2014 Program Managers Meeting

Transcription

1 2014 Program Managers Meeting Atlanta, GA July 10, 2014 Vaccine Storage and Handling What would you do? Scenarios from the Field Cameron Noblit and Pat Beckenhaupt 1

2 Trade Names Disclosure The use of trade names is for identification only and does not imply endorsement by the Centers for Disease Control and Prevention or the U.S. Department of Health and Human Services. 2

3 Financial Conflict Disclosure CDC, our planners, and our presenters wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. Planners have reviewed content to ensure there is no bias. 3

4 Unlicensed Product Disclosure Content will not include any discussion of the unlabeled use of a product or a product under investigational use with the exception of discussion of the use of the following vaccines in a manner recommended by the Advisory Committee on Immunization Practices, but not approved by the Food and Drug Administration: DTaP, Tdap, Hib, HPV, MMR, meningococcal, pneumococcal, rotavirus, and zoster. CDC does not accept commercial support. 4

5 Objectives Participants will be able to: Identify and correct poor or incorrect storage and handling practices. Identify strategies for working with providers to implement proper storage and handling. Tool for Training 5

6 New York Times Article July 2,

7 In Looking at the Unit, do you see any Storage and Handling Issues? The New York Times July 2, 2014 Article by Elisabeth Rosenthal Photo by Ben Sklar for The New York Time Source: Centers for Disease Control and Prevention

8 SCENARIO What would you do? This scenario is a compilation of several different real life storage events reported by immunization programs. Main Points of the Scenario: Site Visit at AIROR Pediatrics They haven t had a visit since their enrollment visit two years ago Relatively new Stand Alone Refrigerator Storage and Handling issues present 8

9 The relatively new refrigerator is experiencing some peculiar temperature fluctuations in which not all shelves are maintaining similar temps 1. From the visual inspection of the unit, what are your concerns about using it for vaccine storage? 2. What would cause the temperature variations and possible ways to correct? 9

10 1. From the visual inspection of the unit, what are your concerns about using it for vaccine storage? Over packed Vaccine in high-risk locations of the unit (Walls, Back, Floor, and by Vent) Minimal Thermal Ballast Location of Temp Probe Type of Unit 10

11 2. What would cause the temperature variation and possible ways to correct? Over packed Lessen the amount of vaccine stored in the unit A minimum of 2 inches spacing Remove from vent area Thermal Ballast More then 2 water bottles are needed for this unit Ballast placement needs to be in high-risk area Type of Unit If unit cannot maintain appropriate temperatures it cannot be used for vaccine storage o Defrost? o Purpose Built/Pharmaceutical Grade? Temp Probe location Buffered Probe should be in central location with vaccines 11

12 They have a Certificate of Conformance and they let you know that they have recently purchased a testing system that they want to use to test the calibrate of the units themselves. 3. Is the digital thermometer being used compliant with VFC policy? Why or why not? 4. Is the Calibration testing machine ok for the staff to use? Why or why not?

13 3. Is the digital thermometer being used compliant with VFC policy? Why or why not? No It does not have a valid certificate of calibration testing and traceability 13

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16 Certificate of Conformance 16

17 Work Order 17

18 Procedure Document 18

19 Spec Document 19

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21 4. Is the Calibration testing machine ok for the staff to use? Why or why not? More Information is needed The testing must conform to international standards 21

22 the Min/Max digital thermometer (not a data logger) showed 1 C for the Min and 10 C for the Max. They have not documented any Min/Max readings. 5. How do you use this thermometer to monitor vaccine storage temperatures? 6. How do you deal with the current Min/Max reading on the thermometer?

23 5. How do you use this thermometer to monitor vaccine storage temperatures? 6. How do you deal with the current Min/Max reading on the thermometer? Review and Record current temperature twice daily Review and record Min/Max each morning and Reset Respond immediately to any out of range readings Determine if provider staff know how to use the thermometer Suggest obtaining a digital data logger that meets CDC recommendations Determine if you have an accurate reading Determine Time at these Min/Max temperatures Have to use worse case scenario Use your program s policy to respond 23

24 Info Graphic 24

25 Knowledge Check 25

26 the temp logs, temperatures were documented every day AM and PM, including weekends, and were filled in using the same pen, same initials and same temp recording. 7. How do you bring up the temp log consistency without being accusatory? 8. What are the next steps if they insist that the temp log data was recorded daily and appropriately?

27 7. How do you bring up the temp log consistency without being accusatory? Enlist the staff member s help in identifying why this unit s temperatures are so consistent

28 8. What are the next steps if they insist that the temp log data was recorded daily and appropriately? Advantages of continuous temperature monitoring over current method Use data and research to show benefits of better monitoring

29 Additional Questions 9. What are the two most important issues to have resolved before you leave the practice? 10. What follow up would likely be most effective? 11. Given the recent investments made by the provider, how do you communicate about the changes needed in a way to get the provider to buy in to them? 12. Are there other issues that you have noted that were not brought up?

30 9. What are the two most important issues to have resolved before you leave the practice? Temp Monitoring Issues (utilizing current thermometer better, obtaining data logger) Thermal Ballast

31 10. What follow up would likely be most effective? Follow up on the thermometer (If storage unit is not big enough or not holding proper temperatures a new unit will be needed) Data logger would make this assessment easier

32 11. Given the recent investments made by the provider, how do you communicate about the changes needed in a way to get the provider to buy in to them? The new investments/recommendations would make things easier, more efficient, cost beneficial

33 12. Are there other issues that you have noted that were not brought up?

34 Scenario Summary Thank You 34