Description: A characteristic of an oral solid dosage form of a medicinal product, specifying the two dimensional representation of the solid dose form, in terms of the outside perimeter of a solid dosage form when the dosage form, resting on a flat surface, is viewed from directly above, including slight rounding of corners. SPLSHAPE does not include embossing, scoring, debossing, or internal cut-outs. SPLSHAPE is independent of the orientation of the imprint and logo. Shapes can include: Triangle (3 sided); Square; Round; Semicircle; Pentagon (5 sided); Diamond; Double circle; Bullet; Hexagon (6 sided); Rectangle; Gear; Capsule; Heptagon (7 sided); Trapezoid; Oval; Clover; Octagon (8 sided); Tear; Freeform.

Definition: A characteristic of an oral solid dosage form of a medicinal product, indicating whether it has one or more coatings such as sugar coating, film coating, or enteric coating. Only coatings to the external surface or the dosage form should be considered (for example, coatings to individual pellets or granules inside a capsule or tablet are excluded from consideration).

Constraints: The Observation.value must be a Boolean (BL) with true for the presence or false for the absence of one or more coatings on a solid dosage form.

Definition: A characteristic of an oral solid dosage form of a medicinal product, specifying the alphanumeric text that appears on the solid dosage form, including text that is embossed, debossed, engraved or printed with ink. The presence of other non-textual distinguishing marks or symbols is recorded by SPLSYMBOL.

Examples: Included in SPLIMPRINT are alphanumeric text that appears on the bands of banded capsules and logos and other symbols that can be interpreted as letters or numbers.

Constraints: The Observation.value must be of type Character String (ST). Excluded from SPLIMPRINT are internal and external cut-outs in the form of alphanumeric text and the letter 'R' with a circle around it (when referring to a registered trademark) and the letters 'TM' (when referring to a 'trade mark'). To record text, begin on either side or part of the dosage form. Start at the top left and progress as one would normally read a book. Enter a semicolon to show separation between words or line divisions.

Definition: A characteristic of an oral solid dosage form of a medicinal product, specifying the number of equal pieces that the solid dosage form can be divided into using score line(s).

Example: One score line creating two equal pieces is given a value of 2, two parallel score lines creating three equal pieces is given a value of 3.

Constraints: Whether three parallel score lines create four equal pieces or two intersecting score lines create two equal pieces using one score line and four equal pieces using both score lines, both have the scoring value of 4. Solid dosage forms that are not scored are given a value of 1. Solid dosage forms that can only be divided into unequal pieces are given a null-value with nullFlavor other (OTH).

**Description:**This observation represents an 'average' or 'expected' half-life typical of the product.

Description: A characteristic representing a single file reference that contains two or more views of the same dosage form of the product; in most cases this should represent front and back views of the dosage form, but occasionally additional views might be needed in order to capture all of the important physical characteristics of the dosage form. Any imprint and/or symbol should be clearly identifiable, and the viewer should not normally need to rotate the image in order to read it. Images that are submitted with SPL should be included in the same directory as the SPL file.

Definition: A characteristic of an oral solid dosage form of a medicinal product, specifying the longest single dimension of the solid dosage form as a physical quantity in the dimension of length (e.g., 3 mm). The length is should be specified in millimeters and should be rounded to the nearest whole millimeter.

Example: SPLSIZE for a rectangular shaped tablet is the length and SPLSIZE for a round shaped tablet is the diameter.

Definition: A characteristic of an oral solid dosage form of a medicinal product, specifying the color or colors that most predominantly define the appearance of the dose form. SPLCOLOR is not an FDA specification for the actual color of solid dosage forms or the names of colors that can appear in labeling.

Constraints: The Observation.value must be a single coded value or a list of multiple coded values, specifying one or more distinct colors that approximate of the color(s) of distinct areas of the solid dosage form, such as the different sides of a tablet or one-part capsule, or the different halves of a two-part capsule. Bands on banded capsules, regardless of the color, are not considered when assigning an SPLCOLOR. Imprints on the dosage form, regardless of their color are not considered when assigning an SPLCOLOR. If more than one color exists on a particular side or half, then the most predominant color on that side or half is recorded. If the gelatin capsule shell is colorless and transparent, use the predominant color of the contents that appears through the colorless and transparent capsule shell. Colors can include: Black;Gray;White;Red;Pink;Purple;Green;Yellow;Orange;Brown;Blue;Turquoise.

Definition: A characteristic of an oral solid dosage form of a medicinal product, to describe whether or not the medicinal product has a mark or symbol appearing on it for easy and definite recognition. Score lines, letters, numbers, and internal and external cut-outs are not considered marks or symbols. See SPLSCORING and SPLIMPRINT for these characteristics.

Constraints: The Observation.value must be a Boolean (BL) with <u>true</u> indicating the presence and <u>false</u> for the absence of marks or symbols.

Example:

This Observation type contains ECG "rhythm" waveforms. The waveform samples are measured in absolute time (a.k.a. "subject time" or "effective time"). These waveforms are usually "raw" with some minimal amount of noise reduction and baseline filtering applied.

This Observation Series type contains waveforms of a "representative beat" (a.k.a. "median beat" or "average beat"). The waveform samples are measured in relative time, relative to the beginning of the beat as defined by the Observation Series effective time. The waveforms are not directly acquired from the subject, but rather algorithmically derived from the "rhythm" waveforms.

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

A sequence of values in the "absolute" time domain. This is the same time domain that all HL7 timestamps use. It is time as measured by the Gregorian calendar

A sequence of values in a "relative" time domain. The time is measured relative to the earliest effective time in the Observation Series containing this sequence.

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

The type of injury that the injury coding specifies.

Admitting diagnosis are the diagnoses documented for administrative purposes as the basis for a hospital admission.

Intermediate diagnoses are those diagnoses documented for administrative purposes during the course of a hospital stay.

Discharge diagnosis are the diagnoses documented for administrative purposes as the time of hospital discharge.

Description: A DNA segment that contributes to phenotype/function. In the absence of demonstrated function a gene may be characterized by sequence, transcription or homology

A code that is used to indicate the type of case safety report received from sender. 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. The unknown/unavailable option allows the transmission of information from a secondary sender where the initial sender did not specify the type of report.

Example concepts include: Spontaneous, Report from study, Other.

Indicates that the ICSR is describing problems that a patient experienced after receiving a vaccine product.

Indicates that the ICSR is describing a problem with the actual vaccine product such as physical defects (cloudy, particulate matter) or inability to confer immunity.

Definition: Identifies the type of Vision Prescription Observation that is being described.

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

**Description:**A general or uncategorized note.

A note that is specific to a patient's immunizations, either historical, current or planned.

**Description:**A note that is specific to a patient's diagnostic images, either historical, current or planned.

**Description:**A note that is specific to a patient's laboratory results, either historical, current or planned.

**Description:**A note that is specific to a patient's medications, either historical, current or planned.

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

Description: Accuracy determined as per the GIS tier code system.

Indicates that the observation is of a person’s living situation in a household including the household composition and circumstances.

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

Criteria which specify the removal of a subject, procedure or unit of measurement from the denominator, only if the numerator criteria are not met. Denominator exceptions allow for adjustment of the calculated score for those providers with higher risk populations. Denominator exceptions are used only in proportion eMeasures. They are not appropriate for ratio or continuous variable eMeasures. Denominator exceptions allow for the exercise of clinical judgment and should be specifically defined where capturing the information in a structured manner fits the clinical workflow. Generic denominator exception reasons used in proportion eMeasures fall into three general categories:

• Medical reasons
• Patient (or subject) reasons
• System reasons

Defines the observation to be performed for each patient or event in the measure population. Measure observations for each case in the population are aggregated to determine the overall measure score for the population.

Examples:

• the median time from arrival in the Emergency Room to departure
• the median time from decision to admit to a hospital to the actual admission for Emergency Room patients

Criteria for specifying the measure population as a narrative description (e.g., all patients seen in the Emergency Department during the measurement period). This is used only in continuous variable eMeasures.

Criteria for specifying subjects who should be removed from the eMeasure's Initial Population and Measure Population. Measure Population Exclusions are used in Continuous Variable measures to help narrow the Measure Population before determining the value(s) of the continuous variable(s).

Criteria which specify subjects who should be removed from the eMeasure population and denominator before determining if numerator criteria are met. Denominator exclusions are used in proportion and ratio measures to help narrow the denominator.

Criteria for specifying the entities to be evaluated by a specific quality measure, based on a shared common set of characteristics (within a specific measurement set to which a given measure belongs). The denominator can be the same as the initial population, or it may be a subset of the initial population to further constrain it for the purpose of the eMeasure. Different measures within an eMeasure set may have different denominators. Continuous Variable eMeasures do not have a denominator, but instead define a measure population.

Criteria for specifying the processes or outcomes expected for each patient, procedure, or other unit of measurement defined in the denominator for proportion measures, or related to (but not directly derived from) the denominator for ratio measures (e.g., a numerator listing the number of central line blood stream infections and a denominator indicating the days per thousand of central line usage in a specific time period).

Criteria for specifying instances that should not be included in the numerator data. (e.g., if the number of central line blood stream infections per 1000 catheter days were to exclude infections with a specific bacterium, that bacterium would be listed as a numerator exclusion). Numerator Exclusions are used only in ratio eMeasures.

Criteria for specifying the entities to be evaluated by a specific quality measure, based on a shared common set of characteristics (within a specific measurement set to which a given measure belongs).

Criteria for specifying the patients to be evaluated by a specific quality measure, based on a shared common set of characteristics (within a specific measurement set to which a given measure belongs). Details often include information based upon specific age groups, diagnoses, diagnostic and procedure codes, and enrollment periods.

Identifies the type of observation that is made about a specimen that may affect its processing, analysis or further result interpretation

Describes the artificial blood identifier that is associated with the specimen.

Domain provides codes that qualify the ActLabObsEnvfctsCode domain. (Environmental Factors)

An observation that reports the dilution of a sample.

The dilution of the specimen made prior to being loaded onto analytical equipment

The dilution of a sample performed by automated equipment. The value is specified by the equipment

The dilution of a sample performed by automated equipment. The value is specified by the equipment

The value of the dilution of a sample after it had been analyzed at a prior dilution value

An observation that relates to factors that may potentially cause interference with the observation

The Fibrin Index of the specimen. In the case of only differentiating between Absent and Present, recommend using 0 and 1

An observation of the hemolysis index of the specimen in g/L

An observation used to describe the Lipemia Index of the specimen. It is recommended to use the optical turbidity at 600 nm (in absorbance units).

An observation that describes the icterus index of the specimen. It is recommended to use mMol/L of bilirubin

An observation that reports the volume of a sample.

The current quantity of the specimen, i.e., initial quantity minus what has been actually used.

The initial quantity of the specimen in inventory

The quantity of specimen that is used each time the equipment uses this substance

The available quantity of specimen. This is the current quantity minus any planned consumption (e.g., tests that are planned)

A subjective evaluation of the seriousness or intensity associated with another observation.

Description: Observation codes which describe characteristics of the immunization material.

Description: Indicates the valid antigen count.

Description: Indicates whether an antigen is valid or invalid.

**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:**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.

**Definition:**The set of LOINC codes for the act of determining the period of time that has elapsed since an entity was born or created.

**Definition:**Estimated age.

**Definition:**Calculated age.

**Definition:**Reported age.

**Definition:**Age at onset of associated adverse event; no implied method of determination.

**Definition:**General specification of age with no implied method of determination.

**Description:**Refines classCode OBS to indicate an observation in which observation.value contains a finding or other nominalized statement, where the encoded information in Observation.value is not altered by Observation.code. For instance, observation.code="ASSERTION" and observation.value="fracture of femur present" is an assertion of a clinical finding of femur fracture.

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

Definition: Indicates the class of actions taken with regard to a substance administration related adverse event. This characterization offers a judgment of the practitioner's response to the patient's problem.

Examples: Example values include dose withdrawn, dose reduced, dose not changed.

NOTE: The concept domain is currently supported by a value set created by the International Conference on Harmonization

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.

Communication of an agent from an animal to a proximate person.

Communication of an agent from a person to a proximate person.

Communication of an agent from one living subject to another living subject through direct contact with blood or blood products where the contact with blood is part of a therapeutic procedure.

Communication of an agent from a living subject or environmental source to a living subject through indirect contact via oral or nasal inhalation.

Communication of an agent to a living subject through direct contact with blood or blood products whether the contact with blood is part of a therapeutic procedure or not.

Communication of an agent from an environmental surface or source to a living subject by direct contact.

Communication of an agent from a living subject or environmental source to a living subject through oral contact with material contaminated by person or animal fecal material.

Communication of an agent from an non-living material to a living subject through direct contact.

Communication of an agent to a living subject via an undetermined route.

Communication of an agent from one living subject to another living subject through direct contact with mammalian milk or colostrum.

Communication of an agent from one animal to another proximate animal.

Communication of an agent from a living subject or environmental source to a living subject via agent migration through intact skin.

Communication of an agent from a food source to a living subject via oral consumption.

Communication of an agent from any entity to a living subject while the living subject is in the patient role in a healthcare facility.

Communication of an agent from a living subject or environmental source to a living subject where the acquisition of the agent is not via the alimentary canal.

Communication of an agent from a living subject to the progeny of that living subject via agent migration across the maternal-fetal placental membranes while in utero.

Communication of an agent from one living subject to another living subject through direct contact with genital or oral tissues as part of a sexual act.

Communication of an agent from a living subject acting as a required intermediary in the agent transmission process to a recipient living subject via direct contact.

Communication of an agent from a contaminated water source to a living subject whether the water is ingested as a food or not. The route of entry of the water may be through any bodily orifice.

Communication of an agent from one living subject to another living subject through direct contact with any body fluid.

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

An observation that states whether the disease was likely acquired outside the jurisdiction of observation, and if so, the nature of the inter-jurisdictional relationship.

OpenIssue: This code could be moved to LOINC if it can be done before there are significant implemenations using it.

Description: Reporting codes that are related to an immunization event.

Description: The school grade or level the patient was in when immunized.

Description: The school division or district associated with the patient during the immunization event.

Description: The school the patient attended when immunized.

Description: The patient's teacher when immunized.

Description: The class room associated with the patient during the immunization event.

Hypersensitivity resulting in an adverse reaction upon exposure to an agent.

Hypersensitivity to an agent caused by an immunologic response to an initial exposure

An allergy to a pharmaceutical product.

An allergy to a substance generally consumed for nutritional purposes.

An allergy to a substance other than a drug or a food. E.g. Latex, pollen, etc.

Hypersensitivity resulting in an adverse reaction upon exposure to a drug.

Hypersensitivity to an agent caused by a mechanism other than an immunologic response to an initial exposure

Hypersensitivity resulting in an adverse reaction upon exposure to food.

Hypersensitivity to an agent caused by a mechanism other than an immunologic response to an initial exposure

Hypersensitivity resulting in an adverse reaction upon exposure to environmental conditions.

Hypersensitivity to an agent caused by a mechanism other than an immunologic response to an initial exposure

Hypersensitivity to an agent caused by a mechanism other than an immunologic response to an initial exposure

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

Definition:

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.

Codes used to define various metadata aspects of a health quality measure.

Summary of relevant clinical guidelines or other clinical recommendations supporting this eMeasure.

The method of adjusting for clinical severity and conditions present at the start of care that can influence patient outcomes for making valid comparisons of outcome measures across providers. Indicates whether an eMeasure is subject to the statistical process for reducing, removing, or clarifying the influences of confounding factors to allow more useful comparisons.

Describes how to combine information calculated based on logic in each of several populations into one summarized result. It can also be used to describe how to risk adjust the data based on supplemental data elements described in the eMeasure. (e.g., pneumonia hospital measures antibiotic selection in the ICU versus non-ICU and then the roll-up of the two).

Open Issue: The description does NOT align well with the definition used in the HQMF specfication; correct the MSGAGG definition, and the possible distinction of MSRAGG as a child of AGGREGATE.

Information on whether an increase or decrease in score is the preferred result. This should reflect information on which way is better, an increase or decrease in score.

Can be a URL or hyperlinks that link to the transmission formats that are specified for a particular reporting program.

Description of individual terms, provided as needed.

The list of jurisdiction(s) for which the measure applies.

A significant word that aids in discoverability.

Disclaimer information for the eMeasure.

The start date of the measurement period.

Succinct statement of the need for the measure. Usually includes statements pertaining to Importance criterion: impact, gap in care and evidence.

Identifies bibliographic citations or references to clinical practice guidelines, sources of evidence, or other relevant materials supporting the intent and rationale of the eMeasure.

Location(s) in which care being measured is rendered

Usage Note: MSRSET is used rather than RoleCode because the setting applies to what is being measured, as opposed to participating directly in the health quality measure documantion itself).

Comparison of results across strata can be used to show where disparities exist or where there is a need to expose differences in results. For example, Centers for Medicare & Medicaid Services (CMS) in the U.S. defines four required Supplemental Data Elements (payer, ethnicity, race, and gender), which are variables used to aggregate data into various subgroups. Additional supplemental data elements required for risk adjustment or other purposes of data aggregation can be included in the Supplemental Data Element section.

Describes the strata for which the measure is to be evaluated. There are three examples of reasons for stratification based on existing work. These include: (1) evaluate the measure based on different age groupings within the population described in the measure (e.g., evaluate the whole [age 14-25] and each sub-stratum [14-19] and [20-25]); (2) evaluate the eMeasure based on either a specific condition, a specific discharge location, or both; (3) evaluate the eMeasure based on different locations within a facility (e.g., evaluate the overall rate for all intensive care units and also some strata include additional findings [specific birth weights for neonatal intensive care units]).

Type of person or organization that is expected to report the issue.

Usage notes.

An attribute of a quality measure describing the weight this component measure score is to carry in determining the overall composite measure final score. The value is real value greater than 0 and less than 1.0. Each component measure score will be multiplied by its CMPMSRSCRWGHT and then summed with the other component measures to determine the final overall composite measure score. The sum across all CMPMSRSCRWGHT values within a single composite measure SHALL be 1.0. The value assigned is scoped to the composite measure referencing this component measure only.

Indicates whether the eMeasure is used to examine a process or an outcome over time (e.g., Structure, Process, Outcome).

Indicates what method is used in a quality measure to combine the component measure results included in an composite measure.

Describes the items counted by the measure (e.g., patients, encounters, procedures, etc.)

Information on whether an increase or decrease in score is the preferred result (e.g., a higher score indicates better quality OR a lower score indicates better quality OR quality is within a range).

The end date of the measurement period.

Used to allow measure developers to provide additional guidance for implementers to understand greater specificity than could be provided in the logic for data criteria.

Indicates how the calculation is performed for the eMeasure (e.g., proportion, continuous variable, ratio)

Identifies the organization(s) who own the intellectual property represented by the eMeasure.

The timestamp when the eMeasure was last packaged in the Measure Authoring Tool.

The time period for which the eMeasure applies.

Indicates that the observation is carrying out an aggregation calculation, contained in the value element.

The maximum time that may elapse following completion of the measure until the measure report must be sent to the receiver.

A clinical judgment as to the worst case result of a future exposure (including substance administration). When the worst case result is assessed to have a life-threatening or organ system threatening potential, it is considered to be of high criticality.

**Definition:**An observation that provides a characterization of the level of harm to an investigation subject as a result of a reaction or event.

There is a clinical issue for the therapy that makes continuation of the therapy inappropriate.

Open Issue: The definition of this code does not correctly represent the concept space of its specializations (children)

Identifies types of detectyed issues for Act class "ALRT" for the administrative and patient administrative acts domains.

The requesting party has insufficient authorization to invoke the interaction.

**Description:**The specified element did not pass business-rule validation.

**Description:**A local business rule relating multiple elements has been violated.

**Description:**The length of the data specified falls out of the range defined for the element.

**Description:**The length of the data specified is greater than the maximum length defined for the element.

**Description:**The length of the data specified is less than the minimum length defined for the element.

Proposed dosage instructions for therapy differ from standard practice.

**Description:**The maximum quantity of this drug allowed to be administered within a particular time-range (month, year, lifetime) has been reached or exceeded.

Proposed length of therapy differs from standard practice.

Proposed length of therapy is longer than standard practice

Proposed length of therapy is longer than standard practice for the identified indication or diagnosis

Proposed length of therapy is shorter than that necessary for therapeutic effect

Proposed length of therapy is shorter than standard practice for the identified indication or diagnosis

Proposed dosage interval/timing differs from standard practice

Proposed dosage interval/timing differs from standard practice for the identified indication or diagnosis

**Description:**Proposed dosage is inappropriate due to patient's medical condition.

Proposed dosage exceeds standard practice

Proposed dosage exceeds standard practice for the patient's height or body surface area

Proposed dosage exceeds standard practice for the patient's age

Proposed dosage exceeds standard practice for the patient's weight

Proposed dosage is below suggested therapeutic levels

Proposed dosage is below suggested therapeutic levels for the patient's height or body surface area

Proposed dosage is below suggested therapeutic levels for the patient's age

Proposed dosage is below suggested therapeutic levels for the patient's weight

**Description:**The element does not follow the formatting or type rules defined for the field.

The ID of the patient, order, etc., was not found. Used for transactions other than additions, e.g. transfer of a non-existent patient.

The ID of the patient, order, etc., already exists. Used in response to addition transactions (Admit, New Order, etc.).

**Description:**More than one element with the same value exists in the set. Duplicates not permission in this set in a set.

**Description:**The specified code is not valid against the list of codes allowed for the element.

**Description:**The specified code has been deprecated and should no longer be used. Select another code from the code system.

Proposed therapy may be inappropriate or contraindicated due to conditions or characteristics of the patient

Proposed therapy may be inappropriate or contraindicated due to patient age

Proposed therapy is outside of the standard practice for an adult patient.

Proposed therapy is outside of standard practice for a geriatric patient.

Proposed therapy is outside of the standard practice for a pediatric patient.

Proposed therapy may be inappropriate or contraindicated due to patient genetic indicators.

Proposed therapy may be inappropriate or contraindicated due to recent lab test results

**Description:**Proposed therapy may be inappropriate or contraindicated because of a common but non-patient specific reaction to the product.

**Example:**There is no record of a specific sensitivity for the patient, but the presence of the sensitivity is common and therefore caution is warranted.

Proposed therapy may be inappropriate or contraindicated based on the potential for a patient reaction to the proposed product

Proposed therapy may be inappropriate or contraindicated because of a recorded patient intolerance to the proposed product. (Intolerances are non-immune based sensitivities.)

Proposed therapy may be inappropriate or contraindicated because of a recorded patient allergy to the proposed product. (Allergies are immune based reactions.)

Proposed therapy may be inappropriate or contraindicated because of a potential patient reaction to a cross-sensitivity related product.

Proposed therapy may be inappropriate or contraindicated because of a recorded patient allergy to a cross-sensitivity related product. (Allergies are immune based reactions.)

Proposed therapy may be inappropriate or contraindicated because of a recorded patient intolerance to a cross-sensitivity related product. (Intolerances are non-immune based sensitivities.)

Proposed therapy may be inappropriate or contraindicated because of a recorded prior adverse reaction to a cross-sensitivity related product.

Proposed therapy may be inappropriate or contraindicated due to patient gender.

Proposed therapy may be inappropriate or contraindicated due to an existing/recent patient condition or diagnosis

Proposed therapy may be inappropriate or contraindicated when breast-feeding

Proposed therapy may be inappropriate or contraindicated during pregnancy

**Description:**The specified element is mandatory and was not included in the instance.

**Description:**The request is missing elements or contains elements which cause it to not meet the legal standards for actioning.

**Description:**The specified element must be specified with a non-null value under certain conditions. In this case, the conditions are true but the element is still missing or null.

There may be an issue with the patient complying with the intentions of the proposed therapy

**Description:**The request is suspected to have a fraudulent basis.

The proposed therapy appears to duplicate an existing therapy

**Description:**The proposed therapy appears to have the same intended therapeutic benefit as an existing therapy, though the specific mechanisms of action vary.

**Description:**The proposed therapy appears to have the same intended therapeutic benefit as an existing therapy and uses the same mechanisms of action as the existing therapy.

This patient was recently supplied a similar or identical therapy from a different pharmacy or supplier.

**Description:**The proposed therapy is frequently misused or abused and therefore should be used with caution and/or monitoring.

A similar or identical therapy was recently ordered by a different practitioner.

Description: Element in submitted message will not persist in data storage based on detected issue.

**Description:**The number of repeating elements falls outside the range of the allowed number of repetitions.

**Description:**The number of repeating elements is above the maximum number of repetitions allowed.

**Description:**The number of repeating elements is below the minimum number of repetitions allowed.

Description: One or more records in the query response have been suppressed due to consent or privacy restrictions.

Description: One or more records in the query response have a status of 'obsolete'.

Description: Metadata associated with the identification (e.g. name or gender) does not match the identification being verified.

Identifies types of detected issues regarding the administration or supply of an item to a patient.

**Definition:**The proposed therapy goes against preferences or consent constraints recorded in the patient's record.

**Definition:**The proposed therapy goes against preferences or consent constraints recorded in the patient's record. An alternate therapy meeting those constraints is available.

Administration of the proposed therapy may be inappropriate or contraindicated as proposed

**Description:**Proposed therapy may be contraindicated or ineffective based on an existing or recent drug therapy.

Proposed therapy may interact with certain foods

Proposed therapy may interact with an existing or recent therapeutic product

Proposed therapy may interact with an existing or recent drug therapy

Proposed therapy may interact with existing or recent natural health product therapy

Proposed therapy may interact with a non-prescription drug (e.g. alcohol, tobacco, Aspirin)

**Definition:**The same or similar treatment has previously been attempted with the patient without achieving a positive effect.

Proposed therapy may be inappropriate or ineffective based on the proposed start or end time.

Proposed therapy may be inappropriate or ineffective because the start of administration is too late after the onset of the condition

Proposed therapy may be inappropriate or ineffective because the end of administration is too close to another planned therapy

**Description:**Proposed therapy may be inappropriate or ineffective based on the proposed start or end time.

**Definition:**Proposed therapy may be inappropriate or ineffective because the start of administration is too late after the onset of the condition.

**Definition:**Proposed therapy may be inappropriate or ineffective because the end of administration is too close to another planned therapy.

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

Description: While the record was accepted in the repository, there is a more recent version of a record of this type.

Supplying the product at this time may be inappropriate or indicate compliance issues with the associated therapy

The patient is receiving a subsequent fill significantly later than would be expected based on the amount previously supplied and the therapy dosage instructions

**Definition:**The therapy being performed is in some way out of alignment with the requested therapy.

**Definition:**The status of the request being fulfilled has changed such that it is no longer actionable. This may be because the request has expired, has already been completely fulfilled or has been otherwise stopped or disabled. (Not used for 'suspended' orders.)

**Definition:**The therapy is being performed at a time which diverges from the time the therapy was requested

**Definition:**The therapy action is being performed too soon after the previous occurrence based on the requested frequency

**Definition:**The therapy action is being performed outside the bounds of the time period requested

**Definition:**The therapy being performed is not sufficiently equivalent to the therapy which was requested.

**Definition:**The therapy being performed is not generically equivalent (having the identical biological action) to the therapy which was requested.

**Definition:**The therapy being performed is not therapeutically equivalent (having the same overall patient effect) to the therapy which was requested.

**Definition:**There should be no actions taken in fulfillment of a request that has been held or suspended.

**Definition:**The requested action has already been performed and so this request has no effect

The patient is receiving a subsequent fill significantly earlier than would be expected based on the amount previously supplied and the therapy dosage instructions

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

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

Identifies the type of detected issue is a care gap

Identifies the type of detected issue is a risk adjustment coding gap

Indicates that the observation is of an unexpected negative occurrence in the subject suspected to result from the subject's exposure to one or more agents. Observation values would be the symptom resulting from the reaction.

An observation that states the mechanism by which disease was acquired by the living subject involved in the public health case.

OpenIssue: This code could be moved to LOINC if it can be done before there are significant implemenations using it.

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

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

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.

FDA label data

FDA label shape

FDA label imprint code

FDA label logo

FDA label coating

FDA label scoring

FDA label size

FDA label color

Definition: An observation related to a query response.

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

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

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

Types of observations that can be made about Preferences.

An observation about how important a preference is to the target of the preference.