Compliance professionals sometimes avoid auditing institutional biosafety programs because they do not fully understand them, but that is detrimental, warned Bret S. Bissey, MBA, FACHE, CHC, CMPE, Senior vice president of Compliance Services at MediTract. Speaking at a Health Care Compliance Association (HCCA) webinar titled, “Performing a Compliance Assessment of the Institutional Biosafety Program,” Bissey and Joan M. Robbins, Ph.D., Senior Vice President of Biosafety & Gene Therapy at WIRB Copernicus Group, warned attendees of the need for strong biosafety programs to combat increased biological risks. Biosafety programs should be viewed as investments, rather than expenses, according to Bissey; a compliance professional should not feel comfortable at an institution where a biosafety assessment discussion is not part of the work plan.
Biosafety measures are required for the safe handling and containment of infectious or potentially infectious biological materials, which may occur in both laboratories and clinical settings, such as a hospital where a clinical trial is occurring. To be effective, they require a fundamental understanding of the particular biological material or agent at issue. They also require an agent-specific risk assessment and a risk group classification, rather than general safety measures. Facilities should institute standard microbiological practices and ensure that appropriate safety equipment is used and appropriate safeguards are put in place. Unlike basic infection prevention control, which protects the patient, effective biosafety protects workers, the environment, and the community.
Institutions should generally perform two types of biosafety reviews: document reviews and facilities reviews. Documents reviewed should include exposure control plans, biosafety policies, environmental health and safety policies, and training plans. Employees should be trained in agent-specific safety polices, rather than mere general policies. For example, certain biologicals can affect the eyes, and employees must understand the need to wear eye shields when dealing with them. Protocols must be in place regarding actions that employees should take if they are exposed to biologicals, for example, through an infected needle.
Auditors should review all sites where a biological will be received, stored, manipulated, administered, or disposed of. Lax access controls over administration and storage are a huge issue. Only those people who need to access certain areas, including refrigerators and freezers should be able to access them; employee lunches should never be stored in the same refrigerator as biological materials. Cabinets, floors, and other surfaces must not only be clean at the time of review, but be easy to clean to ensure that the condition can be maintained. It is typically easier to implement effective biosafety in a laboratory, which may handle biosafety levels 1 and 2 on a regular basis, compared to a clinical setting, which may not deal with the issue as frequently.
Failure to implement biosafety is costly beyond the obvious risks to health and safety. A lack of biosafety can result in delayed research and a diminished public support; they can also result in monetary settlements, such as a hospital’s settlement with a nurse resulting from her exposure in Ebola in the hospital setting. Nurses at that particular institution reportedly were given protective equipment, but not trained it its use.
Compliance officers should ensure that biosafety is addressed at their institution. A biosafety officer will likely have greater understanding of the details and more direct oversight over the program, but compliance officials need to ensure that the program is in place and is working as it should. As Bissey said, it is up to the compliance department to act proactively, rather than retroactively, when it comes to biosafety.