Federal Register: November 2, 2005 (Volume 70, Number 211)
DOCID: FR Doc 05-21866
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
NOTICE: NOTICES
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY:
Agency Information Collection Activities: Proposed Collection; Comment Request
DATES: Comments on this notice must be received by January 3, 2006.
DOCUMENT SUMMARY:
This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) allow the proposed information collection project: ``Security Checkpoints and Patients With
Radiopharmaceuticals.'' In accordance with the Paperwork Reduction Act
of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on
this proposed information collection.
SUMMARY:
Agency information collection activities; proposals, submissions, and approvals,
SUPPLEMENTAL INFORMATION
Proposed Project
``Security Checkpoints and Patients With Radiopharmaceuticals''
Patients receiving radioactive therapeutic or diagnostic compounds (called ``radiopharmaceuticals'') can emit radiation at the time when they are released from a hospital facility and present danger to their families and the public. In addition, these individuals might activate radiation detectors at airports, stadiums, and other public places, and will be stopped for questioning by law enforcement personnel. It is very important that hospitals provide patients with educational materials that explain the unique problems patients may face as a result of receiving this treatment, as well as provide guidance about how to respond to situations where law enforcement questions and other concerns may arise.
The goal of the study is to determine what procedures are followed by hospitals when releasing patients treated with radioactive compounds.
The study will involve interviewing 60 health care providers who are directly involved in the release of patients treated with radioactive compounds.
Specifically, the interview protocol will be centered on the following topics:
(1) How health care providers determine when patients receiving radiopharmaceuticals can be released from care.
(2) What type of information is provided to patients to ensure safety to their families and the public.
(3) How this information is communicated to patients.
(4) What information is (or can be) provided to patients who may
activate radiation detectors at security checkpoints so that their
processing is facilitated should questions regarding their medical procedures arise.
Best practices identified through the analyses of interview data could lead to the development of standardized procedures to: (a) reduce secondary exposure to radiation by members of the patient's family and by the public; and (b) ensure that patients who activate radiation detectors at security checkpoints understand why they emit radiation and carry the appropriate documentation to validate their statements. The study findings will be disseminated to the health care community through a scholarly publication journal article (title is to be determined).
Data Confidentiality Provisions
Data collected by the contractor and the contractor's draft analyses will be retained for one year after final acceptance of all contract deliverables, unless, longer retention is requested by the agency for audit purposes.
All agency documents pertaining to the contract will be archived after the contract is completed and retained in accordance with a Federal Records Act of 1950 retention schedule.
Methods of Collection
The date will be collected using a telephone survey. The contractor will contact each health care provider through appropriate management offices explaining this survey and ask to be directed to the appropriate, knowledgeable staff in their facility. The interviews will be conducted by telephone. If requested, the contractor will provide a copy of the interview questions in advance so that the hospital staff has time to obtain pertinent information. The contractor will also request copies of educational materials provided to patients, any specific tools used to calculate radiation dose to members of the public as well as other pertinent material. The contractor will obtain and evaluate the referenced educational materials qualitatively, describing the content and detail of such materials and reviewing them for clarity. In addition, the contractor will analyze the responses to the interview questions quantitatively and qualitatively as appropriate.
To recruit the appropriate interviewees, we will first contact the
Chief of Medicine's office and ask the staff to refer us to the Head of
the Department of Radiology/Radiation Oncology/Nuclear Medicine. (Based
on our experience surveying health care providers, for smaller
hospitals it is sometimes more effective to start with the Hospital
Administrator's office.) We will introduce ourselves, explain the goals
of the study, and volunteer to provide a cover letter describing the
study and any letters of endorsement. We will then contact the
Department Heads and request that they refer us to the appropriate, knowledgeable staff in their departments.
Estimated Annual Respondent Burden
Estimated
Number of Estimated time Estimated annual cost to
Type of survey respondents per respondent total burden the
in minutes hours respondents
Telephone Interviews............................ 60 45 45 $4500
Total....................................... 60 45 45 4500 Request for Comments
In accordance with the above cited legislation, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of functions of AHRQ, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized
and included in the request for OMB approval of the proposed
information collection. All comments will become a matter of public record.
[[Page 66440]]
Dated: October 25, 2005.
Carolyn M. Clancy,
Director.
[FR Doc. 0521866 Filed 11105; 8:45 am]
BILLING CODE 416090M
FOR FURTHER INFORMATION CONTACT
Cynthia D. McMichael, AHRQ, Reports Clearance Officer, (301) 4271651.