72 FR 224 pgs. 65578-65580 - Agency Forms Undergoing Paperwork Reduction Act Review
Type: NOTICEVolume: 72Number: 224Pages: 65578 - 65580
Docket number: [30 Day-07-0666]
FR document: [FR Doc. E7-22731 Filed 11-20-07; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 Day-07-0666]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395-6974. Written comments should be received within 30 days of this notice.
Proposed Project
National Healthcare Safety Network (OMB Control No. 0920-0666)-Revision-National Center for Preparedness, Detection and Control of Infectious Diseases (NCPDCID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The National Healthcare Safety Network (NHSN) is a system designed to accumulate, exchange, and integrate relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and to promote healthcare safety. Specifically, the data is used to determine the magnitude of various healthcare-associated adverse events and trends in the rates of these events among patients and healthcare workers with similar risks. The data will be used to detect changes in the epidemiology of adverse events resulting from new and current medical therapies and changing risks.
Healthcare institutions that participate in NHSN voluntarily report their data to CDC using a web browser-based technology for data entry and data management. Data are collected by trained surveillance personnel using written standardized protocols. This application to OMB includes a significant increase in the number of burden hours to the previously approved data collection. The increase is due to inclusion of new forms and an increased number of respondents.
NHSN was first approved by OMB in 2005 and CDC proposes to revise this data collection by adding new modules to the NHSN as well as modifying currently approved forms. Four new forms are proposed: (1) Healthcare Worker Influenza Vaccination form; (2) Healthcare Worker Influenza Antiviral Medication Administration form; (3) Pre-season survey on Influenza Vaccination Programs for Healthcare Workers; and (4) Post-season Survey on Influenza Vaccination Programs for Healthcare Workers. The purpose of these new forms is to help participating healthcare institutions and CDC to: (1) Monitor influenza vaccination coverage among healthcare personnel at individual facilities and to provide aggregate coverage estimates for all participating facilities; (2) monitor progress towards attaining the Healthy People 2010 goal of 60% vaccination coverage among healthcare personnel; (3) monitor influenza vaccination coverage by ward/unit of the facility or occupational group so that areas or groups with low vaccination rates can be targeted for interventions; (4) monitor adverse reactions related to receipt of the vaccine or receipt of antiviral medications; and (5) assess the characteristics of influenza vaccination programs pre- and post-influenza season to identify practices associated with high immunization rates.
CDC is proposing to add an additional form, Central Line Insertion Practices Monitoring Form, to the Patient Safety Component Device Associated Module. This new form will enable participating facilities and CDC to (1) monitor central line insertion practices in individual patient care units and facilities and provide aggregate data for all participating facilities (facilities have the option of recording inserter-specific adherence data); (2) link gaps in recommended practice with the clinical outcome both in individual facilities and for all participating facilities; (3) facilitate quality improvement by identifying specific gaps in adherence to recommended prevention practices, thereby helping to target intervention strategies for reducing central line infection rates.
CDC proposes to add the Multi-Drug Resistant Organism (MDRO) Prevention Process Monitoring Module to the Patient Safety Component. This module consists of four forms: (1) MDRO Prevention Process Monitoring Form; (2) MDRO Infection Event Form; (3) Laboratory-identified MDRO Event Form; and (4) Laboratory-identified MDRO Event Summary Form. The purpose of these forms is to: (1) Monitor processes and practices in individual patient care units and facilities and to provide aggregate adherence data for all participating facilities; (2) link gaps in recommended practice with the clinical outcome (i.e., MDRO infection) both in individual facilities and for all participating facilities; (3) facilitate quality improvement by identifying specific gaps in adherence to recommended prevention practices, thereby helping to target intervention strategies for reducing MDRO infection rates.
The fourth new proposed collection to the NHSN is the High Risk Inpatient Influenza Vaccination Module. This module consists of five forms: (1) Influenza High Risk Inpatient Influenza Vaccine Summary Form-Method A; (2) Influenza High Risk Inpatient Influenza Vaccine Summary Form-Numerator Data Form Method B; (3) Influenza High Risk Inpatient Influenza Vaccine Summary Form-Method B; (4) Influenza High Risk Inpatient Influenza Vaccine-Denominator Form Method B; and (5) High Risk Inpatient Influenza Vaccination Standing Orders Form. The last form is an optional form that may be used in NHSN, but is not required as part of the High Risk Patient Influenza Vaccination module. The purpose of these forms is to: (1) Monitor influenza vaccination practices for high risk patients and provide aggregate data in regard to the number of high risk patients receiving vaccination, those already vaccinated, and those who decline due to medical contraindications or other reasons; and (2) to identify reasons that high risk patients are not receiving influenza vaccination.
CDC is also proposing to open enrollment to any healthcare facility; therefore this submission includes a registration form (Registration Form) to collect necessary registration information.
Finally, CDC also proposes to make minor edits and modifications to currently approved forms. The NHSN is currently approved for 65,817 hours for these forms.
CDC is also adding an increased number of participating healthcare institutions from a wide spectrum of settings. Part of this increase in burden hours is due to the passage of legislation in many states requiring mandatory reporting of healthcare-associated infections. Some states plan to use are or using NHSN as their data collection system to meet this mandate.
Participating institutions must have a computer capable of supporting an Internet service provider (ISP) and access to an ISP. The only other cost to respondents is their time to complete the appropriate forms.
The National Healthcare Safety Network is currently approved for 65,817 burden hours. This revision is seeking an increase of 1,212,498 burden hours The total estimated annualized burden hours are 1,278,315.
| Form | No. of respondents | Average no. of responses per respondent | Average burden per response (in hours) |
|---|---|---|---|
| A. Patient Safety Monthly Reporting Plan | 1,500 | 9 | 35/60 |
| AA. Healthcare Worker Survey | 150 | 100 | 10/60 |
| B. Healthcare Personnel Safety Reporting Plan | 150 | 9 | 10/60 |
| BB. Dialysis Survey | 80 | 1 | 1 |
| CC. List of Blood Isolates+ | 1,500 | 1 | 1 |
| D. Primary Bloodstream Infection (BSI)** | 1,500 | 36 | 30/60 |
| DD. Manual Categorization of Positive Blood Cultures+ | 1,500 | 1 | 1 |
| E. Dialysis Event | 80 | 200 | 15/60 |
| FF. Healthcare Worker Influenza Vaccination | 150 | 500 | 10/60 |
| G. Pneumonia (PNEU) (Includes decision algorithms: | 1,500 | 72 | 30/60 |
| Ga. Any Patient-Pneumonia Flow Diagram | |||
| Gb. Infant and Children-Pneumonia Flow Diagram) | |||
| GG. Healthcare Worker Influenza Antiviral Medication Administration | 150 | 50 | 10/60 |
| H. Urinary Tract Infection (UTI) | 1,500 | 27 | 30/60 |
| HH. Preseason Survey on Influenza Vaccination Programs for Healthcare Personnel | 150 | 1 | 10/60 |
| II. Postseason Survey on Influenza Vaccination Programs for Healthcare Personnel | 150 | 1 | 10/60 |
| J. Denominators for Neonatal Intensive Care Units (NICU) | 1,500 | 9 | 4 |
| JJ. Central Line Insertion Practices Adherence Monitoring Form | 1,500 | 100 | 5/60 |
| K. Denominators for Specialty Care Area (SCA) | 1,500 | 9 | 5 |
| KK. Laboratory Testing | 150 | 100 | 15/60 |
| L. Denominators for Intensive Care Units (ICU)/Other locations (not NICU or SCA) | 1,500 | 18 | 5 |
| LL. Multi-drug Resistant Organism (MDRO) Prevention Process and Outcome Measures Monthly Monitoring Form | 1,500 | 24 | 10/60 |
| M. Denominator for Outpatient Dialysis | 80 | 9 | 5/60 |
| MM. MDRO Infection Form | 1,500 | 72 | 30/60 |
| N. Surgical Site Infection (SSI) | 1,500 | 27 | 30/60 |
| NN. Laboratory-identified MDRO Event | 1,500 | 240 | 30/60 |
| O. Denominator for procedure | 1,500 | 540 | 8/60 |
| OO. NHSN Registration Form | 1,500 | 1 | 5/60 |
| P. Antimicrobial Use and Resistance (AUR)-Microbiology Laboratory Data** | 1,500 | 45 | 3 |
| PP. High Risk Inpatient Influenza Vaccination Monthly Monitoring Form-Method A | 1,500 | 5 | 16 |
| Q. Antimicrobial Use and Resistance (AUR)-Pharmacy Data** | 1,500 | 36 | 2 |
| QQ. High Risk Inpatient Influenza Vaccination Numerator Data Form-Method B | 500 | 250 | 10/60 |
| R. Facility Contact Information | 1,500 | 1 | 10/60 |
| RR. High Risk Inpatient Influenza Vaccination Monthly Monitoring Form-Method B | 500 | 5 | 4 |
| S. Patient Safety Component Annual Facility Survey | 1,500 | 1 | 30/60 |
| SS. High Risk Inpatient Influenza Vaccination Denominator Data Form-Method B | 500 | 250 | 5/60 |
| T. Agreement to Participate and Consent | 1,500 | 1 | 15/60 |
| TT. Laboratory-identified MDRO Event Summary Form | 1,500 | 3 | 1 |
| U. Group Contact Information | 1,500 | 1 | 5/60 |
| V. Exposure to Blood/Body Fluids | 150 | 50 | 1 |
| W. Healthcare Worker Post-exposure Prophylaxis | 150 | 10 | 15/60 |
| X. Healthcare Worker Demographic Data | 150 | 200 | 20/60 |
| Y. Healthcare Worker Vaccination History | 150 | 300 | 10/60 |
| Z. Implementation of Engineering (safety device) Controls for Sharps Injury Prevention | 150 | 1 | 30/60 |
| Za. Healthcare Personnel Safety Component Facility Survey | 150 | 1 | 8 |
| ** Burden will be eliminated when reporting these data once an NHSN institution implements electronic data capture. | |||
| + Burden during validation phase only, then eliminated. | |||
Dated: November 14, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E7-22731 Filed 11-20-07; 8:45 am]
BILLING CODE 4163-18-P