Temperature Excursion and Digital Data Loggers. Vaccine Cold Chain. Maintaining the Cold Chain 6/7/2018

Transcription

1 Temperature Excursion and Digital Data Loggers Jayme Lewis, RN & Allison Alejos, RN, BSN & Bradley Carpenter environment of all Kansans. Vaccine Cold Chain Elements for an Effective and Reliable Cold Chain: Well trained staff Reliable storage and temperature monitoring equipment Accurate vaccine inventory management Maintaining the Cold Chain Vaccine Appearance: Not a reliable indicator that vaccines have been stored in appropriate conditions! 1

2 Vaccine Cold Chain Failures Result in: Extra vaccine doses for patients Increased costs for providers Damage to public confidence Lack of protection of vaccine-preventable diseases 2017 Vaccine Doses Ordered & Expenditures Flu Vaccine Doses 91,230 $ 1,380, Other Vaccine Doses 431,130 $ 27,349, Total Vaccine Doses 522,360 $ 28,730, There were 47,533 wasted vaccine doses in 2017 worth $1,912, The Indicated Temperature Range for Vaccine Storage: Cold Storage: 2 C to 8 C (Aim for 4 C to 5 C) Frozen Storage: -50 C to -15 C (Aim for -18 C or less) 2

3 Test Your Knowledge Test Your Knowledge What is a Reportable Temperature Excursion? Refrigerator: > 8 C or higher for 60 minutes or more < 2 C for ANY period of time X on KIP Data Logger Freezer: > -15 C or higher for 60 minutes or more < -50 C for any period of time X on KIP Data Logger 3

4 What Causes an X on the Data Logger? Data Logger Parameters: Refrigerator: < 2 C x 15 Consecutive Minutes > 8 C x 60 Consecutive Minutes Freezer: > -15 C x 60 Consecutive Minutes **Any one of these 3 criteria will place an X on the Data Logger and will also create a Temperature Failure in KSWebIZ. Not All Temperature Excursions Display an X on the Data Logger Although the Data Logger may not display an X, you still may have a reportable Temperature Excursion < 2 C for ANY period of time < -50 C for any period of time Manual Temperature Log: 4

5 Manual Temperature Log: Temperature Excursion: Action Required! Vaccine MUST be Quarantined. Vaccine Administration MUST Stop. (Do NOT resume vaccine administration until approved by your Regional Immunization Consultant) Call your Regional Immunization Consultant and Report ALL Temperature Excursions. If it is After Hours: Leave a message on the On- Call Line at Regional Consultant Map 5

6 Temperature Failures in KSWebIZ Date Range Temperature Failures in KSWebIZ Temperature Range Consecutive Time Cumulative Time Temperature Failures in KSWebIZ Date Range: 2/6/2018 4/3/2018 Temp Range: C to C Consecutive Time: 6 Hours 45 Mins Cumulative Time: 21 Hours 21 Mins 6

7 Failure Reports in KSWebIZ Failure Reports in KSWebIZ Data Logger Reports Downloads Generate 2 Reports:.PDF report and.txt report Save BOTH reports on the clinic s computer system. Don t change the file name when saving the reports. We are unable to retrieve the report from KSWebIZ 7

8 Information Needed When Contacting Vaccine Manufacturers Date Range Temperature Range Consecutive Time Cumulative Time Any previous Temperature Excursion that affected current inventory. When Contacting Vaccine Manufacturers A case number will be assigned Make note of this on the Temperature Excursion Worksheet Request written recommendations on vaccine viability as a result of the temperature excursion - or fax is quickest Requirements for Temperature Excursion Reporting Temperature Excursion Worksheet.PDF &.TXT reports Manual Temperature Logs Manufacturer s Recommendations Submit all to your Regional Consultant 8

9 Typical Vaccine Manufacturer Recommendations: Vaccine may be supported through expiry Vaccine may not be supported for use Vaccine may have shortened expiration date OPEN Multi-Dose Vials may have to be discarded If Vaccine is Deemed Viable Excursion Stickers are used to identify vaccines exposed to a Temperature Excursion Excursion Stickers available in 2 colors: Orange Adversely High TE Green Adversely Low TE Place and Date appropriate colored stickers on exposed vaccine Excursion Stickers Viable vaccines that have a shortened expiration date must be labeled with Temperature Excursion stickers & rotated to be used first It is the provider s responsibility to track each temperature excursion they experience this includes tracking & accounting for the cumulative exposure times for past and current temperature excursions 9

10 If Vaccine is Supported through Expiry You will be notified when you are approved to resume vaccine administration by your Regional Immunization Consultant Current vaccine inventory exposed to the temperature excursion must be labeled with Temperature Excursion stickers If Vaccine is NOT Supported for Use Temperature excursion reporting is reviewed by VFC Manager and a determination is made on whether the vaccine loss is considered Avoidable or Unavoidable Provider will be notified of final determination and whether further corrective actions are necessary If Vaccine Has A Shortened Expiry Date Provider must clearly label their affected inventory with the UPDATED Expiration Date Temperature Excursion stickers will serve a dual purpose in this scenario 10

11 Vaccine Loss Determination Avoidable: The Provider is liable for the vaccine replacement. Unavoidable: The Provider is not liable for the vaccine replacement. Vaccine Replacement If waste is determined to be avoidable, it is required to be replaced by the provider on a dose for dose basis with privately purchased vaccine within 90 days. Test Your Knowledge 11

12 Vaccine Returns Nonviable vaccines in their original container (syringe or vial) are able to be returned for excise tax credit when: A vaccine has been spoiled as a result of: Natural disaster/power outage Refrigerator too warm or too cold Failure to store properly upon receipt Vaccine spoiled in transit Mechanical Failure Recall The provider has vaccine that has expired Exceptions VFC providers are unable to return vaccine that: Is drawn into a syringe but was not administered Is part of an open vial with doses not administered Is compromised (due to a drop causing damage to vial integrity or sterility), broken vial, or lost vial Vaccine Return Process 12

13 Vaccine Return Process Vaccine Return Process Vaccine Return Process 13

14 Notes The CDC does not process expired vaccine return requests prior to the expiration date Submitting an expired vaccine return request prior to the expiration date will result in your request being rejected When you complete your return request the doses you returned will be removed from your on-hand inventory Notes Nonviable vaccine must be reported and submitted via the VFC wasted vaccine return from in KSWebIZ within 72 hours of waste If your have an excursion/return near the end of the month and haven t returned the doses yet, carry them over on your reconciliation Let s Practice! Split into groups as instructed Review the scenario and documents at your table Complete the steps of completing a Temperature Excursion Worksheet Review your findings and decide whether this was an avoidable or unavoidable loss? Report out when time is up 14

15 In closing: A good reminder from a 9 year old boy named, Jax: Vaccines stop diseases and save lives We cannot save lives with temperature excursions So we cannot have temperature excursions and stop diseases Questions 15