Heather Stafford Director, Division of Immunizations (717) ACIC October 2012

The State of Vaccine Program Funding Vaccine – Section $5,838, $5,072, $4,953,139 – VFC Funding $71,646, $72,687,007 – Operations 2010 $889, $9,171, $9,446, $8,974,671

Vaccine Funding Commonwealth of PA, Department of Health (DOH), Immunization Program currently receives two Federal vaccine funding streams – Vaccines for Children (entitlement based on eligibility) – Section 317 (discretionary defined by CDC) – No state funds

Policy Changes As of October 1, 2012 Federal vaccine supplied to the state for DOH clinics, County and Municipal Health Department clinics and FQHC/RHC clinics may only serve Vaccines for Children eligible clients and uninsured and underinsured clients.

Policy Change Impacts Department of Health clinics will screen all clients and refer non-VFC eligible insured clients to a primary care provider Department of Health will not provide Tdap to birthing facilities Department of Health will not provide vaccine to high risk clinics such as STD, HIV/AIDS and Drugs and Alcohol sites

Policy Change Impacts Department of Health will pursue Memorandums of Understanding (MOU)with local Federally Qualified Heath Centers and Rural Health Centers for deputization to be able to serve underinsured clients with VFC vaccine.

Deputizing Definitions Deputization: The formal extension of VFC authority to provide VFC vaccines to eligible underinsured children from a participating FQHC or RHC to another VFC-enrolled provider. Under this arrangement, the deputizing FQHC or RHC retains its full scope of authority as a VFC provider while extending the authority to deputized VFC providers to immunize underinsured children with VFC vaccine. Deputized VFC provider: A VFC provider to which authority to vaccinate underinsured children with VFC vaccine is extended by an FQHC or RHC through the MOU. Deputizing FQHC/RHC: An FQHC or RHC that is extending authority to another VFC provider via the MOU.

Deputized and Non-Deputized Clinic Policy Department of Health sites that are deputized may serve underinsured with VFC vaccine Department of Health sites that are NOT deputized or that do not have a FQHC/RHC in the county may give underinsured Section 317 funded vaccine. Department of Health sites in counties that do have FQHC/RHC and are not deputized may give Section 317 vaccine or may refer underinsured to FQHC/RHC to use VFC vaccine. - Referring saves the 317 funds for truly uninsured clients.

SITEDEPUTIZEDCLIENTSFUNDING DOHYESUnderinsuredVFC DOHNOUnderinsured317 or refer to FQHC/RHC FQHC/RHCN/AUnderinsuredVFC CMHDNot an option at this time Underinsured317 or refer to FQHC/RHC

New Funding: Immunization Capacity Building Assistance to Strengthen Public Health Information Improve vaccine management, shipping and handling at provider and grantee level - $819,781 – AAP contract – Target 200 providers – Research shipping & handling devices School vaccine assessment evaluation - $12,866 – 160 audits – Pilot CDC tool

Pennsylvania Online Vaccine Ordering Effective February 1, 2013 All vaccine orders will be done through the online system The system will use the PA State Registry screens to capture provider’s vaccine orders Providers will enter their orders online through this system To avoid vaccine order delays providers are encouraged to contact PA SIIS Providers with no online capabilities will continue to use the paper form

VFC Vaccine Ordering

Pennsylvania Online Re-Enrollment Effective June 1, 2013 This annual requirement will be online The system will use the PA State Registry screens to capture provider’s enrollment information Providers will enter their re-enrollment updates through this system Providers are encouraged to contact PA SIIS Providers with no online capabilities will continue to use the paper form

Storage and Handling Office of Inspector General Report – Released 6/5/12 – Looked at extent, providers and grantees, adhere to CDC vaccine management – 45 providers (.19%) of 44,000 – CA, TX, FL, NYC, and GA

What Was Found During a 2 week period it was found that VFC vaccines stored by 76% of the 45 providers were exposed to inappropriate temperatures for at least 5 cumulative hours 13 providers stored expired and non-expired together Providers generally did not meet vaccine requirements or maintain proper documentation None of the 5 grantees met ALL VFC oversight requirements Determine that grantee site visits were not effective in ensuring requirements met

Vaccine Storage and Handling o Vaccines are fragile and must be kept at recommended temperatures at all times. Some also must be protected from light. o Stock must be stored to avoid mix-ups of vaccines and diluents and to ensure expired or wrong vaccine or diluent is not used. o Once removed from storage, vaccines should be used promptly. Reconstituted vaccines have specific time limits for use. o It is better to NOT VACCINATE than to administer a dose of vaccine that has been mishandled, has expired, or is the wrong vaccine.

NO Dorm Style Units Small single-door refrigerator-freezer units should not be used for vaccine storage.

Use only Calibrated Thermometers with a Certificate of Calibration

Developing Vaccine Storage & Handling Guidelines Develop written guidelines for standard and emergency vaccine storage and handling. Assign and train primary and back-up vaccine storage and handling (S&H) managers. Make sure all staff are familiar with your practice’s policies and procedures. This may include janitorial, security, reception, and mail staff.

Emergency Vaccine Retrieval & Storage Plan Refrigerator and freezer with a back-up generator to store vaccine in the event of a power outage or natural disaster. Back-up location if you should need it. Emergency contact information. Protocols for transporting vaccine. Instructions for entering building after hours.

Cold Chain Failure Provider Steps Contact the appropriate vaccine manufacturers within one (1) workday of a suspected vaccine cold chain failure, to determine viability of the vaccine. Provide: Vaccine name Lot number Expiration date Number of doses at risk Documented refrigerator and freezer temperatures Duration of exposure to out of range temperatures

Cold Chain Failure Reports Complete and submit the Vaccine Incident Report & Worksheet form within five (5) days of a suspected cold chain failure.

How Are You Doing Allegheny County? Cold Chain Failures in PA VFC in 2011 =194 Cold Chain Failures Allegheny County = 8

Quality Assurance (QA)

Focus of VFC/AFIX Visits Not on coverage rates More on education – Proper thermometers and recording – Decreasing missed opportunities – Giving all eligible vaccines at same visit – Following ACIP schedule Target is 50% of providers in 2012

VFC/AFIX Visits 2011 Goal = 50% of total providers December 31, 2011 = 38% 2012 Goal = 50% of total providers October 1, 2012 = 31%

New Provider Training At the beginning of 2011, there were 1582 providers enrolled in the VFC Program. By December 31, 2011, 48 new enrollment visits were conducted.

2011 VPD Overview Numbers for 2011 are: 13 confirmed measles cases (a bad year for measles; most years we have only 0-3 cases) 545 confirmed pertussis cases (a bad year but not as bad as 2010 which had 762 cases) 1,099 confirmed and probable varicella cases (including one death; overall there has been a decline in varicella numbers every year since we started tracking it in 2005)

Confirmed and Probable Cases of Vaccine Preventable Diseases by Age Group, Pennsylvania, 2011 AGE GROUPMEASLESMUMPSPERTUSSISRUBELLATETANUSVARICELLAHiB ACUTE HEP A ACUTE HEP B < > TOTAL REPORTED TOTAL CONFIRMED

Confirmed Cases of Vaccine Preventable Diseases by Age Group, Pennsylvania, 2011 AGE GROUPMEASLESMUMPSPERTUSSISRUBELLATETANUSVARICELLAHiB ACUTE HEP A ACUTE HEP B < > TOTAL

Confirmed and Probable VPD Cases Investigated in Allegheny with Onset in 2011 DISEASE PERTUSSISVARICELLA Allegheny6571 Note: pertussis and varicella were only VPDs with onset in these jurisdictions for 2011

Outbreaks of VPD Cases Investigated in Allegheny with First Case Onset in 2011 County Where Outbreak Occurred DISEASETOTAL AlleghenyVARICELLA1 (9 cases) AlleghenyPERTUSSIS1 (5 cases)

Influenza 2012/2013 Strains The H1N1-like A strain will remain the same; it is designated A/California/7/2009 (H1N1)-like virus. The H3N2-like A strain will be A/Victoria/361/2011 (H3N2)-like virus. The B strain will be B/Wisconsin/1/2010-like virus.

PA DOH Ordered Influenza Vaccines 2010/ ,500 doses 2011/ ,023 doses (111,000 remaining) 2012/ ,550 doses