Acknowledgement Condition codes describe the conditions under which accept or application level acknowledgements are required to be returned in response to the message send operation.

A site specific code indicating the specific problem being reported by this Ack Detail.

Refelects rejections because elements of the communication are not supported in the current context.

Reflects errors in the syntax or structure of the communication.

A code identifying the specific message to be provided.

A textual value may be specified as the print name, or for non-coded messages, as the original text.*Discussion:*

'Required attribute xxx is missing', 'System will be unavailable March 19 from 0100 to 0300'*Examples:*

Acknowledgement code as described in HL7 message processing rules.

Identifies the the kind of information specified in the acknowledgement message. Options are: Error, Warning or Information.

* Patient billing accounts * Cost center * Cash

Explanatory codes that provide information derived by an Adjudicator during the course of adjudicating an Invoice. Codes from this domain are purely information and do not materially affect the adjudicated Invoice. That is, codes do not impact or explain financial adjustments to an Invoice.

A companion domain (ActAdjudicationReason) includes information reasons which have a financial impact on an Invoice (claim).

Example adjudication information code is 54540 - Patient has reached Plan Maximum for current year.

Codes from this domain further rationalizes ActAdjudicationCodes (e.g. AA - Adjudicated with Adjustment), which are used to describe the process of adjudicating an Invoice.

Explanatory codes that describe reasons why an Adjudicator has financially adjusted an invoice (claim).

A companion domain (ActAdjudicationInformationCode) includes information reasons which do not have a financial impact on an invoice (claim).

Example adjudication reason code is AA-CLAIM-0011 - Only Basic Procedure/Test Eligible.

Codes from this domain further rationalizes ActAdjudicationCodes (e.g. AA - Adjudicated with Adjustment), which are used to describe the process of adjudicating an invoice. For AS - Adjudicated as Submitted, there should be no specification of ActAdjudicationReason codes, as there are no financial adjustments against the invoice.

* adjudicated with adjustments * adjudicated as refused * adjudicated as submitted

* Follow-up appointment * New referral appointment * Consultation appointment * Specimen Collection appointment * Procedure appointment

* Duplicate Therapy * Care protocol * Insurance requirement

* Fraudulent prescription * Patient's preference * Physiotherapy equipment

* Contract * Rostering * Capitation

* arm * leg * heel

* autologous * directed * volunteer

**Description:**The type and scope of responsibility taken-on by the performer of the Act for a specific subject of care.

**Description:**Concepts identifying different types of referral requests. These concepts identify the general type of care or category of services requested. They are not used to represent the indication or diagnosis which triggered the need for the referral. E.g. Anger management service, Intensive Care service, Orthodontics service.

**Description:**Contrains the type of attachment (document, XRAY, bit map image, etc.) included to support a healthcare claim. Vocabulary bound to this domain should be a specification for the type of document (i.e. WCB First Report of Acccident - Form 8).

A code specifying the major type of Act that this Act-instance represents.

Every Act-instance must have a classCode. If the act class is not further specified, the most general Act.classCode (ACT) is used.

The Act.classCode must be a generalization of the specific Act concept (e.g., as expressed in Act.code), in other words, the Act concepts conveyed in an Act must be specializations of the Act.classCode. Especially, Act.code is not a "modifier" that can alter the meaning of a class code. (See Act.code for contrast.)

**Description:**The interaction of entities whereupon a subject entity is brought into proximity to a physical, chemical or biological agent. This includes intended exposure (e.g. administering a drug product) as well as accidental or environmental exposure. (Note: This class deals only with proximity and not the effectiveness of the exposure, i.e. not all exposed will suffer actual harm or benefit.)

**Examples:**Exposure to radiation, drug administration, inhalation of peanut aerosol or viral particles.

**Description:**An observation of genomic phenomena.

**Description:**A mandate, regulation, obligation, requirement, rule, or expectation unilaterally imposed by one party on:

* The activity of another party * The behavior of another party * The manner in which an act is executed

An Act whose immediate and primary outcome (post-condition) is the alteration of the physical condition of the subject.

The act of putting something away for safe keeping. The "something" may be physical object such as a specimen, or information, such as observations regarding a specimen.

The table that provides the detailed or rich codes for the Act classes.

* lab process steps * diagnostic imaging process steps * etc. *(Missing third example)*

Denotes the specific service that has been performed. This is obtained from the professional service catalog pertaining to the discipline of the health service provider. Professional services are generally cognitive in nature and exclude surgical procedures. E.g. Provided training, Provided drug therapy review, Gave smoking-cessation counseling, etc.

**Description:**Lists of high-level categorizations for clinical coded observations that do not require numeric values with a specific unit of measure.

* Symptoms * History * Observations

A context representing a grouped commitment of information to the EHR. It is considered the unit of modification of the record, the unit of transmission in record extracts, and the unit of attestation by authorizing clinicians.

**Description:**Specifies the type of consent directive indicated by an ActClassPolicy e.g., a 3rd party authorization to disclose or consent for a substitute decision maker (SDM) or a notice of privacy policy. Sibling to ActPrivacyPolicyType and Child of ActPolicyType.

To perform one or more operations on information to which the patient has not consented as deemed necessary by authorized entities for providing care in the best interest of the patient; providing immediately needed health care for an emergent condition; or for protecting public or third party safety.

Identifies the heading under which a document is to appear in a pre-defined, pro forma table of contents for a collection of documents within a regulatory category.

* m1-1-forms (eCTD module 1, forms) * m1-1-1-fda-form-1571 (eCTD. Module 1, specific FDA form) * m3-2-s-drug-substance (eCTD module 3, section 2, drug substance by substance)

An agreement of obligation between two or more parties that is subject to contractual law and enforcement.

Codes specify the category of observation, evidence, or document used to assess for services, e.g., discharge planning, or to establish eligibility for coverage under a policy or program. The type of evidence is coded as observation values.

Indication of eligibility coverage for healthcare service(s) and/or product(s).

**Description:**Represents the reason for the level of coverage provided under the policy or program in terms of the types of entities that may play covered parties based on their personal relationships or employment status.

Criteria that are applicable to the authorized coverage.

Codes representing the level of coverage provided under the policy or program in terms of the types of entities that may play covered parties based on their personal relationships or employment status.

**Description:**Identifies the reason or rationale for coverage of a service or product based on characteristics of the provider, e.g., contractual relationship to payor, such as in or out-of-network; relationship of the covered party to the provider.

**Example:**In closed managed care plan, a covered party is assigned a primary care provider who provides primary care services and authorizes referrals and ancillary and non-primary care services.

Maximum amount paid or maximum number of services/products covered; or maximum amount or number covered during a specified time period under the policy or program.

**Description:**Codes used to specify reasons or criteria relating to coverage provided under a policy or program. May be used to convey reasons pertaining to coverage contractual provisions, including criteria for eligibility, coverage limitations, coverage maximums, or financial participation required of covered parties.

**Description:**Identifies the reason or rationale for coverage of a service or product based on clinical efficacy criteria or practices prescribed by the payor.

Codes representing the types of covered parties that may receive covered benefits under a policy or program.

**Description:**The type and scope of legal and/or professional responsibility taken-on by the performer of the Act for a specific subject of care as described by a credentialing agency, i.e. government or non-government agency. Failure in executing this Act may result in loss of credential to the person or organization who participates as performer of the Act. Excludes employment agreements.

**Example:**Hospital license; physician license; clinic accreditation.

**Description:**The type and scope of legal and/or professional responsibility taken-on by the performer of the Act for a specific subject of care as described by an agency for credentialing individuals.

**Description:**The type and scope of legal and/or professional responsibility taken-on by the performer of the Act for a specific subject of care as described by an agency for credentialing programs within organizations.

* Query * Search * Transport * Send * Receive

* Create * Store * Archive

**Description:**The type of data consent directive.

* Disclose * Forward * Publish

* Create * Update * Delete

* Activate * Release * Execute Read * Display * Update * Append * Amend

**Definition:**Identifies what type of issue detected during occurrence of an act (e.g. unrecognized identifiers, drug-drug contraindications, drug-allergy alerts).

* High dosage alert * Conditional element missing * Timing detected issue

Includes coded types of actions that can be taken by a supervising entity in response to inappropriate action (or inaction) on the part of a supervised entity.

**Definition:**A comprehensive term for health care provided in a healthcare facility (e.g. a practitioneraTMs office, clinic setting, or hospital) on a nonresident basis. The term ambulatory usually implies that the patient has come to the location and is not assigned to a bed. Sometimes referred to as an outpatient encounter.

**Definition:**A patient encounter that takes place at a dedicated healthcare service delivery location where the patient receives immediate evaluation and treatment, provided until the patient can be discharged or responsibility for the patient's care is transferred elsewhere (for example, the patient could be admitted as an inpatient or transferred to another facility.)

**Definition:**A patient encounter that takes place both outside a dedicated service delivery location and outside a patient's residence. Example locations might include an accident site and at a supermarket.

**Definition:**Healthcare encounter that takes place in the residence of the patient or a designee

**Definition:**A patient encounter where a patient is admitted by a hospital or equivalent facility, assigned to a location where patients generally stay at least overnight and provided with room, board, and continuous nursing service.

**Definition:**An encounter where the patient is admitted to a health care facility for a predetermined length of time, usually less than 24 hours.

Concepts representing types of patient encounter such as ambulatory encounter, inpatient encounter or emergency encounter.

**Definition:**A patient encounter where the patient and the practitioner(s) are not in the same physical location. Examples include telephone conference, email exchange, robotic surgery, and televideo conference.

* Allergies * Drugs * Referrals

* medications * immunizations

Concepts that identify the type or nature of exposure interaction. Examples include "household", "care giver", "intimate partner", "common space", "common substance", etc. to further describe the nature of interaction.

A qualitative measure of the degree of exposure to the causative agent. This includes concepts such as "low", "medium" and "high". This quantifies how the quantity that was available to be administered to the target differs from typical or background levels of the substance.

A type of Act representing a contract whose value is measured in monetary terms.

* insurance policy * providercontract * billing arrangement

Identifies types of detected issues for Act class "ALRT" for the financial acts domain.

Codes dealing with the management of Detected Issue observations for the financial acts domain.

**Description:**The type of financial participation consent directive.

Code specifying financial indicators used to assess or establish eligibility for coverage under a policy or program; e.g., pay stub; tax or income document; asset document; living expenses.

**Description:**Identifies the type of document that was attached to support the processing of claims, adjudication decision determination or extensions to coverage.

A type of Act representing any transaction between two accounts whose value is measured in monetary terms.

* patient account transaction * encounter accounttransaction * cost center transaction

* requisition * pre-coordinated order set * custom order set

Reason for performing one or more operations on information, which may be permitted by source system's security policy in accordance with one or more privacy policies and consent directives.

* Autopsy report * toxicology report * clinical journal article

* Medical history * previous drug reactions * immunization history

Code identifying the type of identification document (e.g. passport, drivers license)

**Implementation Note:**The proposal called for a domain, but a code was also provided. When codes are available for the value set the code IDENTDOC (identity document) will be used as the headcode for the specializable value set.

Reasons why an immunization was administered.

The act of storing information to long term storage.

* Diagnostic Image Interpretations * Lab Test Results * Electrocardiogram Reports

* allergy information * medication information * professional services information

**Definition:**Indicates the set of information types which may be manipulated or referenced, such as for recommending access restrictions.

* Automobile * Extended healthcare * Worker's compensation

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

An identifying data string for healthcare procedures.

Codes representing a service or product that is being invoiced (billed). The code can represent such concepts as "office visit", "drug X", "wheelchair" and other billable items such as taxes, service charges and discounts.

* Provincial or State sales tax * Harmonized sales tax * Federal sales tax

Type of invoice element that is used to assist in describing an Invoice that is either submitted for adjudication or for which is returned on adjudication results.

Processing consideration and clarification codes.

* number and total value of payable items; * number and value of same period nullify items; * number and value of prior nullify; * number of non-payable nullify items; * number of pending items; * number of rejected items; * number of adjudicated to zero items; * reimbursement items (e.g., pay patient) * Adjudicated non-payee payable prior-period electronic amount * Adjudicated nullified prior-period electronic amount * Adjudicated refused prior-period electronic amount

Invoice elements of this type signify a grouping of one or more children (detail) invoice elements. They do not have intrinsic costing associated with them, but merely reflect the sum of all costing for its immediate children invoice elements.

* CPINV - Clinical product invoice * CSINV- Clinical service invoice * RXDINV - Drug invoice * RXCINV - Compound invoice * CSPINV - Combined service and clinical product invoice

* Re-bill for the professional fee * Good faith override * Wasted Drug

Indicates the importance or priority associated with a detected issue.

Codes for additional metadata to be assigned to document or context of use instances to organize a group of documents within the same table of contents heading. These external code systems specify the category or type of keyword (e.g. Species) and the applicable values.

* Species code system * Species code * Sponsor's manufacturing site code system

Codes for general laboratory process steps.

Provides codes associated with ActClass value of LIST (working list)

Indicates the types of documents that can be associated with a medication or group of medications.

**Definition:**A collection of concepts that identifies different types of 'duration-based' mediation working lists.

**Examples:**"Continuous/Chronic" "Short-Term" and "As Needed"

Chemical reactions in the widest sense of the word.

A code distinguishing whether an Act is conceived of as a factual statement or in some other manner as a command, possibility, goal, etc.

The moodCode of a single Act-instance never changes. Mood is not state.

To describe the progression of a business activity from defined to planned to executed, etc. one must instantiate different Act-instances in the different moods and link them using ActRelationship of general type "sequel". (See ActRelationship.type.)

The Act.moodCode modifies the meaning of the Act class in a controlled way, just as in natural language, grammatical form of a verb modify the meaning of a sentence in defined ways. For example, if the mood is factual (event,) then the entire act object represents a known fact. If the mood expresses a plan (intent,) the entire act object represents the expectation of what should be done. The mood does not change the meaning of individual act properties in peculiar ways.

Since the mood code is a determining factor for the meaning of an entire Act object, the mood must always be known. This means, whenever an act object is instantiated, the mood attribute must be assigned to a valid code, and the mood assignment can not change throughout the lifetime of an act object.

As the meaning of an act object is factored in the mood code, the mood code affects the interpretation of the entire Act object and with it every property (attributes and associations.) Note that the mood code affects the interpretation of the act object, and the meaning of the act object in turn determines the meaning of the attributes. However, the mood code does not arbitrarily change the meaning of individual attributes.

By contrast, most of the Act class' attributes are descriptive for what the Act statement expresses. Descriptive properties of the Act class give answer to the questions who, whom, where, with what, how and when the action is done. The questions who, whom, with what, and where are answered by Participatons, while how and when is answered by descriptive attributes and ActRelationships. The interpretation of a descriptive attribute is aligned to the interpretation of the entire act object, and controlled by the mood.

The DEFINITION mood specifies the Act of "obtaining blood glucose". Participations describe in general the characteristics of the people who must be involved in the act, and the required objects, e.g., specimen, facility, equipment, etc. involved. The Observation.value specifies the absolute domain (range) of the observation (e.g., 15-500 mg/dl.)

In INTENT mood the author of the intent expresses the intent that he or someone else "should obtain blood glucose". The participations are the people actually or supposedly involved in the intended act, especially the author of the intent or any individual assignments for group intents, and the objects actually or supposedly involved in the act (e.g., specimen sent, equipment requirements, etc.) The Observation.value is usually not specified, since the intent is not to measure blood glucose, not to measure blood glucose in a specific range. (But compare with GOAL below.)

In ORDER mood, a kind of intent, the author requests to "please obtain blood glucose". The Participations are the people actually and supposedly involved in the act, especially the placer and the designated filler, and the objects actually or supposedly involved in the act (e.g., specimen sent, equipment requirements, etc.) The Observation.value is usually not specified, since the order is not to measure blood glucose in a specific range.

In EVENT mood, the author states that "blood glucose was obtained". Participations are the people actually involved in the act, and the objects actually involved (e.g., specimen, facilities, equipment.) The Observation.value is the value actually obtained (e.g., 80 mg/dL, or <15 mg/dL.)

In event-CRITERION mood, an author considers a certain class of "obtaining blood glucose" possibly with a certain value (range) as outcome. The Participations constrain the criterion, for instance, to a particular patient. The Observation.value is the range in which the criterion would hold (e.g. > 180 mg/dL or 200?300 mg/dL.)

In GOAL mood (a kind of criterion) the author states that "our goal is to be able to obtain blood glucose with the given value (range)". The Participations are similar to intents, especially the author of the goal and the patient for whom the goal is made. The Observation.value is the range which defined when the goal is met (e.g. 80?120 mg/dl.)

The notion of mood also resembles the various extensions of the logic of facts in modal logic and logic with modalities, where the moodCode specifies the modality (fact, possibility, intention, goal, etc.) under which the Act-statement is judged as appropriate or defective.

A non-mandated intent to perform an act. Used to record intents that are explicitly not Orders. Professional responsibility for the 'proposal' may or may not be present.

Reasons why a patient did not receive an immunization.

**Description:**Concepts representing indications (reasons for clinical action) other than diagnosis and symptoms.

Conveys the mandated workflow action that an information custodian, receiver, or user must perform.

The act of verifying an observations. The subject act related to the observation verification (act relationship SUBJ) must be an observation (OBS)

Identifies the type of verification investigation being undertaken with respect to the subject of the verification activity.

• Verification of eligibility for coverage under a policy or program - aka enrolled/covered by a policy or program

• Verification of record - e.g., person has record in an immunization registry

• Verification of enumeration - e.g. NPI

• Verification of Board Certification - provider specific

• Verification of Certification - e.g. JAHCO, NCQA, URAC

• Verification of Conformance - e.g. entity use with HIPAA, conformant to the CCHIT EHR system criteria

• Verification of Provider Credentials

• Verification of no adverse findings - e.g. on National Provider Data Bank, Health Integrity Protection Data Base (HIPDB)

**Description:**An identifying code for oral health interventions/procedures.

The type of order that was fulfilled by the clinical service

* physical therapies * excisions * surgery

**Description:**Provides a categorization for annotations recorded directly against the patient

**Examples:**"Medication incident", "slips, trips and falls incident".The actual value set for the domain will be determined by each (realm) implementation, whose Patient Safety terminology will be specific, although probably linked to the WHO Patient Safety Taxonomy that is currently under development

Definition: Characterizes how a patient was or will be transported to the site of a patient encounter.

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

**Definition:**Identifies types of dispensing events.

**Description:**Types of policies that further specify the ActClassPolicy value set.

Reasons why a preference has been specified.

* Side Effects * Religious * Request

Concepts representing a type of preference that can be specified.

* Food * Drug * Vegetarian * Sweets

A code or set of codes (e.g., for routine, emergency,) specifying the urgency under which the Act happened, can happen, is happening, is intended to happen, or is requested/demanded to happen.

**Description:**Types of privacy policies that further specify the ActClassPolicy value set e.g. override policy, minor's rights to mask sensitive information policy, opt-in, opt-out policy.

An Act which characterizes a Privilege can have additional observations to provide a finer definition of the requested or conferred privilege. This domain describes the categories under which this additional information is classified.

This domain includes observations used to characterize a privilege, under which this additional information is classified.

*Examples:*A privilege to prescribe drugs has a RESTRICTION that excludes prescribing narcotics; a surgical procedure privilege has a PRE-CONDITION that it requires prior Board approval.

**Description:**Describes the high level classification of professional services for grouping.

**Examples:**Education, Counseling, Surgery, etc.

* immunization * appendectomy * physiotherapy

* some radiology procedures * respiratory therapy * physical therapy

Types of method a product can be obtained for use by the subject of the supply act (e.g. patient). Product examples are consumable or durable goods.

* Loan * Rent * Sale

* Application for new approval * Application for renewal of approval * Application for variation of approval

* Centralized process approval * Mutual recognition process approval * National process approval

* Approval to sell * Approval to initiate clinical trial * Approval to market (i.e., advertise)

A type of documentation that is used to convey information about a product or an aspect of its life as a product - ranging from production to disposition.

* Bill of lading * product label * Report of Product Disposal

* Manufacture * paint * wholesale * dispose

DESCRIPTION

Identifies the nature (or type) of transformation that a (medicinal) product may undergo, prior to its administration to a patient.

* Dilution * Dissolution * Suspension

* adjustment of hearing aid * excision of skin lesion * stitching skin lacerations

Types of state an act may exist in.

A type of document used to represent a health quality measure (aka eMeasure).

A type of document section within a health quality measure (aka eMeasure), used to cluster the various parts of the eMeasure into a more human navigable format.

Identifies the document type from a regulator-defined set of codes similar to the ICH-defined File Tags used on clinical study documents in an eCTD.

* Pre-clinical study report * Study report * Sample CRF

Identifies the legal or administrative category assigned to a regulated product that determines or influences the way in which its submission is reviewed.

* New active ingredients * New ethical combination drug * New administrative route

Identifies different classes of regulatory policy that can be applied within a Regulated Product Submission.

Identifies the reason for citing a related application.

* Data protection period expiry reference * Bioequivalence reference * Drug Master File reference

Identifies the time period in which a submission of a given type is to be reviewed as established by law or practice in the particular regulatory realm.

* 30 days, reduced time * 60 days, regular time * 90 days, extended time

* failing device replaced * medication stopped * medication dose adjusted

A code specifying the motivation, cause, or rationale of an Act, when such rationale is not reasonably representable as an ActRelationship of type "has reason" linking to another Act.

Discussion

Most reasons for acts can be clearly expressed by linking the new Act to another prior Act using an ActRelationship of type "has reason". This simply states that the prior Act is a reason for the new Act (see ActRelationship.) The prior act can then be a specific existing act or a textual explanation. This works for most cases, and the more specific the reason data is, the more should this reason ActRelationship be used instead of the reasonCode.

The reasonCode remains as a place for common reasons that are not related to a prior Act or any other condition expressed in Acts. Indicators that something was required by law or was on the request of a patient etc. may qualify. However, if that piece of legislation, regulation, or the contract or the patient request can be represented as an Act (and they usually can), the reasonCode should not be used.

* CDA R2 * * Electrolytes Battery * Specimen Cluster

Conveys prohibited actions which an information custodian, receiver, or user is not permitted to perform unless otherwise authorized or permitted under specified circumstances.

This is the domain of registry types. Examples include Master Patient Registry, Staff Registry, Employee Registry, Tumor Registry.

Identifies the regulatory processes and/or submission contents specified in law or practice for a particular realm used to organize submitted materials.

* Application Type: NDA * Submission Type: Efficacy Supplement * Submission Unit Type: Amendment

Identifies a temporary or final legal status assigned to a submission by a particular regulatory realm based on the laws and practices of the realm.

* Active (as authorized by section abc) * Approved (under section xyz) * Withdrawn (under section pqr)

A code specifying when in the course of an Act a precondition for the Act is evaluated (e.g., before the Act starts for the first time, before every repetition, after each repetition but not before the first, or throughout the entire time of the Act.)

For all checkpointCodes, except "end", preconditions are being checked at the time when the preceding step of the plan has terminated and this step would be next in the sequence established by the sequenceNumber attribute.

When the checkpointCode for a criterion of a repeatable Act is "end", the criterion is tested only at the end of each repetition of that Act. When the condition holds true, the next repetition is ready for execution.

When the checkpointCode is "entry" the criterion is checked at the beginning of each repetition (if any) whereas "beginning" means the criterion is checked only once before the repetition "loop" starts.

The checkpointCode "through" is special in that it requires the condition to hold throughout the execution of the Act, even throughout a single execution. As soon as the condition turns false, the Act should receive an interrupt event (see interruptibleInd) and will eventually terminate.

The checkpointCode "exit" is only used on a special plan step that represents a loop exit step. This allows an action plan to exit due to a condition tested inside the execution of this plan. Such exit criteria are sequenced with the other plan components using the ActRelationship.sequenceNumber.

Used to enumerate the relationships between a CDA section and its contained entries.

Description still needed

A code specifying how concurrent Acts are resynchronized in a parallel branch construct.

The principal re-synchronization actions are (1) the control flow waits for a branch to terminate (wait-branch), (2) the branch that is not yet terminated is aborted (kill-branch), (3) the branch is not re-synchronized at all and continues in parallel (detached branch).

A kill branch is only executed if there is at least one active wait (or exclusive wait) branch. If there is no other wait branch active, a kill branch is not started at all (rather than being aborted shortly after it is started.) Since a detached branch is unrelated to all other branches, active detached branches do not protect a kill-branch from being aborted.

Description still needed

A code specifying how branches in an action plan are selected among other branches.

In addition to exlusive and inclusive split the splitCode specifies how the pre-condition (also known as "guard conditions" on the branch) are evaluated. A guard condition may be evaluated once when the branching step is entered and if the conditions do not hold at that time, the branch is abandoned. Conversely execution of a branch may wait until the guard condition turns true.

In exclusive wait branches, the first branch whose guard conditions turn true will be executed and all other branches abandoned. In inclusive wait branches some branches may already be executed while other branches still wait for their guard conditions to turn true.

Used to indicate that the target of the relationship will be a filtered subset of the total related set of targets.

Used when there is a need to limit the number of components to the first, the last, the next, the total, the average or some other filtered or calculated subset.

A code specifying the meaning and purpose of every ActRelationship instance. Each of its values implies specific constraints to what kinds of Act objects can be related and in which way.

1.) (De)-composition, with composite (source) and component (target)

2.) Sequel which includes follow-up, fulfillment, instantiation, replacement, transformation, etc. that all have in common that source and target are Acts of essentially the same kind but with variances in mood and other attributes, and where the target exists before the source and the source refers to the target that it links back to.

3.) Pre-condition, trigger, reason, contraindication, with the conditioned Act at the source and the condition or reason at the target.

4.) Post-condition, outcome, goal and risk, with the Act at the source having the outcome or goal at the target.

5.) A host of functional relationships including support, cause, derivation, etc. generalized under the notion of "pertinence".

**Description:**An access control object used to manage permissions and capabilities of users within information systems. (See HL7 RBAC specification fo examples of thes objects.)

Types of security policies that further specify the ActClassPolicy value set.

A sensitivity policy is adopted by an enterprise or group of enterprises (a "policy domain") through a formal data use agreement that stipulates the value, importance, and vulnerability of information. A sensitivity code representing a sensitivity policy may be associated with criteria such as categories of information or sets of information identifiers (e.g., a value set of clinical codes or branch in a code system hierarchy). These criteria may in turn be used for the Policy Decision Point in a Security Engine. A sensitivity code may be used to set the confidentiality code used on information about Acts and Roles to trigger the security mechanisms required to control how security principals (i.e., a person, a machine, a software application) may act on the information (e.g., collection, access, use, or disclosure). Sensitivity codes are never assigned to the transport or business envelope containing patient specific information being exchanged outside of a policy domain as this would disclose the information intended to be protected by the policy. When sensitive information is exchanged with others outside of a policy domain, the confidentiality code on the transport or business envelope conveys the receiver's responsibilities and indicates the how the information is to be safeguarded without unauthorized disclosure of the sensitive information. This ensures that sensitive information is treated by receivers as the sender intends, accomplishing interoperability without point to point negotiations.

**Description:**Concepts representing the categorization of health services available at a particular delivery location site.

* anesthetic service * colonoscopy service * orthopedic service

Concepts identifying the general type of care or category of services being documented.

* Colonoscopy * appendectomy * laboratory test

* Vital Signs * Physiological Measurements * Procedure Results

An anatomical location on an organism which can be the focus of an act.

**Description:**Identifies the type of document that is used to support a request which requires special authorization. Example values in this concept domain could be: coverage extensions, step therapy, medical report, lab result, etc.

**Description:**Constrains vocabulary to that which describes the type of documents that can be attached to a financial transaction such as a Special Authorization Request.

Example values under this concept domain could be: drug, device, service, etc.

The accession act related to a specimen or group of specimens.

* Venipuncture * Swab * Biopsy

The act of printing a specimen label. The printing of a label for a specimen container is a significant act in the workflow for collecting specimens.

The act of adding a specimen to a transportation manifest. For example a laboratory will pack together in a carton all the specimens to be shipped to a reference lab. An electronic manifest showing all the specimens in the shippment is communicated to the reference lab.

Transportation of a specimen.

Concepts representing the states in the state-machine of the RIM Act class.

**Definition:**Identifies the types of substitution that may be permitted when ordering a medication, as well as those which have actually occurred during the act of dispensing.

Describes the type of substance administration being performed. This should not be used to carry codes for identification of products. Use an associated role or entity to carry such information.

Describes the type of substance administration being performed. This should not be used to carry codes for identification of products. Use an associated role or entity to carry such information.

* other substance administrations * respiratory therapy * immunizations

The introduction of ??? with the intent of stimulating an immune response, aimed at preventing subsequent infections by more viable agents.

Acts of producing a substance by processing input material in any way thus deriving the product substance from the inputs

* excision * surgical * passive

Indicates why a fulfiller refused to fulfill a supply order, and considered it important to notify other providers of their decision. E.g. "Suspect fraud", "Possible abuse", "Contraindicated".

(used when capturing 'refusal to fill' annotations)

* central supply * materials management * nurse station supply

* medication order entry * laboratory test results review * problem list entry

Codes used to identify different types of 'duration-based' working lists. Examples include "Continuous/Chronic", "Short-Term" and "As-Needed".

Characterizes how a transportation act was or will be carried out.

A mandate, obligation, requirement, rule, or expectation conveyed as security metadata between senders and receivers required to establish the reliability, authenticity, and trustworthiness of their transactions.

Trust security metadata are observation made about aspects of trust applicable to an IT resource (data, information object, service, or system capability).

Trust applicable to IT resources is established and maintained in and among security domains, and may be comprised of observations about the domain's trust authority, trust framework, trust policy, trust interaction rules, means for assessing and monitoring adherence to trust policies, mechanisms that enforce trust, and quality and reliability measures of assurance in those mechanisms. \[Based on ISO IEC 10181-1 and NIST SP 800-63-2\]

For example, identity proofing level of assurance and Trust Framework.

A code indicating whether the Act statement as a whole, with its subordinate components has been asserted to be uncertain in any way.

*Discussion:*This is not intended for use to replace or compete with uncertainty associated with a Observation.values alone or other individual attributes of the class. Such pointed indications of uncertainty should be specified by applying the PPD, UVP or UVN data type extensions to the specific attribute. Particularly if the uncertainty is uncertainty of a quantitative measurement value, this must still be represented by a PPD<PQ> in the value and NOT using the uncertaintyCode. Also, when differential diagnoses are enumerated or weighed for probability, the UVP<CD> or UVN<CD> must be used, not the uncertaintyCode. The use of the uncertaintyCode is appropriate only if the entirety of the Act and its dependent Acts is questioned.

Note that very vague uncertainty may be thought related to negationInd, however, the two concepts are really independent. One may be very uncertain about an event, but that does not mean that one is certain about the negation of the event.

Any substance which, when combined with other ingredients, delivers all or part of the therapeutic benefit associated with a medication.

A molecular structure (molecule or part of a molecule) which is the part of the molecule causing the intended pharmacological action. The value set for ActiveMoietySubstanceType may often be a subset of a SubstanceType value set. Candidate value sets are subsets of ChEBI, PubChem CID, CAS Number, InChi Key, and UNII.

* Metoprolol (without the succinate or tartrate) * Amoxicillin (anhydrous) * Heparin (ion, without the matching Na or K cation)

Discussion: The hierarchical nature of these concepts shows composition. E.g. "Street Name" is part of "Street Address Line"

Indicates the form in which the drug product should be administered.

This element only needs to be specified when (a) the form in which the drug is measured for dispensing differs from the form in which the drug is administered; and (b) the form in which the quantity of the administered drug being administered is not expressed as a discrete measured mass or volume, e.g. the dose is to be measured in "number of actuations."

Indicates the form in which the drug product should be administered.

This element only needs to be specified when (a) the form in which the drug is measured for dispensing differs from the form in which the drug is administered; and (b) the form in which the quantity of the administered drug being administered is not expressed as a discrete measured mass or volume, e.g. the dose is to be measured in "number of actuations."

**Description:**Indicates the role an entity (player) is playing as the appropriate contact on behalf of another entity (scoper).

The gender of a person used for adminstrative purposes (as opposed to clinical gender)

Represents types of consent that patient must sign prior to receipt of service, which is required for billing purposes.

* Advanced beneficiary medically necessity notice. * Advanced beneficiary agreement to pay notice. * Advanced beneficiary requests payer billed.

* Original source investigation * Secondary party investigation * Report to regulatory authority

Concepts characterizing the type of association formed by player and scoper when there is a recognized Affiliate role by which the two parties are related.

Observation value of a person's age group (e.g., newborn infant, child preschool, young adult).

Categorization of types of observation that captures a person's age as a numeric quantity.

An entity (player) that acts or is authorized to act on behalf of another entity (scoper).

**Description:**Provides additional methodology information not present in the associated AllergyTestCode term.

Indicates the result of a particular allergy test. E.g. Negative, Mild, Moderate, Severe

An anatomical location on a non-human animal which can be the focus of an act.

* Dog * Reptile * Deer

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

A role type that is used to further qualify an inanimate subject playing a role where the playing entity acts or is authorized to act on behalf of a scoping entity.

* Assistive device for impaired or challenged person * Non-living entities that may participate as assigned therapeutic agents * Entities that may be provided to patients to improve general mood, decrease depression and loneliness, and distract from stress-inducing concerns to improve quality of life.

**Description:**A role type that is used to further qualify a non-person subject playing a role where the role class attribute is set to RoleClass AssignedEntity

* Janitor * Chief of Staff * Referral Agent * Security Guard * ICU Runner * Visiting professor

A general association between two entities that is neither partitive nor ontological.

Provides coded key words for attribute AttentionLine.keyWordText, which has data type SC.

**Definition:**The domain of possible values used as the value of attention line specifications in AttentionLine directives.

This code is used to specify the exact function an actor is authorized to have in a service in all necessary detail.

This code is used to specify the exact function an actor is authorized to have as a receiver of information that is the subject of a consent directive or consent override.

Provides coded names for attribute Batch.name, which has data type SC.

**Description:**Physicians Current Procedural Terminology (CPT) Manual is a listing of descriptive terms and identifying codes for reporting medical services and procedures performed by physicians. Available for the AMA at the address listed for CPT above. These codes are found in Appendix A of CPT 2000 Standard Edition. (CPT 2000 Standard Edition, American Medical Association, Chicago, IL).

**Description:**Physicians Current Procedural Terminology (CPT) Manual is a listing of descriptive terms and identifying codes for reporting medical services and procedures performed by physicians. Available for the AMA at the address listed for CPT above. These codes are found in Appendix A of CPT 2000 Standard Edition. (CPT 2000 Standard Edition, American Medical Association, Chicago, IL).

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

One letter calendar cycle abbreviations (Temporary - remove when RoseTree is fixed)

Two letter calendar cycle abbreviations (Temporary - remove when RoseTree is fixed)

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

Code for the method by which the public health department was made aware of the case. Includes provider report, patient self-referral, laboratory report, case or outbreak investigation, contact investigation, active surveillance, routine physical, prenatal testing, perinatal testing, prison entry screening, occupational disease surveillance, medical record review, etc.

Code that indicates whether the disease was likely acquired outside the jurisdiction of observation, and if so, the nature of the inter-jurisdictional relationship. Possible values include not imported, imported from another country, imported from another state, imported from another jurisdiction, and insufficient information to determine.

A code that provides information on the overall effect or outcome of the adverse reaction/adverse event reported in the ICSR. Note the criterion applies to the case as a whole and not to an individual reaction.

Example concepts are: death, disability, hospitalization, congenital anomaly/ birth defect, and other medically important condition.

Code for the mechanism by which disease was acquired by the living subject involved in the public health case. Includes sexually transmitted, airborne, bloodborne, vectorborne, foodborne, zoonotic, nosocomial, mechanical, dermal, congenital, environmental exposure, indeterminate.

OpenIssue: Consider moving this attribute to Observation.

Defines types of certifications for all entities

Internet Assigned Numbers Authority (IANA) Charset Types

A role type used to qualify a person's legal status within a country or nation.

* Full citizen * Asylum seeker * Permit card holder

Identifies types of issues detected regarding the performance of a clinical action on a patient.

Any substance or mixture of substances manufactured, sold or represented for use in: (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals; (b) restoring, correcting or modifying organic functions in human beings or animals.

A role of an organization that further classifies the clincial responsibility for the healthcare care delivered during an encounter. E.g. cardiology service, pediatric service, nursing services.

**Definition:**Specifies the reason that an event occurred in a clinical research study.

**Definition:**SSpecifies the reason that a test was performed or observation collected in a clinical research study.

**Note:**This set of codes are not strictly reasons, but are used in the currently Normative standard. Future revisions of the specification will model these as ActRelationships and thes codes may subsequently be retired. Thus, these codes should not be used for new specifications.

**Definition:**Contains domains for act reasons used in clinical research.

Identifies how to interpret the instance of the code, codeSystem value in a set of translations. Since HL7 (or a government body) may mandate that codes from certain code systems be sent in conformant messages, other synonyms that are sent in the translation set need to be distinguished among the originally captured source, the HL7 specified code, or some future role. When this code is NULL, it indicates that the translation is an undefined type. When valued, this property must contain one of the following values:

SRC - Source (or original) code HL7 - HL7 Specified or Mandated SH - both HL7 mandated and the original code (precoordination)

There may be additional values added to this value set as we work through the use of codes in messages and determine other Use Cases requiring special interpretation of the translations.

The description of this is: "Identifies, as a single concept, a combination dose form description for those products that contain two or more manufactured items in a single authorized product".

* Powder and solvent for solution for injection * Pessary and vaginal cream * Tablets and capsules

**Description:**Indicates why the prescription should be suspended.

* results for individual components of an APGAR score * aberrant * ABO incompatibility reaction

**Description:**Used in a patient care message to value simple clinical (non-lab) observation methods, such as found in SOAP (subjective, objective, assessment, plan) progress notes: subjective section (used for history from patient and other informants); objective section (used for physical exam, lab, and other common results), and assessment section (used for the clinicians assessment of the implications of subjective and objective sections).

\]

**Examples:**An APGAR result, a functional assessment, etc. The value must not require a specific unit of measure.

Used in a patient care message to report and query simple clinical (non-lab) observations.

**Description:**Used in a patient care message to value simple clinical (non-lab) observations.

* ability to articulate * ability to chop food * ability to crouch

* Home support level * Tumor staging * abdominal pain characteristic

Describes the type of communication function that the associated entity plays in the associated transmission.

**Definition:**A container intended to contain sufficient material for more than one use, but grouped or organized to provide individual access to sufficient material for a single use. Often used to ensure that the proper type and amount of material is consumed/expended for each use.

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

Types of privacy metadata classifying an IT resource (data, information object, service, or system capability) according to its level of sensitivity, which is based on an analysis of applicable privacy policies and the risk of financial, reputational, or other harm to an individual or entity that could result if made available or disclosed to unauthorized individuals, entities, or processes.

**Description:**Identifies reasons for nullifying (retracting) a particular control act.

**Examples:**"Entered in error", "altered decision", etc.

This code is used to specify the exact function an actor is authorized to have in authoring a consent directive.

* cardiologist * anesthetist * dietician

* Legal representative * Primary contact * Alternative contact

The type of cap associated with a container

**Definition:**An object used to hold other entities.

* Test tube * Shoe box * Drinking glass

Describes the nature (or type) of the container.

* Carton * Bottle * Vial

**DesignNote:**The material of the container should be separately specified (e.g. the "cardboard" part of cardboard carton or the "glass" part of glass vial should be described elsewhere).

**OpenIssue:**This usage of material form is used in Common Product Model,but it is at variance of what has been done in Specimen where the same information is captured in the Entity.code values. These differences need further study.

A material in a blood collection container that facilites the separation of of blood cells from serum or plasma

**Description:**Identifies the order in which content should be processed.

The styles of context conduction usable by relationships within a static model derived from tyhe HL7 Reference Information Model.

Identifies the control codes that are used to manage the propagation and scope of a particular ActRelationship or Participation within a set of Acts.

**Description:**Identifies reasons for nullifying (retracting) a particular control act.

**Examples:**"Entered in error", "altered decision", etc.

Countries of the world. ISO 3166, part 1, alpha-3 set.

Definition: Identifies the reason or rational for why a person is eligibile for benefits under an insurance policy or progam.

**Description:**Identifies the reason or rationale for coverage of a service or product based on coverage exclusions related the risk of adverse selection by covered parties.

**Description:**Identifies the reason or rationale for coverage of a service or product based on financial participation responsibilities of the covered party.

**Description:**Coded observation values for types or instances of items for which coverage is provided under a policy or program, e.g., a type of vehicle or a named work of art.

**Description:**Coded observation values for types of covered parties under a policy or program based on their personal relationships or employment status.

**Description:**Coded observation values for coverage limitations, for e.g., types of claims or types of parties covered under a policy or program.

**Description:**Identifies the reason or rationale for limitations on the coverage of a service or product based on coverage contract provisions.

**Example:**The maximum cost per unit; or the maximum number of units per period, which is typically the policy or program effective time.

**Description:**Coded observation values for types or instances of locations for which coverage is provided under a policy or program, e.g., in the covered party home, in state or in the country.

**Description:**Codes that indicate a specific type of sponsor. Used when the sponsor's role is only either as a fully insured sponsor or only as a self-insured sponsor. NOTE: Where a sponsor may be either, use the SponsorParticipationFunction.code (fully insured or self insured) to indicate the type of responsibility. (CO6-0057)

A role recognized through the eligibility of an identified living subject for benefits covered under an insurance policy or a program. Eligibility as a covered party may be conditioned on a relationship with (1) the policy holder such as the policy holder who is covered as an individual under a poliy or as a party sponsored for coverage by the policy holder.

**Example:**An employee as a subscriber; or (2) on being scoped another covered party such as the subscriber, as in the case of a dependent.

Values that represent a clinical judgment as to the worst case result of a future exposure (including substance administration).

* High criticality * Low criticality * Unable to assess criticality

**Description:**To be used to code and identify the Microbiology laboratory orderable and resultable observation question.

* Urine; Culture * Deep Wound; Aerobic Culture * Microscopic Examination; Gram Stain

**Description:**Used to code and identify the Microbiology laboratory result value when a result is reported.

* Gram Positive Rods * Epithelial Cells * Polymorphonuclear Leukocyte

The currency unit as defined in ISO 4217

DEA schedule for a drug.

Provides codes for decision methods, initially for assessing the causality of events.

A role of a place that further classifies a setting that is intended to house the provision of services.

Domain values for the Device.Alert\_levelCode

Identifies characteristics (physical, visual, clinical) that may be observed for a particular device or device type.

* Height * Sterility * External diameter

Includes the set of codes used to identify a device that may be referred to in an ICSR report. Example code set reference is the FDA Center for Devices and Radiological Health product code list.

Example product codes include: FOZ = Catheter, Intravascular, Therapeutic, short-term less than 30 days, MOP = Rotator, Prosthetic Heart Valve.

A code set that includes codes that are used to characterize the outcome of the device evaluation process. The code defines the manufacturer's conclusions following the evaluation.

Examples include: inadequate alarms, device maintenance contributed to event, device failed just prior to use, user error caused event

Code assigned to indicate a relevant fact within the context of the evaluation of a reported product. There are a number of concept types including the status of the evaluation, the type of evaluation findings, and the type of activity carried out as part of the evaluation process.

Examples include: Actual device involved in incident was evaluated, electrical tests performed, visual examination.

Code assigned to indicate an outcome of the manufacturer's investigation of a product for which a defect has been reported.

Examples include:.component/subassembly failure: air cleaner, computer-, imaging system-, microprocessor-controlled device problem: cache memory, design -- not fail safe.

Indicates the type of person that is responsible for operating the device related to the incident reported in ICSR.

Examples include: Physician, Nurse, Medical Technician, Respiratory Technician.

Set of codes depicting clinical disease and conditions

Diagnosis Value

Identifies the types of diagnostic image.

Identifies the type of diagnostic image report.

* Echocardiogram Report * Ultrasound Report * Nuclear Medicine Imaging Report

A set of concepts that identifies any texture modifications that should be made to a diet order.

* Pudding Thick * Pureed * Easy to Chew

* \[Observation of\] "thrombocytopenia" is categorized as an observation of "Haematologic system" category * \[Observation of\] "duodenal ulcer" is categorized as an observation of "Gastro-intestinal system" category * \[Observation of\] "eczema" is categorized as an observation of "Dermatologic system" category

**Description:**Codes that further characterize the distribution of a material. Used only with the DST (distributed material) role classCode.

**Examples:**Intensive distribution, Selective distribution and Exclusive distribution.

Identifies the current completion state of a clinical document.

A type of document section (specialization of ActClass "DOCSECT").

Identifies the storage status of a document.

The kind of document. Possible values: discharge summary, progress note, Oncology note, etc.

**Description:**The physical manifestation "entity" that contains the active and/or inactive ingredients that deliver a dose of medicine (i.e., drug). The key defining characteristics of the dose form can be the state of matter, delivery method, release characteristics, and the administration site or route for which the product is formulated. (Derived from ISO IDMP specification, and SNOMED CT).

* Tablet * Capsule * Oral solution

Proposed therapy may be contraindicated or ineffective based on an existing or recent drug therapy

A substance whose therapeutic effect is produced by chemical action within the body.

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

Identifies types of observations about the parameters required for acquisition and processing of ECG data.

* item byte order * sample rate * displayed sweep rate

* Elementary School * College or baccalaureate degree complete * High School

Provides coded names for attribute SortControl.elementName , which has data type SC.

Identifies the reason or rational for why a person is eligibile for benefits under an insurance policy or progam.

A code specifying the job performed by the employee for the employer. For example, accountant, programmer analyst, patient care associate, staff nurse, etc.

A code qualifying the employment in various ways, such as, full-time vs. part time, etc.

Industry and/or jurisdictional classification system for kind-of-work performed by an employee.

Occupation codes are intended primarily as work descriptions that are suitable for a multitude of public uses e.g., job matching, employment counseling, occupational and career guidance, and labor market information services.

* Employee * Volunteer * Consultant

A value representing the method used by an employer to compute an employee's salary or wages.

A code used to define the employment status of the insured individual identified in UB-92 FL 58. UB-92 Form locator 64:Employment Status Code of the Insured. Can be used with Employee\_Employer\_statusCode in HL7. Values include Employed Full Time, Employed Part Time, Not Employed, Retired, On Active Military Duty

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

A code depicting the acuity (complexity of patient care, resource intensiveness of the patient care) of a patient's medical condition upon arrival. Values may be derived from formal acuity coding schemes such as RBS.

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

A code indicating patient status as of the ending service date of the period covered on this bill, as reported in FL6, Statement Covers Period. Values such as: Discharged to home or self care; Discharged/transferred to SNF, Discharged/transferred to an intermediate care facility (ICF); Expired; Hospice-medical facility. NUBC Form Locator 22

A code used to define the place or organization responsible for the patient immediately prior to their admission; for example, in the United States, as this is identified in UB-92 Form Locator 20, Source of Adm(ission).

A code identifying special courtesies extended to the patient. For example, no courtesies, extended courtesies, professional courtesy, VIP courtesies.

A concept that conveys how a material will be administered enterally.

* Continuous Tube Feeding * Gravity Drip * Bolus Feeding

Classifies the Entity class and all of its subclasses. The terminology is hierarchical. At the top is this HL7-defined domain of high-level categories (such as represented by the Entity subclasses). Each of these terms must be harmonized and is specializable.

The value sets beneath are encoded in Entity.code and are drawn from multiple, frequently external, domains that reflect much more fine-grained typing.

A value representing the specific kind of Entity the instance represents.

EntityDeterminer in natural language grammar is the class of words that comprises articles, demonstrative pronouns, and quantifiers. In the RIM, determiner is a structural code in the Entity class to distinguish whether any given Entity object stands for some, any one, or a specific thing.

**Description:**The specific kind of location-tracking tag.

Examples:

* RFID * WiFi * Infrared

A type of manufactured material used in an activity, without being substantially changed through that activity.

Special handling requirements for an Entity.

*Example:*Keep at room temperature; Keep frozen below 0 C; Keep in a dry environment; Keep upright, do not turn upside down.

**Description:**The qualifier is a set of codes each of which specifies a certain subcategory of the name part in addition to the main name part type. For example, a given name may be flagged as a nickname, a family name may be a pseudonym or a name of public records.

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

**Description:**Indicates whether the name part is a given name, family name, prefix, suffix, etc.

A name intended for use in searching or matching

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

**Description:**A set of codes advising a system or user which name in a set of names to select for a given purpose.

**Description:**Risk associated with the handling of the material.

The status of an instance of the RIM Entity class.

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

A code specifying in what way two products are considered equivalent. One example for a value set in the US can be found in U.S. FDA "Orange Book" at the FDA website but the concept is universal and not a U.S. only issue.

* No known or suspected bioequivalence problems * Potential bioequivalence problems have been resolved with evidence supporting bioequivalence * Bioequivalence problems have not been fully resolved

In the United States, federal standards for classifying data on ethnicity determine the categories used by federal agencies and exert a strong influence on categorization by state and local agencies and private sector organizations. The federal standards do not conceptually define ethnicity, and they recognize the absence of an anthropological or scientific basis for ethnicity classification. Instead, the federal standards acknowledge that ethnicity is a social-political construct in which an individual's own identification with a particular ethnicity is preferred to observer identification. The standards specify two minimum ethnicity categories: Hispanic or Latino, and Not Hispanic or Latino. The standards define a Hispanic or Latino as a person of "Mexican, Puerto Rican, Cuban, South or Central America, or other Spanish culture or origin, regardless of race." The standards stipulate that ethnicity data need not be limited to the two minimum categories, but any expansion must be collapsible to those categories. In addition, the standards stipulate that an individual can be Hispanic or Latino or can be Not Hispanic or Latino, but cannot be both.

* Very common * Uncommon * Rare

Indicates the material to which the patient was exposed which is believed to be related to the adverse reaction

Code for the mechanism by which the exposure agent was exchanged or potentially exchanged by the participants involved in the exposure.

FDA label data

The type of familial relationship between a living subject and another living subject.

* Father * Mother * Uncle

A manufactured material that is used during the nutrition process but is not changed via the process.

* Disposable Utensils * Plate Guard * Sippy Cup

**Description:**Describes the supporting information for financial transactions such as a Special Authorization Request.

Example values under this concept domain could be: height, weight, duration of disease, site of fistula, etc.

This concept domain is intended to be used as part of a code/value pair within a generic structure that would convey ANY sort of information or proof of criteria that is needed to support a special authorization request.

**Description:**Contains the supporting information values for financial transactions such as a Special Authorization Request.

This concept domain is intended to be used as the "value" part of a code/value pair within a generic structure that would convey any sort of information or proof of criteria that is needed to support a special authorization request. For example:

One wishes to convey a patient's DSM IV diagnosis to support a special authorization request. One code/value pair is used:

ActSupportingInformationCode1 = DSM IV Diagnosis, value= 315.4

Concepts that identify raw, cooked or edible substances or ingredients that are intended for consumption by humans or animals to supply nourishment.

* Orange * Meat * Milk

A relationship between two entities that is formally recognized, frequently by a contract or similar agreement.

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

A value representing whether the primary reproductive organs of NonPersonLivingSubject are present.

**Description:**Identifies why a change is being made to a record.

Concepts that specify interpretation of genetic analysis.

* positive * negative * carrier * responsive

A code that provides additional detail about the means or technique used to ascertain the genetic analysis. Example, PCR, Micro Array.

* Clearinghouse * Billing Service * Health Information Exchange

* Self * Parent * Legal Guardian

* Parent * Legal Guardian * Health Information Exchange

Qualify the holder or scope of a guardianship relationship over a living subject.

* Guardianship held jointly by separated parents * Guardianship held jointly by parent and another person * Natural guardian * Special guardian * Guardian of property

**Description:**Health Care Financing Administration Common Procedural Coding System (HCPCS) Codes are procedure identifying codes. HCPCS is Health Care Finance AdministrationaTMs (HFCA) coding scheme to group procedures performed for payment to providers. contains codes for medical equipment, injectable drugs, transportation services, and other services not found in CPT4.

**Description:**External value set for accommodation types used in the U.S. Health Care Financing Administration (HCFA) Common Procedure Coding System (HCPCS) including modifiers.

**Description:**Accommodation type. In Intent mood, represents the accommodation type requested. In Event mood, represents accommodation assigned/used. In Definition mood, represents the available accommodation type.

HL7 implementation technology specification versions. These codes will document the ITS type and version for message encoding. The code will appear in the instances based upon rules expressed in the ITS, and do not appear in the abstract message, either as it is presented to received from the ITS.

This is the domain of HL7 version codes for the Version 3 standards. Values are to be determined by HL7 and added with each new version of the HL7 Standard.

The trigger event referenced by the Control Act instance. Values are drawn from the available trigger events used in the release of HL7 identified by the versionCode.

The possible modes of updating that occur when an attribute is received by a system that already contains values for that attribute.

A role type that is used to categorize an entity that delivers health care in an expected and professional manner to a subject in need of health care services.

* Registered Nurse * Physician * Custodial Care Clinic

A set of concepts representing locations and settings where healthcare services are provided.

* Tube rack * Specimen carrier * Tray

HtmlLinkType values are drawn from HTML 4.0 and describe the relationship between the current document and the anchor that is the target of the link

An anatomical location on a human which can be the focus of an act.

* Endometrial biopsy * Thyroid fine needle aspirate * Urine

Codes for the representation of the names of human languages.

* buttock * left upper arm * bilateral eyes

**Description:**International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) are procedure identifying codes. ICD-10-PCS describes the classification of inpatient procedures for statistical purposes.

**Description:**International Classification of Diseases, 9th Revision, Procedure Coding System (ICD-9-PCS) are procedure identifying codes. ICD-9-PCS describes the classification of inpatient procedures for statistical purposes.

* Diagnosis * laboratory result * autopsy determined cause of death

**Description:**Different types of qualification that could be applicable for a party involved in sending or receiving a case safety report, providing the original notification or report of an adverse event or product problem.

* Physician * Veterinarian * Lawyer * Member of the public

* Marketing Authorization Holder * Regulatory Agency * Healthcare Practitioner

* Product defect * adverse event

Provides a set of values for defining the type of Pharmaceutical Product that is related to a PhPID. This in turn determines the type of information that may be conveyed when using the Common Product Model as a vehicle for IDMP model data.

* Chemical Type * Radionuclides (radioactive) Type * Biological Substance

Provides a set of values for defining the relationship between different concepts when using the Common Product Model as a vehicle for IDMP model data

* Medicinal identifier * Pharmaceutical identifier * Underlying pharmaceutical concept identifier

Defines elements of the IDMP model, whether concepts defined by role, or relationships between concepts defined by role, that cannot otherwise easily be distinguished within the Common Product Model structures and associated vocabulary. This domain is a collector for the different types of semantics associated with the IDMP role concept spaces.

A code specifying qualitatively the spatial relation between imaged object and imaging film or detector.

Specifies the type of date that is specified in an immunization forecast. The immunization forecast defines the schedule for a vaccine based on variables like the subject's age, the type of vaccine, and the supply unit. The immunization forecast may involve multiple administrations in a series or just one administration. Each of the administrations has one or more recommended dates.

* Earliest recommended date * Recommended date * Latest acceptable date * Overdue date (date after which to start sending reminders)

Used to represent the patient's status with respect to their immunization guideline as of an evaluation date.

Types of locations,that are not designed for the purpose of providing health care services but where care provision takes place.

* Accident site * Patient's residence * School * Work site

Indicates the specific observation result which is the reason for the action (prescription, lab test, etc.). E.g. Headache, Ear infection, planned diagnostic image (requiring contrast agent), etc.

**Examples:**Weight, color, dimensions.

A code that is used to indicate the type of organization which is originating and sending the ICSR. The current code example reference is from the International Conference on Harmonisation (ICH) Expert Workgroup guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports.

Example concepts are: Pharmaceutical Company, Regulatory Authority, Health Professional, Regional Pharmacovigilence Center, World Health Organization Collaborating Center for International Drug Monitoring.

Types of case safety report received from sender. The current code example reference is from the International Conference on Harmonization (ICH) Expert Workgroup guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports. The unknown/unavailable option allows the transmission of information from a secondary sender where the initial sender did not specify the type of report.

This domain is established as a parent to a variety of value domains being defined to support the communication of Individual Case Safety Reports to regulatory bodies. Arguably, this aggregation is not taxonomically pure, but the grouping will facilitate the management of these domains.

North American Industry Classification System(NAICS) for the United States, a new economic classification system that replaces the 1987 Standard Industrial Classification (SIC) for statistical purposes. NAICS is a system for classifying establishments by type of economic activity. Its purposes are: (1) to facilitate the collection, tabulation, presentation, and analysis of data relating to establishments, and (2) to promote uniformity and comparability in the presentation of statistical data describing the economy. NAICS will be used by Federal statistical agencies that collect or publish data by industry. http://www.census.gov/epcd/www/naicsusr.html

An anatomical location on a human of an injury or disease which is the focus of an act.

Values for observations of injuries.

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

Codes identifying pariticular groupings of allergens and other agents which cause allergies and intolerances. E.g. the drug, allergen group, food or environmental agent which triggers the intolerance

* Case subject * Suspect * Person of interest

Designates a modifier to the code attribute to provide additional information about the invoice element.

**Description:**To be used in the message when there is a requirement to communicate a result observation code that relates to a specific isolate.

* Colony count * Colony count; Viability count FDA method * Growth rate; Visual method

**Description:**Used to code and identify the Isolate observation result value when a coded result is reported.

* Heavy growth * Scant growth * Moderate growth

**Description:**Indicates how result sets should be filtered based on whether they have associated issues.

The combined domain for different types of coded observation issue triggers, such as diagnoses, allergies, etc.

Provides coded names for attribute Employee.jobTitleName, which has data type SC.

Categorization of types of observation that capture a knowledge subtopic which might be treatment, etiology, or prognosis.

Observation values that document the types of observations belonging to the domain KnowledgeSubTopicObservationType.

Categorization of types of observation that capture the main clinical knowledge subject which may be a medication, a laboratory test, a disease.

Observation values that document the types of observations belonging to the domain KnowledgeSubjectObservationType.

* Sickle cell trait * Hereditary Spherocytosis * Deficiency of butyryl-CoA dehydrogenase

**Definition:**Used to identify if a lab result is reported as preliminary, final, or corrected. Provides a consistent way to distinguish the business or reporting status of the lab result.

**Description:**Providers used in Laboratory messaging.

* Lab result activate * Lab result complete * Lab result abort

A value representing the method of expression of the language.

*Example:*Expressed spoken, expressed written, expressed signed, received spoken, received written, received signed.

A value representing the level of proficiency in a language.

*Example:*Excellent, good, fair, poor.

A dynamic list of individual instances of Act which reflect the needs of an individual worker, team of workers, or an organization to view roups of Acts for clinical or administrative reasons.

As a consequence, this class will cease to be shown as a physical class in the RIM, once the attribute is retired. Nevertheless, use of this class via an Act.classCode value of 'LIST' is entirely appropriate so long as only the attibutes inherited from Act are used.

A code depicting the living arrangements of a person

Anything that essentially has the property of life, independent of current state (a dead human corpse is still essentially a living subject).

Types of language sourced from an entity that is a living subject.

Tells a receiver to ignore just the local markup tags (local\_markup, local\_header, local\_attr) when value="markup", or to ignore the local markup tags and all contained content when value="all"

A value representing the current state of control associated with the device.

**Description:**Describes types of identifiers other than the primary location registry identifier for a service delivery location. Identifiers may be assigned by a local service delivery organization, a formal body capable of accrediting the location for the capability to provide specific services or the identifier may be assigned at a jurisdictional level.

The status of an instance of the RIM Participation class.

Identifies a drug or the use of a drug as produced by a specific manufacturer

An Entity or combination of Entities transformed for a particular purpose by a manufacturing process.

* Quality control specimen * Aspirin * Breakfast sausage

**Description:**A role type that is used to further qualify an entity playing a role where the role class attribute is set to RoleClass ManufacturedProduct.

* manufacture * repack * import

Provides coded names for attribute Device.manufacturerModelName, which has data type SC.

The closeness or quality of the mapping between the HL7 concept (as represented by the HL7 concept identifier) and the source coding system. The values are patterned after the similar relationships used in the UMLS Metathesaurus. Because the HL7 coding sy

The domestic partnership status of a person.

*Example:*Married, separated, divorced, widowed, common-law marriage.

* Marketing, (this is required as a singleton value set, as there may be no other use case for this than to distinguish one Act of handling products from other Acts, such as manufacturing.)

Types of Material for EntityClass "MAT"

This identifies the physical state, nature or manifestation of the material.

Examples:

* Powder * Liquid * Gas

Observation values used for an items counted measure attribute in a health quality measure (eMeasure).

Observation values used for a jurisdiction measure attribute in a health quality measure (eMeasure).

* ISO Country codes * State and County codes * FIPS value sets of postal codes * districts * regions

Observation values used for various types of coded measure attributes in a health quality measure (eMeasure).

Observation values used for a reporter type measure attribute in a health quality measure (eMeasure).

* Laboratory * Healthcare Providers * Hospitals * Healthcare facilities that are NOT hospitals * Schools * Pharmacists * Veterinary lab * Veterinarian * Prison/Jail * Institutions * Employers

Observation values used for a service delivery location measure attribute in a health quality measure (eMeasure).

Internet Assigned Numbers Authority (IANA) Mime Media Types

**Definition:**A device with direct or indirect therapeutic purpose.

Identifies the specific hierarchical relationship between the playing and scoping medications.

* adverse effect * drug interaction * drug-food interaction

Identifies types of observations that can be made about a particular drug or medication.

**Description:**Indicates the reason the medication order should be aborted.

**Definition:**A collection of concepts that indicate why the prescription should be released from suspended state.

* \[Observation of\] International Birth Date * \[Observation of\] Data Lock Point * \[Observation of\] Frequency of Safety Report Submission

A classification for further qualifying an entity playing a Member RoleClass.

* tribal member * elected member * *ex officio* member * part-time member

Indicates the highest importance level of the set of messages the acknowledging application has waiting on a queue for the receiving application.

Priority may be used by local agreement to determine the timeframe in which the receiving application is expected to retrieve the messages from the queue.

**Description:**To be used to identify a microorganism when required by an act.

* Escherichia coli * Caulimoviridae * Pseudomonas aeruginosa

Indicates whether the subscription to a query is new or is being modified.

Types of reason why a prescription is revised.

The nature of the bonds by which two molecular parts may be connected.

The generalization of molecular parts (partitive role) and molecular bonds (associative role), or possibly any other role type used for the expression of structural molecular features.

Specific functiona that a participant may have in a molecular interaction.

The senses in which a molecule may be conceptually or actually divided into parts.

• sub-unit of a protein (i.e., sequences held together usually by disulfide bonds);

• domain of a protein or component of a nucleic acid sequence (i.e., a sub-sequence identified to have a certain folding structure or function, e.g. signaling peptide of a protein precursor or promoter and open reading frame of a nucleic acid);

• residue on a molecular base skeleton; atom of a molecule (e.g., to identify substitution with a radioactive isotope);

• dissociable ion.

**Description:**Concepts which further characterizing the type of mutual relationships. Used only with the abstract code\_RoleClassMutualRelationship.

NDC Regulated Drug Entity Type

Codes identifying nation states. Allows for finer grained specification of Entity with classcode <= NAT

*Example:*ISO3166 country codes.

* Duplicate transportation required for physician visit * Wrong size of a product * Rebuilding wheel chair ramp due to a weather condition

Indicates types of allergy and intolerance agents which are non-drugs. (E.g. foods, latex, etc.)

The reason the action was not performed, e.g. why the medication was not taken. If an action was not performed, it is often clinically important to know why the action was not taken.

*Examples:*Patient refused, clinically inappropriate, absolute contraindication etc.

**Description:**Types of NonPersonLivingSubjects for the EntityClass "NLIV"

Indication or reason why a valid value is not present.

Concepts that identify the component source substance (e.g., chemical compound class and/or element) that supply nourishment by providing energy or metabolic support.

* Carbohydrates * Protein * Fat * Calcium * Vitamin D * Fiber

Concepts that are used to convey modifications to the food or serving utensils that should be given in a diet order. These can be derived from patient allergies, intolerances, or preferences. They can also be specific to the order and not have any relationship to the allergies, intolerances, or preferences.

* Vegetarian * Liquids separate from solids * Small Portions * disposable utensils (for psych or isolation rooms)

Concepts that identify a type of natural or manufactured food product, typically liquid or powder mixed with water, for complete or supplemental feeding.

* Milk-based * Breast-milk * Soy-based * Peptide-based * Elemental

A material that is used to provide nutritional value.

* Food * Formula * Supplements

Concepts that identify a type of natural or manufactured food product used to provide additional nutrients or nourishment replacements beyond those consumed in the normal diet.

* High-calorie * High-protein * Clear liquid * Oral electrolyte Replacement

**Description:**To allow queries to specify useful information about the age of the patient without disclosing possible protected health information.

**Description:**Dianostic procedures ordered or performed to evaluate whether a sensitivity to a substance is present. This test may be associated with specimen collection and/or substance administration challenge actiivities.

**Example:**Skin tests and eosinophilia evaluations.

Indicates the type of allergy test performed or to be performed. E.g. the specific antibody or skin test performed

* Clinical status * Administrative status * Reporting status

* Suspect * Confirmed * Probable

**Description:**A kind of observation that allows a Secondary Observation (source act) to assert (at various levels of probability) that the target act of the association (which may be of any type of act) is implicated in the etiology of another observation that is named as the subject of the Secondary Observation

**Example:**Causality assertions where an accident is the cause of a symptom; predisposition assertions where the genetic state plus environmental factors are implicated in the development of a disease; reaction assertions where a substance exposure is associated with a finding of wheezing.

**Description:**Type of coded observation values in evaluating reference ranges.

* Surgically transgendered transsexual, female-to-male * AIDS-associated disorder * Asian race

The set of observation type concepts that can be used to express pre-conditions to a particular dosage definition.

Rationale: Used to constrain the set of observations to those related to the applicability of a dosage, such as height, weight, age, pregnancy, liver function, kidney function, etc. For example, in drug master-file type records indicating when a specified dose is applicable.

* age-based criteria * diagnostic-based criteria * simple observation-based criteria (vital signs)

* age-based criteria * sex-based criteria * condition-based criteria

Includes all codes defining types of indications such as diagnosis, symptom and other indications such as contrast agents for lab tests

The domain of possible values for a categorical assessment of an observation value.

Interpretations of change of quantity and/or severity.

* better * worse * increased

Interpretations of the presence or absence of a component / analyte or organism in a test or of a sign in a clinical observation. In keeping with laboratory data processing practice, this provides a categorical interpretation of the "meaning" of the quantitative value for the same observation.

Technical exceptions resulting in the inability to provide an interpretation, such as "off scale". Does not include normality or severity.

Interpretation of the observed result taking into account additional information (contraindicators) about the patient's situation. Concepts in this category are mutually exclusive, i.e., at most one is allowed.

Interpretations of normality or degree of abnormality (including critical or "alert" level). Concepts in this category are mutually exclusive, i.e., at most one is allowed.

Interpretations of anti-microbial susceptibility testing results (microbiology). At most one allowed.

* Food allergy * Environmental allergy * Fod intolerance

* Public health case investigation * Safety investigation * Surveillance investigation

Distinguishes the kinds of coded observations that could be the trigger for clinical issue detection. These are observations that are not measurable, but instead can be defined with codes. Coded observation types include: Allergy, Intolerance, Medical Condition, Pregnancy status, etc.

Distinguishes between the kinds of measurable observations that could be the trigger for clinical issue detection. Measurable observation types include: Lab Results, Height, Weight.

* Hematology reports * Chemistry reports * Blood gas reports

Observation values used to indicate the type of scoring (e.g. proportion, ratio) used by a health quality measure.

Observation values used to indicate whether a health quality measure is used to sample a process or outcome over time.

A code that provides additional detail about the means or technique used to ascertain the observation.

If the methodCode is used to express method detail that is also implied by the Act.code, the methodCode MUST NOT be in conflict with the implied method of the Act.code.

Also, some variances in methods may be tied to the particular device used. The methodCode should not be used to identify the specific device or test-kit material used in the observation. Such information about devices or test-kits should be associated with the observation as "device" participations.

* red blood cell count * components of a chemistry panel * microbiology sensitivity testing

* lab tests * diagnostic imaging * device summary

* Geographic extent * Jurisdictional extent

* Local * Regional * National

Observation values used to assert that a subject falls into a particular population.

* Included in denominator * Included in numerator

**Definition:**Identifies the kinds of public health cases. Used only with the CASE Act class code.

Examples of types of public health cases includes reportable disease cases, radiation exposure cases and chemical exposure cases.

Used to further classify the type of Outbreak being documented. This concept domain is intended to be used with the OUTB Act class code.

* Epidemic * Pandemic * Endemic

Codes used to define various metadata aspects of a health quality measure (specialization of ActClass "OBS").

**Example:**The degree of match or match weight returned by a matching algorithm in a response to a query.

* red blood cell count * results of micro sensitivity testing * *Missing third example*

* outcomes of lab tests * device summary * therapeutic drug level testing

Identifies the kinds of observations that can be performed

This domain is the root domain to which all HL7-recognized value sets for the Observation.value attribute will be linked when Observation.value has a coded data type.

A relationship in which the scoping Entity defines or specifies what the playing Entity is. Thus, the player's "being" (Greek: ontos) is specified.

Concepts representing diets that can be taken via the mouth.

* General * Pureed * Easy to Chew

**Description:**Indicates the form in which the drug product must be, or has been manufactured, or extemporaneous/magistral prepared .

**Description:**To be used to code and identify the Microbiology laboratory observation code that relates to the microorganism identification.

* Bacteria identified * Bacteria identified in tissue * Fungus identified

Further classifies entities of EntityClass ORG.

* HL7 workgroup * corporation * fraternal organization

Domain provides classification systems for industries.

Concepts which further characterize the association between two Entities which are organizations where the playing Entity (the part) is a component of the whole (scoper). Used only with the PART (part) role classCode.

* business unit * department * executive team

Indicates an observed reason for a medical action other than an indication or symptom. E.g. Need for a contrast agent prior to a diagnostic image, need for anesthesia prior to surgery, etc.

* Tuberculosis * Lyme Disease * SARS

This code is used to specify the exact function an actor is authorized to have in authoring a consent override.

A drug product identified at the level of the package in which it is commonly distributed. Code systems such as UPC (Universal Product Code), NDC (National Drug Code), GTIN(Global Trade Item Number) might be bound to this domain in a given realm.

* 0049-3980-41 (NDC for Geodon Roerig 80 mg capsules 10 capsules x 8 blister packs in a carton)

A code indicating the name of a parameter item. ParameterItem classes are defined in the RIM as name-value pairs and this domain provides the name part of the ParameterItem.

Example: Body part, organization part and moiety.

This code is used to specify the exact function an actor had in a service in all necessary detail. This domain may include local extensions (CWE).

Identifies a means by which an Entity participates in an Act.

A code specifying whether and how the participant has attested his participation through a signature and or whether such a signature is needed.

Used to indicate that the participation is a filtered subset of the total participations of the same type owned by the Act.

Used when there is a need to limit the participations to the first, the last, the next or some other filtered subset.

A code specifying the kind of Participation or involvement the Entity playing the Role associated with the Participation has with regard to the associated Act.

An association between two Entities where the playing Entity is considered in some way "part" of the scoping Entity, e.g., as a member, component, ingredient, or content. Being "part" in the broadest sense of the word can mean anything from being an integral structural component to a mere incidental temporary association of a playing Entity with a (generally larger) scoping Entity.

An association for a playing Entity that is used, known, treated, handled, built, or destroyed, etc. under the auspices of the scoping Entity. The playing Entity is passive in these roles (even though it may be active in other roles), in the sense that the kinds of things done to it in this role happen without an agreement from the playing Entity.

Indicates the type of characteristics a patient should have for a given therapy to be appropriate. E.g. Weight, Age, certain lab values, etc.

Patient VIP code

**Definition:**A collection of concepts identifying why the patient's profile is being queried.

Describes payment terms for a financial transaction, used in an invoice.

This is typically expressed as a responsibility of the acceptor or payor of an invoice.

**Description:**PayorRoleType for a particular type of policy or program benefit package or plan where more detail about the coverage administration role of the Payor is required. The functions performed by a Payor qualified by a PayorRoleType may be specified by the PayorParticpationFunction value set.

**Examples:**A Payor that is a TPA may administer a managed care plan without underwriting the risk.

* surgeon * lab technician * janitor

A code identifying a person's disability.

Types of identifiers for persons.

* Social insurance number * Passport number * Drivers license number * Jurisdiction health number

A "personal and legal" assigned relationship records the role of a person in relation to another person, or a person to himself or herself. These concepts are to be used when recording relationships based on personal or family ties or through legal assignment of responsibility.

* Parent * sibling * unrelated friend * neighbor

A code to capture the reporter's assessment of the extent to which the reaction is related to the suspect product reported in the ICSR.

Example concepts include: related, not related, possibly related and unlikely related.

**Definition:**Identifies why the dispense event was not completed

**Definition:**A collection of concepts that indicates the reason for a "bulk supply" of medication.

**Definition:**Indicates why the request to transfer a prescription from one dispensing facility to another has been refused.

Identifies the reason why a request for a prescription renewal has been refused.

Identifies physical characteristics that may be observed for a particular medicinal product or medicinal product package of types thereof.

* Height * Imprint * Shape * Color

A physical place or site with its containing structure. May be natural or man-made. The geographic position of a place may or may not be constant.

Observation types for specifying criteria used to assert that a subject is included in a particular population.

* denominator * numerator * initial population

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

A relationship between two people in which one person authorizes another to act for him in a manner which is a legally binding upon the person giving such authority as if he or she personally were to do the acts.

Defines types of certifications for practitioners

Values that indicate how important a preference is to the target of the reporter.

* Very Important * Important * Suggested

A "helper" vocabulary used to construct complex query filters based on how and whether a prescription has been dispensed.

Observations specific to a particular prescription to express concepts that cannot be expressed via other modeling approaches.

\*\*\*\* MISSING DEFINITIONS \*\*\*\*

**Description:**A concept whose description/definition provides additional detail about the means or technique used for the procedure.

* neuromuscular reeducation * functional activity * Laparoscopic Gastric Bypass Roux-en-Y

This attribute defines whether the message is part of a production, training, or debugging system.

This attribute defines whether the message is being sent in current processing, archive mode, initial load mode, restore from archive mode, etc.

A code that characterizes the role that the primary reporter felt that the suspect intervention -- either a substance administration or a device related procedure - played in the incident being reported. This code will capture the primary reporter's assessment of the role that the suspect product played in the incident reported in the ICSR.

Examples include: Suspect, Concomitant, Interacting, Re-challenge.

An identifying data string for healthcare products.

Example code sets include Healthcare Common Procedure Coding System (HCPCS) and Universal Product Code (UPC).

* Morphine * wheat germ * calcium

A code specifying a type of responsibility that an entity may take on with respect the lifecycle of a product.

* Manufacturer * Distributor * Retailer

**Examples:**Manufacturer, re-processor

**Note:**These two values are currently used in adverse event and product problem reporting.

* pharmacovigilance masterfile location * COSHH (Control of Substances Hazardous to Health) masterfile location * regulatory dossier storage location * batch release masterfile location

**Description:**Concepts characterizing product related roles.

**Description:**Captures the different roles that are recorded to characterize the qualifications or stations in life of persons or organizations who participate as senders or as receivers of adverse event or product problem reports.

**Example:**Example values may include: physician, healthcare facility, attorney, family member, regulatory agency. Initial effort to find defined concepts for this value set will focus on the HIPAA provider taxonomy.

A role type, which indicates the type of device that authors or in some manner contributes to the generation, management, and/or transmission of health information, the use of which may be tracked for purposes of determining the provenance of health information. The playing device acts or is authorized to act on behalf of a scoping entity..

* Patient selected home monitoring device e.g., to detect and report falls * Provider selected medication adherence monitoring, reporting, and alerting device * Provider designated EKG measuring and reporting device

A role type, which indicates the type of device that in some manner contributes to the generation, management, and/or transmission of health information, the use of which may be tracked for purposes of determining the provenance of health information. The playing device is passive in these roles in the sense that the device is not authorized to act on behalf of a scoping entity.

* Software that aggregates pre-existing content to facilitate the authorship of a new artifact by an assigned entity * Software that translates pre-existing content to facilitate the management of that content by an assigned entity * Software that transmits content to facilitate the exchange of that content by an assigned entity * Privacy protective software that facilitates privacy protection and security enforcement by filtering health information and applying protections such as de-identification, masking, or redaction, and privacy marking.

Healthcare Provider Taxonomy Codes

* Tuberculosis * Lyme Disease * SARS * Lung Cancer

* Physician * Registered Nurse * Product Quality Manager

The domain of coded values used as parameters within QueryByParameter queries.

Identifies the time frame in which the response is expected.

Defines the units associated with the magnitude of the maximum size limit of a query response that can be accepted by the requesting application

Values in this domain allow a query response system to return a precise response status.

State attributes for Query event

In the United States, federal standards for classifying data on race determine the categories used by federal agencies and exert a strong influence on categorization by state and local agencies and private sector organizations. The federal standards do not conceptually define race, and they recognize the absence of an anthropological or scientific basis for racial classification. Instead, the federal standards acknowledge that race is a social-political construct in which an individual's own identification with one more race categories is preferred to observer identification. The standards use a variety of features to define five minimum race categories. Among these features are descent from "the original peoples" of a specified region or nation. The minimum race categories are American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White. The federal standards stipulate that race data need not be limited to the five minimum categories, but any expansion must be collapsible to those categories.

Interpretations of the presence and level of reactivity of the specified component / analyte with the reagent in the performed laboratory test.

Code assigned to indicate the rationale for not performing an evaluation investigation on a device for which a defect has been reported.

Examples include: device received in a condition that made analysis impossible, device evaluation anticipated but not yet begun, device not made by company.

The reason a referral was made.

*Examples:*Specialized Medical Assistance, Other Care Requirements.

**Description:**Codes that further characterize a regulated product role. Used only with the RGPR (regulated product) role classCode.

* Prescription Only * Controlled Substance Schedule II * Standard of Practice

Provides coded names for attribute RelationalExpression.elementName, which has data type SC.

Identifies common relational operators used in selection criteria.

A code specifying the logical conjunction of the criteria among all the condition-links of Acts (e.g., and, or, exclusive-or.)

Assigment of spiritual faith affiliation

* Observational * Investigational

Specifies the administrative functionality within a formal experimental design for which the ResearchSubject role was established. Examples: screening - role is used for pre-enrollment evaluation portion of the design; enrolled - role is used for subjects admitted to the active treatment portion of the design.

Codes to characterize a Resource Group using categories that typify its membership and/or function

.

Specifies whether a response is expected from the addressee of this interaction and what level of detail that response should include

Defines the timing and grouping of the response instances.

Specifies the mode, immediate versus deferred or queued, by which a receiver should communicate its receiver responsibilities.

The role played by a party who has legal responsibility for another party.

**Description:**Codes that further characterize the association of a material playing the role of a retailed material to the scoper which retails the material. Used only with the RET (retailed material) role classCode.

Type of material that provides access to another entity.

This table includes codes for the Role class hierarchy. The values in this hierarchy, represent a Role which is an association or relationship between two entities - the entity that plays the role and the entity that scopes the role. Roles names are derived from the name of the playing entity in that role.

The role hierarchy stems from three core concepts, or abstract domains:

* **RoleClassOntological** is an abstract domain that collects roles in which the playing entity is defined or specified by the scoping entity. * **RoleClassPartitive** collects roles in which the playing entity is in some sense a "part" of the scoping entity. * **RoleClassAssociative** collects all of the remaining forms of association between the playing entity and the scoping entity. This set of roles is further partitioned between: * **RoleClassPassive** which are roles in which the playing entity is used, known, treated, handled, built, or destroyed, etc. under the auspices of the scoping entity. The playing entity is passive in these roles in that the role exists without an agreement from the playing entity. * **RoleClassMutualRelationship** which are relationships based on mutual behavior of the two entities. The basis of these relationship may be formal agreements or they may be *de facto* behavior. Thus, this sub-domain is further divided into: * **RoleClassRelationshipFormal** in which the relationship is formally defined, frequently by a contract or agreement. * **Personal relationship** which inks two people in a personal relationship.

The hierarchy discussed above is represented In the current vocabulary tables as a set of abstract domains, with the exception of the "Personal relationship" which is a leaf concept.

Specific classification codes for further qualifying RoleClass codes.

**Description:**The status of an instance of the RIM RoleLink class.

* Active * No longer active * Nullified

A code specifying the kind of connection represented by this RoleLink, e.g., has-part, has-authority.

The status of an instance of the RIM Role class.

Note that a path is in no sense a description of a *final destination*; it is a stylized description of the path taken. For example, an oral antibiotic may be used to treat a severe infection on a toe; the oral route is used to get the medicine to be able to reach and treat the infection in the toe. For some specific routes of administration there may be an incidental sense of *final destination*, for example an ocular administration usually occurs when treatment of an eye condition is required. However, this is in no sense definitional: rectal administration of a medicine may be for a local effect (a steroid foam for treatment of colitis) or for a systemic effect (metronidazole for treatment of infection). The route of administration of a medicine should only be a description of the path taken and not the form.

* oral * rectal * intravenous (IV) * subcutaneous (SC) * intramuscular (IM)

* Correction * Additional information/Follow-up * Response to regulatory agency request

Type of security metadata observation made about the alteration integrity of an altered IT resource (data, information object, service, or system capability), which indicates the mechanism used for authorized transformation of the resource.

* translation * syntactic transformation * semantic mapping * redaction * masking * pseudonymization * anonymization

Security observation values used to indicate security alteration integrity metadata.

* translation * masking * anonymization

Type of security metadata observation made about the category of an IT resource (data, information object, service, or system capability), which may be used to make access control decisions. Security category metadata is defined by ISO/IEC 2382-8:1998(E/F)/ T-REC-X.812-1995 as: "A nonhierarchical grouping of sensitive information used to control access to data more finely than with hierarchical security classification alone."

* Compartment: A division of data into isolated blocks with separate security controls for the purpose of reducing risk. (ISO 2382-8). Security label metadata that "segments" an IT resource by indicating that access and use is restricted to members of a defined community or project. (HL7 Healthcare Classification System) * Sensitivity: The characteristic of a resource which implies its value or importance and may include its vulnerability. (ISO 7492-2) Privacy metadata for information perceived as undesirable to share. (HL7 Healthcare Classification System)

Codes may be drawn from the union of the following value sets: V:PrivacyPolicyType, V:ActPrivacyLaw, V:ActConsentDirective, V:InformationSensitivityPolicy, V:ActInformationSensitivityPolicy, V:RoleInformationSensitivityPolicy, EntitySensitivityPolicy, and V:ActConsentType. Could be bound R1 to a V:ActUSPrivacyPolicy in a future US Realm.

Security observation values used to indicate security category metadata.

* applicable privacy policy * sensitivity * consent directive type

Type of security metadata observation made about the classification of an IT resource (data, information object, service, or system capability), which may be used to make access control decisions. Security classification is defined by ISO/IEC 2382-8:1998(E/F)/ T-REC-X.812-1995 as: "The determination of which specific degree of protection against access the data or information requires, together with a designation of that degree of protection." Security classification metadata is based on an analysis of applicable policies and the risk of harm to an individual that could result from unauthorized disclosure.

Note that an Act or Role may be associated with an Observation coded as SecurityClassificationObservationType with a SecurityClassificationObservationValue coded with a confidentiality code from V:Confidentiality Code to indicate that the confidentiality level indicated by an Act or Role confidentiality attribute has been overridden by the entity responsible for assigning the SecurityClassificationObservationValue. This supports the business requirement for increasing or decreasing the level of confidentiality (classification or declassification) based on parameters beyond the original assignment of an Act or Role confidentiality.

Security observation values used to indicate security classification metadata.

Type of security metadata observation made about the control of an IT resource (data, information object, service, or system capability), which may be used to make access control decisions. Security control metadata convey instructions to users and receivers for secure distribution, transmission,and storage; dictate obligations or mandated actions; specify any action prohibited by refrain policy such as dissemination controls; and stipulate the permissible purpose of use of an IT resource.

* caveats * dissemination controls * obligations * refrain policies * purpose of use constraints

Security observation values used to indicate security control metadata.

Type of security metadata observation made about the data integrity of an IT resource (data, information object, service, or system capability), which indicates the security mechanism used to preserve resource accuracy and consistency. Data integrity is defined by ISO 22600-23.3.21 as: "The property that data has not been altered or destroyed in an unauthorized manner", and by ISO/IEC 2382-8: "The property of data whose accuracy and consistency are preserved regardless of changes made."

* cryptographic hash function * digital signature

Security observation values used to indicate security data integrity metadata.

* a digital signature * a cryptographic hash function

Type of security metadata observation made about the integrity confidence of an IT resource (data, information object,service, or system capability) that indicates the reliability or trustworthiness of a resource, which may be used to make access control decisions.

* highly reliable * uncertain reliability * not reliable

Security observation values used to indicate security integrity confidence metadata.

Type of security metadata observation made about the integrity of an IT resource (data, information object,service, or system capability), which may be used to make access control decisions.

* Integrity status, which indicates the completeness or workflow status of a resource (data, information object, service, or system capability); * Integrity confidence, which indicates the reliability and trustworthiness of the resource; * Integrity control, which indicates pertinent handling caveats, obligations, refrain policies, and purpose of use for the resource; * Data integrity, which indicate the security mechanisms used to ensure that the accuracy and consistency are preserved regardless of changes made (ISO/IEC DIS 2382-8); * Alteration integrity, which indicate the security mechanisms used for authorized transformations of the resource; * Integrity provenance, which indicates the second-hand origins of a reported or asserted resource.

Security observation values used to indicate security integrity metadata.

* veracity * reliability * trustworthiness * provenance

Type of security metadata observation made about the provenance integrity of an IT resource (data, information object, service, or system capability), which indicates the entity responsible for an assertion relayed "second-hand" about an IT resource.

Security observation values used to indicate security integrity provenance asserted by metadata.

Type of security metadata observation made about the provenance integrity of an IT resource (data, information object, service, or system capability), which indicates the lifecycle completeness and workflow status of an IT resource, such as create, modify, append, amend, suspend, archive, and delete; locations in which the resource has been collected or archived, from which it may be retrieved, and the history of its distribution and disclosure. Integrity provenance metadata about an IT resource may be used to assess its veracity, reliability, and trustworthiness.

Security observation values used to indicate security alteration integrity metadata.

Type of security metadata observation made about the provenance integrity of an IT resource (data, information object, service, or system capability), which indicates the entity responsible for a report relayed "second-hand" about an IT resource.

Security observation values used to indicate security integrity provenance reported by metadata.

Type of security metadata observation made about the integrity status of an IT resource (data, information object,service, or system capability), which may be used to make access control decisions. Indicates the completeness or workflow status of an IT resource, which may impact which users that are authorized to access and use the resource.

* legally authenticated * in progress * incomplete

Security observation values used to indicate security integrity status metadata.

* authenticated * legally authenticated * in progress

Type of security metadata observation made about an IT resource (data, information object, service, or system capability), which may be used to make access control decisions. Security metadata are used in security labels.

* The security policy identifiers shall be identical, * The classification level of the initiator shall be greater than or equal to that of the target (that is, there shall be at least one value in the classification list of the clearance greater than or equal to the classification of the target), and * For each security category in the target label, there shall be a security category of the same type in the initiatorÃs clearance and the initiatorÃs classification level shall dominate that of the target.

Observation values used to indicate security observation metadata.

* Codes conveying the classification of an IT resource, such as confidentiality codes * Codes conveying privacy law, sensitivity, and consent directive types governing an IT resource * Codes conveying dissemination controls, handling caveats, purpose of use, refrain policies, and obligations to which an IT resource custodian or receiver must comply. * Codes conveying an IT resource completeness, veracity, reliability, trustworthiness, and provenance * Codes conveying the mechanism used to preserve the accuracy and consistency of an IT resource such as a digital signature and a cryptographic hash function * Codes conveying the mechanism used to make authorized alterations of an IT resource, such as translation, masking, and anonymization

Type of security metadata observation made about the formal declaration by an authority or neutral third party that validates the technical, security, trust, and business practice conformance of Trust Agents to facilitate security, interoperability, and trust among participants within a security domain or trust framework.

Values for security metadata observation made about the formal declaration by an authority or neutral third party that validates the technical, security, trust, and business practice conformance of Trust Agents to facilitate security, interoperability, and trust among participants within a security domain or trust framework.

For example, DirectTrust, Kantara Initiative, Open Identity

Type of security metadata observation made about security requirements for a security domain. \[ISO IEC 10181-1\]

Values for security metadata observation made about security requirements with which a security domain must comply. \[ISO IEC 10181-1\] Conveys the agreement of an asserter to comply with jurisdictional, community, or contractual (security domains) codes of conduct which an information custodian requires as a condition of authorizing collection, access, use or disclosure.

For example, DURSA, DIRECT Applicability Statement, HIPAA Covered Entity and Business Associate Agreement, and FTC PHR Vendor, Related Entity, and third party agreements.

Type of security metadata observation made about the digital quality or reliability of a trust assertion, activity, capability, information exchange, mechanism, process, or protocol.

Values for security metadata observation made about the digital quality or reliability of a trust assertion, activity, capability, information exchange, mechanism, process, or protocol.

For example, authentication, identity proofing, and non-repudiation level of assurance.

Type of security metadata observation made about a set of security-relevant data issued by a security authority or trusted third party, together with security information which is used to provide the integrity and data origin authentication services for an IT resource (data, information object, service, or system capability). \[Based on ISO IEC 10181-1\]

Values for security metadata observation made about a set of security-relevant data issued by a security authority or trusted third party, together with security information which is used to provide the integrity and data origin authentication services for an IT resource (data, information object, service, or system capability). \[Based on ISO IEC 10181-1\]

For example, a single use certificate, dual use certificate, digital signature certificate.

Type of security metadata observation made about a complete set of contracts, regulations, or commitments that enable participating actors to rely on certain assertions by other actors to fulfill their information security requirements. \[Kantara Initiative\]

Values for security metadata observation made about a complete set of contracts, regulations or commitments that enable participating actors to rely on certain assertions by other actors to fulfill their information security requirements. \[Kantara Initiative\]

For example, FICAM, DirectTrust, and HITRUST.

Type of security metadata observation made about a security architecture system component that supports enforcement of security policies.

Values for security metadata observation made about a security architecture system component that supports enforcement of security policies.

For example, Digital signature, authorization scheme, and certificate token.

Type of security metadata observation made about aspects of trust applicable to an IT resource (data, information object, service, or system capability). Trust applicable to IT resources is established and maintained in and among security domains, and may be comprised of observations about the domain's trust authority, trust framework, trust policy, trust interaction rules, means for assessing and monitoring adherence to trust policies, mechanisms that enforce trust, and quality and reliability measures of assurance in those mechanisms. \[Based on ISO IEC 10181-1 and NIST SP 800-63-2\]

Observation value used to indicate aspects of trust policy applicable to an IT resource (data, information object, service, or system capability).

For example, applicable trust framework, policy, or mechanisms.

SecurityTrustObservationValue may be used as a trust attribute value populating a computable trust policy, trust credential, trust assertion, or trust label field in a security label with trust observation values. The valued trust attributes may be used for used for authentication, authorization, and access control decisions. These may also be used to negotiate trust relationships, adjudicate or bridge trust policies, and to specify requirements for participation in a Trust Domain or for asserting compliance with a Trust Framework.

Specifies direction of sort.

* Ascending * Descending * None

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Categorization of types of observation that capture the interpretation of the result of a laboratory test in terms of normality.

* Mild * Moderate * Severe

* the systolic and diastolic components of a blood pressure * 24-hour urine output * ARAC gene

Types of measurement observations typically performed in a clinical (non-lab) setting. E.g. Height, Weight, Blood-pressure

Provides coded names for attribute Device.softwareName, which has data type SC.

A code indicating the type of special arrangements provided for a patient encounter (e.g., wheelchair, stretcher, interpreter, attendant, seeing eye dog). For encounters in intention moods, this information can be used to identify special arrangements that will need to be made for the incoming patient.

**Definition:**Materials introduced to a specimen. These additives may be introduced in order to preserve, maintain or enhance the particular nature or component of the specimen.

* Ammonium heparin * Boric Acid * Phenol

* Blood * Water * Animal cadaver

* specimen identifier * accession identifier * container identifier

* Specimen process step activate * Specimen process step complete * Specimen process step abort

Indicates why the act revision (status update) is being refused.

Type of role attendance the covered party has at a recognized educational institution as defined by a particular insurance policy.

(abstract) Used within an instance to give the author some control over various aspects of rendering

Contains codes for defining the observed, physical position of a subject, such as during an observation, assessment, collection of a specimen, etc. ECG waveforms and vital signs, such as blood pressure, are two examples where a general, observed position typically needs to be noted.

The spatial relationship of a subject whether human, other animal, or plant, to a frame of reference such as gravity or a collection device.

A code to capture the kind of reaction that was suffered by the investigated subject, and that is being reported in the ICSR. At this point, SNOMED or MedDRA have been suggested as code systems to be used for providing this information.

Example concepts include hives, swelling, rash, anaphylactic shock.

Code that captures the emphasis that the reporter placed on this reaction.

Examples include: highlighted by the reporter, NOT serious, Not highlighted by the reporter, NOT serious, Highlighted by the reporter, SERIOUS, Not highlighted by the reporter, SERIOUS.

Code that captures the type of outcome from an individual outcome of a reaction to the suspect product reported in the ICSR.

Examples include: Recovered/resolved. Recovering/resolving, Not recovered/not resolved, Recovered/resolved with sequelae, Fatal.

Reasons why substitution of a substance administration request is not permitted.

Indicates the reason for substitution when substitution occurs, or reason for non-substitution when substitution is expected.

Indicates the reason for non-substitution when substitution was expected.

* prescriber request * patient request * continuing therapy (where this latter means that the prescribed item was not substituted, even though "policy" implied it should be, so as not to change from the item that the patient had previously received)

Indicates the reason for substitution when substitution has occurred.

* formulary policy * regulatory requirement * out of stock (where this latter means that the prescribed item was out of stock and an equivalent product was substituted)

**Definition:**Indicates why the requested authorization to prescribe or dispense a medication has been refused.

Distinguishing traits, qualities, or properties given about substances, including chemical structure (as encapsulated data in SMILES, MolFile, InChi), nucleic acid sequence, amino acid sequence, molecular sum formula; molecular mass; stereochemistry and optical activity properties; viscosity; pH, pKa, catalytic activity, etc.

Identifies what sort of change is permitted or has occurred between the item that was ordered/requested and the one that was/will be provided.

Indicates why the prescription should no longer be allowed to be dispensed (but can still administer what already has been dispensed).

**Description:**Ensures consistent coding of the susceptibility battery or panel.

* Bacterial susceptibility panel * Fungal susceptibility panel * Mycobacterial susceptibility panel * Viral susceptibility panel

* Disk Diffusion (Kirby-Bauer) * Minimum Inhibitory Concentration * Viral Genotype Susceptibility * Gradient Strip (E-Strip)

**Description:**Ensures consistent coding of antimicrobial information in the Microbiology lab message.

* Ciprofloxacin; Disk Diffusion (Kirby-Bauer) * Vancomycin * Tetracycline; Minimum Inhibitory Concentration

**Description:**Used to code and identify the Susceptibility Observation result value when a coded result is reported.

* Susceptible * Resistant * Moderately susceptible

Indicates an observed abnormality in the patientaTMs condition, but does not assert causation. E.g. Runny nose, swelling, flaky skin, etc.

These values are defined within the XHTML 4.0 Table Model

These values are defined within the XHTML 4.0 Table Model

These values are defined within the XHTML 4.0 Table Model

These values are defined within the XHTML 4.0 Table Model

These values are defined within the XHTML 4.0 Table Model

A code specifying the extent to which the Entity playing the participating Role (usually as a target Participation) is aware of the associated Act.

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* United States * New York * European Union

**Description:**Codes that further characterize the Theraputic Agent as a manufactured product. Used only with the THER (therapeutic agent) role classCode.

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A codes specifying the meaning and purpose of every TransmissionRelationship instance. Each of the values implies specific constraints to what kinds of Transmission objects can be related and in which way.

**Description:**A code specifying the meaning and purpose of every TransmissionRelationship instance. Each of its values implies specific constraints to what kinds of Transmission objects can be related and in which way.

A Universal Resource Locator (URL) is a type of telecommunications address specified as Internet standard RFC 1738 \[http://www.isi.edu/in-notes/rfc1738.txt\]. The URL specifies the protocol and the contact point defined by that protocol for the resource.

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The manufacturer of a vaccine.

Types of manufactured material that when administered are intended to confer protection against specific disease(s).

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Values for observations of verification act results

**Description:**A role type that is used to further qualify an entity playing a role where the role is that of a vision product such as lenses, frames, etc.

**Description:**Codes that further characterize a warranted product role. Used only with the WRTE (warranted product) role classCode.