NCVHS letterhead header

September 13, 2006

The Honorable Michael O. Leavitt
Secretary
Department of Health and Human Services
200 Independence Avenue SW
Washington, D.C. 20201

Dear Secretary Leavitt:

The National Committee on Vital and Health Statistics (NCVHS) appreciates
your continued support for the Consolidated Health Informatics Initiative
(CHI), as evidenced by its widespread inclusion in many Federal solicitations.
This recommendation letter continues the role that NCVHS has played in the CHI
Council acceptance process. In this role, NCVHS provides an open forum for
review of the CHI standards recommendations and provides an independent
assessment of these recommendations.

Enclosed are the CHI recommendations on the Allergy domain. The NCVHS
concurs with these recommendations. The NCVHS recommends approval of this CHI
Standard by the Secretary, and formal government adoption.

We are pleased to continue our role in the CHI recommendation process.

Sincerely,

/s/

Simon Cohn, M.D., M.P.H.

Chairman, National Committee on Vital and Health Statistics

Cc:       HHS Data Council Co-Chairs

Enclosure

NCVHS letterhead footer


Response from Secretary Leavitt 07/31/07


Consolidated Health Informatics

Standards Adoption Recommendation

Allergy

Index

  1. Part I – Sub-team & Domain Scope Identification – basic information defining the team and the scope of its investigation.
  2. Part II – Standards Adoption Recommendation – team-based advice on standard(s) to adopt.
  3. Part III – Adoption & Deployment Information – supporting information gathered to assist with deployment of the standard (may be partial).

Summary

Domain:  Allergy

Standards Adoption Recommendation: 

Health Level Seven® (HL7®) Version 2.4+

And Associated Vocabularies

SCOPE

The standards will be used to set requirements for “exchanging”
allergy data across the federal health enterprise, using allergy information
exchange requirements and several related allergy vocabulary standards for
Allergen Code, Allergen Group, Allergy Type, Allergy Severity and Allergen
Reaction.

RECOMMENDATION

1. Health Level Seven®
(HL7
®), Version 2.4 and higher:  Information
Exchange Segment/Reference Information Model

2. Unique Ingredient Identifier (UNII): Allergen Code, Mnemonic,
Description, for food, drug, biologic and environmental substances. Derived
from the Food and Drug Administration Substance Registration System (FDA SRS)
and Environmental Protection Agency Substance Registry System (EPA SRS).
Supporting standards include FDA’s Structured Product Labeling (SPL),
RxNorm, Unified Medical Language System® (UMLS®),
United States Adopted Names (USAN) and International Nonproprietary Names
(INN), Language of Foods Thesaurus (LanguaL), Food Allergen Labeling and
Consumer Protection Act (FALCPA), Veteran’s Administration (VA) Non Drug
Allergen List.

3. RxNorm BN: Allergen Code, Mnemonic, Description for branded drugs
instances. Supporting standards include Medical Subject Headings (MeSH),
FDA’s SPL, National Drug Code (NDC), Systematized Nomenclature of Medicine
Clinical Terms (SNOMED CT®), and National Drug File Reference
Terminology (NDF-RT™).

4. National Drug File Reference Terminology (NDF-RT):
Allergen group/drug classes (chemical structure). Supporting standards include
MeSH.

5. Systematized Nomenclature of Medicine Clinical Terms (SNOMED
CT®):
Allergy Type, Allergy Severity and Allergy Reaction

OWNERSHIP

Health Level Seven® (HL7®)
holds the copyright,
www.hl7.org

UNII – Food and Drug Administration (FDA) develops and
maintains the public domain FDA SRS, assigns the UNII, and provides chemical
information about the allergens, including such items as chemical structure,
chemical formula, molecular weight, Chemical Abstract Service (CAS) number,
preferred term (as well as synonyms). The Agency for Healthcare Research and
Quality (AHRQ) supports, both conceptually and financially, the development of
the UNII to improve patient safety and quality of care.

The Environmental Protection Agency (EPA) develops and maintains the public
domain EPA SRS and provides access to toxicological and health information
about environmental allergens.  The FDA and EPA are developing an
integration strategy so that the public and other users can access the data
held by both systems.  The integration process will allow UNIIs to be made
available through both the FDA SRS and EPA SRS.

RxNorm – The National Library of Medicine (NLM) has primary
responsibility for the RxNorm terminology. As steward, NLM works in close
collaboration with other governmental agencies (e.g. the VA, and the FDA), with
the private sector (e.g. First Databank, Micromedex, Multum, Medispan) and
other nations (e.g. UK and Australia). AHRQ supports, both conceptually and
financially, the development of RxNorm to improve patient safety and quality of
care. In addition, the FDA Structured Product Label (SPL) will link the Rx Norm
Brand Name to the UNII code.

NDF-RT™ – The Department of Veterans Affairs developed and
maintains the NDF-RT™ through the NDF-RT™ Board. This Board currently
includes subject matter experts from the VA, but will soon be expanding its
scope to also include subject matter experts from other selected federal
agencies.

SNOMED® – SNOMED CT® is a
copyrighted work of the College of American Pathologists (CAP).
www.snomed.org

APPROVALS AND ACCREDITATIONS

HL7® is an ANSI-accredited Standards Developing Organization.
This standard has been approved by full organizational ballot voting.

UNII will be part of both the FDA SRS and EPA SRS, which are both
public domain systems.

RxNorm is a public domain system

NDF-RT™ is a public domain system

SNOMED CT® Healthcare Terminology Structure is
American National Standards Institute (ANSI) approved. The CAP is an ANSI
Standards Development Organization.

ACQUISITION AND COST

HL7® Standards are available from
HL7®.  HL7® asserts and retains copyright in
all works contributed by members and non-members relating to all versions of
the Health Level Seven® standards and related materials, unless
other arrangements are specifically agreed upon in writing. No use restrictions
are applied.

HL7® sells hard and computer readable forms of the various
standard versions, cost from $50 – $500 depending on specific standard and
member status.

UNII is freely available electronically from the FDA and EPA without
a licensing agreement.

RxNorm is freely available through the NLM.

NDF-RT™ – May be obtained from the VA. It is available from the
National Cancer Institute Enterprise Vocabulary Service (EVS) at
http://nciterms.nci.nih.gov/NCIBrowser/Connect.do.
It is also being incorporated into the UMLS®.

SNOMED CT®  is available through the
National Library of Medicine (NLM). The CAP and the NLM entered into an
agreement to provide SNOMED CT® core content (English and
Spanish language editions) via the UMLS ® at no charge to those
who execute a license agreement. This agreement is for healthcare applications
and uses within the US and any application of use of SNOMED CT®
by any US government facility or office, whether permanent or temporary,
wherever located.

Health care entities can also choose to license SNOMED CT® as
a stand-alone terminology directly from SNOMED® International at
(http://www.snomed.org)


Part I – Team & Domain Scope
Identification

Target Vocabulary Domain

Common name used to describe the
clinical/medical domain or messaging standard requirement that has been
examined.

Allergy Information

Describe the specific purpose/primary use of
this standard in the federal health care sector (100 words or less)

The standards, as identified in the following section of this document, will
be used to set the requirements for exchanging allergy data, across the federal
health community to provide the federal health community with a key component
needed to enable federal agencies to build interoperable health data systems
health vocabulary.

It is anticipated that use of these standards will enable the federal health
enterprise to exchange allergy health information across the wide range of
federal activities helping to decrease medication errors, identify food and
drug incompatibilities and provide consistent allergy data across the federal
health community.

Sub-domains  Identify/dissect the domain into
sub-domains, if any.  For each, indicate if standards recommendations are
or are not included in the scope of this recommendation.

Domain/Sub-domain

In-Scope (Y/N)

Allergy

Y

Adverse Reactions

N

Information Exchange Requirements (IERs)  Using the
table at appendix A, list the IERs involved when using this vocabulary.

Care Management Information
Case Management Information
Clinical Guidelines
Customer Demographic Data
Customer Healthcare Data
Customer Risk Factors
Population Member Health Data
Population Risk Reduction Plan
Tailored Education Information

Team Members  Team members’ names and agency
names with phone numbers.

Name

Agency/Department

Marcia Insley (Colead) Department of Veterans Affairs, Veterans
Health Administration
Lenora Barnes (Colead) Department of Veterans Affairs, Veterans
Health Administration
Siew Lam Department of Veterans Affairs, Veterans
Health Administration
Pradnya Warnekar Department of Veterans Affairs, Veterans
Health Administration
Mike J. Lincoln Department of Veterans Affairs, Veterans
Health Administration
Roger Sigley Department of Veterans Affairs, Veterans
Health Administration
Randy Levin Department of Health and Human Services, Food
and Drug Administration
William A. Hess Department of Health and Human Services, Food
and Drug Administration
Elizabeth C. Smith Department of Health and Human Services, Food
and Drug Administration
Stefano Luccioli Department of Health and Human Services, Food
and Drug Administration
William Pierce Department of Health and Human Services, Food
and Drug Administration
Cheryl Ford Department of Health and Human Services,
Centers for Medicare and Medicaid
Don Reese Department of Health and Human Services,
Centers for Medicare and Medicaid
Fola Parrish Department of Defense, OASD(HA)/TRICARE
Management Activity
Nancy Orvis Department of Defense, OASD(HA)/TRICARE
Management Activity
Mark Charles Department of Defense, OASD(HA)/TRICARE
Management Activity
Ronald Nosek Department of Defense, OASD(HA)/TRICARE
Management Activity
Mathew Garber Department of Defense, OASD(HA)/TRICARE
Management Activity
Michael Datena Department of Defense, OASD(HA)/TRICARE
Management  Activity
John Kilbourne Department of Health and Human Services,
National Library of Medicine
John Harman Environmental  Protection Agency

Work Period  Dates work began/ended.

Start

End

May 27, 2005 April 30, 2006

Part II – Standards Adoption
Recommendation

Recommendation Identify the solution
recommended.

Health Level Seven®
(HL7®), Version 2.4 and higher: Information Exchange Segment
UNII: Allergen Code, Mnemonic, Description

RxNorm, Drug Brand Name (BN): Allergen Code, Mnemonic, Description

NDF-RT™: Allergen Group, Drug Classes
(Chemical Structure)
SNOMED CT®: Allergy Type,
Allergy Severity, Allergy Reaction

Ownership Structure Describe who “owns” the
standard, how it is managed and controlled.

HL7®

Headquartered in Ann Arbor, MI, Health Level Seven®
(HL7®) is a not-for-profit volunteer organization. Its members–
providers, vendors, payers, consultants, government groups and others who have
an interest in the development and advancement of clinical and administrative
standards for healthcare—develop the standards. Like all ANSI-accredited
Standards Development Organizations (SDOs), HL7® adheres to a
strict and well-defined set of operating procedures that ensures consensus,
openness and balance of interest.  HL7® develops
specifications; the most widely used being a messaging standard that enables
disparate healthcare applications to exchange key sets of clinical and
administrative data.  Members of HL7® are known
collectively as the Working Group, which is organized into technical committees
and special interest groups. The technical committees are directly responsible
for the content of the standards. Special interest groups serve as a test bed
for exploring new areas that may need coverage in HL7®’s
published standards.

UNII

Food and Drug Administration Substance Registration System  (FDA SRS)

The FDA SRS generates unique, unambiguous authoritative identifiers for
substances in FDA regulated products such as ingredients in drug
products.  These non-proprietary Unique Ingredient Identifiers (UNII) are
designed to be free for use in health information technology systems worldwide
and are one of the core components of the Federal medication terminology.
In addition, AHRQ supports, both conceptually and financially, the
development of the UNII to improve patient safety and quality of care.

The UNII is linked to drug products as part of the FDA’s Structured Product
Labeling (SPL). SPL (including the UNII) will be made available in the
DailyMed®, a web-based distribution of the SPL maintained by
NLM.  In addition, FDA UNII codes will be linked to RxNorm clinical drug
codes. This will allow the brand name clinical drug to be captured and reported
via a UNII code.  The UNII was adopted in May 2004 by the Consolidated
Health Informatics initiative as a part of its Medication Domain after being
recommended to the DHHS Secretary by the National Committee on Vital and Health
Statistics.

The FDA SRS uses chemical structure, names, and descriptions to generate the
UNII.  The primary means for defining a substance is by its molecular
structure represented on a two-dimensional plane.  When a molecular
structure is not available, the UNII is defined by a distinct name, and where
necessary, an identifying description. Substances are registered in the FDA SRS
following detailed business rules for processing the information. The standard
is maintained by the FDA Data Standards Council and is monitored by the FDA SRS
Board consisting of experts from the FDA and USP.

The FDA SRS includes substances used in, or intended to be used in drugs,
biologics, devices, cosmetics and foods.

Drug-related substances include both active and inactive ingredients used in
drug products, including those for veterinary purposes.  FDA is
aggressively working on dramatically increasing the number of UNII codes,
through a Cooperative Research and Development Agreement (CRADA) with the
United States Pharmacopeia.  FDA’s goal is to load all 8,000
drug-related substances that currently appear in the USP Dictionary of USAN
and International Drug Names
by September 2006.  The FDA has (1) UNII
codes available for 100% of the active ingredients that are in approved and
currently marketed prescription human drugs, and these UNII codes are now being
incorporated into Structured Product Labeling (SPL), (2) a total of
approximately 6,000 drug-related substances in the FDA SRS, and of these,
approximately 3,000 have UNIIs, (3) publicly released 972 UNII codes in March
2005, which at that point in time represented approximately 80% of the active
ingredients that were in approved and marketed prescription drug products, and
(4) these 972 UNII codes that were released in March 2005 have appeared in the
National Cancer Institute’s publicly accessible Terminology Browser at
http://nciterms.nci.nih.gov/NCIBrowser/Dictionary.do
since August 2005; they have been, and currently are, accessible through both
an on-line web-based query and through a public API.

Biologic substances include both active and inactive ingredients used in
biologics, such as blood products, therapeutic products, vaccines, cellular and
gene therapy products, allergenic products, tissues, and certain devices (e.g.,
enzymes in stabilized solutions).  Although not technically always
regulated by FDA as a biologic substance, botanical substances (also sometimes
known as ‘herbals’) will be available in the FDA SRS.

Device substances include certain components of some devices (e.g. silicon
for implants, and chemical reagents for glucose test kits). Cosmetic substances
are components of cosmetic products, such as flavors, fragrances, colorants,
vitamins, plant- and animal-derived ingredients, and polymers.

Since allergenic extracts are regulated by FDA, they will be included in the
FDA SRS.  Similarly, since there are many drugs, biologics, foods, and
device components that can result in an allergic response, and since the FDA
regulates these substances, they will be included in the FDA SRS.
Therefore, since there are so many substances that can cause an allergic
response already in the FDA SRS, it makes sense to expand the scope of the FDA
SRS to include other substances that are capable of an allergic response.

Food substances are specific foods or components of food, regardless of
whether the food is in conventional food form or a dietary supplement, such as
vitamins, minerals, herbs, or other similar nutritional substances. While the
SRS will not serve as a classification system, the description of a substance
may sometimes be at a high enough level where classification is readily
understood.  An example of this is the FALCPA (Food Allergen Labeling and
Consumer Protection Act) which identifies eight (8) major food allergen
categories that will be entered in the FDA SRS.

FDA plans to import substances into the FDA SRS from several sources,
including but not limited to, the European Agency for the Evaluation of
Medicinal Products (EMEA), Environmental Protection Agency Substance Registry
System (EPA SRS), Food Allergen Labeling and Consumer Protection Act
(FALCPA), International Nonproprietary Names (INN,) LanguaL (Language of
Foods), VA Non Drug Allergen List, National Cancer Institute (NCI),
National Library of Medicine (NLM), Therapeutic Goods Administration,
Australia (TGA), United States Adopted Names (USAN), and United States
Pharmacopeia (USP).

Environment Protection Agency Substance Registry System (EPA SRS)

The EPA and the FDA have agreed to create direct linkages between the EPA SRS
and the FDA SRS so that users of either system will have access to the data in
both.  The EPA SRS will store the UNII for those substances that are
common between the two systems; the FDA SRS will store the EPA SRS Internal
Tracking Number, which is a unique number assigned to each substance for
computer to computer communication.  The EPA SRS is currently the adopted
Consolidated Health Informatics (CHI) recommended standard for non drug
chemicals terminology.

The EPA SRS is that agency’s authoritative resource for basic
information about chemicals, biological organisms and other substances of
interest to the Environmental Protection Agency (EPA) and its state and tribal
partners.  It relies on standardized fields to ensure that each substance
is uniquely identified across all of the Agency’s programs.  As
chemicals and biological organisms a primary focus of the EPA, it is
fundamental that they are properly cataloged and identified.

EPA created the EPA SRS to provide a central place for identifying
substances that are tracked or regulated at the Agency and to catalog basic
information about them.  It contains records for more than 95,000
chemicals, biological organisms, viruses and other substances.  The
significant work required to maintain the currency of the data, including the
CAS names and numbers, benefits the CHI work.

Each record contains standardized agency identifiers, as required by two
data standards developed between EPA and its state and tribal partners.
States and tribes now are adopting these identifiers internally.  For
chemicals, these standardized identifiers include the Chemical Abstracts
Service (CAS) Number, the molecular weight, and the EPA preferred name.
For biological organisms, standardized identifiers include the Taxonomic Serial
Number (TSN) and the taxonomic name.  In addition, each record includes
synonyms used in the Agency and identifies the statutes, regulations and
databases that use those synonyms.  Importantly for the CHI work, there
are links to health and safety data developed internally at EPA or externally
by states, other federal agencies, or international organizations.

Although there can be many synonyms for the same substance, SRS makes it
possible to determine which EPA program is tracking or regulating a substance
and the name used by that program.  SRS therefore is a one-stop resource
that enables EPA staff, states, tribes, industry, and the public to discover
where to find Agency data about a substance.

RxNorm

RxNorm is a public domain terminology developed by the NLM in conjunction with
the VA and the FDA, in consultation with HL7 and supported by AHRQ

The lack of interoperability among the terminologies used in the proprietary
pharmaceutical knowledge bases was the primary motivation for RxNorm’s
development. A user wishing to use one pharmaceutical knowledge base system for
pricing and inventory control, for example, and a different system for
interaction checking finds it difficult to merge the two systems into a larger
environment.  This issue was discussed at HL7 meetings for several years,
with representatives from each of the pharmaceutical knowledge base providers
as active participants. It became apparent that interoperability at the
clinical drug level might be an achievable goal, if a standard clinical drug
nomenclature was developed and the terminologies in the various proprietary
systems were mapped to it.

The NLM initiated the development of the public domain RxNorm vocabulary to
achieve this goal – and simultaneously to eliminate the problem of
undetected synonymy among proprietary clinical drug names within the
UMLS® Metathesaurus.  RxNorm has a robust information model
that also supports ordering of medications.   The VA, the FDA, the
NCI, and the DOD are building use of RxNorm into their system development
plans.  The NLM continues to add new clinical drugs and links to
additional drug terminologies and to refine the model in response to
feedback.  RxNorm is currently released on a monthly basis, and the May
2006 release had 31432 current clinical drugs. RxNorm links to more complete
information in the VA NDF-RT™, such as drug classes, as well as to other
terminologies available from commercial drug database vendors in the USA.
RxNorm is being continuously developed and upgraded in conjunction with these
various sources as well as with the FDA SPL data, and so represents the best
potential for a comprehensive superset of all available drugs and an
interlingua between various commercial and governmental drug sources.

NDF-RT™: Drug Classification
(Chemical Structure)

The National Drug File Reference Terminology (NDF-RT™) classification
scheme has already been endorsed as a CHI Adopted standard for Physiological
Effect and Mechanism of Action. NDF-RT™ chemical structure classification
is being recommended under the allergy domain for chemical structure
classification. NDF-RT™ contains the chemical structures, and makes links
to drug ingredients, but the chemical structure concepts come
MeSH® stored in the UMLS®. This classification
scheme will assist in identifying a class of drug that a patient may be
allergic to even if a specific drug is not known. If a specific drug is known,
a chemical classification standard may assist in identifying a wider potential
group of drug allergens.

In addition, the FDA UNII codes are being included in NDF-RT™ as
properties of the various drug ingredients. As part of the FDA Structured
Product Label (SPL) initiative, UNII codes will be transmitted to NLM’s
DailyMed®  as part of the SPL and will then be loaded into
NDF-RT™ through the “New Drug Transaction”.  Thus the
percentage of ingredients with UNII will rise progressively.

SNOMED®

The College of American Pathologists (CAP) is holder of the copyright,
trademark and patent rights in SNOMED®.  The CAP owns the
copyright in all editions of SNOMED®, including the copyright in
any allowable adaptations, the trademarks SNOMED® and SNOMED
CT®, and any and all patent rights in
SNOMED®.  Within the governance structure of the CAP, the
SNOMED® International Authority has the direct responsibility
for terminology-related activities. It establishes strategic direction for the
CAP’s clinical terminology activities, advises management, monitors
division performance, and provides connections to the broader outside world.
The SNOMED® International Authority protects the purpose of
SNOMED® for clinical care and prevents drift of its purpose
through its constitution, decision-making criteria, and the expertise of voting
members.

The SNOMED® International Editorial Board is responsible for
the scientific direction, editorial processes, and scientific validity of the
terminology. The Editorial Board, composed of voting members and organizational
liaisons, recommends guidelines for external input and field-testing. It also
oversees the quality assurance process.  The Editorial Board consists of
both clinical content experts and medical informatics experts, with equal
representation from the UK’s National Health Service. In addition,
liaisons from numerous associations reflect the vision of an integrated
clinical vocabulary useful for dentistry, nursing, veterinary medicine,
radiology, ophthalmology, public health, and other clinical specialties, and
that is compatible with standards such as HL7® and
DICOM®. Participation of liaisons ensures scientific input from
a range of clinical specialties and government agencies. Chaired by the
SNOMED® Scientific Director, this group provides scientific
direction for and supports the work of a multidisciplinary team of modelers and
data administrators.

Summary Basis for Recommendation Summarize the
team’s basis for making the recommendation (300 words or less).

The approach of this workgroup was as follows:
  • Identified previously approved CHI standards applicable to the allergy
    domain
  • Performed comprehensive review of standards and early elimination of any
    that did not properly meet the immediate allergy requirements for the data
    elements or concepts identified as allergy related
  • Developed checklist of data elements needed for proper allergy
    descriptions, classifications, types, reactions and severities
  • SMEs performed a comparison of each candidate standard
  • Selected the standard that best met the overall allergy terminology
    requirements identified, along with noting obstacles and recommendations for
    filling any gaps

Summary of Recommendations

Allergy Domain Recommendation Status
Information Exchange Segment HL7® 2.x and above
Allergen Name, Mnemonic, Description for
Brand Name Drugs
RxNorm BN
Allergen Name, Mnemonic, Description, UNII code from the FDA SRS / EPA SRS Conditional as noted below and components
summarized on Allergy Schematic
Allergen Group, Drug Classes (Chemical
structure)
NDF-RT™ Conditional as noted below
Allergy Type, Allergy Severity and Allergy
Reaction
SNOMED CT® With recommendation for
SNOMED®/HL7® collaboration and SNOMED
CT® allergy subset consideration

Conditional Recommendation If this is a conditional
recommendation, describe conditions upon which the recommendation is
predicated.

The Work Group recommends the adoption of the
proposed allergy standards. For implementation purposes, the following
conditions must be met:

  • At least 90% of the UNII codes for active ingredients for approved and
    marketed prescription drugs have been completed by the FDA
  • UNII codes are made publicly available through a simple download mechanism
  • Updates to UNII codes are made publicly available on at least a quarterly
    basis.
  • The plan for UNII code development and maintenance beyond active
    ingredients for approved and marketed prescription drugs is documented.
  • The updated version of the NDF-RT™, 2006 or later, is made publicly
    available through a simple download mechanism.

The workgroup identified gaps and areas of needed improvement in the
standard that would improve utility, these can be found in the “Gaps”
section, Part III.

Approvals & Accreditations

Indicate the status of various accreditations and approvals for HL7 and
SNOMED®:

Approvals

&

Accreditations

Yes/Approved

Applied

Not Approved

Full SDO Ballot

Y

ANSI

Y

Options Considered  Inventory solution options
considered and summarize the basis for not recommending the
alternative(s).  SNOMED
® must be specifically
discussed.

Allergy Information
Exchange/Models/Initiatives:
HL7®SNOMED®CHDRFAETNCPDPNEHTA
Terminologies:Allergen Type: HL7®SNOMED CT®
Allergy Severity:HL7®SNOMED CT®
Allergy Reaction:VA/DOD ListSNOMED CT®
Allergen
Code/Mnemonic/Description:
Drug:  UNII CodesRxNormSNOMED CT®SPLNDCUSP-NF

INN

IUPAC

CAS

Food:

LanguaL

Food Product Code

Codex Alimentarius®

EAFUS

USDA List

Allergome

IUIS

VA Non Drug Allergen Lists

FDA SRS

EPA SRS

Environmental:

EPA SRS

FDA SRS

VA Non Drug Allergen Lists

Non Drug/Other:

EPA SRS

FDA SRS

VA Non Drug Allergen Lists

Class of AllergenDrug Classification:NDF-RT™SPLSNOMED CT®NDCATC

AHFS

USP

FDB

MeSH

Multum

Micromedex

Medispan

Food Classification:

FALCPA- Food Allergen Labeling and Consumer Protection Act

Current Deployment

HL7®

Summarize the degree of market
penetration today; i.e., where is this solution installed today?

HL7® is used in many places as the messaging standard for
health care data.  Furthermore, HL7® has a great deal of
support in the user community and 1999 membership records indicate over 1,600
total members, approximately 739 vendors, 652 healthcare providers, 104
consultants, and 111 general interest/payer agencies. HL7®
standards are also widely implemented, though complete usage statistics are not
available. In a survey of 153 chief information officers in 1998, 80% used
HL7® within their institutions, and 13.5% were planning to
implement HL7® in the future. In hospitals with over 400 beds,
more than 95% use HL7®. As an example, one vendor has installed
856 HL7® standard interfaces as of mid 1996.  It is the
proposed message standard for the Claims Attachment transaction of the
Administration Simplification section of the Health Insurance Portability and
Accountability Act (HIPAA). Anecdotal information indicates that the major
vendors of medical software, including Cerner, Misys (Sunquest), McKesson,
Siemens (SMS), Eclipsys, AGFA, Logicare, MRS, Tamtron, IDX (Extend and
CareCast), and 3M, support HL7®. The most common use of
HL7® is probably admission/discharge/transfer (ADT) interfaces,
followed closely by laboratory results, orders, and then pharmacy.
HL7® is also used by many federal agencies including VHA, DoD
and CDC, hence federal implementation time and cost is minimized. The
widespread and long-standing use of HL7® leads to the team
conclusion that this is a strong recommendation.What number or percentage of federal agencies have adopted the
standard?
Many federal agencies, several of which are represented within the CHI
group, have adopted HL7 for messaging.Is the standard used in other countries? Yes, Argentina, Australia, Canada, China, Czech Republic, Finland, Germany,
India, Japan, Korea, Lithuania, The Netherlands, New Zealand, Southern Africa,
Switzerland, Taiwan, Turkey and the United Kingdom are also part of
HL7® initiatives.Are there other relevant indicators of market acceptance? Yes, this standard is so widely accepted and used across the healthcare
industry; see the market penetration section for vendor and federal agency use.

SNOMED®

Summarize the degree of market penetration
today; i.e., where is this solution installed today?On July 1, 2003, an agreement with the College of American Pathologists
(CAP) and HHS was announced that made SNOMED Clinical Terms (SNOMED
CT®) available to U.S. users at no cost through the National
Library of Medicine’s® Unified Medical Language
System® (UMLS®).Produced by the College of American
Pathologists (CAP)
, SNOMED
CT®
 (Systematized Nomenclature of Medicine–Clinical
Terms) was formed by the convergence of SNOMED RT® and the
United Kingdom’s Clinical Terms Version 3 (formerly known as the Read Codes).
With terms for more than 344,000 concepts, SNOMED CT®  is
the most comprehensive clinical terminology available. It is being implemented
throughout the National Health
Service
in the United Kingdom.The National Library of Medicine (NLM), a component of the National
Institutes of Health (NIH), Department of Health and Human Services, has issued
a 5-year, $32.4 million contract to the CAP for a perpetual
license
for the core SNOMED CT®  (in Spanish and English) and
ongoing updates. NLM is paying the annual update fees. Funding for the one-time
payment for the perpetual license was provided by:Department of Health and Human ServicesNational Institutes of Health (Office of the NIH Director & NLMCenters for Disease Control and Prevention/Agency for Toxic Substances and
Disease RegistryOffice of the HHS Assistant Secretary for Planning and Evaluation

Agency for Healthcare Research and Quality

Centers for Medicare & Medicaid Services

Food and Drug Administration

Indian Health Service

Substance Abuse and Mental Health Services Administration

Health Resources and Services Administration

Department of Defense

Department of Veterans Affairs

NLM distributes SNOMED CT®within the
UMLS®  Metathesaurus under the terms of a
revised
UMLS®  license agreement
, which includes additional
language concerning SNOMED CT® . U.S. licensees will be able to
use SNOMED® (as distributed by NLM) in the U.S. without charge
and without signing a separate license agreement with the CAP. Non-U.S.
UMLS® users will continue to require a separate license
agreement with the CAP for production uses of SNOMED CT®.
Current UMLS® users will have to sign the revised license
agreement before receiving SNOMED CT® within the
UMLS®. With the release of the 2004AA version of the
UMLS®, the Systematized Nomenclature of Medicine Clinical Terms
(SNOMED CT®), produced by the CAP, becomes available for free
U.S. use under a license agreement concluded last year. Users must register via
the Web for a free UMLS® license before downloading the
Metathesaurus or requesting a copy on DVD.

What number or percentage of relevant vendors has adopted the
standard?

The state of incorporation into vendor systems varies and is largely
dependent on the vendor’s development cycle. Following is a representative
list of the vendors who have licensed SNOMED CT®, it should be
noted that license does not equate to adoption.

Cerner CorporationComMedica LimitedEclipsys CorporationEpic Systems CorporationGE Medical Systems Information TechnologiesIDX Systems CorporationMcKesson Information Solutions

MEDITECH, Inc.

Oracle Corporation

Per-Se Technologies

Siemens Medical Solutions Health Services

deCode Genetics

Egton Medical Information Systems (UK)

GeneLogic, Inc.

In Practice Systems (UK)

Institute for Medical Knowledge Implementation (IMKI)

Reuters Health Information, Inc.

Safescript Ltd (UK)

TheraDoc, Inc.

TherapyEdge

WellMed, Inc.

Apelon, Inc.Health Language, Inc.Intelligent Medical ObjectsLanguage & ComputingA4 Health SystemsABLESoftAssistMed

Clinical & Biomedical Computing, Ltd.

Cogient Corporation

Creative Computer Applications

Détente Systems Limited (Australia)

ibex Healthdata Systems, Inc.

IMPATH Inc.

iSOFT

Misys Healthcare Systems

Monarch Medical International Ltd.

Picis

Sysmex Delphic Ltd. (New Zealand)

Torex Laboratory Systems Ltd. (Scotland)

Triple G Systems Group, Inc.

VISICU, Inc.

Dictaphone

Berkeley Computer Systems

William Woodward

What number or percentage of healthcare institutions has adopted the
standard?

More than 50 commercial healthcare software developers have incorporated
SNOMED CT® into their systems.

Two examples of the extent of support for SNOMED CT® are
Kaiser Permanente and the National Health Service (NHS) of the United Kingdom.
Kaiser Permanente, who provides health care coverage to 3% of the U.S.
population, has actively participated in the development of SNOMED
CT® and is actively rolling out SNOMED
CT®-compatible solutions throughout its organization. Kaiser is
using SNOMED CT® within domain-specific standard documentation
templates for use throughout the organization.  Also, as of April 1, 2003,
the NHS, representing a population of 56 million covered lives, officially
stated that: “Subject to successful development and testing of
implementability, after April 1, 2003 any computerized information system being
developed to support any clinical information system, such as EPRs and EHRs,
should use the NHS preferred clinical terminology, SNOMED®
Clinical Terms.”

Other examples of health care institutions that have adopted SNOMED
CT® are summarized as follows: The University of Nebraska
Medical Center is using SNOMED CT® in the development of problem
lists which are then mapped to ICD-9; Cedars Sinai Medical Center used SNOMED
CT® in its web-based order entry system which processed 700,000
orders for over 8,000 patients between October 2002 and January 2003;  HCA
is implementing SNOMED CT® within its laboratory network,
consisting of over 200 sites in both the US and Canada, for lab test results
and diagnosis;  University of Tennessee used SNOMED CT® in
the lab to improve patient safety by detecting cases for which follow-up
intervention did not occur despite abnormal Pap tests;  Barnes Jewish
Christian Health Care is using SNOMED CT® within its
perioperative and surgery suites for medical transcription.

What number or percentage of federal agencies have adopted the
standard?

Versions of SNOMED CT® are currently used by: the Centers for
Disease Control and Prevention (CDC), Department of Defense (DoD), Indian
Health Services (IHS) and the Department of Veterans Affairs (VA) in specific
applicationsAs SNOMED CT® was first released in
January, 2002, most of the government applications for which SNOMED
CT® has been licensed are in evaluation or developmental stages.

Agency/Organization Approved Description
ANSI The structure of SNOMED CT® is
in the process of being balloted as an ANSI standard. On the initial canvass,
72% of the list responded to the ballot, with 86% voting to approve the SNOMED
CT® Structure as an American National Standard. A standard
proposal addressing the concerns raised increased the favorable vote to 89%.
CDC 10/1/20029/22/19997/11/2002 1.  Licensure of SNOMED®
for reporting bioterrorism and infectious disease data from up to 500 sites
plus 150 back-up laptops2.  Licensure of SNOMED® for reporting cancer data from
up to 100 cancer registries3.  Licensure of SNOMED® for internal evaluation
purposes
DoD 1/31/2003 Licensure of SNOMED® for use in
standardization of medical data and treatment protocols in the Special
Operations Forces Medical Handbook
NIH/NCI 1/7/2003 Licensure of SNOMED® for use in
NCI’s Apelon DTS server to evaluate the use of SNOMED®
codes in reporting NCI-sponsored clinical trials. New clinical documentation
system in development will use SNOMED CT®.
Quality Practice Groups Upon request of the National Quality Forum,
the “never events” have been integrated into SNOMED®
Tumor Registries 9/22/1999 Licensure by CDC of SNOMED® for
reporting cancer data from up to 100 cancer registries
VA 9/14/2000 Many VA hospitals have used earlier versions
of SNOMED® for many years, particularly for laboratory
applications, and have made extensive local extensions to reflect their
specific need.The VA, in conjunction with the DoD and Indian Health Service, licensed
SNOMED RT® for use in the pilot phase of the GCPR project, which
has now been replaced by the CHI initiative.
NASA (contract held by Wyle Laboratories) 1/31/2002 Use of SNOMED® in the Astronaut
Longitudinal Database
AFIP 5/26/1999 Use of SNOMED® in coding of
pathology specimens

Is the standard used in other countries?

As of April, 2003, the CAP has licensed users of SNOMED CT®
in 31 countries. Earlier editions of SNOMED® have been licensed
in over 40 countries.  Following are the countries in which SNOMED
CT® has been licensed:

Argentina Mexico
Australia The Netherlands
Belgium New Zealand
Brazil Norway
Canada Peru
China Portugal
Colombia Puerto Rico
Denmark Scotland
Hong Kong South Korea
Iceland Spain
India Sweden
Ireland Turkey
Israel United Kingdom
Italy United States
Japan Venezuela
Kuwait

As previously noted, the UK’s National Health Service has officially
stated that any computerized information system being developed to support any
clinical information system, should use the NHS preferred clinical terminology,
SNOMED® Clinical Terms.

In Australia, where the use of electronic health cares systems to support
general practice is relatively advanced, a “Coding Jury” had been
established to select a single coding system to support GP clinical
systems.  Currently, the GP Vocabulary Project is underway, and is
designed to assist in the building and support of a standard general practice
interface terminology suitable for the management of information collected
during the clinical encounter. Phase 2 of this project will include the mapping
of a subset of the GP Vocabulary to SNOMED CT®.

Are there other relevant indicators of market acceptance?

Market share information provided by CAP indicates that 79% of computerized
patient record systems and 85% of laboratory systems vendors have made
licensing commitment.  Following are other relevant indicators of
SNOMED’s® market acceptance:

  • Both HL7® and DICOM® have formally recognized
    SNOMED® as a standard code set within their messaging standard.
    SNOMED® is embedded in the DICOM® Structured
    Reporting Standard for Wave Forms.
  • The American Veterinary Medical Association (AVMA) has adopted SNOMED
    CT® as the official terminology for veterinary practice in the
    US. It has been used extensively by the veterinary community in a collaborative
    product to track health care data on a national basis.
  • The American Nurses Association (ANA) has recognized SNOMED
    CT® as a terminology that supports nursing practice,
    specifically: nursing assessments, plans, interventions and outcomes.
  • WASPalm, the World Association of Societies of Pathology and Laboratory
    Medicine, representing 59 member societies throughout the world, has endorsed
    SNOMED® as the preferred reference language for laboratory
    clinicians.

UNII

UNII is distributed by FDA and EPA without
restriction.Summarize the degree of market penetration today; i.e., where is this
solution installed today?
UNII is part of the CHI medication domain for active ingredient.  As
such, it is incorporated into FDA’s Structured Product Labeling (SPL)
initiative, which will soon be used worldwide.  In addition, FDA SRS has
already made its substance names and their Unique Ingredient Identifier (UNIIs)
available to the following:  Department of Veterans Affairs
(NDF-RT™), the National Library of Medicine®
(UMLS®), the National Cancer Institute (NCI EVS), Environmental
Protection Agency (EPA SRS) and the United States Pharmacopeia (USP Dictionary
of USAN and International Drug Names).  Finally, each of these
organizations, as well as the European Medicines Agency and Australian
Therapeutics Goods Administration, has expressed a high degree of interest in
loading their substance data into the FDA SRS.Currently, available UNIIs are accessible for public access and download
through the NCI Terminology Browser/NCI_Thesaurus
(see  http://nciterms.nci.nih.gov/NCIBrowser/Dictionary.do).  UNIIs will also be available as part of the new labeling format will be
integrated into FDA’s other e-Health efforts through a variety of ongoing
initiatives. As prescription information is updated in this new format it will
be used to provide medication information for DailyMed
®
 – an interagency online health information clearinghouse,
sponsored by the National Library of Medicine, which is maintaining the most
up-to-date medication information free to consumers, healthcare professionals,
and healthcare information providers. The DailyMed
® is
making up-to-date information about FDA-regulated products widely available on
the Internet at no cost. (http://dailymed.nlm.nih.gov)
 FDA has scheduled a second release of UNIIs by the end of July
2006, and that the dataset will include 100% of the active ingredients of
approved and marketed prescription drug products, as well as many inactive
ingredients; it may also include the initial portion of the USP work, as well
as color additives, 760 botanical substances, vaccine substances, and
allergenic food substances.
As noted, UNIIs for all active ingredients and many inactive ingredients
are being integrated into SPL, and SPL is being made available through
DailyMed
® at NLM.  Therefore, UNIIs are available
by accessing DailyMed
®.  Presently, there are only
a few SPL submissions in DailyMed
®, but that number is
expected to exponentially increase due to a federal regulation that went into
affect in October 2005.  The regulation requires that for approved and
marketed prescription drugs, (1) all labeling that is included in annual
reports shall be submitted in SPL, and (2) all labeling for newly approved
drugs shall be submitted in SPL.  This means that by December 2006, all
approved and marketed prescription drugs shall have SPL available (with UNIIs)
through DailyMed
®.

What number of or percentage of relevant vendors have adopted the
standard?

100% of pharmaceutical companies marketing prescription drug products
in the United States and Structured Product Labeling vendors must use the UNII
standard.  Most likely, a large percentage of healthcare decision support
software vendors will seriously consider, if not overtly adopt, the UNIIs that
enable healthcare decision support will already be embedded in SPL.

What number or percentage of healthcare institutions have adopted the
standard?

None to date, but that is expected to rapidly change.

What number or percentage of federal agencies have adopted the
standard?

100% of federal agencies have adopted the UNII as their standard for active
ingredient through the White House’s Consolidated Health Informatics
initiative.  Many federal agencies are in the process of implementing the
UNII as their standard for active ingredient.  Since the UNII plans to
also include inactive ingredients, it will soon have much greater utility, and
federal agencies have begun to recognize that eventuality.

Is the standard used in other countries?

None to date, but that is expected to rapidly change.  The EMEA, Japan,
Health Canada, and TGA are interested in adopting the UNII as their standard,
and since the USP will be associating a UNII with each INN, and this adoption
would make sense for these and other foreign drug regulatory bodies.

Are there other relevant indicators of market acceptance?

There are no additional relevant indicators of market acceptance.

RxNorm

The need to recommend RxNorm in addition to UNII codes stems from
potential situations where data (historical data) may not be coded to the
ingredient level. This is identified as a data need within DOD, where allergy
information is captured at Brand Name and RxNorm (BN) can be assigned and
exchanged.RxNorm is distributed by without restriction.Summarize the degree of market penetration today; i.e., where is this
solution installed today?
RxNorm is distributed by the NLM without restriction. A listing of current
users is not kept.What number of or percentage of relevant vendors have adopted the
standard?
RxNorm is distributed by the NLM without restriction. A listing of current
users who are vendors is not kept.What number or percentage of healthcare institutions have adopted the
standard?
RxNorm is distributed by the NLM without restriction. A listing of current
users who are healthcare institutions is not kept.

What number or percentage of federal agencies have adopted the
standard?

RxNorm is distributed via  by the NLM without restriction. A listing of
current users who are federal agencies is not kept.

Is the standard used in other countries?

RxNorm is distributed via by the NLM without restriction. A listing of
current users in other countries is not kept.

Are there other relevant indicators of market acceptance?

There are no additional relevant indicators of market acceptance.

NDF-RTTM

Drug classification schemes developed to date
meet specific decision support needs that vary across institutions. Content
requirements placed on legacy systems and their supporting knowledge bases
differ vastly depending on the use cases that the organization has to support.
As a result there are structural classes where drugs are grouped together based
on their chemistry or there are functional classes where drugs are grouped
together based on their mechanism of action or therapeutic intent or
physiologic effect.In the allergy domain, there are two reasons why drugs would need to be
grouped. First, to prevent ordering of drugs similar to the ones that the
patient is allergic to, and second to simplify patient allergy documentation
when it is difficult for a patient to recall the specific drug that (s)he is
allergic to. Allergy to any drug is due to the presence of a specific chemical
entity in the drug. For example, if a patient is allergic to a sulfonamide
containing antimicrobials, then it is very likely that (s)he is also allergic
to one of the  thiazide diuretics that are used to lower blood pressure.
This illustrates that even though the two drugs have completely different
therapeutic uses, they are likely to cause the same allergic reaction in the
patient. This is because of similarity in chemical structures between the two
classes of drugs. Thus, grouping drugs based on chemistry for patient allergy
documentation is critical.NDF-RTTM is a reference terminology for medications developed by
the VHA. It is based on the VHA’s current production system called VA NDF,
but is intended to help separate the specific legacy use cases in VA for drug
interactions and checking from the definitional classifications of drug
ingredients. As a result, NDF-RT™ supports VA legacy codes (beta lactam
antibiotics, opioid analgesics) that support existing VistA use cases. It also
supports, in a parallel fashion, a logically decomposed set of attributes for
all ingredients like mechanism_of_action, physiologic_effect,
chemical_structure, and diseases_treated, etc.The data in NDF-RTTM is modeled using various types of
relationships to represent the semantics between information at different
levels in its hierarchy. NDF-RTTM is also linked with various
external national standards like RxNorm, FDA UNII, MeSH® and
HL7.  NDF-RTTM classes drugs in a complex web of semantics. Two
of the classification schemes (Mechanism of action and Physiological effects)
have been adopted as CHI standards as part of CHI Medications sub domain.
NDF-RTTM’s active ingredients hierarchy was initialized from
MeSH® and is synchronized with the same at regular intervals.
Concepts in this hierarchy are differentiated from the other concepts by a
Ingredient_Kind designation. The following information for Ingredient_Kind
concepts is stored in NDF-RT™.

  • MeSH®_Name
  • MeSH®_UI
  • MeSH®_Definition
  • FDA_UNII
  • RxNorm_CUI
  • RxNorm_CODE
  • RxNorm_UMLS® CUI

Medical Subject Headings (MeSH®)

Benefits- MeSH® offers several advantages as a
drug classification scheme for allergy domain. It offers an unrestricted and
open license, a publicly accessible change control board, and a wide acceptance
and implementation in information systems. Another important advantage of
MeSH® is the multihierarchical arrangement of concepts. This
provides the ability to support different use cases of legacy systems. For
example, ampicillin is categorized as a penicillin, beta lactam, 2-ring
heterocyclic compound and a bridged ring heterocyclic compound. While the
association of ampicillin as a penicillin is useful in allergy checking, the
relationship to beta lactams group could support drug resistance checking.

NDF-RT™ is distributed by without restriction.

Summarize the degree of market penetration today; i.e., where is this
solution installed today?

None to date

What number of or percentage of relevant vendors have adopted the
standard?

None to date

What number or percentage of healthcare institutions have adopted the
standard?

None to date

What number or percentage of federal agencies have adopted the
standard?

100% of federal agencies have adopted the NDF-RT™ as their standard
mechanism of action and physiological effect through the White House’s
Consolidated Health Informatics initiative.

Is the standard used in other countries?

None to date

Are there other relevant indicators of market acceptance?

There are no additional relevant indicators of market acceptance.


Part III – Adoption & Deployment
Information

Provide all information gathered in the course of making the
recommendation that may assist with adoption of the standard in the federal
health care sector.  This information will support the work of an
implementation team.

Existing Need & Use Environment

Measure the need for this standard and the extent of existing exchange
among federal users.  Provide information regarding federal departments
and agencies use or non-use of this health information in paper or electronic
form, summarize their primary reason for using the information, and indicate if
they exchange the information internally or externally with other federal or
non-federal entities.

Column A:        Agency or Department
Identity (name)

Column B:        Use data in this domain
today? (Y or N)

Column C:        Is use of data a core
mission requirement? (Y or N)

Column D:        Exchange with others in
federal sector now? (Y or N)

Column E:        Currently exchange paper or
electronic (P, E, B (both), N/A)

Column F:        Name of paper/electronic
vocabulary, if any (name)

Column G:        Basis/purposes for data use
(research, patient care, benefits, clinical trials, information steward)

Department/Agency

B

C

D

E

F

G

Department of Veterans Affairs (VA)

Y

Y

Y

B

Patient Care

Department of Defense (DOD

Y

Y

Y

B

Patient Care

HHS Office of the Secretary
Administration for Children and Families (ACF)
Administration on Aging (AOA)
Agency for Healthcare Research and Quality
(AHRQ)
Agency for Toxic Substances and Disease
Registry (ATSDR)
Centers for Disease Control and Prevention
(CDC)
Centers for Medicare and Medicaid Services
(CMS)

Y

Y

Y

B

Benefits

Food and Drug Administration (FDA)

Y

Y

Y

B

SPL; DARRTS; AERS; SPOTS

Regulation, Research

Health Resources and Services Administration
(HRSA)
Indian Health Service (IHS)

Y

Y

Y

B

Patient Care

National Institutes of Health (NIH)

Y

Y

Y

B

Clinical Trials

Substance Abuse and Mental Health Services
Administration (SAMHSA)
Social Security Administration (SSA)
Department of Agriculture (DOA)
Department of State (DOS)
US Agency for International Development
(USAID)
Department  of Justice (DOJ)
Department of Treasury (DOT)
Department of Education (DOE)
General Services Administration
Environmental Protection Agency

N

Y

N

Information Steward

Department of Housing & Urban Development
(HUD)
Department of Transportation (DOT)
Department of Homeland Security (DHS)
Number of TermsQuantify the number of vocabulary terms, range of terms or other order
of magnitude.
Approximate numbers of values per vocabulary:Allergen Type 20Allergen Severity 10Allergen Reaction 330Drug Substance Codes (active ingredients 2000; active moieties 1000,
inactive ingredients 5000)
Non-Drug Substance Codes-607

Vaccine Substance Codes -27

Botanicals Codes -750

Drug Classifications-3753 (includes all concepts from
MeSH® Chemical Structure hierarchy in NDF-RT™ not
only drug classes

Food Classification-8

How often are terms updated?

HL7® v2.x standards are issued every two to three
years.  HL7® V 3 vocabulary tables are updated three times
per year.

FDA SRS terms are added daily, and updated as necessary throughout each
year.  The terms can be reviewed several times a year as requested.

EPA SRS The data in the SRS is periodically updated with new EPA regulations
and program system lists. EPA and FDA are developing process to update each
agency’s SRS’.

RxNorm Monthly releases

SNOMED CT®  Semiannually (January 31st and
July 31st)

NDF-RT™ updated with MeSH® annually.

Range of CoverageWithin the recommended vocabulary, what portions of the standard
are complete and can be implemented now? (300 words or less)
HL7® 2.x is currently available for information exchange. The
HL7® v3 Allergy Reference Information Model is in available but
not widely tested.Once the SPL data (including the UNII code portion) has been submitted by
the FDA to NLM for distribution in the DailyMed®, that data will
also be incorporated into RxNormRxNorm maintains Brand Name information but no vocabulary can be
complete.  Drug vocabulary, in particular, is constantly changing, with
new ingredients, new dosage forms, and new strengths.  RxNorm contains all
the clinical drugs contained in the other vocabularies, and has an update
model. With the understanding as stated, it is ready for implementation in its
coverage of prescription drugs.  It remains incomplete for
multi-ingredient OTC preparations (e.g., multivitamins) and contrast media.A new version of NDF-RT™, planned for 2006 or later, will be submitted
to NLM and included in UMLS®.
AcquisitionHow are the data sets/codes acquired and use licensed?Standards are available from HL7®.  HL7®
asserts and retains copyright in all works contributed by members and
non-members relating to all versions of the Health Level Seven®
standards and related materials, unless other arrangements are specifically
agreed upon in writing. No use restrictions are applied.Each recommended vocabulary standard is available as noted in the vocabulary
standards section.
CostWhat is the direct cost to obtain permission to use the data
sets/codes? (licensure, acquisition, other external data sets required,
training and education, updates and maintenance, etc.)
HL7® sells hard and computer readable forms of the various
standard versions, cost from $50 – $500 depending on specific standard and
member status. Draft versions of standards are available to all from their
website. No specific cost is associated with using the standards.Training is offered through HL7® and others are varying costs
from several hundred to several thousand-dollars/per person. Consultation
services are available at standard industry cost for training, update
instillation and maintenance.FDA SRS is available free of charge through SPL and
DailyMed®.  It is then also made public through the NLM and
NCI, and incorporated into the USP Dictionary of USAN and International Drug
Names (a.k.a., ‘USAN’). RxNorm and SPL is available free of charge
through the UMLS®.EPA SRS is available free of charge through EPA website. Enhanced
capabilities are currently being redesigned to improved access to the EPA SRS.RxNorm is available free of charge through NLM UMLS®NDF-RT™ is available free of charge through NCI

SNOMED CT®  is available free of charge through NLM
UMLS®

Systems RequirementsIs the standard associated with or limited to a specific
hardware or software technology or other protocol?
No
GuidanceWhat public domain and implementation and user guides, implementation tools
or other assistance is available and are they approved by the SDO?HL7® is in widespread use and has many implementation guides
and tools, some in the public domain and some accessible by authorized
personnel or organizations.  Please refer to www.hl7.org for more details.Full implementation conformance requirements for interoperability will need
to be developed between exchanging partner built of the HL7 and additional
vocabulary standards being recommended.Is a conformance standard specified?  Are conformance tools
available?
A standard is not specified. Conformance tools are not available through the
SDO, but private sector tools do exist.
MaintenanceHow do you coordinate inclusion and maintenance with the
standards developer/owners?
Voluntary upgrade to new versions of standards, generally by trading partner
agreement. Messages are transmitted with version number and use of prior
versions is generally supported for a period of time after introduction of a
new one.What is the process for adding new capabilities or fixes?The process for adding new capabilities or fixes is addressed at the
individual Standards Development Organization.What is the average time between versions?Various, but approximately annually.What methods or tools are used to expedite the standards development
cycle?

None. The methods or tools used to expedite the standards development cycle
is addressed at the individual Standards Development Organization (SDOs). Some
SDOs conduct standard development meetings up to three times yearly, as well as
in the workgroups between meetings.  The standards development is often a
lengthy process. lengthy.

How are local extensions, beyond the scope of the standard, supported
if at all?

For HL7, yes, but not encouraged (Z segment)

CustomizationDescribe known implementations that have been achieved without
user customization, if any. 
None.If user customization is needed or desirable, how is this
achieved? (e.g, optional fields, interface engines, etc.) 
Free text fields are available bit not recommended.
Mapping Requirements  Describe the extent to which user agencies will likely need to perform
mapping from internal codes to this standard.
Because implementation of the CHI adopted standards is prospective, user
agencies will need to perform mapping from internal codes to the allergy
standards only in new systems and systems undergoing major upgrades.Identify the tools available to user agencies to automate or otherwise
simplify mapping from existing codes to this standard.
The NCI has already begun mapping the FDA SRS to its own databases, and it
is anticipated that USP and NLM will also do the same.United States Health Information Knowledgebase (USHIK) is designing a portal
to provide access to all CHI Standards. NLM UMLS® provide
information for terminology mapping.

Compatibility

Identify the extent of off-the-shelf conformity with other standards
and requirements:

Conformity with other Standards Yes (100%) No (0%)

Yes with exception

HIPAA Transaction and Code Set Standards

X

HL7® 2.4 and higher

X

Implementation
Timeframe

Estimate the number of months required to deploy this
standard; identify unique considerations that will impact deployment
schedules.

Any estimate would differ by agency, due to the legacy systems
currently in. In order to determine the compatibility of the standards, use
cases need to be done, to look at all intended uses of allergy terminology
being addressed.

If some data sets/code sets are under development, what
are the projected dates of completion/deployment?

As of March 2006, the FDA has completed entering 100% of active
ingredients for approved and marketed prescription drug products, 60% of over
the counter and 99% of vitamins and minerals into the FDA SRS. It is
anticipated that by October 2006, all vitamins and minerals will be added into
the FDA SRS, as will the most common inactive ingredients that are in approved
and marketed prescription drug products.

By August 2006, it is anticipated that active ingredients for
common food allergens and botanicals/herbals will be entered into the FDA SRS.

By December 2008, it is anticipated that the FDA SRS will be loaded with

  • active ingredients for all over the counter drugs
  • active ingredients for biologics, food nutritional supplements
  • inactive ingredients (including dyes) for drugs, food (that are known to
    cause an allergic response) and biologics
GapsIdentify the gaps in data, vocabulary or
interoperability.
Any other required federal standards that should emerge will require a
harmonization between HL7® and the vocabulary recommended
standards identified.Availability of the UNII codes within the FDA SRS for all aspects (active
ingredients, inactive ingredients, dyes) of drugs (prescription, OTC, herbals),
biologics and food is progressing as noted in deployment schedule above. Since
this is the basis of the Allergen recommendation, it is recommended that the
FDA SRS UNII code availability be aggressively completed not only for all
inactive ingredients that are in approved and marketed prescription drugs, but
also for active and inactive ingredients that are in OTC drugs, cosmetics,
foods, herbal products, and biologics. The furthest projected completion date
at this point in time would be December 2008.A new version of NDF-RT™ will be submitted to NLM (planned for Summer
2006) to be included in UMLS® and will be made publicly
available through a simple download mechanism.The Allergy Type codes and descriptions available in SNOMED should be
reviewed and refined as necessary. It would be advantageous if all Allergy
Reaction codes could hierarchically descend from a common concept. Current
Allergy Reaction Codes as identified on the VA/DoD recommended allergen
reaction list cross hierarchies, and so must be enumerated individually.A general approach to specifying and maintaining subsets drawn from SNOMED
or other vocabularies has not been fully worked out. Such a process would
indicate the organization maintaining the subset, the specific collection of
concepts in the subset, the manner of distribution of such a subset and its
updates, and other such metadata related to the subset.
ObstaclesWhat obstacles, if any, have slowed penetration of this standard?
(technical, financial, and/or cultural)
To date, there has been no available vocabulary to support standardized
Allergy content of the HL7 transaction, particularly as it is related to the
allergen code. In addition, this is a complex but crucial areas for patient
safety and medical errors. The immaturity of related standards to support this
domain is being addressed by involved agencies including FDA and NLM. The VA
and DOD as large healthcare providers have piloted efforts to share allergy
data. The extent of this sharing is limited by the incomplete status of many of
the allergen related vocabulary. To fill this gap, the VA and DOD have compiled
allergen related vocabularies which are being pointed to SNOMED®
codes and incorporated into the FDA SRS. The FDA is working to establish a
complete set of Unique Ingredient Identifiers for drug, biologics, cosmetics,
herbal products, food and non drug/food allergen. This FDA effort has already
begun with the expected completion of all common allergen codes by December 06
and all ingredients by December 2008.With numerous systems currently deployed throughout the government, the cost
to convert to a new version of HL7® is high.  Furthering
the difficulties are the legacy issues that still need to be addressed.While the team supports the use of HL7® messaging standards
for allergy transactions, it notes that a large gap exists between the message
standard and the ability to currently code allergen contents of the message.
Version 2.x HL7® messages are currently implemented with a high
degree of variability in content of the elements. Some of this difference
relates to the use of local codes or non-standard use of publicly available
codes and some involves subtle differences in the interpretation of the
element’s meaning. The vocabulary standards recommended in this report
attempt to address these obstacles.Version 3 of HL7® has a goal of increasing the ability to
understand a received message by addressing these two broad issues through the
use of an XML message structure and a Reference Information Model (RIM), though
this has not been demonstrated. The acceptance of the message standard without
standardization of code sets between users will not result in increased
interoperability and a large gap will exist.The Allergy Work Group also encourages the continual developmental efforts
to improve access tools to the recommended standards.

Appendix A

Information Exchange Requirements (IERs)

Information Exchange Requirement

Description of IER

Beneficiary Financial / Demographic Data Beneficiary financial and demographic data
used to support enrollment and eligibility into a Health Insurance Program.
Beneficiary Inquiry Information Information relating to the inquiries made by
beneficiaries as they relate to their interaction with the health organization.
Beneficiary Tracking Information Information relating to the physical movement
or potential movement of patients, beneficiaries, or active duty personnel due
to changes in level of care or deployment, etc.
Body of Health Services Knowledge Federal, state, professional association, or
local policies and guidance regarding health services or any other health care
information accessible to health care providers through research, journals,
medical texts, on-line health care data bases, consultations, and provider
expertise. This may include: (1) utilization management standards that monitor
health care services and resources used in the delivery of health care to a
customer; (2) case management guidelines; (3) clinical protocols based on
forensic requirements; (4) clinical pathway guidelines; (5) uniform patient
placement criteria, which are used to determine the level of risk for a
customer and the level of mental disorders (6) standards set by health care
oversight bodies such as the Joint Commission for Accreditation of Health Care
Organizations (JCAHO) and Health Plan Employer Data and Information Set
(HEDIS); (7) credentialing criteria; (8) privacy act standards; (9) Freedom of
Information Act guidelines; and (10) the estimated time needed to perform
health care procedures and services.
Care Management Information Specific clinical information used to record
and identify the stratification of Beneficiaries as they are assigned to
varying levels of care.
Case Management Information Specific clinical information used to record
and manage the occurrences of high-risk level assignments of patients in the
health delivery organization..
Clinical Guidelines Treatment, screening, and clinical management
guidelines used by clinicians in the decision-making processes for providing
care and treatment of the beneficiary/patient.
Cost Accounting Information All clinical and financial data collected for
use in the calculation and assignment of costs in the health organization.
Customer Approved Care Plan The plan of care (or set of intervention
options) mutually selected by the provider and the customer (or responsible
person).
Customer Demographic Data Facts about the beneficiary population such as
address, phone number, occupation, sex, age, race, mother’s maiden name and
SSN, father’s name, and unit to which Service members are assigned
Customer Health Care Information All information about customer health data,
customer care information, and customer demographic data, and customer
insurance information. Selected information is provided to both external and
internal customers contingent upon confidentiality restrictions. Information
provided includes immunization certifications and reports, birth information,
and customer medical and dental readiness status
Customer Risk Factors Factors in the environment or chemical,
psychological, physiological, or genetic elements thought to predispose an
individual to the development of a disease or injury. Includes occupational and
lifestyle risk factors and risk of acquiring a disease due to travel to certain
regions.
Encounter (Administrative) Data Administrative and Financial data that is
collected on patients as they move through the healthcare continuum. This
information is largely used for administrative and financial activities such as
reporting and billing.
Improvement Strategy Approach for advancing or changing for the
better the business rules or business functions of the health organization.
Includes strategies for improving health organization employee performance
(including training requirements), utilization management, workplace safety,
and customer satisfaction.
Labor Productivity Information Financial and clinical (acuity, etc.) data
used to calculate and measure labor productivity of the workforce supporting
the health organization.
health organization Direction Goals, objectives, strategies, policies,
plans, programs, and projects that control and direct health organization
business function, including (1) direction derived from DoD policy and guidance
and laws and regulations; and (2) health promotion programs.
Patient Satisfaction Information Survey data gathered from beneficiaries that
receive services from providers that the health organization wishes to use to
measure satisfaction.
Patient Schedule Scheduled procedure type, location, and date
of service information related to scheduled interactions with the patient.
Population Member Health Data Facts about the current and historical health
conditions of the members of an organization. (Individuals’ health data are
grouped by the employing organization, with the expectation that the
organization’s operations pose similar health risks to all the organization’s
members.)
Population Risk Reduction Plan Sets of actions proposed to an organization
commander for his/her selection to reduce the effect of health risks on the
organization’s mission effectiveness and member health status. The proposed
actions include: (1) resources required to carry out the actions, (2) expected
mission impact, and (3) member’s health status with and without the actions.
Provider Demographics Specific demographic information relating to
both internal and external providers associated with the health organization
including location, credentialing, services, ratings, etc.
Provider Metrics Key indicators that are used to measure
performance of providers (internal and external) associated with the health
organization.
Referral Information Specific clinical and financial information
necessary to refer beneficiaries to the appropriate services and level of care.
Resource Availability The accessibility of all people, equipment,
supplies, facilities, and automated systems needed to execute business
activities.
Tailored Education Information Approved TRICARE program education information
/ materials customized for distribution to existing beneficiaries to provide
information on their selected health plan. Can also include risk factors,
diseases, individual health care instructions, and driving instructions.

Appendix B

Allergy Recommendation Schematic Illustration

Allergy Recommendation Schematic Illustration

Appendix C

Glossary

Acronym Description
ACF Administration for Children and Families
AERS Adverse Event Reporting System
AHFS American Hospital Formulary Service
AHRQ Agency for Healthcare Research and Quality
ANA American Nurses Association
ANSI American National Standards Institute
AOA Administration on Aging
ATC Anatomical Therapeutic Chemical Classification
ATSDR Agency for Toxic Substances and Disease Registry
AVMA American Veterinary Medical Association
CAP College of American Pathologists
CAS Chemical Abstract Service
CDC Centers for Disease Control and Prevention
CHDR Clinical Health Data Repository
CMS Centers for Medicare and Medicaid Services
CRADA Cooperative Research and Development Agreement
DARRTS Document Archiving, Reporting and Regulatory Tracking
DHS Department of Homeland Security
DOA Department of Agriculture
DOD Department of Defense
DOE Department of Education
DOJ Department  of Justice
DOS Department of State
DOT Department of Treasury
DOT Department of Transportation
DTS Distributed Terminology System
EAFUS Everything Added to Foods in the United States
EMEA European Agency for the Evaluation of Medicinal Products
EVS Enterprise Vocabulary Services
EPA Environmental Protection Agency
EPA SRS Environmental Protection Agency Substance Registry System
FAET Federal Adverse Events Task Force
FALCPA Food Allergen Labeling and Consumer Protection Act
FDA Food and Drug Administration
FDA SRS Food and Drug Administration Substance Registration
System
FDB First Data Bank
GCPR Government Computer-Based Patient Record
GSA General Services Administration
HEDIS Health Plan Employer Data and Information Set
HHS/DHSS Department of Health and Human Services
HIPAA Health Insurance Portability and Accountability Act
HL7® Health Level Seven® (HL7®)
HRSA Health Resources and Services Administration
HUD Department of Housing & Urban Development
IERs Information Exchange Requirements
IHS Indian Health Service
INN International Nonproprietary Names
IUIS International Union of International Societies
IUPAC International Union of Pure and Applied Chemistry
JCAHO Joint Commission for Accreditation of Health Care
Organizations
LanguaL Langua aLimentaria; Language of Foods
MeSH Medical Subject Heading
NASA National Aeronautics and Space Administration
NCI National Cancer Institute
NCPDP National Council for Prescription Drug Programs
NDC National Drug Code
NDF-RT™ National Drug File Reference Terminology
NEHTA National E-Health Transition Authority, Australia
NIH National Institutes of Health
NLM National Library of Medicine
OASD(HA) Office of the Assistant Secretary of Defense for Health
Affairs
RxNorm National Library of Medicine standardized nomenclature for
clinical drugs
SAMHSA Substance Abuse and Mental Health Services Administration
SDOs Standards Development Organization
SNOMED® Systematized Nomenclature of Medicine
SNOMED CT® Systematized Nomenclature of Medicine Clinical Terms
SPL Structured Product Labeling
SPOTS Special Products On-Line Tracking System
SSA Social Security Administration
TGA Therapeutic Goods Administration (Australia)
TRICARE Health insurance program for military personnel and their
families
UMLS® Unified Medical Language System
UNII Unique Ingredient Identifier
USAID United States Agency for International Development
USAN United States Adopted Names
USDA United States Department of Agriculture
USHIK United States Health Information Knowledgebase
USP United States Pharmacopeia
USP-NF United States Pharmacopeia-National Formulary
VA Department of Veterans Affairs
VHA Veterans Health Administration
WASPalm World Association of Societies of Pathology and Laboratory
Medicine