Consolidated Health Informatics

Standards Adoption Recommendation

Allergy

**[Index]{.underline}**

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](../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](http://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](http://www.snomed.org/))

####### Part I -- Team & Domain Scope Identification

**[Target Vocabulary Domain]{.underline}**

+-----------------------------------------------------------------------+
| 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]{.underline}** *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)]{.underline}** *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]{.underline}** *Team members' names and agency names
with phone numbers.*

  -------------------- --------------------------------------------------
  **Name**             **Agency/Department**

  Marcia Insley        Department of Veterans Affairs, Veterans Health
  (Colead)             Administration

  Lenora Barnes        Department of Veterans Affairs, Veterans Health
  (Colead)             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

  Elizabeth Halley     MITRE
  -------------------- --------------------------------------------------

**[Work Period]{.underline}** *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]{.underline}** *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]{.underline} 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]{.underline}**

  ----------------- ----------------------------------- ------------------
  **Allergy         **Recommendation**                  **Status**
  Domain**                                              

  *Information      HL7^®^ 2.x and above                
  Exchange Segment*                                     

  *Allergen Name,   RxNorm BN                           
  Mnemonic,                                             
  Description for                                       
  Brand Name Drugs*                                     

  *Allergen Name,   UNII code from the FDA SRS/EPA SRS  Conditional as
  Mnemonic,                                             noted below and
  Description,*                                         components
                                                        summarized on
                                                        Allergy Schematic

  *Allergen         NDF-RT™                             Conditional as
  Group,Drug                                            noted below
  Classes (Chemical                                     
  structure)*                                           

  *Allergy Type,    SNOMED CT^®^                        With
  Allergy Severity                                      recommendation for
  and Allergy                                           SNOMED^®^/HL7^®^
  Reaction*                                             collaboration and
                                                        SNOMED CT^®^
                                                        allergy subset
                                                        consideration
  ----------------- ----------------------------------- ------------------

**[Conditional Recommendation]{.underline}** *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           | Yes/Approved         | Applied    | Not       |
|                     |                      |            | Approved  |
| &                   |                      |            |           |
|                     |                      |            |           |
| Accreditations      |                      |            |           |
+---------------------+----------------------+------------+-----------+
| Full SDO Ballot     | Y                    |            |           |
+---------------------+----------------------+------------+-----------+
| ANSI                | Y                    |            |           |
+---------------------+----------------------+------------+-----------+

**[Options Considered]{.underline}** *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^®^                                                             |
|                                                                       |
| CHDR                                                                  |
|                                                                       |
| FAET                                                                  |
|                                                                       |
| NCPDP                                                                 |
|                                                                       |
| NEHTA                                                                 |
+-----------------------------------------------------------------------+
| **Terminologies**:                                                    |
|                                                                       |
| **[Allergen Type:]{.underline}**                                      |
|                                                                       |
| HL7^®^                                                                |
|                                                                       |
| SNOMED CT^®^                                                          |
+-----------------------------------------------------------------------+
| **[Allergy Severity:]{.underline}**                                   |
|                                                                       |
| HL7^®^                                                                |
|                                                                       |
| SNOMED CT^®^                                                          |
+-----------------------------------------------------------------------+
| **[Allergy Reaction:]{.underline}**                                   |
|                                                                       |
| VA/DOD List                                                           |
|                                                                       |
| SNOMED CT^®^                                                          |
+-----------------------------------------------------------------------+
| **[Allergen Code/Mnemonic/Description:]{.underline}**                 |
|                                                                       |
| **[Drug:]{.underline}**                                               |
|                                                                       |
| UNII Codes                                                            |
|                                                                       |
| RxNorm                                                                |
|                                                                       |
| SNOMED CT^®^                                                          |
|                                                                       |
| SPL                                                                   |
|                                                                       |
| NDC                                                                   |
|                                                                       |
| USP-NF                                                                |
|                                                                       |
| INN                                                                   |
|                                                                       |
| IUPAC                                                                 |
|                                                                       |
| CAS                                                                   |
|                                                                       |
| **[Food:]{.underline}**                                               |
|                                                                       |
| LanguaL                                                               |
|                                                                       |
| Food Product Code                                                     |
|                                                                       |
| Codex Alimentarius^®^                                                 |
|                                                                       |
| EAFUS                                                                 |
|                                                                       |
| USDA List                                                             |
|                                                                       |
| Allergome                                                             |
|                                                                       |
| IUIS                                                                  |
|                                                                       |
| VA Non Drug Allergen Lists                                            |
|                                                                       |
| FDA SRS                                                               |
|                                                                       |
| EPA SRS                                                               |
|                                                                       |
| **[Environmental:]{.underline}**                                      |
|                                                                       |
| EPA SRS                                                               |
|                                                                       |
| FDA SRS                                                               |
|                                                                       |
| VA Non Drug Allergen Lists                                            |
|                                                                       |
| **[Non Drug/Other:]{.underline}**                                     |
|                                                                       |
| EPA SRS                                                               |
|                                                                       |
| FDA SRS                                                               |
|                                                                       |
| VA Non Drug Allergen Lists                                            |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **[Class of Allergen]{.underline}**                                   |
|                                                                       |
| **[Drug Classification:]{.underline}**                                |
|                                                                       |
| NDF-RT™                                                               |
|                                                                       |
| SPL                                                                   |
|                                                                       |
| SNOMED CT^®^                                                          |
|                                                                       |
| NDC                                                                   |
|                                                                       |
| ATC                                                                   |
|                                                                       |
| AHFS                                                                  |
|                                                                       |
| USP                                                                   |
|                                                                       |
| FDB                                                                   |
|                                                                       |
| MeSH                                                                  |
|                                                                       |
| Multum                                                                |
|                                                                       |
| Micromedex                                                            |
|                                                                       |
| Medispan                                                              |
|                                                                       |
| **[Food Classification:]{.underline}**                                |
|                                                                       |
| FALCPA- Food Allergen Labeling and Consumer Protection Act            |
+-----------------------------------------------------------------------+

**[Current Deployment]{.underline}**

**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)](http://www.cap.org/), [SNOMED CT^®^](http://www.snomed.org/)   |
| (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](http://www.nhsia.nhs.uk/snomed/pages/default.asp) 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                                                             |
| [lice                                                                 |
| nse](http://www.nlm.nih.gov/research/umls/Snomed/snomed_license.html) |
| 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 Services                               |
|                                                                       |
| National Institutes of Health (Office of the NIH Director & NLM       |
|                                                                       |
| Centers for Disease Control and Prevention/Agency for Toxic           |
| Substances and Disease Registry                                       |
|                                                                       |
| Office 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                               |
| a                                                                     |
| greement](http://www.nlm.nih.gov/research/umls/license_revised.html), |
| 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 Corporation              | Apelon, Inc.                  |   |
| |                                 |                               |   |
| | ComMedica Limited               | Health Language, Inc.         |   |
| |                                 |                               |   |
| | Eclipsys Corporation            | Intelligent Medical Objects   |   |
| |                                 |                               |   |
| | Epic Systems Corporation        | Language & Computing          |   |
| |                                 |                               |   |
| | GE Medical Systems Information  | A4 Health Systems             |   |
| | Technologies                    |                               |   |
| |                                 | ABLESoft                      |   |
| | IDX Systems Corporation         |                               |   |
| |                                 | AssistMed                     |   |
| | McKesson Information Solutions  |                               |   |
| |                                 | Clinical & Biomedical         |   |
| | MEDITECH, Inc.                  | Computing, Ltd.               |   |
| |                                 |                               |   |
| | Oracle Corporation              | Cogient Corporation           |   |
| |                                 |                               |   |
| | # Per-Se Technologies           | Creative Computer             |   |
| |                                 | Applications                  |   |
| | Siemens Medical Solutions       |                               |   |
| | Health Services                 | Détente Systems Limited       |   |
| |                                 | (Australia)                   |   |
| | deCode Genetics                 |                               |   |
| |                                 | ibex Healthdata Systems, Inc. |   |
| | Egton Medical Information       |                               |   |
| | Systems (UK)                    | IMPATH Inc.                   |   |
| |                                 |                               |   |
| | GeneLogic, Inc.                 | iSOFT                         |   |
| |                                 |                               |   |
| | In Practice Systems (UK)        | Misys Healthcare Systems      |   |
| |                                 |                               |   |
| | Institute for Medical Knowledge | Monarch Medical International |   |
| | Implementation (IMKI)           | Ltd.                          |   |
| |                                 |                               |   |
| | Reuters Health Information,     | Picis                         |   |
| | Inc.                            |                               |   |
| |                                 | Sysmex Delphic Ltd. (New      |   |
| | Safescript Ltd (UK)             | Zealand)                      |   |
| |                                 |                               |   |
| | TheraDoc, Inc.                  | Torex Laboratory Systems Ltd. |   |
| |                                 | (Scotland)                    |   |
| | TherapyEdge                     |                               |   |
| |                                 | Triple G Systems Group, Inc.  |   |
| | WellMed, 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 applications*.* As 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.                                                               |
|                                                                       |
| +------------------+---------+------------------------------------+   |
| | **Agenc          | **App   | **Description**                    |   |
| | y/Organization** | roved** |                                    |   |
| +------------------+---------+------------------------------------+   |
| | 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\. Licensure of SNOMED^®^ for     |   |
| |                  | /1/2002 | reporting bioterrorism and         |   |
| |                  |         | infectious disease data from up to |   |
| |                  | 9/      | 500 sites plus 150 back-up laptops |   |
| |                  | 22/1999 |                                    |   |
| |                  |         | 2\. Licensure of SNOMED^®^ for     |   |
| |                  | 7/      | reporting cancer data from up to   |   |
| |                  | 11/2002 | 100 cancer registries              |   |
| |                  |         |                                    |   |
| |                  |         | 3\. Licensure of SNOMED^®^ for     |   |
| |                  |         | internal evaluation purposes       |   |
| +------------------+---------+------------------------------------+   |
| | DoD              | 1/      | Licensure of SNOMED^®^ for use in  |   |
| |                  | 31/2003 | standardization of medical data    |   |
| |                  |         | and treatment protocols in the     |   |
| |                  |         | Special Operations Forces Medical  |   |
| |                  |         | Handbook                           |   |
| +------------------+---------+------------------------------------+   |
| | NIH/NCI          | 1       | Licensure of SNOMED^®^ for use in  |   |
| |                  | /7/2003 | 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 |         | Upon request of the National       |   |
| | Groups           |         | Quality Forum, the "never events"  |   |
| |                  |         | have been integrated into          |   |
| |                  |         | SNOMED^®^                          |   |
| +------------------+---------+------------------------------------+   |
| | Tumor Registries | 9/      | Licensure by CDC of SNOMED^®^ for  |   |
| |                  | 22/1999 | reporting cancer data from up to   |   |
| |                  |         | 100 cancer registries              |   |
| +------------------+---------+------------------------------------+   |
| | VA               | 9/      | Many VA hospitals have used        |   |
| |                  | 14/2000 | 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   | 1/      | Use of SNOMED^®^ in the Astronaut  |   |
| | held by Wyle     | 31/2002 | Longitudinal Database              |   |
| | Laboratories)    |         |                                    |   |
| +------------------+---------+------------------------------------+   |
| | AFIP             | 5/      | Use of SNOMED^®^ in coding of      |   |
| |                  | 26/1999 | 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-RT^TM^**

+-----------------------------------------------------------------------+
| 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-RT^TM^ 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-RT^TM^ is modeled using various types of              |
| relationships to represent the semantics between information at       |
| different levels in its hierarchy. NDF-RT^TM^ is also linked with     |
| various external national standards like RxNorm, FDA UNII, MeSH^®^    |
| and HL7. NDF-RT^TM^ 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-RT^TM^'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]{.underline}**

###### 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  Y       Y       Y       B                               Patient Care
  Affairs (VA)                                                                    

  Department of Defense   Y       Y       Y       B                               Patient Care
  (DOD                                                                            

  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    Y       Y       Y       B                               Benefits
  and Medicaid Services                                                           
  (CMS)                                                                           

  Food and Drug           Y       Y       Y       B       SPL; DARRTS; AERS;      Regulation,
  Administration (FDA)                                    SPOTS                   Research

  Health Resources and                                                            
  Services Administration                                                         
  (HRSA)                                                                          

  Indian Health Service   Y       Y       Y       B                               Patient Care
  (IHS)                                                                           

  National Institutes of  Y       Y       Y       B                               Clinical
  Health (NIH)                                                                    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           N       Y       N                                       Information
  Protection Agency                                                               Steward

  Department of Housing &                                                         
  Urban Development (HUD)                                                         

  Department of                                                                   
  Transportation (DOT)                                                            

  Department of Homeland                                                          
  Security (DHS)                                                                  
  ----------------------- ------- ------- ------- ------- ----------------------- --------------

##### 

+-----------------------------------------------------------------------+
| **Number of Terms**                                                   |
|                                                                       |
| ***Quantify the number of vocabulary terms, range of terms or other   |
| order of magnitude.***                                                |
|                                                                       |
| Approximate numbers of values per vocabulary:                         |
|                                                                       |
| *Allergen Type 20*                                                    |
|                                                                       |
| *Allergen Severity 10*                                                |
|                                                                       |
| *Allergen Reaction 330*                                               |
|                                                                       |
| *Drug 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 31^st^ and July 31^st^)            |
|                                                                       |
| NDF-RT™ updated with MeSH^®^ annually.                                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| ##### Range of Coverage                                               |
|                                                                       |
| #####                                                                 |
|                                                                       |
| ##### *Within the recommended vocabulary, what portions of the s      |
| tandard 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 RxNorm      |
|                                                                       |
| RxNorm 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^®^.                             |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| ###### **Acquisition**                                                |
|                                                                       |
| ######                                                                |
|                                                                       |
| ###### **How 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.                                         |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| ###### **Cost**                                                       |
|                                                                       |
| ######                                                                |
|                                                                       |
| ###### **What is the direct cost to obtain permission to use          |
|  the data sets/codes? (licensure, acquisition, other external data se |
| ts 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 Requirements**                                              |
|                                                                       |
| Is the standard associated with or limited to a specific hardware or  |
| software technology or other protocol?                                |
|                                                                       |
| No                                                                    |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Guidance**                                                          |
|                                                                       |
| What 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](http://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.                   |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Maintenance**                                                       |
|                                                                       |
| How 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)                          |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Customization**                                                     |
|                                                                       |
| Describe 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:

+----------------------------------------+-------+---------+----------+
| ##                                     | ####  | #####   | Yes with |
| ###### Conformity with other Standards | ####  | ### No  | e        |
|                                        | Yes ( |         | xception |
|                                        | 100%) | ######  |          |
|                                        |       | ## (0%) |          |
+----------------------------------------+-------+---------+----------+
| HIPAA Transaction and Code Set         | **X** |         |          |
| Standards                              |       |         |          |
+----------------------------------------+-------+---------+----------+
| 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                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| ## Gaps                                                               |
|                                                                       |
| Identify 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.                                       |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| ## Obstacles                                                          |
|                                                                       |
| ***What 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]{.underline}***

**Information Exchange Requirements (IERs)**

  ----------------------------------- -----------------------------------
  **Information Exchange              **Description of IER**
  Requirement**                       

  Beneficiary Financial / Demographic Beneficiary financial and
  Data                                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]{.underline}***

**Allergy Recommendation Schematic Illustration**

![](media/image1.png){width="5.99375in" height="7.688194444444444in"}

**[Glossary]{.underline}**

  -------------- --------------------------------------------------------
  **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
  -------------- --------------------------------------------------------