Module 8: Appendices

Appendix A: Outpatient Infusion Site Resources

Sample Staffing Models for Parenteral Therapeutic Administration

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)

• 8 - 10 bed 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

Infused Outpatient Therapeutics Site Suggested Supplies

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)

Site Preparation for Infused Outpatient COVID-19 Therapeutic Administration

• 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 patients
  • 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

For more information reference the CDC guidelines.

Appendix B: COVID-19 Convalescent Plasma

COVID-19 Convalescent Plasma EUA

Emergency Use Authorization of COVID-19 Convalescent Plasma

• Eligibility Criteria
  • The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies, for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment, in either the outpatient or inpatient setting.
• 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 plasma. Read more in the Circular of Information for the Use of Human Blood and Blood Components.

NIH Guidelines Panel- COVID-19 Convalescent Plasma

• 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

For more information see the NIH Guidelines: COVID-19 Convalescent Plasma.

Outpatient COVID-19 Convalescent Plasma (CCP) Resources

• Emergency Use Authorization of COVID-19 Convalescent Plasma
• Implementation of an Outpatient Covid-19 Convalescent Plasma Administration Program
• 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)

Appendix C: Formerly-Authorized Products

EUA Products Not Currently Authorized

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	Latest 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 14 of December 2023, EUA status revoked in 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

Product Expiration Date Summary

• Paxlovid: First lot expiry July 31, most in field supply expiry is later
• Lagevrio: No lots have reached expiry, first expiry is Feb 9, 2024, last is Feb 27, 2025

Therapeutic	First expiry	Last expiry	Extension
Bamlanivimab*	09/5/2022	5/22/2023	No further extension
Etesevimab*	4/8/2022	5/16/2023	No further extension
Regen-COV*	12/31/2022	12/31/2023	No further extension
Evusheld	6/30/2023	8/31/2024	No further extension
Sotrovimab	8/31/2023	8/31/2024	Extension possible
Bebtelovimab	7/11/2023	8/28/2024	Extension possible

* All lots have expired. No expiry extension expected. Dispose of all product.

• For Paxlovid (nirmatrelvir co-packaged with ritonavir): Pfizer's searchable expiry data
• For up-to-date information on expiration dates of all products: ASPR searchable expiry database

Bamlanivimab and etesevimab reporting in HPOP

• Bamlanivimab and etesevimab can now be reported separately in HPOP, when needed
• The products should be reported separately only when there is an excess of one component relative to a patient course
• When reporting separately, each component should be reported in proportion to the amount of the product previously used in a patient course
• In HPOP: 1 vial bam = 1 course bam ; 2 vials ete = 1 course ete
• When remaining product is proportional to the previously used patient course, it should be reported together as bam/ete
  • In HPOP: 1 vial bam and 2 vials ete = 1 course bam/ete​