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AMITA Health COVID-19 Outpatient & ER Infusion Locations ...

REVISED 1/14/2022 11:35 AM. AMITA Health COVID-19 Outpatient & ER Infusion Locations Anti-SARS-CoV-2 monoclonal Antibody Emergency Use Authorization Outpatient monoclonal antibody (mAb) Infusion therapy has been authorized by the FDA for mild to moderate COVID-19 treatment under an emergency use authorization (EUA). Both Outpatient Infusion Locations as well as many of the hospital ER departments are available to provide mAb therapy across AMITA . Currently, sotrovimab is the only monoclonal antibody offered at AMITA Health .

AMITA Health COVID-19 Outpatient & ER Infusion Locations . Anti-SARS-CoV-2 Monoclonal Antibody Emergency Use Authorization . Outpatient monoclonal antibody (mAb) infusion therapy has been authorized by the FDA for mild to moderate COVID-19 treatment under an emergency use authorization (EUA). Both outpatient infusion locations as well as

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Transcription of AMITA Health COVID-19 Outpatient & ER Infusion Locations ...

1 REVISED 1/14/2022 11:35 AM. AMITA Health COVID-19 Outpatient & ER Infusion Locations Anti-SARS-CoV-2 monoclonal Antibody Emergency Use Authorization Outpatient monoclonal antibody (mAb) Infusion therapy has been authorized by the FDA for mild to moderate COVID-19 treatment under an emergency use authorization (EUA). Both Outpatient Infusion Locations as well as many of the hospital ER departments are available to provide mAb therapy across AMITA . Currently, sotrovimab is the only monoclonal antibody offered at AMITA Health .

2 The order form (paper or electronic) must be completed prior to contacting central scheduling for registration/scheduling of the patient. The following Locations are currently accepting Outpatient referrals for mAb Infusion therapy. Information will be updated as information changes. Completed order form, date of positive COVID test, & date of initial symptoms are REQUIRED. All referrals will be triaged based on urgency and available chair space. Infusion Locations : Region Chicago Metro South Northwest Site SM-C SJ-J SJ-E.

3 Vacant First Floor Location St. Elizabeth ED Meadow's Infusion Center Registration Area Days Su-Sa M F M F. Hours 8am 4pm 8am 4pm 8am 4pm Medical Director Dr. Dana Vais Dr. Suma Kaki Dr. Ana Gephart Infusion Clinic Pam Nikiel Stephanie Gendusa Sandy Behning Manager Phone Number , ext. 7896 Fax Number for Order Forms **PLEASE NOTE: In general, the Emergency Departments have been offering mAb Infusion ONLY for ER visit patients newly diagnosed with COVID-19 . Page 1 of 2. Anti-SARS-CoV-2 monoclonal Antibody EUA for COVID-19 ORDER FORM Revised 1/14/2022 11:35 AM.

4 Name: Sotrovimab can be considered for treatment of mild to moderate Patient Info COVID-19 as defined in the EUA or Patient Label: Date of Birth: Age: Sex: Risk vs. benefit should be assessed for overall outcome of the patient. As part of the EUA, patient/caregiver communication on Patient Contact sotrovimab as outlined below must take place prior to requesting Phone Number: these products this communication must be documented in the MRN/FIN/HAR: medical record. Date/Time: Phone: , ext. 7896. (South region Joliet) AMITA Health St.

5 Joseph Medical Center Joliet Fax: Infusion Location Phone: (Chicago Metro region Chicago) AMITA Health St. Mary & Elizabeth Medical Center (select one): Fax: Phone: (Northwest region Elgin) AMITA Health St. Joseph Hospital Elgin Fax: I am referring to a hospital-affiliated clinic/location and I am a credentialed provider/medical staff member at that hospital. Provider Status: I am referring to a hospital-affiliated Infusion clinic/location and I am NOT a credentialed provider/medical staff at that (Select hospital.)

6 Once signed below, the Medical Director (or designee) for the Infusion clinic has reviewed/verified that the patient meets criteria for the Infusion . one). Medical Director Signature: _____ Date/Time: _____. Indication: Mild to Moderate COVID-19 Infection This assessment MUST be completed before prescribing Anti-SARS-CoV-2 monoclonal Antibodies as part of the EUA. PLEASE NOTE: If there are logistical or supply constraints for Anti-SARS-CoV-2 monoclonal Antibody therapy, the following patient populations should be prioritized: Age 75 years Immunocompromised Pregnant In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of Anti-SARS-CoV-2.

7 monoclonal Antibodies, ALL of the follow requirements MUST be met. 1. Patient/Caregiver Communication Patient/Caregiver communication on ALL of the following items: The Fact Sheet for Patients and Caregivers has been reviewed and given to the patient/caregiver, AND. The patient/caregiver has been informed of alternatives to receiving Anti-SARS-CoV-2 monoclonal Antibodies, AND. That Anti-SARS-CoV-2 monoclonal Antibodies are unapproved drugs that are authorized for use under EUA. 2. Documentation of the above Patient/Caregiver Communication in the medical record 3.

8 INCLUSION criteria ALL of the criteria under the indication have been met: 12 yrs and older and at least 40 kg or more High risk for progression to severe COVID-19 , including hospitalization or death Within 10 days of symptom onset (REQUIRED: Date of symptom onset: _____). Has a positive SARS-CoV-2 viral test within the last 10 days (REQUIRED: Date of positive test: _____). [NOTE: Anti-SARS-CoV-2 monoclonal antibodies should be administered as soon as possible after positive results of direct SARS-CoV-2 viral (either PCR or antigen) testing.]

9 Antibody testing will NOT be accepted.]. If patient does NOT have ALL of the above inclusion criteria, this patient If criteria met, does NOT qualify for Anti-SARS-CoV-2 monoclonal Antibodies EUA therapy STOP Continue to Page 2. of the assessment CONTINUE to Page 2 of Assessment for prescribing Anti-SARS-CoV-2 monoclonal Antibodies for COVID-19 . Page 2 of 2. Anti-SARS-CoV-2 monoclonal Antibody EUA for COVID-19 ORDER FORM Revised 1/14/2022 11:35 AM. Name: Sotrovimab can be considered for treatment of mild to moderate Patient Info COVID-19 as defined in the EUA or Patient Label: Date of Birth: Age: Sex: Risk vs.

10 Benefit should be assessed for overall outcome of the patient. As part of the EUA, patient/caregiver communication on Patient Contact sotrovimab as outlined below must take place prior to requesting Phone Number: these products this communication must be documented in the MRN/FIN/HAR: medical record. Date/Time: 4. EXCLUSION criteria Patient does NOT have ANY of the following: Special Consideration: Sotrovimab should not be withheld from a pregnant patient with a high-risk condition if the clinician thinks that the potential Hospitalized due to COVID-19 benefit outweighs the potential risk Requirement of oxygen therapy due to COVID-19 .


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