BAMLANIVIMAB INFUSION

St. John’s Well Child and Family Center

South Los Angeles

SOUTH LOS ANGELES

• Largest area of contiguous poverty in the United States

• 1.5 million residents (larger than Philadelphia)

• Largest concentration of African Americans in state of California

• Largest concentration of undocumented immigrants in the U.S.

• Long history of racial health disparities and lack of health access

ST. JOHN’S WELL CHILD & FAMILY CENTER

• Founded in 1964 in response to the lack of healthcare (which gave rise to the Watts Riots)

• Largest healthcare provider in South Los Angeles

• 18 health center sites; 3 mobile clinic units

• St. John’s serves 100,000 patients (for 450,000 visits) annually

• Innovative programming: people experiencing homelessness; transgender health; re-entry programs and health services; health & slum housing/environmental health programs

• Significant partnerships with labor unions; Compton & LA Unified School Districts; community colleges; elected officials; churches; community based organizations

COVID RESPONSE

• Upon first case of community transmission – convened an internal COVID Task Force to prepare organization to respond to COVID pandemic

• Established new lab relationships to begin testing in March

• No community testing in South LA (racial and ethnic health disparities)

• From early on – saw high positivity rates (25-30%)

• South LA is the epicenter of the COVID pandemic in California

• Low wage workers, frontline workers - factory workers, garment workers, etc.

• Erected 28 isolation/testing tents at all sites; rigorous screening protocols

• By mid-April, testing 500-600 people a day (including mobile testing)

• Developed command center/telehealth to monitor positive patients

TIMELINE

Rolland Curtis Health Center (northern edge of South LA)

• December 8th- Dry run

• December 9th- first patient

• December 10th- 2 patients, increasing by one patient per day

• December 14th- 12 patients scheduled (capacity = 18)

Avalon clinic

• December 21 – First patient

Compton clinic

• January 4th- First patient

SETTING UP FOR INFUSION THERAPY

• Important to note that monoclonal antibody treatment is in-scope for FQHCs and covered by FTCA

• Rooms

• Equipment

• Crash cart medications

• Staffing

• Patient inclusion criteria

• Workflows

ROOMS

• Minimum 2 rooms for Infusion (sink is a requirement for the infusion room).

More to be added

• Each infusion takes place for one hour with observation for another hour

• Patient intake, preparation of the infusion, starting the infusion and cleaning the

room post infusion takes another hour

• Cannot administer more than 3 per each room/chair in 8 hours

• One room for the staff

EQUIPMENT• One comfortable chair for the patient

• IV Infusion stand

• Infusion pump

• Pump is not necessary, can use gravity infusion technique. Acquiring, setting up and monitoring pumps is difficult

• IN needle and IV starter kit

• Saline swabs, gauze pieces, sharp containers, water bottles for staff and patients

• Vitals Machine- Temperature, BP apparatus, Pulse oximeter, weighing scale, with remote monitoring of pulse, BP and Oxygen (RPM)

• Refrigerator

• Negative pressure Air filters for each room

• PPEs- head cap, face shield, n-95 or K-95 mask, gown, gloves, shoe covers- for both patients and staff

• Normal Saline infusion bags

• Polyvinylchloride infusion set containing 0.20/0.22 micron inline polyethersulfone filter

• Syringes- 20 ml syringes, 2ml syringe,

• Crash cart (second one for this site)

• Cameras with remote monitoring

• TV for each room

• Emergency calling bell for the patients

• At least 3 working Computers at staff room and 3 working phones. One of them with DID for patients to call the center

• Antiseptic lotions

• PPE disposing baskets (regular and biohazard)

• Patient call buttons

https://www.graylinemedical.com/products/bd-alaris-pump-modules-alaris-pump-module-set-with-pinch-clamp-luer-lock-22600-0007t?variant=31849103884345&gclid=EAIaIQobChMI8YTzrcuw7QIVVB-tBh2Drg3UEAQYCCABEgKZv_D_BwE

MEDICATIONS

• Ondansetron ODT 4 mg

• Ondansetron 4 mg IV for nausea

• Diphenhydramine 25 mg IV

• Albuterol inhaler

• Solu-Medrol injection

• 0.9% Sodium chloride flush (10 mL)

• 0.9% Sodium Chloride bag (500 mL)

• Epinephrine 0.3 mg IM

• Bamlanivimab 700 mg in 0.9% NaCl

• Famotidine

STAFFING

• One MD on-site

• One NP

• One MA/BC

• Cleaning crew to clean the rooms after each infusion

• Pharmacy Director Supervision

• IT on site for the first day with back up on there after

• RPM training- Sandra

• Infusion therapy specialist/trainer/ maintenance (calibration, disinfection)

R&R

Roles Skills Profile & Staff

Command Center Team Screening, Scheduling, Patient Pre-infusion checklist

Review. Make sure to document emergency contact

Confirm the appointment day before and on the day

of appointment

MA at Infusion center, ensure patient has someone

available in case of emergency

Infusion: Drug preparation & Start IV infusion NP/PA/RN with IV experience

Infusion: Administer infusion NP/PA/RN with IV experience

Monitoring Vitals q15mins & document Medical Assistant trained in checking vitals/RPM

Post infusion observation Infusion Team: NP/RN + Medical Assistant

On-site Infusion Supervision MD/DO

Treatment for Adverse Reaction RN/NP/PA and MD/DO must be notified

Cleaning Person trained in COVID cleaning / disinfection

Patient Discharge with RPM equipment and F/U next

day by phone call (pt will be followed up with RPM

team thereafter); unless needed

Medical Assistant

• Treatment of Mild to Moderate COVID-19 positive patients

• Within 10 days of symptoms onset, the sooner the better

• 12 or older age group

• Weighing at least 40 Kgs

• At risk for progressing to severe COVID disease or potential to be hospitalized

• With the following high risk factors…

• Insured/Uninsured/non-St. john’s patients?

PATIENT INCLUSION CRITERIA

PATIENT SELECTION CRITERIA

High risk is defined as patients who meet at least one of the following criteria:o Have a body mass index (BMI) ≥35o Have chronic kidney diseaseo Have diabeteso Have immunosuppressive diseaseo Are currently receiving immunosuppressive treatmento Are ≥65 years of age

Are ≥55 years of age AND have cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease other chronic respiratory disease.

Are 12 – 17 years of age AND have BMI ≥85th percentile for their age and gender based on CDC growth charts,

https://www.cdc.gov/growthcharts/clinical_charts.htm, OR sickle cell disease, OR congenital or acquired heart disease, OR neurodevelopmental disorders, for example, cerebral palsy, OR a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.

EXCLUSION CRITERIA

• who are hospitalized due to COVID-19, OR

• who require oxygen therapy due to COVID-19, OR

• who require an increase in baseline oxygen flow rate due to COVID-19 in

those on chronic oxygen therapy due to underlying non-COVID-19 related

comorbidity.

• We will not treat pregnant and breast feeding patients until more literature

available on safety of medication

BAM TEAM WORKFLOW - CLINICALCommand Center: Screening,

Scheduling, enrolling with RPM

Patient (N-95) calls MA for BAM

Infusion Visit from parking lot

Security guard will escort pt to MA,

who will take the pt to Infusion Room

NP/RN/PA will start Infusion (60

minutes)

Post-Infusion (60 minutes

• Patient PPE: N-95

• Staff PPE: N-95, Gown, Gloves,

Face Shield (All Personnel ),

shoe covers, head covers

STOP & Refer to ER if:

• O2 saturation

FINAL THOUGHTS

• Staff can be reluctant to work in infusion center

• Many patients are refusing treatment (50-60%)• Significant fear, lack of education about treatment

• Engaging focus groups and UCLA to develop messaging

• Overall• Infusion is relatively easy• No patient has had adverse reactions• Treatment seems to be extremely effective

• Builds capacity for other needed services that FQHCs can provide