Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices 57957 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Call for Comments on the Existing 

National Standards for the Culturally 

and Linguistically Appropriate 

Services in Health Care 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary for 

Health, Office of Minority Health. 

ACTION: Notice. 

SUMMARY: The HHS Office of Minority 

Health (OMH) announces the launch of 

an enhancement initiative of the 

existing National Standards for 

Culturally and Linguistically 

Appropriate Services in Health Care 

(CLAS Standards). The public comment 

period will begin September 20, 2010 

and conclude December 31, 2010. 

During this time three regional meetings 

on the standards will be held 

throughout the country. Individuals and 

organizations are encouraged to submit 

their comments on the 14 standards and 

their current application and use. The 

enhanced national standards, as revised 

in accordance with public comment and 

subject matter expertise, will be 

published for review in spring of 2011 

with the final versions being published 

in fall of 2011. 

DATES: The initial comment and 

submission period is September 20 

through December 31, 2010. 

ADDRESSES: (1) Electronically through 

the public comment site http://

clasenhancements.thinkculturalhealth.

org. 

(2) By mail, comments postmarked no 

later than December 31, 2010, can be 

submitted to: CLAS Standards c/o HHS 

Office of Minority Health, 1101 Wootton 

Parkway, Suite 600, Rockville, 

Maryland 20852. Comments sent by 

courier will be accepted until 5 p.m. 

EST on December 31. 

(3) Individuals may register for one of 

the regional meetings by using the 

online registration form at http://

clasenhancements.thinkculturalhealth.

org. To request a registration form by 

mail, write to CLAS Standards 

Enhancement Initiative meeting, c/o 

SRA International, Inc., 6003 Executive 

Blvd, Suite 400, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Guadalupe Pacheco, Office of Minority 

Health, 1101 Wootton Parkway, Suite 

600, Rockville, MD 20852, Attn: CLAS, 

Telephone: (240) 453–6174; Fax: (240) 

453–2883; E-mail: 

Guadalupe.Pacheco@hhs.gov. 

Background: To help achieve its 

mission of ‘‘improving the health of 

racial and ethnic minority populations 

through the development of effective 

health policies and programs that help 

to eliminate disparities in health,’’ the 

OMH published the National Standards 

for Culturally and Linguistically 

Appropriate Services in Health Care 

(CLAS Standards) in 2001. The CLAS 

Standards were developed on the basis 

of an analytical review of key laws, 

regulations, contracts, and standards 

used by Federal and State agencies and 

other national organizations, with input 

from a national advisory committee of 

policymakers, health care providers, 

and researchers. Open public hearings 

were held to obtain input from 

communities throughout the nation. The 

CLAS Standards represent the first 

national standards for cultural 

competence in health care and offer 

comprehensive guidance on what 

constitutes culturally competent service 

delivery. They consist of 14 guidelines, 

recommendations, and mandates that 

serve to inform, guide, and facilitate 

implementation of culturally and 

linguistically appropriate services in 

health care. The CLAS Standards are 

organized by three themes: Culturally 

Competent Care, Language Access 

Services, and Organizational Supports. 

They recognize that culture and 

language are central to the delivery of 

health services. 

Disparities in health care have been 

documented in a number of 

groundbreaking reports: Findings of the 

Supplement to Mental Health: A Report 

of the Surgeon General (CMHS, 2001a) 

reveal that ‘‘racial and ethnic minorities 

bear a greater burden from unmet 

mental health needs and thus suffer a 

greater loss to their overall health and 

productivity.’’ Findings from the 2000 

Surgeon General’s Report Oral Health in 

America: A Report of the Surgeon 

General indicated significant disparities 

‘‘between racial and socioeconomic 

groups in regards to oral health and 

ensuing overall health issues’’ (DHHS, 

2000). The 2003 report from the 

Institute of Medicine, Unequal 

Treatment: Confronting Racial and 

Ethnic Disparities in Healthcare 

(Smedley, Stith & Nelson, 2003), and its 

supplementary paper contributions such 

as Racial and Ethnic Disparities in 

Diagnosis and Treatment: A Review of 

the Evidence and a Consideration of 

Causes (Geiger, 2003) and The Civil 

Rights Dimension of Racial and Ethnic 

Disparities in Health Status (Perez, 

2003), brought to the forefront that 

minorities receive lower quality health 

care even when socioeconomic and 

access-related factors are controlled. 

The report also showed that bias, 

stereotyping, prejudice, and clinical 

uncertainty may contribute to racial and 

ethnic disparities in health care 

(Smedley et al., 2003). 

A significant body of research 

released since the 2003 IOM report 

corroborates these findings. The 

National Healthcare Disparities Report 

prepared by the Agency for Healthcare 

Research and Quality states that 

‘‘although varying in magnitude by 

condition and population, disparities 

are observed in almost all aspects of 

health care’’ (The Agency for Healthcare 

Research and Quality, 2006). Inspired 

by the CLAS Standards, national 

organizations including the American 

Medical Association (AMA), American 

Association of Medical Colleges 

(AAMC), the Joint Commission, the 

National Committee for Quality 

Assurance (NCQA), the National Quality 

Forum (NQF) and others have released 

standards to help support the provision 

of culturally and linguistically 

appropriate care. Many of these 

standards promote the education and 

training of health care providers in 

culturally appropriate care. 

Increasingly, national experts are 

looking to cultural competency training 

as a means to reduce disparities in 

health care. Evidence suggests that the 

most effective cultural competence 

training helps providers develop new 

knowledge, skills, and attitudes in order 

to effectively treat minority and 

immigrant populations (Smedley et al., 

2003). The concepts of cultural and 

linguistic competency as well as health 

disparities are featured prominently in 

the health care reform legislation 

enacted and signed by President Barack 

Obama in March 2010. References to the 

concepts of cultural and linguistic 

competency illustrate how pervasive 

and important the constructs have 

become. 

Public comment period: It has been 

nearly ten years since the release of the 

landmark report regarding the CLAS 

Standards. In the report, the HHS, OMH 

provided the framework for all health 

care organizations to establish services 

and policies to best serve our 

increasingly diverse communities. In 

the decade following the release of the 

CLAS Standards, the field of cultural 

and linguistic competency has seen 

tremendous growth. It has evolved from 

a fledgling concept to a recognized 

intervention in the quest for health 

equity. The field of cultural and 

linguistic competency is dynamic and 

as such requires routine enhancement 

and nurturing. With this in mind, HHS, 

OMH has begun to revisit the National 

CLAS Standards. 

The OMH has determined that the 

appropriate next step is for the CLAS 


srobinson on DSKHWCL6B1PROD with NOTICES
57958 Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices 

Standards to undergo a national process 

of public comment that will result in a 

broader awareness of HHS interest in 

CLAS, significant input from 

stakeholder groups on the existing 

CLAS Standards, as well as a final 

revision of the CLAS Standards and 

accompanying commentary supported 

by the expertise of a National Project 

Advisory Committee. The final revisions 

will be published in the Federal 

Register as recommended national 

standards for adoption or adaptation by 

stakeholder organizations and agencies. 

The publication of the CLAS 

Standards in the Federal Register, and 

publicizing the availability of the 

complete report with commentary on 

the Internet and through local, regional, 

and national organizations will facilitate 

reaching as wide an audience of 

stakeholders as possible. This period of 

dissemination and awareness-raising 

will include three regional meetings to 

gather and solicit detailed input from 

interested individuals and organizations 

that will complement and enhance the 

public comments received by OMH 

through electronic and written means. 

Individuals and organizations 

desiring to provide input on the 

standards are encouraged to send 

comments during the public comment 

period which is from September 20 

through December 31, 2010. Individuals 

mailing comments are requested to 

include the following information: 

Name, position, organization, mail, and 

e-mail addresses and to identify 

specifically those portions of their 

comments that pertain to: The wording 

or the content of individual standards, 

the purpose of the standards and/or the 

intended audience for the national 

standards. 

Dates and locations of the meetings 

are as follows: 

Baltimore, Maryland, Friday, October 

22, 2010, The Hyatt Regency, 300 Light 

Street, Baltimore, MD 21202. 

San Francisco, California, Thursday, 

November 4, 2010, The Stanford Court, 

A Renaissance Hotel, 905 California 

Street, San Francisco, CA 94108. 

Chicago, Illinois, Monday, November 

15, 2010, The James Hotel, 55 East 

Ontario Street, Chicago, IL 60611–2727. 

All meetings will convene at 9 a.m. 

and conclude at 3 p.m. On-site 

registration will be available starting at 

7:30 a.m. 

Information about the CLAS 

Standards Enhancement Initiative is 

available electronically at http://

clasenhancements.thinkculturalhealth.

org. 

Dated: September 2, 2010. 

Garth N. Graham, 

Deputy Assistant Secretary for Minority 

Health. 

[FR Doc. 2010–23760 Filed 9–22–10; 8:45 am] 

BILLING CODE 4150–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Solicitation of Written Comments on 

Draft Tier 2 Strategies/Modules for 

Inclusion in the ‘‘HHS Action Plan to 

Prevent Healthcare-Associated 

Infections’’ 

AGENCY: Department of Health and 

Human Services, Office of the Assistant 

Secretary for Health, Office of 

Healthcare Quality. 

ACTION: Notice. 

SUMMARY: The Office of Healthcare 

Quality is soliciting public comment on 

three new strategies or modules of the 

‘‘HHS Action Plan to Prevent 

Healthcare-Associated Infections.’’ To 

further the HHS mission to protect the 

health and well-being of the nation, the 

HHS Steering Committee for the 

Prevention of Healthcare-Associated 

Infections has developed draft 

comprehensive strategies for preventing 

and reducing healthcare-associated 

infections in ambulatory surgical 

centers and end-stage renal disease 

facilities, as well as a strategy to 

increase influenza vaccination coverage 

among healthcare personnel. These Tier 

2 modules build upon and are to be 

included in the existing ‘‘HHS Action 

Plan to Prevent Healthcare-Associated 

Infections’’ that focuses on reducing 

hospital-acquired infections (Tier 1). 

DATES: Comments on the draft Tier 2 

modules should be received no later 

than 5 p.m. on October 11, 2010. 

ADDRESSES: The draft Tier 2 modules 

can be found at http://www.hhs.gov/ 

ophs/initiatives/hai/actionplan/ 

index.html#tier2. Comments are 

preferred electronically and may be 

addressed to OHQ@hhs.gov. Written 

responses should be addressed to the 

Department of Health and Human 

Services, 200 Independence Ave, SW., 

Room 719B, Washington, DC 20201, 

Attention: Draft Tier 2 Modules. 

FOR FURTHER INFORMATION CONTACT: 

Danielle Doughman, (202) 690–6476 or 

OHQ@hhs.gov. 

SUPPLEMENTARY INFORMATION

I. Background 

Healthcare-associated infections are 

among the leading causes of morbidity 

and mortality in the United States and 

the most common type of adverse event 

in the field of healthcare today. They are 

defined as localized or systemic adverse 

events, resulting from the presence of an 

infectious agent or toxin, occurring to a 

patient in a healthcare setting. An 

epidemiologic study by the Centers for 

Disease Control and Prevention (CDC) 

revealed that the subset of HAIs with 

hospital-onset accounted for 1.7 million 

infections annually and were associated 

with 99,000 deaths in 2002. The fiscal 

cost is steep as well. Healthcareassociated infections contribute to an 

additional $28 to $33 billion dollars in 

healthcare expenditures annually. 

For these reasons, the prevention and 

reduction of healthcare-associated 

infections is a top priority for the U.S. 

Department of Health and Human 

Services (HHS). Multiple agencies 

within HHS have been working to 

reduce the incidence and prevalence of 

healthcare-associated infections for 

decades. To further efforts, the HHS 

Steering Committee for the Prevention 

of Healthcare-Associated Infections was 

established in July 2008 and charged 

with developing a comprehensive 

strategy to progress toward the 

elimination of healthcare-associated 

infections. 

In 2009, the Steering Committee 

issued the initial version of the ‘‘HHS 

Action Plan to Prevent HealthcareAssociated Infections.’’ The initial 

strategy (Tier 1) focused on the 

prevention of infections in the acute 

care hospital setting and includes a 

prioritized research agenda; an 

integrated information systems strategy; 

policy options for linking payment 

incentives or disincentives to quality of 

care and enhancing regulatory oversight 

of hospitals; and a national messaging 

plan to raise awareness of HAIs among 

the general public, providers, and other 

stakeholder groups. The Action Plan 

also delineates specific measures and 

five-year goals to focus efforts and track 

national progress in reducing the most 

prevalent infections. In addition, the 

plan intended to enhance collaboration 

with non-government stakeholders and 

partners at the national, regional, state, 

and local levels to strengthen 

coordination and impact of efforts. 

Recognizing the need to coordinate 

prevention efforts across healthcare 

facilities, HHS began to transition into 

the second phase (Tier 2) of the Action 

Plan in late 2009. Tier 2 expands efforts 

outside of the acute care setting into 

outpatient facilities (e.g., ambulatory 

surgical centers, end-stage renal disease 

facilities). The healthcare and public 

health communities are increasingly 

challenged to identify, respond to, and 

prevent healthcare-associated infections 

across the continuum of settings where 


srobinson on DSKHWCL6B1PROD with NOTICES