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Vaccine Storage and Handling Keeping Vaccines Viable

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Title: Vaccine Storage and Handling Keeping Vaccines Viable


1
Vaccine Storage and HandlingKeeping Vaccines
Viable
I am so happy because my parents made sure I was
vaccinated by a wonderful vaccine provider in
North Carolina!
Mary Ivers Vaccines for Children Site Visit
Coordinator 2009 North Carolina State
Immunization Conference
2
North Carolina
3
Session Objectives
  • Describing the basics of vaccine storage and
    handling
  • Understanding how to handle storage and handling
    mishaps

4
Introduction
It is all about teamwork boys!!!. Hey, I am
starting to slip move to the left just a
little.
  • Controlling the spread of infectious disease
  • Maintaining the cold chain
  • Basic elements
  • Personnel
  • Standard Operating Procedures
  • Equipment

5
Revaccination due to Non Viable Vaccine
6
Administer Viable Vaccine
Im only smiling because you tickled me. Wait
until you give me the shot then you will know
the size of my lungs!
7
Vaccine Preventable Diseases
  • Tetanus
  • Haemophilus influenzae type b
  • Chickenpox
  • Polio
  • Whooping Cough

8
Vaccines Cold Chain
9
Personnel
  • Designated in charge (requirement)
  • Back-up person (requirement)
  • All staff who handle vaccine

10
Minimum Required Ordering Handling and Storage
Procedures
11
Standard Operating Procedures
Written Procedures (requirement)
What did you say? Written procedures?
Dudeleave me alone, I know there is a juicy bone
in here somewhere. Yummy! I wish my legs were
longer so I could reach the cheesecake on the
next shelf!
  • Minimum Required Ordering Handling and Storage
    Procedures
  • Designation of primary vaccine coordinator and at
    least one back-up staff

12
Standard Operating Procedures
  • Proper vaccine storage and handling
  • Vaccine shipping (includes receiving,
    transport)

We keep our Written Procedures in a notebook next
to the refrigerator for easy access.
13
Standard Operating Procedures
  • Procedures for vaccine relocation
  • Disaster Recovery Plan
  • Power failure
  • Mechanical difficulty
  • Emergency situation
  • Review update annually
  • Update when there is a change in responsible staff

14
Standard Operating Procedures
Where did I put that thermometer?
  • Vaccine ordering
  • Inventory control (e.g. stock rotation)
  • Vaccine wastage
  • Provide training to all staff

15
Vaccine Wastage Due to Improper Storage
16
Vaccine Storage Equipment Recommendations
17
Vaccine Storage Equipment
Purpose Built Refrigerators/Freezers
  • Maintains temperature
  • More usable space
  • Built-in temperature gauge
  • Alarms
  • Self closing/glass doors
  • Wheels

18
Vaccine Storage Equipment
Purpose Built Refrigerators/Freezers
Stand-alone freezer
19
Vaccines are expensive!!
  • HPV vaccine 105.58
  • PCV7 71.04
  • Tdap 30.75
  • Average inventory 25,000.00

20
Vaccine Storage Equipment
Purpose Built Refrigerators/Freezers
21
Vaccine Storage Equipment
Purpose Built Refrigerators/Freezers
Upright Combination Refrigerator Freezer
Under the counter style
22
Vaccine Storage Equipment
23
Vaccine Storage Equipment
36
thermometer
24
Vaccine Storage Equipment
This is an improper way to store vaccine. There
are many reasons why this is unacceptable but the
main reason is improper/poor air circulation.
This provider will be required to purchase
additional refrigerator space to allow air
circulation.
  • Problems with Household Combination
  • For food/ beverage storage
  • Temperature fluctuations
  • Inadequate usable space

25
Vaccine Storage Equipment
Who stuffed me in this cup? There is not enough
air circulation in here!
  • Problems with Household Combination
  • Numerous vaccines
  • Prefilled packaging
  • Inventory issues
  • Financially responsible
  • Separate temperature controls
  • (recommendation)

26
Vaccine Storage Equipment
  • Phase out interior freezer by 12/31/2009
    (requirement)
  • Any size unit with interior freezer
  • Day storage only
  • Temperatures 2 X daily

Phase out units with interior freezers,
regardless of size. This is effective December
31, 2009 (requirement)
27
Vaccine Storage Equipment
  • National Institute of Standards and Technology
    (NIST) certified and calibrated thermometers
    (requirement)

Graph style
Digital style
Liquid or Crystal style
Examples of certificates showing thermometer was
certified in accordance with NIST standards
28
Preventive Measures
  • Separate temperature controls (recommendation)
  • Plug guard or safety-lock plug (recommendation)
  • Post a warning sign above the plug and on the
    refrigerator (requirement)
  • Label fuses and circuit breakers (requirement)
  • Install a temperature alarm (recommendation)

29
Preventive Measures
Refrigerator/Freezer Lock
Clock/plug style
Penny in a cup
30
Preventive Measures
31
Vaccine Storage Practices
I am stuck again but it is worth it because I
know there is some tuna in here somewhere!!
  • Household units must meet required specifications
    (requirement)
  • Remove vegetable bins

32
Vaccine Storage Practices
  • Extra space filled with bottles of water
    (requirement)
  • Store vaccine in middle of the compartment, away
    from the walls and coils, and off the floor
    (requirement)
  • Never store vaccines in the door of the
    refrigerator (requirement)

33
Vaccine Storage Practices
  • Cold packs in the freezer (requirement)
  • Never store vaccines in the door of the freezer
    (requirement)

NOTE Gel packs in the refrigerator do not help
stabilize temperatures.
34
Vaccine Storage Practices
  • Thermometer and vaccine on the same shelf
    (requirement)
  • Open vials in a tray

35
Vaccine Storage Practices
  • Store vaccine by type and expiration date
    (requirement)
  • Proper air circulation (requirement)
  • No food/sodas with vaccine (requirement)

Hey what is food doing in the vaccine
refrigerator? Oh wow!!!! My favorite tuna
salad!!!
36
Vaccine Storage Practices
  • Best practice no patient specimens

Thank you for protecting the vaccine supply so
the vaccines I receive are safe.
My chin feels wet am I drooling again? Grandma
wipe my chin.
Wow, am I tired. All this thinking is wearing me
out. I am ready for a nap NOW!
I love you Grandma!!! Grandma, you are way to
young to be a grandmother.
37
Vaccine Storage Practices
Diluents
Water Bottles
Water Bottles
Diluents
38
Vaccine Ordering and Inventory Management
  • Rotate by expiration date (requirement)

Someone is going to have to help me! My paws are
not big enough to rotate the vaccine!!
39
Vaccine Ordering and Inventory Management
  • Never use outdated vaccines
  • Distinguish between public/private (requirement)
  • Use specific diluents
  • Multi-dose products until expiration date
    (requirement)
  • Expiration dates month/year (last day month)
    (requirement)

40
Vaccine Ordering and Inventory Management
  • Label shelves/trays
  • Mark multi-dose vials
  • Date open
  • Doses used

41
Vaccine Preparation
I am so happy you read the package insert before
you gave me that shot. My leg still hurts from
the last one.
  • Never leave vaccine out when not in use
    (requirement)
  • Read the package insert

42
Vaccine Preparation
  • Do not pre-draw vaccine, draw vaccine at the time
    of administration (requirement)

Hello, my name is Alexander and I just started
1st grade. My Mom says it is important not to
draw vaccine until you are ready to administer
it! How do I know my Mom is right? Because my
Mom works with the NCIR and is really, really,
really smart.
43
Vaccine Preparation
  • Frozen Vaccine
  • Store diluents separately at room temperature or
    refrigerator

44
Vaccine Preparation
  • Frozen Vaccine
  • Do not reconstitute until ready to administer
  • Never freeze reconstituted vaccine

45
Temperature Monitoring
  • Refrigerator temperature (requirement)
  • 2 Celsius (C) to 8 C (36 F to 46 F)
  • Optimum of 5 C (40 F)
  • Report/document out of range
  • 0 C (out of range)
  • 1 C (out of range)
  • 8.1 C (out of range)

2 C to 8 C (36 F to 46F)
46
Temperature Monitoring
  • Freezer temperature (requirement)
  • (-)15 C (5 F) or colder
  • Optimum of -20 C (-4 F)
  • Report/document out of range
  • -14 C (out of range)
  • -13 C (out of range)

47
Temperature Monitoring
  • Check and record temperatures twice a day
    (requirement)
  • Read and record
  • First thing in the AM
  • Last thing in the PM
  • Maintain proper temperatures (requirement)

48
Temperature Monitoring
  • Check doors to ensure they are closed at the end
    of each day

I told you to always make sure the barn door was
closed at night. Now look what happened I had
kittens!
49
Vaccine Shipments
  • Shipments
  • Hours of clinic
  • Alert all staff

Post your vaccine order for everyone to see!
50
Vaccine Shipments
  • Receiving vaccine (requirement)
  • Develop and post protocol
  • Open vaccine box immediately
  • Check invoice against vaccine received

Match invoice to vaccine received
51
Vaccine Shipments
  • Receiving vaccine (requirement)
  • Refrigerate immediately
  • Shipment problems call immediately

52
Storage and Handling Mishaps
Open Door
Unplugged
53
Report Mishaps
I am so embarrassed. I do not want to call for
help!!!
If you cannot see me then I am not in trouble!
54
Do Not Assume the Worst
Oh my, I do not want anyone to know what
happened!
55
The Help Desk is waiting for your call!
Please call me! I miss hearing from you!
56
Storage and Handling Mishaps
  • Requirements
  • Record the temperatures
  • Transfer vaccine to a working unit
  • Mark Do Not Use

57
Storage and Handling Mishaps
  • Requirements
  • Report all mishaps
  • Do not assume the worst
  • Call the Help Desk

58
Disaster Recovery Plan
The cleaning crew unplugged me by mistake!
  • Requirement
  • Train staff
  • Designate person
  • List back-up systems
  • Post Disaster Recovery Plan

59
Post the Disaster Recovery Plan
  • Update yearly (requirement)

60
Disaster Recovery Plan
  • Back-up generator
  • Test quarterly
  • Annual maintenance

61
Safety 1st Do Not Take Risks
62
Disaster Recovery Plan in Action
  • Conduct an inventory

63
Transporting Vaccine
  • Package vaccine to transport (requirement)
  • Use insulated container
  • Protect vaccines from gel packs
  • Keep refrigerated vaccine container in the car

64
Transporting Vaccine
  • Package vaccine to transport (requirement)
  • Put containers with dry ice in the trunk

Wear goggles, thick gloves, and suitable clothing
(long sleeves) to minimize the risk of skin
contact with dry ice.
65
Site Visit Requirements
  • Appropriate Refrigerator/Freezer
  • Distinguish private/state
  • Biological specimens
  • Jugs of water refrigerator
  • Ice packs - freezer
  • Certified calibrated thermometer (middle with
    vaccine)

66
Site Visit Requirements
  • Appropriate Refrigerator/Freezer
  • No food
  • Vaccine not in door
  • Proper air circulation
  • MMR in the freezer
  • Properly rotate vaccine
  • Do not pre-draw
  • DO NOT DISCONNECT signs on the outlet and
    circuit breaker

67
Site Visit Requirements
  • Temperatures log
  • Checked and documented in a.m. p.m.
  • Temperatures maintained
  • Written documentation of action taken

68
Site Visit Requirements
  • Vaccine Inventory
  • Physical inventory 1X month
  • Reconcile inventory
  • Record vaccine at time of administration
  • Report transactions
  • Transfers
  • Wasted
  • Expired

69
Site Visit Requirements
  • Vaccine Information Statements (VIS)
  • Current
  • Provide at each encounter

70
Site Visit Requirements
  • Vaccine Administration
  • Administration fee(s) to non-Medicaid VFC
    eligible patients
  • Patient is unable to pay administration fee
  • Office fee for an immunization only visit
  • Prerequisite (i.e. physical exam) prior to an
    immunization only visit

71
Site Visit Requirements Vaccine Schedule
72
Site Visit Requirements Vaccine Schedule
73
Site Visit Requirements
  • Chart Review
  • Current Coverage Criteria
  • Misuse of state-supplied
  • VFC eligibility screening
  • Provide/stock required/recommend to VFC
  • Follow required/recommended schedule/
    immunization rules/laws
  • Do not refer
  • Copy/update lifetime immunization
    card/immunization record

74
Site Visit Requirements
  • Chart Review (medical record)
  • Name of vaccine given
  • Date vaccine was given
  • Date VIS was given
  • Name of vaccine manufacturer
  • Lot Number
  • Name and title of person who gave the vaccine
  • Address of clinic where vaccine was given
  • Publication date of VIS
  • Site noted in the patients medical record
  • Route noted in the patients medical record

75
Site Visit Requirements
  • Other items
  • Proper needle length for intramuscular injection
  • VAERS forms/report adverse reactions

76
Items Most Often Out of Compliance at a Site
Visit
  • Incorrect administration fee charged to
    non-Medicaid VFC eligible patients
  • Current Coverage Criteria not followed
  • Misuse of state-supplied vaccine
  • Inappropriately use
  • HPV, MCV4, PCV7, Rotavirus for insured/Health
    Choice
  • MMR, Td, Tdap for Adults
  • Use DTaP instead of Tdap for Adults

77
Items Most Often Out of Compliance at a Site
Visit
  • Does not provide and or stock required and or
    recommend vaccines for VFC children (Medicaid, No
    Insurance, American Indian/Alaskan Native,
    Underinsured)
  • Does not follow required and or recommended
    schedule
  • Does not follow immunization rules/laws
  • Improper needle length for intramuscular injection

78
Items Most Often Out of Compliance at a Site
Visit
  • Vaccine Information Statements (VIS)
  • VIS not up to date
  • Publication date of VIS not recorded
  • Medical Record
  • Does not consistently record the date VIS was
    given
  • Did not document signature and title of person
    who gave the vaccine
  • Did not document publication date of VIS
  • Did not document route

79
Items Most Often Out of Compliance at a Site
Visit
  • Vaccine Storage
  • Written procedures for vaccine storage are not in
    place
  • Temperatures out of range
  • No action taken
  • No written documentation of action taken
  • Did not call the Immunization Branch for guidance
  • A Do Not Disconnect stick was not on the
    circuit breaker

80
Educational Tools
  • Immunization Branch web page
  • www.immunizenc.com
  • National Immunization Program http//www.cdc.gov/v
    accines/
  • Epidemiology and Prevention of Vaccine
    Preventable Disease (The Pink Book)
  • Vaccine Storage and Handling Toolkit
  • Vaccine Management - Recommendations for Handling
    and Storage of Selected Bilogicals
  • North Carolina Immunization Branch Customer
    Service staff
  • 1-877-873-6247

81
Educational Tools
  • Vaccine Storage and Handling Toolkit

82
Contact Information
  • Mary Ivers, Site Visit Coordinator
  • Main Telephone line
  • 1-877-873-6247
  • Direct line
  • 919-707-5574
  • Fax
  • 919-870-4826
  • Email
  • mary.ivers_at_ncmail.net
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