Quality Laboratory Management (QLM) is an attainable standard for all laboratories, but in the case of the Infectious Disease laboratory the stakes are much higher, and strenuous precautions must be taken.
Five essential QLM plans should be developed and implemented in all clinical laboratories:
- Facility Management Plan
- Safety Management Plan
- Personnel Management Plan
- Supplies and Services Management Plan
- Equipment Management Plan
However, in the case where laboratories process suspected infectious disease samples, additional precautions must be considered and taken. For example:
- Design and use of allocated work space to meet all applicable requirements for design and safety: Is the proper Biosafety Level workspace provided?
- Design of workspace for work process and staff efficiency: Does the workflow limit the number of steps needed to process the sample to reduce the risk of exposure/contamination?
- Adequate storage space and conditions to maintain the integrity of samples, files, equipment, reagents, supplies, and records: In addition to maintaining proper documentation on all suspected infectious agents, is information shared to the proper points of contact and in a timely fashion?
- Monitoring, documenting, and controlling environmental conditions: Is the proper Biosafety Level being used for the suspected infectious agent?
- Maintenance of the laboratory in a functional, reliable, and clean condition: Has the laboratory staff been properly trained on proper cleaning disinfection techniques for the suspected infectious agent? Has building facility maintenance been instructed on how to or how not to handle any suspected infectious agents?
- Handling of emergencies: What is the SOP (Standard
- Operating Procedure) for communicating possible exposure
- or contamination?
- Handling, transport, and disposal of biologic and chemical materials: QLM protocols should always include methods for proper specimen handling. These protocols will vary based not only on the BSL but the specific infectious agent. Will autoclaving be adequate or should items also be incinerated? For each infectious waste product, is there a protocol in place to properly dispose of it?
- Safety training for laboratory staff: For all suspected infectious agents, there must be proper training of laboratory staff, including any administrative employees who will be communicating with various departments. Does this training include any applicable SOPs for Specimen Handling, processing, disposal, communication, and dissemination of information to necessary parties?
One of the most important components of deploying a Quality Laboratory Management System within Infectious Disease is to ensure that the laboratory is certified according to the applicable Biosafety Level of testing.
Biosafety Level 1
BSL-1 is appropriate for working with microorganisms that are not known to cause disease in healthy humans. This is the level found in municipal water-testing laboratories, in high schools, and in some community colleges teaching introductory Microbiology classes, where the agents are not considered hazardous.
Biosafety Level 2
The facility, the containment devices, the administrative controls, and the practices and procedures that constitute BSL-2 are designed to maximize safe working conditions for laboratorians working with agents of moderate risk to personnel and the environment. The agents manipulated at BSL-2 are often ones to which the workers have had exposure in the community, often as children, and to which they have already experienced an immune response.
In contrast to the guidelines for BSL-1, a number of immunizations are recommended before working with specific agents. Most notable is hepatitis B virus immunization, which is recommended by the Occupational Safety and Health Administration for persons, including laboratorians, at high risk of exposure to blood and blood products. These agents are generally transmissible following ingestion, exposure of mucous membranes, or intradermal exposure.
Eating, drinking, and smoking are prohibited in BSL-2 laboratories, and extreme precautions are taken while handling needles and other sharp instruments.
Biosafety Level 3
BSL-3 is suitable for work with infectious agents which may cause serious or potentially lethal diseases as a result of exposure by the inhalation route. BSL-3 laboratories should be located away from high-traffic areas. Examples of agents that should be manipulated at BSL-3 are M. tuberculosis (research activities), St. Louis encephalitis virus, and Coxiella burnetii.1
Biosafety Level 4
BSL-4 builds upon the containment requirements of BSL-3 and is the highest level of biological safety. There are a small number of BSL-4 labs in the United States and around the world. The microbes in a BSL-4 lab are dangerous and exotic, posing a high risk of aerosol-transmitted infections. Infections caused by these microbes are frequently fatal and without treatment or vaccines. Two examples of microbes worked with in a BSL-4 laboratory are Ebola and Marburg viruses.2
There may be instances in which unique needs, unknown hazards associated with unknown pathogens, or other contributing requirements will cause supervisors or biosafety professionals to seek higher biosafety requirements. These can be established after appropriate risk assessments have been conducted.1
Documentation and communication in the Digital Age
Within the laboratory’s LIS or EHR/EMR, for ICD-10 there must be specified documentation for samples from infectious disease patients. For example, the CDC guidelines require code Z22 for a carrier of infectious disease. “Carrier status indicates that a person harbors the specific organisms of a disease without manifest symptoms and is capable of transmitting the infection.”3 QLM dictates that the proper data management is used to ensure appropriate actions will be taken for each suspected infectious agent encountered.
In working with Infectious Disease agents the laboratory is responsible for communicating when there is an infectious agent that is a risk to the public health of the community.4 There are protocols that must be followed specific to each locality, and all laboratories should research and identify the specific protocols for their jurisdiction. It is also important to note that there may be some overlap in necessary communication based on where the laboratory is located. For example a laboratory in Washington, DC, may have to contact the local Public Health Department, local police, Federal Bureau of Investigation, Capital Police, and the Centers for Disease Control and Prevention. But the critical point is that all information must be communicated properly, in a time-sensitive manner, and with as many details as the level of security warrants.
QLM in Infectious Disease comes with its challenges but also its rewards. Laboratories that can successfully identify suspected infectious agents have the chance not only to save and preserve life, but also to improve the quality of life in many communities. Professionals who take on the day-to-day challenges that come with working with some of the most threatening agents known to man do so with great care and respect for their craft. These laboratorians have taken the time to properly learn not only how to handle these threats but also how to manage them.
- The 1, 2, 3’s of Biosafety Levels. http://www.aphl.org/aphlprograms/preparedness-and-response/Smallpox/pdf/the-1-2-3s-of-biosafety-levels.pdf. Accessed October 8, 2014.
- Recognizing the Biosafety Levels. http://www.cdc.gov/training/quicklearns/biosafety. Accessed October 8, 2014
- CD-10-M Official Guidelines for Coding and Reporting 2014. http://www.cdc.gov/nchs/data/icd/icd10cm_guidelines_2014.pdf. 84-85. Accessed October 8, 2014.
- Case Definitions for Infectious Conditions Under Public Health Surveillance. http://www.cdc.gov/mmwr/PDF/rr/rr4610.pdf. Accessed October 8, 2014.