Core Elements for AFIX Training and Implementation
April 2004 
SECOND EDITION 
www.cdc.gov/vaccines/programs/afix/ 
Department of Health and Human Services 
Centers for Disease Control and Prevention
Please send comments and feedback on this document to: 
Nancy Fenlon, NFenlon@cdc.gov 
or 
Amy Kirsch, AKirsch@cdc.gov 

This 80 page document includes the following sections:
Introduction 
Acknowledgements 
Assessment (A) 
Methodology  
Preparation for Visit 
The Visit  
Organize and Analyze Data 
Feedback (F)  
Preparing for Feedback Session  
Methods of Conducting Feedback Session  
Concluding a Feedback Session  
After Conclusion of Feedback Session  
Incentives (I) 
Informal Incentives
Formal Incentives 
Funding and Partnering for Incentives 
eXchange of Information (X)
Comparison of Immunization Coverage Levels  
Successful Processes/Systems Implemented by Other Practices 
Ideas for Removing Barriers  
Encouraging Ownership of This Initiative  
Offer Additional Education Opportunities 
Resources 
Final Advice
Appendix A  List of High Risk Conditions  
Appendix B  Hybrid Assessment Method 
Appendix C  Examples of Pre-Assessment Forms and Letters 
Appendix D  Public Health Implications of the Health Insurance Portability & Accountability Act (HIPAA) 
Appendix E  Examples of Confidentiality Information 
Appendix F  Methods for Selecting a Random Sample 
Appendix G  Using Registries for Immunization Assessment 
Appendix H  Examples and Tips on Partnering  
Appendix I  Graphical Representation of Immunization Coverage Levels Between Practices
Appendix J  Examples of Vaccine Administration Records for Medical Records 
Appendix K  Additional Resources  
Appendix L  Glossary of Terms 
 
Introduction to Core Elements 
For AFIX Training and Implementation 
AFIX (Assessment, Feedback, Incentive, and eXchange) is a continuous quality improvement 
tool that consists of: 
1) assessment of the health care providers vaccination coverage levels and immunization 
practices; 
2) feedback of the results to the provider along with recommended strategies to 
improve coverage levels; 
3) motivating the provider through incentives to improve vaccination 
coverage levels; 
4) and exchanging health care information and resources necessary to facilitate 
improvement. 
The AFIX methodology is a comprehensive and effective tool for improving the vaccination 
coverage levels and immunization practices of health care providers. The improved 
outcomes produced by AFIX through implementation of recommendations and 
best immunization practices can be quantified through successive AFIX participation over 
time. The efficacy of AFIX has been documented in published and unpublished studies. 
Perhaps the greatest potential value of AFIX is when a majority of providers in a community 
participates in the AFIX process. This is because vaccine preventable disease risk 
declines when higher rates of immunization coverage confer higher levels of immunity to 
these preventable diseases. 

For several years, state and local immunization programs have been utilizing the AFIX 
methodology in public health clinics where many childhood immunizations had been 
previously administered. Over the past decade, however, there has been a shift to the 
private sector for comprehensive health care and immunization services. Programs such 
as Vaccines for Children (VFC), Medicaid, the State Childrens Health Insurance Program 
(SCHIP), and the impact of the managed care industry have been responsible for these 
changes, resulting in more than 80% of children receiving some or all of their recommended 
vaccines in private primary care settings. State and local public health immunization 
programs are strongly encouraged to provide their AFIX services to all health 
care providers that provide any type of immunization services, regardless of VFC 
participation. 

Although AFIX has traditionally been conducted to assess immunization delivery 
systems for children, several states are applying the AFIX process to assess adolescent and 
adult populations. In this edition of the Core Elements, we have generalized the AFIX 
process so that it can be applied to any age group. When differences between populations 
do exist with respect to the AFIX process, we have clearly identified the difference and 
provided helpful strategies for modifying the AFIX methodology. 

The CDC Task Force on Community Preventive Services has endorsed the AFIX 
methodology as an effective quality improvement activity to improve immunization 
coverage levels in persons of all ages. 

With this endorsement, CDC convened a work group consisting of local, state, and 
federal participants. A subcommittee of the Clinic Provider Assessment Work Group 
(CPAWG) developed this document and the CDC AFIX committee recommends these 
core elements be used as guidelines when providing AFIX education and training in 
any health care setting, whether public or private. One activity that the group determined 
to be a priority was the development of these guidelines to ensure AFIX activities 
are conducted in a standardized fashion. The use of these core elements should assist any 
health care provider to improve immunization practices. CPAWG continues to meet 
bi-annually to develop an agenda of priority activities on which to focus. 

To ensure proper use of the core elements, training sessions to conduct AFIX visits are 
essential. The core elements will provide guidance in: 
 Training key staff to conduct AFIX visits 
 Creating AFIX process protocols 

This document is intended to be used by individuals and immunization programs that 
plan to utilize the AFIX methodology. Individual users will find this methodology 
to be flexible for their specific needs while statewide programs can use these same  
concepts in their settings, as well. AFIX users need to be reminded that facilitating immunization 
practice (behavior) changes in the health care provider offices requires skillful 
collaboration. In all cases, health care providers should be encouraged to take 
ownership of the initiative by being active participants in making decisions through all 
phases of the process, from assessment to exchange. The use of AFIX has been 
demonstrated to change immunization practice behaviors and improve outcomes in 
any health care setting.

Acknowledgements 
The development of this document was made possible by the hard work and dedication of the 
following individuals and their organizations: 
R. Clinton Crews 
Eastern Virginia Medical School 
Center for Pediatric Research 
Norfolk, Virginia 23510 

Nancy Fenlon 
Program Operations Branch 
National Immunization Program 
Centers for Disease Control and Prevention 
Atlanta, Georgia 30333 

Stephanie Sanchez 
Communicable Disease and Immunization Division 
Michigan Department of Community Health 
Lansing, Michigan 48909 

Shelley Vaughn 
San Diego County Infant Immunization Initiative 
County of San Diego Immunization Program 
San Diego, California 92186-5222 

Shannon Stokley 
Health Services Research and Evaluation Branch 
National Immunization Program 
Centers for Disease Control and Prevention 
Atlanta, Georgia 30333 

Judy Schmidt 
Education Information and Partnership Branch 
National Immunization Program 
Centers for Disease Control and Prevention 
Atlanta, Georgia 30333 

The second edition revisions to this document were made possible by the input of the following 
individuals and their organizations: 
Nathan Crawford 
AFIX Coordinator 
Immunization Program 
Oregon Department of Health Services 
Portland Oregon, 97232 

Andrew Chilkatowsky 
Division of Disease Control 
Philadelphia Department of Public Health 
Philadelphia, PA 19146 

Terry Adams 
Indiana VFC Program 
Indiana State Health Department 
Indianapolis, IN 46204 

John Stevenson 
Health Services Research and Evaluation Branch 
National Immunization Program 
Centers for Disease Control and Prevention 
Atlanta, Georgia 30333 

Lisa Luna 
Oregon Department of Human Services 
Oregon Health Division 
Portland, Oregon 97232 

Ruby Jones 
Arkansas Department of Health 
Division of Communicable Disease/ Immunization 
Little Rock, Arkansas 72205-3867 

Judy Yates 
Mississippi Department of Health 
Division of Immunization 
Jackson, Mississippi 39215 

Ken Anderson 
Program Support Branch 
National Immunization Program 
Centers for Disease Control and Prevention 
Atlanta, Georgia 30333 

Amy Kirsch 
Program Operations Branch 
National Immunization Program 
Centers for Disease Control and Prevention 
Atlanta Georgia 30333 

Marcia Levin 
VFC Program Supervisor 
Chicago Department of Public Health 
Chicago, IL 60612 

Carolyn Bachino 
Fellow, Health Services Research and Evaluation Branch 
National Immunization Program 
Centers for Disease Control and Prevention 
Atlanta Georgia 30333 

Assessment (A) 
The A in AFIX stands for Assessment of 
immunization coverage levels and immunization 
delivery patterns at the practice level. 
The Advisory Committee on Immunization 
Practices (ACIP) recommends the regular 
assessment of vaccination rates for both 
public and private providers. Assessment 
should include qualitative and quantitative 
observations. 
Although the activities listed below can be 
applied to an assessment of any population, 
there are some differences between pediatric 
and adult assessments. These differences 
have been explained when appropriate. 
6 
I. METHODOLOGY 
A. Choose Assessment Method 
Assessment methods supported by CDC 
include: 
1. Chart Based 
a. Standard 
The standard method for conducting 
an assessment is to randomly select 
a number of patient charts and 
calculate vaccination coverage rates 
based on the information obtained 
from the charts. Different methods 
can be used for selecting charts (see 
section III-B). 
b. Hybrid 
The hybrid assessment method may 
be used for conducting assessments. 
This method typically involves 
reviewing 30 charts. Results from 
the hybrid method allow the assessor 
to classify a provider as having 
coverage levels above or below a 
specific level but do not produce 
actual vaccination coverage rates. 
2. Registry Based 
A registry-based methodology is one in 
which all data used come from an 
immunization registry. This method 
generally assesses a pre-defined 
population rather than a sample of that 
population. 
B. Determine Assessment Parameters 
The following parameters should all be 
determined prior to conducting any 
assessment. 
1. Define active patient 
The definition of an active patient is at 
the discretion of the project conducting 
the assessment.The project may wish to 
use the number of office visits within a 
given time period for their definition. 
An alternative is to ask the clinic manager 
what his/her definition of an 
active patient would be, however, definitions 
may not be consistent across 
practices.
2. Age range to be assessed 
Age range to be assessed can vary. 
Common options are: 
PEDIATRIC ADULT 
Adults are considered 
any person 19 years of 
age or older 
1949 
50+ 
65+ 
(Infants & Adolescents) 
12-23 months 
19-35 months 
24-35 months 
combination of the above 
11-18 years 
3. Sample size 
Determine a sample size that is realistic 
for your resources (this includes 
personnel and time). 
PEDIATRIC ADULT 
(Infants & Adolescents) 
If using standard If using standard 
assessment method, it is assessment method, it 
recommended to review 
50-200 charts. 
If using hybrid 
assessment method, the 
sample size is 30 charts. 
is recommended to 
review 50 charts, 
although more may be 
reviewed. (Estimate 
that each adult chart 
will take approximately 
15 minutes to assess.) 
If using hybrid 
assessment method, the 
sample size is 30 charts. 
4. Define flu season of interest 
If influenza vaccine is among the 
vaccines of interest for your assessment, 
it is important to determine the flu season 
of interest. A flu season is typically 
defined as October through March, but 
this may be altered based on the 
providers situation or the date on 
which you are doing the assessment. 
For example, if the purpose of the 
assessment is to evaluate the 2001/2002 
flu season coverage, but the provider 
did not receive vaccine supply until 
November, then you may define the flu 
season as November 1, 2001March 30, 
2002. More than one flu season may be 
evaluated during an assessment. 
5. High-risk conditions 
Many vaccine recommendations are 
risk based and/or age based. For 
example, a person with the high risk 
condition of asthma is recommended 
to receive the influenza vaccine each 
year. Depending on your quality 
improvement goals, you may decide to 
do the assessment only for patients 
with a particular risk factor. For a list 
of high risk medical conditions and 
their recommended vaccines, refer to 
Appendix A*. 
6. If using the hybrid assessment method, 
determine the threshold level. (See 
Appendix B) 
C. Identify Data Fields 
Identify data fields (as determined by 
your project) to be collected during assessments. 
Standardizing the variable order 
may increase speed and accuracy of data 
entered over time. 
1. Patient demographic information 
(sex, race/ethnicity, etc.) 
2. Insurance status 
3 Disease/medical history (e.g. varicella 
history, heart disease, asthma, etc.) 
4. Social/behavioral risk factors 
(if applicable) 
5. Other variables of interest (if applicable) 
to enable data collection and reporting 
of additional information (e.g. zip 
code, dates of first and last visits). 
6. Type of vaccine 
7. Date of vaccine 
8. Comments and observations: during 
the assessment, assessors may identify 
issues with chart organization, documentation 
problems, etc. A designated 
space on the data abstraction form (or 
a separate form) should be made available 
for documenting comments and 
observations. 
D. Choose Data Collection Method 
Choose the method of data collection that 
will be used. Options include: 
1. Laptop computer: abstracting data 
from a chart and directly entering into 
a computerized database 
2. Paper and pencil: abstracting data from 
a chart and recording onto a data 
abstraction form 
3. Import registry data or electronic 
patient information system data into 
7
software system that analyzes immunization 
histories (e.g. CASA, ACASA) 
E. Supplies 
The supplies for staff to take to an AFIX 
provider site visit may include: 
1. Computer and supplies (if applicable) 
2. Data abstraction forms (if applicable) 
3. Reference sheets 
(e.g. list of high risk conditions) 
4. Sampling instructions/tally sheets 
(if applicable) 
5. Post it notes 
6. Pens/pencils 
7. Calculator 
8. Information for providers 
(e.g. updated VIS statements) 
8 
II. PREPARATION FOR VISIT 
A. Provider Selection 
Identify providers that your program 
would like to target for AFIX activities. 
Provider selection may be based on a variety 
of variables. Some of the strategies for 
choosing providers are: 
1. Actively promote AFIX to your network 
of immunization partners and professional 
contacts (e.g. state or local AAP, 
AAFP, or AARP chapter; immunization 
coalitions; etc) 
a. Ask them to participate in your 
program 
b. Ask them to help you recruit 
providers 
2. Recruit practices with the largest target 
patient populations first 
3. Recruit from all levels of practices 
a. Promote your program to physician 
groups 
b. Contact office managers 
c. Contact medical group administrators 
or quality assurance personnel 
4. Use several sources for the development 
of your recruitment list 
a. VACMAN (vaccine ordering system) 
provider profiles 
b. Local medical society and professional 
associations (AAP, AAFP) 
c. Health plan provider lists 
d. Medical group provider lists 
e. Referrals from other providers 
f. Providers with poor immunization 
practices 
g. Geographic area of need 
5. If doing a registry-based assessment, 
the participation level of the interested 
clinics in the registry should be 
considered. 
B. Scheduling the Assessment 
and/or Feedback 
The approach you take for scheduling the 
site visit will set the tone for the visit itself. 
1. Call the office manager and explain 
exactly what you will be doing, how 
long it will take, and what you will 
need when you get there. (Refer to 
Appendix C for examples of
pre-assessment forms and letters from 
several state programs.) 
2. Identify a mutually convenient date 
and time for the assessment. 
(Coordinate with the VFC site visit if 
appropriate.) 
3. Arrange for a workspace out of the 
flow of traffic with a table, chairs, and 
an electrical outlet for the computer (if 
applicable). 
4. Ask for a computer-generated list of 
patients in the identified age range and 
pre-select the sample, if possible. 
5. Determine staffing requirements and 
length of time for assessment based on 
sample size, file selection method, and 
workspace availability. 
6. Confirm the date and time of the 
assessment with a follow-up letter 
and/or phone call. 
7. Confirm office address and directions 
if unfamiliar with area. 
8. Communicate when and how the 
assessment results will be reported 
back to the office. 
C. Confidentiality 
The confidentiality of a providers patients 
is often an important issue for the provider. 
1. Be prepared to discuss concerns 
providers have with the issue of 
confidentiality. Some may ask for 
documentation showing your assessors 
have the right to extract information 
from their patients medical records 
and that assessments will maintain the 
confidentiality of the information. 
Others may ask about state or federal 
regulations such as HIPAA (Health 
Insurance Portability &Accountability 
Act). For more information on HIPAA, 
please review Appendix D or go to 
http://www.cms.hhs.gov/hipaa. 
Additionally, the Morbidity and 
Mortality Weekly Report (MMWR) has 
published information on the privacy 
rule at http://www.cdc.gov/mmwr/ 
preview/mmwrhtml/ su5201a1.htm. 
2. Address the issue of confidentiality 
with those conducting the assessments. 
Have assessors sign an oath of 
confidentiality to be kept on file in 
your office. (Refer to Appendix E for 
state program examples of confidentiality 
statements). 
3. Establish and follow procedures for 
distribution, handling and disposal of 
confidential information 
III. THE VISIT 
A. Make a Good Impression 
There are a number of ways to make a 
good impression when making a provider 
site visit: 
1. Be prompt; give the office a 15-30 
minute time range for arrival 
2. Smile and be friendly 
3. Let everyone know who you are and 
what you are doing 
4. Wear professional attire 
5. Carry identification (business card 
and/or badge) 
6. Provide immunization information 
and resources 
7. Consider bringing food if resources 
allow 
B. Chart Selection 
Methods for selecting patient charts for 
review include: 
1. Pre-select the sample from a computergenerated 
list of patients 
2. Shelf selection: computerized lists of 
eligible patients may not be available; 
thus the shelf selection method may be 
the only method appropriate for selecting 
a sample of patients. Several 
options for using the shelf selection 
method can be seen in Appendix F. 
3. Registry-based assessment chart 
selection: When doing a registry-based 
assessment, it is crucial to first determine 
how the clinic population will be 
defined, because this will drive how 
the patients are selected. Then, a 
request is made to the registry for an 
extract of those patients and their 
9
immunizations. It is also important to 
include in that request the date-of-birth 
range of interest. Please refer to 
Appendix G for a full discussion of the 
use of registry data for assessments. 
C. Data Extraction 
The following guidelines will assist you in 
developing a method of extracting data 
from the charts: 
1. Review completely all sections of the 
first few charts to become familiar 
with the system in the office. If more 
than one person is extracting data, 
agreement must occur on how to 
interpret immunization issues. 
2. Ask office staff for clarification of 
documentation procedures for 
immunizations. 
3. If documentation is inadequate, do 
further follow up to verify doses were 
given. This may include further chart 
review or office staff consultation. 
4. Note problems for office staff to correct 
and put records aside for review. 
5. Perform the quality assurance review, 
whereby spot checks are performed to 
assure data were correctly extracted. 
D. Wrap UpLeave a Good Impression 
The way you end your visit is just as 
important as how you begin it. Improve 
your chances of gaining re-entry to a 
provider office by following these 
guidelines: 
1. Offer to replace the records 
2. Collect all materials 
3. Leave the workspace tidy 
4. Thank the staff for their hospitality 
5. Avoid discussion of results until data 
can be appropriately analyzed 
10 
IV. ORGANIZE AND ANALYZE DATA 
A. Select Reports and Feedback Methods 
Determine what data to share with 
provider. Projects may customize reports 
or use standardized reports available in 
various software programs (i.e. CASA, 
ACASA). Report results and on-site 
observations may include: 
1. Vaccine coverage levels of the target 
population 
2. Single antigen coverage levels 
3. List of patients with incomplete 
immunizations 
4. Quality of record documentation 
5. Missed opportunities including failure 
to simultaneously administer all needed 
immunizations 
6. Frequency of invalid doses 
B. Prepare Reports 
Some things to consider when preparing 
reports for providers: 
1. Present data in user-friendly format 
(graphs, pie charts) 
2. Retain provider confidentiality when 
presenting data comparing providers 
to each other 
3. Identify areas of strength 
4. Identify areas for improvement 
C. Summarize Each Assessment for Internal 
Program Purposes 
1. Document methods and parameters 
2. Document program planning 
3. Document results of each provider 
assessment for comparison over time 
4. Document recommendations/goals 
and follow-up activities with provider
Feedback (F) 
The F in AFIX stands for Feedback, the 
process of informing immunization providers 
about their performance in providing vaccines 
to a specifically defined population. It provides 
information on immunization coverage 
levels for a particular office or provider. 
Feedback provides a forum to discuss with 
the office how to improve its immunization 
delivery system and improve immunization 
coverage levels. The feedback process 
requires time, flexibility, creativity and 
knowledge of immunization recommendations 
and standards of practice. The feedback 
process is given in a sensitive, respectful 
manner that assures provider confidentiality. 
The person conducting the feedback session 
needs well-developed skills for dealing with 
people in a range of situations. 
Feedback is a two-way conversation. It 
encourages the application of knowledge, 
attitudes and practice improvement in the 
immunization delivery system. You must get 
input from the provider to find out what 
changes are reasonable for the practice to 
institute. 
I. PREPARING FOR 
FEEDBACK SESSION 
A. Helpful Hints for the Feedback Session 
Suggestions for designing your feedback 
session: 
1. Schedule your feedback session at a 
mutually convenient time for the office 
and yourself if session is to occur 
separately from the assessment visit 
2. Determine presentation mode and 
needed equipment and/or materials: 
handouts, PowerPoint presentation, 
easel and flip chart, overhead and 
transparencies, etc. 
3. Use visual aids if possible for presenting 
data, especially key points 
4. Be comfortable in presenting information
practice feedback session(s) in 
front of your office staff 
5. Bring resources to improve immunization 
delivery 
a. Immunization record for medical 
charts 
b. Vaccine Information Statements 
(VIS) 
c. Most current ACIP schedule 
d. Vaccine oriented educational 
materials for provider and patients 
6. If incorporating food at feedback 
session, coordinate with caterer, and 
consider space, time available, clean 
up, etc. 
B. Develop Feedback Plan 
Use the following as a guide for preparing 
your feedback session: 
1. Who will be present for the feedback 
session? 
 Have at least one key decision 
maker present (office manager, 
provider, nurse or other staff) and 
encourage as much staff participation 
as possible 
2. Be aware of time limits and keep 
within the limit for the session 
11
3. What information will you present in 
the session? 
a. Outline key points of assessment 
findings 
i. Coverage level 
ii. Diagnostic information 
iii. Observation of office practices 
b. Highlight offices strengths 
c. Identify areas for improvement 
i. Documentation 
ii. Missed opportunities 
iii. Reminder/recall 
iv. Patient education 
v. Provider education 
vi. Vaccine handling and storage 
issues 
4. Brainstorm with practice on improvement 
strategies that can be adopted 
a. Include easy fixes 
b. Target areas that provide the 
biggest bang for the buck 
c. Be empathetic and supportive to 
office concerns 
d. Outline and discuss follow up activities 
e. Foster an environment of change in 
practice 
f. Utilize incentives and exchange of 
Information during feedback session 
12 
II. METHODS OF CONDUCTING 
FEEDBACK SESSION 
When and how will you present the feedback 
session? There is no one ideal method for 
feedback. Do what works best for your 
program and/or the providers you are 
working with to improve coverage levels. 
A. Feedback conducted at a later scheduled 
date (after day of assessment) 
Pros: Allows time for analysis and 
development of feedback plan 
Ensures key players are available to 
participate in feedback session 
Uses both verbal and written 
formats 
Cons:Time and labor intensive 
Situations best suited to this feedback 
method: Large, high priority 
practices 
B. Feedback conducted on day of assessment 
Pros: Immediate information provided 
back to office 
Staff interest in immunizations may 
be at highest level 
Cons: May not be able to get key players 
to attend 
Limited prep time for presentation 
Lack of prep time may limit discussion 
on improving immunization 
practices 
Time constraints: If assessment runs 
long, time available for feedback is 
decreased 
Situations best suited to this feedback 
method: Difficult to reach providers 
who are unlikely to schedule a 
follow-up feedback session; small 
volume practices 
Providers who request immediate 
feedback session at conclusion of 
assessment 
C. Written feedback report mailed to office 
after assessment as sole feedback 
method. 
Pros: No additional time required by 
office staff 
Since feedback is not immediate, 
allows for more thoughtful analysis 
of data
Office has hard copy of findings 
does not rely on memory of what 
went on in feedback meeting 
and/or notes taken during meeting 
Cons: Information may never be read or 
shared with appropriate staff 
Limits incentives and exchange of 
information 
Difficult to develop working 
relationship with office 
Situations best suited to this feedback 
method: Limited project resources. 
Repeat assessments in high 
performing offices with limited, 
identified areas for improvement 
III. CONCLUDING A 
FEEDBACK SESSION 
Before leaving the office, remember to: 
 Thank the office for participation in 
program 
 Leave office work area clean and neat 
 Review key findings of assessment 
 Review agreed upon follow-up activities 
IV. AFTER CONCLUSION 
OF FEEDBACK SESSION 
Additional activities 
A. Written follow-up report to provider 
Include the following items as appropriate 
in the written report to the provider: 
1. Summary of results 
2. Agreed upon short-term goals 
3. Clear and concise outline of follow-up 
activities to be conducted and responsible 
party 
4. Retain a copy of the follow-up report 
for your own records for future followup 
with each provider 
B. Periodic follow-up telephone contact 
with office 
Allows project staff to follow up on 
progress of immunization activities with 
provider on specific issues 
13
Incentives (I) 
The I in AFIX stands for the Incentives to 
motivate providers and practices to improve 
immunization coverage levels. The key to 
this part of the AFIX process is to provide 
effective motivational rewards for positive 
change and improvement in immunization 
services and rates. Incentives promote 
change and reward achievement. 
Incentives may be informal or formal. 
Informal incentives can be as simple as providing 
contact names and numbers for local, 
state and federal immunization resources. 
Formal incentives may be as elaborate as providing 
funding to send office staff to training 
at state or national immunization conferences. 
The purpose is to motivate and encourage all 
staff to accept improving immunization coverage 
levels as part of their job. Public 
recognition of positive changes, as well as 
acknowledging high performing practices, is 
encouraged. When considering the following 
examples of incentives, be aware that practice 
characteristics such as provider type, size 
and location will influence what incentives 
are effective, relevant, and genuinely motivating 
to the provider. 
I. INFORMAL INCENTIVES 
Some examples of informal incentives used 
at the practice level include: 
 Free immunization materials 
 Educational in-services for staff 
 On-going immunization updates 
 Assistance with developing an immunization 
quality improvement plan for 
the office 
 Letters of Commendation 
14 
II. FORMAL INCENTIVES 
Some examples of formal types of incentives 
include: 
 Certificates of Participation, 
Improvement and Collaboration 
 Plaques 
 Promotion of clinics/offices as 
Immunization Champions or role 
models 
 Recognition of clinics/offices with significant 
improvement or high coverage 
levels at local or state conferences, educational 
seminars, professional meetings 
 Celebration lunches for the winners 
within the projects service area 
 Recognition of clinics and offices in 
feature articles in various state and local 
professional newsletters and journals 
 Catered lunch/breakfast in-services for 
staff 
 Grants to improve immunization 
delivery services using evidence-based 
strategies 
 Scholarships to local, state and/or 
national immunization conferences 
III. FUNDING AND PARTNERING 
FOR INCENTIVES 
To fund some of the more involved and/or 
costly incentives, consider partnering with 
other agencies or organizations with similar 
goals. Explore non-traditional partners as 
well. If unable to provide financial support, 
seek support to promote AFIX. Potential 
funding sources include: 
 Immunization coalitions 
 State chapters of professional 
organizations 
 Health maintenance organizations 
 Pharmaceutical manufacturers 
 State medical societies 
(Refer to Appendix H for examples and tips 
on partnering)
eXchange of Information (X) 
The X in AFIX stands for the eXchange of 
information. The X can interact with both 
the Feedback (F) and the Incentive (I) 
components of AFIX. Information can be 
exchanged during feedback of assessment 
results to provider and staff as well as in many 
other settings where health professionals 
might meet, such as professional meetings. 
The exchange of information section will 
include examples of efforts that have been 
successfully implemented in practices and 
clinics. Exchanging information should reinforce 
the strengths of practices (acknowledge 
what the practice is doing well), as well as 
make recommendations for changes in their 
immunization practices. This exchange of 
information can be applied to individual 
practices, professional organizations and 
health systems. 
I. COMPARISON OF IMMUNIZATION 
COVERAGE LEVELS 
A. National levels and goals 
Comparing provider immunization 
coverage levels to national levels and 
goals gives providers a broad context for 
their immunization level and where they 
stand. 
B. State levels and goals (if available) 
State levels and goals can give a provider 
a picture of how their coverage levels 
compare to others in the state. 
C. Provider practice levels 
Public providers can be shown their 
progress in relation to other providers by 
using a blinded rank order (refer to 
Appendix I for examples of how programs 
present comparison coverage levels). 
There are two things to keep in mind 
to maintain professional confidentiality if 
you choose to do this: 
1. DO NOT identify specific practices 
without their permission 
2. Do generalize rates for practices in 
geographic areas or by practice type 
15
II. SUCCESSFUL PROCESSES/ 
SYSTEMS IMPLEMENTED 
BY OTHER PRACTICES 
A. Mentoring or testimony by an 
immunization champion 
Using a local provider or immunization 
champion to speak with area providers is 
one method of educating providers. Local 
immunization staff may provide expertise 
as an immunization advocate and in identifying 
other immunization champions. 
B. Evidence-based strategies 
Another method of immunization coverage 
improvement is to show providers how 
implementing quality-assurance methods 
in other practices improved the coverage 
levels for those providers. For examples of 
evidence-based strategies to improve 
immunization coverage, go to the Task 
Force on Community Prevention Website 
at http://www.thecommunityguide.org/ 
vaccine/default.htm 
C. Competition 
Friendly competition can be used as a 
motivator for increasing immunization 
coverage levels. For example, this can be 
done between staff at a large practice or 
among clinics or offices within a larger 
health system. This may be effective in 
conjunction with incentives discussed in 
the prior section. 
D. Share success stories 
It is important that immunization 
programs and providers do not try to 
reinvent the wheel. There are numerous 
examples of success stories at the provider 
level. Projects need to communicate about 
what has worked for programs, and 
encourage providers to contact each other 
to do the same. 
E. Share experiences that have not worked 
It is equally important that states and 
providers share experiences that have not 
been successful to collectively address 
barriers. Remember that while some 
strategies work well in a local area, strategies 
may not be universally successful. 
16 
III. IDEAS FOR 
REMOVING BARRIERS 
A. Standard vaccine documentation 
1. Standard immunization record in chart 
A standard immunization record in 
each clients chart is an efficient and 
accurate way to review a clients 
immunization status (refer to 
Appendix J for examples of vaccine 
administration records for medical 
charts). 
2. Vaccination records for patients 
that are accurate, complete, and 
easily accessible 
This is standard #12 in the 2003 
Standards for Child and Adolescent 
Immunization Practices developed by 
the National Vaccine Advisory Committee. 
This standard states, Vaccination 
records for patients should be 
recorded on a standard form in an 
easily accessible location in the medical 
record to facilitate rapid review of 
vaccination status. Accurate record 
keeping ensures that only needed 
vaccinations are given. The medical 
record maintained by the primary care 
provider should document all vaccines 
received including those received at a 
specialists office or in another health 
care setting. The Standards for child 
and adolescent immunization practices 
were published in Pediatrics, Volume 
112 Number 4, October 2003. Additionally, 
the Standards are available on the 
CDC website at www.cdc.gov/vaccines/recs/vac-admin/rev-immz-stds.htm. 
3. Legal requirements 
Providers are required by federal law 
(42 US Code 300aa-25) to ensure that 
records for each vaccine given contain 
the date the vaccine was given (month, 
day, year), the name of the manufacturer 
of the vaccine, the lot number, the 
signature and title of the person who 
gave the vaccine, and the address 
where the vaccine was given. In addition, 
providers should record on the 
clients personal immunization record
card what vaccine was given, the date 
the vaccine was given and the name of 
the provider. Additional state statutes 
may apply. 
B. Assess immunization status at 
all encounters 
Providers should use all clinical encounters 
to screen and, when indicated, immunize 
clients. 
C. Tracking, reminder and recall 
Operating a tracking system that produces 
reminders of upcoming immunizations as 
well as recall notices for clients who are 
overdue is another strategy for overcoming 
barriers to immunizations. The tracking 
system may be automated or manual and 
may include, but is not limited to, mailed 
or telephone messages. 
IV. ENCOURAGING OWNERSHIP 
OF THIS INITIATIVE 
A. Determine who makes decisions 
Determine who in the practice can authorize 
changes in protocol. 
B. Changes in immunization 
practice patterns can make 
clinical time more efficient 
Give examples of how improving immunization 
practice patterns will enable the 
practice to operate more efficiently. 
C. Discuss potential changes 
Encourage the decision-maker to explore 
what immunization activities the practice 
is willing to implement to improve coverage 
levels. Determine some changes that 
may improve assessment results. 
D. Liability 
Discuss potential liability situations related 
to immunizations such as failure to use 
the most current VIS statements. 
E. Maintaining and continuing 
improvement 
Discuss the option of periodic return visits 
for reassessment to measure the success of 
practice changes. Practices should be 
encouraged to set realistic improvement 
goals. 
17
V. OFFER ADDITIONAL 
EDUCATION OPPORTUNITIES 
A. CDC conferences and satellite courses 
Inform staff of dates and times of CDC 
conferences and satellite courses. 
B. State/regional/national 
immunization conferences 
Inform staff of dates and times of other 
immunization conferences. 
C. Inservices for office staff 
Provide in-services for nursing and office 
staff on immunization topics. 
D. Provide in-services for medical providers 
Provide inservices for medical providers 
on immunization topics. 
E. Consider offering CEUs for participation 
in AFIX visits 
18 
VI. RESOURCES 
Develop a list of immunization resources for 
your providers. Following are some examples 
to include: 
 Yourself 
 Local/county health department 
 State immunization program 
 CDC Hotline 
 Immunization coalitions in area 
 Website addresses 
 Vaccine manufacturers 
(Refer to Appendix K, Additional Resources, 
for websites and telephone numbers) 
VII. FINAL ADVICE 
Some final points to keep in mind: 
 Be empathetic/supportive 
 Encourage creativity 
 Expect and accept mistakes 
 Allow for candid opinions 
 Offer positive feedback 
 Offer appreciation for a job well done 
With all the components in place, your 
program will be successful in private provider 
practices participating in your assessment 
process. As a result of using the AFIX process 
to its full extent, you will see an increase in 
properly immunized populations. The 
process never ends, and vigilance must be 
kept to achieve our goal: 
Protect Vulnerable Populations 
from Vaccine Preventable Diseases
Appendix A 
List of 
High Risk Conditions 
This is a list of common high-risk medical conditions 
that are indications for obtaining a certain vaccination. 
It is not an all-inclusive list of 
who should be vaccinated against certain conditions. 
19
High Risk Conditions 
Heart Disease 
Influenza Vaccine 
394 Diseases of mitral valve 
395 Diseases of aortic valve 
396 Diseases of mitral and aortic valves 
398.91 Rheumatic heart failure (congestive) 
402.01, .11, .91 
Hypertensive heart disease with CHF 
404.01, .03, .11, .13 
Hypertensive heart and renal disease with 
CHF 
410 Acute myocardial infarction 
411 Other acute and subacute forms of 
ischemic heart disease 
412 Old myocardial infarction 
413 Angina pectoris 
414 Other forms of chronic ischemic heart 
disease 
416 Chronic pulmonary heart disease 
425 Cardiomyopathy 
428 Heart failure 
440 Artherosclerosis 
Pneumococcal Vaccine 
398.91 Rheumatic heart failure (congestive) 
402.01, .11, .91 
Hypertensive heart disease with CHF 
404.01, .03, .11, .91, .93 
Hypertensive heart and renal disease with 
CHF 
416 Chronic pulmonary heart disease 
425 Cardiomyopathy 
428 Heart failure 
20 
Cancer/HIV/Organ Transplantation 
Influenza Vaccine 
042 Human immunodeficiency virus 
(HIV) disease 
V42.0 Kidney transplant 
V42.1 Heart transplant 
V42.6 Lung transplant 
V42.7 Liver transplant 
V42.8 Bone marrow transplant 
V58.0 Radiation therapy 
V58.1 Chemotherapy 
Pneumococcal Vaccine 
042 Human immunodeficiency virus 
(HIV) disease 
V42.0 Kidney transplant 
V42.1 Heart transplant 
V42.6 Lung transplant 
V42.7 Liver transplant 
V42.8 Bone marrow transplant 
V58.0 Radiation therapy 
V58.1 Chemotherapy 
200 Lymphosarcoma and reticulosarcoma 
201 Hodgkins disease 
202 Other malignant neoplasms of 
lymphoid and histiocytic tissue 
203 Multiple myeloma and 
immunoproliferative neoplasms 
204 Lymphoid leukemia 
205 Myeloid leukemia 
206 Monocytic leukemia 
207 Other specified leukemia 
208 Leukemia of unspecified cell type
Liver Disease 
Pneumococcal Vaccine and 
Hepatitis A Vaccine 
571, 572, 573.0 
Chronic liver disease and cirrhosis 
Hepatitis A Vaccine 
Hepatitis C positive antibodies 
Cerebrospinal Fluid (CSF) Leak 
Pneumococcal Vaccine 
V45.2 CSF drain 
Travel 
Hepatitis A Vaccine 
(certain countriesrefer to ACIP 
recommendations) 
Hepatitis B Vaccine 
(certain countriesrefer to ACIP 
recommendations) 
Nursing home/ 
Long Term Care Facility Resident 
Influenza Vaccine 
Health Care Occupation 
Influenza Vaccine 
Lung Disease Other than Asthma 
Influenza Vaccine 
491 Chronic bronchitis 
492 Emphysema 
494 Bronchiectasis 
496 Chronic airway obstruction, NEC 
506.4 Chronic respiratory conditions due 
to fumes and vapors 
518 Compensatory emphysema 
Pneumococcal Vaccine 
491 Chronic bronchitis 
492 Emphysema 
494 Bronchiectasis 
496 Chronic airway obstruction, NEC 
506.4 Chronic respiratory conditions due 
to fumes and vapors 
518 Compensatory emphysema 
Alcoholism 
Pneumococcal Vaccine 
291 Alcoholic psychoses 
303 Alcohol dependence syndrome 
Asthma 
Influenza Vaccine 
493 Asthma 
Diabetes 
Influenza Vaccine 
250 Diabetes mellitus 
Pneumococcal Vaccine 
250 Diabetes mellitus 
Renal Disease 
Influenza Vaccine 
and Hepatitis B Vaccine 
585 Chronic renal failure 
Pneumococcal Vaccine 
and Hepatitis B Vaccine 
581 Nephrotic syndrome 
585 Chronic renal failure 
Blood Disorders 
Influenza Vaccine 
and Hepatitis A Vaccine 
282.4 Thalassemias 
282.6 Sickle-cell anemia 
Pneumococcal Vaccine 
and Hepatitis A Vaccine 
282.6 Sickle-cell anemia 
Asplenia 
Pneumococcal Vaccine 
759.0, 746.87 
Asplenia, asplenia with mesocardia 
21
Behavioral 
Hepatitis A Vaccine 
and Hepatitis B Vaccine 
Men who have sex with men (MSM) 
Intravenous (IV) Drug Use 
Hepatitis A Vaccine 
Non-Injecting Drug Use 
Hepatitis B Vaccine 
Drug usetype unknown 
High-risk sexual activity 
(defined as >2 sex partners in 6 months) 
Health care occupation 
22 
Race 
Pneumococcal Vaccine 
American Indian 
Alaskan Native 
Pregnancy 
(2nd or 3rd trimester during flu season) 
Influenza Vaccine
Appendix B 
Hybrid Assessment Method 
23
24
Hyprid Assessment Method 
What is the Hybrid Method? 
The hybrid method is a screening tool to help 
determine if a providers immunization coverage 
level is at or below a specific threshold. 
The hybrid method uses small sample sizes 
so it takes less time to conduct. Unfortunately, 
the hybrid method does not have diagnostic 
capabilities to determine why a provider 
might have low immunization coverage levels. 
The hybrid method incorporates the best of 
each method. It maintains the small sample 
size of Lot Quality Assurance (LQA) while 
providing some diagnostic information from 
a traditional assessment method. Please keep 
in mind that the hybrid method is not 
designed to determine the actual immunization 
coverage level for the practice but to 
determine if the practice is performing above 
or below a specific level. 
Terms Used 
The following is a list of terms that are used 
throughout the protocol. 
Threshold Level: 
The standard against which the provider 
is evaluated. If the threshold level is set at 
70%, then the assessment will determine if 
the provider has immunization coverage 
level above or below 70%. Use existing 
information to determine the appropriate 
threshold level for your area (for example: 
NIS estimates, public health center or private 
provider assessment information). 
Reference Number: 
The number of children in the sample 
allowed to be not up-to-date (UTD). If the 
number of children in the sample not 
UTD exceeds the reference number, then 
the provider has an immunization coverage 
level below the threshold level. 
Steps for Conducting 
a Hybrid Assessment 
Use the following protocol when using the 
hybrid method for the assessment. 
1. Prior to conducting the assessment, 
determine the threshold level and use 
the table below to identify the appropriate 
reference number. We will use a 
sample size of 30 charts, regardless of 
where the threshold level is set. 
REFERENCE NUMBER THRESHOLD LEVEL 
1
2
3
4
5
6
7 
90% 
85% 
80% 
75% 
70% 
65% 
60% 
2. Select charts. 
To be eligible for inclusion in the 
hybrid sample, a child must: 
 be 19-35 months of age 
 have made at least 2 visits to the 
practice 
 have no documentation in the chart 
of having moved or gone elsewhere 
for services 
We recommend selecting an extra 10-15 
charts so that there will be the appropriate 
number of charts remaining after excluding 
ineligible children. If more than 30 charts 
remain after removing the ineligible children, 
just review the first 30 charts in the group. 
Use one of the following methods to select a 
random sample of charts: 
1. If possible, obtain a listing of all ageeligible 
patients of the practice prior to 
conducting the assessment and 
randomly select 4550 children. 
2. If obtaining a list of patients is not 
possible, use the shelf method. 
Divide the sample size by the number 
25
of shelves holding patient charts. This 
will determine the number of charts to 
pull per shelf (i.e., if there are 10 
shelves and the sample size is 30, select 
3 charts per shelf). Randomly select a 
starting point on the shelf and sequentially 
review each chart until you find 
the appropriate number of charts from 
each shelf. 
3. As a last resort, review the appointment 
book to identify children. Select each 
age-eligible child who visited the 
practice during the month prior to the 
assessment until the appropriate sample 
size is met. You may need to extend 
the time period in order to select the 
appropriate number of children. 
3. Define up-to-date (UTD) for the 
assessment. 
4. In the immunization input screen, 
enter the childs name, date-of-birth 
and the number of doses of vaccine the 
child received. If you wish to do so, 
you may choose the Immunization 
History option to enter the actual date 
of each immunization. We recommend 
doing this only if the child is not UTD 
(this information is used for the 
diagnostic evaluation of missed 
opportunities and other causes of 
being not UTD). 
5. Separate the charts of children who are 
not UTD for the feedback session with 
the provider. 
6. When you have completed inputting 
information for the sample, select the 
option to run the Final Report. The 
Final Report will state the number of 
children UTD and not UTD in the sam- 
26 
ple, whether or not the practice has 
passed the Hybrid assessment based 
on the selected threshold level, as well 
as provide a listing of each child 
included in the sample. 
The hybrid software determines if the 
provider passed the assessment based 
on the number of children not UTD in 
the sample: 
 If this number is less than or equal 
to the reference number that corresponds 
to your selected threshold 
level, then the practice has a high 
probability of having coverage above 
the threshold level. 
 If this number is greater than the 
reference number that corresponds 
to you selected threshold level, then 
the practice has a high probability 
of having coverage below the 
threshold level. 
7. After running the Final Report, you 
will be prompted if you want to select 
a further analysis of the not UTD 
children. If you select yes, the hybrid 
method will provide a listing of 
children not UTD along with their 
immunization histories and comments 
describing the reason for being not 
UTD. 
8. During the feedback session, present 
results to the provider. Indicate 
whether or not the practice has an 
immunization coverage level above the 
threshold. Present the final report 
along with the analysis of the children 
not UTD. Use the charts of the children 
who are not UTD as a tool to discuss 
strategies for improving coverage. Appendix C 
Examples of 
Pre-Assessment Forms and Letters 
27
28
Provider name 
Address 
Phone # 
Private Provider Initial Contact Form 
Contact person (name and title) 
Fax # 
Number of children served Number in age range 
Patient age range in practice 
What kind of record keeping system for immunization records is used? 
 Computer  Medical Records  Card File  Other (Specify) 
How can we access records? (computer printout, pulled files, etc.) 
How are completed records reported? 
 Immunization cards 
 Summary form 
 Other (specify) 
Immunization screening policy used (ACIP, AAP, etc.) How long has this policy been used? 
When is DTP #4 given? 
When is MMR given? 
IPV schedule? 
Varicella, PCV-7, Hep A given? 
Type of insurance accepted: 
Percentage Medicaid 
How are active/non-active patients defined? 
Are they separate? 
Best day/time to do audits? 
Number of non-English speaking clients? 
What languages are spoken? 
How many staff ? (MD, RN, PA, MA, etc.) 
Computer system? 
Software: 
Notes: 
29
Department of Human Services: Immunization Offices 
AFIX Application and Enrollment Profile 
Thank you for your interest in AFIX and for your interest in improving immunization rates and practices 
in your clinic. Please fill out all fields on both of these forms and submit them to X (fax: xxx-xxx-xxxx). 
You will need to complete a separate Part B for each clinic site in your practice. We will contact you 
shortly by phone to discuss the next steps in the AFIX process. 
Part A: General Practice Information 
1. Name of practice or organization: 
2. Are there multiple sites for this practice? Yes  No 
If yes, please list each clinic or site name: 
1. 
2. 
3. 
4. 
5. 
3. Does this practice or organization participate in the immunization registry? 
Yes  No 
If yes, how often is immunization data submitted to the immunization registry? 
4. By which method is this data submitted? 
 Barcodes 
 Electronic file transfer from practice billing system 
 Electronic file transfer from medical records system 
 Public clinic: automated data entry 
5. Please describe general impressions of the immunization registry within your practice or 
organization: 
6. Does this practice or organization participate in the Vaccines for Children (VFC) program? 
Yes  No 
For Office Use Only: 
Time Frame Future Current 
30
Part B: Specific Clinic Site Location Information 
Please fill out a separate Part B for each clinic or site location within your practice. 
1. Clinic or site name: 
2. Clinic specialty: (Check one) 
 Pediatric  Family practice  Both  Neither/other: 
3. Clinic type: (please check one) 
 Private, FQHC 
 County health department 
 Other public agency 
 Other: 
 Private, non-FQHC 
 M/CHC 
 WIC site 
 Tribal agency 
4. Clinic contact information: 
Clinic website: 
Street address: 
City/State: Zip code: 
County: 
Clinic phone: Clinic fax: 
Clinic e-mail: 
5. Clinic Practitioners: 
Number of pediatricians at this clinic: 
Number of family physicians at this clinic: 
Number nurse practitioners at this clinic: 
Number physician assistants at this clinic: 
Number nursing staff (RN, LPN, CNA, etc.): 
Number office staff at this clinic: 
6. Approximate the number of children under 3 years old seen at this clinic: 
Please complete next page 
31
7. Who will be designated as the primary AFIX contact? 
First name: Last name: 
Title: E-mail: 
Phone: Fax: 
Hours at this phone number (ex: M, W, F, 9am - 2:30pm): 
8. Who is designated as the primary VFC contact? 
First name: Last name: 
Title: E-mail: 
Phone: Fax: 
Hours at this phone number (ex: M, W, F, 9am - 2:30pm): 
9. Who is the lead physician overseeing immunizations in this clinic? 
First name: Last name: 
Title: E-mail: 
Phone: Fax: 
Hours at this phone number (ex: M, W, F, 9am - 2:30pm): 
Authorizing signature 
of physician: 
By authorizing this application, I confirm that this practice recognizes AFIX as a continuous 
improvement process for immunization practices and is in the best interest of our practice 
and our patients. 
Thank you for completing these forms. 
Please return to: 
32
Department of Community Health 
Immunization Record Assessment Confirmation 
Thank you for your request to participate in an immunization record assessment, and for your 
interest in improving immunization rates and practices in your clinic. Please verify the 
information on this profile, make corrections as necessary, and sign the confirmation where 
indicated. Please fax the completed confirmation to . The immunization 
assessment office will mail a letter to your office that will confirm the scheduled dates for the 
chart review and the feedback meeting. 
NAME OF PRACTICE: 
DATE OF CHART REVIEW: 
DATE OF FEEDBACK MEETING: 
TIME OF FEEDBACK MEETING: 
The primary contact for the immunization record assessment is: 
Name: Title: 
Fax: Phone: 
E-mail: 
Hours at this phone number (ex: M, W, F, 9am  2:30pm): 
This practice recognizes the X immunization record assessment as a continuous improvement 
process for immunization practices that is in the best interest of our practice. By 
signing this confirmation, the practice 1) agrees to participate in the immunization record 
assessment, 2) grants X permission to review the immunization data for the provider in 
the X Childhood Immunization Registry, and 3) commits to the have medical staff in 
attendance at the feedback meeting on Feedback Date at Feedback Time. The list of patients 
with birth dates Birth Date Age Range, being generating by this practice, will be faxed to X 
within the next five business days. 
Signature of primary contact person: 
Provider ID: 
The immunization assessment staff will conduct a chart review for immunization data and 
review the immunization data for the provider in the registry. All information abstracted 
from the charts will be treated as confidential. 
The immunization record assessment for PracticeName is supervised by XX 
Immunization Assessment Coordinator. XX can be contacted at XXX-XXXX or by 
e-mail at 
33
(Date) 
PROVIDER ADDRESS INFO 
Dear CONTACT PERSON: 
Thank you for your interest in the Immunization Record Assessment. The chart review date is 
scheduled for Date of Chart Review. The list of patients with dates of birth from Birth Date Age 
Range has not yet been generated by your practice. When the list of children is generated, please 
call our office to let us know you have the list and then fax the list of children to the X 
Immunization Assessment office, attention XX at . Name of Assessor, a Department 
of Community Health Immunization Assessment Specialist, will arrive at your office at approximately 
ARRIVAL TIME and will be conducting the chart review for approximately 4 hours. 
During the chart review Name of Assessor will need a table or empty desk upon which she may 
place a lap top computer and a full-size keyboard. An electrical outlet is also required in an 
adequate space to review the charts (i.e., conference room, break room, empty desk, etc.). When 
we receive a faxed copy of your list of children, you will be instructed on which charts to pull 
before the assessors arrival. 
After the chart review, the immunization assessment staff will compare the immunization data 
in the X Childhood Immunization Registry with the data collected at the chart review. The 
results of this data review will be discussed at the feedback meeting. 
The Assessment Feedback meeting is scheduled for Feedback Date at Time of Feedback. All clinical 
staff is to attend this 1-hour meeting. Name of Presentor, Immunization Assessment Specialist, 
will present this feedback meeting. The immunization coordinator from your local health 
department, the regional staff and the X immunization field representative are interested in 
increasing immunization levels for your practice, and they will be invited to attend the feedback 
meeting. 
If you have any questions concerning the methods used to assess your records or need to 
reschedule, please feel free to call me at . Otherwise, we look forward to seeing 
you on Date of Chart Review. Your continued partnership is critical to our efforts to ensure the 
health and well being of children in our state through the administration of age-appropriate 
immunizations. 
Sincerely, 
XXX, Immunization Assessment Coordinator 
Communicable Disease and Immunization Division 
Bureau of Epidemiology 
cc: Immunization Coordinator, County County Health Department 
Field Rep, Immunization Field Representative 
34
Appendix D 
Public Health Implications of the 
Health Insurance Portability and Accountability Act (HIPAA) 
Informational Memo and Fact Sheet 
A Product of the National Immunization Program 
35
36
Date: August 11, 2003 
From: Director, National Immunization Program 
Subject: Public Health Implications of the Health Insurance Portability and Accountability Act 
(HIPAA) Privacy Rule 
To: Immunization Program Managers 
State Epidemiologists 
Dear Colleague: 
MEMORANDUM 
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, which went 
into effect April 14, 2003, is having unintended consequences on some of the core functions of 
public health. The intent of HIPAA is to establish national standards for consumer privacy 
protection and insurance market reform. Unfortunately, a lack of information and 
misinterpretation of some HIPAA provisions has begun to hamper the conduct of time-honored 
public health activities. In some instances, confusion about the intent and implementation of 
the rules has resulted in health care providers refusing public health officials access to patient 
records for immunization assessment and surveillance purposes. We recognize that providers 
are concerned about compliance and they need clear and accurate information about the practical 
application of the HIPAA Privacy Rule on public health practices. 
The National Immunization Program (NIP) of the Centers for Disease Control and Prevention 
(CDC) is working closely with Health and Human Services (HHS) Office for Civil Rights, which 
is the lead agency for interpreting and enforcing HIPAA, and the CDC legal counsel to clarify 
public health provisions of the Privacy Rule and disseminate information to our partners at the 
state and local levels. Due to the complexity of the HIPAA Privacy Rule, NIP plans to develop 
periodic advisories regarding policy issues and interpretation of confidentiality provisions that 
may affect public health activities. Some principal areas on which states have requested 
clarification deal with access to patient records to conduct VFC and AFIX site visits, 
participation in immunization registries, and disease surveillance and epidemiologic follow-up 
as part of outbreak investigation. 
The first of a series of HIPAA guidance statements is attached with this mailing. The one page 
HIPAA and Public Health Factsheet provides a brief summary of HIPAA and Privacy Rule 
definitions. The HIPAA and Public Health Site Visits: Access to Patient Records during AFIX 
and VFC Visits provides responses to specific questions asked by the states regarding 
disclosure of patient health information without prior authorization during VFC and AFIX 
provider site visits. The responses to these questions were prepared by the CDC Office of 
General Counsel, which provides legal advice for CDC programs on issues such as 
implementation of HIPAA. Additional information is available on the Office for Civil Rights 
website at http://www.hhs.gov/ocr/hipaa and in the MMWR, HIPAA Privacy Rule and Public 
Health: http://www.cdc.gov/mmwr/pdf/other/m2e411.pdf. 
37
Page 2 - Dear Colleague/Public Health Implications - HIPAA 
We hope you will find this information helpful as you educate your provider groups and work 
with your respective legal offices on HIPAA issues. We are encouraged that all of the written 
and oral questions NIP has submitted to HHS about the impact of HIPAA on immunization 
activities have affirmed NIPs position that state and local health agencies may continue to carry 
out routine public health activities while remaining in full compliance with HIPAA. 
/ Original Signed By / 
Walter A. Orenstein, M.D. 
Attachment 
cc: 
Chair, Association of State and Territorial Health Officials 
Chair, Association of Immunization Managers 
38
Health Insurance Portability and Accountability Act 
and Public Health Factsheet 
What is HIPAA? 
The Health Insurance Portability and 
Accountability Act of 1996 (Public Law 104- 
191) established a national floor of consumer 
privacy protection and marketplace reform. 
Some key provisions include: insurance 
reforms, privacy and security, administrative 
simplification, and cost savings. 
What is the HIPAA Privacy Rule? 
HIPAA required Congress to enact privacy 
legislation by August 1999 or the Secretary of 
DHHS was to develop regulations protecting 
privacy. The HIPAA Privacy Rule (Standards 
for Privacy of Individually Identifiable 
Health Information) sets national minimal 
standards for protected health information. 
Implications for Public Health 
The Privacy Rule strikes a balance between 
protecting patient information and allowing 
traditional public health activities to continue. 
Disclosure of patient health information 
without the authorization of the individual is 
permitted for purposes including but not 
limited to 1) disclosures required by law (45 
CFR  164.512(a)) or 2) for public health 
activities and purposes. This includes 
disclosure to a public health authority that 
is authorized by law to collect or receive such 
information for the purpose of preventing or 
controlling disease, injury, or disability, 
including but not limited to, the reporting of 
disease, injury, vital events. . ., and the 
conduct of public health surveillance,. . . 
investigations, and. . . interventions. 
(45 CFR  164.512(b)(i)) 
Definition of 
Public Health Authority 
Defined as an agency or authority of the 
United States, a State, a territory, a political 
subdivision of a State or territory, or an 
Indian tribe, or a person or entity acting 
under a grant of authority from or contract 
with such public agency, including the 
employees or agents of such public agency or 
its contractors or persons or entities to whom 
it has granted authority, that is responsible 
for public health matters as part of its official 
mandates. (45 CFR  164.501) 
39
HIPAA and Public Health Site Visits 
Access to Patient Records during AFIX and VFC Visits 
Responses to Frequently Asked Questions about AFIX and VFC 
This guidance is intended to give health care 
providers and public health agencies specific 
information regarding the HIPAA Privacy 
Rule and access to patient records during 
Assessment, Feedback, Incentives, Exchange 
(AFIX) and Vaccines for Children (VFC) site 
visits. Several frequently asked questions 
posed to the CDC legal counsel for interpretation 
are presented below. Additional 
sources of information and reference 
materials available on the internet are also 
included. 
Q1. Can patient records be reviewed by 
health department staff, or their contractual 
agents such as the American 
Academy of Pediatrics (AAP) or the 
Visiting Nurses Association (VNA), 
for the purpose of conducting AFIX 
provider site visits? 
A1. Yes. Under 45 CFR  164.512(b) of the 
HIPAA Privacy Rule, covered entities 
may disclose protected health information 
without authorization to public 
health authorities that are authorized 
by law to collect such information for 
public health purposes. AFIX, authorized 
under section 317 of the Public 
Health Service Act, is a public health 
strategy to raise immunization coverage 
levels and improve standards of 
practices at the provider level. AFIX 
providers, as covered entities, may 
share patient records with health 
department staff or their contractors 
because a health department is a public 
health authority authorized by law to 
review patient records for AFIX purposes, 
or because health department 
contractors are acting under a grant of 
authority from a public health authority. 
In addition, state health departments 
may have authority under 
applicable state law to collect this 
information. 
40 
Q2. Can patient records be reviewed by 
health officials or their agents for the 
purpose of conducting VFC provider 
site visits? 
A2. Yes. As explained in A1. above, under 
45 CFR  164.512(b) of the HIPAA 
Privacy Rule, covered entities may 
disclose protected health information 
without authorization to public health 
authorities that are authorized by law 
to collect such information for public 
health purposes. VFC is a public health 
program that provides vaccines for 
children in certain eligibility groups. 
The VFC program was authorized 
under Section 1928 of the Social 
Security Act and has been delegated to 
CDC to administer. VFC providers, as 
covered entities, may share patient 
records with health officials or their 
agents because a health department is 
a public health authority authorized by 
law to review patient records for VFC 
purposes, or because contractors are 
acting under a grant of authority from 
a public health authority. 
Q3. Are VFC providers required to allow 
health officials access to the immunization 
records of children in their 
practice to determine compliance with 
VFC requirements? 
A3. The HIPAA Privacy Rule permits 
providers to share immunization 
records with public health officials for 
public health purposes as otherwise 
authorized by law. Under the VFC 
statute, at 42 U.S.C. 1396s(c)(2), as a 
condition of participation in the VFC 
program providers must share immunization 
records with health officials to 
verify compliance with VFC program 
requirements, including:
1. screening of all children in their 
practice to determine VFC eligibility 
2. to determine provider compliance 
with the VFC immunization 
schedule regarding the appropriate 
periodicity, dosage and contraindications 
applicable to the vaccines 
3. to determine provider compliance 
with applicable State law, including 
any such law relating to any 
religious or other exemption 
4. to verify that VFC vaccine-eligible 
children are not being charged for 
the cost of the vaccine 
5. to verify that any administration 
fees being charged do not exceed 
the caps established by CMS; 
6. to verify that the provider does not 
deny administration of vaccine to 
vaccine-eligible children due to the 
inability of the childs parent to pay 
an administration fee. 
Q4. Can health care providers, daycare 
operators, Head Start and school officials 
share immunization information 
with another provider or school to 
update missing immunization history 
or bring children into compliance 
with daycare, Head Start and school 
requirements? 
A4. Health care providers (or other covered 
entities) may share immunization 
information with other health care 
providers as needed to make treatment 
decisions, such as to give further 
immunizations. Providers may also 
disclose immunization information to 
schools, without authorization, if permitted 
or required by State law. These 
State laws would not be preempted by 
the Privacy Rule. (45 CFR 160.203(c)). 
In the absence of such a State law, it 
appears that such disclosures to schools 
will require individual authorization. 
Immunization records held by day care 
centers and schools are not protected 
health information under the Privacy 
Rule. Disclosures of immunization 
information by schools is covered by 
the Family Educational Rights and 
Privacy Act (FERPA). (45 CFR 164.501). 
Q5. Can patient identifiers, including 
name and birthdate, be collected and 
stored electronically, incidental to 
AFIX or VFC visits? 
A5. Yes. Under 45 CFR  164.512(b) of the 
HIPAA Privacy Rule, covered entities 
may disclose protected health information
including name, birthdate, and 
other individually identifiable health 
informationto public health authorities 
that are authorized by law to collect 
such information for public health 
purposes. However, other requirements 
of the Privacy Rule (including minimum 
necessary, verification of identity, and 
accounting requirements) may apply to 
covered entities making these disclosures. 
For a full explanation of these 
requirements, see the website of the 
Office for Civil Rights (www.hhs.gov/ 
ocr/hipaa) (responsible for enforcing the 
Privacy Rule), or CDC/HHS guidance 
on the Privacy Rule and Public Health, 
available at http://www.cdc.gov/mmwr/ 
pdf/other/ m2e411.pdf. Once protected 
health information has been disclosed 
to a public health authority for a public 
health activity pursuant to section 
164.512(b) of the Privacy Rule, the 
information may be stored in whatever 
way is reasonable for conducting the 
public health activity, including electronically, 
so long as the storage is 
consistent with other applicable state 
and federal law. 
Links to additional sources of information 
may be found on the CDC website at 
www.cdc.gov/vaccines/programs/iis/ 
41
42
Appendix E 
Examples of Confidentiality Information 
Examples based on state program forms 
43
Statement of Confidentiality 
Immunization Survey Data 
(Date) 
Pursuant to Section N of the Health and Safety Code regarding immunization data gathered 
during the conduct of surveys or studies:
(insert law here) 
Immunization data collected during the conduct of clinic assessments and/or special immunization 
studies shall be released as aggregate statistics only to maintain confidentiality. 
Assessed entities shall be provided individual immunization histories of their clients upon 
request and for the purpose of identifying persons who may be in need of immunizations. 
Director of Health 
44
Confidentiality Statement for 
Review of Private Patient Information 
During VFC Site Reviews 
During the VFC Site Review, the VFC Field Representative enters immunization information of 
a sample of your private and VFC-eligible patients into a laptop computer in order to obtain an 
overall evaluation of your immunization coverage rates. The data gained in this process allow 
VFC staff to offer tailored solutions to the problems of missed opportunities to vaccinate and 
under-vaccination. 
Private patient immunization data, in addition to VFC-eligible patient data, is used to obtain 
more accurate results, for better feedback to VFC providers about ways to maximize immunization 
levels in their practices. 
VFC staff will use these data solely for the purpose of statistical analysis. VFCs reports will not 
reflect any patient information obtained by VFC staff from a provider. To the extent permitted 
by law, VFC staff will distribute only information from site review assessments in aggregate 
form. VFC staff intends to use patient identifiers solely for the purpose of avoiding duplication 
of data entry. 
The analysis of immunization data from both private and VFC-eligible patients is a critical component 
in providing an accurate evaluation of immunization rates within this state. Thank you 
for your cooperation. Please contact, , Provider Services Specialist, if you 
have any questions. 
45
46
Appendix F 
Methods for 
Selecting a Random Sample 
47
A Menu of Options for Sampling Plans 
The clinics choice of a sampling plan 
depends on the type of record keeping 
system already in place. 
A. Census or Complete Enumeration 
If a clinic has a computerized data system, 
it would be relatively easy to do a census 
or complete enumeration of the records in 
the system. Assessment becomes a simple 
matter of accessing the computer files, 
selecting all eligible 2-year-olds, and 
counting the number of these children 
who are up-to-date on vaccinations at 
their second birthday and at earlier age 
markers. Similarly, if a clinic has fewer 
than 50 2-year-olds, the time spent doing a 
complete enumeration may not be much 
more than the time it would take to do a 
survey. In both clinics, sampling error 
would no longer be an issuean advantage 
that a complete enumeration has over 
a sample survey. However, a census could 
still be subject to nonsampling error. 
In other clinics, it would be difficult, timeconsuming, 
and expensive to do a complete 
enumeration. In these clinics a 
sample survey needs to be done. This 
involves deciding on a sampling procedure, 
calculating sample sizes, selecting 
the sample, and computing the appropriate 
estimates and the corresponding sampling 
error. Following are some options 
for the sampling procedure. 
B. Simple Random Sampling 
With simple random sampling (SRS), 
every possible sample of n children from a 
population of size N has the same chance 
of being chosen. Following are the steps to 
be taken when selecting a simple random 
sample. 
Step 1 Label the children in the survey 
population from 1 to N. 
Step 2 Take n random numbers between 
1 and N. The selection must be 
done without replacement; i.e., if 
48 
a number is the same as any one 
of the previous numbers selected, 
discard it and continue until n 
different numbers between 1 and 
N have been chosen. (Use either 
a table of random numbers like 
Table 1 or a computerized random 
number generator.) 
Step 3 Select the children corresponding 
to the n numbers generated in 
step 2. 
Example 
Suppose that we need to select 10 records 
from a collection of 100 clinic records. We 
number the records in the sampling frame 
from 1 to 100. Then, using a table of random 
numbers such as in Table 1, we pick 
10 random numbers. Because we want 
numbers between 1 and 100, we read off 
three digits at a time. Reading from left to 
right and from top to bottom, the first two 
numbers (332 and 767) are discarded 
because they are larger than 100. The next 
number, 099, is chosen. The second number 
selected is 034. All numbers read that 
fall between 1 and 100 are in boldface 
(Table 1). Note that 099 is selected twice, 
but we include it only once. The number 
34 is also read twice but is included only 
once. Hence, the 10 numbers selected are 
99, 34, 15, 81, 43, 25, 1, 5, 85, and 100. We 
then pull out the 1st, 5th, 15th, 25th, 34th, 
43rd, 81st, 85th, 99th and the 100th records 
from our files. 
Conceptually, SRS is the simplest type of 
sampling plan. At the implementation stage, 
however, SRS may present some problems. In 
some clinics, it may be difficult to construct a 
list of all the N children before sampling and 
to train personnel to generate n random 
numbers . In these situations, systematic 
sampling may be easier to implement. Table 1 
A Portion of a Table of Random Numbers 
33276 70997 79936 56865 05859 90106 
03427 49626 69445 18663 72695 52180 
92737 88974 33488 36320 17617 30015 
85689 48237 52267 67689 93394 01511 
08178 77233 13916 47564 81056 97735 
51259 77452 16308 60756 92144 49442 
60268 89368 19885 55322 44819 01188 
94904 31273 04146 18594 29852 71685 
58586 23216 14513 83149 98736 23495 
09998 42698 06691 76988 13602 51851 
14346 09172 30163 90229 04734 59193 
74103 47070 25306 76468 26384 58151 
24200 13363 38005 94342 28728 35806 
87308 58731 00256 45834 15398 46557 
07351 19731 92420 60952 61280 50001 
C. Systematic Sampling 
Systematic sampling is easy to apply 
because it simply involves taking every 
kth child after a random start. The following 
are steps to be taken when selecting a 
1-in-k systematic sample. 
Step 1 Divide the population size N by 
the required sample size n to get 
the sampling interval k, 
k = N/n. 
If k is not an integer, round it 
down to the nearest integer, i.e., 
truncate the number. 
Step 2 Take a random number between 1 
and k to determine the first child 
to be included in the sample. 
Step 3 Add into the sample every kth 
child after the random start in the 
preceding step. 
Example 
Suppose that we need a sample of 5 out of 
28 records. Then k=28/5=5.6, not an 
integer, and hence we round it down to 
the nearest integer, 5. Using a table of 
random numbers, select a number between 
1 and 5, say 2. The random start is 2, and 
the second record is selected first. Starting 
with the third record, count from 1 to 5 
and pull the last record, i.e., the seventh 
record from the file is selected. Repeat the 
procedure until 5 records are selected or 
the end of the file is reached. Thus, with a 
random start of 2 and a sampling interval 
of 5, the 2nd, 7th, 12th, 17th, 22nd, and 
27th records are selected. Note that because 
we rounded the sampling interval down 
to the nearest integer, we get a sample size 
of 6 instead of the intended size of 5. This 
process is illustrated in Table 2. Note that 
the 1-in-k systematic sampling essentially 
divides the population into groups of k 
(k=5 in our example) and one record is 
selected from each group. The random 
start fixes the position of the record selected 
within each group; in our example, every 
2nd record in a group of 5. If the selection 
process got interrupted, it is helpful to 
know that the jth selection is determined 
by the formula 
jth selection = (random start) + (j-1) 
(sampling interval). 
For example, the 3rd selection will be 
2+(3-1)(5)=12 and the 6th selection will be 
2+(6-1)*5=27. 
D. Two-step shelf method 
Step 1 Determine total number of 
eligible patients in the practice 
1. Choose one typical shelf in the 
practice. Review each chart on 
that shelf to identify the number 
of patients meeting your 
eligibility criteria. 
2. Count the total number of shelves 
in the office. 
3. Complete the following formula: 
(   ) 
# eligible 
in practice 
# shelves 
total 
# eligible 
on 1 shelf 
49
Step 2 Select a sample of eligible patients 
1. Randomly select a shelf 
2. Pull each eligible chart from the 
shelf (use the table below to keep 
track of the number of charts 
pulled from each age group) 
3. Repeat steps 1 and 2 until you 
have selected the number of 
charts required for your assessment 
(e.g. 100 charts) 
Birth date range 
for eligibility 
Age 
Group 
Number of eligible 
charts abstracted for 
data in each age group 
/ /  / / 1849 
/ /  / / 5064 
/ /  / / >65 
When you have reached your 
quota of eligible charts, complete 
the following: 
Total # eligible patients sampled: 
1849 
5064 
>65 
50 
Table 2 
A 1-in-5 Systematic Sampling from 
28 Records Using a Random Start of 2 
Record 
Number 
1
2
3
4
5
6
7
8
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 
25 
26 
27 
28 
Record to be selected 
in the sample 
x
x
x
x
x
x
Appendix G 
Using Registries 
for 
Immunization Assessment 
51
Using Registries for Immunization Assessment 
The purpose of this appendix is to provide 
guidance on how to begin using registry data 
for assessments and crucial issues to first 
address. 
What is a registry-based assessment? 
A registry-based assessment is one in which 
all data come from the immunization registry 
rather than clinic charts. 
Why use a registry-based assessment 
methodology with AFIX activities? 
As immunization registries grow to be more 
complete, advantages become available for 
AFIX visits. Such advantages include: 
 Capability to target provider site visits 
to clinics with low coverage rates or 
problematic practice issues 
 Ease of assessing longitudinal impact of 
AFIX activities 
 Assistance in building synergy amongst 
providers and immunization registry 
efforts in the pursuit of achieving 2010 
goal of 90% immunization coverage 
 Reduction in time spent extracting and 
replacing medical records, and entry of 
immunization data 
 Incorporating key registry functions into 
AFIX Feedback visits that will help 
assist providers in their pursuit of 
increasing immunization coverage levels 
of their patient population (i.e. 
reminder/recall systems) 
Registry-based 
Allows for true population-based rates 
True missed opportunities cannot be 
discussed unless all visits (not just 
immunization visits) are recorded 
Records entered electronically 
Provides opportunities to study impact 
of AFIX activities longitudinally with 
relative ease 
What are the differences 
between a 
chart-pull assessment 
and a registrybased 
assessment? 
(Differences will 
largely depend on 
how each project has 
defined its 
methodology, but 
these are some 
potential differences) 
Time can be devoted to feedback, since 
the assessment is relatively fast and not 
resource intensive 
52 
What are some key initial data issues? 
(to be addressed when first thinking about going 
to a registry-based assessment) 
 Define the denominator (the patients to 
be included from that site) 
> All patients who have ever received 
at least one immunization 
> All patients who have received an 
immunization in the past year 
> Those patients who were last seen at a 
particular location 
> Other 
Defining the denominator and being able to 
describe the rationale for it is one of the most 
important steps. The definition of choice 
should, in part, be based on what information 
will be most valuable to the providers 
receiving the assessments. 
 Denominator analysis (checking the 
chosen denominator definition) 
> How do the denominators showing 
up in the registry-based assessments 
relate to what is known about the 
population of the related clinics? (i.e., 
Does a clinic with 100 patients have a 
denominator of 1000?) There must be 
a reasonable answer for the denominator 
before the data are used. 
> Compared with other sources of data 
for this same age group, how do the 
denominators compare in terms of 
numbers and patient characteristics? 
Chart-pull based 
Rates are based on a sample 
Missed opportunities can be discussed 
Records entered manually 
Research opportunities available but 
more time intensive 
Time must be split between the 
assessment and the feedback, both of 
which may be time intensive
(Note that providers are unreliable 
sources of information on denominators
they are often not sure how 
many children between 1 and 3 that 
they see.) 
 Understand the differences between 
the current methodology (chart-pull) 
and what the registry-based assessment 
will provide. 
> Denominator differences 
> Resource differences 
Understanding these and other differences 
will be important to communicating the 
assessment methodology to providers. Also, 
understanding these differences will enable 
providers to better understand the assessment 
results. 
 Determine a method to quantify the 
consistency, timeliness, and accuracy 
with which different providers send 
data to the registry. 
> When given the name of a particular 
provider, do you have a way of knowing 
how well they submit/enter data? 
> Are you and providers confident in 
the accuracy of your method? 
Registry participation can significantly affect 
the results of the assessment, so this is an 
important step. Knowing how well a provider 
participates in the registry becomes a tool to 
better understand and communicate the 
results of the assessment. 
Not being able to quantify this information 
should not stop one from continuing, but this 
information will become important with more 
registry-based assessments. 
As part of feedback sessions, it is wise to 
devote time to discussing registry participation 
with the practice. 
 Foster a good relationship with the 
registry staff. This will be a crucial component 
and communicating regularly 
and openly will be important. 
 Understand how the registry maintains 
internal data quality. 
> What is the frequency of and process 
for data deduplication? 
> How are data merged from various 
sources? 
> What is the registry doing about 
merging immunization records? 
> How is the registry actively involved 
in improving data quality? 
> Does the registry allow providers 
regular access to the reported data 
(i.e. monthly registry reports) for the 
purpose of appropriate feedback? 
These are all key issues to understand, 
because they can affect the quality of the 
assessments. Developing a strong relationship 
with the registry staff can begin to 
uncover these and other important data 
issues. 
Also, it is important to communicate to the 
registry staff that AFIX can be a useful feedback 
tool that can help provide the registry 
with valuable information about its data 
quality. 
Key Data Quality Checks 
Issues of reliability and validity must be 
addressed, because providers will inevitable 
ask questions about these issues. 
In general, be prepared to take the time to 
critically assess the registry-based assessments 
before beginning to provide them to 
clinics. 
 Historical and concurrent data analysis 
(use as many sites as possible) 
> Up-to-date rates (compare rates as 
well as differences in rates; are the 
registry-based rates lower than the 
chart-pull assessments by a consistent 
percentage over time?) 
> Do several registry-based assessments 
provide similar trend information 
(drop-offs, late starts, etc) as the chartreview 
assessments? 
> If reliable historical coverage rates are 
available for many clinic sites, 
compare registry-based assessments 
with these data. Look for individual 
practice and group differences. When 
ranked highest to lowest with the 
reliable historical data, do the 
53
registry-based assessments show similar 
rankings (keeping confidence 
intervals in mind)? 
> When doing quartile analysis (boxplots) 
with the registry assessments, 
do clinics remain in the same quartiles 
in which they were previously 
placed? 
There will likely not be a perfect correlation 
between chart-review assessments and registrybased 
assessments, but that isnt necessary to 
begin using the data (see General Philosophy of 
Registry Data Use for more on this). 
Once the above issues have been addressed and 
you are able to articulate the process, you may be 
ready to begin using the data in assessments. 
Selling Providers on the 
Benefits of Registry Participation 
Promoting registry participation should 
become an integral part of a registry-based 
AFIX program. Part of promoting the registry 
involves showing providers how assessments 
are only one advantage among many of participating 
in a registry. 
The following are important benefits to participating 
in a registry: 
 Allows for free and easy assessment of 
immunization rates and practices 
 Allows for access to more complete histories 
 Allows schools and other authorized 
users to view the immunization information 
rather than calling the provider 
for the information 
 When needing to recall a certain patient 
population, the registry becomes a powerful 
tool 
 Registry-based reminder/recall becomes 
a possibility 
54 
General Philosophy of 
Registry Data Use 
 Use the data, and it will get better 
 Use it or lose it 
 Show providers tangible results of the 
data they are submitting to the registry 
 Improving immunization practice is 
more important than improving rates, 
and rates will improve with practice 
(focusing less on the rates will help 
providers focus more on discussing 
practice rather than debating the 
pros/cons of the data itself) 
 Be willing to admit that the data are not 
perfect 
 Use registry data for assessments only 
when able to articulate the methodology 
to providers. Do careful analyses and be 
confident 
 Communicate to providers the strengths 
of the registry-based assessments
Appendix H 
Examples and Tips on Partnering 
55
56
Partnering to Implement AFIX 
AFIX has primarily been a health department 
initiated activity. However, a variety of partners 
could be involved in the various parts of 
the AFIX process. Please consider the following 
suggestions for partnering when implementing 
AFIX. 
Assessment: This is often the most labor 
intensive part of AFIX and can provide 
opportunities to partner with a variety 
groups or organizations such as VFC programs, 
immunization coalitions, managed 
care organizations, insurers, local chapters of 
the AAP & AAFP, service clubs, and colleges 
and universities. These partners may assist 
by extracting data, pulling/re-filing charts, 
enlisting private practices to participate, and 
preparing reports. 
Feedback: Within the feedback process, 
opportunities to partner are limited due to 
the sensitive and confidential nature of this 
part of the process. However, partners like 
immunization coalitions, managed care 
organizations, insurers, vaccine representatives, 
local chapters of the AAP & AAFP and 
service clubs may be able to assist by 
providing resources (food, space, funds to 
cover reproduction costs for reports) to 
support the feedback session. 
Incentives: Most AFIX programs have 
minimal resources to provide incentives. 
Therefore, partnering with other organizations 
to offer incentives is recommended. 
Please refer to the Incentive section for incentive 
ideas. 
eXchange of Information: Partnering is 
useful during this part of AFIX. Identifying 
partners that are willing to reinforce the 
strengths and monitor the recommended 
changes of practices can lead to increased 
commitment by practices and sustain 
improvement in immunization rates over 
time. Immunization coalitions, local 
AAP/AAFP chapters and insurers are good 
partners for this activity. 
57
58
Appendix I 
Graphical Representation of 
Immunization Coverage Levels 
Between Practices 
Examples based on state program graphics 
59
60
HMO A 
Age-Appropriate* Up-to-Date Rates: HMO Average 
HMO B 
61
62
Appendix J 
Examples of Vaccine Administration Records 
for Medical Charts 
Examples provided by 
Immunization Action Coalition 
http://www.immunize.org/ 
63
64
65
66
67
68
69
70
Appendix K 
Additional Resources 
71
72
Helpful Resources for You and Your Providers 
TELEPHONE NUMBERS: 
National Immunization Hotline: 
(English) 1-800-232-2522 
(Spanish) 1-800-232-0233 
(TTY) 1-800-243-7889 
FREQUENTLY USED 
IMMUNIZATION WEBSITES: 
National Immunization Program 
http://www.cdc.gov/vaccines 
AFIX 
http://www.cdc.gov/vaccines/programs/afix/ 
Immunization Action Coalition 
http://www.immunize.org/ 
The Childrens Hospital of Philadelphia 
http://www.vaccine.chop.edu/ 
National Network for 
Immunization Information 
http://www.immunizationinfo.org/ 
Every Child by Two 
http://www.ecbt.org 
American Academy of Pediatrics 
Childhood Immunization Support 
Program 
http://www.cispimmunize.org 
HIPAA (MMWR 2003) 
http://www.cdc.gov/mmwr/preview/ 
mmwrhtml/su5201a1.htm 
CONTINUTING EDUCATION 
CREDENTIALING ORGANIZATIONS: 
International Association for 
Continuing Education and Training 
http://www.iacet.org/ and 
http://www.iacet.org/index2.htm 
American Nurses Credentialing Center 
of American Nurses Association 
http://www.ana.org/ancc/reviews.htm 
Accreditation Council for 
Continuing Medical Education 
www.accme.org 
National Commission for Health 
Education Credentialing, Inc (CHES) 
http://www.nchec.org/newhome.htm 
http://www.nchec.org/continuing_education 
%20map.htm 
American Association of 
Medical Assistants, Inc. 
http://www.aama-ntl.org/ed/pprm.html 
National Center for Competency Testing  
National Certified Medical Office 
Assistant (NCMOA) 
http://www.ncctinc.com/reference/ 
onlineCEU00.htm 
73
74
Appendix L 
Glossary of Terms 
75
76
ACASA The Adult (and Adolescent) Clinic 
ACIP 
Administrative Data 
AFIX 
AARP 
AAP 
Glossary 
Assessment Software Application 
(ACASA) to facilitate obtaining 
immunization data on adults and adolescents. 
Like its pediatric counterpart, 
CASA, ACASA is a tool for assessing 
immunization practices within a clinic, 
private practice, or any other 
environment where immunizations are 
provided. 
Advisory Committee on Immunization 
Practices (ACIP) is a panel of experts 
who make recommendations on the use 
of vaccines in the United States. The 
panel is advised on current issues by 
representatives from the Centers for 
Disease Control and Prevention, Food 
and Drug Administration, National 
Institutes of Health, American 
Academy of Pediatrics, American 
Academy of Family Physicians, 
American Medical Association and 
others. The recommendations of the 
ACIP guide immunization practice at 
the federal, state and local level. 
Information on medical procedures 
such as immunizations that is collected, 
processed and stored in automated 
information systems. 
Acronym for the continuous quality 
improvement strategy of Assessment 
of immunization coverage levels, 
Feedback of coverage level to provider 
and staff, Incentives to improve 
coverage levels and eXchange of 
information of how to make changes in 
immunization service delivery to 
improve coverage levels. 
American Association of Retired 
Persons is a nonprofit membership 
organization dedicated to addressing 
the needs and interests of persons 50 
and older. The organization seeks to 
enhance the quality of life for all by 
promoting independence, dignity and 
purpose. www.aarp.org 
The American Academy of Pediatrics 
(AAP) and its member pediatricians 
are dedicated to the health, safety and 
well-being of all infants, children, adolescents 
and young adults. The AAP 
has members in the United States, 
Canada and Latin America. Members 
include pediatricians, pediatric medical 
sub specialists and pediatric surgical 
specialists. www.aap.org/ 
AAFP The American Academy of Family 
Physicians is the national association 
of family doctors. It is one of the 
largest national medical organizations, 
with members in 50 states, D.C., 
Puerto Rico, the Virgin Islands, and 
Guam. www.aafp.org/ 
Assessment 
The Standardized collection, analysis 
and summary of how well a provider 
is delivering immunizations. Both 
qualitative (office workflow, interaction 
with patients) and quantitative 
(immunization coverage levels) data 
should be collected during this 
component of AFIX. 
CASA Clinical Assessment Software 
Application a menu driven software 
program developed by the National 
Immunization Program/Centers for 
Disease Control (CDC) to assist in the 
assessment component of AFIX. 
Continuous Quality Improvement (CQI) 
A process which continually monitors 
performance on specific measure such 
as immunizations. When a problem is 
identified, CQI develops a new 
method of implementing services 
related to the measure and monitors 
the success of the intervention. 
CMS Centers for Medicare & Medicaid 
Services (CMS), the federal agency that 
runs the Medicare program. In 
addition, it works with the States to 
run the Medicaid program. CMS works 
to make sure that the beneficiaries in 
these programs are able to get high 
quality health care. 
Centers for Disease Control and Prevention 
(CDC) 
The Centers for Disease Control and 
Prevention is the lead federal agency 
for protecting the health and safety of 
Americans. CDC's mission is to 
promote health and quality of life by 
preventing and controlling disease, 
injury, and disability. 
77
EPSDT Early, Periodic Screening, Diagnosis 
and Treatment Program. The comprehensive 
well child program available 
to children enrolled in Medicaid under 
the age of 21 years. 
Exchange of Information 
Providing access to more experience 
than individuals can accumulate by 
themselves. Exchanging information 
maybe done formally or informally 
and should be included in the feedback 
session. The gold standard for 
information exchange is peer to peer 
with an immunization champion. 
Informal methods used during the 
feedback can be very effective in 
certain situations. 
Feedback The process of informing immunization 
providers about their performance 
in providing vaccines to a specifically 
defined population. It must be a two 
way conversation between the assessment 
staff and the provider and office 
staff to determine what interventions 
can realistically be implemented in that 
office. 
Health Employer Data and Information Set 
(HEDIS) 
A set of standard performance 
measures that can provide information 
on the quality of care provided 
generally at a Health Plan level. 
HHS Department of Health and Human 
Services is the United States government's 
principal department for 
protecting the health of all Americans 
and providing essential human services. 
CDC and CMS are located within 
DHHS. 
HIPAA A Federal law that allows persons to 
qualify immediately for comparable 
health insurance coverage when they 
change their employment relationships. 
Title II subtitle F of HIPAA (Administrative 
Simplification) gives HHS, the 
authority to mandate the use of 
standards for the electronic exchange 
of health care data; and among other 
items to specify the types of measures 
required to protect the security and 
privacy of personally identifiable heath 
care information. Public law 104191. 
Incentives
Something that motivates individuals 
to make changes in practices. Incentives 
may be either formal or informal. 
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Managed Care Organizations 
Entities that provide health care 
services to enrolled members through 
a network of employed or affiliated 
providers. The term may include 
Health Maintenance Organizations, 
Preferred Provider Organizations and 
Point of Service Plans. These 
organizations integrate the financing 
and delivery of appropriate health care 
services to enrolled members. 
Medicaid A joint federal and state program that 
helps with the medical cost of certain 
low income individuals. Medicaid 
programs vary from state to state. 
National Committee for Quality Assurance 
(NCQA) 
An organization that accredits 
managed care organizations. NCQA 
maintains the HEDIS reporting system. 
Network A group of doctors, hospitals, 
pharmacies and other health care 
providers hired by a health plan to 
take care of its members. 
Random Sample 
A group of people or items with some 
common attribute arbitrially selected 
for study from a larger group of people 
with the same attribute. 
Vaccines for Children Program (VFC) 
A Federal program that provides 
public purchased vaccine, for eligible 
children, at no charge to public and 
private providers in all states and 
territoriesbased on the recommendations 
of the Advisory Committee on 
Immunization Practices (ACIP) and 
approved by the Centers for Disease 
Control and Prevention (CDC). Saves 
parents and enrolled providers out-ofpocket 
expenses for vaccine. Eliminates 
vaccine cost as a barrier to immunizing 
eligible children. Reduces the practice 
of referring children from the private 
sector to the public sector for vaccination, 
thereby keeping children in their 
medical home for comprehensive 
health care. 
SCHIP The Balanced Budget Act of 1997 
created a new children's health 
insurance program under Title XXI of 
the Social Security Act called the State 
Children's Health Insurance Plan 
(SCHIP). This program enabled States 
to initiate and expand health insurance 
coverage for uninsured children. States 
could create a separate insurance
program, expand Medicaid, or 
combine both approaches. 
Invalid dose 
A vaccination administered before the 
ACIP recommended age for receipt or 
when a dose of vaccine is given before 
the minimal time interval has elapsed 
for an individual to receive that vaccine 
and be considered a valid dose. 
VIS Vaccine Information Statements 
provide information on the vaccine to 
be received by the patient. VISs are 
required to be given prior to the 
administration of the vaccine in accordance 
with the National Childhood 
Vaccine Injury Act. The most current 
VIS must be given prior each and 
every vaccination. 
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