1. Assessment of Hepatitis B Birth Dose Program Participation in New York State
Debra Blog, MD, MPH
Director, Bureau of Immunization
Kimberly Noyes, MD, MPH
Director, Bureau of Communicable Disease Control
New York State Department of Health
National Immunization Conference
March 30, 2009

2. Presentation Outline
Historical overview of perinatal hepatitis B prevention strategies in New York State (excluding New York City)
Hypothesized barriers and challenges to perinatal hepatitis B prevention
Survey of all birthing hospitals in New York State (outside of NYC)

3. Basis for Perinatal Hepatitis B Prevention Strategy in New York State
Perinatal disease leads to
serious long-term health issues
Chronic carrier status higher – 90%
Liver cirrhosis
Liver cancer
HBV-infected women may be unaware of status or deny risk factors
Post-exposure prophylaxis (vaccine + HBIG) is extremely effective
Over 95% of cases
can be prevented!!
Hepatitis B virus infection affecting a pregnant woman may result in severe disease for the mother and chronic infection for the newborn.
Neither pregnancy nor lactation should be considered a contraindication to vaccination.

4. Historical Overview of Perinatal Hepatitis B Prevention Efforts in New York State
Public Health Law 2500-e enacted
Lot Quality Assurance monitoring began
Survey of hospitals shows cost barrier
Hospital birth dose initiative began
ACIP recommends universal birth dose
Commissioner letter
Birthing hospital survey
1990

5. Perinatal Hepatitis B Prevention in New York State
1990 Public Health Law (PHL) 2500-e mandates hepatitis B screening and reporting for all pregnant women
Goals of PHL 2500-e:
All pregnant women screened each pregnancy
Treatment of all infants born to HBsAg-positive women
Provide STAT testing for women with unknown status and treatment of their infants
Require reporting

6. Lot Quality Assurance Monitoring
Initiated around 1993
A systematic medical record review method to evaluate hospital compliance with state PHL
100% of the records reviewed must contain HBsAg status in both maternal and infant record
Review performed by state Immunization staff with local health departments rather than hospital staff
Opportunity for regional state immunization staff and local health department staff to interface with local hospital
Valuable educational opportunity

7. Lot Quality Assurance Monitoring
Provides opportunity to assess other variables
Prenatal and post-partum immunization practices
Tdap, influenza, varicella, MMR, etc.
Immunization documentation
Birth dose rates and practices

8. Hepatitis B Birth Dose Initiative
Program Goal
Eliminate transmission of hepatitis B
Introduced in 10/2003
2002 survey of hospitals showed cost was a barrier
Provides hepatitis B vaccine at no cost to hospitals
Hospital enrolls in VFC program

9. Hepatitis B Birth Dose Initiative
Hospital adopts a universal birth dose policy
Hospital must have a hepatitis B birth dose standing order in place stating that all newborns, regardless of maternal HBsAg status, individual provider preference or infant’s insurance status, will be offered hepatitis B vaccine
Parental consent is obtained as per NYS law

10. Official New York State Department of Health Letter to Facilities Defines Universal Birth Dose as the Standard of Care in NYS
April 2006, Commissioner of Health
“Standard of care that NYSDOH supports…all NYS birthing hospitals should immediately comply by implementing standing orders for vaccination of all newborns with hepatitis B vaccine within 12 hours of birth”

11. Enrollment in Birth Dose Initiative

12. National Immunization Survey Data
New York State outside of New York City
*National average in 2005 reflects birth to 2 days. National average in 2006 and 2007 reflects birth to 3 days

13. So, why such low numbers?
Robust perinatal hepatitis B prevention program
Strong public health law
Routine hospital monitoring
Vaccine provided to hospitals at no cost
…..What are we missing?

14. Birth Dose – Hypothesized Challenges
Lack of education (provider, parental, nursing, etc.)
Misconception that hepatitis B infection is no longer a problem in NYS
Misconception that hepatitis B infection is not a risk in certain locations, usually more rural parts of the state
Complacency because NYS law requires screening of all pregnant women
Physician concerns about administering 4 doses when combination vaccines are used for follow up doses
Desire by some physicians to administer the 1st dose of hepatitis B vaccine in the office setting rather than at birth

15. Birth Dose – Hypothesized Challenges
Physician desire to bill for vaccine in office
Objection to government (CDC, NYSDOH, JCAHO) involvement in physician practices
The birth dose initiative requires hospitals to have “standing orders” but many hospitals are not using true non patient specific standing orders
Many physicians are still opting out of administering the birth dose
Parental fear about vaccines

16. Birthing Hospital Survey, April 2008
To better understand the various factors that may be contributing to the overall low birth dose administration rate
Quantify and describe
Implementation of universal birth dose policies and standing orders
Existence of barriers impeding full program participation
Perceived effectiveness of potential remedies

17. Birthing Hospital Survey, April 2008
Methods
Electronic Survey distributed to all birthing facilities via the Department’s Health Emergency Response Data System (HERDS)
Medical Directors and Nurse Managers of Newborn Nursery Units were asked to individually complete the same 20-question survey
Periodic telephone follow-up to all non-responders

18. Birthing Hospital Survey
Self-administered, brief, voluntary
Basic demographic and professional information
Existence of a universal birth dose policy and standing orders at hospital
Usefulness?
Type of standing orders?
Perceived barriers to administering birth dose
Perceived effectiveness of potential strategies to address barriers

19. Results Overall survey response rate high—95%
All hospitals represented
Nurse response slightly higher than physician response
Nurse response rate 99%
Physician response rate 91.1%

20. Characteristics of Survey Respondents
Proportion (%)
Professional Degree (n=192)
Physician
47.4
Nurse 51
Midlevel 1
Other
0.5
Profession/Specialty (n=192)
Pediatrics
32.3
Obstetrics
28.1
Nursing
20.8
Administration
6.8
Neonatology
6.3
3.1
Family Medicine
2.6

21. Birth Dose Policy Proportion (%) Adopted birth dose policy? (n=192) No
2.1
Yes
97.9
Perceived usefulness? (n=184)
Very
79.9
Somewhat
15.8
Not so much
4.3
Not at all

22. Standing Orders Use standing orders for hepatitis B vaccine? (n=192)
Proportion (%) No
2.1
Yes
97.9
What type?
(n=188)
Patient specific
(n=105)
55.9
Non patient specific (n=83)
44.1

23. Perceived barriers to use of non patient specific standing orders
Proportion (%)
Physicians not supportive
39.8
Physicians unaware of this option
21.4
Hospital unaware of this option
14.3
Hospital not supportive
11.2
Nurses not supportive
5.1
Other*
36.7
*Other=Perception of need for parental consent

24. Additional information
Which provider completes newborn admission orders? (n=192)
Proportion (%)
Pediatric provider under whom newborn is admitted
92.7
Obstetrician/Delivering provider
7.3
Where is the hepatitis B dose given most of the time? (n=192)
Delivery Room
25.5
Newborn Nursery/Postpartum Unit
74.5

25. Prenatal education classes
Does your hospital provide prenatal/childbirth education classes? (n=192)
Proportion (%) No
2.1
Yes
97.9
Does the curriculum include information on infant immunizations? (n=188)
77.1 9
Don’t Know
13.8

26. Perceived Barriers Frequently or Occasionally Seldom or Never
When infants discharged home without receiving hepatitis B birth dose, how often do you feel this is related to: (n=192)
Lack of awareness of recommendation by nursing
3.6
96.4
Lack of awareness of recommendation by obstetrician
6.3
93.8
Lack of awareness of recommendation by pediatrician
10.9
89.1
Lack of awareness of recommendation by parent(s)
22.9
77.1
Physician disagreement with recommendation
33.3
66.7
Nursing disagreement with recommendation
VIS unavailable
1.6
98.4
Parent refusal
76.6
23.4
Parent preference to discuss with pediatrician
55.2
44.8
Lack of physician availability for vaccine counseling

27. Perceived Barriers: Provider-related factors
Frequently or
Occasionally
Seldom or
Never
When physician disagreement and/or lack of physician awareness are the reasons for discharge without receipt of birth dose, how often do you feel this related to: (n=191)
Physician plans to give vaccine in private office
56.5
13.5
Physician desires to bill for vaccine in private office 22 78
Physician not aware that vaccine is free for hospitals
5.2
94.8
Hospital pharmacy not aware that vaccine is free
2.1
97.9

28. Perceived Barriers: Parent-related factors
Frequently or
Occasionally
Seldom or
Never
When parental refusal is the reason for discharge without receiving the birth dose, how often do you feel this is related to: (n=192)
Plan for pediatrician to give vaccine in office
77.6
22.4
Parental fear of vaccination in newborn
65.6
34.4
Parental fear of vaccination in general
56.3
43.8
Parental cultural belief(s)
33.3
66.7
Community belief(s)
15.6
84.4

29. Prior Knowledge About Birth Dose
Answer to the question: What percentage of pregnant women presenting to Labor & Delivery have prior knowledge of the recommendation for all infants to receive a hepatitis B dose? (provide estimate)
Histogram: Proportion of women that were estimated to have prior knowledge

30. Perceived effectiveness of potential strategies to address barriers
Very or
Somewhat
effective
Not so/
not at all
How effective would you find these potential remedies? (n=192)
Parental education on hepatitis B birth dose prenatally
94.8
5.2
Obstetrician education
67.7
32.3
Pediatrician education
78.6
21.4
Nursing education
70.3
29.7
Adoption of non-patient specific standing orders
60.4
39.6
Offering providers financial incentives to vaccinate
45.3
54.7

31. Survey Limitations Subjective data Limited generalizeability
Personal opinions about universal birth dose recommendation could have affected responses (in either direction)
Some data reflects best estimates
Limited generalizeability
May not apply to all health care providers in the state
Low representation of family physicians
Responder bias
Survey conducted by Immunization Program that provides vaccine at no cost to hospitals
Could have skewed the results in positive direction

32. Interesting Discovery…
New York State Immunization Information System (NYSIIS) became mandatory statewide in 2008
In December 2008, vital statistics loaded all birth records of infants born in NYS (outside of NYC) back to 2004 into NYSIIS
Vital statistics has collected newborn hepatitis B immunization status since approximately 1997
Should reflect ACTUAL birth dose administration statewide

33. Vital Statistics Reporting of Hepatitis B Birth Dose by Hospital Size (annual birth cohort)
% Receiving Birth Dose
Represents NIS estimate for New York State

34. Percent of Births Receiving Hep B Birth Dose By Hospital
NIS Estimates – 13.6 sd – 17.0 sd – 16.9 sd – 32.3 sd 7.7

35. Survey estimate vs. Vital statistics data vs. NIS estimate
% Receiving Birth Dose

36. Next Steps Use vital statistics data and survey results to:
Provide positive feedback to hospitals who are successfully implementing their universal birth dose policies
Provide impetus to hospitals with low birth dose rates to adhere to the policy they have adopted
Encourage use of non patient specific standing orders
Education
Parent (prenatal focus)
Provider (Pediatrics and OB focus)
Conduct QA review of hepatitis B immunization reporting to vital statistics (and ultimately, NYSIIS)
Conduct QA review of doses ordered vs birth dose rates

37. Many thanks to… Survey evaluation Survey design and follow-up
Michael Flynn
Suzanne Solghan
Survey design and follow-up
John Kushner
Geri Naumiec
Barbara Wallace

38. New York State Department of Health
Perinatal Hepatitis B Prevention Program
Bureau of Immunization
Corning Tower Room 649
Empire State Plaza
Albany, NY 12237
(518)
Perinatal Hepatitis B Coordinator
Lynn Pollock, RN