south carolina vaccine management and disaster recovery plan · south carolina department of health...

Vaccine Management Plan and Disaster Recovery Plan

of 21 DHEC 1225 (Rev. 7/2018)

South Carolina Department of Health and Environmental Control

Divison of Immunization

South Carolina

Vaccine Management and Disaster Recovery Plan

PRACTICE NAME:_____________________________________________________

PROVIDER PIN:_______________________________________________________

This document provides a template for development of a comprehensive vaccine management

plan for protection and maintenance of your practice’s vaccine supply. The Vaccine

Management and Disaster Recovery Plan consists of two sections: (1) the Routine Storage and

Handling Plan, which covers all aspects of routine vaccine management and (2) the Disaster

Recovery Plan, which is used in the event of an emergency situation that may affect the storage

and potential viability of your vaccines.

The completed Vaccine Management and Disaster Recovery Plan (VMDR) must be easily

accessible and posted on or near the vaccine storage equipment. Ensure that all staff (current and

new), that are responsible for administering vaccines or who may be required to transport

vaccine in an emergency situation, read the plan and understand it. Also, ensure that janitorial

and security staff are aware of the plan and know the procedures to follow for notifying

designated personnel about any problems with the vaccine storage equipment.

One staff member must be designated as the primary vaccine coordinator, providing oversight

for all vaccine management within the office and ensuring all vaccines are stored and handled

correctly. At least one back-up vaccine coordinator should be trained to perform the same

responsibilities as the primary vaccine coordinator in the event that the primary person is

unavailable. VFC Providers are required to notify SC DHEC Division of Immunization when

there are changes in primary and back up vaccine coordinators.

Annual Review of Vaccine Management and Disaster Recovery Plan: The entire plan must be reviewed, updated and signed annually to ensure all information in this

plan is up to date and accurate. Review and update the contact lists as needed. Please indicate

below the date the entire plan was reviewed and updated as well as the name, title and signature

of the reviewer:

Date

Reviewed/Updated

Reviewed By (Print Name) Title Signature


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Education and Training Responsibilities of Vaccine Coordinators at Provider Sites:

1. Train any provider staff involved in receipt of vaccine deliveries to immediately

open, inspect and store vaccines upon delivery. Provider staff will alert primary

and/or back up Vaccine Coordinator of vaccine delivery.

2. Ensure all staff with vaccine management responsibilities are trained on proper

vaccine storage and handling procedures.

3. Train other staff who are responsible for administering vaccines or who may be

required to transport vaccine in an emergency situation on proper vaccine storage and

handling procedures.

4. Train responsible staff on all elements of the routine and emergency vaccine

management storage and handling plans.

5. Document completed staff training below. Include the staff member’s name and date

of training:

Staff Member’s Name Date of Training

Contact Information 1. Contact information for Vaccine Coordinator:

Name of Employee Title of

Employee

Work Phone Ext Home Phone

Primary:

Back-Up:

2. Contact Information for Health Department

Resources Name of Employee Work Phone Ext Other

SC DHEC

(Central Office/ Columbia): 803-898-0460 800-277-4687

SC DHEC (Regional Immunization

Program Manager)


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3. Points of contact for restoring electrical power in the event of a power failure:

Electrical Power Company Point of Contact Work Phone Ext Emergency Phone

Building Maintenance Point of Contact Work Phone Ext Emergency Phone

4. Designated company responsible for repair when the compressor or other

refrigeration equipment has been destroyed or you need emergency maintenance:

Name of Repair Company Point of Contact Work Phone Ext Emergency Phone

5. Vaccine Manufacturers and National Weather Service Contact Information:

Part A: Routine Storage and Handling

I. Vaccine Storage

A. Types of Vaccine Storage Units

Purpose built or pharmaceutical/medical grade units should be used to store vaccines.

Dormitory-style refrigerator units are never acceptable for storage of any vaccine due to inability

to reliably maintain temperatures needed to store vaccine within required temperature ranges.

Sites should consider moving away from combination refrigerator and freezer vaccine storage

units to store frozen vaccines as they do not maintain frozen vaccine storage temperatures. If a

combination storage unit is used, only the refrigerated portion of a combination refrigerator and

freezer storage unit is recommended to be used. For recommended vaccine storage units, please

Manufacturer/Weather Service Telephone Number/Contact

Information

Vaccine Manufacturers

GlaxoSmithKline 888-825-5249

MedImmune 877-633-4411

Merck 800-672-6372

Pfizer (formerly Wyeth) 800-438-1985

Sanofi Pasteur 800-822-2463

Seqirus (CSL) 919-577-5000

National Weather Service www.nsw.noaa.gov


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review the CDC Recommended vaccine storage units section below and reference the Vaccine

Storage & Handling Toolkit provided by CDC.

1. Vaccine Storage Units must meet the following requirements:

a. Have a separate freezer compartment with separate exterior door or stand alone

refrigerator and freezer.

b. Have enough room to store the year’s largest inventory without crowding (this includes

flu season and back to school times).

c. Have enough room to store water bottles (in the refrigerator) and frozen water bottles

and phase change materials (in the freezer) to stabilize the temperatures and minimize

temperature excursions that can impact vaccine potency. The addition of water bottles in

the refrigerator reduces the risk of freezing due to the latent heat released from water

prior to freezing.

d. Have a certified, calibrated continuous temperature monitoring devices also known as

a digital data loggers (DDL’s) centrally located inside all refrigerator and freezer

compartments used for vaccine storage in order to monitor temperatures.

e. Reliably maintain the appropriate vaccine storage temperatures year-round.

f. Be dedicated to the storage of vaccines. Food and beverages must NOT be stored in a

vaccine storage unit because this practice results in frequent opening of the door and

destabilization of the temperature.

2. CDC recommended vaccine storage units:

a. CDC recommends purpose built designed to either refrigerate or freeze. These units

can vary in size, from compact, under-the-counter style to large

b. If a stand-alone, unit is not available, use a stand-alone household unit. If you must use

a household grade, combination refrigerator/freezer unit, only use the refrigerator

compartment for storing vaccines.

c. A separate stand-alone refrigerator should be used for refrigerated vaccines that require

storage temperatures between 36°F and 46°F (2°C and 8°C).

d. A separate stand-alone freezer should be used to store frozen vaccines that require

storage temperatures between -58°F and +5°F (-50°C and -15°C). A storage unit that is

frost-free or has an automatic defrost cycle is preferred.

B. Types of DDLs

VFC Providers must have at least one backup continuous temperature monitoring device known

as a digital data logger (DDL) with a current certificate of calibration on hand readily available

to ensure that temperature assessement and recordings can be performed (the DDL is not stored

in a unit but is a backup DDL).

1. DDLs must meet the following requirements:

a. Providers are required to have certified, calibrated DDL in all refrigerator and freezer

compartments used for vaccine storage in order to monitor temperatures.

b. The documentation of a Certificate of Traceability and Calibration Testing (also

known as Report of Calibration) must be provided for each DDL used to monitor VFC

vaccine.

http://www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf

http://www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf


of 21 DHEC 1225 (Rev. 7/2018)

c. A copy of the DDL certificate must be maintained at the provider office as well as

provided to the Division of Immunization for each DDL used in all refrigerator and

freezer compartments. The backup DDL’s certificate of calibration will not need to be

submitted to our office until the DDL is in use.

d. DDL calibration must be tested annually, or according to manufacturer

recommendations (Please see section C below “Certificates of Calibration” to verify what

must be contained in the certificate for the calibration to be considered valid).

e. The DDL are to be placed in the center of each vaccine storage unit.

f. A supply of extra batteries is maintained for DDLs, if applicable.

2. The DDL is required to have the following characteristics:

o Temperature Probe

o Active temperature display that can be easily read from the outside of the unit

o Ability to continuously monitor temperatures and record when data is routinely

downloaded

The following additional recommended features for these DDL’s are:

Alarm for out-of range temperatures

Current, minimum, and maximum temperature indicator

Low battery indicator

Accuracy of +/-0.5° C (+/-1° F)

Memory storage of at least 4,000 readings

Logging interval (or reading rate) recommended at a maximum time of

every 30 minutes

Detachable probe in a thermal buffered material (e.g., glycol, glass

beads, sand, Teflon®)

C. Certificates of Calibration

To be considered valid, the certificate of calibration must contain specific elements (your certificate

must contain all items from #1 or all items from #2).

1. If calibration testing was performed by ILAC/MRA Accredited Laboratories, certificates

must include the following elements:

a. ILAC/MRA signatory body-accredited laboratory

Laboratory accreditation should be clearly identifiable (for a list of ILAC-

accredited laboratories see listings below)

An ILAC MRA-accredited laboratory is the easiest way to identify that the

instrument has been tested correctly according to international standards

The certificate may have an Accrediting Body Symbol, which is the logo, and a

unique laboratory code or certificate number included on the certificate

b. Name of Device (optional)

c. Model Number

d. Serial Number

e. Date of Calibration (report or issue date)

f. Measurement results indicate unit passed test and the documented uncertainty is within

suitable limits (recommended uncertainty = +/- 1°F [0.5°C])


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2. If calibration testing was performed by non-ILAC accredited laboratory, certificates must

include the following elements:

a. Name of Device (optional)

b. Model Number

c. Serial Number

d. Date of Calibration (report or issue date)

e. Measurement results indicating unit passed test and the documented uncertainty is

within suitable limits (recommended uncertainty = +/- 1°F [0.5°C])

f. Measurement results for the device

g. Statement that calibration testing conforms to ISO 17025

For listings of accredited laboratories:

A2LA: http://www.a2la.org/dirsearchnew/newsearch.cfm

L-A-B: http://www.l-a-b.com/content/directory-accredited-labs

ACLASS: http://www.aclasscorp.com/search-accredited-companies.aspx

IAS: http://www.iasonline.org/Calibration_Laboratories/CL.html

PJLA: http://www.pjlabs.com/search-accredited-labs

A listing of signatory bodies outside of the U.S. can be found on the ILAC website:

https://www.ilac.org/

Indicate the following for DDLs at your site:

DDL # Date the

DDL

certification

expires

Stored in

Refrigerator

or Freezer?

Date the

DDL was

initially

placed in Unit

Location/

Description/

Manufacturer

Serial Number

or Model

Number

1

2

3

4

5

D. DDL Placement

1. DDL placement within the unit is just as important as DDL selection. The DDL (probes) are

to be placed in the center of each vaccine storage unit, in proximity to the vaccines being stored.

2. DDLs should not be placed in the doors, near or against the walls, close to vents, or on the

floor of the unit. A DDL can inadvertently be displaced during a busy workday.

3. Ensure appropriate placement of the DDL in each unit with daily inspection of each storage

unit. Proper placement is very important since it helps the provider to most accurately identify

the actual vaccine vial/syringe temperature and to take immediate corrective action if necessary.

4. Ensure that the probes of the DDL are near where vaccines are stored. The probes should be

located on the center of a shelf that is located in the main body (center) of the storage unit away

from walls, ceiling, cooling vents, doors, floor and back of unit.

E. Temperature Monitoring

1. Regardless of the type of certified, calibrated DDL used, VFC providers must record the

Minimum and Maximum (Min/Max) temperatures at the start of the clinic day and are record


of 21 DHEC 1225 (Rev. 7/2018)

temperatures on the appropriate Refrigerator or Freezer Temperature Log (DHEC 3266 or DHEC

3265) along with the date, exact time and initial’s of the person reviewing and documenting the

temperatures on the appropriate Refrigerator or Freezer Temperature Log (DHEC 3266 or DHEC

3265).

2. Review the current temperature prior to accessing and administering vaccines.

3. After the temperatures are checked, check that each unit’s door is closed.

4. The current month’s log for each unit is posted on each unit’s door.

5. Logs will be retained in a file for 3 years.

6. If out-of-range temperatures are found, immediate corrective action will take place. See

section VI, Inappropriate Vaccine Storage Conditions/Storage and Handling Events

7. Action taken will be documented on the “Vaccine Storage Troubleshooting Record” section

of the DHEC 3266 or DHEC 3265 (appropriate Refrigerator or Freezer Temperature Log).

F. Routine Maintenance

1. The unit is defrosted on a routine basis, if applicable

2. The following routine maintenance is performed:

a. Clean coils and motor to keep unit coils and motor free of dust and dust build-up.

b. Clean inside refrigerator and freezer units to discourage bacterial and fungal growth.

Cleaning should be done quickly to minimize risk of the temperature going out of range.

c. Check the door seal and check door hinges.

d. Clean the drain pan periodically.

3. Back-up generators should be tested quarterly and receive maintenance at least annually

(check manufacturer specifications for test procedures and maintenance schedules).

G. Vaccine Storage Unit Set Up

1. Vaccines Stored in a Freezer

a. Varicella-containing vaccines, Proquad® (MMRV), Varivax® (VAR), and Zostavax®( HZV) must be stored in a freezer between -58°F and +5°F (-50°C and -15°C) until

reconstitution and administration. These vaccines can deteriorate rapidly after they

are removed from the freezer.

b. Measles, mumps, and rubella vaccine, MMRII® (MMR), can be stored in a

refrigerator or in a freezer.

2. Vaccines Stored in a Refrigerator

a. All other routinely recommended vaccines should be stored in a refrigerator between

36°F and 46°F (2°C and 8°C), with a desired average temperature of 40°F (5°C).

b. Exposure to temperatures outside this range may result in reduced vaccine potency

and increased risk of vaccine-preventable diseases.

3. To help stabilize the temperatures, water bottles and are stored along the walls, back, bottom

of freezer and in door racks of the freezer.

4. Water bottles are stored in the door racks, on the top shelf and the bottom of the refrigerator.

Water bottle placement in the refrigerator units help stabilize or extend temperatures during a

power outage, mitigate the effects of frequent opening/closing of door during busy clinic days,

and serve as physical blocks preventing the placement of vaccines in areas of the unit that are at

higher risk for temperature excursions.


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5. To prevent accidental power loss, a “Do Not Disconnect” warning sign is placed on the outlet

that the unit is plugged into and on the circuit breaker that supplies power to the storage unit.

6. It is recommended that the plug connected to the unit is secured by using a plug guard.

7. Avoid using power outlets with the following:

a. Built-in circuit switches (they have little red reset buttons)

b. Outlets that can be activated by a wall switch

c. Multi-outlet power strips

8. To allow for cold air circulation around the vaccines, there should be space between the

vaccines and the storage unit walls and between each large package, block, tray, or bin of

vaccines. Adequate cold air circulation helps each vaccine reach a consistent temperature

throughout its mass, and is necessary for the storage unit to maintain a consistent temperature.

Packing any vaccine storage unit too tightly can negatively affect the temperature.

9. Store vaccines in the middle of the unit. In the refrigerator, vaccines should be placed away

from the walls, floor, and vents in the part of the unit best able to maintain the required

temperature between 36°F and 46°F (2°C and 8°C).

10. Do not store vaccines in the doors, vegetable bins, or floor of the unit or under or near

cooling vents. The temperature and/or air flow in these areas may not be stable and may expose

vaccines to inappropriate storage temperatures.

11. If the refrigerator of a combination unit is used, the top shelf of the refrigerator compartment

may be colder than the recommended temperature range because of cold air venting on it from

the freezer compartment. If the top shelf of the refrigerator must be used to store vaccine, place

water bottles in the vaccine bins closest to the vent and only store vaccine that is not sensitive to

the coldest temperatures (e.g., MMR). The freezer compartment is not recommended to be used

and the thermostat should be adjusted to avoid temperatures below 36°F (2°C). Refrigerated

vaccines should always be stored far enough away from the air vent to avoid freezing the

vaccines. Freezing destroys many vaccines quickly, so care should be taken to avoid freezing the

vaccines.

12. Vaccines should be stored away from the walls and vents in the part of the freezer best able

to maintain the required temperature range (between -58°F and +5°F (-50°C and -15°C).

Vaccines should not be stored in the freezer door. The temperature in the door is not stable and

differs from that inside the unit. Frozen water bottles can be stored in the freezer door.

13. No food or beverages are stored in the same unit where vaccines are stored.

H. Appropriate Diluent Storage Conditions

1. Diluents are not interchangeable.

2. MMRII® (MMR), Proquad® (MMRV), Varivax® (VAR), and Zostavax® (HZV) diluent is

packaged separately from the corresponding lyophilized (freeze-dried) vaccine and can be stored

at room temperature or in the refrigerator.

3. Diluents packaged separately from their corresponding vaccines may be stored at room

temperature (as long as they do not contain any antigen) or in the refrigerator.

4. Diluents that contain antigen or that are packaged with their vaccines, e.g., Pentacel® (DTaP-

IPV/Hib) and Menveo® (MCV4) should be stored in the refrigerator next to their corresponding

vaccines.

5. Never store any diluents in the freezer.

6. The location that diluent is stored: _____________________________________.


of 21 DHEC 1225 (Rev. 7/2018)

I. Vaccine Packaging

1. Store vaccines in their original packaging (including UV protective bags used by McKesson

for repackaged vaccines only).

2. Separating vaccines from their original packaging can increase the risks for storage, handling,

and administration errors.

3. Manufacturer product information could be misplaced and repackaged vaccines may not be

labeled appropriately or easy to read.

J. Light Sensitivity

Vaccine is kept in the original box until time of use. MMRII® (MMR), Proquad® (MMRV),

Varivax® (VAR), and Zostavax® (HZV), Shringrix®, Gardasil®9 (HPV), Rotarix® and

Rotateq® (Rotavirus), Afluria®, Agriflu®, Fluarix®, Flublok®, Flucelvax®, FluLaval® (IIV),

Menveo® (MCV), Bexsero®, IPOL® (Polio), and Hiberix® vaccines are protected from light by

keeping box lids intact and closed.

The National Center for Immunization and Respiratory Diseases (NCIRD), Centers for

Disease Control and Prevention, strongly recommends that providers draw vaccine only

at the time of administration to ensure that the cold chain is maintained and that vaccine

is not inappropriately exposed to light. Do not pre-draw doses before they are needed.

II. Handling:

A. The vaccine in this practice is handled according to the following:

1. Private stock, VFC, and State Vaccine Program vaccines are labeled and stored

separately.

2. Vaccines that will expire first are stored in the front of the unit.

3. Rotate vaccine every week and when a new shipment comes in so newer vaccines are

stored toward the back of the unit, while those soonest to expire are stored in the

front.

4. It is recommended to only open only one box of vaccine of a particular vaccine at a

time to control vaccine use and allow easier inventory control.

5. In routine clinics, vaccines should be prepared immediately prior to administration.

CDC strongly recommends NOT pre-drawing vaccine doses before they are needed.

6. Vaccines are inventoried monthly. Order and stock only enough vaccines to ensure

there is an adequate supply to meet patient needs.

a. An adequate supply for most facilities would normally be enough vaccines to last

60 days, with re-ordering threshold of 30 days.

b. Smaller, more frequent orders rather than large orders should occur to minimize

the amount of vaccine loss if an incident occurs during shipment or in the vaccine

storage unit and to reduce the risk of expiry.

c. If a provider demonstrates waste of vaccine single component vaccine that is

contained in a combination vaccine, the SC DHEC Division of Immunization will

reduce or cut orders for combination vaccines.

7. SC DHEC Division of Immunization will be notified 3 months before a vaccine will

expire if vaccine will not be used by the expiration date. Providers should use all


of 21 DHEC 1225 (Rev. 7/2018)

vaccine that is ordered for their site before expiration and ensure that over ordering

does not occur.

8. Short dated exchange of vaccine is allowed to reduce waste in the program. Please

see section IV below, Borrowing of Pediatric Vaccine, for more information.

III. Ordering and Receiving:

A. The vaccine in this practice will be ordered and received according to the following:

1. Inventory will be taken monthly to determine what vaccines are needed in order to maintain

approximately a 60 day supply.

2. VFC vaccine will be ordered on the Federal Vaccines For Children (VFC) Order form

(DHEC 1117). State vaccine will be ordered on the State Childhood Vaccine Program Order

Form (DHEC 0713). These forms will be completed and faxed to SC DHEC Division of

Immunization at 803-898-0318 in order to request vaccine. Providers enrolled in the State

Vaccine Program must submit order forms for both the VFC Program and the State Vaccine

Program with completed inventories for both programs for every vaccine order. Health

Departments order VFC vaccine on the Childhood Vaccine Programs: VFC Order Form (DHEC

1130) and State vaccine on the Childhood Vaccine Program: State and 317 Order Form (DHEC

0711).

3. Partially completed order forms may be returned, which could delay shipping of vaccines.

Vaccine doses used will not be automatically replaced in the next order; the provider must enter

the number of doses desired. The VFC Program may modify the provider’s vaccine order, as

needed to manage vaccine supply.

4. If a provider wishes to switch from one brand of vaccine to another (example from ActHib®

to Pedvax Hib®), they must submit the request in writing. A signed statement on the letterhead

of the facility indicating which brand of vaccine the site would like to begin ordering should be

submitted along with their order with the request of the new brand(s). The site is expected to

deplete the old brand of vaccine before using the new brand.

5. Alert reception staff to be ready to receive vaccine shipment on arrival.

6. Arrange for vaccine deliveries to be made only when the primary vaccine coordinator or back

up vaccine coordinator is on duty. This can be completed by adjusting the days/times your site

receives vaccine shipments in SCIAPPS on the DHEC 1145, VFC Provider Profile Form.

Consider holidays, vacations, staff schedules, and changes in hours of operation when

designating vaccine delivery date and time.

7. Appropriate staff must be on site to receive vaccine shipments at least one day a week other

than Monday, and for at least four consecutive hours on that day.

8. All staff members (including non-medical staff, e.g., receptionists and other front

desk personnel) who accept vaccine deliveries must be aware of the importance of maintaining

the vaccine cold chain and the need to immediately notify the primary vaccine coordinator or

back up vaccine coordinator of the arrival of the vaccine shipment so that it can be handled and

stored appropriately.

9. Once delivery has arrived, the primary vaccine coordinator, back up vaccine coordinator, or

designated backup person will be notified immediately.

10. Upon receiving a vaccine shipment, providers must:

Open vaccine packages immediately

Inspect the vaccine and packaging for damage

https://www.scdhec.gov/Apps/Health/SCIAPPS/


of 21 DHEC 1225 (Rev. 7/2018)

Compare the vaccine received with the vaccine products that appear on the pack list and

what was ordered by your site and approved by SC DHEC.

Immediately store vaccine at appropriate temperatures

Check the temperature readings (shipments from McKesson only)

If the McKesson vaccine shipment appears to be compromised or there is a problem with

temperature monitors, the provider must contact SC DHEC Division of Immunization

immediately to report the event. If the temperature monitor is out of range, McKesson

will be contacted by calling 1-877-836-7123 on the same day the vaccine arrives.

Determine length of time the vaccine was in transit (shipments of frozen vaccine only).

If the frozen vaccine appears to be compromised upon arrival, providers must contact SC

DHEC Division of Immunization immediately to report the event. The manufacturer will

also need to be contacted for replacement and return.

11. Varicella containing vaccines are directly shipped from the manufacturer (Merck) to the

provider office. It is packed for shipping with frozen gel packs as refrigerant in the shipping

containers. Large shipping containers will maintain appropriate temperatures for 4 days. Small

shipping containers will maintain appropriate temperatures for 2 days. ProQuad® (MMR-V)

shipping containers will maintain appropriate temperatures for 1 day. Sites will need to check the

shipper insert supplied in the box to verify if the shipping container is approved for one day, two

day, or four days. PLEASE NOTE: If the container is received after the four-day shipping time

period for the large shipper, after the two-day shipping time period for the small shipper, or after

one day shipping time period for ProQuad® (MMR-V), contact the Merck Order Management

Center immediately for replacement (1-800-637-2590) and report the event to the SC DHEC

Division of Immunization (DO NOT USE VACCINE).

12. Packing slip/Invoice will be cross-checked with vaccines shipped and vaccines ordered.

Check shipment for diluent, if applicable, and match dose-for-dose with appropriate vaccine.

SC DHEC Division of Immunizations (803-898-0460) will be notified immediately if there is

a discrepancy found or a problem with cold chain while being shipped. Packing List/Invoice will

be retained in a file for 3 years.

13. Check the vaccine expiration dates to ensure that you have not received any vaccines or

diluents that have already expired or will expire soon.

14. After the vaccine shipment has been checked according to the procedures described in this

section, immediately store the vaccines and diluents at the recommended temperatures. Do not

leave the shipment unattended. The vaccines inside might warm to inappropriate temperatures

and become unusable. All staff who accept packages for the facility must be aware that vaccine

shipments require immediate attention. Staff who do not routinely handle vaccines but who

accept vaccine shipments should alert the primary vaccine coordinator (or the back-up vaccine

coordinator/designated alternate coordinator) as soon as vaccine shipments arrive so that they

can be stored properly.

IV. Borrowing of Pediatric Vaccine

PRIOR APPROVAL IS REQUIRED

Borrowing and replacement of vaccines requires approval by the VFC program.

For approval call the Immunization Division at 803-898-0460 or email the VFC

Program at [email protected].

mailto:[email protected]


of 21 DHEC 1225 (Rev. 7/2018)

The Vaccine For Children (VFC) Borrowing Report (DHEC 1167) must be completed

when either: Non-VFC purchased (Private stock/SC State stock) vaccine is

administered to a VFC-eligible child, or VFC vaccine is administered to a Non-VFC

eligible child (private or SC State).

VFC-enrolled providers are expected to manage and maintain an adequate inventory

of vaccine for both their VFC and Non-VFC-eligible patients.

Planned borrowing of VFC vaccine including the use of VFC vaccine as a

replacement system for a provider’s privately purchased vaccine inventory is NOT

permissible. VFC- enrolled providers must ensure borrowing VFC vaccine will not

prevent a VFC- eligible child from receiving a needed vaccination.

Borrowing of vaccine may occur to prevent vaccine loss due to expiring vaccine.

This two way exchange can be used by a VFC-enrolled provider with a patient

population that is mostly VFC-eligible. This means the provider has a small number

(ten or less) of Non-VFC (state eligible and/or privately insured) children. Non-VFC

vaccine that is short-dated may be administered to a VFC-eligible child, and the dose

replaced with a longer-dated VFC dose.

Infrequent exchanging between VFC and Non-VFC stock of a short dated vaccine

dose must follow the parameters listed below:

The provider serves a small number of private pay patients,

The dose is one month from expiration,

Or the dose of vaccine cannot be used for the population it is intended for prior to

the expiration date.

Other RARE Unplanned borrowing reasons: Borrowing between VFC and Non-VFC stock is permitted if:

Lack of Non-VFC stock due to unexpected circumstances, such as delayed

vaccine shipment,

Vaccine spoiled in-transit to provider, or

New staff that calculated ordering time incorrectly

The reason cannot be that a provider planned vaccine borrowing from either the

Non-VFC stock, or the VFC stock.

VFC Provider must keep the invoice (shipping labels) for review by Immunization Division field representatives to verify exchange. This will ensure that the inventory is made whole.

Unintentional Retrieval ofVaccine:

Provider staff who unintentionally retrieved the wrong vaccine stock type to

administer to a patient must report it on the VFC Vaccine Borrowing

report (DHEC 1167) using the appropriate code as indicated on the form.

NOTE: Inventory must be rotated to ensure that the shortest dated vaccine is used first.

VFC or SC State vaccine with short expiration dates (expiring within 3 months)


of 21 DHEC 1225 (Rev. 7/2018)

should be reported to the VFC program, if the provider site does not anticipate using

these short- dated vaccines before they expire.

VFC BORROWING EXCEPTION:

SEASONAL INFLUENZA VACCINE BORROWING REPORT (DHEC 3226)

For seasonal influenza vaccine, providers may use PRIVATE-STOCK seasonal

influenza vaccine to vaccinate VFC/STATE eligible children IF VFC seasonal

influenza stock is not yet AVAILABLE. Those PRIVATE STOCK doses used on

VFC/STATE eligible children can later be replaced when VFC/STATE influenza stock

becomes available. This ONE-DIRECTIONAL (private to VFC/STATE) borrowing

exception is unique to seasonal influenza vaccine only.

VFC providers who borrow seasonal influenza vaccine must accept the VFC

presentation allocated for replacement of private stock vaccines.

ALL vaccine stock types (VFC, STATE*, and PRIVATELY PURCHASED) must be

labeled and separated within the vaccine storage unit for easy identification by

provider staff member, as well as Immunization Division field representatives.

*State Vaccine is only supplied to sites enrolled in the SC State Vaccine

Program.

V. Wastage and Return of Non-Viable Vaccines

A. The vaccine in this practice will be wasted or returned to the distributor (if appropriate)

according to the following:

1. Expired vaccine will be removed from the storage unit once it has expired and labeled as “DO

NOT USE.”

2. All non-viable vaccine (includes spoiled, doses drawn up but not administered,

dropped/broken vials, lost vials, expired, and recalled vaccine) will be reported to SC DHEC

Division of Immunization (800-277-4687 or 803-898-0460).

3. Instructions will be given by SC DHEC for disposal or return of non-viable vaccine.

4. A Vaccine Wastage and Return Form (DHEC 1209) will be completed and faxed to SC

DHEC Division of Immunization at 803-898-0318. This form will be retained for 3 yrs.

5. If instructed to return vaccine to McKesson, a UPS return label will be e-mailed to the

primary vaccine coordinator of the provider office. The non-viable, returnable vaccine along

with a copy of the wastage report will be packaged properly and sent back to McKesson.

Vaccine must be returned to McKesson within one month of reporting the event to SC DHEC

Division of Immunization. If two weeks have lapsed and a return label has not been received,

please contact the SC DHEC Division of Immunization at (800-277-4687 or 803-898-0460).

Expired vaccine must be reported to the program and the return to McKesson completed within 6

months of the vaccine expiring.

VI. Inappropriate Vaccine Storage Conditions / Storage and Handling Events


of 21 DHEC 1225 (Rev. 7/2018)

A. Out of range temperatures (temperatures excursions):

1. If out-of-range temperatures are found, immediate corrective action will take place.

2. Quarantine vaccine and label as “DO NOT USE”.

3. Place vaccine in a unit where it can be stored under proper conditions.

4. Report the excursion to SC DHEC Division of Immunization at 800-277-4687 or 803-898-

0460. Do not leave voice mails when reporting storage and handling events.

5. Contact the vaccine manufacturer to determine if vaccine potency has been compromised. See

page 3 for contact information.

6. Excursion and actions taken will be documented on the Vaccine Storage Troubleshooting

Record” section of the DHEC 3266 or DHEC 3265 (appropriate Refrigerator or Freezer

Temperature Log).

7. Temperatures and duration of event must be monitored and vaccines should not be discarded

or administered until the situation has been discussed with SC DHEC Division of Immunization.

DO NOT PRESUME THAT THE VACCINE HAS BEEN COMPROMISED.

B. Power Outages:

1. In any type of power outage: Freezers and refrigerators should not be opened until power is

restored, except to transport vaccine to an alternative storage location.

C. If refrigerator temperature is too warm:

1. Immediately label affected vaccines as “Do Not Use” and report the event to SC DHEC

Division of Immunization at 800-277-4687 or 803-898-0460. Do not leave voice mails when

reporting storage and handling events.

2. Contact the vaccine manufacturer to determine if vaccine potency has been compromised.

3. Do not presume that the vaccine has been compromised.

D. If refrigerator temperature is too cold:






E. If freezer temperature is too warm:






F. If MMRV, varicella, or shingles vaccine(s) have been placed in the refrigerator:

1. Label the affected vaccine(s) as “Do Not Use” and place in the freezer unit.

2. Contact SC DHEC Division of Immunization at 800-277-4687 or 803-898-0460 to report the

excursion. Do not leave voice mails when reporting storage and handling events.




of 21 DHEC 1225 (Rev. 7/2018)

G. If HPV, MMR, MMRV, rotavirus, varicella, IIV*, and/or MCV* vaccines have been

exposed to light:

1. Return the vaccine to a dark environment at the appropriate storage temperature and record

the length of time the vaccine may have been exposed.

2. Contact SC DHEC Division of Immunization at 800-277-4687 or 803-898-0460 to report the

excursion. Do not leave voice mails when reporting storage and handling events.



5. *See Storage and Handling Requirements for Specific Vaccines for specific brands.

H. Store all potentially compromised vaccines under appropriate conditions in a properly

functioning vaccine storage unit until the integrity of the vaccine is determined. If your vaccine

storage unit is not maintaining the appropriate storage conditions, it may be necessary to

activate your Disaster Recovery Plan.

Part B: Disaster Recovery Plan

I. General Information

A. Purpose

The purpose of the Disaster Recovery Plan is to offer guidance for protecting your vaccine in the

event of a refrigerator or freezer malfunction due to mechanical failure, power failure, natural

disaster, or other emergencies that might compromise appropriate vaccine storage conditions.

B. Location

The completed Disaster Recovery Plan is required to be posted on or near the vaccine storage

equipment.

C. Education

Ensure that all staff (current and new) read the plan and understand it. Staff that are required

to transport vaccine in an emergency are to be trained on emergency transport and following

the site's Disaster Recovery Plan. Please complete the Education and Training

Responsibilities of Vaccine Coordinators at Provider Sites table on page 2. Also ensure

that janitorial and security staff are aware of the plan and know the procedures to follow for

notifying designated personnel about any problems with the vaccine storage equipment.

D. Review

Review and update the contact lists in the plan quarterly; review and update the entire plan annually.

E. Contact

SC DHEC for questions regarding vaccine transportation or stability at 800-277-4687 or

803-898-0460.


of 21 DHEC 1225 (Rev. 7/2018)

II. Content

A. The Disaster Recovery Plan for this practice contains the following:

1. Name of person(s) responsible for preparing and transporting vaccine in the event of

an emergency, including contact information.

2. Location that will receive the vaccine.

3. Receiving location will be notified of transport.

4. Sources for packing materials and certified, calibrated DDLs.

5. How to pack vaccine for transport.

6. How to document the steps taken when vaccine is involved in a power or equipment

failure.

7. Identification of an alternative storage facility (i.e. hospital, fire department, etc) with

back-up power (generator) where the vaccine can be properly stored and monitored for

the interim.

8. Provide training for staff regarding the proper way to transport vaccine.

9. Ensure the availability of staff to pack and move the vaccine.

10. Maintain the appropriate packing materials (coolers, water bottles, frozen water

bottles, frozen coolant packs, etc.).

11. Ensure a means of transport for the vaccine to the secure storage facility.

12. Store water bottles in the floor, top shelf, and in door racks of refrigerator and place

water bottles and frozen coolant packs along walls, back and bottom of freezer and inside

door racks. In the event that your refrigerator/freezer is out of order, this practice will

help maintain the temperature for a longer period of time.

NOTE: Whenever possible, facilities should suspend vaccination activities BEFORE the

onset of emergency conditions to allow sufficient time for packing and transporting

vaccine.

III. Vaccine Packing for Emergency TransportA. Refrigerated vaccines:

1. CDC recommends transport with a portable refrigerator unit.

2. If this type of unit is not available, a hard-sided insulated cooler or Styrofoam™

vaccine shipping containers may be used if they can maintain the recommended

temperature range (between 36°F and 46°F [2°C and 8°C]).

3. CDC requires using a DDL with continuous monitoring and recording capabilities.

4. Pack refrigerated vaccines before packing frozen vaccines as indicated here:

a. Line bottom of the cooler with a single layer of “conditioned” water bottles.

Conditioned water bottles are 16.9 oz or 8 oz (depending on size of cooler) water

bottles that have been frozen in a freezer. The water bottles are “conditioned” by

placing them in a sink filled with several inches of cool or lukewarm water until

you see a layer of water forming near the surface of bottle. The bottle is properly

conditioned if ice block inside spins freely when rotated in your hand. Dry each

bottle before placing in cooler.

b. Place 1 sheet of corrugated cardboard over water bottles to cover them

completely. Do not use vaccine coolant packs from original vaccine shipping

containers. These can freeze and damage refrigerated vaccine.


of 21 DHEC 1225 (Rev. 7/2018)

c. Place a layer of insulating material such as bubble wrap, packing foam or

Styrofoam™ on top. This layer much be at least 1 in. thick and must cover

cardboard completely.

d. Stack boxes of refrigerated vaccine and diluent on top of insulating material in

the transport container.

e. When cooler is halfway full, place a certified, calibrated DDL with a buffered

probe in center of vaccine. Probes should be pre-chilled for at least 5 hours in

refrigerator. Keep the DDL’s display outside of cooler until finished loading. As

these devices are NOT waterproof.

f. Add remaining vaccines and diluents to cooler, covering DDL probe.

g. Cover vaccines with another 1 in. layer of insulating material such as bubble

wrap, packing foam or Styrofoam™.

h. Place another sheet of corrugated cardboard over insulating material if needed

to support top layer of water bottles.

i. Fill the remaining space in the cooler with an additional layer of conditioned

frozen water bottles along with an inventory list of the vaccines in the container.

j. Close the lid and attach the DDL’s display and temperature log to the top of the

lid of the cooler. Ensure the transport container’s temperature is between 36°F

and 46°F [2°C and 8°C]

k. When a multi-dose vial is used, Food and Drug Administration (FDA)

regulations require that it only be used in the facility where it was first opened.

Only if absolutely necessary, a partially used vial may be transported to or from

an off-site facility operated by the same provider, as long as the vaccine cold

chain is properly maintained. However, a partially used vial may not be

transferred to another provider or transported across state lines.

l. Attach label to outside of container to clearly identify contents as vaccines.

m. Document the following information:

i. Time/temperature of refrigerator storage unit temperature at the time the

vaccine is removed for transport.

ii. Time/temperature of insulated container at end of transport.

iii. Time/temperature of refrigerator storage unit at alternate vaccine

storage facility upon receipt of vaccine(s).

iv. If the vaccine will be in transport for longer than one hour, hourly

temperatures will need to be recorded during transport.

B. Frozen vaccines:

1. Transport of frozen vaccines is not recommended.

2. If frozen vaccines must be transported, the CDC recommends transport with a

portable freezer that maintains a temperature between –58°F and +5°F (–50°C and –

15°C). Any portable freezer used to transport vaccine in a frozen state must be used

according to specific manufacturer’s instructions for maintaining appropriate freezer

temperature during transport.

3. Portable freezers may be available for rent in some areas.

4. CDC requires using a DDL with continuous monitoring and recording capabilities.

5. Pack frozen vaccines for frozen transport as indicated here:


of 21 DHEC 1225 (Rev. 7/2018)

a. Use the same packing layers as noted above for packing refrigerated vaccine

with either phase change materials or conditioned water bottles16.9 oz or 8 oz

(depending on size of cooler) water bottles that have been frozen in a freezer.

b. Place a certified, calibrated DDL with a buffered probe in the container used

for transport as close as possible to the vaccines. As these devices are NOT

waterproof.

c. The phase change materials or conditioned water bottles are 16.9 oz or 8 oz

(depending on size of cooler) water bottles that have been frozen in a freezer. Do

NOT use dry ice.

d. Ensure the transport container is between –58°F and +5°F (–50°C and –15°C)

before placing the frozen vaccine in the transport container.

e. If transporting frozen vaccine under frozen conditions, the following

information must be documented:

i. Time/temperature of freezer storage unit temperature at the time the

vaccine is removed for transport and placed in the container.


iii. Time/temperature of freezer storage unit at alternate vaccine storage

facility upon receipt of vaccine(s).

5. If varicella-containing vaccine must be transported and a portable freezer unit is not

available, the vaccine may be transported under refrigerated conditions for up to 72

continuous hours prior to reconstitution. Immediately upon arrival at the alternate storage

facility, place the varicella-containing vaccine in the freezer between -58ºF and +5ºF

(-50ºC and -15ºC). Contact the manufacturer (Merck, 1-800-672-6372) for guidance

regarding vaccine use and stability as transporting frozen vaccines under refrigerated

conditions is an excursion.

6. Pack frozen vaccines for refrigerated transport as indicated here:

a. Refrigerated and frozen vaccines can be transported together in the same

container as long as there is adequate space.

b. Frozen vaccines should be separated from refrigerated vaccines. This can be

accomplished by placing rubber bands around the separate vaccines.

c. Use the same packing layers as noted above for refrigerated vaccine.

d. Place a certified, calibrated DDL with a buffered probe in the container used

for transport as close as possible to the vaccines.

e. Ensure the transport container’s temperature is between 36°F and 46°F [2°C

and 8°C] before placing the refrigerated vaccine in the transport container.

f. Insulating material (e.g., bubble wrap) should be placed around the refrigerated

vaccines to protect them from being exposed to freezing temperatures.

g. Contact the vaccine manufacturer (Merck, 1-800-672-6372) immediately upon

arrival at the alternate storage facility for further guidance.

h. Do NOT discard the vaccines without contacting the manufacturer or the VFC

Program for guidance.

i. If transporting frozen vaccine under refrigerated conditions, the following

information must be documented:

i. Time/temperature of freezer storage unit temperature at the time the

vaccine is removed for transport and placed in the container.



of 21 DHEC 1225 (Rev. 7/2018)

iii. Time/temperature of freezer storage unit at alternate vaccine storage

facility upon receipt of vaccine(s).

iv. Recommendation from Merck on stability and use of the vaccine after

the transport.

C. Protocol for transporting vaccine to and from alternate vaccine storage facility

(follow pre-arranged plan)

1. How to load transportation vehicle. Transport vaccine in the passenger

compartment of the vehicle, NOT in the trunk.

2. Vaccines are to be attended at all times during transport and delivered directly to the

alternate vaccine storage facility.

3. Routes to take (alternative routes if necessary).

4. Time enroute.

5. Ensure vaccine containers are promptly unpacked and stored properly in the

emergency storage facility. (Placed within appropriate storage unit, adequate circulation,

functioning temperature monitoring devices, etc.).

6. Contact VFC Program before transfer of vaccine back to original storage facility

and submit completed Vaccine Transfer Form (DHEC 1208).

7. Contact the vaccine manufacturer (1-800-672-6372) immediately upon arrival

at the alternate storage facility for further guidance when transporting frozen vaccine

under refrigerated conditions. Do NOT discard any vaccines without contacting the

manufacturer and the VFC Program for guidance.

D. Packing Diluents

1. Diluents should be transported with their corresponding vaccines to ensure that there

are always equal numbers of vaccine vials and diluent vials for reconstitution.

2. Diluents that do not contain antigen can be transported at room temperature or at

refrigerator temperature.

3. Diluents that contain antigen (e.g., DTaPIPV diluent used with Hib lyophilized

vaccine) should be transported with their corresponding vaccines at refrigerator

temperature.

4. NEVER transport any diluents at freezer temperature because the vials could crack, or

in some cases, the diluents may contain vaccine antigen.

5. Place an insulating barrier between the diluents and water bottles because of the

potential for freezing.

6. If any diluents that have been stored at room temperature are to be transported in the

container with refrigerated vaccines, refrigerate the diluents in advance so they will not

increase the temperature in the shipping container.

IV. Vaccine Storage FacilitiesA. Entering vaccine storage facilities: Describe how to enter the building and vaccine storage

spaces in an emergency if practice is closed or after hours.Include a floor diagram and locations of

the following:Unit # Location and

Description

Category

(Refrigerator/

Freezer)

Grade of Unit

(Household,

Commercial,

Pharmaceutical)

Type

(Stand-

Alone,

Combined)

Make

(GE, Sub-

zero,

Amana)

Contains

Varicella?

(Yes or No)

Active/

Inactive

(Currently

Used)?

1


of 21 DHEC 1225 (Rev. 7/2018)

2

3

4

5

Items and location listed below must correlate or match the floor diagram submitted. Item Location(s)

Doors

Flash Lights

Spare Batteries

Light Switches

Keys

Locks

Alarms

Circuit Breakers

Packing Materials

B. Alternative storage facility(s) with a back-up generator

1. Arrangements must be made to store your vaccine at an alternative storage facility with a

backup generator when the following conditions occur:

a. When severe weather conditions (i.e. tornadoes, hurricanes, major ice/snow storms) are

predicted.

b. When your vaccine storage equipment cannot be repaired, or when the power cannot

be restored before the temperature in your vaccine storage unit rises above the

recommended ranges.

c. Before moving your vaccine, call the alternative storage facility location to ensure

their back-up generator is operational, if necessary.

d. Examples of appropriate alternative storage sites include local hospitals, retirement

homes, fire stations, pharmacies, or another practice.

Indicate your alternate vaccine storage facilities here (Must list at least two sites that can

receive vaccine):

Alternate Facility Point of Contact Work Phone Ext Emergency Phone Ext


of 21 DHEC 1225 (Rev. 7/2018)

SOUTH CAROLINA DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL

Vaccine Management and Disaster Recovery Plan

Instructions for Completing

Purpose: The purpose of the Vaccine Management and Disaster Recovery Plan is to provide a template for

development of a comprehensive vaccine management plan for protection and maintenance of

your practice’s vaccine supply.

Item-By-Item Instructions: 1. Provider will enter identifying information.

2. Provider will enter Provider PIN number, as applicable.

3. Provider review, update and sign this form annually.

4. Provider will complete contact information for the facility, alternate facility, and

complete all requested information under parts A and B.

Office Mechanics and Filing: 1. Upon completion, the provider will retain current version and also post a copy on the

vaccine storage unit(s). A copy must be sent as part of annual re-enrollment to the DHEC

Division of Immunization annually.

2. Plan should be updated as necessary.

3. Previously completed plans should be retained for three (3) years.

4. Form Retention:

-VFC & STATE Vaccine providers: retain the original form for (3) three years as

required by the Federal Immunization Program.

-DHEC Immunization Program: retain providers' copies for (3) three years as required by

the Federal Immunization Program.

-Contracting Parties under a DHEC Memorandum of Agreement (MOA) for Adult

Vaccines: Both Provider and DHEC must retain the original/copy for (6) six years.

south carolina vaccine management and disaster recovery plan · south carolina department of health...

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