Survey of Influenza Rapid Diagnostic Test Practices in Laboratories
Request for Approval of New Data Collection
Supporting Statement A
November 30, 2011
Contact:
Laurina Williams, PhD, MPH
Division of Laboratory Science and Standards
Laboratory Science, Policy, & Practice Program Office
Centers for Disease Control and Prevention
1600 Clifton Rd. USPS
MS G25
Atlanta, Georgia 30333
Phone: 404.498.2267
Fax: 404.498.2219
Email: low1@cdc.gov
Table of Contents
Page Number
A. Justification 4
A. 1. Circumstances Making the Collection of Information Necessary 4
A. 2. Purpose and Use of Information Collection 5
A. 3. Use of Improved Information Technology and Burden Reduction 5
A. 4. Efforts to Identify Duplication and Use of Similar Information 6
A. 5. Impact on Small Businesses or Other Small Entities 6
A. 6. Consequences of Collecting the Information Less Frequently 6
A. 7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 6
A. 8. Comments in Response to the Federal Register Notice and 6
Efforts to Consult Outside the Agency
A. 9. Explanation of Any Payment or Gift to Respondents 7
A. 10. Assurance of Confidentiality Provided to Respondents 7
A. 11. Justification for Sensitive Questions 7
A. 12. Estimates of Annualized Burden Hours and Costs 7
A. 13. Estimates of Other Total Annual Cost Burden to Respondents 8
or Record Keepers
A. 14. Annualized Cost to the Government 9
A. 15. Explanation for Program Changes or Adjustments 9
A. 16. Plans for Tabulation and Publication and Project Time Schedule 9
A. 17. Reason(s) Display of OMB Expiration Date is Inappropriate 9
A. 18. Exceptions to Certification for Paperwork Reduction Act Submissions 9
Attachments
Attachment A: Authorizing Legislation
Attachment B: 60-day Federal Register Notice
Attachment C: Data collection instrument
Attachment D: 30-day Federal Register Notice
Attachment E: ADS Office non-human research determination documentation
Attachment F: Worksheet part 1
Attachment G: Worksheet part 2
Attachment H: Privacy Act Checklist
Attachment I: Telephone script for the reminder calls
Attachment J: Cover letter for the survey
A. Justification
Circumstances Making the
Collection of Information Necessary
The Survey of Rapid Influenza
Diagnostic Testing Practices in Laboratories is a national systematic
study investigating rapid influenza diagnostic testing practices in
clinical laboratories. This will be a new collection. Influenza
epidemics usually cause an average more than 200,000 hospitalizations
and 36,000 deaths per year in the U.S. Respiratory illnesses caused
by influenza viruses are not easily differentiated from other
respiratory infections based solely on symptoms, and influenza
viruses may adversely affect different subpopulations. The
effective use of rapid influenza diagnostic testing practices is an
important component of the differential diagnosis of
influenza-like-illness in both inpatient and outpatient treatment
facilities. Test results are used for making decisions about
antiviral vs. antibiotic use, and in making admission or discharge
decisions. In many cases, rapid influenza tests are the only tests
that can provide results while the patient is still present in the
facility. Thus, the appropriate use of the tests, and interpretation
of test results is critical to the treatment and control of
influenza. More than a
dozen rapid tests have been approved by the U.S. Food and Drug
Administration and are in widespread use. The reliability of rapid
influenza tests is influenced by the individual test product used and
the setting. Reported sensitivities range from 10-75%; while the
median specificities reported are 90-95%. Other factors influencing
accuracy are the stage (or duration) of illness when the diagnostic
specimen is collected, type and adequacy of the specimen collected,
variability in user technique for specimen collection or assay
performance, and disease activity in the community. Given
these and other collective findings, it is imperative for public
health and for response planning that CDC develops sector-specific
guidance and effective outreach to the clinicians on appropriate use
of RIDT in their practices.
Previous
studies by CDC of outpatient facilities showed that clinical
laboratories usually perform the rapid tests for emergency
departments, and provide results for both inpatient and outpatient
treatment. Thus, understanding the use of rapid influenza testing in
clinical laboratories, how the laboratories report results to
emergency departments and treatment facilities and health
departments, and what quality assurance practices are used will guide
future efforts of the CDC to develop appropriate influenza testing
guidelines and sector-specific training materials for clinicians and
improve health outcomes of the American public.
The survey
will cover basic laboratory demographic characteristics, specimen
collection and processing, testing practices, reporting of results to
emergency departments and other treatment facilities, reporting
results to health departments, quality assurance practices, and
methods of receiving updated influenza-related information. The
majority of the questions request information about laboratory
influenza testing practices. To date, no systematic study has been
conducted to investigate how laboratories use these tests, how they
report results, or how they interact with outpatient treatment
facilities. This survey seeks to provide insight into how
laboratories use and report the test results, assure quality of
testing, and interact with treatment facilities, especially
outpatient facilities. The survey will be conducted on a national
sample of clinical laboratories.
For maximum relevance and
utility, the data needs
to be collected at the end of the current influenza season and before
the next season.
The survey will be administered by the Joint Commission (JC). The data will be collected by the Northern Illinois University Public Opinion Laboratory (NIUPOL) under contract with the JC. After removal of identifiers, the data will be sent to the JC. The JC will analyze the data.
During the data collection process, respondent information will be kept secure. No IIF is being collected from respondents. The survey does not ask for any information related to individual patients. The survey primarily asks for information regarding laboratorians’ work and processes. Survey responses will be submitted via a paper survey, and neither the survey operations staff nor subsequent data analysts will have access to the identities of the respondents. No patient identifiers will be retained in the final survey dataset.
Purpose and Use of Information Collection
The primary objectives are to:
1) Determine which rapid influenza diagnostic testing practices are used in clinical laboratories and especially in the laboratories that perform testing for emergency departments and outpatient facilities that use test results to treat patients and to make admission/discharge decisions.
2) Use information from this survey to inform the development of a rapid influenza diagnostic testing training program for clinicians, especially physicians, nurses, and other outpatient providers.
3) Use information from this survey in the development of sector-specific influenza testing guidelines for clinicians and health care workers in outpatient treatment facilities.
The Division of Laboratory Science and Standards will provide a final written report through cooperative agreement partners. The results of the work published in peer-reviewed journals and will be available to the public.
Use of Improved
Information Technology and Burden Reduction
All data for this study will be collected via a paper-and-pencil questionnaire. A paper survey is being used because e-mail addresses are not available for all laboratory groups from which we are drawing the sample. For example, we do not have email addresses for the hospitals that are accredited by the College of American Pathology (CAP). In addition, many laboratory personnel, particularly those working in resource –poor settings do not have access to a computer during working hours. Both of these factors would tend to bias the study against resource-challenged laboratories. Since the survey is comprised of short-answer, checkbox – type questions, the burden, in terms of time required to answer the survey would be no more than the burden for an electronic survey.
Efforts to Identify
Duplication and Use of Similar Information
This is a new program.
Information has not been previously collected for this purpose.
Previous studies of
outpatient facilities showed that clinical laboratories usually
perform the rapid tests for emergency departments, and provide
results for both inpatient and outpatient treatment. Thus,
understanding the use of rapid influenza testing in clinical
laboratories, how the laboratories report results to emergency
departments and treatment facilities and health departments, and what
quality assurance practices are used will guide future efforts of the
CDC to develop appropriate influenza testing guidelines and
sector-specific training materials for clinicians and improve health
outcomes of the American public.
To date, no systematic
study has been conducted to investigate how clinical laboratories use
these tests, how they report results, or how they interact with
outpatient treatment facilities. This has been confirmed by
consulting with experts in the CDC Influenza Division, at HHS,
clinical experts at the JC and by checking electronic such as
Medline/PubMed resources.
Impact on Small Businesses
or Other Small Entities
There will be no impact on small business. The study is limited to hospital laboratories and we will not be sampling independent laboratories.
Consequences of Collecting
the Information Less Frequent Collection
This is a one-time data collection.
Special Circumstances
Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances.
Comments in Response to
the Federal Register
Notice/Outside Consultation
As required by 5 CDR 1320.8(d), a notice of this proposed data collection appeared in the Federal Register, June 8, 2011, Vol. 76, No. 110, pp. 33303-33304 (Attachment B). One non-substantive comment was received from the public.
The following public comment was received:
“Subject: PUBLIC COMMENT ON FEDERAL REGISTER FW: influenza spending OF AMERICAN TAX DOLLARS TO BENEFIT BIG PHARMA, BIG MEDICINE WITH BIG MONEY
CDC, IS A FRAUD. CDC NEEDS
TO BE SHUT DOWN. IT WORKS ONLY FOR BIG PROFITEERS WHO WANT TO MAKE
A FAST BUCK OUT OF HARMING AMERICA FOR BIG MONEY. CDC IS A COMPLETE
AND UTTER FRAUD AS A HEALTH AGENCY.
JEAN PUBLIC ADDRESS IF
REQUIRED”
CDC Standard response to the public comment was sent:
We received your comment and have forwarded it to the appropriate program. Thank you for your interest. CDC
Explanation of any
Payment/Gift to Respondents
Not applicable.
Assurance of Confidentiality Provided to Respondents
This submission has been reviewed by CIO who determined that the Privacy Act does not apply. During the data collection process, respondent information will be kept secure. No IIF is being collected from respondents. The survey does not ask for any information related to individual patients. The survey primarily asks for information regarding laboratorians’ work and processes. Survey responses will be submitted via a paper survey, and neither the survey operations staff nor subsequent data analysts will have access to the identities of the respondents. No patient identifiers will be retained in the final survey dataset.
Data management will be closely monitored by the project staff. All responses will be entered in a secure database at NIUPOL. Ultimately, a data file without organization or individual identifiers will be sent in a secure electronic manner from NIUPOL to the JC project staff for analysis.
NIUPOL will initially have contact information for the directors of laboratories. No contact information will be shared with the JC or with CDC. Once the data collection has been completed, all names, addresses, and telephone numbers of contact persons will be destroyed, Participation in the survey is completely voluntary and participants will be notified of this. The information collected will be limited to operational processes and activities in the laboratory. No personal information or individually identifiable information will be collected. The data will be stored in a secure database on a password protected computer. Ultimately, the survey data results will be presented in aggregate form only; no individual laboratory-level data or personal information will be identified. All grant information will be maintained in a secure manner.
Justification for
Sensitive Questions
No sensitive information will be collected.
Estimates of Annualized Burden Hours (Total Hours & Wages)
The participants will be taken from the JC data base and from the CAP data base of accredited hospital laboratories. There are approximately 4,000 US hospitals the vast majority of which are accredited by the JC. Approximately 2400 of those hospitals have labs that are accredited by the College of Pathology (CAP). The JC accredits an additional 1000 hospital based laboratories. Thus, 85% of hospital based labs are accredited by the JC or CAP. We will reach out to all 3400 laboratories (1,000 TJC and 2,400 CAP accredited). Surveys will be sent to laboratory supervisors with a request to respond within one month of receipt of the questionnaire. The NIU, contractors to the JC will place two reminder follow-up calls to all laboratories that do not initially respond to bolster response rate. Assuming a 60% overall response rate we anticipate receiving 2040 completed surveys. The survey takes 30 minutes for each participant to complete.
Estimated Annualized Burden Costs
Type of Respondent
|
Form Name |
No. of Respondents |
No. of Responses per Respondent |
Average Burden per Response (in hours) |
Hourly Wage Rate |
Total Burden hours |
Total Respondent Costs |
Clinical Laboratory Supervisors |
Rapid Influenza Diagnostic Testing Practices in Laboratories |
2040 |
1 |
30/60 |
$27.34 |
1020 |
27,886.80 |
Total $27,886.80
|
Note: The salary for the clinical laboratory supervisor is taken from the Department of Labor Wage Reports (http://www.bls.gov/oes/current/oes292011.htm) for Medical and Clinical Laboratory Technologists.
Estimates of other Total
Annual Cost Burden to Respondents or Record Keepers/Capital
Costs
There are no additional recordkeeping/capital costs.
Annualized Cost to Federal
Government
Health Scientists will be creating the survey, collecting and analyzing the data, and reporting the results.
Type of Federal employee support
|
Total Hours
|
Hourly Wage Rate
|
Total Federal Costs
|
Health Scientist |
104 (.05% FTE) |
$56 |
$5,824 |
JC Project Manager (contractor) |
208 (10% FTE |
$45 |
$9,360 |
Contract Cost |
|
|
$50,000 |
Total |
|
|
$65,184 |
The average hourly wage rate is for a health scientist is estimated at the GS-14, step 6 Level, taken from the federal employee wage tables for the Atlanta area (http://www.opm.gov/oca/11tables/html/atl.asp).The hour wage for the Project Manager was taken from contractor estimates. There are no travel costs associated.
Explanation for Program
Changes or Adjustments
This is a new data collection.
Plans for Tabulation and
Publication and Project Time Schedule
Data collection will begin as soon as clearance is received. The following is a timeline in months following OMB approval Administration, collection and cleaning and analysis are overlapping
Administer survey – Upon OMB approval
Data collection and cleaning – completed 3 months after OMB approval
Data analysis – completed 5 months after OMB approval
Following completion of the survey, data will be summarized into tables. Aggregate data will be reported to the CDC. Selected data of interest will be published by the JC.
Reason(s) Display of OMB
Expiration Date is Inappropriate
Not applicable.
Exceptions to
Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
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