All posts by Angela Griffith

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Root Cause

Maternity Death from Blood Loss after Normal Delivery

By ThinkReliability Staff

In 2010 a woman arrived at a California Medical Center at 2 AM for a full term delivery.  The woman was in good health.  Her membranes were artificially ruptured at 11:26 AM and her baby was delivered vaginally at 3:18 PM.  Unfortunately, after the delivery the patient continued to bleed.  After an hour, the patient was moved to the operating room.  The bleeding source could not be located and the bleeding continued for another 41 minutes until a senior obstetrician was called.  Although the doctor indicated that the Rapid Response Team (RRT) was not needed, it arrived shortly after but was refused entry to the operating room until after a breathing tube had been inserted.  Although Code Blue resuscitative procedures were continued for 72 minutes, the patient died due to excessive blood loss.

This tragic incident can be examined in a visual root cause analysis, or Cause Map, using the information released by the California Department of Public Health.  The first step to performing a root cause analysis is to determine which goals were impacted.  In this case, the patient safety goal was impacted due to the death of a patient.  In cases involving death or injury to a patient, employees can also be impacted in what is known as a second victim.  The death of a healthy patient associated with a normal delivery is considered an “adverse event” per the California Department of Public Health and a “never event” as defined by the National Quality Forum, which can be considered an impact to the compliance goal. The center was fined $50,000, an impact to the organizational goal.  Additionally, the delay in life saving measures to the patient is an impact to the patient safety goal.

Beginning with an impacted goal, asking “Why” questions allows the development of the cause-and-effect relationships that led to the incident.  In this case, the patient died from excessive blood loss and a delay in life saving measures.  The blood loss started as damage from delivery, but was unable to be stopped and treatment of the bleeding was delayed.  All three of these causes contributed to the total amount of blood loss experienced by the patient.  There was a delay moving the patient to the operating room (OR) and a delay calling for assistance from a senior obstetrician (OB).  Additionally, there was delay in treatment by the RRT, which was initially not allowed to enter the OR.

As a result of this incident, the medical center has reviewed and revised its policies regarding post-delivery hemorrhage and response.  Specifically, when a patient suffers more than 750 cc’s of blood loss after vaginal delivery (this patient lost more than 1500 cc’s), she is transferred to the main OR.  An OB Hemorrhage Toolkit, including checklist, has been adopted in Labor & Delivery, and the hospital has joined  a maternal care collaborative.  According to the CEO of the Medical Center, “We have reviewed these situations with everyone involved . . . to learn from them, improve patient care, update our policies and make sure nothing like these incidents can happen again.”

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

Root Cause

Bed Rail Death

By ThinkReliability Staff

A patient’s death in 2006 at an assisted living facility in Vancouver, Washington has helped spurred a review of the safety of bed rails.  The patient’s death was due to strangulation when her neck got caught in side rails on her bed.  The side rails had been provided by her family at the suggestion of the assisted living facility.

A recent Consumer Product Safety Commission (CPSC) review of bed rail fatalities indicates that there have been 155 deaths due to the use of bed rails between 2003 and May 2012 but until now, regulation of the use and design of bed rails has been somewhat haphazard.  We can examine the issues that led to the 2006 death – and have likely contributed in many of the other bed rail-related deaths, in a Cause Map, or visual root cause analysis.

We begin by considering the impacts to the goals.  The patient safety goal is impacted due to the patient strangulation and death.  The patient services goal is impacted because of the patient getting stuck in the bed rail.  Indeed, injuries resulting from bed rails are far more common than deaths, with about 36,000 injuries requiring emergency room treatment reported since 2003.  There is a concern about potentially inappropriate use of bed rails, which can be considered a property goal and the ensuing review of bed rail deaths can be considered a labor impact.

We begin with the patient safety goal and ask “Why” questions to determine the cause-and-effect relationships that resulted in the impacted goals.  The patient death was due to being trapped in bed rails.  This occurred due to her illness – about half of patients who die in bed rail incidents have medical problems, a gap between the bed rail and mattress, and the use of bed rails.  The gap can be attributed to the design of the bed rail and/or the incompatibility between the mattress and bed rail.  In this case, the bed rail was purchased by the family and the mattress provided by the facility.  ASTM standards for bed rails are voluntary and regulations governing bed rails are insufficient in their current state.

Bed rails are used primarily to keep patients from falling out of bed and to assist patients in getting in and out of bed.  However, hospitals and nursing home use has decreased since dangers have become more well known.    Most deaths (61%) attributed to bed rails occur at home.  It is suggested that a decrease in availability of caregivers may increase the use of bed rails.

When the FDA issued a safety alert regarding bed rails in 1995, it adopted voluntary guidelines and did not require safety labels or recall of any types of bed rails.  At the time, there was political support for less regulation, industry was concerned about legal issues and resistant to any tougher regulation and there was – and still is – confusion over which regulatory agency is actually responsible for bed rails.  The CPSC maintains that bed rails are medical devices and not under their authority.  However, the FDA claims that if no medical claims are made associated with the bed rails, they are not within their regulatory authority either.  Additionally, because deaths and injuries related to bed rails are not necessarily reported, and problems not highlighted to consumers, the issues are not well known.  Some are hoping to change that.

Representative Edward J. Markey has called for the formation of a task force to address the issue.  The CPSC completed a report on deaths, which has been provided to the FDA.  And, manufacturers say that newer designs and safety straps will reduce the risk of patient death.

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

Root Cause

Baby Breastfed by Wrong Mom

By ThinkReliability Staff

After a newborn baby at a Minneapolis hospital was placed in the wrong bassinette, he was delivered to the wrong mother and breastfed.  Because breastfeeding can carry risks of transmission of communicable diseases the CDC recommends HIV and hepatitis testing after such events.

We can examine this incident – and what went wrong – in a visual root cause analysis, or Cause Map.  The Cause Mapping procedure begins by determining the impact to the organization’s goals.  In this case, the patient safety goal is impacted due to the risk of transmissible disease.  The hospital involved has stated there will be consequences to staff for not following hospital procedure.  This is an impact to the hospital’s employee impact goal.  The patient services goal is impacted because babies were switched (and apparently misplaced for some period of time) and because of the testing that the baby who was breastfed by the wrong mother will require.  The hospital will pay for the testing, which can be considered an organizational goal impact.

The analysis step of the Cause Mapping process begins with the impacted goals.  To continue the analysis, we ask “why” questions.  The patient safety goal is impacted because of the risk of disease.  The risk of disease is caused by being breastfed by the wrong mother.  This occurred because the wrong baby was brought to the mother,  the mother was breastfeeding, and the infant’s bands were not matched to the mother’s bands, although this was hospital procedure.  According to the hospital’s statement, “While hospital procedures require staff to match codes on the infant’s and mother’s identification bands in   order to prevent incidents like this, it appears these procedures were not followed in this case.”

The wrong baby was brought to the mother because multiple babies were kept in bassinettes in the nursery, and the baby had been placed in the wrong bassinette.  It is unclear what procedure was used to determine which bassinette the baby should be placed in, but the procedure was obviously ineffective.

The hospital has stated that its procedures will be reviewed.  Certainly the procedure to verify a baby’s wristband to a mother’s will be emphasized and retrained.  Additionally, matching of the baby’s wristband with a tag on the bassinette would reduce these types of issues.  Some hospitals have gone so far as to stop using nurseries where multiple babies are placed and instead keep the newborn in the mother’s room.  This also would reduce the risk of baby switching incidents.

To view the Outline, Cause Map and potential solutions, please click “Download PDF” above.

Root Cause

A Tongue Tie Release Wrongly Performed in Case of Tongue Lesion Resection

By ThinkReliability Staff

A California hospital has been fined $50,000 – its fifth administrative penalty from the State since 2009 – for performing the wrong procedure on a 6-year-old boy.  The boy was supposed to receive a tongue lesion resection, but instead a tongue tie release was performed.

We can examine the issues that resulted in this incident within a Cause Map, or visual root cause analysis.  The first step in any analysis is to define what you are analyzing.  We begin with impacts to the organization’s goals.  In this case, we look at the impacted goals from the respect of the hospital.  First, the patient safety goal  was impacted due to an increased risk of bleeding, infection, and complications from anesthesia.  The compliance goal is impacted because performing the wrong surgical procedure on a patient is a “Never Event” (events that should never happen).  The organizational goal is impacted because of the $50,000 fine levied by the State of California.  The patient services goal is impacted because the wrong procedure was performed and the labor goal was impacted due to the additional procedure that was required to be performed.

The second step of our analysis is to develop the cause-and-effect relationships that describe how the incident occurred.  We can develop these relationships by beginning with the Impacted Goals and asking “why” questions.  For example, the patient safety goal was impacted because of the additional risk to the patient. The patient received additional risk because of the performance of an additional procedure.  An additional procedure was necessary because the wrong procedure was initially performed.

There are many causes that contributed to the wrong surgery being performed.  These causes are outlined in the  report provided by the California Department of Public Health.  In this case, there were several causes that likely resulted in the wrong procedure.  The Operative Report had the incorrect diagnosis – tongue tie – which would suggest that a release would be the appropriate procedure.  Additionally, the Anesthesia Record contained the wrong procedure (tongue tie release), possibly because the Pre-Anesthesia Evaluation originally noted that a tongue tie release was to be performed and was later corrected (by crossing out the incorrect procedure and writing in the actual procedure).

The type and site of surgery was not verified.  The surgeon who performed the surgery could not remember if a time-out had been performed, although there was a record of a time-out performed immediately prior to the surgical procedure.  Since the time-out was performed immediately prior to the procedure and the surgeon was unable to remember the proper procedure, the time-out was obviously ineffective.

The surgeon stated after the surgery that he believed that the tongue tie release surgery which was performed was indicated based on scar tissue that was found under the tongue.  The surgeon did not notice the lesion on the tongue during the surgery and no pre-surgical exam was performed by the surgeon.  Additionally, the surgical site was not marked (as the site of the correct, as well as the incorrect, surgeries were both within the patient’s mouth).

During the procedure, none of the other staff stopped the surgery as it was occurring.  However, given the proximity of the “correct” site to the “incorrect” site, it may have been difficult for the other staff to see what was going on.  The surgeon did note that the lesion removal should have created a sample, the lack of which was not noted by staff.

The surgeon involved in this case has indicated that he will be examining his patients prior to surgery in the future. Hopefully this incident will also serve as a reminder to all medical staff that in the case of a site that cannot be marked as per procedure, extra care should be taken to ensure the correct site is operated on and the correct procedure is performed.

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

Root Cause

Fighting Polio in India

By ThinkReliability Staff

On February 25, 2012, the World Health Organization removed India from the list of countries with active transmission of endemic polio.  This leaves three countries – Nigeria, Pakistan and Afghanistan – that are still struggling to eradicate polio from their population.  (See our previous blog for a discussion of the difficulties these countries are facing.)   India is an example of a remarkable success story made possible by hard work and meticulous planning.  In 2009, India reported the most polio cases of any country in the world – 741.  By the next year, the country reported on 42.  The last case of polio in India was reported on January 13, 2011.

We can use root cause analysis to determine causes of problems, and to learn from the issues of others.  We can also use it to learn from the successes of others.  Here we can use “success mapping” to create a Cause Map, or visual root cause analysis, of a successful outcome – in this case, the eradication of polio from India.  The steps of success mapping are the same as for incident mapping.  In this case, the public health goal was impacted – positively – by the absence of polio cases since 2011 in India.

We begin with the impacted goal, and ask “Why” questions.  The absence of polio cases in India is due to a successful vaccination campaign – covering more than 99% of children.  The successful program is due to a comprehensive, detailed vaccination plan, which we can lay out in a process map.  (To read more about India’s polio vaccination campaign, please see the Global Polio Eradication Initiative’s Website.)

The process for successful vaccination addresses some of the common problems with vaccination programs, which are still seen in the remaining endemic countries.  Notably, access to children is a major difficulty with vaccination programs.  In India, local volunteers canvass neighborhoods and determine the number of children in each home to provide vaccination workers with a number of children to look for and vaccinate.   Vaccination teams are also provided special tracking booklets for newborns, to ensure that any children that were not previously accounted for are added to the total.

There are many reasons that children are unable to be vaccinated.  Aid workers track the specific reason for each child that is not vaccinated and, depending on the reason, an appropriate follow-up team is sent to the house later on the same day and, if still unsuccessful, later in the week.  Follow-up teams include a community influencer if a parent refuses to vaccinate the child and a medical officer if a vaccination is not given because a child is ill.

Because some children are not found at home, transit teams were formed.  These teams vaccinate children at major intersections and transit points, such as train and bus stations.  To ensure full coverage (and that each child is vaccinated only once), children’s fingers are marked after they have received vaccinations.

It is hoped that some of these ideas can also be used by the vaccination teams in the remaining countries that have endemic polio and to ensure that polio does not return to countries that have already been removed from the list.  When ideas are successful at one site, other sites may be able to benefit from them as well.

However, a great process means nothing if you don’t have a team of dedicated workers.   As stated by India’s Prime Minister, “The real credit goes to the 2.3 million volunteers who repeatedly vaccinated children even in the most remote areas, often in very bad weather conditions. I commend each one of them for their dedication, commitment and selfless service.”  We second that commendation, and thank you for helping reduce the risk of this horrible disease.

To view the Process Map, please click “Download PDF” above.  Or click here to read more.

Root Cause

Only 3 Countries Remain with Endemic Polio

By ThinkReliability Staff

Polio is a horrible, crippling disease.  According to the World Health Organization (WHO), of the children who contract polio, 1 of 200 will be irreversibly paralyzed.  Of the children who are paralyzed, 5 to 10% will die because their breathing muscles are paralyzed.  The Global Polio Eradication Initiative was formed in 1988.  That year, more than 350,000 people were paralyzed.  So far in 2012 only 181 cases have been reported.  Obviously this is a huge success, but unfortunately, it’s not quite enough.  As Centers for Disease Control & Prevention (CDC) Director Dr. Frieden states “If we fail to get over the finish line, we will need to continue expensive control measures for the indefinite future…More importantly, without eradication, a resurgence of polio could paralyze more than 200,000 children worldwide every year within a decade.”

Because polio cannot live outside the body for long periods of time (unlike most diseases) it can be eradicated.  The only human disease that has been completely eradicated is smallpox.

On February 25, 2012, India was removed from the list of endemic countries, leaving only three countries where polio is endemic: Afghanistan, Nigeria and Pakistan.  Eradication in these countries continues to be difficult for various reasons.  We can look at some of the causes of why eradication has been difficult in these countries and ongoing solutions to these difficulties by analyzing the issue in a Cause Map, a visual form of Root Cause Analysis.

We begin with the impacts to the goals.  Public safety is impacted because of the risk of death and paralysis.  Public services are impacted due to the risk of contracting polio.  Additionally, the compliance goal is impacted because children are not receiving full vaccinations against polio.

There are myriad reasons for children not receiving full immune protection from vaccination against polio.  First is the difficulty finding and accessing children.  Many children in endemic areas are nomadic or homeless.  The use of “transit teams” – vaccination teams stationed at transportation stations and large crossings – aims to increase vaccination of these children.  Children are marked after they receive vaccines, to ensure the vaccines are not repeated and to allow tracking of the success of the program.  In many of the endemic areas, children are inaccessible to vaccination teams due to conflict or violence in these areas.  In some areas vaccination teams are blocked by local governments or even subject to violence.  Some religious and local government leaders do not support the vaccination program, or the makeup of the vaccination teams.  Outreach campaigns aim to reach the public, community and religious leaders.  The GPEI, WHO and CDC are trying to work with governments and religious organizations to increase acceptance of the vaccines.  The creation of small scale immediate immunization response strategies aims to allow fast response when a previously inaccessible area becomes accessible, to maximize immunization during that time.

Some parents will not allow their children to be vaccinated.  In many cultures, women will not open the door to men.  Vaccination teams will generally include at least one woman to help increase acceptance from parents.  Parents are also reluctant to vaccinate newborns, or children who are sick or sleeping.  The importance of vaccinating these children is being added to outreach information and polio hotlines are being created to attempt to provide information to reluctant parents.  Because at least four doses of the polio vaccine are required to fully protect against the disease, these issues are magnified.  Permanent polio teams in the endemic areas aim to maximize the immunization coverage and attempt to eradicate this disease once and for all.

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

Root Cause

Update: Contaminated Injections Have Now Killed 29

By ThinkReliability Staff

In a previous blog, we discussed deaths related to fungal meningitis believed to have resulted from fungal contamination of a compounded drug used as an injection for back pain.  Sadly, since our last post, the numbers of deaths and injuries has risen.  So far, 29 patients have been killed and more than 360 have been sickened by the infected injections.  Because drugs from the three affected lots were injected for pain relief to approximately 14,000 patients, investigators expect to see many more cases in the coming months.  Some of these patients received injections in other joints, so they are suffering from peripheral joint infection, which is less severe and less likely to lead to death than fungal meningitis.

We can update the Cause Map, or visual root cause analysis, which was started in our previous blog.  Specifically, as investigators are able to provide more detail about the case, we can update causes and validate them with evidence.  We are also able to update the outline as more patient deaths and sickness are discovered.

Investigators have verified that the source of the fungal contamination was the compounding company.  They noted in investigations that the clean room was contaminated due to lack of control of the humidity and temperature.  It appears that the air conditioning was shut down at night, resulting in environmental issues. Additionally, sterilization at the company was found to be inadequate.  Sterilization procedures were not followed, and sterilization equipment was found to be contaminated, possibly because it was not properly tested.  Once the contamination made it into the drug, the drug was shipped without the company knowing of the contamination, because shipping on some lots took place before the results of sterility testing were received.

The Massachusetts Department of Health has announced increased oversight of compounding companies, including annual inspections.  A bill has been introduced in Congress for FDA regulation of compounding companies that produce larger quantities of drugs for mass distribution, as appears to be the case in this instance.  It also recommends requiring compounded drugs to contain a label stating they have not been FDA-approved.  Although the compounding company responsible for the contamination has been closed down, it is hoped that a higher level of regulation will reduce the possibility of similar deaths in the future.

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

Root Cause

Manifestation of Poor Glycemic Control Part 3

By ThinkReliability Staff

In previous blogs, we wrote about nonketotic hyperosmolar coma and diabetic ketoacidosis, which are both conditions related to hyperglycemia, or high blood glucose.  In this blog, we consider the last type of manifestation of poor glycemic control that, when it occurs in the hospital, is considered a hospital-acquired condition by Medicare & Medicaid, meaning that hospitals will not receive additional payment for cases when this condition is acquired during hospitalization.  Hypogelycemic coma, along with nonketotic hyperosmolar coma and diabetic ketoacidosis, results from poor glycemic control within the hospital, but is caused by low blood glucose.

As we did with the other two manifestations of poor glycemic control, we can look at the impacted goals for a hospital and the potential causes and solutions for this condition in a visual root cause analysis or Cause Map.  The goals for hypoglycemic coma are the same to the other manifestations of poor glycemic control and include increased risk of patient death, length of patient stay and treatment needs.  The costs associated with hypoglycemic coma (greater than $7 million in the US from the 212 cases reported to CMS in 2007) are no longer reimbursable when the condition is acquired in the hospital.  There is also always the potential that a patient death can result in a second victim – the patient’s provider(s).

Hypoglycemic coma results from uncontrolled hypoglycemia, which can result from overtreatment with insulin, drug-induced hypoglycemia, drug interaction with insulin, decreased glucose production and/or loss of glucose.  Overtreatment with insulin was implicated in 90% of hypoglycemia cases in a recent study and can result from medication errors (see our analysis on medication errors in hospital settings),  or a failure to adjust insulin for diet or other factors.  Drug-induced hypoglycemia can result from administration of fluoroquinolones (the mechanism for this effect is unknown) and/or inadequate nutrition.  Drugs that interact with insulin may be administered to a diabetic patient if providers are lacking in knowledge about glycemic control.  Underlying disease or infection, such as chronic renal insufficiency, which was implicated in approximately 50% of hypoglycemia cases in the study, can result in decreased glucose production or loss of glucose.

As with the other types of manifestations of poor glycemic control, efforts must be made to prevent these types of incidents.  As suggested with hyperglycemic events, insulin plans should be individualized, accounting for all relevant factors related to glycemic control and diet.  Patients treated with insulin in the hospital should have their blood glucose levels monitored frequently, especially as insulin has been identified as a High-alert medication by The Joint Commission.   Any patients found unconscious should also immediately have their blood glucose levels measured.  Patient’s nutritional intake must be carefully monitored, especially for cases involving medications that might cause hypoglycemia.  Last but not least, controls and procedures involving drugs given to diabetic patients should be carefully controlled, due to the high potential and risk for interaction with insulin.

Two other conditions are considered hospital-acquired manifestations of poor glycemic control: nonketotic hyperosmolar coma and diabetic ketoacidosis.   In previous blogs, we discussed the causes of these issues, and suggested solutions to reduce the risk of these types of incidents.

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

Root Cause

Manifestation of Poor Glycemic Control Part 2

By ThinkReliability Staff

In a previous blog, we discussed how poor glycemic control can result in hyperglycemia which could lead to nonketotic hyperosmolar coma.  Diabetic ketoacidosis, if resulting from poor glycemic control within a hospital setting, is another hospital-acquired condition as determined by Medicare & Medicaid, meaning that hospitals will not receive additional payment for cases when this condition is acquired during hospitalization.  Like nonketotic hyperosmolar coma, diabetic ketoacidosis can have a significant impact on patient safety and can be investigated within a Cause Map, or a visual root cause analysis.

The impacted goals for a hospital resulting from hospital-acquired diabetic ketoacidosis are very similar to those for nonketotic hyperosmolar coma.  Patient safety is impacted due to an increased risk of death, which can also result in a provider being a “second victim.  This is a “no-pay” hospital acquired condition, which is estimated to cost $42,974 per case.  According to the Centers for Medicare & Medicaid Services (CMS), in 2007 there were 11,469 cases of hospital-acquired diabetic ketoacidosis, resulting in a total cost to the healthcare system of almost half a billion dollars.

According to a study  published in the International Journal for Quality in Health Care, diabetic emergencies, including nonketotic hyperosmolar coma,  increases the risk of patient death (from 9% to 16%),  length of patient stay (from 7 to 14 days) and treatment requirements.  The costs associated with nonketotic hyperosmolar coma (greater than $114 million in the US in 2007, according to CMS) are no longer reimbursable when the condition is acquired in the hospital.  Additionally, patient death due to hospital-acquired conditions can result in a second   victim – the healthcare provider(s).  Additionally, this diagnosis results in increased stay and treatment requirements.

Beginning with the impacted goals and asking “Why” questions, we quickly determine that diabetic ketoacidosis, like nonketotic hyperosmolar coma, results from uncontrolled hyperglycemia.  Rather than perform the same analysis of causes of hyperglycemia (which, if we’re doing our job right, should result in the same cause-and-effect relationships), we can link to the analysis shown in our previous blog.   However, for diabetic ketoacidosis, we also have a cause of dehydration.  Since this was not a cause previously analyzed, we will add to this portion of the Cause Map.

Patient dehydration can result from a medication that increases fluid loss, an underlying medical condition, or inadequate water intake.  Inadequate water intake can result from a patient’s limited access to water, such as a patient who is bedridden and is not provided adequate water from a caregiver, or the patient feels too ill to drink, or the patient is unable to drink, due to incapacitation, confusion, restraints or sedation.  A combination of these causes may also occur.

Because of the importance of preventing these conditions resulting from hyperglycemia and dehydration, every effort should be made to prevent these outcomes from occurring.

Two other conditions are considered hospital-acquired manifestations of poor glycemic control, diabetic ketoacidosis and hypoglycemic coma.  In future blogs, we will discuss the causes of these issues, and suggested solutions to reduce the risk of these types of incidents.  It is recommended that an individualized insulin plan be used, rather than a sliding scale, to ensure blood glucose levels are kept at or below 110 mg/dL.  A specific glycemic management team, which carefully coordinates medical nutritional therapy with insulin control, can also reduce the risk of glycemic events.  Patients who are found to have an insulin deficiency should be treated with intravenous insulin.

Because 20-30% of diabetic ketoacidosis cases are estimated to be the initial presentation of previously undiagnosed diabetes, some experts recommend testing the glucose levels of all children who have not been diagnosed with diabetes, and all patients who are vomiting or require intravenous hydration.  To reduce the risk of dehydration, patient’s fluid intake should be tracked and any patients who are unable to  drink should have intravenous fluids.

Nonketotic hyperosmolar coma and diabetic ketoacidosis are two hospital-acquired events that result from hyperglycemia.  The remaining hospital-acquired manifestation of poor glycemic control, hypoglycemic coma, will be covered in a future blog.

To view the Outline, Cause Map, and Solutions please click “Download PDF” above.  Or click here to read our previous blog.

Root Cause Analysis

Medical Information from 20,000 Patients Posted Online

By ThinkReliability Staff

Unfortunately, privacy of health records has become an increasingly frustrating issue.  The Department of Health and Human Services revealed that records for 11 million people were potentially made public for over two years.  A recent medical records privacy breach has made the news for the length of time the records were publicly exposed.

A hospital in California recently notified 20,000 patients that their data had been published on a commercial website from September 9, 2010 to August 23, 2011.  The published data was discovered by a patient and had been used to demonstrate the use of turning data into a bar graph.  This particular data had been given to an outside contractor for billing purposes. Although it did not contain information usually used for identity theft – such as social security numbers, it did include names and diagnosis codes, meaning that extremely personal information was included.

We can examine this issue in a Cause Map, or visual root cause analysis.  A Cause Map begins with the impacts to an organization’s goals and uses the principles of cause-and-effect to examine the causes that contributed to these impacts.  Any breach of patient privacy can be considered an impact to the patient services goals.  In fact, health care organizations may choose to add a new goal category of “Patient Privacy”.  (This is shown on the  downloadable PDF.  To view, click “Download PDF” above.)  In addition to the impacted patient services and patient privacy goals, the hospital was fined $250,000 (the maximum) by the California Department of Public Health and provided identity protection services to the affected patients.  Given the astonishingly large numbers of medical records accidentally made public, this is an issue to which all healthcare facilities should be paying attention.

The exact method that the data made it onto a public website (which provided homework assistance) is not known, but the data had been provided to an outside contractor used for billing purposes.  The contractor is no longer being used by the hospital, and some privacy experts say that better confidentiality agreements are needed by hospitals who provide patient information to outside contractors.  What is particularly disturbing about this case is that the data remained online for nearly a year – and was discovered by a patient.  However, there does not seem to be a practical way for individual organizations to monitor the internet for misplaced patient data.  Instead, focus should be on ensuring better protection upfront for medical data, in an attempt to limit breaches of patient privacy.

To view the Outline and Cause Map, please click “Download PDF” above.  Or view the New York Times article to learn more.