• value @ url

Placeholder for providing any comments that are relevant to the specification. [Source: SME Defined] Examples: replaces method ABC, using the XYZ facility.

The alphanumeric text assigned by the sponsor to a particular edition of a specification. [Source: SME Defined] Examples: 2.1, 13.2, ST1, 00001, 00002, <companyname>001. Note: This value should be unique across all specifications for a given material, not just those with the same name

The textual identification for the specification. [Source: SME Defined] Example: <drug name> 75 mg chewable tablets Note: This may include the name of the drug substance, product or the raw material/excipients

An additional textual identification for the specification [Source: SME Defined].

The date when the sponsor assigned a date to a specific version. [Source: SME Defined] Note: This is the date a particular version of the specification was internally accepted by the submitter.

The current FDA regulatory status of the specification. [Source: SME Defined] Examples: Approved, Not Approved, Reported in a CBE or AR. Note: There are instances when FDA does approve the Specifications in a supplement or an amendment where other information in the dossier has not changed. Note: This is different from Application Status

• type @ $this

The date on which the FDA approval status for a specification became effective. [Source: SME Defined] Note: If the application is not yet approved, then this is the date of the current submission OR the date of the complete response (CR). Note: This is not the application approval status date.

The text of the acceptance criteria as provided in the specification. [Source: SME Defined] Examples: White to off-white cake; 22.5 - 27.5 mg/ml Note: This is the text as it appears in the Specification.

A coded value specifying when a particular analytical procedure or measurement is being performed on a substance or a product. [Source: SME Defined] Examples: Release, Stability. Note: The concept of 'In-Process' is subsumed by the Release code.

A textual field to provide any additional information about the acceptance criteria. [Source: SME Defined] Example: value changed from 4% to 5% on 01/01/2010)

• type @ $this

The acceptable quantitative or numeric value for the result of the test. [Source: SME Defined]

A code that describes how to relate the given value to an acceptance value. [Source: SME Defined] Note: When result value is numeric there is a controlled vocabulary; when result value is textual the vocabulary is Pass/Fail.

The acceptable quantitative or numeric value for the result of the test. [Source: SME Defined]

A code that describes how to relate the given value to an acceptance value. [Source: SME Defined] Note: When result value is numeric there is a controlled vocabulary; when result value is textual the vocabulary is Pass/Fail.

A code that describes how to relate the given value to an acceptance value. [Source: SME Defined] Note: When result value is numeric there is a controlled vocabulary; when result value is textual the vocabulary is Pass/Fail.

A code that describes how to relate the given value to an acceptance value. [Source: SME Defined] Note: When result value is numeric there is a controlled vocabulary.

A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP <711>) Note: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - USP <151>; 21 CFR 610.13 (b) Test for pyrogenic substances)

An identification number for a member of the set of results for a test, usually the sequence order in which the test was executed. Individual tests are executed on multiple samples to give greater validity to the findings. [Source SME Defined] Examples: Prepare six aliquots from the sample. Test 8 samples. If any fall above 110%, test an additional 7 samples. Record all replicate values as stated in the method.

• value @ url

Test Order: The sequential number assigned to each Test to specify the order of display on the Quality Specification. [Source: SME Defined] [Source: SME Defined] Examples: 1, 2, 3.

A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP <711>) Note: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - <151>; 21 CFR 610.13 (b) Test for pyrogenic substances)

Implememtation Note: Value at this level is 'Single Stage'

The textual description of a procedure or analytical method. [Source: SME Defined] Examples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities. Note: as defined by the sponsor

Test Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined]. If there is more than one comment, include in this element. Markdown allows formating for clarity.

A coded value specifying the source of the method. [Source: SME Defined] Example: Compendial

The name of the technique used to determine the nature of a characteristic. [Source: SME Defined].

A high level grouping of quality attributes for products, substances, raw materials, excipients, intermediates and reagents. [Source: SME Defined] Examples: Assay, Biological Properties.

A sponsor/applicant provided alphanumeric code that identifies the procedure. [Source: SME Defined]. Example: HP1234-2008 Note: This could also be a transferred lab method.

Alternate Tests are one or more test that are equivalent often using differnt method or equipment. The tests are used interchangeably and only one is used to satisfy the drug product specificaion.

• value @ url

The order of the stages in regular succession. [Source: SME Defined] Examples: 1, 2, 3.

A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP <711>) Note: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - <151>; 21 CFR 610.13 (b) Test for pyrogenic substances)

Implememtation Note: not requried if action.prefix is 'Single Stage'

Test Name: The textual description of a procedure or analytical method. [Source: SME Defined] Examples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities. Note: as defined by the sponsor Note: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus.

Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined].

Implementation Note: If there is more than one comment, include in this element. Markdown allows formating for clarity.

Any visual data described andor referenced in additional informatation

A format or abbreviation name that identifies a file structure. [Source: SME Defined] Used for the following: Analytical Instrument Data File Type, Impurity Analysis Graphic, Impurity Analytical Instrument Data File, Impurity Chemical Structure Data File, and Substance Structure Graphic.

• value @ url

The sequential number assigned to each Test to specify the order of display on the Quality Specification. [Source: SME Defined] Implementation note: This is a decimaal value. Number the nested test by inheriting the value action.extension[testOrder]. For example, if the action.extension[testOrder] equals 3, then the first action.action.action.extension[testOrder] would be 3.1.

RRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP] Example: 1:23 (a ratio) Note: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value.

Implementation Note: This value can only be 'RRT'. It is used to desinate that RRT value(s) expressed in action.action.action.title are relative retention times.

Test Name: The textual description of a procedure or analytical method. [Source: SME Defined] Examples: Assay by HPLC, moisture by Karl Fischer, analysis for impurities. Note: as defined by the sponsor Note: The test name of the action.action can be different than the action. Example, the action test is Microbial Limits and the action.action test is Staphylococcus aureus.

RRT: The ratio of the retention time of a component relative to that of another used as a reference obtained under identical conditions as an alias for the name of the unidentified impurities. [Source: Adapted from USP] Example: 1:23 (a ratio) Note: This is the title or name of the impurity (sometimes expressed as a ratio) and not the value.

Implementation Note: For RRT, if there is a range associated with the unidentified peak then the range can be entered instead of indivual values. E.g.: 0.4 – 0.8.

Test Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined]. Stage Additional Information: Placeholder for providing any comments that are relevant to the Test. [Source: SME Defined] If there is more than one comment, include in this element. Markdown allows formating for clarity. If both types are present, indicate type.

This resource allows for the definition of various types of plans as a sharable, consumable, and executable artifact. The resource is general enough to support the description of a broad range of clinical and non-clinical artifacts such as clinical decision support rules, order sets, protocols, and drug quality specifications.

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

An Extension

• value @ url

A classification of specification related to the kind of the entity it is referencing.

Placeholder for providing any comments that are relevant to the specification. [Source: SME Defined] Examples: replaces method ABC, using the XYZ facility.

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

A formal identifier that is used to identify this plan definition when it is represented in other formats, or referenced in a specification, model, design or an instance.

Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this plan definition outside of FHIR, where it is not possible to use the logical URI.

Allows externally provided and/or usable business identifiers to be easily associated with the module.

The alphanumeric text assigned by the sponsor to a particular edition of a specification. [Source: SME Defined] Examples: 2.1, 13.2, ST1, 00001, 00002, <companyname>001. Note: This value should be unique across all specifications for a given material, not just those with the same name

There may be different plan definition instances that have the same identifier but different versions. The version can be appended to the url in a reference to allow a reference to a particular business version of the plan definition with the format [url]|[version]. The version SHOULD NOT contain a '#' - see Business Version.

The textual identification for the specification. [Source: SME Defined] Example: <drug name> 75 mg chewable tablets Note: This may include the name of the drug substance, product or the raw material/excipients

This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc.

An additional textual identification for the specification [Source: SME Defined].

The status of this plan definition. Enables tracking the life-cycle of the content.

Allows filtering of plan definitions that are appropriate for use versus not.

See guidance around (not) making local changes to elements here.

A code, group definition, or canonical reference that describes or identifies the intended subject of the plan definition. Canonical references are allowed to support the definition of protocols for drug and substance quality specifications, and is allowed to reference a MedicinalProductDefinition, SubstanceDefinition, AdministrableProductDefinition, ManufacturedItemDefinition, or PackagedProductDefinition resource.

Note that the choice of canonical for the subject element was introduced in R4B to support pharmaceutical quality use cases. To ensure as much backwards-compatibility as possible, it is recommended to only use the new canonical type with these use cases.

The date when the sponsor assigned a date to a specific version. [Source: SME Defined] Note: This is the date a particular version of the specification was internally accepted by the submitter.

The date is often not tracked until the resource is published, but may be present on draft content. Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the plan definition. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource.

See guidance around (not) making local changes to elements here.

The current FDA regulatory status of the specification. [Source: SME Defined] Examples: Approved, Not Approved, Reported in a CBE or AR. Note: There are instances when FDA does approve the Specifications in a supplement or an amendment where other information in the dossier has not changed. Note: This is different from Application Status

When multiple useContexts are specified, there is no expectation that all or any of the contexts apply.

Assist in searching for appropriate content.

A code that identifies the type of context being specified by this usage context.

A value that defines the context specified in this context of use. The interpretation of the value is defined by the code.

• type @ $this

A value that defines the context specified in this context of use. The interpretation of the value is defined by the code.

A reference to a code defined by a terminology system.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Allows for alternative encodings within a code system, and translations to other code systems.

The date on which the FDA approval status for a specification became effective. [Source: SME Defined] Note: If the application is not yet approved, then this is the date of the current submission OR the date of the complete response (CR). Note: This is not the application approval status date.

The 'date' element may be more recent than the approval date because of minor changes or editorial corrections.

See guidance around (not) making local changes to elements here.

A goal describes an expected outcome that activities within the plan are intended to achieve. For example, weight loss, restoring an activity of daily living, obtaining herd immunity via immunization, meeting a process improvement objective, meeting the acceptance criteria for a test as specified by a quality specification, etc.

Goal information needs to be captured for order sets, protocols, and care plan definitions to better describe the objectives of the protocol activities and to guide the creation of specific goals within the derived care plans and orders.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The text of the acceptance criteria as provided in the specification. [Source: SME Defined] Examples: White to off-white cake; 22.5 - 27.5 mg/ml Note: This is the text as it appears in the Specification.

If no code is available, use CodeableConcept.text.

Identifies problems, conditions, issues, or concerns the goal is intended to address.

A reference to a code defined by a terminology system.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Allows for alternative encodings within a code system, and translations to other code systems.

A coded value specifying when a particular analytical procedure or measurement is being performed on a substance or a product. [Source: SME Defined] Examples: Release, Stability. Note: The concept of 'In-Process' is subsumed by the Release code.

Need to refer to a particular code in the system.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Very often the text is the same as a displayName of one of the codings.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Didactic or other informational resources associated with the goal that provide further supporting information about the goal. Information resources can include inline text commentary and links to web resources.

The type of relationship to the related artifact.

The presence of both sides of a relationship type (e.g. successor and predecessor) is required to support use cases where one side of a relationship is not represented in FHIR. However, this feature SHALL NOT be used to create bi-directional resource links in FHIR instances. Specifically, following the methodology of "new points to old" and "many points to one", when using related artifact elements to describe and reference FHIR resources, the type element SHALL be drawn from the fhir-related-artifact-type ValueSet.

A textual field to provide any additional information about the acceptance criteria. [Source: SME Defined] Example: value changed from 4% to 5% on 01/01/2010)

Indicates what should be done and within what timeframe.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The parameter whose value is to be tracked, e.g. body weight, blood pressure, or hemoglobin A1c level.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Very often the text is the same as a displayName of one of the codings.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

The target value of the measure to be achieved to signify fulfillment of the goal, e.g. 150 pounds or 7.0%, or in the case of pharmaceutical quality - NMT 0.6%, Clear solution, etc. Either the high or low or both values of the range can be specified. When a low value is missing, it indicates that the goal is achieved at any value at or below the high value. Similarly, if the high value is missing, it indicates that the goal is achieved at any value at or above the low value.

A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the goal.target.measure defines a coded value.

• type @ $this

The acceptable quantitative or numeric value for the result of the test. [Source: SME Defined]

A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the goal.target.measure defines a coded value.

An Extension

• value @ url

A code that describes how to relate the given value to an acceptance value.

An Extension

• value @ url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

A code that describes how to relate the given value to an acceptance value. [Source: SME Defined] Note: When result value is numeric there is a controlled vocabulary; when result value is textual the vocabulary is Pass/Fail.

The value of the measured amount. The value includes an implicit precision in the presentation of the value.

The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

Precision is handled implicitly in almost all cases of measurement.

How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

A human-readable form of the unit.

There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

A computer processable form of the unit in some unit representation system.

The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

The acceptable quantitative or numeric value for the result of the test. [Source: SME Defined]

A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the goal.target.measure defines a coded value.

The low limit. The boundary is inclusive.

If the low element is missing, the low boundary is not known.

An Extension

• value @ url

A code that describes how to relate the given value to an acceptance value.

An Extension

• value @ url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

A code that describes how to relate the given value to an acceptance value. [Source: SME Defined] Note: When result value is numeric there is a controlled vocabulary; when result value is textual the vocabulary is Pass/Fail.

The value of the measured amount. The value includes an implicit precision in the presentation of the value.

The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

Precision is handled implicitly in almost all cases of measurement.

Not allowed to be used in this context

Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

A human-readable form of the unit.

There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

A computer processable form of the unit in some unit representation system.

The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

The high limit. The boundary is inclusive.

If the high element is missing, the high boundary is not known.

An Extension

• value @ url

A code that describes how to relate the given value to an acceptance value.

An Extension

• value @ url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

A code that describes how to relate the given value to an acceptance value. [Source: SME Defined] Note: When result value is numeric there is a controlled vocabulary; when result value is textual the vocabulary is Pass/Fail.

The value of the measured amount. The value includes an implicit precision in the presentation of the value.

The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

Precision is handled implicitly in almost all cases of measurement.

Not allowed to be used in this context

Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

A human-readable form of the unit.

There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

A computer processable form of the unit in some unit representation system.

The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

The target value of the measure to be achieved to signify fulfillment of the goal, e.g. 150 pounds or 7.0%, or in the case of pharmaceutical quality - NMT 0.6%, Clear solution, etc. Either the high or low or both values of the range can be specified. When a low value is missing, it indicates that the goal is achieved at any value at or below the high value. Similarly, if the high value is missing, it indicates that the goal is achieved at any value at or above the low value.

A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the goal.target.measure defines a coded value.

A code that describes how to relate the given value to an acceptance value. [Source: SME Defined] Note: When result value is numeric there is a controlled vocabulary.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Allows for alternative encodings within a code system, and translations to other code systems.

A textual description and/or a number that identifies a level within a sequential test. [Source: SME Defined] Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to as L1, L2 L3 or A1, A2 as in USP <711>) Note: A Stage may or may not provide a conditional sequence with associated acceptance criteria. [Source: SME Defined] (e.g., dissolution test, pyrogen test - USP <151>; 21 CFR 610.13 (b) Test for pyrogenic substances)

Very often the text is the same as a displayName of one of the codings.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

An identification number for a member of the set of results for a test, usually the sequence order in which the test was executed. Individual tests are executed on multiple samples to give greater validity to the findings. [Source SME Defined] Examples: Prepare six aliquots from the sample. Test 8 samples. If any fall above 110%, test an additional 7 samples. Record all replicate values as stated in the method.

A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the goal.target.measure defines a coded value.

Indicates the timeframe after the start of the goal in which the goal should be met.

An action or group of actions to be taken as part of the plan. For example, in clinical care, an action would be to prescribe a particular indicated medication, or perform a particular test as appropriate. In pharmaceutical quality, an action would be the test that needs to be performed on a drug product as defined in the quality specification.

Note that there is overlap between many of the elements defined here and the ActivityDefinition resource. When an ActivityDefinition is referenced (using the definition element), the overlapping elements in the plan override the content of the referenced ActivityDefinition unless otherwise documented in the specific elements. See the PlanDefinition resource for more detailed information.

An Extension

• value @ url

Test Order: The sequential number assigned to each Test to specify the order of display on the Quality Specification. [Source: SME Defined] [Source: SME Defined] Examples: 1, 2, 3.

An Extension

• value @ url

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.