D.32 COVID 19 Moderna Vaccine Redistribution to CBOC SOP.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 22, 2021

Responsible Owner: Recertification Date:

Chief, Pharmacy March 22, 2021

1. PURPOSE: To establish policy and procedures for the redistribution of COVID- 19 Moderna Vaccine to CBOCs.

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 Moderna COVID Vaccine transportation and administration.

3. POLICY: All processes will be in compliance with VHA Moderna COVID Vaccine redistribution plan. Moderna COVID Vaccine may be stored at CBOC locations that meet the medication refrigeration requirements.

4. RESPONSIBILITIES:

a. Chief of Pharmacy Services is responsible for appropriate storage of Moderna COVID Vaccine at the Salem VAMC and facilitating proper transportation of Modern Vaccine utilizing appropriate coolers and temperature recording devices to ensure proper redistribution of the vaccine.

b. Designated Salem VAMC employee is responsible for the proper handling of vaccine during transport.

c. CBOC Licensed Health Care Profession (LHCP) is responsible for proper handling and storage of vaccine during vaccination process at the CBOC.

5. PROCEDURES:

• Vaccination Clinics at CBOCs o The delivery of Moderna COVID Vaccine to each CBOC is dependent upon the veteran vaccination schedule and if the CBOC is able to store vaccine in their medication refrigerator.

D.32 COVID 19 Moderna Vaccine Redistribution to CBOC SOP 36C24621R0068

The Danville CBOC, Lynchburg CBOC, Staunton CBOC and Wytheville CBOC are able to store vaccine in their medication refrigerator.

• Moderna COVID Vaccine needed for the weekly clinics will be delivered prior to the first weekly clinic (day before or earlier in the same week). Once the clinics are completed for the week, there should be zero vials on hand to minimize any loss over weekends.

The Tazewell CBOC is unable to store vaccine in their medication refrigerator.

• Moderna COVID Vaccine needed for the weekly clinic will be delivered day of. Once the clinic is completed for the week, there should be zero vials on hand.

o The weekly delivery schedule of Moderna Vaccine to the CBOCs is as follows:

Monday delivery: Staunton CBOC Tuesday delivery: Danville CBOC Wednesday delivery: Lynchburg CBOC Wednesday delivery: Wytheville CBOC Friday delivery (every other week): Tazewell CBOC

• Preparation:

o Moderna COVID Vaccine will be stored at the Salem VAMC in frozen state at -20° Celsius (range: -15 to -25°Celsius).

o Only liquid refrigerated Moderna COVID Vaccine will be redistributed to CBOCs.

o Pharmacy staff will review contract CBOC COVID Vaccine clinic appointments 24 hours in advance (or the Friday before for Monday deliveries) of the transportation day to determine the number of Moderna vaccines to be prepared for transportation. Pharmacy staff will remove the appropriate number of doses from the -20° freezer and place in a pharmaceutical grade purpose-built refrigerator capable of maintaining temperature of 2 to 8° Celsius (36 to 46° Fahrenheit) to properly thaw the Moderna COVID Vaccine 24 hours prior to day of transport. Vaccine vials will be labeled with date and time the vial(s) were placed in the refrigerator for thawing with expiration date of 30 days from the date placed in the refrigerator. The vaccine vials will also be labeled with the manufacturer’s expiration date and a “DO NOT FREEZE” label.

o The required number of administration kits will be obtained and bagged for transport by Pharmacy Staff (needles, syringes, alcohol pads, vaccination cards, blue Moderna syringe labels, syringe labels, “Do Not Use After” labels). The kits will also include the necessary forms (COVID-19 Vaccine Monitoring Record, Pre- Vaccination Checklist for COVID-19 Vaccines, and Fact Sheet for Recipients and Caregivers Emergency Use Authorization (EUA) of the Moderna COVID-19 Vaccine).

• Packaging:

o Moderna COVID Vaccine vials will be transported in original container when possible to protect from shocks, drops and vibrations. If vials are removed from original container, they will be placed in a photo protective bag, labeled as Moderna COVID Vaccine, then wrapped in bubble wrap prior to placement in pharmaceutical grade cooler for transportation.

o Only purpose-built pharmaceutical grade transport cooler will be used for transportation and must be capable of maintaining temperature of 2 to 8° Celsius (36 to 46° Fahrenheit). An alternate transport cooler will be provided for emergency use due to temperature issues.

o Each transport cooler must be equipped with a temperature logger capable of recording temperatures of 2 to 8°Celsius (36 to 46° Fahrenheit) and have an audible alarm when the temperature falls below or rises above 2 to 8°Celsius (36 to 46° Fahrenheit).

If the alternate transport cooler must be utilized, the temperature logger will be transferred from the transport cooler.

o Two different pharmaceutical grade coolers may be utilized for transport from Salem VAMC pharmacy The Intelsius BioCarrier transport cooler ice packs

(PHARMACHILL 3020) must be conditioned at -20°Celsius for a minimum of 24 hours. Before the transport cooler system can be assembled, the transport cooler ice packs (PHARMACHILL 3020) must be placed at room temperature +20°Celsius (±5 degrees) for approximately 20 minutes.

Once the transport cooler ice packs have been assembled in the transport cooler, it will take approximately 75 minutes for the transport cooler to obtain the required storage temperature.

The VeriCor transport cooler ice packs (Cool Cube Series 4 PCM panels) must be conditioned in a freezer until solid, shake to verify. Before the transport cooler system can be assembled, the transport cooler ice packs (Cool Cube Series 4 PCM panels) must be placed at room temperature for 35 minutes. Once the transport cooler ice packs have been assembled in the transport cooler, it will take approximately 55 minutes for the transport cooler to obtain the required storage temperature.

o The pharmacy staff/supervisor involved in repackaging the liquid/refrigerated vaccine will document on the Moderna COVID Vaccine Redistribution Checklist (Appendix A).

• Transportation:

o Only VA employees may transport Moderna COVID Vaccine to contract CBOCs utilizing government car, van or truck not to exceed 12 hours travel time.

o Only VA employees who have completed “COVID-19 Distribution and Handling Moderna Training” TMS Module #43314 will be permitted to transport vaccine doses to CBOCs.

o The designated VA employee will obtain the vaccine from the pharmacy already in the purpose-built pharmaceutical grade transport cooler prepared the morning of transport.

o Pharmacy Staff will verify and record temperature of cooler, using the Moderna COVID Vaccine Redistribution Checklist (Attachment A), prior designated VA employee taking possession.

o Designated VA employee and Pharmacy Staff will verify and document the number of doses prepared for transport documenting, date, time, number of doses, LOT, manufacturer expiration date, and 30-day refrigerated expiration date on the Moderna COVID Vaccine Redistribution Checklist.

o Both the designated VA employee and Pharmacy Staff member will sign the Moderna COVID Vaccine Redistribution Checklist at the time of vaccine transfer.

o A copy of the Moderna COVID Vaccine Redistribution Checklist will be given to the designated VA employee.

o The designated VA employee will transport Moderna COVID Vaccine received directly to government car, truck or van and properly secure to limit shock and turbulence during transport.

o All Moderna COVID vaccine must remain in the designated VA employee immediate possession during transport.

o At any time during transport if the temperature data logger audible alarm sounds, the designated VA employee will stop and transfer Janssen COVID Vaccine to alternate transport cooler, transfer the temperature logger, and then contact Chief of Pharmacy (540-982- 2463 x2343) or Associate Chief of Pharmacy (540-982-2463 x4165) for further direction. If unable to reach the Chief or Pharmacy or Associate Chief of Pharmacy, then contact the main pharmacy (540-982-2463 x2345).

• Arrival:

o Upon arrival at the CBOC, the designated VA employee and CBOC

LHCP will immediately record the temperature reading from the temperature data logger utilizing the Moderna COVID Vaccine Redistribution Checklist. The CBOC LHCP will sign the checklist taking possession of the Moderna COVID vaccine.

o For Lynchburg CBOC, Wytheville CBOC, Staunton CBOC, and Danville CBOC:

CBOC LHCP will verify that the medication refrigerator is in range (2 to 8° Celsius/36 to 46° Fahrenheit) and then immediately transfer the vaccine from the transportation cooler into the medication refrigerator.

A copy of the Moderna COVID Vaccine Redistribution Checklist will be made and placed into the transportation cooler.

The designated VA employee will transport the cooler back to the Salem VAMC and return the cooler to the pharmacy department.

o For Tazewell CBOC:

The vaccine will be removed from the transport cooler and labeled with a Beyond-Use-Date (BUD) of 12 hours (storage at room temperature) by the CBOC LCHP.

A copy of the Moderna COVID Vaccine Redistribution Checklist will be made and placed into the transport cooler.

The designated VA employee will transport the cooler back to the Salem VAMC and return the cooler to the pharmacy department.

o The number of Moderna COVID vaccine doses received will be documented on the Moderna COVID Vaccine CBOC Administration and Storage Log (Appendix B).

For Lynchburg CBOC, Wytheville CBOC, Staunton CBOC, and Danville CBOC, the CBOC will document the receipt of the Janssen COVID vaccine and supplies on the PBM site at COVID-19 Vaccines (sharepoint.com) by 1600 (Appendix C:

COVID Vaccine CBOC PBM Reporting).

For Tazewell CBOC, this information will be communicated to Chief of Pharmacy or Associate Chief of Pharmacy by 1600 daily (vhasampharmacyleadership@va.gov)

• Vaccine Dose Preparation at Clinic:

o All doses used during CBOC COVID Vaccine clinic shall be drawn up by CBOC LHCP utilizing proper sterile technique.

Swirl vial gently between each withdrawal. DO NOT SHAKE.

The Moderna COVID-19 Vaccine is a white to off-white suspension. It may contain white or translucent product-related particles.

Visually inspect the Moderna COVID-19 Vaccine vials for other particulate matter and/or discoloration prior to administration.

o Only LHCP who have completed “COVID-19 Distribution and Handling Moderna Training” TMS Module #43314 will be permitted to prepare vaccine doses for administration.

o Doses of 0.5ml will be drawn into provided syringe at time of veteran administration.

o All available doses must be administered within 6 hours from time the vial is punctured and shall be labeled with expiration time (6 hours) at time of initial puncture.

o If syringes are drawn up prior to administration, the syringes must be labeled with the following information:

Medication Strength Beyond use date and time https://dvagov.sharepoint.com/sites/VHAPBM/VA_MedSAFE/App/SitePages/COVID-Vaccine.aspx mailto:vhasampharmacyleadership@va.gov

• Administration:

o Only LHCP who have a documented intramuscular competency

(IM) and have completed the “COVID-19 Moderna Vaccinator Training” TMS Module #43315 are permitted to administer the Moderna COVID-19 Vaccine.

o Moderna COVID-19 Vaccine should be administered as an IM injection.

o Prior to administration the CBOC LHCP will review the Moderna COVID 19 Vaccine EUA Fact Sheet for Caregivers and Recipients with the veteran and verify the veteran can return to receive their second dose in 28 days. Note: If the veteran cannot return in 28 days for second dose – DO NOT administer the vaccine. The veteran will need to be rescheduled.

o Documentation of vaccine administration shall be accomplished by completion of the COVID-19 Clinical Reminder dialogue at the time of administration.

o All veterans who receive Moderna COVID vaccine must be observed for 15 minutes after vaccine administration. Note:

Observation time of 30 minutes post administration is required for any veteran who has previously had an anaphylactic reaction of any kind.

o All Adverse Drug Reactions (ADRs) must be reported utilizing the VA ADER system. Note: Management of any anaphylactic reaction should be managed in compliance with CDC guidelines.

o The daily total of doses available, number of extra doses (e.g. more than 10 doses in a vial), number of doses administered, and number of doses wasted will be documented on the Moderna COVID Vaccine CBOC Administration and Storage Log (Appendix B). On days when Moderna Vaccine is on hand and no vaccination clinic occurred, the number of vials on hand must be documented on the storage log. When no vaccine is on hand, daily reporting to PBM sharepoint is still required.

For Lynchburg CBOC, Wytheville CBOC, Staunton CBOC, and Danville CBOC, the CBOC will document daily on the PBM site at COVID-19 Vaccines (sharepoint.com) prior to 1600 (Appendix C: COVID Vaccine CBOC PBM Reporting)

For Tazewell CBOC, this information will be communicated to Chief of Pharmacy or Associate Chief of Pharmacy by 1600 on vaccine clinic days only (every other Friday) (vhasampharmacyleadership@va.gov)

• No Shows:

o All doses of vaccine must be administered once the vial is punctured, within 6 hours. If a scheduled veteran no shows, the CBOC LHCP should work with CBOC staff to identify another eligible veteran on site who chooses to receive the vaccine and administer the vaccine to not incur waste.

o Any doses of vaccine not administered within 6 hours once the vial is punctured must be wasted and documented on the Moderna COVID Vaccine CBOC Administration and Storage Log. For Tazewell CBOC, any unpunctured vials must be wasted after 12 hours at room temperature.

For Lynchburg CBOC, Wytheville CBOC, Staunton CBOC, and Danville CBOC, the CBOC must document the waste on the PBM site at COVID-19 Vaccines (sharepoint.com) prior to 1600 (Appendix C: COVID Vaccine CBOC PBM Reporting)

For Tazewell CBOC: the CBOC must be document the waste on the Moderna COVID Vaccine CBOC Administration and Storage Log and report the waste to the Chief of Pharmacy or Associate Chief of Pharmacy by 1600 (vhasampharmacyleadership@va.gov) o Any losses of 5 doses or more will require an Issue Brief.

• Refrigerator Monitoring o TempTrak will be utilized to monitor the medication refrigerators at each CBOC location, except Tazewell. CBOC staff will monitor TempTrak during business hours.

After hours, clinical pharmacist at Salem VAMC will monitor

TempTrak at the CBOC locations, excluding Tazewell.

If temperature is outside of range, the clinical pharmacist will contact the CBOC POC for after hours.

The CBOC POC will travel to the CBOC and visually verify the refrigerator temperature.

o Temperature outside of range (2 to 8°Celsius/36 to 46° Fahrenheit)

At this time, there is no guidance available if the vaccine can continue to be refrigerated (with 30-day BUD) OR if the vaccine has to be placed at room temperature and utilized within 12 hours.

CBOC POC will contact the Salem VAMC Pharmacy. The Clinical Pharmacist will contact Moderna at 1-866-663-3762.

They will perform an assessment that consists of 7 questions to determine what to do next.

The Clinical Pharmacist will communicate with CBOC POC the necessary actions communicated by Moderna. An email will be sent to: vhasampharmacyleadership@va.gov, VHASAMClinicalPharmacist@va.gov and CBOC POC.

If guidance from Moderna is that the vaccine is to remain at room temperature and be administered within 12 hours, CBOC will contact veterans to schedule and administer within the window.

• Any vaccine that cannot be administered must be wasted and documented.

• Any losses of 5 doses or more will require an Issue Brief.

https://dvagov.sharepoint.com/sites/VHAPBM/VA_MedSAFE/App/SitePages/COVID-Vaccine.aspx mailto:vhasampharmacyleadership@va.gov mailto:VHASAMClinicalPharmacist@va.gov

6. Creation/Rescission: Replaces SOP 658-119-IP-46 with effective date of 2/24/2021.

Jeff Thompson, Pharm.D.

Chief, Pharmacy Service March 22, 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 i s decremented from on-hand pharmacy vaul t 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 di rectly 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 i s 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 i s 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.

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”