[Federal Register Volume 66, Number 27 (Thursday, February 8, 2001)]
[Notices]
[Pages 9578-9580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3221]



[[Page 9578]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


 Statement of Organization, Functions, and Delegations of 
Authority

    Part C (Centers for Disease Control and Prevention) of the 
Statement of Organization, Functions, and Delegations of Authority of 
the Department of Health and Human Services (45 FR 67772-76, dated 
October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as 
amended most recently at 66 FR 1363-1364, dated January 8, 2001) is 
amended to retitle and revise the functional statement of the Hospital 
Infections Program (HIP), National Center for Infectious Diseases 
(NCID).
    Section C-B, Organization and Functions, is hereby amended as 
follows:
    Delete in its entirety the titles and functional statements for the 
Hospital Infections Program (CRM) and insert the following:
    Division of Healthcare Quality Promotion (CRM). Protects patients, 
protects healthcare personnel, and promotes safety, quality, and value 
in the healthcare delivery system by providing national leadership for 
(1) Measuring, validating, interpreting, and responding to data 
relevant to healthcare outcomes, healthcare-associated infections/
antimicrobial resistance, related adverse events, and medical errors 
among patients and healthcare personnel; (2) investigating and 
responding to outbreaks and emerging infections and related adverse 
events among patients, healthcare providers, or associated with the 
healthcare environment; (3) detecting, evaluating, monitoring, and 
responding to emerging antimicrobial resistant pathogens and 
infections; (4) creating and evaluating the efficacy of new 
interventions designed to prevent infections/antimicrobial resistance, 
related adverse events, and medical errors; (5) promoting clinical 
microbiology laboratory quality; (6) promoting water quality in 
healthcare settings; (7) identifying effective interventions that 
prevent healthcare-associated infections/antimicrobial resistance, 
related adverse events, and medical errors among patients and 
healthcare personnel; (8) promoting the nationwide implementation of 
these interventions; and (9) evaluating the impact of their 
implementation across the spectrum of healthcare delivery sites.
    Office of the Director (CRM1). (1) Manages, directs, and 
coordinates the activities of the Division of Healthcare Quality 
Promotion (DHQP); (2) provides leadership and guidance on policy, 
program planning and development, program management, and operations; 
(3) provides DHQP-wide administrative and program services and 
coordinates or ensures coordination with the appropriate National 
Center for Infectious Diseases (NCID) and Centers for Disease Control 
and Prevention (CDC) staff offices on administrative and program 
matters; (4) provides liaison with other governmental agencies, 
international organizations, and other outside groups; (5) coordinates, 
in collaboration with the appropriate NCID and CDC components, global 
health activities relating to the prevention of healthcare-associated 
infections/antimicrobial resistance, related adverse events, and 
medical errors; (6) manages the division local area network (LAN) and 
coordinates the evolving LAN design with the Information Resources 
Management Office and the NCID LAN administrator; (7) provides hardware 
and software support to DHQP personnel in response to the changing 
information technology environment; and (8) advises the Director, NCID, 
on policy matters concerning DHQP activities.
    Epidemiology and Laboratory Branch (CRM2). (1) Coordinates rapid 
and effective epidemiologic and laboratory response to outbreaks and 
emerging threats associated with infections/antimicrobial resistance 
and related adverse events throughout the healthcare delivery system; 
(2) provides comprehensive laboratory support and expertise (including 
consultation; organism recovery and identification; microbiologic, 
toxin, chemical, and molecular assays; and strain typing) for 
investigations of recognized and emerging bacterial agents (including 
those resistant to available antimicrobials) in healthcare settings; 
(3) implements surveillance and response systems to detect emerging 
threats, including those related to agents of bioterrorism, among 
patients and healthcare personnel; (4) investigates novel and emerging 
mechanisms of antimicrobial resistance among targeted pathogens found 
in healthcare settings; (5) conducts epidemiologic and basic and 
applied laboratory research to identify new strategies to prevent 
infections/antimicrobial resistance, related adverse events, and 
medical errors, especially those associated with indwelling medical 
devices, contaminated products, dialysis, and water; (6) evaluates the 
accuracy of commercial microbial identification and susceptibility 
testing systems and products through research and facilitates their 
improvement; (7) provides leadership in reducing microbiology 
laboratory errors that affect patient outcomes by evaluating laboratory 
proficiency and promoting laboratory quality improvements; (8) 
investigates the role of biofilms, particularly those detected in 
indwelling medical devices and medical water systems, in medicine and 
public health; and (9) in collaboration with other CDC Centers, 
Institutes, and Offices (CIOs) and partners, provides expertise (e.g. 
environmental sampling, microbial assays, environmental engineering, 
disinfection strategies), research opportunities, and laboratory 
support for investigations of environmental sources of infections and 
related adverse events, including those related to bioterrorism.
    Epidemiology Section (CRM22). (1) Coordinates and ensures rapid and 
effective response to requests from state and local health departments 
and healthcare organizations for assistance with investigations of 
outbreaks and emerging threats associated with infections, 
antimicrobial resistance, and related adverse events throughout the 
healthcare delivery system; (2) provides comprehensive epidemiologic 
support (including detection systems, consultation, field 
investigation, risk factor evaluation, and control strategies) for 
investigations of recognized and emerging bacterial pathogens 
(including those resistant to available antimicrobials) in healthcare 
settings and potential bioterrorism events; (3) evaluates the 
relationship between bacterial strain characteristics and epidemiologic 
characteristics of pathogens associated with healthcare infections/
antimicrobial resistance; and (4) develops and evaluates the efficacy 
of interventions designed to prevent healthcare-associated infections/
antimicrobial resistance, related adverse events, and medical errors 
across the spectrum of healthcare delivery sites.
    Diagnostic Microbiology Section (CRM23). (1) Provides laboratory 
support and expertise for outbreak investigations and special studies 
of aerobic and anaerobic bacteria causing healthcare-associated 
infections; (2) evaluates the relationship between bacterial strain 
characteristics and epidemiologic characteristics of pathogens; (3) 
provides reference diagnostic services for identification and 
classification of the Micrococcaceae, many Enterobacteriaceae, and all 
anaerobic

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bacteria; (4) develops, evaluates, and improves novel or existing 
laboratory methods for identifying and characterizing bacteria causing 
health-associated infections; (5) evaluates in vitro reagents and 
products that show public health promise in improving the 
identification and characterization of bacterial pathogens; (6) 
conducts biochemical, immunochemical, and genetic studies of bacterial 
pathogens to determine marker systems useful for epidemiologic purposes 
such as determining pathogenicity, or virulence; (7) provides reference 
diagnostic activities for detection of staphylococcal toxins in 
isolates obtained from clinical specimens and environmental sources, 
including those that may be associated with bioterrorism events; (8) 
serves as the World Health Organization (WHO) National Klebsiella 
Center; (9) manages the bacteriology laboratory component of the 
College of American Pathologists (CAP) proficiency testing program for 
NCID/CDC; and (10) provides leadership in laboratory quality 
improvement practices directed toward reducing laboratory errors that 
affect healthcare outcomes.
    Environmental and Applied Microbiology Section (CRM24). (1) 
Provides laboratory support and expertise for epidemic evaluations, 
consultation, and field investigations of healthcare-associated 
infections involving medical devices, therapeutic or diagnostic 
products and devices, environmental reservoirs of microorganisms/
pathogens, or issues involving water quality; (2) investigates and 
defines environmental factors associated with healthcare-associated 
infections/antimicrobial resistance and related adverse events that 
affect healthcare outcomes; (3) conducts basic and applied laboratory 
research to identify new strategies to prevent infections/antimicrobial 
resistance, related adverse events, and medical errors, especially 
those associated with indwelling medical devices, contaminated 
products, dialysis, and water; (4) investigates and defines the role of 
biofilms and develops and evaluates methods to control them in water 
distribution systems and on indwelling medical devices; (5) develops 
and evaluates reliable methods to detect and quantify bacterial 
endotoxin, bioterrorism agents associated with institutional outbreaks, 
and dialysis-associated diseases; (6) develops and evaluates reliable 
methods and protocols for the disinfection and sterilization of medical 
devices, formites, potable water, recreational water, and water 
associated with healthcare-associated infections/antimicrobial 
resistance, in collaboration with other NCID divisions, the 
Environmental Protection Agency (FDA), and the Food and Drug 
Administration (FDA); (7) provides laboratory and field capability in 
environmental microbiology, and collaborates with other NCID 
organizations in epidemic investigations, evaluation of bioterrorism 
events, and field studies requiring expertise in environmental 
microbiology; (8) serves as the NCID/CDC lead for information, 
recommendations, and technical support concerning environmental 
sterilization, disinfection, and disposal/handling of medical waste; 
and (9) serves as the NCID/CDC lead for information, recommendations, 
and technical support concerning dialysis-associated infections and 
related adverse events, sterilization and disinfection strategies, 
water quality, and bacterial endotoxins.
    Anti-infectives Investigation Section (CRM25). (1) Provides 
laboratory support for investigations of antimicrobial-resistant 
infections conducted by DHQP Epidemic Intelligence Service (EIS) 
officers and staff; (2) provides reference antimicrobial susceptibility 
testing services to state health departments, healthcare organizations, 
and other laboratories; (3) evaluates and reports on the accuracy of 
commercial antimicrobial susceptibility testing methods; (4) develops 
and evaluates new methods for detecting bacterial resistance to 
antimicrobial agents, in collaboration with the National Committee for 
Clinical Laboratory Standards; (5) improves the proficiency of 
microbiology laboratories by providing quality control and proficiency 
testing organisms to clinical laboratories in the United States and 
throughout the world in cooperation with state health departments, 
Emory University Rollins School of Public Health, and the WHO; (6) 
serves as a WHO Collaborating Center on Global Antimicrobial Resistance 
Monitoring in Bacteria; (7) collaborates with state health departments 
to perform surveys of antimicrobial susceptibility testing procedures 
in clinical laboratories; (8) investigates the molecular basis of 
antimicrobial resistance in bacteria through DNA hybridization studies, 
DNA sequence analysis, iso-electric focusing, and other analytical 
methods; and (9) provides bacterial strain typing services to evaluate 
dissemination of resistant organisms.
    Prevention and Evaluation Branch (CRM3). (1) Supports local, state, 
national, and international efforts to prevent healthcare-associated 
infections/antimicrobial resistance, related adverse events, and 
medical errors using evidence-based recommendations and state-of-the 
art informatics and health communications strategies that enhance rapid 
and reliable information exchange; (2) develops and demonstrates the 
effectiveness of health communications, guidelines, recommendations, 
and other interventions to prevent healthcare-associated infections/
antimicrobial resistance, related adverse events, and medical errors 
across the spectrum of healthcare delivery sites; (3) promotes the 
implementation of effective guidelines, recommendations, and other 
interventions to prevent healthcare-associated infections/antimicrobial 
resistance, related adverse events, and medical errors; (4) evaluates 
the impact of implementation of effective guidelines, recommendations, 
and other interventions on healthcare-associated infections/
antimicrobial resistance, related adverse events, and medical errors; 
(5) provides consultation, guidance, and technical support to domestic 
and international partners on the prevention of healthcare-associated 
infections/antimicrobial resistance, related adverse events, and 
medical errors; and (6) develops and disseminates training tools and 
other strategies that enhance local capacity to protect patients and 
healthcare personnel and to promote quality healthcare.
    Interventions and Evaluation Section (CRM32). (1) Collaborates with 
partners to promote healthcare safety, quality, and value across the 
spectrum of healthcare delivery sites; (2) coordinates the development 
of and disseminates evidence-based guidelines and recommendations to 
prevent and control healthcare-associated infections/antimicrobial 
resistance, related adverse events, and medical errors; (3) evaluates 
the effectiveness of interventions to prevent healthcare-associated 
infections/antimicrobial resistance, related adverse events, and 
medical errors; (4) promotes the implementation and evaluates the 
impact of guidelines, recommendations, performance measurement systems, 
best practices, and other strategies to prevent healthcare-associated 
infections/antimicrobial resistance, related adverse events, and 
medical errors; (5) develops, implements, and evaluates the 
effectiveness and impact of interventions to prevent transmission of 
healthcare-associated human immunodeficiency virus (HIV) and

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other bloodborne pathogen infections; and (6) develops, implements, and 
evaluates the effectiveness and impact of interventions to prevent the 
dissemination of infections endemic in the community (e.g., as 
tuberculosis and influenza) in healthcare settings.
    Health Communications Section (CRM33). (1) With input from DHQP 
branches, NCID/CDC Centers, Institutes and Offices (CIO's), partners 
and stakeholders, develops, implements, and evaluates the effectiveness 
of the DHQP health communications strategic plan to (a) deliver 
effective messages to target audiences that protect patients, protect 
healthcare personnel, and promote quality healthcare and (b) inform 
patients, partners, the public, decision makers, and other constituents 
about these issues; (2) coordinates provision of DHQP technical support 
and consultation to partners and constituents on the prevention of 
healthcare-associated infections/antimicrobial resistance, related 
adverse events, and medical errors; (3) develops and tests health 
communication materials in a variety of media, including but not 
limited to electronic and print; (4) develops and implements a real-
time communication network for the delivery of information to 
intramural and extramural partners and stakeholders; (5) disseminates 
information to medical, technical, scientific, and lay audiences and 
news media about healthcare-associated infections/antimicrobial 
resistance, adverse events, and medical errors; (6) develops, 
coordinates, and maintains DHQP website; (7) develops and tests 
material, technologies, and strategies for training programs to prevent 
and control healthcare-associated infections/antimicrobial resistance, 
related adverse events, and medical errors; (8) develops and implements 
national health communication campaigns to promote the prevention and 
control of healthcare-associated infections/antimicrobial resistance, 
related adverse events, and medical errors; (9) evaluates the 
effectiveness of DHQP's health communication strategies to determine 
the impact and contribution to prevention and control of healthcare-
associated infections/antimicrobial resistance, related adverse events, 
and medical; and (10) oversees DHQP's scientific and editorial 
clearance process for all print and non-print materials and ensures 
adherence to and consistency with CDC's scientific and editorial 
policies and clearance processes.
    Healthcare Outcomes Branch (CRM4). (1) Evaluates the impact of 
healthcare-associated infections/antimicrobial resistance, related 
adverse events, and medical errors on healthcare outcomes and costs in 
order to establish priorities for DHQP intervention programs; (2) 
improves methods to measure healthcare outcomes, performance, and cost-
effectiveness of intervention strategies; (3) improves systems by which 
health organizations collect, manage, analyze, report, and respond to 
data on healthcare outcomes, healthcare-associated adverse events, and 
medical errors; (4) implements and coordinates the National Healthcare 
Safety Network (NHSN) (a representative sample of healthcare 
organizations that report data on targeted healthcare-associated 
adverse events and medical errors) to obtain locally relevant and 
scientifically valid benchmarks and performance measurements that 
promote healthcare quality and value; (5) provides national estimates 
of targeted adverse events and medical errors among selected 
populations of patients across the spectrum of healthcare delivery 
sites; and (6) provides national estimates of targeted occupational 
illnesses and injuries among healthcare workers across the spectrum of 
healthcare delivery sites.
    Quality Research Section (CRM42). (1) Evaluates the impact of 
healthcare-associated infections/antimicrobial resistance, related 
adverse events, and medical errors on patient outcomes, healthcare 
costs, and resource utilization; (2) develops scientifically valid and 
locally relevant methods of risk adjustment for interpreting and 
comparing performance measures and healthcare outcomes and costs among 
targeted populations; (3) develops analytic methods to provide reliable 
national estimates of the frequency and impact of targeted adverse 
health events among patients and healthcare personnel; and (4) develops 
analytic methods to evaluate the relationship among healthcare 
structure, processes of care, and healthcare outcomes.
    Performance Measurement Section (CRM43). (1) with collaborating 
partners, establishes, maintains, and expands the NHSN to collect, 
report, monitor, interpret, and disseminate data relevant to healthcare 
safety, quality, and value; (2) with collaborating partners, develops 
and validates standard definitions of monitored healthcare events in 
targeted populations and healthcare settings. These events may include 
medical device-associated infections/adverse events/errors, drug-
associated adverse events/errors, antimicrobial use/misuse, blood 
product-associated infections/adverse events/errors, procedure-
associated infections/adverse events/errors, laboratory-associated 
adverse events/errors, vaccine-preventable and antimicrobial-resistant 
infections, and occupational exposures and infections; (3) develops, 
implements, and validates protocols for reporting monitored health 
events in targeted populations and healthcare settings; (4) develops 
analytic tools to create performance measures and other locally 
relevant data to enhance quality promotion activities; (5) collaborates 
with NCID, other CDC CIOs, and other information system partners to 
ensure that the NHSN and related information systems adhere to relevant 
standards and emerging architecture for integrated surveillance and 
information management; (6) coorindates translation of NHSN functional 
specifications and CDC standards to software developers and maintains 
ongoing communication with developers as the system evolves; (7) 
coordinates NHSN data management, data warehousing, and analysis 
systems; (8) develops information system capacity and transfer 
protocols to acquire data from various existing databases and sources 
to provide national estimates of monitored adverse health events among 
patients and healthcare personnel; (9) develops, updates, and 
disseminates public use de-identified data sets relevant to healthcare 
outcomes, infections and other adverse events, and medical errors; (10) 
investigates novel strategies for data acquisition and electronic 
reporting of adverse event and relevant data from healthcare 
organization information systems; and (11) identifies novel strategies 
for electronic detection, automated reporting, and interpretation of 
healthcare-associated infections/antimicrobial resistance, related 
adverse health events, and medical errors.

    Dated: January 30, 2001.
Jeffrey P. Koplan,
Director.
[FR Doc. 01-3221 Filed 2-7-01; 8:45 am]
BILLING CODE 4160-18-M