1. Vaccines for Children Program Incident Follow-up Protocol Betsy Hubbard MN, RN Darren Robertson Krista Rietberg, MPH David Bibus, MPH Lauren Greenfield BSN, RN Public Health–Seattle & King County

2. Background  Vaccines for Children (VFC) is a federally funded program that provides free vaccines to eligible children.  Washington State is a universal vaccine state providing supplemental funding for vaccines to all children age 0-18 years (19 years for hepatitis B).  Public Health has conducted VFC quality assurance site visits since 1999.

3. Site Visits  Over the study period 1999-2002, King County had 250 - 300 VFC provider organizations  Site visits to 20% of VFC providers annually  Most sites were randomly selected

4. Site Visits  Sites were assessed for compliance with VFC standards  Standard “Provider Site Visit Tool” used for each assessment

5. Site Visit Assessment Covered:  Vaccine storage, handling, and accountability  Administration and documentation of vaccines  Access to immunization resources and training

6. Site Visit Results 1999-2002 (N=139)  10% of clinics did not store their vaccine properly  33% of clinics did not have a written protocol for handling power outages and other emergencies  36% of clinics did not have a list of people responsible for vaccine retrieval, transportation, and storage during emergencies

7. Site Visit Results 1999-2002 (N=139)  28% reported that staff did not attend in-service education classes on current immunization recommendations  32% did not have an immunization recall system  Nearly 20% of clinics were not prepared with appropriate emergency medications

8. Site Visit Results 1999-2002  48% did not have a method for securing the refrigerator/freezer door*  37% of clinics did not have “Do Not Disconnect” warning labels*  59% did not have access to educational videos* * N=105, 1999 through February 2002

9. Site Visit Results 1999-2002  53% did not record dose and route*  49% did not record Vaccine Information Statement (VIS) dates in chart* * N=105, 1999 through February 2002

10. Public Health - Seattle & King County Vaccines for Children Program Incident Protocol

11.  Drafted in April 2002  Offers clearly defined actions to respond to the variety of issues encountered in administrating the VFC program  Applied to providers using information collected from the Site Visit Tool, monthly temperature logs and usage reports, and “problem” calls.

12. Incident Protocol allows for...  Problem to be prioritized  Predetermined action to be implemented  Consideration of mitigating circumstances  Consistency in handling incidents and problems as they arise

13. Making the Grade  Sites receive a letter grade, “A” through “E,” based on the results of a random site visit or “incident”  Protocol is for internal use by Public Health VFC staff

14. Grade “A”  No problems detected  Letter sent to provider describing exemplary performance

15. Grade “B”  Lower priority Provider Agreement provisions not met  Site receives a letter or fax describing findings or recommendations

16. Grade “C”  Medium priority Provider Agreement provisions not met or concerns raised regarding immunization practice –no recall system for kids < 3 year old –failure to observe age guidelines –first time incident with storage –inadequate emergency response kit

17. Grade “C” Response  Letter or fax describing findings  Requires a written response from site documenting correction (for no recall, describe the system to be used)  Inadequate responses may result in a site visit  Suspend giving immunizations until emergency response kit is up-to-date

18. Grade “D” High priority - damaged vaccine, severe problems with immunization practice, or repeat problems  repeated Grade “C” incidents  second storage and handling incident  unwillingness to schedule site visit  refusal to cease using vaccine deemed “compromised” by VFC

19. Grade “D” Response  Letter or fax sent  Immediate probation for 6 months  Requires a written response from site documenting correction  Compromised vaccine must be returned  Provider purchases replacement vaccine  Possible follow-up visit

20. Grade “E” Severe problems regarding immunization practice, vaccine handling or storage  practices that may put patients at risk  repeated Grade “D” incidents  falsification of records

21. Grade “E” Response  Letter or fax sent  Automatic suspension of 3 to 6 months  Written response documenting corrective action (may include patient revaccination)  Provider must purchase replacement vaccines

22. Grade “E” Response  Possible report to Medical Quality Assurance Board  Follow-up site visit required; provider must show corrections have been made

23. Mitigating Circumstances  Expressed acknowledgement of the serious nature of the problem  Expressed desire to improve performance  Immediate positive response when notified of the problem  Financial hardship of replacing vaccine when documented in writing (allowed for first incident only)

24. Using the Protocol  The overall Grade is assigned based on the most serious violation recorded  Violation may result from site visit findings, review of monthly reports, or an incident reported by the provider  Sites receiving a Grade of “C,” “D,” or “E” are notified in writing; VFC staff track provider’s response to the violation

25. Using the Protocol  A table listing all current unresolved issues will be maintained  VFC staff will note on the list the date the problem was resolved  All violations and incidents will be noted in the site’s file

26. The results are in…...  68 clinic sites have been evaluated under this protocol since April 2002  A = 5 sites  B = 26 sites  C = 32 sites  D = 4 sites  E = 1 site

27. Protocol Evaluation  Makes it easier to track problems  Results in fewer storage incidents and improved accounting  Helps us determine areas to focus provider education  Protocol is a work in progress, adjusted as new issues arise

28. Changes...  Every site we visit receives a Pink Book, “Immunization Works” CD, and “Iced Champagne and Roses” video  All sites have received the California “Immunization Techniques” video  Since January 2003, VFC staff are conducting pre-enrollment visits  Follow-up provider education project is in the planning stage.