Biosafety Practice for Gene Therapy

Preparation and/or administration of a Genetically Modified Therapy must only be undertaken by suitable qualified and trained staff. Ie staff trained by the manufacturer, sponsor to specifically prepare and administer the GMO.

General principle – follow STANDARD PRECAUTIONS (see below) for infection prevention and control UNLESS advised of alternative safety measures by the Lead Clinician that may have been required by the TGA as part of the license conditions for the specific GMO treatment.

There will be a note in the EMR indicating the requirements for managing the patient post GMO therapy; including who to contact if you have any queries.

Standard precautions represent the minimum infection prevention measures that apply to all patient care, regardless of suspected or confirmed infection status of the patient, in any setting where healthcare is delivered.

Standard Precautions comprise the following safety Measures (Ref Victorian Dept of Health Infection control- standards and transmission based precautions)

·       hand hygiene before and after all patient contact

·       the use of personal protective equipment, which may include gloves, impermeable gowns, plastic aprons, masks, face shields and eye protection

·       the safe use and disposal of sharps

·       the use of aseptic "non-touch" technique for all invasive procedures, including appropriate use of skin disinfectants

·       reprocessing of reusable instruments and equipment

·       routine environmental cleaning

·       waste management

·       respiratory hygiene and cough etiquette

·       appropriate handling of linen.

Waste, other than that created in the preparation and administration of the GMO, is disposed of in the regular clinical waste stream (i.e. yellow biohazard bins).

Ref:  Safeguards for Using Viral Vector Systems in Human Gene Therapy: A Resource for Biosafety Professionals Mitigating Risks in Health Care Settings - PMC