Strict lab procedures and guidelines ensure safety

The emergence of the SARS-CoV-2 virus, commonly known as the virus that causes the COVID-19 disease, has prompted the discussion of testing procedures in communities around the world. Testing to see if one has acquired the virus is important but the prior guidelines and procedures that follow are critical for a correct diagnosis. There are over 250,000 CLIA – certified laboratories in the United States with each operating at different scales and areas of expertise. However, all of these labs generally have strict guidelines to ensure that safety and efficiency is met.

Testing to see if one has acquired the virus is important but the prior guidelines and procedures that follow are critical for a correct diagnosis.

How Are Medical Labs Operated?

Labs are ranked and operated differently through biological safety levels (BSL) which are a series of regulations and procedures based on the organisms and infectious agents being researched and worked with. These regulations are important as it not only helps keep personnel in a lab safe but prevent errors that can lead to falsified results. There are four different BSL levels with each ascending level requiring stricter guidelines and uses of personal protective equipment (PPE) due to the agents being worked with. These biosafety levels are BSL-1, BSL-2, BSL-3, and BSL-4.

Strict lab procedures are important as they not only keep personnel in a lab safe but prevent errors that can lead to falsified results.

BSL-1 is the lowest biosafety level in which the agents and toxins that are utilized do not consistently cause disease in healthy adults and pose little to no threat. The use of a nonpathogenic strain of E. coli or other similar microbes are the types of agents that are typically used. PPE equipment that are recommended consists of gloves, lab coats, and eye protection.

BSL-2 is the second biosafety level in which the agents being worked are present in the community and may have a moderate risk to humans in case of accidental swallowing, inhalation, or skin exposure to the agent. Procedures that can cause infection are to be done within a biological safety cabinet (BSC) which is an enclosed workspace that filters the inflow and exhaust air. The use of Hepatitis B would be an example of an agent typically used at BSL-2 labs. Hand and eye washing stations, doors that can lock automatically, and unidirectional airflow are typical designs for BSL-2 labs. Equipment that can decontaminate waste such as an autoclave or incinerator are also required depending on the risk of the agent used. PPE that are required include gloves, eye/face protection, and lab coats.

BSL-3 labs are used to study and work with agents that may be transmitted aerially and cause lethal infection if inhaled. An example of an agent would be M. tuberculosis. In addition to BSL- 2 guidelines, all work in BSL-3 labs are done within a biosafety cabinet and designs such as directional airflow, sealed windows, ventilation and filtrations systems, and physical separation from access doors are utilized. The PPE that is used include eye/face protection, gloves, lab coats, and respiratory protection when needed.

BSL-4 labs are reserved for working with dangerous agents that have high mortality rates and in which no therapy or vaccine is available. An example of a BSL-4 agent would be the Ebola virus. These labs are isolated and are typically in a restricted zone of a building or an entire separate building altogether. Personnel that are working in these labs are required to change clothing before entering and shower when exiting. All materials used must be decontaminated before exiting as well. Personnel working in BSL-4 labs wear a full body and air-supplied suit which offers the most protection of all biosafety level PPE. These labs are specifically designed to prevent contamination and all work with agents or toxins are done in a Class III biosafety cabinet.

There are four different BSL levels with each ascending level requiring stricter guidelines and uses of personal protective equipment (PPE) due to the agents being worked with.

The Dangers of Mistakes

Mistakes in lab procedures can not only be dangerous to the personnel working in the lab but can result in false data. The reason for biosafety levels is to ensure that the necessary safety measures are practiced to not only keep the personnel in the lab safe but to produce an efficient environment with dependable results. In addition to this, an important component to creating such an environment is the use of machines or kits to automate procedures; nonetheless, the failure to comply with the guidelines in manufacturing, distributing, and using such kits or machines, especially in a laboratory setting, can have consequences.

The reason for biosafety levels is to ensure that the necessary safety measures are practiced to not only keep the personnel in the lab safe but to produce an efficient environment with dependable results.

In the case of the COVID-19 pandemic, a key topic is the accuracy of test results. From the moment a sample is taken from a patient, there are factors that can cause errors in results. This is the reason why the CDC submitted guidelines to follow when collecting, handling, and testing clinical specimens with COVID-19; along with their purposed BSL-2 usage of the SARS-CoV-2 virus in routine diagnostic testing and BSL-3 practices when isolating the virus. Despite these guidelines, there are factors such as contamination or other mechanical errors that can falsify results which was seen in the initial testing kits for COVID-19.

Per WebMD, the initial COVID-19 testing kits that were created by the CDC falsified results due to a contaminated component which was found in a review by the Department of Health and Human Services.

Per WebMD, the initial COVID-19 testing kits that were created by the CDC falsified results due to a contaminated component which was found in a review by the Department of Health and Human Services. It was also reported that the Food and Drug Administration (FDA) concluded that the tests had improper manufacturing procedures and violations in laboratory protocol. Because of this, the number of cases for COVID-19 may have likely been skewed at the beginning of the pandemic and due to not following the proper procedures, may have costed lives through failed diagnoses. In adhering to the correct procedures and regulations of laboratory work, critical mistakes can more likely be avoided which can not only save the lives of the laboratory personnel, but the lives of the general population as well.