[Federal Register Volume 78, Number 185 (Tuesday, September 24, 2013)]
[Notices]
[Pages 58539-58543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23164]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Standards for Culturally and Linguistically Appropriate 
Services (CLAS) in Health and Health Care

AGENCY: Office of Minority Health, Office of the Secretary, Department 
of Health and Human Services.

ACTION: Notice.

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[[Page 58540]]

SUMMARY: The Department of Health and Human Service (HHS), Office of 
the Secretary, Office of Minority Health (OMH) announces the 
publication of the final enhanced National Standards for Culturally and 
Linguistically Appropriate Services (CLAS) in Health and Health Care, 
known as the enhanced National CLAS Standards. In developing the 
enhanced National CLAS Standards, OMH undertook the National CLAS 
Standards Enhancement Initiative. From 2010-2012, this initiative 
included input from a National Project Advisory Committee composed of 
subject matter experts representing public, private and government 
sectors, regional public meetings, public comment period, and a 
systematic literature review. The enhanced National CLAS Standards, 
including a brief background summary of the development process and 
public comment period, are printed below.

DATES: The final enhanced National Standards for Culturally and 
Linguistically Appropriate Services (CLAS) in Health and Health Care 
will be available beginning September 24, 2013.

ADDRESSES: The final enhanced National Standards for Culturally and 
Linguistically Appropriate Services (CLAS) in Health and Health Care 
can be found online at www.thinkculturalhealth.hhs.gov.

FOR FURTHER INFORMATION CONTACT: CDR Jacqueline Rodrigue, Deputy 
Director, Office of Minority Health, Department of Health and Human 
Services, 1101 Wootton Parkway, Suite 600, Rockville, MD 20852. Attn: 
Enhanced National CLAS Standards. Telephone: (240) 453-2882.

SUPPLEMENTARY INFORMATION: In 2001, the HHS OMH published the National 
Standards for Culturally and Linguistically Appropriate Services (CLAS) 
in Health Care, known as the original National CLAS Standards, to 
address inequities that existed in the provision of health services, 
and to make these services more responsive to the individual needs of 
all patients and consumers. The original National CLAS Standards 
resulted from extensive research, discussions, input from stakeholders 
across the country, and offered a practical framework for the 
implementation of services and organizational structures that helped 
health care organizations and providers become more responsive to 
culturally and linguistically diverse communities. For the past decade, 
the original National CLAS Standards have served as catalyst and 
conduit for efforts to improve the quality of care and achieve health 
equity.
    The HHS OMH undertook the National CLAS Standards Enhancement 
Initiative from 2010 to 2012 to recognize the nation's increasing 
diversity, to reflect the tremendous growth in the fields of cultural 
and linguistic competency over the past decade, and to ensure relevance 
with new national policies and legislation, such as the Affordable Care 
Act. A decade after the publication of the original National CLAS 
Standards, there is still much work to be done. Racial and ethnic 
disparities in health and health care remain a significant public 
health issue, despite advances in health care technology and delivery, 
even when factors such as insurance coverage, income, and educational 
attainment are taken into account. Cultural and linguistic competency 
strives to improve the quality of care received and to reduce 
disparities experienced by racial and ethnic minorities and other 
underserved populations. Through the National CLAS Standards 
Enhancement Initiative (Enhancement Initiative), a new benchmark is 
being established for culturally and linguistically appropriate 
services to improve the health of all individuals.
    The Enhancement Initiative followed the same development process as 
the original National CLAS Standards project in 1999-2001. The 
development process had three major components: (1) Input from a 
National Project Advisory Committee comprised of subject matter experts 
representing public, private, and government sectors; (2) regional 
public meetings, public comment period; and (3) a systematic literature 
review. The goals of the Enhancement Initiative were to update the 
original National CLAS Standards in order to reflect the advancements 
of the past decade, expand their scope, and improve upon their clarity 
in order to encourage more widespread understanding and implementation. 
The Enhancement Initiative also sought to develop a product that could 
assist individuals and organizations in the implementation of the 
enhanced National CLAS Standards.

Public Comment Period and Regional Public Meetings

    As part of the National CLAS Standards Enhancement Initiative, OMH 
invited the public to submit comments on the original National CLAS 
Standards in late 2010, with the purpose of increasing public awareness 
of the National CLAS Standards. The announcement of the public comment 
period appeared in the Federal Register published on September 23, 2010 
(75 FR 57957--58), at www.thinkculturalhealth.hhs.gov/CLCCHC/HealthNews/FederalRegister_CLAS.pdf.
    The Federal Register announcement highlighted the various ways in 
which the public could provide comment, including submitting comments 
via an online portal, or submitting letters directly to OMH and/or its 
support team at SRA International, Inc. Individuals and organizations 
were encouraged to review the original National CLAS Standards and send 
written and/or online public comments during a 103-day period between 
September 20, 2010, and December 31, 2010. Over 500 individuals and 90 
organizations participated in the public comment period.
    Concurrent with the public comment period, three in-person regional 
public meetings were convened. The purpose of the regional public 
meetings was to gather and solicit detailed feedback from interested 
individuals and organizations that would complement and enhance the 
public comments received by OMH through online and written submissions. 
These three public meetings were held on October 22, 2010, in 
Baltimore, Maryland; November 4, 2010, in San Francisco, California; 
and on November 15, 2010, in Chicago, Illinois. The total number of 
attendees for all three meetings was approximately 100 individuals from 
different organizations. The project team recorded and transcribed all 
three meetings. A qualitative theme analysis of the public meetings' 
transcripts was completed to determine relevant themes.

Analysis and Response to Public Comments Meetings on the enhanced 
National CLAS Standards

    The following themes arose from the comments heard across the three 
public meetings.
    The enhanced National CLAS Standards should:
     Encompass a broad definition of culture to include 
religion and spirituality; lesbian, gay, bisexual, and transgender 
community individuals; deaf and hearing impaired individuals; and blind 
and vision impaired individuals
     Incorporate the areas of patient satisfaction and safety
     Address issues of health literacy
     Establish congruency with other standards in the field
     Be action oriented
     Reflect advancements in terminology, technology, and more,

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including medical homes, electronic health records, and language 
access.

Analysis and Response to Written and Online Comments on the enhanced 
National CLAS Standards

    A series of Likert-type statements were posed to those responding 
via the online portal and written submissions, and respondents were 
asked to indicate the degree to which they agreed or disagreed with 
each statement. Examples of the statements and responses are as 
follows:
    1. ``The National CLAS Standards meet my needs.''
    Fifty-nine percent (59%) of the respondents either strongly agreed 
or agreed with the statement that the original National CLAS Standards 
met their needs as someone who works to improve the health of diverse 
communities. In a follow-up question, ``In order for the CLAS Standards 
to meet my needs, the following enhancements would need to be made:'' 
29%, (n=51) of the respondents requested additional resources (e.g., 
additional training, funding, guides). In addition, 13% (n=24) 
requested CLAS enforcement mechanisms, 7% (n=13) requested promotion 
(i.e., need for increased awareness), 7% (n=13) requested increased 
clarity, and 7% (n=12) requested increased inclusivity of the 
populations addressed.
    2. ``I believe the National CLAS Standards [as a whole] should be 
revised'' Forty-eight percent (48%) of respondents either strongly 
agreed or agreed with the statement that the CLAS Standards should be 
revised. In a follow-up question, ``I believe with revisions my 
utilization of the CLAS Standards will* * *'' 29% (n=103) indicated 
that their utilization of the CLAS Standards would increase upon 
revision, while 25% (n=88) indicated that their utilization would stay 
the same. Similarly, 32% (n=113) of respondents indicated their belief 
that their organization's utilization of the CLAS Standards would 
increase upon revision.
    After December 31, 2010, when the public comment period ended, the 
project team analyzed the public comments received from all sources, 
including the 90 organizations that submitted online or written public 
comments. The following overarching themes emerged:
    The enhanced National CLAS Standards should:
     Expand the target audience beyond health care 
organizations
     Encompass a broad definition of culture to include 
religion and spirituality; lesbian, gay, bisexual, and transgender 
individuals; deaf and hearing impaired individuals; and blind and 
vision impaired individuals
     Offer more guidance pertaining to language assistance 
services
     Establish congruency with other related standards in the 
field.

National Project Advisory Committee

    The National Project Advisory Committee (NPAC) of National CLAS 
Standards Enhancement Initiative is comprised of 36 subject matter 
experts in the fields of cultural and linguistic competency 
representing HHS agencies, academic institutions, health associations, 
and other private organizations. A complete list of NPAC members is 
available at www.thinkculturalhealth.hhs.gov. The NPAC provided 
insight, recommendations, and review throughout the development of the 
enhanced National CLAS Standards. The Enhancement Initiative Project 
Team conducted informal interviews in fall 2010 with the members of the 
NPAC to gather input on the enhanced National CLAS Standards from 
subject matter experts representing a myriad of roles in the field of 
cultural and linguistic competency. These conversations, along with the 
public comment and the systematic literature review, served to begin 
the laying of the foundation for the enhanced National CLAS Standards 
in fall 2010. The topics of discussion included the purpose and scope 
of the future National CLAS Standards, the target audience, and issues 
surrounding implementation and promotion.
    The NPAC convened twice in Washington, DC during 2011. At the 
January 2011 meeting, the NPAC discussed the following topics in depth: 
Purpose, Definitions, Inclusivity, Audience, Health Literacy, Language 
Access Services, Measurements, Implementation, Promotion, and End 
Product.
    The January 2011 meeting built the framework for the Project Team 
to begin drafting the enhanced National CLAS Standards. During spring 
2011, the NPAC reviewed and provided feedback on a document of 
terminology and definitions that would serve as the conceptual 
underpinning of the enhanced National CLAS Standards. The NPAC met 
virtually for a series of webinars in summer 2011 to define the 
direction of the enhanced National CLAS Standards and discuss draft 
Standards. Another recurring theme throughout the public comment 
portion of the National CLAS Standards Enhancement Initiative was the 
request for additional support and guidance in the implementation and 
maintenance of the National CLAS Standards. To address this issue, the 
NPAC began compiling information and materials for the guidance 
document, National Standards for Culturally and Linguistically 
Appropriate Services in Health and Health Care: A Blueprint for 
Advancing and Sustaining CLAS Policy and Practice (The Blueprint) to 
accompany the enhanced National CLAS Standards. The Blueprint, which 
describes each stage of the development process, is available at 
www.thinkculturalhealth.hhs.gov.

Systematic Literature Review

    The systematic literature review, developed in 2010, discusses the 
evolution of the efforts to improve cultural and linguistic 
appropriateness since the publication of the original National CLAS 
Standards in 2001. It addresses the broad dissemination, promotion, and 
implementation nationwide of the National CLAS Standards and the 
concepts of CLAS. In addition, the report covers cultural competency 
education initiatives; adoption of CLAS at the federal, state, and 
organizational levels; changes in accreditation standards to explicitly 
include CLAS; the proliferation of technical assistance regarding CLAS; 
and research and evaluation of the National CLAS Standards' impact. The 
report concludes with areas for consideration that emerged from the 
literature and research of the last 10 years, which provided insight 
into the issues the enhanced National CLAS Standards should address.

Rationale for the Enhancement of the CLAS Standards

    The public comments from the online portal, the written 
submissions, the regional public meetings, systematic literature 
review, and the NPAC offered a great pool of suggestions on how to 
enhance the National CLAS Standards. The enhanced National Standards 
for Culturally and Linguistically Appropriate Services in Health and 
Health Care are composed of 15 Standards that provide individuals and 
organizations with a blueprint for successfully implementing and 
maintaining culturally and linguistically appropriate services. 
Culturally and linguistically appropriate health care and services, 
broadly defined as care and services that are respectful of and 
responsive to the cultural and linguistic needs of all individuals, are 
increasingly seen as essential to reducing disparities and improving 
health care quality.
    All 15 Standards are necessary to advance health equity, improve 
quality,

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and help eliminate health care disparities. As important as each 
individual Standard is, the exclusion of any Standard diminishes health 
professionals' and organizations' ability to meet an individual's 
health and health care needs in a culturally and linguistically 
appropriate manner. Thus, it is strongly recommended that each of the 
15 Standards be implemented by health and health care organizations.

Statement of Intent

    In response to public comment and the National Project Advisory 
Committee feedback requesting further clarification on the intent of 
the National CLAS Standards, a statement of intent for the enhanced 
National CLAS Standards was crafted and has been added as an 
introductory sentence to the Standards:
    The National CLAS Standards are intended to advance health equity, 
improve quality, and help eliminate health care disparities by 
establishing a blueprint for health and health care organizations to:
    As the enhanced National CLAS Standards are disseminated, the 
inclusion of the statement of intent within the actual Standards 
ensures that every person who uses the Standards will understand their 
importance. Although this introductory sentence does not convey the 
only purpose of the Standards, it does convey their primary goal. The 
addition of the statement of intent ties the culturally and 
linguistically competent policies and practices posed in the enhanced 
National CLAS Standards directly to the goals of advancing health 
equity, improving quality, and eliminating health care disparities.

Advance Health Equity

    Health equity is defined as the attainment of the highest level of 
health for all people (HHS OMH, National Stakeholder Strategy for 
Achieving Health Equity, 2011). Currently, many individuals are unable 
to attain their highest level of health for several reasons, including 
social factors such as inequitable access to quality care and 
individual factors such as limited resources. Lack of health equity has 
a significant economic and societal impact.

Improve Quality

    Culturally and linguistically appropriate services and related 
education initiatives affect several aspects of an organization's 
continuous quality improvement initiatives. For example, research 
suggests that after implementation of CLAS initiatives, there are 
substantial increases in provider knowledge and skill acquisition and 
improvements in provider attitudes toward culturally and linguistically 
diverse patient populations.\1\ Studies also indicate that patient 
satisfaction increases when culturally and linguistically appropriate 
services are delivered.\2\ At the organizational level, hospitals and 
clinics that support effective communication by addressing CLAS have 
been shown to have higher patient-reported quality of care and more 
trust in the organization.\3\ Preliminary research has shown a positive 
impact of CLAS on patient outcomes,\4\ and a growing body of evidence 
illustrates the effectiveness of culturally and linguistically 
appropriate services in improving the quality of care and services 
received by individuals.\5\
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    \1\ Beach, M.C., Cooper, L.A., Robinson, K.A., Price, E.G., 
Gary, T.L., Jenckes, M.W., [hellip] Powe, N.R. (2004). Strategies 
for improving minority healthcare quality. (AHRQ Publication No. 04-
E008-02). Retrieved from the Agency of Healthcare Research and 
Quality Web site: http://archive.ahrq.gov/downloads/pub/evidence/pdf/minqual/minqual.pdf.
    \2\ Beach, M.C., Cooper, L.A., Robinson, K.A., Price, E.G., 
Gary, T.L., Jenckes, M.W., * * * Powe, N.R. (2004). Strategies for 
improving minority healthcare quality. (AHRQ Publication No. 04-
E008-02). Retrieved from the Agency of Healthcare Research and 
Quality Web site: http://archive.ahrq.gov/downloads/pub/evidence/pdf/minqual/minqual.pdf.
    \3\ Wynia, M.K., Johnson, M., McCoy, T.P., Passmore Griffin, L., 
& Osborn, C.Y. (2010). Validation of an organizational communication 
climate assessment toolkit. American Journal of Medical Quality, 
25(6), 436-443. doi:10.1177/1062860610368428.
    \4\ Lie, D.A., Lee-Rey, E., Gomez, A., Bereknyel, S., & 
Braddock, C.H. (2010). Does cultural competency training of health 
professionals improve patient outcomes? A systematic review and 
proposed algorithm for future research. Journal of General Internal 
Medicine, 26(3), 317-325. doi:10.1007/s11606-010-1529-0.
    \5\ Beach, M.C., Cooper, L.A., Robinson, K.A., Price, E.G., 
Gary, T.L., Jenckes, M.W., [hellip] Powe, N.R. (2004). Strategies 
for improving minority healthcare quality. (AHRQ Publication No. 04-
E008-02). Retrieved from the Agency of Healthcare Research and 
Quality Web site: http://archive.ahrq.gov/downloads/pub/evidence/pdf/minqual/minqual.pdf.
    Goode, T.D., Dunne, M.C., & Bronheim, S. M. (2006). The evidence 
base for cultural and linguistic competency in health care. 
(Commonwealth Fund Publication No. 962). Retrieved from The 
Commonwealth Fund Web site: http://www.commonwealthfund.org/usr_doc/Goode_evidencebasecultlinguisticcomp_962.pdf.
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Help Eliminate Health Care Disparities

    Eliminating health care disparities is one of the ultimate goals of 
advancing health equity. Disparities exist and persist across many 
culturally diverse groups, with individuals who identify as racial or 
ethnic minorities being less likely to receive preventive health 
services, even when insured.\6\
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    \6\ DeLaet, D.E., Shea, S., & Carrasquillo, O. (2002). Receipt 
of preventive services among privately insured minorities in managed 
care versus fee-for-service insurance plans. Journal of General 
Internal Medicine, 17, 451-457. doi:10.1046/1525-1497.2002.10512.x.
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Clarity and Action

    Each of the National CLAS Standards was revised for greater clarity 
and focus. In addition, the wording of each of the 15 Standards now 
begins with an action word to emphasize how the desired goal may be 
achieved.

Standards of Equal Importance

    The original National CLAS Standards designated each Standard as a 
recommendation, mandate, or guideline. The recommendation (original 14 
Standards) was a suggestion for voluntary adoption by health care 
organizations. The mandates (original Standards 4, 5, 6, and 7) were 
Federal requirements for all recipients of Federal funds. The 
guidelines (original Standards 1, 2, 3, 8, 9, 10, 11, 12, and 13) were 
activities recommended for adoption as mandates by federal, state, and 
national accrediting agencies.
    However, the enhanced National CLAS Standards promote collective 
adoption of all Standards as the most effective approach to improve the 
health and well-being of all individuals. The Standards are intended to 
be used together, as mutually reinforcing actions, and each of the 15 
Standards should be understood as an equally important guideline to 
advance health equity, improve quality, and help eliminate health care 
disparities.
    Although the enhanced National CLAS Standards are not statutory or 
regulatory requirements, failure by a recipient of Federal financial 
assistance to provide services consistent with Standards 5 through 8 
(Communication and Language Assistance Standards) could result in a 
violation of Title VI of the Civil Rights Act of 1964 and its 
implementing regulations (42 USC 2000d et seq. and 45 CFR Part 80). 
Therefore, implementation of these goals may help ensure that health 
care organizations and individual providers serve persons of diverse 
backgrounds in a culturally and linguistically appropriate manner in 
accordance with the law. Health care organizations and individual 
providers are encouraged to seek technical assistance from the HHS 
Office for Civil Rights or review the HHS Guidance to Federal Financial 
Assistance Recipients Regarding Title VI Prohibition Against National 
Origin Discrimination Affecting Limited

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English Proficient Persons document (HHS Office for Civil Rights, 2003) 
to assess whether or to what extent language access services must be 
provided in order to comply with the Title VI requirement to take 
reasonable steps to provide meaningful access to their programs for 
persons with limited English proficiency.

Principal Standard and Three Enhanced Themes

Principal Standard

    Standard 1 has been made the Principal Standard with the 
understanding that it frames the essential goal of all of the 
Standards, and if the other 14 Standards are adopted, implemented, and 
maintained, then the Principal Standard will be achieved.
    1. Provide effective, equitable, understandable, respectful, and 
quality care and services that are responsive to diverse cultural 
health beliefs and practices, preferred languages, health literacy, and 
other communication needs.

Theme 1: Governance, Leadership, and Workforce

    Changing the name of Theme 1 from Culturally Competent Care to 
Governance, Leadership, and Workforce provides greater clarity on the 
specific locus of action for each of these Standards and emphasizes the 
importance of the implementation of CLAS as a systemic responsibility, 
requiring the investment, support, and training of all individuals 
within an organization.
    The Standards in this theme include:
    2. Advance and sustain governance and leadership that promotes CLAS 
and health equity
    3. Recruit, promote, and support a diverse governance, leadership, 
and workforce
    4. Educate and train governance, leadership, and workforce in CLAS

Theme 2: Communication and Language Assistance

    Changing the name of Theme 2 from Language Access Services to 
Communication and Language Assistance broadens the understanding and 
application of appropriate services to include all communication needs 
and services, including sign language, braille, oral interpretation, 
and written translation.
    The Standards in this theme include:
    5. Offer communication and language assistance
    6. Inform individuals of the availability of language assistance
    7. Ensure the competence of individuals providing language 
assistance
    8. Provide easy-to-understand materials and signage

Theme 3: Engagement, Continuous Improvement, and Accountability

    Changing the name of Theme 3 from Organizational Supports to 
Engagement, Continuous Improvement, and Accountability underscores the 
importance of establishing individual responsibility in ensuring that 
CLAS is supported, while retaining the understanding that effective 
delivery of CLAS demands actions across an organization. This revision 
focuses on the supports necessary for adoption, implementation, and 
maintenance of culturally and linguistically appropriate policies and 
services regardless of one's role within an organization or practice. 
All individuals are accountable for upholding the values and intent of 
the National CLAS Standards.
    The Standards in this theme include:
    9. Infuse CLAS goals, policies, and management accountability 
throughout the organization's planning and operations
    10. Conduct organizational assessments
    11. Collect and maintain demographic data
    12. Conduct assessments of community health assets and needs
    13. Partner with the community
    14. Create conflict and grievance resolution processes
    15. Communicate the organization's progress in implementing and 
sustaining CLAS.
    The past decade has shown that the National CLAS Standards are a 
dynamic framework. Therefore, as best and promising practices in the 
field of cultural and linguistic competence develop, there will be 
future enhancements of the National CLAS Standards. The HHS OMH also 
maintains a Web version of The Blueprint to provide a more 
comprehensive and up-to-date resource, with supporting material online 
at www.thinkculturalhealth.hhs.gov.

    Dated: September 11, 2013.
J. Nadine Gracia,
Deputy Assistant Secretary for Minority Health, Office of Minority 
Health, U.S. Department of Health and Human Services.
[FR Doc. 2013-23164 Filed 9-23-13; 8:45 am]
BILLING CODE 4150-29-P