D.31 Salem Save Lives Act SOP v.2 4.8.2021.pdf

COVID 19 Moderna Vaccine Redistribution Plan to Community Based Outpatient Clinics (CBOC)

SOP 658-119-IP-46

Salem VA Medical Center Service Lines(s):

Salem, VA 24153 Pharmacy

Primary Care

Signatory Authority: Effective Date:

Jeffrey Thompson March 31, 2021

Responsible Owner: Recertification Date:

Chief, Pharmacy March 31, 2026

1. PURPOSE: To establish policy and procedures for the vaccination of veteran spouses/caregivers/non-registered veterans in compliance the Save Lives Act.

2. SCOPE: This Standard Operating Procedure (SOP) applies to all personnel at the Salem VA Medical Center and the CBOCs who are involved in the COVID-19 Vaccine scheduling and administration.

3. POLICY: All processes will be in compliance with the Save Lives Act.

4. RESPONSIBILITIES:

a. Health Benefits Service will be responsible for enrolling the spouse/caregiver/non-registered veteran into the eligibility system and responsible for scheduling vaccine appointments for spouse/caregivers/non-registered veterans who wish to receive the COIVD-19 Vaccine.

b. Designated Salem VAMC and CBOC employees are responsible for the proper administration of the vaccine.

5. PROCEDURES:

Clinics and CBOCs will direct any spouse/Caregivers/non-registered veterans to the COVID Vaccine Interest Portal as the preferred method to register to receive a COVID- 19 Vaccine. Note: If the spouse/caregiver/non-registered veteran does not have access to a computer HAS will transfer the spouse/caregiver/non-registered veteran to the Health Benefits Office at Salem VAMC to complete the registration via phone.

COVID-19 Coordinator will provide a spouse/caregiver/non-registered veteran vaccine interest list to Health Administrative Services (HAS) daily Monday thru Friday. HAS

D.31 Salem Save Lives Act SOP 36C24621R0068 https://www.va.gov/health-care/covid-19-vaccine/ staff will contact spouse/caregivers/non-registered veterans listed on the vaccine interest list, obtained from the web portal within 3 business days to offer a vaccine appointment and schedule to receive a COVID-19 Vaccine.

HAS will provide training to Call Center, Primary Care and CBOC MSAs on proper procedure to enroll a spouse/caregiver/non-registered veteran to receive the COVID-19 Vaccine as outlined below.

Calls received by the Salem call center:

1. HAS will field calls via the call center line.

2. HAS will direct the spouse/caregiver/non-registered veteran to the COVID

Vaccine Interest Portal to enter the required information to complete enrollment to receive a COVID-19 Vaccine. Note: If the spouse/caregiver/non-registered veteran does not have access to a computer HAS will transfer the spouse/caregiver/non-registered veteran to the Health Benefits Office at Salem

VAMC to complete the registration via phone

3. HAS will notify the Spouse/Caregiver/Non-registered Veteran that they will need to complete and “sign” the Save Lives Act Vaccine worksheet upon arrival for their vaccine the day of the vaccine appointment.

Web Site Interest List:

1. COVID-19 Vaccine Coordinator will provide a COVID Vaccine Interest list daily to

Chief / Associate Chief of HAS.

2. HAS personnel will contact Spouse/Caregiver/Non-registered Veteran listed on the COVID Vaccine Interest list to offer and schedule a COVID Vaccine appointment within 3 business days from date of entry.

3. HAS will notify scheduled spouse/caregiver/non-registered veteran they will need to review and sign a Notification of Privacy form upon arrival at COVID-19

Vaccine Clinic.

Spouse/Caregiver/Non-registered Veteran Check-In to Clinic / CBOC:

1. Upon arrival the MSA will check-in the scheduled spouse/caregiver/non-registered veteran, schedule them for their second appointment (if receiving

Moderna Vaccine) and provide them a Notification of Privacy Statement and VA

Form 100483 for signature, COVID-19 Vaccine Monitoring Record, vaccine specific COVID-19 Vaccine Emergency Use Authorization Notice, and a Pre-

Vaccination Checklist.

2. Vaccinator will call up the Spouse/Caregiver/Non-registered Veteran.

3. Designated Spouse/Caregiver/Non-registered Veteran MSA will provide signed

VA Form 100483, COVID-19 Vaccine Monitoring Record, vaccine specific

COVID-19 Vaccine Emergency Use Authorization Notice, and a Pre-Vaccination

Checklist to the vaccinator

4. Vaccinator will keep the signed VA Form 100483 and the pre-Vaccination

Checklist. The VA Form 100483 will be scanned into the spouse/caregiver/non-registered veteran record.

5. Vaccinator will instruct Spouse/Caregiver/Non-registered Veteran to proceed to waiting area for 15-minute observation.

6. All CPRS vaccination documentation will be completed by the end of the day.

7. All VA Form 100483 will be kept and scanned into Spouse/Caregiver/Non-registered Veteran record.

Walk In – Salem Vaccine Clinic Only

1. Walk In that identify as Spouse/Caregiver/Non-registered Veteran will be directed to the Health Benefits Office at the Salem VA Medical Center to enroll to receive the COVID-19 Vaccine. Upon completion of enrollment by Health Benefits Office the spouse/caregiver/non-registered veteran will be directed to go back to the

Salem COVID Vaccine Clinic in Building 5 (Auditorium) to be scheduled to receive the vaccine the same day or spouse/caregiver/non-registered veteran preference.

2. Once scheduled Salem COVID-19 Vaccine Clinic will follow normal arrival procedures as listed above.

Walk IN – CBOC Only

1. Spouse/Caregiver/Non-registered veteran who comes into the CBOC and wishes to be enrolled to receive a COVID-19 Vaccine will be directed to the COVID

Vaccine Interest Portal or the CBOC MSA will call the Salem VAMC Health

Benefits Office and allow the spouse/caregiver/non-registered veteran to speak with Salem VAMC Health Benefits to enroll via phone.

2. Upon completion of enrollment the CBOC MSA should schedule the enrolled spouse/caregiver/non-registered veteran to receive a COVID-19 vaccine based on CBOC Vaccine Clinic availability.

3. Upon arrival for scheduled appointment CBOC MSA will follow normal check-in process as outline above.

Creation/Rescission: New SOP

Jeff Thompson, Pharm.D.

Chief, Pharmacy Service March 31, 2021

NOTE: The signature remains valid until rescinded by an appropriate administrative action.

Distribution:

SOP’s are available at:

https://dvagov.sharepoint.com/sites/salem/Salem%20SOPs/Forms/AllItems.aspx

Liquid/refrigerated

Number of vials redistributed:

30-day Beyond Use Date:_____________________

Signature required for Pharmacy

Signature required for Individual Responsible for Transport

Repackager

Initials

Pharmacy

Supervisor

Transporter

Initials

Receiver

Initials

Number of vaccines (vials) transported:

Number of vaccines (vials) received:

Signature required for CBOC LHCP

Signature required for Individual Responsible for Transport

Lot#: __________________ Manufacturer Expiration Date:_____________________

Date/Time of Depature:_____________________________________

Date/Time of Arrival:_____________________________________

TEMP at arrival (°C) : __________________

Vaccine will be stored at the redistributed product location: Yes No

Destination CBOC Location: Danville Lynchburg Staunton Tazewell Wytheville

(11) An a l ternate s torage conta iner, with a temperature logger, i s ava i lable during transport for triggered a larms

(9) If vaccine wi l l be s tored at the receiving faci l i ty, inventory i s adjusted in CDC Perpetual

Inventory tracker to decrement from sending faci l i ty and increment receiving faci l i ty (initial

(7) If transporting individual via ls , they are packed in protective padding (such as bubble wrap) and protected from l ight

(8) If vaccine wi l l be s tored at the receiving faci l i ty, inventory to be redis tributed is decremented from on-hand pharmacy vault inventory (initial if applicable)

Date and Time of Receipt:

RECEIPT OF LIQUID/REFRIGERATED VACCINE

(7) Via ls were counted to assure quanti ty received matches number of via ls dis tributed

(1) Vaccine i s packaged in protective padding, protected from l ight and via ls are upright

(2) Vaccine arrived refrigerated at 2C to 8C

(3) Temperature logger i s within range

(4) No temperature excurs ions occur during transport (verify with transporter)

(6) Product was del ivered directly to a secured location in pharmacy or another secure location i f pharmacy not on-s i te

(Or) be adminis tered within 12 hours of reaching room temperature

(6) Tota l transport time, in a qual i fied conta iner, did not exceed 12 hours (preferrable to be shipped short distances within 4 hrs)

Short duration transport should be completed within 1 hr and transport should be via hand carry or wel l -functioning cart on smooth pathway

Medium/long duration ground transport may be via motor vehicle on smooth driving surface and must be completed in 12 hours

(5) If temperature excursion occurred , vaccine was ei ther:

Immediately transferred to an a l ternative refrigerated conta iner and mainta ined refrigerated at 2C to 8C

(6) A padded vaccine carrier/transporter capable of mainta ining 2C to 8C is uti l i zed

(1) Vaccine i s thawed and s tored in a refrigerator at originating s i te prior to repackaging

(4) Vaccine has NOT been refrozen and is labeled DO NOT FREEZE

(3) Vaccine i s labeled with expiration date (30 days from time product was thawed)

(2) Vaccine i s labeled with date and time thaw began

Transport in original carton with padding material, when possible

Appendix A : Moderna COVID Vaccine Redistribution Checklist

(5) Vaccine i s handled with care and protected from shocks , drops , vibrations , etc.

TEMP at departure (°C):_____________

Copy of transport record must be kept at site of origin, with product during transport, and at the receiving site

All redistribution issues MUST be reported directly to the PBM via email at VHAPBM COVID Vaccine Orders

Vaccine is being shipped:

(8) Thawed vaccine i s immediately placed in a secured REFRIGERATOR maintianing 2C to 8C

REPACKAGING LIQUID/REFRIGERATED VACCINE

(9) Refrigerator has 24/7 temperature monitoring, with a larms (verify with receiver)

(10) Temperature logger i s in working order and within range (2C to 8C)

(any discrepancies must be immediately resolved)

Appendix B: Moderna COVID Vaccine CBOC Administration and Storage Log

Moderna COVID Vaccine CBOC Administration and Storage Log

NOTE: Information will need to be documented on PBM sharepoint site (Lynchburg, Danville, Staunton, Wytheville) by 1600 daily. For Tazewell, information needs to be communicated to Salem VAMC Chief of Pharmacy or Associate Chief of Pharmacy by 1600 on days when vaccination clinic occurred.

Date Starting # Vials

Starting Doses (10 doses/vial)

Extra Doses Prepared (no pooling)

Total Doses Prepared

# Doses Given

# Doses Wasted

Waste Description (reason for each wasted dose)

LHCP Signature

Appendix C: COVID Vaccine CBOC PBM Reporting

1. Add a user to the PBM COVID-19 Vaccine Site for the CBOC

a. Log on to the COVID-19 VA MedSAFE Application (COVID-19 Vaccines (sharepoint.com)

b. Select “Site Registration”

c. On this page, you will see the contacts listed for each site (Primary and

Secondary).

d. Select “Add Contact”

e. Select “VISN 06”, select your CBOC location and then use the browse icon to search for the new contact.

https://dvagov.sharepoint.com/sites/VHAPBM/VA_MedSAFE/App/SitePages/COVID-Vaccine.aspx

f. Type in contact’s name and search. Highlight name and select “OK”

g. Make sure “Secondary POC” is selected, then select “Proceed to next step”

h. Verify telephone number and phone extension are correct and then select “Submit Data”

2. Daily Reporting and Receipt of COVID Vaccine

1. Log on to the COVID-19 VA MedSAFE Application (COVID-19 Vaccines

2. Select “Daily Inventory Tracking”

3. Select your facility location and then the vaccine product

4. Select “Insert New Record” and a new line will be created for today

a. Receive Vaccine from Salem

i. On days that you receive a shipment from Salem, you will need to check “Ancillary Kit Received”, check “Vaccine Shipment Received Today” and enter the “Total Doses Received”.

ii. You will also need to document the number of doses remaining at the end of day (Total Doses on Hand), how many “Doses of Overfill Dispensed” that day and also how many “Doses Wasted” that day.

iii. Select “SUBMIT ALL”

b. Vaccine on Hand or Clinic that Day

i. You will need to document the doses remaining at the end of the day

(Total doses on Hand), how many “Doses of Overfill Dispensed” that day and also how many “Doses Wasted” that day.

1. If all doses on hand were used that day, the “Total Doses on Hand” is zero (0) and it will have a message “No more remaining as of YYYY-MM-DD”

ii. Select “SUBMIT ALL”

c. No Vaccine On Hand or Clinic Closed (weekend/holiday)

i. When no vaccine is on hand OR if the clinic is closed, select “Site

Closed/No Utilization”

ii. Click on the calendar icon and then select the day. If doing multiple days (e.g. closed for the weekend), you will need to select “Insert New Record” for each additional day. Once all of the days are populated, select “SUBMIT ALL”.

3. Report WASTE to the PBM COVID-19 Vaccine Site for the CBOC

a. Log on to the COVID-19 VA MedSAFE Application (COVID-19 Vaccines

b. Select “Wastage Reporting”

c. Select “New”

d. Select your CBOC facility and which COVID vaccine is being wasted

i. For the “Wastage Reason”, select from the following options:

e. Provide a brief description of what occurred

f. Select the Lot Number for the vaccine product being wasted

g. For the Lot Expiration Date, select “Other” and then enter the expiration date as

YYYYMMDD

h. Enter the quantity of DOSES wasted

i. Hit “Submit”