Particulate Matter Closes Operating Rooms at VA Hospital

By ThinkReliability Staff

On February 17, 2016, the 5 operating rooms at a New York Veterans Affairs (VA) hospital were closed due to particulates falling from the air ducts. An internal email from the engineer & safety officer to administrators at the hospital described the problem as this: “The dust is depositing on HVAC registers, ceilings, walls, and on medical equipment. Maintenance continues to clean the surfaces but, as the staff has observed, the dust reappears within a short time. At least three staff members have indicated their concern that this environment has affected them. They have been sent to employee health and to their individual physicians.”

The information related to this issue determined as part of the incident investigation can be captured within a Cause Map, a visual form of root cause analysis. The first step of the process is to determine the impacts to the goals. In this case, both patient and employee safety are impacted due to the risk of illness from exposure to the particulates. The environmental goal is impacted because of the release of the particulates into the facility. Patient services are impacted because patients are being sent to other facilities as sterile procedures are not being performed (an impact to the production/ schedule goal). The labor and time required for an investigation is also an impact to the goal.

The second step of the process is the analysis: determining why these goals were impacted. The release of the particulates into the facility is because there are particulates within the air ducts, and the air ducts open into the facility to provide heating, ventilation and air conditioning. In order to determine where the particulates come from, first it must be determined what they are composed of. An environmental analysis determined that the particulates were rust, crumbling concrete, fiberglass fibers, and cladosporium (a common mold).

The analysis also identified that rust in air systems typically results from aged equipment exposed to moisture. Cladosporium also results from exposure to moisture. The air duct system pulls in outside air, including humidity, resulting in the system being exposed to moisture. The VA hospital is 45 years old, which actually makes it one of the “newer” VA facilities. (According to the VA, about 60% of its facilities are more than 60 years old.) While it’s unclear what maintenance or replacements have been performed on these components over the life of the facility, deferred maintenance is a general problem at VA facilities. According to the VA inspector general, there is a $10-12 billion maintenance backlog at the department.

Once the causes of the problems (or impacted goals) have been determined, the last step is to implement action items to reduce the risk of the problem recurring. There are two parts to this step: brainstorming possible solutions, and determining which will be most effective to meet the organization’s needs. The hospital considered bringing in mobile surgical units and installing high efficiency particulate air filters in the vents in the operating rooms. The cost of the mobile surgical units (over $70,000 per month) led the hospital to select only the solution of the air filters. At least one operating room is expected to be ready to return to service June 1st.

To view a one-page downloadable PDF of the incident investigation, including the impacted goals, analysis with evidence, and possible solutions, please click on “Download PDF” above.

Multiple Factors Contributing to Health Care Crisis in Venezuela

By ThinkReliability Staff

Venezuela is facing a health care crisis of massive proportions. Since 2012, the infant mortality rate has skyrocketed from 0.02% to more than 2%. (The latest numbers are from 2015, so this is a hundred-fold increase within 3 years.) The mortality rate for new mothers increased almost 5 times over the same period. Everyone else isn’t doing too well either. Says Dr. Yamila Battaglini, a surgeon at J. M. de los Ríos Children’s Hospital, “There are people dying for lack of medicine, children dying of malnutrition and others dying because there are no medical personnel.” That doesn’t even cover all of the problems facing Venezuela right now, which include:

Rolling blackouts: The government has announced official “rolling” blackouts of at least 40 days. That includes hospitals and other medical facilities. (Doctors are reporting having to work in the dark.) At least one hospital has a generator that doesn’t work. One reason electricity is being rationed is that even though money has been allocated to building new power plants, the plants aren’t online, and the money hasn’t been accounted for. (Unfortunately this kind of potential theft/ corruption is much too common in Venezuela). Another reason is . . .

Drought: The Guri hydroelectric dam provides 75% of the nation’s electricity, and currently has extremely low levels due to drought. The drought, caused by El Niño, has also resulted in a general lack of water, which is now being rationed. The combination means that the hospital doesn’t have adequate water supplies, resulting in . . .

Lack of sanitation: Without water, sanitation suffers. Doctors have reported performing surgery after a quick rinse from a water bottle, and no rinsing down of surgical beds or instruments before the next surgery, or procedure. But the people who are getting surgery or procedures are lucky, because many hospitals are also suffering from . . .

Shortages of medical personnel: Many medical professionals have left Venezuela during the severe ongoing economic issues (such as inflation, currently pegged at 700%) due to both the decreasing price of oil (Venezuela’s main export) and what have been called “disastrous” government policies. Says Ricardo Hausmann, Professor at the Kennedy School of Government (and Venezuela native), “Venezuela’s problems are a consequence of the craziest economic policy ever in a country or in the world. It’s a country that has gone through its longest and highest oil boom in its history, and ended that period over-indebted, with a destroyed productive capacity, and now it cannot face the reduction in the price of oil.” Doctors that remain face exhaustion – without water and power, many are attempting to save lives by manually operating equipment (such as respirators for newborns). Even this can’t save lives with . . .

Shortages of drugs and equipment: The Pharmaceutical Federal of Venezuela estimates that the country is lacking ~80% of needed basic medical supplies. Price controls in Venezuela resulted in official selling prices lower than manufacturing costs. This made it financially infeasible to provide many products. The government can’t afford to import drugs, and individuals have difficulty doing so because official currency exchange isn’t available. (Even if it was, Venezuelan money is virtually worthless at this point, as the government keeps printing more.) Theft and corruption have also resulted in the loss of some equipment. And as if this all weren’t enough, the country is also suffering from . . .

Zika outbreak: To a country that lacks almost all ability to provide health care, add an ongoing outbreak (see our previous blog) for which there is currently no cure, and you end up with a situation where “some come here healthy, and they leave dead.” (Dr. Leandro Pérez, Luis Razetti Hospital)

With this many (and this severe) problems, there are no easy answers. Making the situation even worse is the government’s denial that there IS a problem. Says President Nicolás Maduro, “I doubt that anywhere in the world, except in Cuba, there exists a better health system than this one.” This is preventing other countries from providing aid, sometimes because they are unaware the extent of the need. At least one country, India, is offering drugs for oil, though that may be mainly to recoup funds they are already owed, not for providing new medication.

In order to see the multitude of causes that have resulted in the health care crisis in Venezuela laid out in a visual cause-and-effect format, click on “Download PDF” above. Or click here to read more.

Regulators ask hard questions about blood testing startup Theranos

By Kim Smiley

The biotech startup Theranos has been all over headlines in recent years.  At first the company made news for its ambitious goals of running comprehensive laboratory testing on just a few drops of blood.  The company has claimed to have created a handheld medical device (nicknamed Edison) that uses only a finger prick of blood and makes blood testing less painful, faster and cheaper.  Theranos’ young and compelling founder Elizabeth Holmes has been featured in multiple magazines, gave a popular Ted talk and has even been compared to Steve Jobs and Bill Gates. In 2014, the company was valued at $9 billion.

Lately, the type of headlines the company has made have changed as the company has been embroiled in controversy.  The multiple concerns about Theranos can be visually represented in a Cause Map, a visual format for performing root cause analysis.  A Cause Map intuitively breaks down a problem to the basic cause-and-effect relationships and visually lays them out.  (Click on “Download PDF” to view an intermediate Cause Map of these issues.)  Many of the issues raised haven’t been proven yet and require more evidence so a question mark is used to note this open question within the cause box.

The problems for the company started coming to a head in the latter half of 2015. A December 2015 report by The Wall Street Journal, At Theranos, Many Strategies and Snags, raised concerns about the accuracy of the company’s propriety handheld blood testing device.  Studies showed that the results of the Edison device differed from testing done by traditional blood testing methods. Additionally,  inspections over a three-week period in August and September 2015 at two Theranos facilities found multiple issues.  Specifics on the exact problems found during the inspections have not been released, but they have been described generically as problems with record keeping, quality audits, and handling of consumer complaints. The FDA has also raised concerns about the approval of a medical device called a nanotainer that is used by Theranos. The nanotainer was classified as a Class I exempt device during the approval process and it should have been classified as a risky Class II device that would have received greater scrutiny during the approval process.

A federal criminal investigation into Theranos is now underway looking into claims the company made about its technology.  A separate probe by the Securities and Exchange Commission is working to determine whether the company misrepresented its new blood testing technology and its claim that it could run a full range of laboratory tests from just a prick of blood from a finger.

As of right now, Theranos has taken a beating in the court of public opinion, but the company has not been convicted of anything and is still selling blood tests from 40 Walgreens in Arizona.  Only time will tell the fate of the company, but the issues it has faced can be seen as a cautionary tale for other biotech startups.  Even if the company is cleared of all wrongdoing, there are lessons to be learned about ensuring laboratories meet all appropriate standards and ensuring proper approvals of all medical devices.

Deadly medication error illustrates danger of discharge period

By ThinkReliability Staff

Medical errors can happen anywhere and at any time. However, these errors may be most likely to occur at transitions, especially the transition from the hospital to home when follow-up care is still required. Says Alicia Arbaje, an assistant professor at the Johns Hopkins School of Medicine, “Poor transitional care is a huge, huge issue for everybody, but especially for older people with complex needs. The most risky transition is from hospital to home with the additional need for home care services, and that’s the one we know the least about.”

The case of a woman’s death from medication errors during that transition period illustrates multiple errors that can occur during this period. We will capture the known details of this issue in a Cause Map, or root cause analysis. The first step in the Cause Mapping process is to capture the what, when, where and impacted goals in a Problem Outline. In this case, the patient passed away October 30, 2013, after discharge from a regional medical center in Missouri, where the patient was treated for congestive heart failure. Organizational goals that were impacted by the patient death (an impact to the patient safety goal), settlements with both the hospital and pharmacy (impacts to both organization’s legal/ financial goals), and the patient being administered a high dose of the wrong medication (an impact to the patient safety goal).

These impacts to the goals become “effects” of cause-and-effect relationships. The Cause Map contains all the cause-and-effect relationships that led to these impacted goals. Causes included in the map are verified with evidence, which can be provided by a variety of sources. Causes can be determined by asking “Why” questions, but more than one cause may be required to produce an effect. In this case, all necessary causes are included and joined with an “AND”.

The patient safety goal was impacted because of a patient’s death due to multiple organ failure when her bone marrow became unable to create blood cells as a result of an overdose of methotrexate. Methotrexate can damage blood cell counts and is primarily used to treat cancer and severe arthritis. The patient was administered a high dose (for methotrexate) of a drug that was not prescribed for her. When the patient left the hospital, the hospital phoned an order for a daily dose of the diuretic metolazone. However, according to court evidence, the order was written down by a pharmacy technician as a daily dose of methotrexate.

Because of the side effects of methotrexate, it is included in a list of eight “high-alert” medications that warrant special safeguards to prevent incorrect dispensing. The typical dose of methotrexate is much lower, usually only once or twice a week. Despite this, the pharmacist missed the error. In a testimony, he was unable to identify a specific reason for this oversight. The pharmacy manager said “there was a breakdown in the system.”

There were more opportunities for this error to be caught before this drug was dispensed to the patient. The patient herself could have noticed the incorrect medication based on the name or information on the enclosed information sheet. However, the patient likely did not fully understand the discharge instructions. Federal data shows that less than half of patients say they’re confident they understand discharge instructions. This patient was also receiving home health care, but neither of the two nurses that saw the patient identified the medication mix-up. Even though a primary purpose of home health care is to develop and follow-up on patient care, a 2013 government report found that more than a third of facilities did not do this properly. Medicare requires that home health agencies verify patient’s medications and check for possible interaction, but inspectors found that nearly a quarter of home health agencies inadequately reviewed or tracked medications for new patients. One of the challenges is that the typical providers of post-discharge patient care (nursing homes, rehabilitation facilities and home health care providers) did not receive any of the funding provided by Congress to upgrade to electronic medical records.

Several systemic issues were identified in this case and actions meant to improve these issues are still ongoing. One reason for increased use of electronic medical records is to avoid delivering prescriptions over the phone, which can result in transcription errors. Ensuring patients better understand their discharge instructions is another goal that could improve patient safety. Lastly, improvements to home health care agencies to ensure their required tasks are being completed effectively is clearly needed, but it has been difficult to determine the most effective way to do this.

To view the Cause Map of this incident, click on “Download PDF” above. Or, click here to read more.