[Federal Register: December 22, 2000 (Volume 65, Number 247)]
[Notices]
[Page 80865-80879]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de00-91]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Minority Health; National Standards on Culturally and
Linguistically Appropriate Services (CLAS) in Health Care
AGENCY: HHS/OS/Office of Public Health and Science, Office of Minority
Health, DHDS.
ACTION: Final report.
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SUMMARY: The HHS Office of Minority Health announces the publication of
final national standards on culturally and linguistically appropriate
services (CLAS) in health care, following a 120-day comment period on
draft standards in 2000 and revisions to the standards. The CLAS
standards, with a brief background summary of the development and
comment process, are printed below.
FOR FURTHER INFORMATION CONTACT: Guadalupe Pacheco, Office of Minority
Health, 5515 Security Lane, Suite 1000, Rockville, MD 20852, Attn:
CLAS; Office Telephone: (301) 443-5084, FAX: (301) 594-0767, E-Mail:
gpacheco@osophs.dhhs.gov. The standards, the public comments from the
regional meetings, and a complete report on the project can be found
online at [www.omhrc.gov/CLAS].
SUPPLEMENTARY INFORMATION:
Table of Contents
--Background
--Public Comment Period and Regional Informational Meetings
--National Project Advisory Committee (NPAC)
--Analysis and Response to Public Comments on the CLAS Standards
--National Standards for Culturally and Linguistically Appropriate
Services in Health Care
Background
Cultural and linguistic competence is the ability of health care
providers and health care organizations to understand and respond
effectively to the cultural and linguistic needs brought by patients to
the health care encounter. As health providers begin to treat a more
diverse clientele as a result of demographic shifts and changes in
insurance program participation, interest is increasing in culturally
and linguistically appropriate services that lead to improved outcomes,
efficiency, and satisfaction. The provision of culturally and
linguistically appropriate services is in the interest of providers,
policymakers, accreditation and credentialing agencies, purchasers,
patients, advocates, educators and the general health care community.
Many health care providers do not have clear guidance on how to
prepare for, or respond to, culturally sensitive situations. Until now,
no comprehensive nationally recognized standards of cultural and
linguistic competence in health care service delivery have been
developed. Instead, Federal health agencies, State policymakers, and
national organizations have independently developed their own standards
and practices. Some have developed definitions of cultural competence
while others mandate providing language services to limited English
proficient (LEP) speakers. Some specify collection of language, race,
and ethnicity data. Many approaches attempt to be comprehensive, while
others target only a specific issue, geographic area, or subfield of
health care such as mental health. The result is a wide spectrum of
ideas about what constitutes culturally appropriate health services,
including significant
[[Page 80866]]
differences with respect to target population, scope, and quality of
services. Although limited in their jurisdiction, many excellent
policies do exist, and the increasing numbers of model programs and
practices demonstrate that culturally competent health services are
viable, beneficial, and important to health care consumers.
In 1997, the U.S. Department of Health and Human Services' (HHS)
Office of Minority Health (OMH) asked Resources for Cross Cultural
Health Care and the Center for the Advancement of Health to review and
compare existing cultural and linguistic competence standards and
measures in a national context, propose draft national standard
language where appropriate, assess the information or research needed
to relate these guidelines to outcomes, and develop an agenda for
future work in this area. Assuring Cultural Competence in Health Care:
Recommendations for National Standards and an Outcomes-Focused Research
Agenda was the result of this request, with a two-part report submitted
to OMH in May 1999.
The first part of the 1999 report contained draft national
standards for culturally and linguistically appropriate services in
health care. Based on an analytical review of key laws, regulations,
contracts, and standards currently in use by Federal and State agencies
and other national organizations, these draft standards were developed
with input from a national project advisory committee of policymakers,
health care providers, and researchers. Each standard was accompanied
by a discussion that addressed the proposed guideline's relationship to
existing laws and standards, and offered recommendations for
implementation and oversight to providers, policymakers, and advocates.
Public Comment Period and Regional Informational Meetings
The Office of Minority Health determined that the appropriate next
step for the draft CLAS standards was to undergo a national process of
public comment that would result in a broader awareness of HHS interest
in CLAS in health care, significant input from stakeholder groups on
the draft standards, and a final revision of the standards and
accompanying commentary supported by the expertise of a National
Project Advisory Committee.
The draft CLAS standards were published in the Federal Register on
December 15, 1999 (Volume 64, Number 240, pages 70042-70044), and the
full report was made available for review online at [www.omhrc.gov/
CLAS]. Individuals and organizations desiring to comment on the
standards were encouraged to read the standards and full report, and to
send comments during the public comment period, which ran from January
1 to April 30, 2000. During this period, written comments sent by e-
mail and regular mail were received from 104 individuals and
organizations.
Individuals also had the opportunity to participate in one of three
regional meetings on the CLAS standards. The purpose of these one-day
meetings was to present information on the standards' development
process, and for participants to discuss and provide feedback on issues
related to the standards themselves or their implementation. Meetings
were publicized in the Federal Register notice, on the website, and in
letters mailed to more than 3,000 stakeholders. The meetings were held
on January 21, 2000, in San Francisco, California; March 10, 2000, in
Baltimore, Maryland; and April 7, 2000, in Chicago, Illinois. More than
309 individuals, representing themselves or their organizations,
participated in the three meetings. All sessions of each meeting were
audiotaped and transcribed for inclusion in the analysis of public
comments.
Following the closure of the public comment period on April 30,
2000, the project team (consisting of staff members of OMH, IQ
Solutions, Inc., and its subcontractor Resources for Cross Cultural
Health Care) implemented the following steps to analyze the public
comments on the CLAS standards received through the three regional
meetings, mail, and e-mail.
The public comments received from all sources were organized
according to the following categories (the numbers used to identify the
standards pertain to the numbering system of the draft standards. The
standards have been reordered in the final revision):
General Comments (made on the overall report).
Diverse and Culturally Competent Staff (Standards 1, 4,
and 5).
Consumer and Community Input (Standard 3).
Bilingual/Interpreter Services (Standards 6, 7, and 9).
Translated Written Materials (Standard 8).
The Culturally Competent Organization (Standards 2 and
13).
Data Collection and Performance Evaluation (Standards 10,
11, 12, and 14).
Within these categories, comments were organized by individual
standards and within standards by major identified themes. Staff
reviewed the compilations of comments to identify issues and
controversies for each standard, and the original comments were
organized topically for each standard and for the General Comments. The
project team then conducted a series of meetings to discuss comments on
topically grouped sets of standards. Deliberations on the CLAS
Standards addressed the following set of questions:
Is there a powerful consensus from public comments to
change the standard in any way? If so, what are the issues?
Are there any meaningful secondary issues that are so
compelling or sensible that they need to be considered in terms of
changes to the standard?
Are there any other issues that should be addressed (e.g.,
controversies raised by the standard) by the CLAS Standards National
Project Advisory Committee (NPAC)?
Deliberations on the general comments addressed the following set
of questions:
What are the major themes or issues related to the
previous process of developing the standards, and how should these
issues be addressed in the final CLAS standards report?
What are major themes related to contextual issues, and
how should these themes be addressed in the final CLAS standards
report?
What are major issues related to the subsequent standards
development process, and how should these themes be addressed?
National Project Advisory Committee
Based on the discussions related to these questions, the project
team prepared a deliberation report for the NPAC that included an
analysis of comments on the general comments and each standard. Each
analysis:
Makes recommendations for changes to the standards when
clearly indicated by a consensus in either public comments or project
team deliberations;
Identifies key themes, issues, and controversies; and
Provides rationales for changes or controversies that the
NPAC is being asked to consider.
The CLAS Standards National Project Advisory Committee was composed
of 27 individuals representing State and Federal agencies, health care
organizations, health care professionals, consumers, unions, and health
care accrediting agencies. A complete list of NPAC members is available
at [www.omhrc.gov/CLAS]. The NPAC
[[Page 80867]]
met with the project team in Washington, DC, on July 21-22, 2000.
Together, the group:
Considered the recommendations proposed in the
deliberation report and either concurred on the suggested changes to
the standard or offered an alternative approach to responding to public
comments on the issues;
Examined key issues for which recommendations were not
presented in the analysis (due to a lack of clear consensus) and, when
possible, recommended changes to the standards that were responsive to
public comments;
Identified and addressed other issues not raised in the
deliberation report; and
Made recommendations for next steps.
Following the meeting the project team revised the standards based
on the public comments and the deliberations of the NPAC, whose members
were given the opportunity to review and comment on subsequent
revisions. No formal consensus was obtained from the NPAC after the
meeting, although most comments were integrated into the final
standards by the project team, and the NPAC was given the opportunity
to review and comment on the final revisions. The final revisions are
now being published in the Federal Register as recommended national
standards for adoption or adaptation by stakeholder organizations and
agencies.
The project team will also produce a comprehensive final report
documenting all phases of the project and discussing issues related to
the standards in depth. This report will be available in early January
2000 online at [www.omhrc.gov/CLAS] and in hard copy by request to:
Guadalupe Pacheco, Office of Minority Health, 5515 Security Lane, Suite
1000, Rockville, MD 20852, Attn: CLAS; Office: Telephone (301) 443-
5084, FAX: (301) 594-0767, E-Mail: gpacheco@osophs.dhhs.gov.
Analysis and Response to Public Comments on the CLAS Standards
In response to publication in the Federal Register of the CLAS
Standards on December 15, 1999, OMH received public comments from 413
individuals or organizations, along with comments from the NPAC.
Comments were received from a broad range of stakeholders, including
hospitals, community-based clinics, managed care organizations, home
health agencies, and other types of health care organizations;
physicians, nurses, and other providers; professional associations;
state health departments; government and other purchasers of health
care; accreditation and credentialing agencies; patient advocates and
advocacy groups; policymakers; and educators. We present comments and
responses generally in the order in which the issues appeared in the
recommended CLAS Standards.
General Comments
The comments called for more specificity regarding terms such as
culture and competence. Two comments affirmed the choice of definition
used by the report; there were other votes for and against culturally
sensitive/effective/appropriate/competent. Culturally and
linguistically appropriate services (CLAS) was retained as the overall
descriptor for the package of activities described by standards.
Cultural competence remains the mainstream term for this area, and will
be used within standards and defined in the glossary. The NPAC
generally agreed with the continued use of the definition of cultural
and linguistic competence from the original report.
Comments suggested that the scope of the project include other
consumer groups/issues such as the poor, homeless, disabled, gender,
socioeconomic status, HIV, gay, bisexual, transgender, immigrants,
American Indians, different ages, countercultures, cultures within
cultures, individuals within cultures. In the discussion for this
section, the final report on the CLAS standards will articulate an
inclusive definition of culture that promotes a broad understanding of
the whole person. The report will note that every aspect of culture
does not need to be addressed in each standard in order for them to
apply to different groups, although we will emphasize the original
focus on racial, ethnic, and linguistic issues.
Comments asked that the standards be more precise and directive and
include more discussion in the standards themselves. To provide added
details without encumbering the language of the standards, the format
for presenting the revised CLAS standard was revised to continue using
concise language for the standard itself and incorporate wordsmithing
changes that enhance the clarity of each standard. Additional
clarification of key issues or requirements are provided in a brief
commentary accompanying the standard. It is our intent that the
commentary will not be separated from the standard in executive
summaries or other abbreviations of the full report. We also moved many
important points from the discussion section of each standard in the
original report into the commentary and will include more examples of
models and implementation practices in the discussion section of the
final report. However, much of the research on and verification of this
information should be conducted within the context of the anticipated
pilot tests of the standards by health care organizations. Suggestions
also were made for reorganizing the standards by topic area; the
revised standards reflect this reorganization, with three main
categories (culturally competent care, language assistance, and
organizational supports for cultural competence).
Comments raised concerns about too much emphasis on foreign
language issues, and it was suggested that they be broadened to include
other communication issues. The policies from which the standards were
derived are much more specific on the issue of language than culture,
and this reflects the current abstract nature of cultural competence
and the clear mandates that exist on language issues. We have tried to
strengthen the commentary and discussions on cultural competence
generally, separate the general cultural competence and language issues
into different categories, and call for more work on developing
national standards for cultural competence training and other aspects
of cultural competence.
Comments raised questions about several implementation issues,
including the cost burden and the applicability of the CLAS standards
to different kinds of health care organizations (e.g., community
clinics/community-based organizations (CBOs), mono-ethnic or
``already'' culturally competent providers, with extensive ethnic
diversity/little diversity, rural providers, home health care
agencies). Although the comments raise valid issues, we cannot address
cost implications and the implementation nuances according to
organization type within the scope of this project. Follow-up projects
to pilot test implementation of the CLAS standards and address such
issues are planned.
Commenters suggested that additional groups might have participated
in the development and comment process, including: health care
providers, practicing clinicians, CBOs, community health centers,
consumer groups, ethnic organizations, grassroots advocacy groups,
Indian reservations, tribal organizations, primary consumers, direct
service personnel, Native Americans, Asians, and people who don't speak
English. They also suggested that the outreach/public comment process
could have been more inclusive by using more participatory
[[Page 80868]]
approaches to getting information, offering interpreters, doing a
better job of informing people about the process, and targeting certain
audiences. The final report will detail the public comment process used
and its limitations. For example, alternative methods to get input,
such as focus groups, ethnic media advertising, were constrained by
resource limitations. We used recommendations from public meetings and
developed a matrix to assist with our analysis and inclusion of
different stakeholder groups in the NPAC. We attempted to recruit
representatives from key groups and added additional stakeholders to
the NPAC who provided community- and patient-based perspectives.
Comments indicated that many people are not aware of existing laws
that addressed issues raised by the CLAS standards, and some standards
can be strengthened on the basis of Federal legislation. The commentary
of the revised standards identifies the relationship between each
standard and any existing Federal laws or regulations. Input from the
NPAC was used to identify relevant Federal requirements.
Comments raised concerns about whether the recommended CLAS
standards should be guidelines, standards, or mandates. Overall, there
was a broad continuum of support for and opposition to different
conceptualizations of the standards. Fifty comments supported the
standards as mandates, with another 37 expressing endorsement, support
for their adoption, agreement with the intent, and other general
expressions of praise. Thirty-four comments expressed some level of
concern about seeing the standards as national standards or
requirements. Some prefer the standards as guidelines, and others
disliked them in any format. Among the reasons for their concern or
opposition include: The potential costs/burden of implementation; the
standards are too broad, too narrow, or too prescriptive; and the lack
of research evidence to support the CLAS activities. These issues were
raised in the pre-NPAC analytical report and discussed by the
committee. The NPAC offered up a consensus on three types of standards
of varying stringency: mandates, guidelines, and recommendations. The
revised CLAS standards are identified according to these types.
Several comments were raised about elevating the issues of racism,
bias, discrimination, and the issues of gender, social class, and
socioeconomic status more directly into the standards. Unconscious and
conscious referral bias and its impact on health disparities was
emphasized, as well as a tension between recognizing the needs of
newcomers vs. English-speaking individuals who may still not be
respectfully treated in health care. The revised preamble highlights
bias and discrimination issues, and the final report will further
discuss these issues.
Preamble
Public comments offered a variety of suggestions on how to revise
the preamble to the CLAS standards. The principal themes focused on
describing the purpose and desired outcomes of the standards,
elucidating the standards' overarching principles, and providing
definitions to key terms. Other comments suggested that the preamble
should include a list of stakeholders and specifically address issues
such as bias, ethics and confidentiality, and access. We have revised
the preamble to provide both a visionary and practical foundation for
understanding the CLAS standards while focusing on a principal theme
rather than the array of issues identified. We also have added
explanations of the three types of standards (mandates, guidelines, and
recommendations), definitions of key concepts used in the standards,
and a list of intended stakeholders.
Standard 1
Public comments took issue with the overall language of the
standard, questioning whether its vague language will render it
difficult to implement and enforce. Various comments cited the lack of
operationally defined and measurable requirements, recommended that the
standard be moved to the preamble or combined with Standard 5, and
suggested ways that the standard could be strengthened. The revised
standard, along with the accompanying Commentary, is intended to
encompass the spirit and overall purpose of the CLAS standards as well
as the details that can help organizations ``actualize'' and
``operationalize'' the requirements of Standard 1. As suggested in
public comments and by the NPAC, portions of the discussion in the CLAS
standards report have been incorporated into the standard's Commentary,
including actions organizations can take to support culturally
competent encounters. The intent of the standard is more fully
explicated in the discussion section of the final report.
Public comments focused on the term ``attitudes'' or the phrase
``attitudes, behaviors, knowledge, and skills'' of staff. The lack of
definitions and measures for these terms was cited as an obstacle to
implementing Standard 1. The revised standard deletes this phrase and
focuses instead on concrete actions as reflected in the commentary.
Comments requested that the CLAS standards address the issue of
traditional health practices. The response to these comments was to
include a reference to traditional health practices in the Commentary
to Standard 1. The Commentary cites ``being familiar with and
respectful of various traditional healing systems and beliefs and,
where appropriate, integrating these approaches into treatment plans.''
The discussion section for this standard in the final report will
include additional information and examples.
NPAC members emphasized the need to define ``respectful,''
``effective,'' ``understandable,'' and ``culturally competent'' care.
The revised standard calls more explicitly for ``care that is provided
in a manner compatible with [patients'/consumers'] cultural health
beliefs and practices and preferred language'' rather than merely
culturally competent care. This language was recommended by a NPAC
member and supported by the committee. The definition and assessment of
cultural competence are discussed more fully in the final report.
Further explanation of the other terms provided in the Commentary as
well as the discussion section of the final report.
Standard 2
One comment pointed out that ``diverse staff'' and ``culturally
competent staff'' are two distinct concepts that have been combined in
a single standard. The conceptual issues raised by combining in one
standard two distinct notions about the staff of a culturally competent
organization were addressed by separating the two different notions.
With the deletion of ``culturally competent,'' Standard 2 now focuses
on the need for a diverse staff that reflects the racial/ethnic and
cultural profile of the communities being served and is primarily
concerned with strategies for staff recruitment and retention. Standard
3 now focuses on the need for cultural competence in that staff and
addresses issues related to education and training.
Comments raised concerns about the definition of diverse staff in
Standard 2. With additional input from the NPAC, the standard now
defines a diverse staff within the standard as one that is
``representative of the demographic characteristics of the service
area.'' The standard's accompanying Commentary provides numerous
examples of the types of staff members who should reflect the
communities' diversity.
[[Page 80869]]
Comments criticized the use of the phrase ``administrative,
clinical, and support staff'' in the original draft standard. Although
comments differ in their suggested approach, they expressed a consensus
that the standard needs to be inclusive of all position levels in an
organization. The revised standard substitutes ``at all levels of the
organization'' for ``administrative, clinical, and support staff.'' The
commentary accompanying the standard provides more detailed information
about the various position levels and types of staff members that are
included in this specification.
Public comments recommended making Standard 2 more inclusive by
deleting the words ``racial and ethnic.'' The phrase was considered too
limiting a descriptor of communities and not synonymous with culture or
diversity. The term was deleted to encompass all cultural groups in the
communities being served.
Public comments indicate that use of the term ``qualified'' staff
within Standard 3 is controversial. Another issue is that the term
``qualified'' raises questions about its definition, including the
different levels of qualification that might be required for various
types of staff. NPAC input was sought on whether the term ``qualified''
should be included within the standard and, if it was to be included,
how it should be defined in the Commentary. However, no consensus among
the group was reached. One member urged that the issue be addressed in
the final report if not in the commentary.
Standard 3
Public comments focused on the nature of the organization's
responsibility in arranging for ongoing education and training.
Interpretations differed on whether the original terminology, ``arrange
for,'' implies that the organization itself should conduct in-service
training or should be responsible merely for making arrangements and
paying for the training to be offered (possibly outside of the
organization) to staff members. Substitution of the term ``ensure,''
along with an explanation in the Commentary of the intent of the
standard, clarifies the role of the health care organization.
Comments questioned whether specific types of staff members should
be specified in Standard 3. Comments addressed the need to define who
should be included in the various staff categories and to include all
position levels in an organization. Similar comments were made about
Standard 2, and a similar approach was used to revise Standard 3 with
the substitution of ``staff at all levels and across all disciplines''
for ``administrative, clinical, and support staff.''
More than 50 public comments on Standard 3 dealt with ways to offer
more explicit guidance on cultural competency education and training.
Comments emphasized the need to develop a standard or measures for
cultural competency training; offered recommendations on the process of
cultural competency education and training as well as specific topics
that should be included in cultural competency trainings. Despite the
preponderance of comments related to providing greater specificity
about the conduct and evaluation of cultural competency education and
training, the fact remains that there is no consensus on the definition
of cultural competency or what constitutes a culturally competent
health professional. Moreover, there are no standard curricula or
universally accepted certification or credentialing for cultural
competence and no standardized measures for evaluating the
effectiveness of cultural competency trainings. Given the lack of
certainty or consensus in this area, we sought NPAC advice on whether
Standard 3 or its accompanying Commentary should be more prescriptive
about the content and process of cultural competency education and
training. The Commentary reflects suggestions by NPAC members.
Standards 4 and 5
Comments raised questions about the relationship between standards
4, 5, and 6. The project team originally decided to combine standards 4
and 5 as a complete articulation of the healthcare organization's
responsibility to advertise, offer, and provide language services as
stipulated in Title VI of the Civil Rights Act of 1964. However, the
NPAC thought that the obligation to provide verbal and written notices
was sufficiently important to warrant its own standard. Thus, Standard
4 now addresses the organization's obligation to offer and provide
language assistance services, and standard 5 addresses the obligation
to provide verbal and written notices of patients'/consumers' rights to
such services.
Public comments emphasized the need to clarify the link between
Standards 4 and 5 and Title VI of the Civil Rights Act of 1964. The
link between these standards and Title VI and VII is explicitly
highlighted in the Commentary, and organizations are referred to the
August 30, 2000 Office for Civil Rights (OCR) guidance on Title VI with
respect to LEP individuals [www.hhs.gov/ocr/lep]. Because of this
reference, language in the standard and commentary for standards 4-7
was changed to reflect requirements of terminology in the guidance. For
example, the term ``language assistance services,'' taken from the OCR
guidance, was chosen as a generic term for bilingual interpreter
services, and written materials in other languages.
A reference to the needs of patience/consumers speaking American
Sign Language (ASL) was made in the commentary in response to public
comments.
Standard 6
Comments indicated confusion related to the abilities and
responsibilities of bilingual staff who do not function as
interpreters. Abilities and responsibilities of bilingual staff who
communicate directly with patients/consumers are now specified in a
paragraph in the commentary. NPAC comments were incorporated into
descriptions of what constitutes the competence of these staff members
as well as of interpreters. The abilities and responsibilities of
interpreter staff are similarly addressed. The commentary now also
addresses the need for assuring competence, and the requirements of
Title VI with respect to assuring competence.
Numerous public comments and the NPAC raised issues related to the
use of family and friends as interpreters. The wording in the standard
about family and friends was revised, and additional details are
provided in the commentary.
Standard 7
Comments suggested the deletion of the term ``translated'' and
raised concerns about the advisability of merely translating materials
versus creating original documents in non-English languages. The new
standard no longer uses the term ``translated.''
The term ``signage'' was cited in comments for being too vague and
needing clarification. Public comments were addressed by including
guidance in the commentary on the types of signage that should be
translated. The NPAC suggested that signage in Standard 7 should not
include the posted notices already addressed in Standard 5. The
language of the standard was further refined to reflect NPAC input, and
in the commentary, other types of notices (e.g., regarding patients
rights) have been added to examples of way-finding signage.
Comments cited the term ``commonly used'' as being too ``broad'' or
``unclear.'' One concern is that the term could be interpreted as
requiring
[[Page 80870]]
translation of every document, however insignificant or large. Other
comments raised questions about what constituted ``patient education
materials and other materials.'' These comments have been addressed by
deleting the term ``commonly used'' and using the broader term
``patient-related materials'' instead of patient education materials.
``Patient-related materials'' encompasses alternative formats (see
below) as well as various forms, notifications, and health prevention
and promotion materials. The standard's commentary refers organizations
to the OCR guidance for examples of the types of documents that may be
important to translate.
The term ``predominant language groups'' was commonly cited in
public comments, many of which were concerned about the vagueness of
the term. However, suggestions for defining the term varied. Public
comments have been addressed by revising the language of the standard
and including the clarification of requirements in the accompanying
commentary. The term ``commonly encountered,'' as suggested in one
comment, addresses the need for organizations and providers to assess
needs in their particular service areas. It also is consistent with
language in OCR Title VI policy guidance, which refers to ``regularly
encountered'' language groups. Because there is existing policy
guidance on the Federal mandate for translated materials, the
standard's commentary refers to that document for guidance in
determining for which language groups materials should be translated.
There was a general consensus among commenters that materials
should be consistent with a patient's culture and literacy level.
Comments emphasized that literal translation of patient information is
not sufficient. Signage and materials also must use culturally
appropriate images and take into account people's acculturation levels,
medical beliefs, and practice systems. The inappropriately high reading
level for forms and health education materials in English was cited
often, and this problem is compounded when materials with inappropriate
reading levels are translated. The need for consistency with a
patient's culture and literacy levels was addressed in the discussion
section of the original CLAS standards report. In response to public
comments, the wording of the standard itself has been revised to
include ``easily understood.'' The new terminology mirrors that used in
the first article in the Consumer Bill of Rights and Responsibilities,
which states that ``Consumers have the right to receive accurate,
easily understood information * * *'' The term is intended to emphasize
the need to help ensure the patient's comprehension of information, a
requirement that goes beyond mere literal translation. For further
emphasis on this issue, the accompanying commentary for the standard
specifies that signage and patient information should be responsive not
only to language differences but also to patients' cultures and
literacy levels.
Comments called attention to the need for alternative formats to
address the needs of people with sensory, developmental, and/or
cognitive impairments and persons whose languages lack a written
version. Public comments have been addressed by including in the
standard's commentary a reference to the need to develop alternative
materials as a detail of the standard's requirements. Deletion of the
word ``written'' also addresses the issue raised in comments of
providing information for people who are illiterate or whose language
has no written form.
Public comments addressed issues concerning the appropriate
translation process. In response to such comments, the commentary
accompanying the standard now specifies three important aspects of the
translation process: use of a trained translator, back translation and/
or review by a target audience group, and periodic updates.
Comments expressed concern that standard 7 could be interpreted as
a way to replace oral interpretation with translated written materials.
Rather than address this important concern by complicating the language
of the standard itself, specific reference to the continued importance
of oral interpretation is contained in the commentary accompanying the
standard.
Standard 8
Comments suggested that a rationale for the standard should be
provided. Language from comments and the original report articulate the
central nature of this standard, which is now stated in the first
paragraph of the commentary.
Comments observed that the word ``have'' in the original standard
lacked the power to convey the critical importance of the activities
described in this standard. The response to these comments was to
replace ``have'' with ``develop, implement, and promote.''
Many comments spoke to the need for integrating CLAS into the
mission and activities of the organization. This concept is now
articulated in the commentary.
Nearly half of the comments on Standard 8 addressed the issue of
internal and external accountability for cultural competence in an
organization. Some comments identified a bottom-up or line-staff
approach to initiating cultural competence activities, although most
comments recognized the need for top management support for cultural
competence to assure accountability and longevity, and shared
responsibility for implementation throughout the organization. This
issue is now raised in the commentary.
One comment directly addressed the need to involve communities and
patient/consumers in the development of an organization's management
strategy on cultural competence. This issue is now mentioned in the
commentary, with a reference to Standard 12, which more fully explores
the role of community involvement.
In accordance with suggestions from the NPAC, ``management
strategy'' has been changed to ``strategic plan.''
Standard 9
Comments pointed out the need to identify the purpose and use of
the data collection activities called for in the CLAS standards. These
comments have been addressed by describing the purpose of
organizational self-assessment at the beginning of the standard's
commentary. The role of initial and ongoing organizational self-
assessment is described in more detail in the discussion section of the
final report.
The NPAC was divided on whether to classify Standard 9 as a
guideline or recommendation. The two aspects of the standard--
conducting an initial and ongoing self-assessment and integrating
measures of cultural and linguistic competence into existing quality
improvement activities--were supported by different levels of evidence.
Self-assessment was considered by some committee members to be a
prerequisite for developing the strategic plan called for in Standard
8. Consequently, this aspect of the standard has been identified as a
guideline. Many public comments and NPAC members emphasized the
importance of taking organizational self-assessment to another level by
assessing the impact of CLAS services on patient care, access,
satisfaction, and health outcomes. Because the current evidence base
does not support a guideline to link organizational self-assessment
with the impact of CLAS on patients, building such links is a
recommendation of this standard.
Comments raised issues about the use of patient surveys in
organizational self-
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assessments. Concerns were expressed about the need for the surveys to
be culturally and linguistically appropriate, to be suitable for
measuring patient acceptance or compliance, and to be jointly designed
with the appropriate patient population. Comments also pointed out the
difficulties in identifying valid patient surveys that can be used
across cultures and the possibility that a qualitative approach might
be more appropriate than patient surveys for finding out how serious
organizations are about implementing the CLAS standards. The response
to these comments is to include in the commentary a statement that
patient/consumer and other community surveys are an important component
of organizational self-assessment of cultural and linguistic
competence, but they should not constitute the only self-assessment
tool. The commentary also notes that these surveys should be culturally
and linguistically appropriate. The final report will contain a
discussion on patient satisfaction surveys.
Organizational self-assessment appears to be an issue for which
many commenters sought clarification. Comments called for more
specificity in Standard 9, made suggestions about the processes and
components of self-assessment, addressed self-assessment tools, and
discussed the need for and appropriateness of indicators and measures
of organizational competence in CLAS. Although the general consensus of
these comments was that the standard should be more prescriptive
regarding the organizational self-assessment, no preferred process,
tool, or measures emerged. This situation is mirrored in the field,
where there also is a lack of consensus about what constitutes valid
tools and measures for organizational cultural competence. Given the
lack of information and consensus, we requested NPAC input on what
specific details, if any, should be provided to help organizations
implement the standard. Input from NPAC members and other experts
contributed to a discussion in the final report that will provide
examples of ways that some organizations are linking self-assessment
with CLAS impact.
Standard 10
Public comments focused on how the standard should describe the
data collected on language. Clarification was requested on what was
meant by ``primary spoken language,'' and several comments cited the
need to address both written and spoken languages. Comments suggested
using the term ``preferred'' language. The term ``preferred'' has the
advantage of implying that the patient/consumer, rather than the
organization's staff, makes the decision about which language is noted
in the management information system (MIS) and patient record. The
response to the public comments is to use the term ``preferred
language'' as well as both spoken and written languages in the
standard. The commentary describes what is meant by ``preferred'' and
``written'' language.
One public comment raised the important issue of the potential for
variations in data, depending on when they are collected. This comment
recognizes that there may be multiple points of entry (e.g.,
physician's office, pharmacy, and enrollment office) into a health care
organization and that information may not be routinely shared across
the various service components. To address this issue, the commentary
calls for data to be collected at the patient's/consumer's first point
of contact with the health care organization and be collected in health
records and integrated into the organization's MIS. This requirement is
designed to ensure consistency and continuity of information across
appropriate service components of the organization.
Public comments emphasized the importance of explaining the purpose
of data collection, particularly to populations that may fear negative
reprisals for providing personal information. To respond to this
important concern, the commentary accompanying the standard lists five
purposes for the collection of data on race/ethnicity and language.
More public comments addressed the issue of race/ethnicity data
than any other topic related to this standard. Comments focused on how
these data should be collected, including the need to collect
information on subpopulations and to standardize race/ethnicity data,
recommended systems for classifying race and ethnicity, and the
importance of self-identified race/ethnicity. To respond to these
concerns, the standard's commentary recommends using the standard
procedures and racial/ethnic categories specified in the Office of
Management and Budget (OMB) standards for maintaining , collecting, and
presenting Federal data on race and ethnicity (revision to OMB
directive #15) and adapted in the U.S. Census 2000. In keeping with the
OMB requirements and Census 2000, the commentary calls for
organizations to allow individuals to select more than one race/ethnic
category. The commentary also encourages organizations to enhance their
information on subpopulations by collecting additional identifiers such
as country of origin.
Comments and NPAC members suggested that data on language be
inclusive of diverse dialects or languages such as American Sign
Language (ASL). The response to these comments is to specify in the
commentary that data collected on language should include dialects and
ASL.
Public comments raised the issue of special data collection
considerations that should be made in certain cases involving minor
children. The response to these comments is to include in the
commentary a statement calling for the collection and documentation of
information about the preferred language and interpretation needs of
non-English-speaking parents of an English-speaking minor child. NPAC
input helped modify this statement.
Comments raised concerns about the confidentiality and privacy of
individual data collected on language and race/ethnicity. In addition
to clarifying the purpose of such data collection, the commentary for
Standard 10 requires that health care organizations maintain all
patient data according to the highest standard of confidentiality and
privacy. In response to NPAC concerns, organizations also are asked to
inform patients/consumers about the purposes of data collection and to
emphasize that the data will not be used for discriminatory purposes.
Additionally, the commentary states that no patient/consumer should be
required to provide data on race, ethnicity, or language or be denied
care or services if he or she chooses not to provide such information.
Standard 11
Comments cited a lack of clarity in the draft of Standard 11, but
no consensus emerged on how to reframe the standard. Our deliberations
on how to rewrite Standard 11 centered first on its purpose, which is
now stated at the beginning of the commentary. Based on this identified
goal, we have honed the focus of the standard on the maintenance of two
tools for helping organizations understand their communities (i.e., a
demographic, cultural, and epidemiological profile of the community,
and a needs assessment) and on the use to which this information should
be put (i.e., to plan for and implement responsive services).
Additional details provided in the commentary are intended to further
clarify the language of the standard.
[[Page 80872]]
Public comments suggested that the aggregate data collected under
the terms of Standard 11 should be updated regularly. Two comments
specifically suggested annual updates. Because many characteristics of
a community change over time, it is important that health care
organizations ensure that information on their community is up to date.
However, some organizations might consider an annual update too
burdensome. To address this issue without being too prescriptive, the
revised standard requires organizations to maintain a current profile
of the community and needs assessment, and the commentary calls for
organizations to obtain baseline data and update it regularly.
Comments and the NPAC discussed various methods and information
sources that could be used to maintain the profile and the needs
assessment. To respond to these comments, the commentary calls for
health care organizations to use a variety of methods and information
sources and presents examples of each.
Comments suggested that both qualitative and quantitative methods
should be used to collect information on the community. These comments
have been addressed by calling for the use of qualitative and
quantitative methods in the standard's commentary.
Comments emphasized the need to involve the community in data
collection efforts. This issue is addressed by including in the
standard's commentary the reminder that health care organizations
should involve the community in the design and implementation of the
community profile and needs assessment in accordance with Standard 12.
At the request of the NPAC, the commentary includes a statement
that organizations should not use the collected data for discriminatory
purposes.
Standard 12
Many comments focused on wordsmithing changes to the language of
the draft standard. The standard has been streamlined, although the
major thrust is the same. As rewritten, the standard is intended to be
directive, but not prescriptive. The commentary provides a rationale
for the standard, examples that elucidate key words, and examples of
the types of activities in which communities might become involved.
Comments suggested that both informal and formal mechanisms should
be used to facilitate community and patient/consumer involvement. This
language has been added to the standard, along with examples of such
mechanisms in the commentary.
Comments suggested using a stronger term than ``involvement.'' At
the suggestion of the NPAC, the standard was revised to recommend
``participatory, collaborative partnerships'' to strengthen the
standard.
The NPAC did not achieve consensus on whether Standard 12 should be
a guideline or recommendation. Although a summary chart developed by
the NPAC at the committee meeting listed Standard 12 under guidelines,
some individual members voiced a minority opinion that it should be a
recommendation. Given the overwhelming number of public comments about
the critical role of community in CLAS, in the final report, this
standard is listed as a guideline.
Standard 13
Comments noted the ambiguity of certain terms used in the standard.
The standard was rewritten based on several suggestions provided by
commenters. ``Develop structures and procedures to address'' was
replaced with ``provide a process to identify, prevent, and resolve,''
and additional details of staff and patient complaints were included in
the commentary.
In response to public comments, language was included in the
commentary that recognizes that many existing legal requirements cover
some of the issues raised in the standard.
NPAC members recommended that staff issues be separated from
patient/consumer issues because there are many mechanisms (e.g., EEO,
labor grievance processes) within organizations to work with staff-
staff problems. The revised standard focuses on conflict and grievance
resolution processes for patients/consumers and does not refer to staff
issues.
NPAC members expressed concerns that the draft standard did not
provide a sufficient link with existing organizational mechanisms for
patient complaint/grievance processes. Although it was suggested that
complaint processes for cross-cultural issues should be integrated with
existing mechanisms rather than be separate parallel systems, it was
agreed that the key was that the process be culturally competent and
include culturally competent staff. The revise standard calls for
organizations to ensure that conflict and grievance resolution
processes are culturally and linguistically sensitive and capable of
identifying, preventing, and resolving cross-cultural conflicts or
complaints by patients/consumers, rather than develop structures and
procedures to address cross-cultural issues.
Standard 14
The requirement in Standard 14 did not appear in any of the source
documents for the original CLAS standards report. However, its
inclusion as a CLAS standard was recommended and approved by the
National Advisory Committee that met in July 1998. The original intent
of the standard was to address the accountability of health care
organizations to their patients/consumers and communities by calling
for organizations to publish an annual report. However, opinions
expressed in the public comments differed on the need for this standard
as well as on the nature of the report and the extent to which its
preparation should involve the community. A major issue was believed to
be the fear that the standard would become a mandated process that
would be used by Federal agencies as a monitoring tool. The general
consensus of comments is that the standard must be more specific if it
is to have any meaning.
Given the level of uncertainty about the report's intended purpose
and lack of specificity in the draft standard, the NPAC was requested
to provide input on the purpose of the annual report and on any details
that should be added to the standard or commentary to help
organizations implement this standard. The revised standard reflects
the NPAC's consensus that the standard should be a recommendation
rather than a guideline and that organizations should be encouraged not
to make an annual report but rather to regularly make available to the
public information about their progress in implementing the CLAS
standards. The commentary explains the potential purposes of the
standard and provides examples of ways that organizations could report
this information.
After consideration of the comments received and further analysis
of specific issues, the revised CLAS Standards are presented below.
National Standards for Culturally and Linguistically Appropriate
Services in Health Care
Preamble
The following national standards issued by the U.S. Department of
Health and Human Services' (HHS) Office of Minority Health (OMH)
respond to the need to ensure that all people entering the health care
system receive equitable and effective treatment in a culturally and
linguistically appropriate manner. These standards for culturally and
[[Page 80873]]
linguistically appropriate services (CLAS) are proposed as a means to
correct inequities that currently exist in the provision of health
services and to make these services more responsive to the individual
needs of all patients/consumers. The standards are intended to be
inclusive of all cultures and not limited to any particular population
group or sets of groups; however, they are especially designed to
address the needs of racial, ethnic, and linguistic population groups
that experience unequal access to health services. Ultimately, the aim
of the standards is to contribute to the elimination of racial and
ethnic health disparities and to improve the health of all Americans.
The CLAS standards are primarily directed at health care
organizations; however, individual providers are also encouraged to use
the standards to make their practices more culturally and
linguistically accessible. The principles and activities of culturally
and linguistically appropriate services should be integrated throughout
an organization and undertaken in partnership with the communities
being served.
The 14 standards are organized by themes: Culturally Competent Care
(Standards 1-3), Language Access Services (Standards 4-7), and
Organizational Supports for Cultural Competence (Standards 8-14).
Within this framework, there are three types of standards of varying
stringency: mandates, guidelines, and recommendations as follows:
CLAS mandates are current Federal requirements for all recipients of
Federal funds (Standards 4, 5, 6, and 7).
CLAS guidelines are activities recommended by OMH for adoption as
mandates by Federal, State, and national accrediting agencies
(Standards 1, 2, 3, 8, 9, 10, 11, 12, and 13).
CLAS recommendations are suggested by OMH for voluntary adoption by
health care organizations (Standard 14).
The standards are also intended for use by:
--Policymakers, to draft consistent and comprehensive laws,
regulations, and contract language. This audience would include
Federal, State and local legislators, administrative and oversight
staff, and program managers
--Accreditation and credentialing agencies, to assess and compare
providers who say they offer culturally competent services and to
assure quality for diverse populations. This audience would include the
Joint Commission on Accreditation of Healthcare Organizations, the
National Committee for Quality Assurance, professional organizations
such as the American Medical Association and American Nurses
Association, and quality review organizations such as peer review
organizations
--Purchasers, to advocate for the needs of ethnic consumers of health
benefits, and leverage responses from insurers and health plans. This
audience would include government and employer purchasers of health
benefits, including labor unions
--Patients, to understand their right to receive accessible and
appropriate health care services, and to evaluate whether providers can
offer them
--Advocates, to promote quality health care for diverse populations and
to assess and monitor care being delivered by providers. The potential
audience is wide, including legal services and consumer education/
protection agencies; local and national ethnic, immigrant, and other
community-focused organizations; and local and national nonprofit
organizations that address health care issues.
--Educators, to incorporate cultural and linguistic competence into
their curricula and to raise awareness about the impact of culture and
language on health care delivery. This audience would include educators
from health care professions and training institutions, as well as
educators from legal and social services professions
--The health care community in general, to debate and assess the
applicability and adoption of culturally and linguistically appropriate
health services into standard health care practice
The CLAS standards employ key concepts that are defined as follows:
CLAS standards: The collective set of CLAS mandates, guidelines,
and recommendations issued by the HHS Office of Minority Health
intended to inform, guide, and facilitate required and recommended
practices related to culturally and linguistically appropriate health
services.
Culture: ``The thoughts, communications, actions, customs, beliefs,
values, and institutions of racial, ethnic, religious, or social
groups. Culture defines how health care information is received, how
rights and protections are exercised, what is considered to be a health
problem, how symptoms and concerns about the problem are expressed, who
should provide treatment for the problem, and what type of treatment
should be given. In sum, because health care is a cultural construct,
arising from beliefs about the nature of disease and the human body,
cultural issues are actually central in the delivery of health services
treatment and preventive interventions. By understanding, valuing, and
incorporating the cultural differences of America's diverse population
and examining one's own health-related values and beliefs, health care
organizations, practitioners, and others can support a health care
system that responds appropriately to, and directly serves the unique
needs of populations whose cultures may be different from the
prevailing culture'' (Katz, Michael. Personal communication, November
1998).
Cultural and linguistic competence: ``Cultural and linguistic
competence is a set of congruent behaviors, attitudes, and policies
that come together in a system, agency, or among professionals that
enables effective work in cross-cultural situations. `Culture' refers
to integrated patterns of human behavior that include the language,
thoughts, communications, actions, customs, beliefs, values, and
institutions of racial, ethnic, religious, or social groups.
`Competence' implies having the capacity to function effectively as an
individual and an organization within the context of the cultural
beliefs, behaviors, and needs presented by consumers and their
communities'' (Based on Cross, T., Bazron, B., Dennis, K., & Isaacs,
M., (1989). Towards A Culturally Competent System of Care Volume I.
Washington, DC: Georgetown University Child Development Center, CASSP
Technical Assistance Center)
Culturally and linguistically appropriate services: Health care
services that are respectful of and responsive to cultural and
linguistic needs.
Health care organizations: Any public or private institution
involved in any aspect of delivering health care services.
Patients/consumers: Individuals, including accompanying family
members, guardians, or companions, seeking physical or mental health
care services, or other health-related services.
Staff: Individuals employed directly by a health care organization,
as well as those subcontracted or affiliated with the organization.
[[Page 80874]]
1. Health Care Organizations Should Ensure That Patients/Consumers
Receive From All Staff Members Effective, Understandable, and
Respectful Care That Is Provided in a Manner Compatible With Their
Cultural Health Beliefs and Practices and Preferred Language
This standard constitutes the fundamental requirement on which all
activities specified in the other CLAS standards are based. Its intent
is to ensure that all patients/consumers receiving health care services
experience culturally and linguistically competent encounters with an
organization's staff. The standard is relevant not only to staff, who
ultimately are responsible for the kinds of interactions they have with
patients, but also to their organizations, which must provide the
managers, policies, and systems that support the realities of
culturally competent encounters.
Respectful care includes taking into consideration the values,
preferences, and expressed needs of the patient/consumer.
Understandable care involves communicating in the preferred language of
patients/consumers and ensuring that they understand all clinical and
administrative information. Effective care results in positive outcomes
for patients/consumers, including satisfaction; appropriate preventive
services, diagnosis, and treatment; adherence; and improved health
status.
Cultural competence includes being able to recognize and respond to
health-related beliefs and cultural values, disease incidence and
prevalence, and treatment efficacy. Examples of culturally competent
care include striving to overcome cultural, language, and
communications barriers; providing an environment in which patients/
consumers from diverse cultural backgrounds feel comfortable discussing
their cultural health beliefs and practices in the context of
negotiating treatment options; using community workers as a check on
the effectiveness of communication and care; encouraging patients/
consumers to express their spiritual beliefs and cultural practices;
and being familiar with and respectful of various traditional healing
systems and beliefs and, where appropriate, integrating these
approaches into treatment plans. When individuals need additional
assistance, it may be appropriate to involve a patient advocate, case
manager, or ombudsperson with special expertise in cross-cultural
issues.
Ways to operationalize this standard include implementing all the
other CLAS standards. For example, in accordance with Standard 3,
ensure that staff and other personnel receive cross-cultural education
and training, and that their skills in providing culturally competent
care are assessed through testing, direct observation, and monitoring
of patient/consumer satisfaction with individual staff/personnel
encounters. Assessment of staff and other personnel could also be done
in the context of regular staff performance reviews or other
evaluations that could be included in the organizational self-
assessment called for in Standard 9. Health care organizations should
provide patients/consumers with information regarding existing laws and
policies prohibiting disrespectful or discriminatory treatment or
marketing/enrollment practices.
2. Health Care Organizations Should Implement Strategies To Recruit,
Retain, and Promote at All Levels of the Organization a Diverse Staff
and Leadership That Are Representative of the Demographic
Characteristics of the Service Area
The diversity of an organization's staff is a necessary, but not
sufficient, condition for providing culturally and linguistically
appropriate health care services. Although hiring bilingual and
individuals from different cultures does not in itself ensure that the
staff is culturally competent and sensitive, this practice is a
critical component to the delivery of relevant and effective services
for all patients/consumers. Diverse staff is defined in the standard as
being representative of the diverse demographic population of the
service area and includes the leadership of the organization as well as
its governing boards, clinicians, and administrative personnel.
Building staff that adequately mirrors the diversity of the patient/
consumer population should be based on continual assessment of staff
demographics (collected as part of organizational self-assessment in
accordance with Standard 9) as well as demographic data from the
community maintained in accordance with Standard 11. Staff refers not
only to personnel employed by the health care organization but also its
subcontracted and affiliated personnel.
Staff diversity at all levels of an organization can play an
important role in considering the needs of patients/consumers from
various cultural and linguistic backgrounds in the decisions and
structures of the organization. Examples of the types of staff members
whose backgrounds should reflect the community's diversity include
clinical staff such as doctors, nurses, and allied health
professionals; support staff such as receptionists; administrative
staff such as individuals in the billing department; clergy and lay
volunteers; and high-level decisionmakers such as senior managers,
corporate executives, and governing bodies such as boards of directors.
Acknowledging the practical difficulties in achieving full racial,
ethnic, and cultural parity within the workforce, this standard
emphasizes commitment and a good-faith effort rather than specific
outcomes. It focuses not on numerical goals or quotas, but rather on
the continuing efforts of an organization to design, implement, and
evaluate strategies for recruiting and retaining a diverse staff as
well as continual quality evaluation of improvements in this area. The
goal of staff diversity should be incorporated into organizations'
mission statements, strategic plans, and goals. Organizations should
use proactive strategies, such as incentives, mentoring programs, and
partnerships with local schools and employment programs, to build
diverse workforce capacity. Organizations should encourage the
retention of diverse staff by fostering a culture of responsiveness
toward the ideas and challenges that a culturally diverse staff offers.
3. Health Care Organizations Should Ensure That Staff at All Levels and
Across All Disciplines Receive Ongoing Education and Training in
Culturally and Linguistically Appropriate Service Delivery
Hiring a diverse staff does not automatically guarantee the
provision of culturally competent care. Staff education and training
are also crucial to ensuring CLAS delivery because all staff will
interact with patients/consumers representing different countries of
origin, acculturation levels, and social and economic standing. Staff
refers not only to personnel employed by the health care organization
but also its subcontracted and affiliated personnel.
Health care organizations should either verify that staff at all
levels and in all disciplines participate in ongoing CME-or CEU-
accredited education or other training in CLAS delivery, or arrange for
such education and training to be made available to staff. This
training should be based on sound educational (i.e., adult learning)
principles, include pre- and post-training assessments, and be
conducted by appropriately qualified individuals. Training objectives
should be tailored for relevance to the particular functions
[[Page 80875]]
of the trainees and the needs of the specific populations served, and
over time should include the following topics:
Effects of differences in the cultures of staff and
patients/consumers on clinical and other workforce encounters,
including effects of the culture of American medicine and clinical
training;
Elements of effective communication among staff and
patients/consumers of different cultures and different languages,
including how to work with interpreters and telephone language
services;
Strategies and techniques for the resolution of racial,
ethnic, or cultural conflicts between staff and patients/consumers;
Health care organizations' written language access
policies and procedures, including how to access interpreters and
translated written materials;
The applicable provisions of:
(1) Title VI of the Civil Rights Act of 1964, 42 U.S.C. 2000d, 45
C.F.R. 80.1 et seq. (including Office for Civil Rights Guidance on
Title VI of the Civil Rights Act of 1964, with respect to services for
(LEP) individuals (65 FR 52762-52774, August 30, 2000).
Health care organizations' complaint/grievance procedures;
Effects of cultural differences on health promotion and
disease prevention, diagnosis and treatment, and supportive,
rehabilitative, and end-of-life care;
Impact of poverty and socioeconomic status, race and
racism, ethnicity, and sociocultural factors on access to care, service
utilization, quality of care, and health outcomes;
Differences in the clinical management of preventable and
chronic diseases and conditions indicated by differences in the race or
ethnicity of patients/consumers; and
Effects of cultural differences among patients/consumers
and staff upon health outcomes, patient satisfaction, and clinical
management of preventable and chronic diseases and conditions.
Organizations that conduct the trainings should involve community
representatives in the development of CLAS education and training
programs, in accordance with Standard 12.
4. Health Care Organizations Must Offer and Provide Language Assistance
Services, Including Bilingual Staff and Interpreter Services, at No
Cost to Each Patient/Consumer With Limited English Proficiency at All
Points of Contact, in a Timely Manner During All Hours of Operation
Standards 4, 5, 6, and 7 are based on Title VI of the Civil Rights
Act of 1964 (Title VI) with respect to services for limited English
proficient (LEP) individuals. Title VI requires all entities receiving
Federal financial assistance, including health care organizations, take
steps to ensure that LEP persons have meaningful access to the health
services that they provide. The key to providing meaningful access for
LEP persons is to ensure effective communication between the entity and
the LEP person. For complete details on compliance with these
requirements, consult the HHS guidance on Title VI with respect to
services for (LEP) individuals (65 FR 52762-52774, August 30, 2000) at
[www.hhs.gov/ocr/lep].
Language services, as described below, must be made available to
each individual with limited English proficiency who seeks services,
regardless of the size of the individual's language group in that
community. Such an individual cannot speak, read, or understand the
English language at a level that permits him or her to interact
effectively with clinical or nonclinical staff at a health care
organization. (Patients needing services in American Sign Language
would also be covered by this standard, although other Federal laws and
regulations apply and should be consulted separately.)
Language services include, as a first preference, the availability
of bilingual staff who can communicate directly with patients/consumers
in their preferred language. When such staff members are not available,
face-to-face interpretation provided by trained staff, or contract or
volunteer interpreters, is the next preference. Telephone interpreter
services should be used as a supplemental system when an interpreter is
needed instantly, or when services are needed in an unusual or
infrequently encountered language. The competence and qualifications of
individuals providing language services are discussed in Standard 6.
5. Health Care Organizations Must Provide to Patients/Consumers in
Their Preferred Language Both Verbal Offers and Written Notices
Informing Them of Their Right To Receive Language Assistance Services
LEP individuals should be informed--in a language they can
understand--that they have the right to free language services and that
such services are readily available. At all points of contact, health
care organizations should also distribute written notices with this
information and post translated signage. Health care organizations
should explicitly inquire about the preferred language of each patient/
consumer and record this information in all records. The preferred
language of each patient/consumer is the language in which he or she
feels most comfortable in a clinical or nonclinical encounter.
Some successful methods of informing patients/consumers about
language assistance services include: (a) using language identification
or ``I speak * * *'' cards; (b) posting and maintaining signs in
regularly encountered languages at all points of entry; (c) creating
uniform procedures for timely and effective telephone communication
between staff and LEP persons; and (d) including statements about the
services available and the right to free language assistance services
in appropriate non-English languages in brochures, booklets, outreach
materials, and other materials that are routinely distributed to the
public.
6. Health Care Organizations Must Assure the Competence of Language
Assistance Provided to Limited English Proficient Patients/Consumers by
Interpreters and Bilingual Staff. Family and Friends Should Not Be Used
To Provide Interpretation Services (Except on Request by the Patient/
Consumer)
Accurate and effective communication between patients/consumers and
clinicians is the most essential component of the health care
encounter. Patients/consumers cannot fully utilize or negotiate other
important services if they cannot communicate with the nonclinical
staff of health care organizations. When language barriers exist,
relying on staff who are not fully bilingual or lack interpreter
training frequently leads to misunderstanding, dissatisfaction,
omission of vital information, misdiagnoses, inappropriate treatment,
and lack of compliance. It is insufficient for health care
organizations to use any apparently bilingual--person for delivering
language services'they must assess and
[[Page 80876]]
ensure the training and competency of individuals who deliver such
services.
Bilingual clinicians and other staff who communicate directly with
patients/consumers in their preferred language must demonstrate a
command of both English and the target language that includes knowledge
and facility with the terms and concepts relevant to the type of
encounter. Ideally, this should be verified by formal testing. Research
has shown that individuals with exposure to a second language, even
those raised in bilingual homes, frequently overestimate their ability
to communicate in that language, and make errors that could affect
complete and accurate communication and comprehension.
Prospective and working interpreters must demonstrate a similar
level of bilingual proficiency. Health care organizations should verify
the completion of, or arrange for, formal training in the techniques,
ethics, and cross-cultural issues related to medical interpreting (a
minimum of 40 hours is recommended by the National Council on
Interpretation in Health Care). Interpreters must be assessed for their
ability to convey information accurately in both languages before they
are allowed to interpret in a health care setting.
In order to ensure complete, accurate, impartial, and confidential
communication, family, friends or other individuals, should not be
required, suggested, or used as interpreters. However, a patient/
consumer may choose to use a family member or friend as an interpreter
after being informed of the availability of free interpreter services
unless the effectiveness of services is compromised or the LEP person's
confidentiality is violated. The health care organization's staff
should suggest that a trained interpreter be present during the
encounter to ensure accurate interpretation and should document the
offer and declination in the LEP person's file. Minor children should
never be used as interpreters, nor be allowed to interpret for their
parents when they are the patients/consumers.
7. Health Care Organizations Must Make Available Easily Understood
Patient-Related Materials and Post Signage in the Languages of the
Commonly Encountered Groups and/or Groups Represented in the Service
Area
An effective language assistance program ensures that written
materials routinely provided in English to applicants, patients/
consumers, and the public are available in commonly encountered
languages other than English. It is important to translate materials
that are essential to patients/consumers accessing and making educated
decisions about health care. Examples of relevant patient-related
materials include applications, consent forms, and medical or treatment
instructions; however, health care organizations should consult OCR
guidance on Title VI for more information on what the Office considers
to be ``vital'' documents that are particularly important to ensure
translation (65 FR 52762-52774, August 30, 2000) at [www.hhs.gov/ocr/
lep].
Commonly encountered languages are languages that are used by a
significant number or percentage of the population in the service area.
Consult the OCR guidance for guidelines regarding the LEP language
groups for which translated written materials should be provided.
Persons in language groups that do not fall within these guidelines
should be notified of their right to receive oral translation of
written materials.
Signage in commonly encountered languages should provide notices of
a variety of patient rights, the availability of conflict and grievance
resolution processes, and directions to facility services. Way-finding
signage should identify or label the location of specific services
(e.g., admissions, pediatrics, emergency room). Written notices about
patient/consumer rights to receive language assistance services are
discussed in Standard 5.
Materials in commonly encountered languages should be responsive to
the cultures as well as the levels of literacy of patients/consumers.
Organizations should provide notice of the availability of oral
translation of written materials to LEP individuals who cannot read or
who speak nonwritten languages. Materials in alternative formats should
be developed for these individuals as well as for people with sensory,
developmental, and/or cognitive impairments.
The obligation to provide meaningful access is not limited to
written translations. Oral communication often is a necessary part of
the exchange of information, and written materials should never be used
as substitutes for oral interpreters. A health care organization that
limits its language services to the provision of written materials may
not be allowing LEP persons equal access to programs and services
available to persons who speak English.
Organizations should develop policies and procedures to ensure
development of quality non-English signage and patient-related
materials that are appropriate for their target audiences. At a
minimum, the translation process should include translation by a
trained individual, back translation and/or review by target audience
groups, and periodic updates.
It is important to note that in some circumstances verbatim
translation may not accurately or appropriately convey the substance of
what is contained in materials written in English. Additionally, health
care organizations should be aware of and comply with existing State or
local nondiscrimination laws that are not superceded by Federal
requirements.
8. Health Care Organizations Should Develop, Implement, and Promote a
Written Strategic Plan That Outlines Clear Goals, Policies, Operational
Plans, and Management Accountability/Oversight Mechanisms To Provide
Culturally and Linguistically Appropriate Services
Successful implementation of the CLAS standards depends on an
organization's ability to target attention and resources on the needs
of culturally diverse populations. The purpose of strategic planning is
to help the organization define and structure activities, policy
development, and goal setting relevant to culturally and linguistically
appropriate services. It also allows the agency to identify, monitor,
and evaluate system features that may warrant implementing new policies
or programs consistent with the overall mission.
The attainment of cultural competence depends on the willingness of
the organization to learn and adapt values that are explicitly
articulated in its guiding mission. A sound strategic plan for CLAS is
integrally tied to the organization's mission, operating principles,
and service focus. Accountability for CLAS activities must reside at
the highest levels of leadership including the governing body of the
organization. Without the strategic plan, the organization may be at a
disadvantage to identify and prioritize patient/consumer service need
priorities.
Designated personnel or departments should have authority to
implement CLAS-specific activities as well as to monitor the
responsiveness of the whole organization to the cultural and linguistic
needs of patients/consumers.
Consistent with Standard 12, the strategic plan should be developed
with the participation of consumers, community, and staff who can
convey the needs and concerns of all communities and all parts of the
organization affected by the strategy.
[[Page 80877]]
And, consistent with Standards 9, 10, and 11, the results of data
gathering and self-assessment processes should inform the development
and refinement of goals, plans, and policies.
9. Health Care Organizations Should Conduct Initial and Ongoing
Organizational Self-Assessments of CLAS-Related Activities and Are
Encouraged To Integrate Cultural and Linguistic Competence-Related
Measures Into Their Internal Audits, Performance Improvement Programs,
Patient Satisfaction Assessments, and Outcomes-Based Evaluations
Ideally, these self-assessments should address all the activities
called for in the 14 CLAS standards. Initial self-assessment, including
an inventory of organizational policies, practices, and procedures, is
a prerequisite to developing and implementing the strategic plan called
for in Standard 8. Ongoing self-assessment is necessary to determine
the degree to which the organization has made progress in implementing
all the CLAS standards. The purpose of ongoing organizational self-
assessment is to obtain baseline and updated information that can be
used to define service needs, identify opportunities for improvement,
develop action plans, and design programs and activities. The self-
assessment should focus on the capacities, strengths, and weaknesses of
the organization in meeting the CLAS standards.
Integrating cultural and linguistic competence-related measures
into existing quality improvement activities will also help
institutionalize a focus on CLAS within the organization. Linking CLAS-
related measures with routine quality and outcome efforts may help
build the evidence base regarding the impact of CLAS interventions on
access, patient satisfaction, quality, and clinical outcomes.
Patient/consumer and community surveys and other methods of
obtaining input are important components of organizational quality
improvement activities. But they should not constitute the only method
of assessing quality with respect to CLAS. When used, such surveys
should be culturally and linguistically appropriate.
10. Health Care Organizations Should Ensure That Data on the Individual
Patient's/Consumer's Race, Ethnicity, and Spoken and Written Language
Are Collected in Health Records, Integrated Into the Organization's
Management Information Systems, and Periodically Updated
The purposes of collecting information on race, ethnicity, and
language are to:
Adequately identify population groups within a service
area;
Ensure appropriate monitoring of patient/consumer needs,
utilization, quality of care, and outcome patterns;
Prioritize allocation of organizational resources;
Improve service planning to enhance access and
coordination of care; and
Assure that health care services are provided equitably.
Collection of data on self-identified race/ethnicity should adhere
to the standard procedures and racial and ethnic categories specified
in the Office of Management and Budget's most current policy directive
and adapted in the U.S. Census 2000. To improve the accuracy and
reliability of race and ethnic identifier data, health care
organizations should adapt intake and registration procedures to
facilitate patient/consumer self-identification and avoid use of
observational/visual assessment methods whenever possible. Individuals
should be allowed to indicate all racial and ethnic categories that
apply. Health care organizations can enhance their information on
subpopulation differences by collecting additional identifiers such as
self-identified country of origin, which provides information relevant
to patient/consumer care that is unobtainable from other identifiers.
The purpose of collecting information on language is to enable
staff to identify the preferred mode of spoken and written
communication that a patient/consumer is most comfortable using in a
health care encounter. Language data also can help organizations
develop language services that facilitate LEP patients/consumers
receiving care in a timely manner. To improve the accuracy and
reliability of language data, health care organizations should adapt
procedures to document patient/consumer preferred spoken and written
language. Written language refers to the patient/consumer preference
for receiving health-related materials. Data collected on language
should include dialects and American Sign Language.
For health encounters that involve or require the presence of a
legal parent or guardian who does not speak English (e.g., when the
patient/consumer is a minor or severely disabled), the management
information system record and chart should document the language not
only of the patient/consumer but also of the accompanying adult(s).
Health care organizations should collect data from patients/
consumers at the first point of contact using personnel who are trained
to be culturally competent in the data collection process. Health care
organizations should inform patients/consumers about the purposes (as
stated above) of collecting data on race, ethnicity, and language, and
should emphasize that such data are confidential and will not be used
for discriminatory purposes. No patient/consumer should be required to
provide race, ethnicity, or language information, nor be denied care or
services if he or she chooses not to provide such information. All
patient/consumer data should be maintained according to the highest
standards of ethics, confidentiality, and privacy, and should not be
used for discriminatory purposes.
11. Health Care Organizations Should Maintain a Current Demographic,
Cultural, and Epidemiological Profile of the Community as Well as a
Needs Assessment to Accurately Plan for and Implement Services That
Respond to the Cultural and Linguistic Characteristics of the Service
Area
The purpose of this standard is to ensure that health care
organizations obtain a variety of baseline data and update the data
regularly to better understand their communities, and to accurately
plan for and implement services that respond to the cultural and
linguistic characteristics of the service area.
Health care organizations should regularly use a variety of methods
and information sources to maintain data on racial and ethnic groups in
the service area. It is important that health care organizations go
beyond their own data, such as marketing, enrollment, and termination
figures, which may provide an incomplete portrait of the potential
patient/consumer population, many of whom may not be aware of or use
the organization's services. A more useful and in-depth approach would
use data sources such as census figures and/or adjustments, voter
registration data, school enrollment profiles, county and State health
status reports, and data from community agencies and organizations.
Both quantitative and qualitative methods should be used to determine
cultural factors related to
[[Page 80878]]
patient/consumer needs, attitudes, behaviors, health practices, and
concerns about using health care services as well as the surrounding
community's resources, assets, and needs related to CLAS. Methods could
include epidemiological and ethnographic profiles as well as focus
groups, interviews, and surveys conducted in the appropriate languages
spoken by the patient/consumer population. Health care organizations
should not use the collected data for discriminatory purposes.
In accordance with Standard 12, health care organizations should
involve the community in the design and implementation of the community
profile and needs assessment.
12. Health Care Organizations Should Develop Participatory,
Collaborative Partnerships With Communities and Utilize a Variety of
Formal and Informal Mechanisms to Facilitate Community and Patient/
Consumer Involvement in Designing and Implementing CLAS--Related
Activities
The culturally competent organization views responsive service
delivery to a community as a collaborative process that is informed and
influenced by community interests, expertise, and needs. Services that
are designed and improved with attention to community needs and desires
are more likely to be used by patients/consumers, thus leading to more
acceptable, responsive, efficient, and effective care. As described
below, this standard addresses two levels of consumer/patient and
community involvement that are not token in nature, but involve working
with the community in a mutual exchange of expertise that will help
shape the direction and practices of the health care organization.
Patients/consumers and community representatives should be actively
consulted and involved in a broad range of service design and delivery
activities. In addition to providing input on the planning and
implementation of CLAS activities, they should be solicited for input
on broad organizational policies, evaluation mechanisms, marketing and
communication strategies, staff training programs, and so forth. There
are many formal and informal mechanisms available for this, including
participation in governing boards, community advisory committees, ad
hoc advisory groups, and community meetings as well as informal
conversations, interviews, and focus groups.
Health care organizations should also collaborate and consult with
community-based organizations, providers, and leaders for the purposes
of partnering on outreach, building provider networks, providing
service referrals, and enhancing public relations with the community
being served.
Related to Standard 11, health care organizations should involve
relevant community groups and patients/consumers in the implementation
of the community profile and needs assessment.
13. Health Care Organizations Should Ensure That Conflict and Grievance
Resolution Processes Are Culturally and Linguistically Sensitive and
Capable of Identifying, Preventing, and Resolving Cross-Cultural
Conflicts or Complaints by Patients/Consumers
This standard requires health care organizations to anticipate and
be responsive to the inevitable cross-cultural differences that arise
between patients/consumers and the organization and its staff. Ideally,
this responsiveness may be achieved by integrating cultural sensitivity
and staff diversity into existing complaint and grievance procedures as
well as into policies, programs, offices or committees charged with
responsibility for patient relations, and legal or ethical issues. When
these existing structures are inadequate, new approaches may need to be
developed. Patients/consumers who bring racial, cultural, religious, or
linguistic differences to the health care setting are particularly
vulnerable to experiencing situations where those differences are not
accommodated or respected by the health care institution or its staff.
These situations may range from differences related to informed consent
and advanced directives, to difficulty in accessing services or denial
of services, to outright discriminatory treatment. Health care
organizations should ensure that all staff members are trained to
recognize and prevent these potential conflicts, and that patients are
informed about and have access to complaint and grievance procedures
that cover all aspects of their interaction with the organization. In
anticipation of patients/consumers who are not comfortable with
expressing or acting on their own concerns, the organization should
have informal and formal procedures such as focus groups, staff-peer
observation, and medical record review to identify and address
potential conflicts.
Among the steps health care organizations can take to fulfill this
standard are: providing cultural competence training to staff who
handle complaints and grievances or other legal or ethical conflict
issues; providing notice in other languages about the right of each
patient/consumer to file a complaint or grievance; providing the
contact name and number of the individual responsible for disposition
of a grievance; and offering ombudsperson services. Health care
organizations should include oversight and monitoring of these
culturally or linguistically related complaints/grievances as part of
the overall quality assurance program for the institution.
14. Health Care Organizations Are Encouraged to Regularly Make
Available to the Public Information About Their Progress and Successful
Innovations in Implementing the CLAS Standards and To Provide Public
Notice in Their Communities About the Availability of This Information
Sharing information with the public about a health care
organization's efforts to implement the CLAS standards can serve many
purposes. It is a way for the organization to communicate to
communities and patients/consumers about its efforts and
accomplishments in meeting the CLAS standards. It can help
institutionalize the CLAS standards by prompting the organization to
regularly focus on the extent to which it has implemented each
standard. It also can be a mechanism for organizations to learn from
each other about new ideas and successful approaches to implementing
CLAS.
Health care organizations can exercise considerable latitude in
both the information they make available and the means by which they
report it to the public. For example, organizations can describe
specific organizational changes or new programs that have been
instituted in response to the standards, CLAS-related interventions or
initiatives undertaken, and/or accomplishments made in meeting the
needs of diverse populations. Organizations that wish to provide more
in-depth information can report on the data collected about the
populations and communities served in accordance with Standard 11 and
the self-assessment results gathered from Standard 9. Organizations
should not report scores or use data from self-assessment tools that
have not been validated. However, as standard self-assessment
instruments and performance measures are developed and validated,
additional information gathered by using these tools could be made
available to the public.
Health care organizations can use a variety of methods to
communicate or report information about progress in implementing the
CLAS standards, including publication of stand-alone documents focused
specifically on cultural and linguistic competence or
[[Page 80879]]
inclusion of CLAS components within existing organizational reports and
documents. Other channels for sharing this information include the
organization's member publications; newsletters targeting the
communities being served; presentations at conferences; newspaper
articles; television, radio, and other broadcast media; and postings on
Web sites.
The complete report, along with supporting material, is available
online at www.OMHRC.gov/clas.
Dated: December 15, 2000.
Nathan Stinson, Jr.,
Deputy Assistant Secretary for Minority Health.
[FR Doc. 00-32685 Filed 12-21-00; 8:45 am]
BILLING CODE 4160-17-P