[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,
[[Page 58542]]
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]
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