Mass Dispensing Operations. Lou Ann Lance, RN, MSN Public Health Emergency Epidemiology New York State Department of Health

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1 Mass Dispensing Operations Lou Ann Lance, RN, MSN Public Health Emergency Epidemiology New York State Department of Health November 1, 2013

2 Participants will: Objectives Understand procedures for cold chain management. Demonstrate ability to safely package and ship vaccine Demonstrate vaccine safety and infection control standards Perform vaccine administration in accordance with current guidelines and practice standards.

3 Cold Chain Process to maintain optimal conditions during the transport, storage and handling of vaccines. Manufacturer Distributor Provider POD Client

4 Storage Recommendations 35⁰F - 46⁰F (2⁰C - 8⁰C) IIV LAIV RIV until use Do not freeze Inactivated Influenza Vaccine Do not allow vaccine to come into direct contact with ice or frozen surfaces Discard vaccine that has been frozen Recombinant vaccine vials should be protected from light

5 Vaccine at POD Locations Considerations: Always try to limit the number of times a vaccine is transported Only transport the amount to be used. Avoid transporting a partially used (multidose) vial to or from an off-site location whenever possible. Avoid opening additional vials once demobilization has begun Never transfer a partially used vial to another provider or across state lines.

6 Considerations: Vaccine Management Single dose vials and manufacturer-filled syringes should be discarded if vaccine has been withdrawn or reconstituted. CDC recommends that when the rubber diaphragm on a single dose vial is exposed, the vaccine in the vial should be used that work day or discarded. The same applies to manufacturer filled syringes that have been activated (sterile seal broken). Unused vaccine pre-drawn into a syringe from should be discarded at the end of the work day. Always review manufacturer protocols (Product Information and Package Inserts) for expiration dates for multi-dose vials.

7 Considerations cont. Transport containers CDC recommends transport with a portable refrigerator unit OR A hard-sided insulated cooler with at least 2- inch walls that can maintain the recommended temperature range (between 35⁰F and 46⁰F) Place a calibrated thermometer as close as possible to the vaccines (if the vaccines will be kept in the transport container during a POD.

8 Considerations cont. Avoid transporting vaccine in the trunk of a vehicle.

9 Considerations cont. Dormitory/bar style refrigerators are not recommended for vaccine storage under any circumstance. Consistently unacceptable temperature control Pose significant risk of freezing vaccine even when used for temporary storage.

10 Considerations cont. Place vaccines in an appropriate storage unit (refrigerator), with a calibrated thermometer, upon arrival at the POD location. If vaccine is left in the transport containers: Keep the container closed as much as possible. Only remove the amount of the vaccine needed at one time. Keep a calibrated thermometer as close as possible to the vaccine. Read and document the temperature inside the containers hourly.

11 Inventory Tracking Data Management

12 Data Collection Goals Fast Accurate Standardized

13 Benefits Timely Recall Adverse Event Monitoring Vaccine Inventory Management and Ordering Procedures Standardized Medical Screening Situational Awareness Location and Times of Dispensing Operations Vaccination Penetration of Local Jurisdictions Priority Groups Critical Infrastructure Immunization Rates

14 Vaccination Data Flow NYSIIS Immunization Registry CDMS EMR Financial Systems Paper Forms

15 Packing and Shipping Influenza Vaccine

16 Packaging Supplies 1. Insulated Foam Container 2. Foam Sheets or Bubble Wrap 3. Box for Vaccine 4. Refrigerant Packs 5. Freeze Indicator 6. Exterior Cardboard Box

17 EXAMPLES

18 Freeze Indicator

19 Step 1 Select Appropriate Container Line the bottom of the container with thawed refrigerant packs. Do not use frozen packs.

20 Step 2 Add Refrigerant Packs to Bottom Line the bottom of the container with thawed refrigerant packs. Do not use frozen packs.

21 Step 3 Cover Refrigerant Packs with Foam Place a layer of foam wrap over the refrigerated packs. There should always be a barrier between refrigerant packs and the vaccine.

22 Step 4 Add Vaccine Layer the vaccine on top of the foam insulator. You may add multiple layers of vaccine. Larger shipments will require larger containers and may require additional refrigerant packs.

23 Step 5 Placement of Freeze Indicator Check the expiration date of the freeze indicator before placing the indicator between the vaccine boxes.

24 Step 6 Cover Vaccine with Foam Cover the vaccine with a layer of foam prior to adding additional refrigerant packs.

25 Step 7 Fill Remaining Space with Refrigerant Add thawed refrigerator packs to fill remaining space in the container. ONLY in HOT WEATHER: Place a frozen pack on top of the thawed refrigerants. Never let inactivated vaccine come into direct contact with frozen material.

26 Step 8 Place Container in Shipping Box Secure the Styrofoam container lid and place inside a shipping box. Add a bubble wrap product as necessary to ensure the vaccine is secure. Seal openings with packaging tape and add shipping labels.

27 General Shipping Guidelines Never place vaccine directly on frozen surface Never use dry ice for shipping Ship Ground UPS USP ensures next day shipping if shipped within NYS Ship on Monday, Tuesday or Wednesday Overnight Shipments Are Not Routinely Necessary Only if the vaccine is shipped on Thursday To Schedule a Pick-Up or at UPS.com Always Notify Recipient of Impending Delivery Do Not Ship on Friday/Weekends/Holiday

28 Clinical Considerations Vaccine Administration

29 Mass Immunization Goal is to vaccinate many people in a short period of time. Not a traditional method of vaccination. Keep people moving Limit chairs Remove arm covering while in line Avoid asking redundant questions Establish standardized vaccination site (i.e. always the left arm unless contraindicated)

30 Just in Time Training Reinforce Proper Vaccination Technique Ensure Standard Practice Reinforce Documentation/Dat a Requirements Encourage Return Demonstration to Evaluate Efficacy of Training Visual Observation by POD Manager

31 JITT Specifics Always review the expiration dates Never transfer vaccine from one syringe to another. Do not combine partial doses from separate vials into a single dose. It is unnecessary to inject air into a multi-dose vial prior to withdrawing vaccine (potential for vaccine loss) Do not attempt to pull back on the needle after insertion into the skin (no major blood vessels).

32 JITT Cont. Generally, you should only administer the vaccines that you have prepared for administration. Mass clinics 10 dose recommendation. Electronic systems are not a substitute for careful documentation! Reinforce patient confidentiality Need to Know. Maintain aseptic technique Never remove the syringe cap with your teeth!!!

33 MCM Planning Considerations Include procedures for cold chain management for external locations. Evaluate primary dispensing locations for adequate refrigeration. Develop infection control procedures for mass dispensing operations. Develop JITT tools to include vaccine

34 QUESTIONS?