Infectious Diseases Journal discusses causes of the death of an infant from legionellosis (commonly known as Legionnaires’ disease) apparently due to a contaminated tub used for a home water birth. While the tub had been disinfected since the birth (and so did not test positive for legionnella), it is believed that the source of the infection was the tub the baby was born in.

The investigation into the baby’s death discusses various issues with the home water births along with solutions. According to the study, “Findings from this investigation revealed a gap in the standardization and implementation of infection control practices for midwives during home water births. . . recommendations included use of standard written procedures for employees and clients before, during, and after the water birth. These procedural documents were suggested to outline proper timing of tub filling to reduce proliferation of microorganisms, documentation of client awareness of possible risks when deviating from written procedures, and laboratory testing procedures to be followed when birthing tubs are suspected of being contaminated with Legionella or other pathogens.” The specific cause-and-effect relationships that led to the contamination and infant’s death can be viewed in a Cause Map, or visual root cause analysis, by clicking “Download PDF” above.

The birthing tub in this particular case was filled with private well water two days prior to the birth. Upon filling, enzyme-based, non-FDA-approved water purifying drops were added to the water and the water was kept warm and circulated in the tub until the delivery. The tub used was a recreational-grade, jetted tub with internal tubing that is not approved for use as medical equipment and is particularly difficult to disinfect.

There were no procedures provided by the midwifery center that discussed required steps before and during the water birth, though this is not uncommon. The study found that, although most certified nursing midwives supported water birth, only 30% had received training.

Shortly after the infant’s death, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists issued a joint statement saying that water births should be avoided (see our previous blog on this topic). It’s unclear whether or not information regarding the infant’s death in January 2014 was known prior to the statement released in March, 2014, though one of the concerns with water births (along with drowning) was the possibility that the infant could obtain an infection from a water birth.

Over the summer, another infant developed legionellosis from a birthing pool in England, and the National Health Service banned the use of home birthing pools with built-in heaters and recirculation pumps. Internationally, there were no other cases of infants developing legionellosis from water births since the late 1990s.

Though water births or the use of specific types of birthing equipment have not been banned in the US, birthing in a tub is discouraged. The CDC study recommends that procedures and training about cleaning and the disinfection required before and during water births be developed and disseminated through the midwifery community and potential clients. While legionellosis in infants is rare, it is believed that additional cases may be discovered with better surveillance.

Read more: Fritschel E, Sanyal K, Threadgill H, Cervantes D. Fatal legionellosis after water birth, Texas, USA, 2014. Emerg Infect Dis [Internet]. 2015 Jan 7. http://dx.doi.org/10.3201/eid2101.140846 DOI: 10.3201/eid2101.140846

 

 

Root Cause

Humidity May Cause Loss of Hospital Accreditation

By ThinkReliability Staff

A hospital in California has received a preliminary denial of accreditation from The Joint Commission, which may lead to a loss of Medicare and Medicaid funding.  This move is rare – less than 1% of hospitals are denied accreditation.  The ruling was made during an onsite survey after reports that four patients had developed surgical-site infections after hip replacement surgery within a month.  (The patients all recovered after administration of antibiotics.)

Says the hospital’s Associate Director of Emergency Services, “Surgical infections are extremely rare. When we saw the cluster we stood up and took notice. We stabbed every corner and every crevice.”

However, that may not be entirely true.  First of all, surgical infections are probably not what’s considered “extremely rare”.  In a recent study, the Centers for Disease Control and Prevention (CDC) found that 1 in 25 patients acquires an infection while in the hospital  and infections are among the leading cause of death worldwide.  (See our previous blog for more details.)  Only slightly more than 20% of those infections were found to be surgical site infections from inpatient surgery, but that still results in about 157,500 surgical site infections a year.

There’s also a question about how quickly action was taken to address the issues identified by The Joint Commission, specifically high humidity.  After the four patients were infected with enterobacter (a bacteria that is harmless in the gut but can cause illness in a wound), the hospital cultured equipment and instruments and found no contamination.  However, three of the surgeries which resulted in the surgical site infections took place in an operating room that had been identified in February or March to have high humidity due to issues with the heating and ventilation system.  Although a new system would not be installed for several months, surgeries continued to take place in that operating room until The Joint Commission identified problems with heat and humidity.

The germs that caused these infections can also be introduced to a surgical site by medical staff – usually due to improper hand washing or surgical prep procedures.  It’s unclear if this may have been the case here – there has been no discussion of this possibility – but handwashing issues are a constant source of infections at healthcare facilities.  According to studies, more than 50% of infections are largely preventable with good hygiene and technique.

The hospital has 23 days from the October 8th preliminary denial of accreditation to meet federal standards.  The hospital is installing new heating and air conditioning equipment and is reviewing its procedures for “hospital documentation and staff communication”.   Hopefully other processes will be reviewed as well.  The hospital expects to reopen its operating rooms soon.

To view an overview of the investigation of this issue, please click “Download PDF” above. The downloadable PDF shows the goals impacted by this issue, a visual layout of the cause-and-effect relationships that led to the impacted goals, and the solutions being discussed by the hospital to improve patient safety regain their accreditation.

Root Cause Analysis

Delay in Treatment for Sepsis Results in Death of a Child

By ThinkReliability Staff

On April 1, 2012, a patient at a university medical center in New York died from sepsis.  The death was especially heartbreaking as the patient was 12 years old . . . and had been healthy just 4 days prior.  However, he had contracted a bacterial bloodstream infection (sepsis), which has a high mortality rate (nearly 40%, according to the United Hospital Fund) that grows with every passing hour.  (A study cited by the New York Times found that the survival rate decreases by 7.6% every hour before antibiotics are given.)  With response time so crucial to patient outcome, rapid action at every step of the process is required.

We can look at this incident in a visual root cause analysis, or Cause Map.  The purpose of this map is not to assign blame, but rather to discover and document causes in the hope of finding solutions to reduce the occurrence of this type of issue.

We begin with the impacts to the goals.  In this case, the patient safety goal was impacted due to a patient death.  Because of the high potential for emotional impact to providers, employees are also impacted.    The potential for a lawsuit is an impact to the organizational goal, and the initial misdiagnosis of the patient is an impact to the patient services goal.

We begin with the patient safety goal and ask “Why” questions to develop cause-and-effect relationships that will show all the causes of the incident.  The patient died of severe septic shock and insufficient intervention.  (Had intervention come earlier, the patient may have lived.)  The onset of the sepsis appears to have been a cut acquired at school, which was bandaged, but possibly not cleaned, likely due to the lack of severity of the initial injury.  Delay of treatment allowed the sepsis to overwhelm the immune system.  The treatment was delayed due to an initial misdiagnosis of dehydration.     Sepsis is particularly difficult to diagnose because many of its symptoms mirror symptoms of other more common ailments.  Information was not shared between providers – the child’s primary care pediatrician, parents, and the hospital staff, which may have contributed to the difficulty in diagnosis.  Test results taken at the hospital came in after discharge and were not shared by phone with the primary provider or parents.  Additionally, even after lab results from the hospital suggested that the white blood cell count was abnormally high, indicating infection, no action was taken.

From this very basic, high level map, at least four areas of specific improvement can be noted.  Protocol at the school for injuries that involve cuts – even if they seem minor – should include cleaning or disinfection.   The hospital should have – and follow – protocol for that specifies action to be taken upon receipt of lab results.   This protocol should include documenting and sharing test results with other providers and caregivers.  Because of the difficulty in diagnosing sepsis, and the importance of quick action, the United Hospital Fund is current developing a STOP Sepsis Collaborative, which aims to “reduce mortality in patients with severe sepsis and septic shock by implementing a protocol-based approach to case identification and rapid treatment”.  Ideally, implementation of the results of this collaborative will reduce the risk of patient death from a situation like this tragic case.

To view the Outline, event Timeline, Cause Map, and Solutions, please click “Download PDF” above.  Or click here to read more.

Root Cause Analysis

Contaminated IV Bags Sicken 19

By Kim Smiley

With the aid of the State Health Department and the Centers for Disease Control and Prevention (CDC), six hospitals have traced back recent patient infections to contamination in total parenteral nutrition (TNP) delivered via intravenous (IV) bags.

Although the first infection occurred in January, 2011, a pattern was not established until March, 2011, after nineteen patients were infected with serratia marcescens bacteria.  Patient infection is an impact to the patient safety goal.

The infections occurred as a result of the patients being given contaminated product – in this case, the IV bags.  The bags were recalled, and are no longer in production.  Ten of the patients died.  Investigators have said they won’t be able to determine whether the infection caused the deaths because the patients were already very ill (TNP is used for patients who are too ill to eat on their own).

The IV bags were compounded at a local pharmacy.  There was a potential for contamination in the raw material used for compounding, during the compounding at the pharmacy, or at the hospital.  Because six different hospitals experienced the same rare bacterial contamination, it is unlikely that the contamination occurred at the hospital.

According to Dr. Alexander J. Kallen, a medical officer with the Centers for Disease Control and Prevention, “Historically, what we’ve seen is a breakdown in the manufacturing process.”  The investigation is underway to determine if the contamination was caused by an issue with the manufacturing process, an issue with the sterility of equipment, or a contamination of the raw material.  As the investigation continues, more detail can be added to the Cause Map.  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.

While investigating an issue, it can also be helpful to look at the process for identifying and isolating issues, and implementing improvements.  In this case, after patients receive or use products, they are monitored for certain reactions.  If those reactions occur (such as those that indicate a bacterial infection), they are reported to the State Health Department, then the CDC.  The CDC investigates to determine the source of the infection and then pulls the affected products off the market.  Currently, the CDC has identified the product that is contaminated, though not the source of the contamination.

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.  To view the Cause and Process maps, click “Download PDF” above.