Procedures · Web view– A temperature-controlled supply chain that includes all vaccine-related equipment and procedures. It begins with vaccine manufacturing and ends with vaccine

COVID-19 Vaccination ProgramPOLICIES AND PROCEDURES

December 2020

Table of Contents1.1 Ordering..................................................................................................................................32.1 Receiving................................................................................................................................53.1 Storage...................................................................................................................................83.2 Security and Inventory Management.................................................................................114.1 Vaccination Program Communications............................................................................134.2 Workload Planning..............................................................................................................175.1 Order Entry and Pharmacist Initial Verification (PV1)......................................................195.2 Packaging and Pharmacist Final Verification (PV2).........................................................215.3 Transport..............................................................................................................................245.4 Claims Adjudication, Coverage and Reimbursement......................................................266.1 Vaccination Clinic Preparation...........................................................................................276.2 Vaccination Clinic Set-Up...................................................................................................306.3 Vaccine Reconstitution and Administration.....................................................................336.4 Vaccination Clinic Exiting...................................................................................................367.1 Vaccine Adverse Event Reporting System (VAERS).......................................................387.2 Immunization Information System (IIS) Reporting...........................................................407.3 Immunizer Certifications.....................................................................................................418.1 Pharmacy Personnel Training............................................................................................439.1 Disposal, Return and Waste...............................................................................................45

COVID-19 Vaccination Program Policy

Title 1.1 Ordering

Department Pharmacy Operations Effective Date 12-2020

Version A Revision Date(s)

Policy Statement

COVID-19 vaccine ordering shall be initiated and managed centrally by Operations Inventory Management. Orders shall be placed for each pharmacy site according to the Confirmed Clinic Day Calendar.

Purpose

The purpose of this document is to detail COVID-19 vaccine ordering process.

Scope

All pharmacy ordering personnel.

Definitions/Acronyms

Confirmed Clinic Day Calendar – Published calendar documenting facilities who have provided all required clinic day information and have a confirmed vaccine clinic date/time scheduled.

PPE – Personnel Protective Equipment

VPoP – Vaccine Provider Ordering Portal

Procedure

1. Operations Inventory Management shall review the Confirmed Clinic Day Calendar daily and will place all vaccine orders through VPoP. These orders will be processed against the allocation (order cap).

2. The minimum order size and increment for centrally distributed vaccines will be 975 doses per order (Pfizer manufacturer) or in accordance CDC allocation guidelines.

3. Operations Inventory Management will confirm vaccine order quantities and expected arrival date with each pharmacy site in advance of receiving. An email communication will be sent to local coordinators at each site to confirm shipment details.

4. Vaccine will be delivered within 24-48 hours of order placement. All vaccine shipments will be tracked from the vendor to all pharmacy locations

5. Shipment will arrive in thermal shipper cartons. Each thermal shipper shall include a reusable GPS enabled temperature monitoring device which will be enabled when the shipper is packed and will monitor for temperature excursions while in transit.

Disclaimer: COVID-19 vaccine information is continually evolving. All policies and procedures have been developed with the most current guidance available from federal, state and health agencies.

6. Ancillary supply kits will be automatically added to vaccine orders and do not require additional action or separate orders. Ancillary supply kits will include diluent and administration materials (including appropriate needles, syringes, alcohol swabs, and limited PPE).

7. An initial dry ice resupply will be provided to facilitate storage in coordination with each vaccine shipment.

Related Documents

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Revision History

Version Description of Change Date

A Initial Release 12-2020


Title 2.1 Receiving



Policy Statement

Pharmacy personnel will safely identify, inspect and receive all COVID-19 vaccine supply deliveries. Pharmacy personnel shall strictly adhere to the vaccine receiving procedures outlined in this policy to maintain vaccine integrity and potency.

Purpose

The purpose of this document is to detail the receiving process for the COVID-19 vaccine upon delivery to the pharmacy.

Scope

All pharmacy receiving personnel.


CDC – Centers for Disease Control and Prevention

Cold Chain – A temperature-controlled supply chain that includes all vaccine-related equipment and procedures. It begins with vaccine manufacturing and ends with vaccine administration. Vaccines must be stored properly from the time they are manufactured until they are administered. Potency is reduced every time a vaccine is exposed to an improper condition. This includes overexposure to heat, cold, or light at any step in the cold chain. Once lost, potency cannot be restored.

Delivery Agent – Entity (e.g. FedEx or UPS) that physically transports drug inventory to pharmacy location.

ULT Shipper – Ultra Low Temperature thermal shipper used to ship vaccine and maintain temperature at recommended manufacturer standards.

Procedures

Receiving Delivery, Opening and Unpacking Vaccine CartonAll vaccine shipments will be tracked from the vendor to all pharmacy locations.

All vaccine shipments will arrive in packaged master carton or ULT Shipper cartons from the vendor delivery agent.

Upon arrival, receiving personnel must inspect vaccine shipment for visible damage or tampering while the delivery agent is on the premises. Count the number of vaccine cartons and compare to the delivery paperwork provided by the delivery agent.

a. All vaccine cartons must be opened, and contents visually inspected to verify quantity received matches ordered quantity and identify any damaged vials.

b. Initial inspection process must be completed in less than ten (10) minutes to prevent premature thawing of vaccine vials.

c. If the paperwork exactly matches the number of vaccine cartons delivered, sign and date the paperwork and provide a copy to the delivery agent (when required). After paperwork has been completed, the delivery agent may leave the premises.

d. If the paperwork does not exactly match the number of vaccine cartons delivered, note the discrepancy on the paperwork by indicating the actual number of vaccine cartons received. Sign and date the paperwork and provide a copy to the delivery agent. After paperwork has been completed, the delivery agent may leave the premises. Immediately inform the vendor of all discrepancies noted at the time of delivery.

e. Once initial inspection completed, the thermal shipping container may only be opened twice per day for three (3) minutes during each opening.

Login to the vaccine portal and enter vaccine count received and any discrepancies for each shipment delivered. Confirm that quantity and unit used (package size or # of vials) is accurate when entering values in inventory tab

Email Operations inventory team to confirm receival and provide any additional comments similar to paperwork in bullet 3.

Prior to vaccine cartons being stored, all vaccines must be brought to a secured area or approved pharmacy storage area with limited employee access and within proximity to the freezer/refrigerators as needed for storage preparation as per manufacturer guidelines.

Before opening ultra-cold vaccine shipments, make sure the vaccine can maintain the cold chain supply. Quickly place the vaccine shipment in the appropriate storage location, that will maintain the temperature requirement as set forth by the manufacturer guidelines

a. If pharmacy has Ultra-cold freezer-proceed with placing shipment into freezer and record temperature in inventory app

b. If pharmacy does not have ultra-cold freezer, use dry ice for re-icing the shipping container to ensure vaccine remains at the appropriate ultra-cold temperature a set forth by the manufacturer guidelines. Refer to dry ice safety policy

Remove vaccine vials/trays from carton and immediately store in pharmaceutical-grade freezer.

If ULT Shipper will be utilized for temporary storage the trays and vials/trays should remain inside shipper, closed with dry ice pod.

The total quantity of vaccine in each carton must be updated in inventory on-hand count.

Cold Chain Verification1. Upon receipt, GPS enabled logger should be disabled by pressing the stop button on the device if

applicable per manufacturer delivery guidelines

2. All shipments must be tracked and monitored to ensure end-to-end distribution within required temperatures.

3. Temperature records of all shipments must be verified to ensure manufacturer recommended temperatures were maintained prior to delivery.

4. Temperatures must be checked periodically and recorded in the appropriate system.

Delivery Discrepancies and/or Defected Product (Broken Vial)1. All carton quantity variances, carton damage or tampering must be reported to delivery agent and shipping vendor immediately upon identifying discrepancy.

2. Damaged/broken vials should be removed from trays, adjusted from inventory on-hand count, and properly disposed of and reported in accordance with CDC guidelines.

Perpetual Inventory Records1. Receiving must be completed in the pharmacy system. All transactions impacting vaccine

inventory levels or status to include receiving, storage, preparation, destruction, waste and returning to stock must be recorded at the time of transaction to maintain accuracy of vaccine on-hand inventory count on daily basis

2. The pharmacy is required to submit the following information to the CDC daily through designated methods:

a. The number of doses ordered and on hand at each pharmacy location

b. The number of doses distributed and administered at the long-term care facilities serviced.

Related Documents

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Revision History




Title 3.1 Storage



Policy Statements

COVID-19 vaccine shall be stored in accordance with CDC and vaccine manufacturer requirements.

Each vaccine storage unit must have a temperature monitoring device to ensure that vaccines are stored within the correct temperature range. Temperature records must be kept for a minimum of three years.

Pharmacy personnel shall strictly adhere to the vaccine storage procedures outlined in this policy to maintain vaccine integrity and potency.

Purpose

The purpose of this document is to detail the COVID-19 vaccine storage and temperature monitoring requirements.

Scope

All pharmacy personnel.




PPE – Personnel Protective Equipment

Temperature Excursion – Any temperature reading outside the range recommended by the manufacturer

UCT – Ultra Cold Temperature

Procedures

I. Designated Storage Areas1. Pfizer specific

a. All vaccine cartons must be secured in the controlled substance room (?) or approved pharmacy storage area with limited employee access immediately after delivery.

b. All vaccine inventory must be stored in freezer units capable of ultra-cold temperatures (-60°C to -80°C) frozen

c. The shipping container (thermal shipper) may be used to temporarily store vaccines. Once received, thermal shipping container must be replenished with pelleted dry ice within 24 hours.a. The thermal shipping container may only be opened twice per day for three (3)

minutes during each opening.

b. Containers must be replenished with dry ice every 5 days to maintain required temperature.

d. Once removed from thermal shipping container, store vaccines and diluents in original packaging.

2. Position vaccines and diluents two to three inches from the storage unit walls, ceiling, floor, and door.

3. Arrange vaccines and diluents in rows and allow space between them to promote air circulation.

4. Place vaccines and diluents with the earliest expiration dates in front of those with later expiration dates.

5. In preparation for vaccine thawing and administration, transfer vials immediately to a refrigerator at manufacturer specified temperature and time length to maintain vaccine stability.

Cold Chain Monitoring & Adding Dry Ice

1. All shipments must be tracked and monitored from vendor to pharmacy to ensure end-to-end distribution within required temperatures using the manufacturer GPS tracker (if provided)

2. Cold chain storage and handling requirements for each COVID-19 vaccine product will vary from refrigerated (20°C to 80°C) to frozen (-20°C) to ultra-cold (-60°C to -80°C) temperatures.

3. Temperature records of all shipments must be verified to ensure manufacturer recommended temperatures were maintained prior to delivery. Pfizer manufacturer instructions

4. All vaccine inventory must be stored in freezer units capable of ultra-cold temperatures (UCT - 60C to - 80C) frozen. Remove vaccine vials/trays from carton and store in UCT freezer.

5. Thermal shipping containers may be used to store vaccines temporarily.

6. If thermal shipper is used for temporary storage; you must top off dry ice within 24hrs of delivery and then add additional dry ice every 5 days for a total of 3 times up to 15 days.

7. Direct handling of dry ice needed for re-icing the containers will require the use of appropriate PPE and following all safety protocols for handling dry ice safely.

8. Thermal shipper may only be opened two times a day to maintain proper temperature. When removing vials/trays from the thermal shipper minimize the amount of time the shipper is open (less than 3 minutes) to prevent premature thawing of vaccine vials.

9. Thermal shipping container should be monitored in alignment with guidance provided by CDC and information provided by the manufacturer.

10. Thermal shipping container should be returned within 10 days once use is completed. Follow instructions mailing back to vendor.

Temperature Recordings & Managing Temperature Excursions

I. Check and record temperatures frozen and refrigerated vaccine daily at the start of the workday

Check current temperature each time you access vaccines in the freezer or thawing in refrigerator.

II. Frozen vaccines should be maintained (-20°C) to ultra-cold (-60°C).III. Refrigerated temperatures should be maintained (20°C to 80°C).

Immediate action is required if a temperature excursion is identified. Email inventory operations team immediately to alert them of incorrect temperatures date, time and location of freezer or refrigerator Contact vaccine manufacturer and report a temperature excursion immediately.

IV. The manufacturer will determine the vaccine viability by analyzing the information about the magnitude of the temperature excursion, including the total amount of time that temperatures were out of range.

V. Manufacturer will provide guidance on whether to use affected vaccines. VI. After contacting the manufacture, report the incident to the COVID-19 Vaccine CommitteeVII. To provide the manufacturer with sufficient information to determine vaccine viability,

pharmacy personnel must do the following:VIII. Label the vaccine “Do Not Use” and store at the recommended temperature range until

you receive manufacturer guidance. If it is a frozen vaccine that has been thawed, store in the refrigerator between 2° C and 8° C until you receive manufacturer guidance, as refreezing the vaccine may damage it.

IX. Document the date and length of time of the excursion, the storage unit temperature (minimum/maximum, if available), and inventory affected.

X. Record any other relevant information.XI. Document the event and actions taken for record-keeping requirements XII. The manufacturer must be contacted for each temperature excursion identified. Each

event is unique, and manufacturer recommendations cannot be applied to future events that may appear to be similar.

XIII. Request repair/maintenance for freezers and refrigerators that are not maintaining proper temperature ranges. Discontinue use until repaired.

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Revision History




Title 3.2 Security and Inventory Management



Policy Statement

All COVID-19 vaccine inventory shall be stored safely and securely in the controlled substance room or approved pharmacy storage area with limited employee access immediately after delivery and prior to being opened. Pharmacist in Charge or designee is responsible for performing mandatory daily inventory count and appropriate inventory adjustment transactions must be documented.

Purpose

The purpose of this document is to detail the security and inventory management of the COVID-19 vaccine.

Scope

All pharmacy personnel.


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Procedures

II. Security1. All vaccine shipments will be tracked from vendor to intended Pharmacy location.

2. Vaccine storage area must be under 24-hour video surveillance with a minimum video retention of thirty (30) days.

3. Vaccine carton count discrepancies and carton tampering must be notated on delivery paperwork and delivery agent and shipping vendor notified immediately at time of delivery.

4. Only trained Pharmacy employees are authorized to unpack, transport or change vaccine inventory records.

5. Vaccine doses may only be transported in approved containers that maintain manufacturer recommended temperature.

6. Pharmacy employee must maintain possession and control of vaccine container while at the long-term care facility during vaccine clinic day.

Inventory Management

I. All pharmacies must perform a daily inventory count and reconciliation.

II. Vaccine inventory must be managed by documenting appropriate transaction that corresponds to action being taken:

a. Receive

b. Storage

c. Preparation/Thawing

d. Destroyed/Not Expired

e. Expired/Waste

f. Distribution

g. Administered

h. Returned to Stock

i. Inventory Adjustment

III. Do not dispose of any broken or tampered vials without confirming appropriate inventory adjustment transaction was completed.

IV. Pharmacy must account for each vial of vaccine and maintain all records related to COVID-19 vaccine management for a minimum of three (3) years, or in accordance with federal, state, local, or territorial law.

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Vaccine Clinic Planning

Initial Vaccine planning –"Clinic Kickoff”

V. As soon as pharmacy is notified of the timeline to procure the vaccine, pharmacy will reach out to the facility for a kickoff call

VI. Pharmacy will host a conference call or host an online seminar with facility leadership and review the following:a) Discuss general vaccination plan and verify access to general information resources available

for facility, patient, and caretakers

b) Review with facility resources available

c) Instruct facility on requirements that must be completed, to receive a confirmed clinic date. Required items include submitting executed consent forms for patient and facility staff that agree to be vaccinated and other related information needed in advance.

d) Instruct facility that a Clinic day will not be scheduled unless majority of required items have been submitted, once items are completed pharmacy will communicate with facility scheduled clinic dates

7 to 10 days Prior to Clinic Datea) Overview call with your facility will be scheduled

b) Confirm facility demographics – number of nursing stations and wing/room set-up to map an efficient vaccine administration plan

a. Discuss proper training and preparedness, set expectations for facility including facility administrative support needs on clinic day, room with appropriate work surface to prep vaccine and complete necessary paperwork, etc.

c) Communicate where facility can obtain answers to vaccine questions.

d) Identify LTCF’s on-site clinic coordinator to help immunize

e) Finalize LTCF On-site clinic preparedness checklist

f) Scheduling LTCF required COVID-19 testing protocol for pharmacy staff

g) Scheduling LTCF required training for pharmacy staff.

h) Follow up summary of all initial call details will be sent via email to facility leadership.

The facility will be instructed to distribute and return key documents to each resident and staff member:

Consent Form – for remaining patients and staff

o The facility must obtain consent from all residents or legal guardians. (Return to pharmacy prior to clinic)

o Employees must also complete a consent form

VIS (Vaccine Information Sheet) (Distribute only)

Family Member Vaccine Communication (Distribute only) - Benefits of immunizations

5 days Prior to Clinic Date1. A designated customer service representative will follow up with the facility to ensure that the

facility is on track with reviewing and completing the Pre-Clinic Day packet.

2. Finalize facility’s support with administration and preparation for the clinic.

3. Remind Immunizers and pharmacy support to obtain COVID-19 test result.

3 days Prior to Clinic Date1. Pharmacy will host a conference call/webinar with the facility and review the following:

2. Reminder communications of clinic day plans with facility leadership

3. Confirm designated areas for clinic set up and nursing station mapping

4. Confirm that the Pre-Clinic Day packet is sent back to the pharmacy including the completed roster and signed consent forms for all patients and employees to be vaccinated on scheduled clinic day.

5. Confirm final number of doses required

6. Final confirmation of the vaccine clinic start time

7. Follow up summary of call details will be sent via email to facility leadership.

8. COVID Vaccine Committee will create a facility specific vaccination plan utilizing the facility layout and information collected from the initial call

9. Confirm Immunizer and pharmacy support have uploaded their COVID-19 test result. If the result is positive, they will immediately report to COVID-19 vaccine coordinator. Coordinator will re-select the immunizer and support and confirm.

1 day Prior to Clinic Date1. An email reminder will be sent to facility leadership with COVID Vaccine clinic specifics and any

outstanding tasks.

2. Pharmacy will host a conference call/webinar with facility leadership and review the following:

3. Facility leadership will confirm the final patient and staff vaccine roster.

4. Communicate any last-minute needs of the pharmacy or facility.

5. Review the Clinic Day Checklist, schedule, and execution plan one final time.

6. Pharmacy vaccine team will plan to arrive at the facility 1-2 hours prior to scheduled start time. A customer service representative must confirm arrival time of pharmacy vaccine team at the facility.

7. Follow up summary of call details will be sent via email to facility leadership.

8. An email notification will be sent to data entry staff, pharmacy site vaccine coordinator and Immunizer/pharmacy support.

9. Data Entry will enter bulk quantity of the vaccine based on the roster faxed back from the facility.

10. Pharmacy site vaccine coordinator will prepare the Clinic Day package. Refer to Policy 6.1.

11. Coordinate delivery with dispatch.

Related Documents

6. Pre-Clinic Day Packet

Clinic Day Checklist

Revision History




Title 4.2 Workload Planning



Policy Statement

The pharmacy is responsible for developing comprehensive workload plans for all vaccination clinics.

Purpose

The purpose of this document is to outline vaccination clinic workload planning.

Scope

All Pharmacy vaccination personnel.


None this section

Procedures

III. General

1. Facility selects their preferred immunizers.

2. Facility will be instructed to compile required information and documents prior to a clinic date schedule to be released

3. Required items include: a list of patients agreeing to be vaccinated and their signed consent forms, a list of employees agreeing to be vaccinated and their consent form and insurance information if available and finally a list of employees that are registered immunizers and can assist in vaccinating on clinic day

4. Once a facility has achieved 75% completion of required items in 2a. The clinic dates will be scheduled and communicated to the facility

5. Facility will be scheduled for 3-4 clinic days for vaccine administration. Clinic days will be scheduled based on the vaccine intervals recommended by the manufacturer (example: clinic 1 on day 0, clinic 2 on day 21 etc.)

6. Vaccine clinic day 1 will be scheduled based on facility’s location and availability For each clinic day, a minimum of 2 full time employees will be scheduled per clinic, including one (1) Immunizer and one (1) supporting staff that will help in preparing screening documentation and vaccine prep on site at clinic to ensure efficiency.

Non-Pharmacy (Employees and Residents)

1. Follow Procedure Section II. Steps 1 through 6

2. Non-Pharmacy facility (Residents and/or Employees):

3. Clinic day will be scheduled. A customer service representative and an immunizer will be selected based on proximity to pharmacy and will be notified of facility’s information and contact person to coordinate vaccination clinic details.

4. Each employee that requests to receive the COVID-19 vaccine from pharmacy must complete a consent form and provide insurance coverage information

5. Clinic day will include residents and employees belonging to the facility on the same clinic day.

Second Dose Planning and Coordination1. Event will be scheduled for all clinic days 1-4 for each facility.

2. On clinic day 2, a notification alert will be communicated to the Immunizer and the customer service representative. Follow Procedure Section II. Steps 1 through 6

3. Roster from clinic day 1 will be reconciled with roster from clinic 2 to confirm all residents that have received the first dose of vaccine will receive the second dose of vaccine on clinic day 2. Any discrepancy in rosters will be clarified with the facility and documented

Related Documents

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Revision History




Title 5.1 Order Entry and Pharmacist Initial Verification (PV1)



Policy Statement

COVID-19 vaccine supply orders must be entered in Pharmacy system and all subsequent standard medication dispensing workflow steps completed prior to distributing for vaccination clinic use.

Purpose

The purpose of this document is to detail the COVID-19 vaccine order entry and pharmacist initial verification procedures.

Scope

All Pharmacy order entry personnel and pharmacists.


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Procedures

IV. Facilities Serviced by Pharmacy: Patients and Employees1. Pre-clinic day event

2. Facility will collect information (Name, DOB, signed consent form) of residents and employees who are agreeing to be vaccinated ("Roster").

3. Once the facility collects and submits the information, a Vaccine Coordinator) will print a roster. 1 day prior to the clinic day, assigned Data Entry staff will use the roster to enter a one-time bulk order with total number of doses needed for the clinic day under the facility profile following:

a. Roster will display the total number of residents and employees that have signed up. Ensure that the number of vaccine vials needed to fulfill the order matches the total number from the roster.

i. The vaccine is a multi-dose vial that holds either 5 doses or 10 doses per vial based on manufacturer

b. In the pharmacy system, enter the total number of vaccine vials needed under the Facility Profile. The vaccine vials will be dispensed as a bulk supply similar to house stock items.

c. SIG should include total number of vials and doses, example 10 vials= 50 dosesd. Associate the Rx Number and route the document to RPh Review

4. Pharmacist Initial Review (PV1) must be performed to verify the following:

a. Correct facility was selected

5. Correct calculation of total vials needed was entered

On the day of clinic, immunizer, customer service representative or Clerk will evaluate vaccine eligibility for each patient by completing a screening document. Each vaccine administration record and any other relevant data element required by IIS is collected upon each patient's vaccine administration. IT job will transmit the data above to Pharmacy system under each patient's profile a new prescription will be entered as B-Billing Only transaction with administration record in Custom tab in “COVID” batch.

Post Vaccination Clinic Documents

1. On the day of clinic, Immunizer, customer service representative or Clerk will enter vaccine administration records and any other relevant data elements required by IIS and other authorities onto the vaccine form upon each vaccine administration. (Informed consent and Screening form)

2. Vaccine Team with fax all post vaccination clinic documents into document folder named Post Vaccination Clinic Documents.

3. Designated Data Entry staff will associate the entered order of residents and employees to the faxed to the resident or employee profile.

4. Technical issues

a. If you consider technical difficulties, please print forms, fill and fax to pharmacy for manual data entry to be completed

Related Documents

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Title 5.2 Packaging and Pharmacist Final Verification (PV2)



Policy Statement

COVID-19 vaccine thawing procedures shall only be performed by trained personnel and only for the quantity needed to fulfill confirmed vaccination clinic supply orders.

Purpose

The purpose of this document is to detail the COVID-19 vaccine thawing, packaging and pharmacist final verification procedures.

Scope

All Pharmacy pharmacies.



UCT – Ultra Cold Temperature

Procedures

V. General

An email communication will be sent to local coordinators at each site to start the thawing and packaging process, this will occur 24 hours prior to a scheduled clinic day

VI. Thawing Vaccine1. Remove the total amount of vaccine vials needed from UCT freezer or thermal shipper.

Pfizer specific instructions: Note: Thermal shipping containers may only be opened twice per day for three (3) minutes during each opening.

2. The vials/trays should not be exposed to room temperature for more than three (3) minutes to prevent premature thawing.

3. Vials should be transferred into a secondary container for safe transport to refrigerator.An entire tray of will take about 3 hours to thaw, a smaller number of vials may thaw more quickly

4. Protective gloves must be worn while handling frozen vials.

5. Vials must be immediately transferred to a refrigerator for storage (2oC to 8oC)

6. Vials may be stored in refrigerator prior to dilution for up to five (5) days (120hrs).

7. Once thawed, vials may be stored at room temperature for no more than two (2) hours prior to dilution.

Packaging & Cold Chain MonitoringPlace the vaccines in an approved, secure container that maintains the manufacturer recommended temperature range.

Approved containers:

a. Portable vaccine refrigerator unit

b. Qualified container and packets specifically designed and tested to maintain correct temperatures when opened and closed during the clinic. A temperature monitoring device must be included with each container.

To maintain manufacturer recommended temperature range, the following may be used:

a. Coolant materials such as phase change materials (PCMs) or frozen water bottles that can be conditioned to 4° C to 5° C.

b. Insulating materials such as bubble wrap and corrugated cardboard—enough to form two layers per container.

Soft-sided containers specifically engineered for vaccine transport are acceptable. Do not use commercially available soft-sided food or beverage coolers because most are poorly insulated and likely to be affected by room or outdoor temperatures.

Do not use frozen gel packs or coolant packs from original vaccine shipments to pack refrigerated vaccines. They can still freeze vaccines even if they are conditioned or appear to be “sweating.”

The device should have an accuracy of +/-0.5° C (+/-1° F).a. Place buffered probe material in a sealed vial directly with the vaccines.

b. Keep the device display on top of vaccines so you can easily see the temperature.

Pharmacist Final Verification (PV2)1. To minimize potential opportunities for a temperature excursion, a pharmacist must perform both

the Pharmacy system packaging and PV2 steps at the same time.

2. Pharmacist will verify the following:

a) Correct vaccine

b) Correct quantity

c) Correct auxiliary labeling

d) Correct temperature

3. Do not leave vaccine unattended. Request staging technician to generate a delivery packing slip and affix to cooler.

4. Pharmacist or Site Vaccine Coordinator will perform a physical hand off of packaged vaccine to the designated transport staff.

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Revision History




Title 5.3 Transport



Policy Statements

COVID-19 vaccine must be transported in an approved, stable storage unit with a temperature monitoring device placed with the vaccines.

The quantity of vaccine transported to off-site vaccination clinic should be based on the anticipated number of COVID-19 vaccine recipients and the ability of the facility to store, handle, and transport the vaccine appropriately. This is critical to minimizing the potential for vaccine waste.

The total time for transport alone or transport plus clinic workday must be a maximum of eight (8) hours.

Purpose

The purpose of this document is to detail the COVID-19 vaccine transporting process.

Scope

All Pharmacy and delivery personnel.


Transport - Involves the movement of vaccine between providers or other locations over a short distance and time frame and is appropriate for events such as an emergency or off-site clinic or to ensure vaccines that are about to expire can be used rather than wasted.

Procedures

VII. General Guidelines

I. Move transport containers directly to a vehicle that is already at a comfortable temperature, neither too hot nor too cold.

II. Only transport vaccines inside the passenger compartment (not in the trunk or bed of a truck).

III. Avoid leaving containers in areas where they are exposed to direct sunlight.

IV. Check vaccine temperature upon arrival at the vaccination clinic immediately.

Temperature Monitoring During Transport1. A temperature monitoring device, specifically a digital data logger (DDL) must be used for

monitoring and recording temperatures while transporting vaccines.

2. The device should have an accuracy of +/-0.5° C (+/-1° F).

3. Place buffered probe material in a sealed vial directly with the vaccines.

4. Keep the device display on top of vaccines so you can easily see the temperature.

Temperature Monitoring After Transport1. Immediately upon arrival at the destination, vaccines should be stored in an appropriate storage

unit with a temperature monitoring device.

a. If the device displays min/max temperatures, this information should be checked and recorded.

b. If the device does not display min/max temperatures, then the current temperature should be checked and recorded a minimum of two times.

2. If vaccines cannot be stored in an on-site storage unit, they should be kept in the portable vaccine storage unit using the following guidance:

a. Place the device (preferably with a probe in a thermal buffer) as close as possible to the vaccines, and check and record temperatures hourly.

b. Keep the container closed as much as possible.

c. Remove only one multi-dose vial or 10 doses at a time for preparation and administration by each person administering vaccines.

Related Documents

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Revision History




Title 6.1 Vaccination Clinic Preparation



Policy Statement

Designated Vaccine Coordinator at each pharmacy is responsible for preparing all supplies and material required for each scheduled vaccination clinic.

Purpose

The purpose of this document is to detail the supplies and material that must be prepared prior to each vaccination clinic.

Scope

All Pharmacy and facility vaccine coordinators.



Clinic Day Package – Package that contains all necessary supplies and material for vaccination clinic

EPA – Environmental Protection Agency

EUA – Emergency Use Authorization

VAR – Vaccine Administration Record

VIS – Vaccine Information Statement

Procedures

Site vaccine coordinator will prepare the Clinic Day Package which will include the following.

1. COVID-19 vaccine. Refer to Policy 5.2 and 5.3

2. Vaccine diluent (provided by vaccine manufacturer)

3. Ancillary Supply Kit (provided by vaccine manufacturer)

4. Vaccine Administration Emergency Kita. Antihistamine: diphenhydramine, hydroxyzineb. Epinephrine in prefilled autoinjectorc. First aid kitd. Tongue depressorse. Tourniquet

5. Thermometer to monitor the vaccine temperature

6. Thermometers for checking patient temperature before entering the clinic

7. Digital clock to monitor time to reconstitute and administration

8. Sharps container

9. Additional face coverings

10. Gloves

11. Bandages

12. Gown

13. Hand sanitizer (at least 60% alcohol)

14. Disposable table cover

15. Partition screens: plastic shields

16. Paper towels

17. EPA registered sanitizing products for vaccination and preparation surfaces

18. Wastebaskets

19. Print out the following forms:a. Clinic Day Checklist b. Signed facility roster consent form c. EUA/VIS (in multiple languages as appropriate) d. VAR/Consent/screening checklist form (blanks): COVID-19 symptom and temperature

checklist e. Immunizer: licensure and CPR certificate copies

20. Office suppliesa. Table (if not provided by facility)b. Clipboardsc. Notepadsd. Pense. Rope, Cones, and/or tape (to direct traffic flow): signs, barriers, and floor markers to

instruct patients to remain 6 feet apart from other patients and clinic staff have been set up before the clinic.

f. Signage for clinic hours, future clinics, clinic flow, and display equipmentg. Trash bags

Related Documents

Pharmacy Clinic Day Package Checklist

COVID-19 Vaccination Program Policy 5.3


Revision History




Title 6.2 Vaccination Clinic Set-Up



Policy Statement

CDC guidelines and best practices shall be observed during vaccination clinics.

Purpose

The purpose of this document is to detail the vaccination clinic day set-up and procedures.

Scope

All Pharmacy and vaccine coordinators.


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Procedures

1. Upon arrival at the facility, pharmacy vaccination team will commence the physical set up of the clinic site/designated area:

a. All staff to have their temperature checked and answer COVID screening questions.

b. Find the designated clean area for vaccine preparation.

c. Set up tables, table coverings and place plastic shields.

d. Clean the workspace with EPA registered sanitizing product.

e. Place ropes, cones, tapes, signs, barriers, and/or floor markers to instruct patients to remain 6 feet apart from other patients.

f. Place signage for clinic hours, future clinics, clinic flow, and display equipment

g. Place all items in the clinic day package to appropriate areas.

h. All staffs to wear recommended PPE.

2. Pharmacy vaccination team will ensure the integrity of the vaccine in intact and not compromised prior to initiating administration process:

a. Upon arrival at the facility/clinic, confirm that the vaccines were still within the manufacturer-recommended temperature range without damage.

b. Ensure that the vaccines are being kept in proper storage equipment that maintains the manufacturer-recommended temperature range (i.e., a portable vaccine refrigerator or qualified container and packout specifically designed and tested to maintain correct temperatures when opened and closed during the clinic).

c. Vaccine temperature is monitored during the clinic using a digital data logger with a buffered probe (placed directly with vaccines).

d. If vaccines are being stored in a storage unit at the site, vaccine temperature data are being reviewed and documented a minimum of 2 times during each clinic workday to ensure they remain at correct temperatures

e. If vaccines cannot be stored in a storage unit at the site, they are being kept in the portable vaccine refrigerator or qualified packout with a temperature monitoring device (with a probe in a thermal buffer) placed as close as possible to the vaccines, and temperatures are being read and recorded hourly.

f. The container is kept closed as much as possible.

g. Vaccines are being protected from light during the vaccination clinic per the manufacturer’s package insert.

3. Upon completion and confirmation of steps 1 and 2, pharmacy vaccination team will begin administration process:

a. Take patient’s temperature and fill out COVID screening questions.

b. Provide VIS/EUA.

c. Have (or assist with) the patient fill out the patient screening/ and consent form.

d. Immunizer uses proper hygiene techniques to clean hands and change gloves before administration and between patients.

e. Triple-check the vaccine label, contents, expiration dates, beyond use dates, vaccine appearance, patient information, vaccine age indication, dosage (volume) of vaccine and route of administration.

i. If 2nd dose, also check that the current dose at the correct interval is being administered.

f. Identify the injection site correctly.

i. Staff is identifying injection site correctly. (For intramuscular route: deltoid muscle of arm [preferred] or vastus lateralis muscle of anterolateral thigh for adults, adolescents, and children aged ≥3 years; vastus lateralis muscle of anterolateral thigh [preferred] or deltoid muscle of arm for children aged 1–2 years; vastus lateralis muscle of anterolateral thigh for infants aged ≤12 months. For subcutaneous route: thigh for infants aged <12 months; upper outer triceps of arm for children aged ≥1 year and adults [can be used for infants if necessary].)

g. Administer the vaccine using aseptic technique and following safe injection practices.

h. Wipe down all areas during vaccine preparation and administration between patients.

i. Ensure that multi-dose vials are being used only for the number of doses approved by the manufacturer.

j. Used needles and syringes are being immediately placed in a sharps container following administration. (Needles are NOT being recapped.)

k. Each vaccination is being fully documented with name of person vaccinated; vaccination date; vaccine type, lot number, manufacturer; patient receipt of vaccine information statement (VISs or Emergency Use Authorization [EUA] form), including edition date and date VIS was provided; injection site; vaccination route; dosage; and name, title, and office/company address of person who administered the vaccine.

l. Patients are receiving documentation for their personal records and to share with their medical providers.

Related Documents

Pharmacy Vaccination Clinic Area Setup Checklist

Revision History




Title 6.3 Vaccine Reconstitution and Administration



Policy Statement

CDC and vaccine manufacturer recommendations and guidelines shall be observed when preparing vaccine for administration.

Purpose

The purpose of this document is to detail the guidelines to follow when reconstituting and preparing the COVID-19 vaccine for administration.

Scope

All Pharmacy vaccinators.


BUD - Beyond use date

CDC - Centers for Disease Control and Prevention

IM - Intramuscular

MDV - Multi dose vial

PF - Preservative free

SDV - Single dose vial

Reconstitution - mixing powder or pellet form with a liquid (diluent) in a specific process before administration

Procedures

VIII. Vaccine Preparation for Administration1. Prepare vaccines in a designated area away from any space where potentially contaminated

items are placed.

2. Only prepare vaccines when you are ready to administer them.

3. Always check expiration dates and confirm that you have selected the correct vaccine.

4. Perform hand hygiene

a. CDC guideline recommends washing your hands with soap and water. Rub your hands together vigorously for at least 15-20 seconds, covering all surfaces of the hands and fingers

b. Rinse your hands with water and use disposable towels. Use towel to turn off the faucet

c. When using alcohol-based hand sanitizer, put product on hands and run hands together covering all surfaces until hands feel dry. This should take around 20 seconds

5. Only administer vaccines you have prepared. This is a quality control and patient safety issue and a best practice standard of medication administration.

6. Different types of vaccine vials

a. SDV: a single dose vial contains one dose and should be use one time for patient. Never combine leftover vaccine from one SDV to another, only open SDV when ready to use.

MDV: a multi-dose vial contains more than one dose of vaccine. MDVs may contain a preservative to help prevent the growth of microorganisms and hence can be entered or punctured more than once. Only the number of doses indicated in the manufacturer’s package should be withdrawn from the vial. Any residual vaccine should be discarded. Never use partial doses from two or more vials to obtain a dose of vaccine.

Vaccine Reconstitution7. Vaccines are either in powder or pellet form and must be mixed with diluent directly before

administration. Diluent may vary in volume based on manufacturer package insert. Diluents are not interchangeable unless specified by the manufacturer.

8. Never use a stock vial (bulk) of sterile water or normal saline to reconstitute vaccines.

9. Always check expiration dates on both diluent and vaccines before reconstituting them.

10. Reconstitute and draw up vaccine only at the time of administration to avoid waste.

11. Drawn syringes must be stored at the manufacturer recommended temperatures throughout the clinic day.

12. If vaccines must be pre-drawn for a vaccination clinic, observe the following:a. Wipe the top of the vial with the alcohol swab, using a one direction firm stroke sweeping

motion. Allow alcohol to air dry b. Draw up vaccines only after arriving at the clinic site, drawing up doses days or even

hours before administering is not best practicesc. Each person administering vaccines should only draw up no more than one MDV or max

10 doses at one timed. Monitor patient flow to avoid drawing up unnecessary doses

e. If a pre-drawn reconstituted vaccine is not used within 30 minutes of being reconstituted, follow manufacturer guidelines for storage conditions and time limits.

f. Discard any remaining vaccine, never transfer pre-drawn reconstituted vaccine back into a vial for storage

Manufacturer Vaccine Size and related info

Reconstitution Preparation Special instructions

Pfizer and BioNTech COVID-19 Vaccine

0.3mcg/0.3mL

Suspension for IM injection, (PF) MDV

Vial contains a fill volume of 0.45ml, concentration 0.5mg/ml (pre-reconstitution)

Cleanse vial stopper with antiseptic swab

Dilute thawed MDV with 1.8ml of Normal saline (0.9% Sodium chloride) to deliver five (5) 30 mcg doses in 0.3ml injections

Invert gently 10 times to mix, do not shake

Draw 0.3ml of the diluted dosing solution into a new sterile dosing syringe with a needle appropriate for IM injection

For each additional dose, use a new sterile syringe and ensure the vial stopper is cleansed with antiseptic before each withdrawal

Equalize vial pressure by withdrawing 1.8ml air into the empty diluent syringe before removing the needle from the vial

Rev 11/12/20

Related Documents

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Revision History




Title 6.4 Vaccination Clinic Exiting



Policy Statement

Upon completion of a vaccination clinic day, Immunizer and pharmacy support staff will perform a standardized exiting process.

Purpose

The purpose of this document is to detail the vaccination clinic exiting procedures.

Scope

All Pharmacy vaccinators and supervisors.



Procedures

Upon completion of administering COVID-19 vaccine to all scheduled recipients, on-site pharmacy staff will execute the following prior to exiting the facility.

1. The roster will be compared against each individual COVID-19 vaccine screening sheet and full reconciliation will be performed. Discrepancies between the two documents will be recorded (i.e. brought 10 doses, administered 7 doses)

2. On-site pharmacy staff to review and confirm that the facility has the following:

3. Personal Vaccine Record Card that includes name and date of vaccine administered4. EUA Fact Sheet and V-Safe information

5. Printed and/or electronic PDF VAERS online form to report any adverse reactions

6. Fax documents to pharmacya. Patient screening/Vaccine Administration Record/Consent sheetb. Roster form with documentations of administration and discrepancyc. Copy of Personal Vaccine Record Card

7. Leave the Record Card with the facility

8. For Clinic Day 1, facility is to keep them in a secured place until Clinic Day 2 and Clinic Day 3.

9. Facility is to follow their protocol on immunization record for resident discharging and for facility employees.

10. Collect all documents to be returned to the pharmacy.

a. Patient screening/Vaccine Administration Record/Consent sheetb. Roster form with documentations of administration and discrepancyc. Copy of Personal Vaccine Record Card

11. Collect any unused vaccines, emergency kits, and supplies to be returned to the pharmacy.

12. For unused vaccine: count the remaining quantity and document.

13. Email COVID-19 Vaccine Committee that the clinic has been completed and documents have been faxed.

14. On-site pharmacy staff will return to the pharmacy with items collected at the facility.

15. Pharmacy site local coordinator: receive and review the returned items from the clinic. 16. Inspect the returned vaccines, review documentations regarding the remaining quantity and

document the accurate quantity in inventory section of the portal. 17. Follow CDC and manufacturer guide on discarded vaccine. Refer to Policy 9.218. Clean, disinfect and replenish the Vaccine Administration emergency kit.

Related Documents


Revision History




Title 7.1 Vaccine Adverse Event Reporting System (VAERS)



Policy Statement

Reporting vaccine adverse events is a critical element for monitoring vaccine safety and cataloging side effects associated with the vaccine. Any clinically significant adverse event that occurs after the administration of a vaccine must be reported to the Vaccine Adverse Event Reporting System (VAERS).

Purpose

The purpose of this document is to detail the process and information to be provided to the Corporate QA department for VAERS reporting.

Scope

All Pharmacy vaccine and facility vaccine coordinators.


N/A

Procedures

13. All vaccine adverse events must be communicated to the pharmacy.

14. The following information must be included in the email:

a. Patient full nameb. Name and title of person reporting and contact informationc. Name of facilityd. Vaccine information

The pharmacy department will be contact the facility to obtain all additional required information.

Once all pertinent information is obtained, pharmacist will initiate VAERS reporting process by completing all required steps within the VAERS portal.

Upon receiving confirmation of a successful submission, pharmacist will provide the facility the VAERS E-Report number

The pharmacy department will be responsible for maintaining all records for VAERS reporting which will be readily retrievable for a minimum of three (3) years.

Related Documents

N/A

Revision History




Title 7.2 Immunization Information System (IIS) Reporting



Policy Statement

***State by state workflow/procedures***

Purpose

The purpose of this document is to detail the

Scope

Pharmacy IT and pharmacy department.


N/A

Procedures

Related Documents

N/A

Revision History




Title 7.3 Immunizer Certifications



Policy Statement

Immunizers administering vaccine as part of Pharmacy’s COVID-19 vaccination clinics must have an active medical provider license in good standing and meet all state/federal immunizer certification requirements.

The COVID-19 Vaccine Committee is responsible for verifying all required immunizer licenses and certifications are current and maintaining a readily retrievable data file.

Purpose

The purpose of this document is to detail immunizer requirements.

Scope

All Pharmacy immunizers


ACPE - Accreditation Council for Pharmacy Education

EUA – Emergency Use Authorization

FDA – Food and Drug Administration

PREP Act - Public Readiness and Emergency Preparedness Act

Procedures

I. All immunizers must complete immunization training including but not limited to:a. Practical training program of at least 20 hours that is approved by the Accreditation

Council for Pharmacy Education (ACPE) b. State, Local, and/or territory required continuing education requirements to maintain

certification. c. Cardiopulmonary Resuscitation or Basic Life Support Certification for Healthcare

providers (or equivalent)

Copies of relevant licenses and certifications must be provided to the COVID-19 Vaccine Committee for recordkeeping.

The COVID-19 Vaccine Committee is responsible for providing immunizer certification information to the long-term care facility prior to the scheduled vaccination clinic day.

Pharmacists must also follow state and federal guidance under PREP Act (Updated 9/3/20):

a. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This

training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.

b. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.

c. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.

d. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

e. The licensed pharmacist must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.

f. The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

g. This authorization preempts any State and local law that prohibits or effectively prohibits those who satisfy these requirements from ordering or administering COVID-19 vaccines but this authorization shall not preempt State and local laws that permit additional individuals to administer COVID-19 vaccines to additional persons.

Related Documents

N/A

Revision History




Title 8.1 Pharmacy Personnel Training



Policy Statement

Personnel handling the COVID-19 vaccine shall complete initial and annual training specific to their job functions.

If an employee who has been trained demonstrates a lack of knowledge or behavior which leads the supervisor to believe the employee does not have a proper understanding of vaccine handling, the employee must be retrained prior to resuming job duties.

If there are changes in the workplace or processes that change the vaccine handling procedures, all affected employees must be retrained.

Purpose

The purpose of this document is to ensure all personnel who handle the COVID-19 vaccine are adequately trained.

Scope

All Pharmacy personnel.


N/A

Procedures

1. Training is documented on the ‘COVID-19 Vaccine Handling Employee Training Record’ form and must be readily retrievable.

2. Pharmacy Department shall provide comprehensive training for each Pharmacist in Charge and Site Vaccine Coordinator.

3. Each Pharmacist in Charge and Site Vaccine Coordinator is responsible for providing the appropriate training modules to personnel.

4. A copy of all employee training records must be retained at pharmacy.

Related Documents

COVID-19 Vaccine Handling Employee Training Record

Revision History




Title 9.1 Disposal, Return and Waste



Policy Statement

COVID-19 vaccine disposal, return and waste activities will be performed in accordance with CDC and state environmental agency guidelines and requirements.

Purpose

The purpose of this document is to detail the COVID-19 vaccine disposal, return and wastes processes.

Scope

All Pharmacists and technicians.


N/A

Procedures

IX. General Vaccine Disposal Guidelines1. Expired or compromised vaccine: In some instances, unused vaccine and diluent

doses, unopened vials, expired vials, and potentially compromised vaccine may be returned for credit, even if they must be discarded. Contact the vaccine manufacturer for vaccine-specific information.

2. Open and broken vials and syringes, manufacturer-filled syringes that have been activated, and vaccine pre-drawn by provider: Cannot be returned and should be discarded according to state requirements.

3. Empty vaccine vials: Most are not considered hazardous or pharmaceutical waste and do not require disposal in a biomedical waste container. Each pharmacy site must check and comply with state requirements for disposal.

4. Medical waste disposal requirements vary from state to state because they are set by state environmental agencies. Each Pharmacist in Charge is responsible for checking with state environmental agency for guidance to ensure vaccine disposal procedures comply with regulations.

Related Documents

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Revision History

