Module 6: Appendices

Examples of staff plans (recommended positions may vary depending on the State’s scope of practice for Paramedics as it related to Subcutaneous and or Intravenous administration of medications or mAbs)

• 8 - 10 bed mAb infusion/observation site
  
• 1 physician / advanced practitioner (present or available via telemedicine)
• 2 Nurses
• 1 Nurse or Paramedic
• 2 Paramedics
• 1 flex position – administrative/ logistics/ runner
  
• Single station or mobile visit Subcutaneous administration site
  
• 1 physician / advanced practitioner (present or available via telemedicine)
• 1 Nurse / Paramedic per single mobile visit or single station

Average patient (door to door) visit can range from 80-120 minutes.

To learn more, refer to COVID-19 Monoclonal Antibody Therapeutics Calculator for Infusion Sites

Infrastructure

• Seating area with appropriate spacing for patients to receive infusion
• Steel table for product preparation
• Privacy screens if needed
• Protocol/outline for patient flow (written protocol not required however patient flow and infection control should be addressed at each administration site)
• Emergency response plan (written plan not required, however all staff should be aware of the plan for emergency response)
  

General supplies

• Infusion Reaction Kit
• Refrigerator
• Optional to store prepared solution onsite
• Sharps container
  
• Biohazard disposal bag
• Trash bins and liners
• Disposable disinfecting wipes
• Hand sanitizer
• Thermometer probe covers (if required)
• 70% alcohol wipes
• Paper towels

PPE

• NIOSH-certified, disposable N95 filter facepiece respirators or better
• Gloves in appropriate sizes
• Gowns
• Surgical face masks for patients
• Eye and face protection (e.g., goggles, safety glasses, face shields)

Patient Intake

• Vital signs machine
• Pulse oximeter
• Thermometer
• Copies of eligibility checklist for treatment/PEP

Administrative

• Site-specific documentation
• Patient fact sheets to provide each patient (copies in English, Spanish and other appropriate languages)

Administration Supplies- Subcutaneous

• Alcohol wipes
  
• 3 or 5 mL luer lock syringes (4 required for each patient for subcutaneous administration)
• Appropriate needles for product preparation and subcutaneous administration
• 21-gauge 1.5-inch needles for product transfer
• 25- or 27-gauge needles for subcutaneous administration (4 per each patient course)

Administration Supplies- Intravenous

• IV poles
• Alcohol wipes
• 2x2 gauze pads
• Adhesive bandages
• Medical tape
• Tegaderm bio-occlusive dressing
• Absorbent underpads (blue pads)
• Normal saline bags for mixing/administration- 50-250 mL
  
• IV administration sets:
• For monoclonal antibody infusion: PVC infusion set with/without DEHP containing 0.2- or 0.22-micron polyethersulfone (PES) in-line filter
• IV catheters
• IV extension set tubing
• 3mL saline syringes
• Needles – stainless steel 18ga
• Optional: Transilluminator (vein finder)

• Collect administration site location(s), address, and points of contact
  
• For mobile or deployed teams, identify the point of contact at the administration site and make contact
• Site will need dedicated space for isolation of COVID-19 patients¹
• Rededication of existing clinical space is permitted under the CMS Hospital Without Walls Initiative
• Ensure a patient scheduling and referral process is in place
• Identify and understand which therapeutics will be administered
• Determine who is responsible for ordering infused therapeutic administration
• Referring provider
• On-site or telemedicine provider
• Standing order
• Brief administration team with site objectives
• Team training
• Site workflow
• Therapeutic Administration
• Managing adverse reactions with rescue medications on site as applicable

¹ For more info reference CDC guidelines.

• Eligibility Criteria
  
• Adult and pediatric patients with immunosuppressive disease or receiving immunosuppressive treatment at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized/approved by FDA are not accessible or clinically appropriate
  
• Not authorized for
  
• Treatment of immunocompetent patients with COVID-19 infection
  
• Contraindications
  
• Individuals with a history of severe allergic reactions or anaphylaxis to plasma transfusion
  
• Administration Considerations
  
• Administer according to standard institutional medical and nursing practices for the administration of plasma²
  

¹Emergency Use Authorization of COVID-19 Convalescent Plasma

²Circular of Information for the Use of Human Blood and Blood Components

• There is insufficient evidence for the Panel to recommend either for or against the use of high-titer CCP for the treatment of COVID-19 in hospitalized or nonhospitalized patients who are immunocompromised
  
• Some panel members would use CCP to treat an immunocompromised patient with significant symptoms attributable to COVID-19 and with signs of active SARS-CoV-2 replication and who is having an inadequate response to available therapies. In these cases, clinicians should attempt to obtain high-titer CCP from a vaccinated donor who recently recovered from COVID-19 likely caused by a SARS-CoV-2 variant similar to the variant causing the patient’s illness
  
• There is insufficient evidence for the Panel to recommend either for or against the use of high-titer CCP for the treatment of COVID-19 in nonhospitalized patients who are immunocompetent
  
• The panel recommends against the use of CCP for the treatment of COVID-19 in hospitalized patients who are immunocompetent
  

¹NIH Guidelines: COVID-19 Convalescent Plasma

• Emergency Use Authorization of COVID-19 Convalescent Plasma
  
• Implementation of an OutpatiEarly Outpatient Treatment for COVID-19 with Convalescent Plasma-NEJM
  
• Early Outpatient Treatment for COVID-19 with Convalescent Plasma-NEJM
  
• New COVID-19 Treatments Add-On Payment (NCTAP) | CMS
  
• ICD-10-PCS Code: XW13325, XW14325 (Only applies to inpatient use)
  
• Addendum A and Addendum B Updates | CMS
  
• APC Code: 9540 / HCPCS Code: C9507 (Only applies to outpatient use)
  

HHS continuously monitors emerging variants to assess their potential impacts on testing, treatments and vaccines, including susceptibility to therapeutics. There is potential for paused products to play a role in addressing future COVID-19 variants. Sites are encouraged to retain all product in the event that the below authorizations change in the future. For current variant data, refer to CDC Nowcast Projections.

Product	Last Status
Evusheld	as of 26 January 2023, not currently authorized for emergency use in the US
Bebtelovimab	as of 30 November 2022, not authorized in any US region
Sotrovimab	as of 05 April 2022, not authorized in any US region
Bamlanivimab plus etesevimab	as of 24 January 2022, not authorized in any US region
Casirivimab plus imdevimab (REGEN-COV)	as of 24 January 2022, not authorized in any US region
Bamlanivimab alone	as of 16 April 2021, EUA status revoked for product when administered alone

To learn more refer to COVID-19 Therapeutic Product Expiration Database (hhs.gov) .

• Jurisdictions can transfer product to other jurisdictions/states/territories
  
• Doses discarded on-site and doses returned need to be recorded in HPOP
  
• If undamaged product needs to be disposed of, destroy it on-site in accordance with the HPOP attestation, or follow the returns instructions below:
  
• For Paxlovid, visit Inmar https://returns.healthcare.inmar.com, email rarequest@inmar.com, or call 800-967-5952
• For bam and bam/ete, see The Lilly Return Goods Procedure, detailed guidance can be found at: https://www.lillytrade.com/. Bebtelovimab returns are not being accepted.
  
• For REGEN-COV, call 844-734-6643
  
• For sotrovimab, see the GSK Returns Goods Policy at: www.gsk-ecs.com
  
• For Evusheld, visit https://www.evusheld.com/ or call 1-833-EVUSHLD
  

• For licensed provider locations with destruction procedures in place that follow all federal, state, and local regulations, therapeutics can be destroyed on site only if:
  
• Guidelines are followed on what product can be destroyed
  
• Only expired product or unauthorized product that can no longer be stored
  
• No unexpired product that is currently authorized for use can be destroyed
  
• Sites are to follow established protocols for destruction and attest in HPOP to following all regulations
  
• Quantities of any product destroyed is recorded in HPOP
  
• The established returns process for each product is still an option for sites who do not have an established method for proper destruction or otherwise prefer to go through the returns process
  
• Returned product must also be recorded in HPOP