This article was originally published in the 2015, Q1 edition of CLMR.
By Daniel J. Scungio, MT(ASCP), SLS, CQA (ASQ)
In 2014, the largest outbreak of a hemorrhagic fever virus known as Ebola occurred in several nations in West Africa. Four infected patients imported to the United States and two healthcare workers contracting the disease within the country’s borders prompted a nation-wide Ebola response. Hospitals, local and state health departments with the U.S. Centers for Disease Control and Prevention (CDC) worked together to create Ebola response plans. This response included new personal protective equipment (PPE) and infection control procedures for direct patient caregivers and laboratorians.
Ebola Comes to the United States
In August 2014, the United States brought two people known to have Ebola to the infectious disease unit at Emory University Hospital in Atlanta, Ga. These patients were successfully treated and released. In September, the CDC announced its first laboratory-confirmed case of Ebola diagnosed within the country. The patient was a man who had travelled from Liberia to Dallas but had not exhibited symptoms of the disease until he had been in the United States for four days. The man was given medical care at Texas Presbyterian Hospital in Dallas where he was placed into an isolation unit. Local public health officials identified all close contacts of this patient to perform daily monitoring for 21 days after exposure. Unfortunately, the patient passed away on Oct. 8.
Two days later, a nurse at Texas Presbyterian Hospital, who provided care for that patient, tested positive for the virus. The healthcare worker was isolated after an initial report of a fever. She was transferred to the National Institutes for Health (NIH) Clinical Center in Bethesda, Md. The nurse recovered and was later discharged. On Oct. 15, a second healthcare worker who provided care for the Ebola patient at Texas Presbyterian Hospital was diagnosed with the disease.
This second healthcare worker was transferred to Emory University Hospital. On Oct. 23, the New York City Department of Health and Mental Hygiene reported a case of Ebola in a medical aid worker who had returned to New York City from Guinea where the medical aid worker had served with the group Doctors Without Borders. The diagnosis was confirmed by the CDC on Oct. 24. The patient was treated at Bellevue Hospital Center and released in November.1 Later that month, a U.S. physician working in Sierra Leone was diagnosed with Ebola and was treated at the Nebraska Medical Center in Omaha, Neb., but his illness was advanced and he did not survive.
Hospitals Make Preparations
As each Ebola case in the country unfolded and information was disseminated via the media and other sources, hospitals across the United States attempted to quickly react to what appeared to be a growing crisis. Many sites began making decisions about accepting patients, creating treatment areas and choosing the correct Personal Protective Equipment (PPE).
As the first U.S. patients were treated, hospital administrators wanted to know about the protocols that Emory University staff were using, including information about direct patient contact and laboratory testing. The reported “failure” to follow safe protocols at Texas Presbyterian Hospital, which resulted in the infection of two caregivers, further drove a desire for hospitals to ensure they were appropriately responding to the situation should they encounter infected patients. After the first two Ebola patients were treated at Emory University Hospital, a report was released detailing to some degree both how patients were treated and how laboratory testing was performed.2
In the report, it was revealed that Emory had created a serious communicable disease unit in 2002 in collaboration with the CDC for patients presenting with unidentified or highly contagious diseases (see Figure 1, see page 21). This unit, now used for Ebola patients, consisted of negative pressure patient rooms, an anteroom and “patient support” rooms, one of which is used to house the unit’s laboratory. While the CDC clearly states that universal, droplet and contact precautions are sufficient protection against the Ebola virus, Emory University medical staff felt it was best to utilize the much higher levels of containment afforded by their serious communicable disease unit. Once this information became available, many other hospitals began to develop their own action plans, which in many locations included the development of Ebola task forces. Through these teams, many sites began construction or development of an infectious disease suite or unit, recruiting of volunteer staff, procurement of PPE and training.
Many manufacturers of various PPE (including PAPR and N95 respirators, Hazmat suits, and various other items) struggled to keep up with the demand for their products across the nation.3 For laboratory testing, many sites also followed the Emory model, which included a limited bedside point-of-care testing menu reinforced with more complex testing in the nearby support lab. Certain analyzer manufacturers strove to keep up with installation and training support as orders began to multiply. The accidental infection of healthcare employees at Texas Presbyterian Hospital prompted many questions about the proper selection and use of PPE both for treating Ebola-infected patients and for performing laboratory tests on their specimens.
The CDC put forth specific recommendations for PPE to be used by healthcare workers during the management of patients with Ebola. The agency also provided very specific instructions for donning and doffing that PPE, and these instructions included using a trained observer and the “buddy system” when performing these functions. Proper donning and doffing of the complex PPE is critical to avoiding exposure, and it is recommended that the observer read the instructions to the healthcare worker as each donning or doffing step is completed.4
As Ebola events progressed during these short months in 2014, and as several hospitals struggled to create their own Ebola response plans, interim guidance was provided by the CDC to help locations with this overall process. This plan included a regional care model or tiered method, which was meant to help provide a coordinated hospital network approach to the evolving situation. In the network system, acute care hospitals could serve in one of three roles: as an Ebola treatment center, as an Ebola assessment center or as a frontline healthcare facility.
As each hospital determined its role, the CDC provided further guidance for how those hospitals with specific designations should respond with regard to its supply needs and its capabilities (see Figure 2, see page 23). At first, only four sites in the United States were listed as Ebola treatment centers. These sites were the aforementioned Emory University Hospital, the National Institutes of Health Clinical Center, the Nebraska Medical Center, and St. Patrick Hospital in Missoula, Mont. By December, there were more than 35 hospitals nationwide listed by the CDC as Ebola treatment centers.
As events progressed at the hospitals during these months, laboratories were working to create policies and procedures that would keep workers safe should Ebola-infected samples need to be handled and tested. As the first information became available, laboratories looked to what was known already about lab exposure prevention and attempted to apply it should samples from known Ebola patients arrive onsite.
Many issues arose, however; and to date, not all of them have been resolved. In some healthcare facilities, it was decided that such samples would not be tested in the main clinical laboratory. As at Emory University Hospital, a special satellite lab would be created and utilized near the Ebola patient unit. This option considerably limits the testing menu, but many of these satellite labs are able to offer basic hematology, chemistry and urinalysis testing. Other point-of-care instruments would be used at the patient bedside.
Considerations in this scenario include training an adequate number of lab staff on the use of the testing equipment as well as the use of the necessary PPE. In order to be compliant with Department of Transportation regulations, these laboratory employees would also need specific training on the packing and shipping of any samples that would need to be transported to the state or CDC laboratory. Because of the fear of infection, it was reported that some specimen courier businesses refused to transport such specimens as news first began spreading about the disease. Some larger commercial laboratories also notified customers that they would not accept specimens from Ebola-infected patients.5
The laboratory test menu for the adequate treatment of Ebola patients has been debated, and decisions were made to create the best balance between good patient care and laboratory staff safety. Two tests in particular created some issues for patient containment unit labs that offer the limited test menus — malaria testing and blood cultures. Malaria testing was deemed an important addition to the Ebola lab test menu as malaria symptoms can mimic those of Ebola, but when the first patients arrived in the United States, there was no easy method to provide high-quality malaria microscopy in a bio-containment unit laboratory. That became unnecessary, however, as in the summer months a rapid diagnostic antigen card test had become available in the United States.
Many physicians have stated that blood cultures are an important diagnostic test for Ebola patients, but, again, these tests prove difficult to perform in a satellite lab with space limitations and the potential need to pierce a blood culture bottle and create subcultures with infected blood. Some sites have opted not to perform blood cultures, but others have provided the necessary equipment in their bio-containment unit labs. If testing of Ebola patient samples occurs in the main clinical lab, safety measures should include the prevention of aerosols. Centrifugation, if necessary, should occur only with contained rotors or safety cups.
Cap piercing, which is known to create aerosols, should be avoided. Specimens should be handled and tested only with specific CDC-recommended PPE (see Figure 3, see page 24), and all specimen manipulation should be performed inside of a Class II Biological Safety Cabinet. Other considerations for laboratories that have emerged with the advent of Ebola in the United States are the repair, maintenance and handling of laboratory analyzers used for testing samples from infected patients. Some analyzer manufacturers have notified laboratories that would not support any analyzers that were used for the testing of Ebola-infected samples. That support included repair and disposal of the analyzers.
Some manufacturers even recommended incineration of their analyzers after such use. This lack of support from laboratory instrument manufacturers made national headlines and manufacturers have begun looking at alternative solutions but many have not materialized yet.6 Some laboratory administrators have decided to simply restrict the use of the designated analyzers to the infectious disease labs for which they were purchased and handle any repair issues on a case-by-case basis. Knowing that the virus lasts only several hours on dry surfaces and a few days in wet conditions, safe decisions can be made for the handling of such equipment while personnel utilize standard precautions.
The Next Infectious Disease
Hospitals and laboratories worked quickly to respond to the “Ebola crisis” in the United States, but it was very difficult as the situation changed each time new information became available. New facts and updated guidance from national agencies altered the approach plan, and sometimes, those alterations were costly. An important lesson learned from these events is that laboratory leaders need to obtain adequate information in order to make sensible decisions, and that patience and flexibility are key to successfully responding to new and emerging circumstances.
Many hospitals utilized a great amount of time, money and human resources to create Ebola patient care units, laboratories and testing and treatment procedures. These items were accomplished in order to keep healthcare workers safe and to prevent the spread of a deadly disease. If no more Ebola patients arrive in this country, there are those who believe that the use of those valuable resources was wasted. The fact is, however, that the Ebola outbreak of 2014 helped create a sound infectious disease response plan across the United States that may be used for Ebola or for the next infectious disease that may be right around the corner.
1. Centers for Disease Control. Cases of Ebola Diagnosed in the United States. Available at www.cdc.gov 12/8/2014.
2. Laboratory Test Support for Ebola Patients Within a HighContainment Facility. Laboratory Medicine, Summer 2014, 45:e109-e111
3. http://www.cdc.gov/vhf/ebola/healthcare-us/ppe/ supplies.html
4. Centers for Disease Control. Guidance on Personal Protective Equipment To Be Used by Healthcare Workers During Management of Patients with Ebola Virus Disease in U.S. Hospitals, Including Procedures for Putting On (Donning) and Removing (Doffing). Available at www.cdc.gov 10/20/2014.
5. https://www.labcorp.com/wps/wcm/connect/ f944030045ad6d43b860beeff024ee27/Ebola+Service+Annou ncement+October+2014_FINAL.pdf?MOD=AJPERES&CACHE ID=f944030045ad6d43b860beeff024ee27&CACHEID=86ec6 80045ad664b84d4b56e8b8d2bae&CACHEID=86ec680045ad 664b84d4b56e8b8d2bae&CACHEID=86ec680045ad664b84d 4b56e8b8d2bae
6. http://www.usatoday.com/story/news/nation/2014/11/06/ hospital-laboratories-ebola-equipment/18546709/