Clinical Core Expanded Research Mode Guidelines

The Clinical Core will adhere to Guidelines for Expanded Research Mode put forth by the COVID Preparedness Committee (CPC). Additional special considerations pertaining to the Core which are not specifically contained within will include:

Masks
Masks must be worn at all times unless in a single occupancy room with the door closed. Staff will continue to wear eye protection and gown when obtaining and/or handling donor samples. Masks can be reused after proper disinfection using UV lightboxes in lab processing or Vivarium.

PPE
Phlebotomy practice will continue with full PPE when dealing with donors per SOP 34-3126 Clinical Core PPE Use and Disinfection Procedures No more than 2 people per room at any time.

Special Procedure for Human Subjects
34-3126 SOP for Clinical Core Suite Disinfection will continue to be followed pre and post donor visits. All other spaces will be disinfected by staff. All steps for human subjects’ donors will be followed in accordance with SOP 34-3127 Interaction with Human Subjects Participants.

Phlebotomy Room
Only Clinical Core staff are to enter the phlebotomy room unless prior permission is obtained from Gina Levi, Core manager. Because of the disinfection protocol, we are trying to minimize the traffic. If the red waste needs to be emptied, please send Dave Hall a message and he will arrange for someone to empty it.

Donor scheduling
Decreased work volume due to disinfection protocol for all Human Subjects coming in and out of LJI and the phlebotomy room. Only one donor can be scheduled in this extended draw period to allow for cleaning protocol mandates.

Lab processing areas
Continued regular cleaning and maintenance of all spaces, hoods, countertops and equipment. Including, but not limited to door handles, computer keyboards, light switches, refrigerator handles and any frequently touched items to be done at the end of each day and as needed.

Staffing
Minimum staff required to process urgent or essential samples will be on site and should not exceed the number which can safely and comfortably maintain proper 6ft social distancing. Functionally, this will not exceed two staff members in any of our 5 Clinical spaces. Phlebotomy will remain 1 staff member and 1 study subject at any given time during blood donation. Phlebotomy room may also be utilized as an office space for Clinical staff when not in use for blood draws.

Rotational schedule for lab processing room with no overlapping shifts due to proximity of working space. Staff will be on-site for only as long as necessary to perform essential or urgent work or processing. Any and all work that can be completed from home, should be performed off-site.

Samples
The hierarchy of sample acceptance will be:
1. Internal COVID samples
2. External COVID samples
3. Long term essential projects (includes NBDP and time sensitive vaccinations)
4. Other long-term projects already in progress, but currently on hold

Internal and external sample/reagent delivery will be made using a drop-off container (at proper temperature). Staff will wear gloves to unbox and proceed by disinfecting all inner containers. All external packaging will be disposed of as soon as possible. Any bench or countertop which has been in contact with any packaging/containers will be disinfected.
 

Contact:
– Shariza Bautista: shariza@lji.org / 858-752-6569
– Gina Levi: glevi@lji.org / 858-752-6929