[Federal Register Volume 65, Number 247 (Friday, December 22, 2000)]
[Notices]
[Pages 80865-80879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32685]


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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: 
[email protected]. 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: [email protected].

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-

[[Page 80871]]

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