Record Keeping Procedures: Biosafety

Due to the regulations surrounding research with infectious materials and agents alike, a variety of records must be kept to document specific activities. Any and all records that are kept must be maintained for the minimum retention time although some employee records must be retained for 30 years post employment whereas other documents may have a 3 or 5 year retention time. Lack of written documentation, either due to premature destruction/ disposal or the lack of documentation practices, will result in enforcement action from the corresponding regulatory agency as well as possible disciplinary action pursuant to the escalation procedures contained in the appendices of this document.

All records shall be provided upon request. Medical records will be made available to the employee as well as any person with written consent from the employee to view or copy records.

A sharps injury log shall be provided to Cal/ OSHA, Department of Health and Human Services and to NIOSH upon request.

Training Records

All training records will be kept by Environmental Health and Safety and must include the following information to meet the qualification or a training verification document:

Date training was performed and completed; (if different)
Outline describing the material and topics;
Name and qualifications of the trainer; and
Names and job titles of all attendees.

Employees shall have the ability to view their training records during normal business hours must be presented to representatives from Cal/OSHA, the employee and employee’s representatives upon request for examination or copy. Note that it is the responsibility of the PI to submit copies of all training documentation or training records to EH&S within 24 hours of conducting the training session or within 72 hours if the training was conducted at the end of a work week. Online training where a certificate is assigned should be printed in duplicate so a copy can be sent to EH&S while the other is retained by the trainee.

Medical Records

Employee medical records are regarded as confidential but are sometimes necessary for certain tasks in the lab and for assessing a level of fitness required to use some levels of PPE. All employees have the right to maintain their confidentiality with respect to their health and medical history and due to this, there are various standards that ensure those rights are protected. All employers are encouraged to review HIPAA standards to ensure that the confidentiality of your employees is upheld. It is important to note that certain activities such as vaccinations require an employer to see if an employee has been vaccinated. In situations where an employer does not need to see actual medical records, merely a positive or negative result (e.g. vaccinated) EH&S suggests using a qualified physician as an intermediary. Allowing the patient to interact directly with a physician allows their safety to be assessed appropriately and protects their privacy as the physician can then interact with the employer by filtering out any confidential information, thus only providing the employer with the information they need with no access to any medical records.

All medical records must be retained for 30 years after employment ends. These records must be stored appropriately and securely to maintain employee privacy protection.

Exposure Incidents

All exposure incidents must be reported to EH&S immediately and must provide the following information:

Agent Identity
Route of Exposure
Quantity
Location
Number Exposed

Depending on what agent or material is being used, reporting requirements may require the contact of outside agencies such as the CDC. Good practice in the event of exposures can be the difference between life and death. It is important to follow all safe handling procedures as well as refer to the BMBL 5thed, for more information. It is the responsibility of the PI to be familiar with all reporting requirements specific to all agents in use.

*Note: all research labs are encouraged to adopt an incident response plan to help coordinate life-saving resources in the event of an emergency, spill or exposure. A sample Incident Response Plan can be found in the appendices of this document. The implementation of an Incident Response Plan will require additional training and coordination with Cal Poly Police Department.

Equipment Maintenance

All equipment within the lab must be maintained appropriately to ensure the safe work practice with agents within the scope of this plan. Any equipment which serves as a Primary Barrier must be documented when calibrated, decontaminated, tested or repaired. This documentation must be kept for a minimum of 3 years by the department and must be available upon request. The BSC should have a maintenance sticker attached to the unit that certifies it for use.

Material Inventory

Certain agents require routine inventory to ensure that the agent cannot be diverted unlawfully for an unintended use. Various risks should be identified along with a Threat Assessment Matrix (TAM) to help determine if a material inventory is needed.

Materials like Select Agents and Controlled Substances require routine inventory documentation. This documentation must be maintained indefinitely until consulting with EH&S for a specific document retention time. These records must be stored securely by the PI and available to be produced upon request.

Access Logs

Certain agents require restricted access to the laboratory to which only authorized individuals shall be allowed to gain entry. These agents are typically identified through a Threat Assessment Matrix (TAM) and will also require the implementation of a Security Access Plan. All guests or visitors whom are not authorized individuals must undergo a safety orientation prior to entering the secured area, dawn all applicable personal protective equipment and be accompanied by an authorized individual. Guests may not be granted access while the agent is currently in use. Guests must sign in by creating an entry on a Security Access Log which shall include information such as Name, Date, Time-In, Time-Out, Escort etc.

A sample Access Log is available in the appendices of this document.

Authorized Individuals

Certain agents which require restricted access to the lab may only be accessed by Authorized Individuals or escorted by an Authorized Individual. Depending on the agent of use, special levels of clearance may be needed from various Federal agencies including but not limited to:

An application process is required for new authorized users which includes DOJ Live Scan and an approval process prior to submission to the corresponding government agency. All application records, approval/ rejection documents must be kept for an indefinite period of time. For specific retention times, consult directly with EH&S.

Transfer of Records

Submission of records to EH&S shall be made in person or through inter-department campus mail C/O EH&S. If any confidential information is present, the envelope should be marked “Confidential”. Unlawful transfer of confidential documents or records is subject to disciplinary action pursuant to the escalation procedures outlined in this document.

Furthermore, if the employer ceases to do business and there is no successor, the employer shall notify NIOSH at least three months prior to their disposal and transmit them to NIOSH, if required to do so within that three-month period.