Monoclonal antibody infusion therapy treatment space

When setting up a monoclonal antibody (mAb) infusion therapy treatment space, COVI-19 positive patients should be treated in a setting that is readily accessible, separate from any immunocompromised in- or outpatient populations, and proximate from a campus perspective to the pharmacy that would be responsible for preparing treatment regime. 

As part of the Centers for Medicare & Medicaid Services Hospital Without Walls initiative, hospitals can provide services outside of standard hospital settings. Alternate care sites must be linked to the hospital to allow for reimbursement of medical services. Regardless of whether treatment space is within the walls of the hospital or located in an alternate care site, you should consider the following physical environment needs: 

• Dedicated preparation area with sufficient capacity onsite or nearby for mAb drug aseptic preparation.
• Acceptable equipment for mAb drug storage.
• Space for fast turnaround testing capabilities.

Additional considerations include:

• Ensure controlled access to infusion area, with appropriate space/vestibules for donning and doffing gear prior to entering staff area or infusion zone.
• Facilities should be equipped with separate staff support area that may include dedicated staff toilets.
• As determined, balance ventilation airflow from staff areas to induce positive pressure relative to patient infusion zone. 
• The ventilation system and critical equipment should be backed up by emergency power. 
• For treatment spaces that consist of an exam/treatment/patient type room with single patient, recommend following the Centers for Disease Control and Prevention (CDC) Passive Isolation strategy. 
• Ventilation should comply with ASHRAE/ASHE Standard 170, Ventilation of Health Care Facilities:
  • Emergency department public waiting area — 2 outdoor ACH and 12 total ACH.
  • Radiology waiting rooms — 2 outdoor ACH and 12 total ACH.
• Utilize Infection Control Risk Assessment approach to address staff safety considerations, factoring in the personal protective equipment and administrative controls related to the specific space conditions:
  • Open bay infusion area with multiple patients may necessitate at least 2 outdoor ACH and 12 total ACH to mitigate exposure risks.
• Portable HEPA units may be utilized to supplement the air conditioning/ventilation system provided in the space to achieve the recommended total air changes.    
• Treatment space(s) should be adjacent and accessible to dedicated patient toilets provided with continuous ventilation/exhaust during occupied hours.
• Follow the application of the CDC Air Contaminant Removal Table before and after space occupancy/use

For additional information, please see the Operation Warp Speed Therapeutics Pre-EUA Playbook – Monoclonal Antibodies.